The Rest of the Story: Tobacco News Analysis and Commentary

Cleveland Clinic Won't Hire Smokers, But Has No Problem Hiring Suspected White Collar Criminals

2012-01-30T07:02:00.000-05:00

The Cleveland Clinic will not hire a smoker - or even someone attempting to quit by using nicotine replacement therapy - because of the supposed principle that it sends a bad message. However, this employer has no problem hiring a suspected white collar criminal who is costing the taxpayers in his former state tens of thousands of dollars to defend him from criminal charges.

According to an article in the Kansas City Star, the Cleveland Clinic has hired Tom Thornton, the ex-CEO of the Kansas Bioscience Authority, who left his former position in disgrace after being criminally investigated and having to hire a high-profile white collar criminal defense lawyer.

According to a report from Kansas Watchdog: "Tom Thornton's laptop was deliberately erased prior to an examination of the records it held."

That audit, according to the Kansas City Star article: "faulted Thornton for destroying documents, misusing public funds for personal expenses, and creating an uncomfortable work environment by having an office romantic relationship with a woman he hired and later married."

The audit, according to Kansas Watchdog, also faulted Thornton for:

"Failure to communicate information to the board of directors regarding his personal relationship with KBA staff member Lindsay Holwick, whom he married in January 2011 (page 82)
Removal of content from his KBA laptop computer after his resignation (page 100);
Travel to interview for his current position in Cleveland, Ohio, on a plane ticket purchased by KBA (page 112); and
Personal use and gifting of a KBA-owned painting (page 110)."

Moreover, according to the Kansas City Star, there was forensic evidence of the use of Thorton's work laptop computer for the viewing of pornographic web sites: "Auditors found some file extensions and data consistent with pornography, the audit said."

According to that article: "When Thornton resigned from the authority on April 13, seven days after filing his letter, he retained possession of his work computer. When he returned it on April 25, “Forensic analysis of Thornton’s KBA-owned computer indicated that information had been removed from the computer, essentially all of the user-created content had been deleted, and that the free space had been wiped making the recovery of deleted items impossible,” the BKD report said. Programs to delete and electronically shred documents had been run on April 21, 22 and 23, the audit said. Thornton admitted in an August interview with the auditors that he had wiped the computer."

Also according to the article: "Former Kansas Bioscience Authority CEO Tom Thornton knew he was under criminal investigation and asked the agency for personal legal representation at least two weeks before he electronically shredded documents on his laptop computer, according to a letter obtained by The Eagle. In a letter dated April 7, Thornton asked the KBA board to pay for his personal legal fees and indicated that he had retained James Eisenbrandt, a Prairie Village lawyer who specializes in white-collar criminal defense. Eisenbrandt is best known in Wichita for representing former Westar Energy CEO David Witting on federal charges of looting the utility. The KBA, a state-funded agency, agreed to pay Thornton’s legal bills and has so far spent $53,671 on his defense, including about $1,800 to fly two lawyers to meet with Thornton in Ohio, where he is now employed in the Innovations division at the Cleveland Clinic."

Because the Kansas Bioscience Authority is a state entity, the taxpayers of Kansas may have to foot the bill for Thornton's legal defense. The Kansas governor, however, is not happy with this, and is calling on the Authority to suspend all payments for Thornton's legal defense and to recover expenses already covered:

"Gov. Sam Brownback’s administration weighed in Saturday on Thornton’s legal fees and questioned why taxpayers should have to foot the bill for Thornton’s personal legal expenses. “As good stewards of Kansas taxpayer monies, the KBA board should suspend all payments to Thornton’s attorneys and then pursue all legal means possible to seek a maximum recovery of taxpayer dollars from him," said an e-mail statement from Sherriene Jones-Sontag, the governor’s spokeswoman. “I just think most Kansas taxpayers are going to find these expenses repulsive,” said Sen. Susan Wagle, R-Wichita, who has led legislative efforts to investigate the KBA since last year. “It’s a colossal waste of taxpayer funds. The salary he earned, at $1.8 million (over 4 1/2 years) should have covered his legal expenses.” Wagle also said the expenses paid so far could be just the beginning. “There haven’t even been any charges filed yet,” she said."

The Rest of the Story

These are apparently the principles that the Cleveland Clinic stands for in its hiring policies. Under no circumstances will the Cleveland Clinic hire a smoker or a nicotine user because it sends a "bad example," but hiring a suspected criminal is perfectly fine.

While a smoker would have to wait six months after quitting smoking in order to prove that he or she did indeed quit before being hired by the Cleveland Clinic, a suspected criminal apparently has to prove nothing, and is welcomed with open arms. Shouldn't Thornton also have to wait six months to reapply, after having proven that he committed no crimes?

In reality, the Cleveland Clinic ban on hiring smokers only applies to "suspected smokers" because the Clinic cannot prove that these individuals actually smoke. They can only prove that they use nicotine, which could have been in the form of nicotine replacement therapy. They will not, however, take the person's word for it.

In contrast, if you are a suspected criminal, the Cleveland Clinic will apparently take your word that you are not guilty. They do not require proof of your innocence.

The rest of the story, then, is that the Cleveland Clinic will not hire suspected smokers, but it will hire suspected criminals.

And if you are a suspected smoker, you have to prove that you are not actually a smoker by waiting six months and providing a negative urine test. But if you are a suspected criminal, there is apparently no need to prove anything. They'll simply take your word for it. You apparently won't be turned away from the Cleveland Clinic unless and until you are hauled away to prison.

They apparently have a trusting relationship with their job applicants, unless they think those applicants might be smokers.

So much for the principle of hiring only employees who will set a good example. Unless the Cleveland Clinic considers suspected white collar crime, suspicion of having relationships with employees under your supervision, suspicion of destroying possible criminal evidence, suspicion of misuse of state funds, and suspected use of work computers for viewing pornography to be good examples of personal behavior.

(Thanks to Sheila Martin for the tip.)

Live Call-in Show on Nicotine-Free Hiring Policies on WHYY, Philadelphia's NPR Station

2012-01-26T08:07:00.002-05:00

Yesterday, Dr. Paul Terpuluk - medical director of the Cleveland Clinic - and I participated in a discussion of nicotine-free hiring policies on Radio Times with Marty Moss-Coane. You can listen to the show here.

For me, two interesting things came out of the discussion.

First, I hadn't realized that the Cleveland Clinic policy denies employment even to ex-smokers who have quit successfully using nicotine replacement therapy. Any nicotine use is grounds for denial of employment, even using NRT or electronic cigarettes. Thus, the policy actually punishes exactly the people who it should be rewarding.

Second, Dr. Terpuluk repeatedly made the point that this is a policy based on principle: that patients shouldn't have to smell a smoker. Without even getting to the appropriateness of that "principle," it struck me that the Cleveland Clinic is not adhering to that principle at all, because it continues to allow smokers to take care of patients. The policy only applies to new hires. If the Cleveland Clinic really was interested in ensuring that its patients didn't have to be taken care of by people who smell like smoke, it would certainly have gotten rid of all its existing smoking employees (or given them a six-month or one-year period to quit smoking).

By the end of the discussion, it was clear to me that this policy has nothing to do with public health and nothing to do with any principle. Instead, it is merely a political action that makes it look like the hospital system is taking a stand when it is doing nothing other than punishing smokers, even those who are trying to quit.

Would the Chief Scientist of a Research Consulting Firm Pen an Editorial that Would Harm the Financial Interests of Many of His Company's Clients?

2012-01-25T07:41:00.000-05:00

The answer is no. It would be quite unusual for such a scientist to voluntarily write a commentary in which he argues, for example, that a major class of drugs manufactured by many of his clients is ineffective. Doing so would almost certainly risk losing his job. And the company's clients.

Therefore, it is not difficult to see that if such a scientist were to write a commentary about the effectiveness of the drugs in question, the fact that he is high up in a company with pharmaceutical clients - clients who manufacture the drugs in question - would constitute a financial conflict of interest that would have to be disclosed in any articles that he were to write about the effectiveness of these drugs.

The Rest of the Story

As I revealed yesterday, this is not a hypothetical scenario. It played out just last week.

In a response a recent article which argued that nicotine replacement medications (NRT) are largely ineffective, Dr. Douglas Kamerow - chief scientist at RTI International and associate editor at BMJ - published a commentary in BMJ last week in which he dismisses the findings of the Alpert et al. study based primarily on what he states are a very low sample size and a high likelihood of recall bias. He also suggests that the results of "hundreds" of randomized clinical trials are being nullified by a "single" cohort study.

Indeed, many of the pharmaceutical companies that manufacture NRT products are clients of RTI International. Thus, there is a profound conflict of interest. RTI International receives or has received funding from a host of pharmaceutical companies, many of which produce and market the very products about which Dr. Kamerow is opining in the commentary. Among the pharmaceutical companies listed as clients of RTI are: Abbott Laboratories; AstraZeneca; Bristol-Myers Squibb; Eli Lilly and Company; The Johnson & Johnson Family of Companies; Merck & Co., Inc.; Novartis; Novo Nordisk; Pfizer; Roche; Sanofi-Aventis; Takeda Pharmaceuticals UK; and Tioga Pharmaceuticals.

However, this scenario differs from the hypothetical one above in one important way. In this case, the conflict of interest was not disclosed in the commentary.

This apparent failed disclosure appears to be in conflict with BMJ's stated policy: "We believe that, to make the best decision on how to deal with a paper, we should know about any competing interests that authors may have, and that if we publish the article readers should know about them too."

Well in this case, readers do not know about them too. Unless they also happen to read The Rest of the Story.

Chief Scientist of RTI Attacks Alpert et al. Study But Fails to Disclose Conflict of Interest; Which Side of the Story Would You Believe?

2012-01-24T07:11:00.002-05:00

Two weeks ago, I reported the results of a new study by Alpert et al. which showed that nicotine replacement medications (NRT) are not effective in helping smokers to quit long-term. Based on this finding, the article argued that public expenditures for NRT provision to smokers is a waste of resources.

Calling this a landmark study, I wrote: "This study provides important empirical evidence that over the long-term, population-based use of NRT in real-life situations - outside of the clinical trial setting where there is extensive counseling and other support provided - is not an effective treatment to aid smoking cessation. It does not appear to be any better than smokers attempting to quit unaided. This does not mean that in individual patients, NRT is not effective and should not be considered. But it does mean that on a population basis, as a matter of public health policy, the role of NRT has been way over-rated. I agree that with limited funding available, using those funds to provide NRT is of limited value. Instead, limited public funding for tobacco control should be used for proven programs such as smoking prevention media campaigns, which have been shown to reduce youth smoking by as much as 50%."

In a response to the Alpert et al. article, Dr. Douglas Kamerow - chief scientist at RTI International and associated editor at BMJ - published a commentary in BMJ last week in which he dismisses the findings of the Alpert et al. study based primarily on what he states are a very low sample size and a high likelihood of recall bias. He also suggests that the results of "hundreds" of randomized clinical trials are being nullified by a "single" cohort study.

From what I can tell from the commentary page, no conflicts of interest are noted.

The Rest of the Story

The rest of the story is that unlike the original Alpert et al. study, in which none of the investigators had any conflicts of interests (including the fact that none has received funding for their work from pharmaceutical companies), this commentary is written by an individual with a quite profound conflict of interest:

His company - RTI International - receives or has received funding from a host of pharmaceutical companies, many of which produce and market the very products about which he is opining in this article. Yet nowhere in the article is this conflict revealed.

Among the pharmaceutical companies listed as clients of RTI are:

Abbott Laboratories;
AstraZeneca;
Bristol-Myers Squibb;
Eli Lilly and Company;
The Johnson & Johnson Family of Companies;
Merck & Co., Inc.;
Novartis;
Novo Nordisk;
Pfizer;
Roche;
Sanofi-Aventis;
Takeda Pharmaceuticals UK; and
Tioga Pharmaceuticals.

That is no fewer than 13 pharmaceutical companies which are clients of RTI, several of which produce and/or market nicotine replacement medications which are the precise topic of the commentary.

How BMJ let this through without a disclosure of this severe conflict of interest is beyond me, but how the author failed to voluntarily disclose these conflicts is equally mystifying. The fact that these severe conflicts of interest are hidden creates the appearance that indeed, someone is trying to hide something. Perhaps the commentary would have less credibility if it were known that the author's company relies upon contracts from pharmaceutical companies that have a huge financial stake in the profitability of NRT, and therefore, in the conclusions of this very commentary.

This is not only a scientific, but an economic battle. The results of the scientific debate over the efficacy of NRT has billions of dollars worth of financial implications for the pharmaceutical clients of RTI International. Doesn't it seem that a disclosure of this conflict of interest would have been appropriate and necessary in order to provide the reader with information needed to judge the scientific objectivity of the commentary?

There are a number of statements made in the commentary which I view as scientifically flawed. First, the author asserts that there is only one cohort study and that those who are calling for policy change are dismissing hundreds of clinical trials on the basis of a single cohort study. This is a misrepresentation of the scientific literature. There are many population-based studies which call into question the effectiveness of NRT when used in real-life situations, outside of the clinical trial setting.

Second, the author laments the fact that many NRT users did not continue to use the NRT for the recommended eight weeks, which lowers the sample size. Yet that very piece of information is itself evidence that these smokers found NRT ineffective. Why did most of them fail to use NRT for the full eight weeks? Probably because they resumed smoking. That is, the NRT failed. The very reason why the sample size was so low is that NRT is quite ineffective and many smokers using NRT relapsed.

Finally, the author asserts that the majority of cold turkey quitters are highly motivated to quit, much more so than the subjects in NRT clinical trials. This is most likely not true, as most clinical trials involve the recruitment of smokers who are willing to try to quit smoking, are treated with intensive counseling, multiple follow-up visits, and frequent supportive phone calls, all in the context of what is essentially an unblinded study. The chances of quitting in real-life settings, in my opinion, are much lower than in these clinical trials. Thus, the fact that quitting rates in unaided attempts appear higher than with the use of NRT is, I believe, strong evidence that NRT's effectiveness has been grossly exaggerated based on the clinical trial results.

Unfortunately, because of the undisclosed and hidden conflict of interest, it creates the appearance that financial interests, rather than scientific ones, may be influencing the scientific points made in this article, albeit subconsciously. I have no idea whether this occurred here or not. But that's precisely the problem with undisclosed conflicts of interest. They open the door to speculation as to the potential role of investigator bias.

The rest of the story is that this commentary was written by an author with severe conflicts of interest by virtue of the fact that his company relies upon a large number of pharmaceutical companies as clients, many of which produce the very drugs about which the commentary opines. This severe conflict of interest, unfortunately, is not disclosed in the article, creating at least the appearance that there was an attempt to hide it. This calls into question the scientific objectivity of the commentary, and creates at least an appearance that this lack of objectivity could be in part a result of the conflict of interest.

One thing is for sure. The commentary does a great job of protecting the financial interests of many of RTI International's corporate clients.

Federal Tobacco Policy Deliberations Continue to Focus on Products For Which There is No Evidence of Substantial Use by Youth: Dissolvable Tobacco

2012-01-23T06:59:00.000-05:00

Last week, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) spent three days deliberating on dissolvable tobacco products - a form of smokeless tobacco that includes products such as Camel Orbs, Strips, and Sticks, Ariva, and Stonewall.

Other products which have received serious scrutiny by the FDA include electronic cigarettes (which were essentially banned by the FDA until that action was overturned by the courts).

One product has been banned: flavored cigarettes, such as the strawberry, chocolate, pineapple, grape, banana, coconut, and melon varieties.

And one product has so far received no scrutiny by the FDA: plain old, regular, tobacco cigarettes.

The Rest of the Story

One might argue that federal tobacco control efforts are doing the exact opposite of what they should be doing. Rather than focusing on the most toxic and lethal products on the market, they are instead focusing on the least hazardous products. And rather than focusing on the products which are most favored by children and adolescents, they are focusing on the products for which there is no evidence of substantial use by young people.

Dissolvable tobacco products are a perfect example. These products, while not safe, are certainly safer than cigarettes. More importantly, there is no evidence that any substantial number of youths are using these products. The same is true of electronic cigarettes.

Flavored cigarettes - like your strawberry, chocolate, pineapple, grape, banana, coconut, and melon varieties - were used by zero youths prior to their "ban" by federal legislation.

The only products which are getting a free ride are regular cigarettes, which happen to be the most toxic tobacco product on the market, as well as the one that is most popular among youths.

I find it hard to believe that the TPSAC spent three days debating a product for which there is no evidence of any substantial youth use. Would not the time have been much better spent discussing the actual problem that is afflicting millions of youths: cigarette use.

Even addressing old-fashioned smokeless tobacco use would have been a better use of time, as the old-fashioned smokeless tobacco products are being used by a significant proportion of youths.

But spending three days discussing a product that we're not even sure any youths are using makes little sense to me. What is demonstrates is a complete lack of perspective on the problem of tobacco use in the United States.

Now don't get me wrong. This is obviously not completely TPSAC's fault. The advisory committee was charged by statute with exploring the dissolvable issue. The fault is largely that of the anti-smoking groups which promoted this legislation. It is the Tobacco Act itself which ensures that federal tobacco efforts lack any kind of perspective on the problem of tobacco-related morbidity and mortality. That legislation was crafted by the anti-smoking community (a.k.a., the Campaign for Tobacco-Free Kids) to protect the market share of the most toxic tobacco products on the market at the expense of less hazardous but potentially competitive alternative products. This was done with intent; it was no accident.

The rest of the story is that thanks to misguided legislation, federal efforts on tobacco control have become largely misguided. They are focused largely on the products which are least hazardous and least used by youth, while ignoring (giving a free ride to) the most hazardous products that are most used by youth.

How does this make any sense?

New Study Reveals that Widespread Use of Nicotine Replacement Therapy and Quitlines Has Not Increased Cessation Rates; Quitting Cold Turkey Still Best

2012-01-19T07:01:00.000-05:00

A groundbreaking study published in the upcoming 2012 issue of the Annual Review of Public Health challenges the wisdom of the nation's entire approach to smoking cessation.

The study examines quit rates over the past five decades and finds that despite the widespread proliferation of smoking cessation quitlines and the increasing use of smoking cessation drugs like NRT and Chantix during the past decade, the rate of successful quitting among smokers has not improved.

(see: Pierce JP, Cummins SE, White MM, Humphrey A, Messer K. Quitlines and nicotine replacement for smoking cessation: Do we need to change policy? Annu Rev Public Health 2012; 33:12.1-12.16)

The study finds that while the number of quit attempts has greatly increased in the past decade, the rate of successful smoking cessation has not changed. This means that the use of smoking cessation drugs and telephone quitlines has not resulted in an improvement in the proportion of smokers who are able to quit smoking successfully over the long-term.

The study also argues that the smoking cessation Clinical Practice Guideline, established by an expert panel in 2008, is not evidence-based because it recommends that every smoker be treated with smoking cessation drugs, even thought the science suggests that unaided quitting is more effective. According to the study, the three-month success rate with NRT is only 19% for light smokers, compared to 26% for unaided quitting. For heavy smokers, the three-month success rate is 9% for NRT compared to 15% for unaided quitting.

The authors write: "In the United States, both the 2008 Update of the Clinical Practice Guideline and the 2011 Joint Commission on Standards on Smoking Cessation for Hospitals recommended that every smoker be treated or offered a pharmaceutical cessation aid... . ... Given the above-mentioned research, it would appear that this recommendation is based on questionable science. ... the majority of successful quitters have achieved that status without assistance... ."

The article concludes: "In randomized trials, pharmaceutical aids have significantly increased cessation among heavy smokers who seek help to quit. ... These results have encouraged governments to recommend strongly that pharmaceutical aids be used in all quit attempts, and many have provided free NRT to smokers who call quitlines. To date, there is no evidence that such policies lead to an increase in successful cessation in the population. .. That successful smoking cessation has not increased ... despite the increased efforts focused on it suggests that there is an urgent need to revisit current tobacco control policy."

The Rest of the Story

Coming on the heels of the Alpert et al. article I highlighted last week, which produced population-based data from Massachusetts showing that NRT has had no effect on smoking cessation, we now have a salvo of articles that challenge the dogma of the tobacco control movement and suggest a lack of a science base for the entire basis of national smoking cessation policy.

Current smoking cessation policy is based on the use of NRT and quitlines, with expenditures going almost exclusively to these two areas. Current clinical guidelines, as well as government recommendations for smoking cessation, are based on the premise that all smokers should be treated with pharmaceutical agents.

The new research demonstrates, however, that there is no scientific evidence to support current policy. Moreover, there is strong population-based evidence which suggests that current policy is misguided. As I argued in my earlier piece on the Alpert et al. study: "with limited funding available, using those funds to provide NRT is of limited value. Instead, limited public funding for tobacco control should be used for proven programs such as smoking prevention media campaigns, which have been shown to reduce youth smoking by as much as 50%." If all expenditures currently going into quitlines and the provision of free NRT were diverted to anti-smoking media campaigns, I believe there would be a substantial increase in smoking cessation and a decline in smoking prevalence.

What is most unfortunate is that the current national policy is not based on scientific advice from unconflicted, unbiased scientific experts. Instead, the policy is based largely on advice from scientists who have financial conflicts of interest by virtue of their having received money from pharmaceutical companies that manufacture smoking cessation drugs.

One thing that both the Clinical Practice Guideline and the Joint Commission standard have in common is a conflicted expert - Dr. Michael Fiore - behind both of them. Dr. Fiore chaired the committees which were responsible for both of these guidelines. Yet Dr. Fiore has severe conflicts of interest.

In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

Most recently, Dr. Fiore is currently receiving grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."

It is unfortunate that with such severe conflicts of interest, Dr. Fiore was allowed to be in a position where these biases could affect national policy. He should never have been allowed to chair any committee making national recommendations for smoking cessation policy. Nor should anyone with similar financial conflicts have been allowed to serve on these panels.

But unfortunately, eight panelists of the group that made the 2008 recommendation to treat every smoker with drugs had financial conflicts of interest with Big Pharma.

Even more unfortunate is the fact that four of the members of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC), including the committee chair, have similar financial conflicts of interest with Big Pharma. That committee is therefore in no position to be able to make objective scientific judgments about smoking cessation science or policy. The chances of an effective national approach to smoking cessation coming out of TPSAC are remote, given the financial-related biases of a good number of the committee members.

Sadly, we don't seem to be learning from our mistakes. Instead, we seem to be repeating them and even magnifying them.

Pairing of Letters on E-Cigarettes Shows Contrast Between Ivory Tower Anti-Smoking Advocates and Real-World Realities

2012-01-18T06:51:00.000-05:00

An interesting pairing of letters to the editor of the National Post on the topic of electronic cigarettes illustrates the stark contrast between the ivory tower thinking of anti-smoking ideologues and the real-life experience of actual smokers whose lives are at stake.

In the first letter, Stan Shatenstein (contributing editor of the journal Tobacco Control) argues that electronic cigarettes should not be allowed on the market at the present time because of uncertainty about their absolute health risks, even though the fact that these products reduce the carcinogenic risk from cigarette smoking is "obvious." He writes:

"Against the obvious reduction in carcinogens must be calculated the risk that smokers will use e-cigarettes to get themselves through times when they can’t smoke, and that sustaining the hand-to-mouth habit will induce a return to “real” cigarette smoking. It is utterly scurrilous for Mr. Kline to argue that e-cigarettes have not received regulatory approval because the government “has become addicted to the lucrative tobacco industry.” We are now facing the prospect of one billion — yes, billion with a “b” — lives lost prematurely to tobacco use this century, the majority in developing countries. If e-cigarettes have to pass some regulatory hurdles before they’re allowed on the market, we should be grateful to the government for its due diligence."

In the second letter, a former smoker who quit smoking and has remained smoke-free for the past years thanks to electronic cigarettes, shares his experience:

"Thanks to Jesse Kline for his column on e-cigarettes. I smoked for 45 years and never could quit for more than three months with conventional smoking cessation methods. With the e-cigarette, I quit smoking almost immediately and I have not had as much as a puff from a regular cigarette in almost two years. It is very refreshing to see Mr. Kline’s common sense column on this subject."

The Rest of the Story

The contrast in these letters is emblematic of the conflict between the ivory tower ideology of the anti-smoking movement - which wants to see costly and time-consuming clinical trials before it concludes that smoking is more harmful than vaping - and the reality of the lives of the millions of real people who are addicted to smoking, cannot easily quit, and have been largely unhelped by the dismal effectiveness of FDA-approved smoking cessation products, which have about a 92% long-term failure rate.

To adapt an analogy first made by Jacob Sullum, the anti-smoking ideologues would advise victims of a shipwreck not to use the lifeboats because they haven't been fully tested to ensure their safety. And if thousands of victims of that shipwreck were successfully keeping afloat because of the lifeboats, the anti-smoking ideologues would advise them to abandon the lifeboats and stick to "government approved" survival methods.

If we lived in a different world - one in which electronic cigarettes were not yet on the market and therefore were not being successfully used by thousands of ex-smokers to remain off cigarettes - then the anti-smoking ideology would be appropriate: don't introduce the products into the market until they have been thoroughly tested.

But that's not the world we live in. The reality is that these products are already on the market and have been for at least four years. Several million smokers are using them, and literally thousands are using them successfully to keep off tobacco cigarettes. To ban these products from the market would be equivalent to forcing most of these thousands of ex-smokers to return to smoking. That would have devastating health consequences.

Anti-smoking groups and advocates need to go beyond the confines of their ivory tower ideology and start talking to the people they are supposedly trying to help: people who live in the real world, one in which existing smoking cessation products are highly ineffective and in which electronic cigarettes are filling a void by offering a cessation device that replaces the behavioral and physical stimuli of cigarette smoking, not just the pharmacologic reinforcement.

College Anti-Smoking Advocates in Florida Admit that Tobacco-Free Campus Policies are Not About Protecting People from Secondhand Smoke

2012-01-17T07:21:00.000-05:00

According to an article in the Ft. Lauderdale Sun-Sentinel, several colleges and universities in Florida have banned, or are gearing up to ban, all smoking on campus grounds, even in private vehicles.

According to the article: "If you smoke, you may be breathing less easily on college campuses these days. Looking for the designated smoking area at Florida International University? There is none. Want to light a cigarette inside your car at the University of Florida? Don't let the cops see you. Hoping to smoke during your break at Nova Southeastern University? You have six months left until NSU becomes the latest college to go tobacco-free. Come July 1, the covered smoking benches will come down and smoke-free-campus signs will go up."

When questioned about whether banning smoking even in private vehicles where no one would be exposed to secondhand smoke was going too far, the chief advocate for the campus smoking ban at Nova Southeastern University said that extending the smoking ban to private vehicles was important to send the right message: "'We don't want your car to be a safe haven, where you do any activity you want as long as you're in your car,' he said."

According to an article in the Current, Nova Southeastern University newspaper: "Patricia Kelly, associate professor, director and doctor of the Health Science Program in the Health Professions Division, said, “Secondhand smoke has been proven to be dangerous in a number of instances. Eliminating exposure to secondhand smoke is important for many people with chronic pulmonary (lung) problems, such as asthma or chronic obstructive pulmonary disease.” Kelly believes that the policy will also help by distancing smokers from nonsmokers, which will prevent others from picking up the habit. “Students who do not see their peers smoke, either in public or in private, are less likely to start smoking themselves,” she said."

The Rest of the Story

In my view, the purpose of smoking bans is to protect the public from the significant hazards associated with exposure to secondhand smoke. If we start deviating from that message, by suggesting that the actual purpose is to protect nonsmokers from even having to see a smoker in a public place, then we risk undermining the rationale, justification, and support for these much-needed public policies that protect the public from the morbidity and mortality associated with what is often involuntary tobacco smoke exposure.

The rest of the story is that health advocates in Florida are admitting that the rationale for complete campus smoking bans goes far beyond the protection of the public from secondhand smoke. These advocates are admitting that these policies are paternalistic. That is, they are intended to protect smokers from themselves. Second, the advocates are admitting that their intention is to protect nonsmokers from even having to see smokers, thus reducing the chances that other people will start smoking.

The logical extension of such a rationale, if it were justified, would be to simply ban all smoking in public. People should only be allowed to smoke in their own homes, if the reasoning being given for these smoke-free college policies is valid.

Clearly, someone who is smoking in his own car is not threatening others with secondhand smoke exposure. Thus, the anti-smoking advocates have long since left the realm of promoting policies to protect the public from secondhand smoke exposure. They are now in the area of paternalistic policy making which aims to segregate and isolate smokers so as to prevent the rest of the public from ever having to see these people.

This is such a far cry from the reasons I went into tobacco control in the first place. It was when I was a medical student and medical intern that I decided to dedicate my career to tobacco control. The impetus was my experience treating diseases caused by smoking and my chief desire was to help my patients who smoked by finding more effective ways of preventing them from suffering the myriad of diseases caused by cigarettes. The idea that one day we would be advocating policies to prevent the public from having to see these people never would have occurred to me.

Administration Admits Tobacco Act Crafted to Protect Tobacco Sales: Menthol Cigarettes Must Remain on Market Because Millions of Smokers Use Them

2012-01-13T07:18:00.004-05:00

The United States has appealed a World Trade Organization (WTO) ruling that the Tobacco Act's ban on flavored cigarettes is discriminatory and violates international trade agreements because it exempts menthol, thereby treating like products differently in a way that favors domestic cigarettes.

According to an article at Law360, the U.S. appeals brief argued that the WTO erred in deeming that menthol and clove cigarettes are "like products." The brief also argued that the WTO erred in concluding that the Tobacco Act treats imported cigarettes less favorably than domestic cigarettes.

The crux of the argument in the brief, according to the article, was this:

"The problem, according to the U.S., is that it should be allowed to regulate menthol cigarettes, a product to which millions of adults are addicted, differently than it deals with clove cigarettes, which are 'used almost exclusively by novice smokers.'"

The Rest of the Story

What the U.S. is implicitly admitting is that it chose to ban clove cigarettes because almost no one in the U.S. smokes them, but it exempted menthol cigarettes because millions of adults actually use these products.

In other words, the Tobacco Act was largely a hoax played on the American people, in which Congressmen and anti-smoking groups could make it look like they were fighting tobacco use, but without actually taking the difficult actions which would make a dent in cigarette use.

By banning clove, strawberry, chocolate, banana, and raspberry cigarettes, politicians and anti-smoking groups could boast to their constituents that they have protected America's children from the scourge of flavored cigarettes. But by exempting menthol, the politicians and anti-smoking groups didn't actually have to put any dent in cigarette sales and profits.

The cigarettes that were banned made up less than 0.1% of the domestic cigarette market, while the cigarettes that were exempted make up about 50% of the American youth cigarette market and more than one quarter of the adult market.

As a result of the Tobacco Act, not a single cigarette brand manufactured by a major U.S. cigarette manufacturer had to be removed from the market. However, the Act did have a significant effect on foreign importers, especially manufacturers of clove cigarettes.

In fact, in many ways the flavoring provision in the Tobacco Act is essentially a ban on clove cigarettes. That is the only tangible result of the provision. The same effect would have occurred had the Congress simply banned clove cigarettes. Since those cigarettes are largely imported, the provision is tantamount to Congress banning the importation of clove cigarettes.

So yes, clearly this is a violation of international trade agreements.

As I argued previously, the Tobacco Act's flavored cigarette ban violates international trade policy by arbitrarily (without a health basis) treating like products differently -- favoring domestic cigarettes over imported ones. As I wrote at that time: "the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does appear to violate international trade agreements. Specifically, it appears to violate Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures."

I summarized the basis for my opinion as follows: "As I have argued extensively, there is no public health or scientific justification for the menthol exemption. It was clearly a political compromise that served purely political purposes. In fact, a number of health groups and policy makers have readily acknowledged that the menthol exemption was inserted for political reasons. I have yet to hear any credible scientific or public health justification for such an exemption."

The WTO decision follows the reasoning that I outlined. Clove cigarettes and menthol cigarettes are "like products." They are both flavored cigarettes. However, there is no public health justification for banning clove cigarettes while exempting menthol cigarettes. Since clove cigarettes are almost exclusively imported and menthol cigarettes are almost exclusively produced domestically, the policy represents discrimination which maximizes trade effects.

This ruling exposed the hypocrisy of the national anti-smoking groups and politicians who crafted the Tobacco Act. It also exposes the fact that the Tobacco Act is largely a political show-piece, designed to make it look like anti-smoking groups and politicians are taking on Big Tobacco, when in fact they are protecting the domestic cigarette market.

Both major arguments in the appeals brief are flawed.

Based on the intent of the Family Smoking Prevention and Tobacco Control Act, there is no question to me that they are like products because they are both flavored cigarettes and there is no qualitative difference relevant to the regulation of the characterizing flavor of a menthol versus a clove cigarette.

If they are like products, then there is no question that the Act treats clove cigarettes less favorably than menthol cigarettes, creates an unnecessary obstacle to trade, and does both of these without any scientific justification. The sole justification for exempting menthol is a political and economic one, not a scientific one. As Article 2.2 of the Technical Barriers to Trade Agreement (TBT) does not list political or economic considerations as legitimate objectives that would allow a discriminatory trade restriction, it is clear that the flavoring ban violates Article 2.2.

The law also violates the General Agreement on Tariffs and Trade (GATT). Article 3.4 of GATT states that "The products of the territory of any contracting party imported into the territory of any other contracting party shall be accorded treatment no less favourable than that accorded to like products of national origin in respect of all laws, regulations and requirements affecting their internal sale, offering for sale, purchase, transportation, distribution or use."

Furthermore, the law violates Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS), which state:

"Members should, when determining the appropriate level of sanitary or phytosanitary protection, take into account the objective of minimizing negative trade effects.
With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade."

The rest of the story, then, is that the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does violate international trade agreements. Specifically, it violates Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures.

Moreover, not only is the U.S. appeal of the WTO's decision flawed in its defense of the discriminatory treatment of menthol cigarettes vs. clove cigarettes, but the appeals brief essentially admits that the reason for the differential treatment of these products was political, not based on public health concerns.

The reason for the differential treatment? Menthol cigarettes are actually smoked by millions of Americans, while clove cigarettes are used by very few. Thus, banning menthol cigarettes would actually put a dent in cigarette sales while banning clove cigarettes would not.

The hypocrisy of the national anti-smoking groups and politicians who crafted the Tobacco Act has now been thoroughly exposed. The Tobacco Act was largely a political show-piece, designed to make it look like anti-smoking groups and politicians are taking on Big Tobacco, when in fact they are protecting the domestic cigarette market.

UCSF Discourages Smokers from Quitting By Banning Electronic Cigarette Use on All University Property

2012-01-12T07:37:00.000-05:00

In an effort that will discourage many smokers who are trying to quit smoking using electronic cigarettes, the University of California San Francisco has adopted a new policy that prohibits the use of electronic cigarettes anywhere on university property, including outdoors.

University policy already prohibited smoking on the campus; now, electronic cigarettes have been added.

The Rest of the Story

Not only does this action discourage smokers from quitting, but it punishes people who are making a valiant effort to quit smoking using electronic cigarettes. Why punish these individuals? Instead, shouldn't we be encouraging smokers to quit and supporting them in their efforts? This is about as anti-public health of a policy as I can think of.

Moreover, the policy provides no documented public health benefits. There is no evidence that secondhand exposure to exhaled electronic cigarette vapor ("secondhand vaping"?) is hazardous to health, or that the exhaled vapor even contains any significant levels of chemicals that are hazardous.

Instead, the policy is part of a wave of activity in the tobacco control movement which is designed to discourage people from quitting smoking, unless they use the most ineffective methods available (FDA-approved pharmacotherapy). It is part of what is quickly becoming an abstinence-only movement, instructing ex-smokers who have quit using electronic cigarettes that they are better off returning to smoking than remaining ex-smokers by virtue of those electronic cigarettes.

New Study Finds Nicotine Replacement Therapy Ineffective in Smoking Cessation

2012-01-10T19:04:00.006-05:00

A groundbreaking study on the effectiveness of nicotine replacement therapy in the smoking cessation process has found that these medications are not effective in helping smokers to quit long-term.

An article published Monday online ahead of print in the journal Tobacco Control challenges the prevailing wisdom in the tobacco control movement by arguing that nicotine replacement therapy (NRT) is ineffective for smoking cessation and that therefore, public expenditures for NRT provision to smokers is a waste of resources.

See: Alpert HR, Connolly GN, Biener L. A prospective cohort study challenging the effectiveness of population-based medical intervention for smoking cessation. Tobacco Control 2012; doi:10.1136/tobaccocontrol-2011-050129.

According to the study press release from the Harvard School of Public Health (HSPH):

"In the prospective cohort study the researchers, including lead author Hillel Alpert, research scientist at HSPH, and co-author Lois Biener of the University of Massachusetts Boston's Center for Survey Research, followed 787 adult smokers in Massachusetts who had recently quit smoking. The participants were surveyed over three time periods: 2001-2002, 2003-2004, and 2005-2006. Participants were asked whether they had used a nicotine replacement therapy in the form of the nicotine patch (placed on the skin), nicotine gum, nicotine inhaler, or nasal spray to help them quit, and if so, what was the longest period of time they had used the product continuously. They also were asked if they had joined a quit-smoking program or received help from a doctor, counselor, or other professional.

The results showed that, for each time period, almost one-third of recent quitters reported to have relapsed. The researchers found no difference in relapse rate among those who used NRT for more than six weeks, with or without professional counseling. No difference in quitting success with use of NRT was found for either heavy or light smokers.

"This study shows that using NRT is no more effective in helping people stop smoking cigarettes in the long-term than trying to quit on one's own," Alpert said. He added that even though clinical trials (studies) have found NRT to be effective, the new findings demonstrate the importance of empirical studies regarding effectiveness when used in the general population.

Biener said that using public funds to provide NRT to the population at large is of questionable value, particularly when it reduces the amount of money available for smoking interventions shown in previous studies to be effective, such as media campaigns, promotion of no smoking policies, and tobacco price increases."

The Rest of the Story

This landmark study confirms a point that I have repeatedly argued here at The Rest of the Story: that population-based studies of the use of NRT in real-life situations do not support the results from clinical trials showing that NRT is effective for smoking cessation, at least not in the long-term.

This study provides important empirical evidence that over the long-term, population-based use of NRT in real-life situations - outside of the clinical trial setting where there is extensive counseling and other support provided - is not an effective treatment to aid smoking cessation. It does not appear to be any better than smokers attempting to quit unaided.

This does not mean that in individual patients, NRT is not effective and should not be considered. But it does mean that on a population basis, as a matter of public health policy, the role of NRT has been way over-rated.

I agree that with limited funding available, using those funds to provide NRT is of limited value. Instead, limited public funding for tobacco control should be used for proven programs such as smoking prevention media campaigns, which have been shown to reduce youth smoking by as much as 50%.

New Study Shows that in Contrast to Tobacco Cigarettes, Electronic Cigarettes Do Not Impair Acute Lung Function

2012-01-10T07:52:00.002-05:00

A new study published online ahead of print in the journal Chest demonstrated that in contrast to both tobacco cigarette smoking and secondhand smoke exposure, which have been shown to cause acute impairment of lung function, electronic cigarettes have no acute effect on pulmonary function as measured by spirometry testing.

See: Constantine I. Vardavas, Nektarios Anagnostopoulos, Marios Kougias, Vassiliki Evangelopoulou, Gregory N. Connolly, Panagiotis K. Behrakis. Acute pulmonary effects of using an e-cigarette: impact on respiratory flow resistance, impedance and exhaled nitric oxide. Chest 2011. Published online before print December 22, 2011, doi: 10.1378/chest.11-2443.

Active smoking is known to impair lung function, as measured by pulmonary function testing of lung air flow rates (also called spirometry). For example, short-term active smoke exposure has been shown to reduce forced expiratory flow rates.

Secondhand smoke exposure has also been shown to impair lung function, as evidenced by decreased FEV1 and FEV1/FVC ratios in tobacco smoke-exposed nonsmokers.

In this study, 30 smokers used an electronic cigarette for for 5 minutes, with lung function tested before and after use. A control group of smokers used an electronic cigarette with the cartridge removed.

The study found "no differences between basic pulmonary measurements" between the two groups, demonstrating that acute exposure to electronic cigarette vapor did not affect FEV1, FVC, PEF or MEF50 and MEF75.

However, the study did find that acute electronic cigarette vapor exposure decreased exhaled nitric oxide and increased peripheral airway resistance.

The study concludes: "E-cigarettes assessed in the context of this study were found to have immediate adverse physiologic effects after short term use that are similar to some of the effects seen with tobacco smoking, however the long term health effects of e-cigarette use are unknown but potentially adverse and worthy of further investigation."

The Rest of the Story

It is first interesting to note that although the study's declared purpose was to "assess whether using an e-cigarette for five minutes has an impact on pulmonary function tests and exhaled nitric oxide," the study's abstract only reported the observed reduction in exhaled nitric oxide, not the lack of any effect on pulmonary function tests.

Moreover, the study failed to compare the acute respiratory effects of electronic cigarette exposure with those of active smoking, which is the most important comparison that needs to be made.

In contrast to what some are reporting, the study found no effect of e-cigarettes on lung function, as measured by spirometry. This is in contrast to tobacco smoking, which does have effects on lung function that can be measured using spirometric testing.

While previous research indicates that active smoking and even secondhand smoke exposure can affect acute lung function as measured by spirometry, the study demonstrated that electronic cigarette use led to no impairment of lung function detectable via spirometric testing.

What the study did show was subclinical evidence of impaired lung function, meaning that the observed (measurable) lung function was unchanged, but that there was evidence of physiologic effects consistent with some bronchial inflammation. What is not known is whether this acute bronchial inflammation has any significance in the long-term. The presence of bronchial inflammation may be a result of propylene glycol having a respiratory irritant effect. But this does not necessarily mean that long-term exposure would lead to any adverse effect on lung function. More research is necessary to clarify that point.

The authors acknowledge this: "We must state though that while the differences within our study are of statistical significance, the clinical changes may be too small to be of major clinical importance."

While this is only conjecture, I suspect that the study is detecting a respiratory irritant effect of propylene glycol. It will be interesting to see if the same effect is present or not with glycerin-based products.

The study does not change my overall assessment, which is that e-cigarettes are much safer than smoking. But it does suggest that e-cigarettes are not “safe” in any absolute sense (which we knew already because they contain nicotine). The real question is whether there are effects of long-term exposure to propylene glycol. Whether there are or not, I don’t think it will change the conclusion that e-cigarettes are much safer than smoking. However, it may have implications for the composition of e-cigarette liquid, as it may be that glycerin-based juice is safer than propylene glycol-based juice. It may be, for example, that a glycerin-based liquid fails to produce the airways inflammation that is being observed with a propylene-glycol based electronic cigarette.

In news coverage of the study, one of the authors was quoted as recommending: "If you're trying to quit, stick to the methods that are known to work." (i.e., nicotine replacement therapy and pharmacotherapy like Chantix and Buproprion).

I find this to be irresponsible advice, because these methods that are "known to work" actually are quite ineffective, with dismal results in terms of long-term cessation. Advising smokers to stick with the FDA-approved medications is tantamount to advising the overwhelming majority of smokers to continue smoking.

More importantly, since thousands of ex-smokers are remaining smoke-free with the help of electronic cigarettes, the study author's advice is essentially telling these ex-smokers that they are better off returning to active smoking than continuing to vape. Clearly, if these vapers switch to NRT or Chantix, they are very unlikely to be successful and will most likely return to cigarette smoking.

The American Council on Science and Health made the same point in its Facts and Fears column yesterday, writing: "The study’s lead researcher recommends that, instead of trying e-cigarettes as a reduced-risk method to quit smoking, smokers should “stick to the methods that are known to work.” But Dr. Ross criticizes this recommendation. 'He would have more accurately said, ‘stick to the methods that are known to not work,’ since those currently approved have a ‘success’ rate of only 5 to 10 percent. It’s the old ‘quit or die,’ abstinence-only agenda.'".

The rest of the story is that a propylene-based electronic cigarette system has been shown to produce airways inflammation in users, resulting in subclinical evidence of increased airway resistance. Whether long-term use of electronic cigarettes would lead to clinical manifestations due to actual airway obstruction is unclear, and more research is necessary to make such a determination. What we do know, however, is that long-term continuation of cigarette smoking will almost certainly lead to clinically significant airway obstruction.

The bottom line: if a smoker is choosing between active smoking and electronic cigarette use, the use of the electronic cigarette is clearly the wiser choice. And in fact, this is the choice that most electronic users are facing. The idea that any substantial proportion of electronic cigarette users will quit smoking if they take the article's advice and stick to approved NRT or pharmacotherapy products is unsupported by the scientific evidence.

Social Stigma Created by Anti-Smoker Policies Found to Negatively Impact Health Care for Smokers

2012-01-09T07:26:00.000-05:00

In my last post of 2011, I suggested that the anti-smoking movement has recently changed from a focus on fighting tobacco smoke exposure to a near obsession with fighting smokers themselves. This is evidenced by policies such as those which ban smoking in large, wide-open outdoor areas such as Central Park or entire areas of a downtown and by policies which ban smokers, rather than just tobacco smoke, from the workplace.

I argued that: "These policies are instead intended to punish smokers by either: (1) making it more difficult for them to smoke outdoors; or (2) making it more difficult for them to find employment. The latter effect can be quite significant in communities in which a single hospital system is the major employer. If that hospital system refuses to consider applications from smokers, it truly does make it much more difficult for smokers to find employment. This is especially true with the job shortages we are facing today. The implications of this development for public health is that we are now using employment discrimination as a strategy for health promotion."

Similarly, I argued that: "At a national level, the tobacco control movement has waged a war on smokers, rather than on the tobacco industry and its most hazardous products."

I concluded with the hope that: "2012 will bring a re-examination of the public health practice of tobacco control and a return to the basic public health objectives that the movement is supposed to serve."

The year 2012 began with a feature article in USA Today about the issue of employment discrimination against smokers. The article discussed the growing trend of policies by which employers fail to hire smokers. Some of these policies apply not only to smokers, but to anyone using nicotine, whether in the form of cigarettes, smokeless tobacco, or even nicotine-containing medications designed to help smokers quit.

According to the article: "'These policies represent employment discrimination. It's a very dangerous precedent,'' says Michael Siegel, a professor at Boston University's School of Public Health. He says the restrictions punish smokers rather than helping them quit."

In perhaps a ray of hope, the American Lung Association appeared at least somewhat ambivalent about these policies: "Paul Billings of the American Lung Association says he's seen no data that prove nicotine-free hiring gets people to quit."

Last week came news from a new survey by the American Legacy Foundation, which reported that the social stigma associated with smoking has become so severe that "one-in-ten smokers (13%) in the United States did not disclose their smoking status to their health care providers (HCP), who are among the most important resources that a smoker could have in quitting successfully. Furthermore, social stigma around smoking may contribute to why smokers sometimes keep their smoking status a secret from their doctors."

This means that six million smokers fail to disclose their smoking status to their health care providers.

Dr. Cheryl Healton, president and CEO of the Foundation stated: "As an unintended result of higher prices of cigarettes, increased measures to ban smoking in public places, and create smoke-free workplaces, many smokers may feel marginalized and less compelled to discuss smoking with their physicians and other providers."

The Rest of the Story

I agree with Dr. Healton that the increased social stigma associated with smoking is a direct result of certain anti-smoking policies. However, I disagree that it is an "unintended" result of these policies. Instead, I believe that this result is precisely what many anti-smoking groups have intended.

If the goal were simply to prevent substantial exposure of the public to secondhand smoke, then why the need to ban smoking in an entire downtown area, or in a huge, wide-open park like New York City's Central Park? If the goal were simply to protect workers from secondhand smoke, then why the need to ban smokers from the workforce, even if they only smoke in the privacy of their own home? And why the need to deny employment to people who are trying to quit, albeit with the use of nicotine-containing devices like the nicotine patch or electronic cigarettes? Why the need to ban smoking on an entire college campus, rather than just indoors and in public areas where people congregate near the entrances to the buildings? Why the need to prevent smokers from adopting or fostering children, even if they agree not to smoke in the vicinity of their children? Why the desire to define smoking in the presence of children as a form of child abuse, and to treat it as such?

I would contend that the philosophy which supports each of the above policies is intended to stigmatize smoking. There is nothing "unintended" about it.

Importantly, I do not believe that all anti-smoking policies increase the stigma associated with smoking. I believe that certain policies are the chief culprit: namely, the kinds of policies discussed above, which directly target the smoker rather than the smoke.

And there is evidence to back up this contention. Policies intended to prevent tobacco smoke exposure in the workplace, such as smoke-free restaurant policies, do not appear to lead to a feeling of discrimination among smokers, while smoker-free hiring policies do.

A 2005 article published in the American Journal of Public Health asks tobacco control and public health practitioners to reconsider the use of stigmatization of smokers as a strategy to reduce tobacco use (see: Bayer R, Stuber J. Tobacco control, stigma and public health: Rethinking the relations).

The article notes that strategies used to combat tobacco use have, in some cases intentionally, stigmatized smokers in an effort to try to reduce smoking rates. For example: "The advocacy group Americans for Non-Smokers' Rights noted that tobacco control advocates had stumbled onto the best strategy for reducing tobacco consumption, 'encouraging society to view tobacco use as an undesirable and antisocial behavior.'"

Another example provided by Bayer and Stuber is the discriminatory and intrusive employment policies that have been discussed in recent months in The Rest of the Story: "Firms boldly announce that they will not employ and may even fire smokers because of the additional cost of their medical care, or because smoking does not project the 'image' they wish to present to the public."

For perhaps the first time in a major public health journal, these authors are questioning, on an ethical as well as utilitarian basis, whether the stigmatization of smokers is justified in public health. They note that efforts to reduce smoking by stigmatizing smokers "run counter to a revisionist orthodoxy that had emerged during the last years of the 20th century that asserts that stigmatization of those who are already vulnerable provides the context within which disease spreads, exacerbating morbidity and mortality by erecting barriers between caregivers, and those who are sick, and by imposing obstacles on those who would intervene to contain the spread of illness. In this view, it is the responsibility of public health officials to counteract stigmatization if they are to fulfill the mission to protect the communal health."

The authors note that the tendency of the tobacco control movement to "ignore without comment the overarching concerns raised in prior years about the relation between stigmatization and effective public health interventions. ... the moral question of how to balance the overall public health benefit that may be achieved by stigmatization against the suffering experienced by those who are tainted by 'spoiled identities' is virtually never addressed."

The authors suggest that the answer to this balancing question may lie with a careful analysis of "the nature and extent of stigma-associated burdens and on how the antitobacco movement deploys stigmatization as an instrument of social control. For example, policies and cultural standards that result in isolation and severe embarrassment are different from those that cause discomfort. Those that provoke a sense of social disease are not the same as those that mortify. Acts that seek to limit the contexts in which smoking is permitted are different from those that restrict the right to work, to access health or life insurance, or to reside in communities of one's choice."

While I believe that there are some advocates in the tobacco control movement who do not support smoker-free hiring policies, the tobacco control movement has made it difficult if not impossible for them to voice their opinions because it has sanctioned such behavior. Moreover, anti-smoking groups have conspired to hide internal dissent on smoker-free employment policies from public knowledge.

In 2006, in a strategy discussion reminiscent of the type of actions we in tobacco control often criticize the tobacco companies for engaging in, anti-smoking groups successfully hid from the public awareness of strong internal dissent within the tobacco control community regarding policies by which employers refuse to hire smokers.

In the wake of the World Health Organization's (WHO's) decision to refuse to hire smokers, there was a vigorous internal debate involving a number of anti-smoking groups and advocates on a list-serve of which I was a member (Globalink). A fair number of tobacco control practitioners expressed strong opposition to what they considered to be a discriminatory policy that unduly intruded into employee privacy in the home and did not represent an appropriate public health intervention.

A number of discussants attempted to facilitate a vote in order to provide a somewhat objective indication of the position of anti-smoking groups and advocates on this policy issue, so as to gauge the position of the tobacco control community on the policy and inform WHO of where public health groups stand on its seemingly controversial decision.

Such information would be very useful and important for the public, the media, policy makers, and employers to have in order to help inform their decisions regarding the public health appropriateness of adopting such policies.

I observed this debate with great interest (I actually did not start the discussion or participate directly in it) and initially, I thought it was a good example of meaningful discussion and dialogue within the movement about an important policy measure. However, to my great surprise (at the time), the entire discussion was coopted by a bloc of adamant groups and advocates which stifled further debate, attacked the dissenters, and resisted any vote or any public revelation that there was indeed dissent about this important matter within the tobacco control community.

These groups were successful not only in putting an end to the debate, but also in stopping a vote on the issue and allowing any knowledge of the dissent with the tobacco control community to be brought to public attention.

The most interesting aspect of this story was not the stifling of debate on the issue, but rather the reasons provided for not assessing the views of tobacco control practitioners. Here are some examples of the arguments advanced for blocking any vote on the issue, followed by some commentary:

"If a poll is taken on the WHO policy, we should anticipate its results (which will be a split, regardless of the outcome) are likely to become grist for a blog and websites of FORCES and Forest, amid editorials espousing a right-to-smoke that is under attack by the anti smoker cabal. And if a majority polled oppose the WHO policy, we should anticipate significant media coverage pitching the story as a conflict between the WHO and some anti smoking advocates. Meanwhile, tobacco industry executives would have a good laugh as they send more checks to Lewis Maltby, dust off their right-to-smoke legislation from 15 years ago, and consider coalition building and lobbying budgets in more states and nations. Although I agree that further debate on XXX over the WHO policy probably won't be productive, the larger public policy issue regarding [smoker-free employment policies] and right-to-smoke legislation is unlikely to go away, and could further divide tobacco control advocates. ... I'd prefer debating our differences here on XXX [rather] than in state legislatures or in the news media."

Let's not find out how much dissent there is in the anti-smoking movement about these policies because if we do, it's going to harm our efforts to advance these policies. Knowledge of the internal dissent will become public, as it will appear on Mike Siegel's blog as well as the FORCES and other smokers' rights websites. We shouldn't ever expose to the public that we disagree about anything. It's important that any disagreement with the prevailing dogma and agenda of the movement remain hidden from the public so that it doesn't interfere with the advancement of this agenda through legislative policy enactment. Any dissent must only be expressed internally; dissenters cannot publicly state their views or they are helping the tobacco industry advance their cause. Even though we know that the movement is split on this issue, those who are taking the stronger anti-smoking position which penalizes smokers more must prevail and those who oppose the stronger position should keep their thoughts to themselves or share them only with other anti-smoking advocates.

"A XXX vote on the WHO hiring policy will help only the tobacco cartel. Sorry, I just had to yell that, I am so worried about a possible vote. If one happens, I will not vote, and I will urge all WHO policy supporters to not vote as well. It will not help tobacco control people in any way. We already know a small number of us are very vocal and on opposite sides of this issue. I do not want to fight new legislation on this issue again. I have much more important issues to work on. A XXX vote may lead to the tobacco cartel introducing more smokers' rights bills throughout the world. Those who promote a vote should be required to tell us if they or their close family members smoke or use tobacco, and if their company has or will take money from a tobacco company. XXX, XXX, XXX, XXX, XXX, XXX, XXX, XXX, XXX and others [most of whom had spoken out against the WHO's policy], when was the last time you had a smoke or spit tobacco? Have or will you and/or your companies take money from any tobacco company - including Kraft and all of their other subsidiaries?"

We must not let the public know that there is any dissent about the prevailing anti-smoking agenda. If the majority decides to have a vote, we must sabotage the process to avoid knowledge of dissent from becoming public. Dissent is simply a diversion from the important work that the rest of us in tobacco control are doing to actually advance the cause. Besides, anyone who opposes this anti-smoking policy must, by definition, either be a closet smoker or smokeless tobacco user or be on the Big Tobacco dole in some way. You can't go against the grain of the prevailing anti-smoking agenda and be a respectable individual. Even those who simply want to exercise the democratic process and are promoting a vote here must be either closet smokers or tobacco stooges.

"Other than allowing people to blow off steam, I do not see what a poll would accomplish other than giving FORCES et al grist for its mill."

Those who oppose the prevailing agenda of the movement are simply full of steam. They and their views should not be taken seriously and should not be allowed to get in the way of what the cool-minded majority of the movement is trying to accomplish. Allowing it to be known that there is significant dissent in the movement will provide ammunition to our enemies, so we must not allow knowledge of the dissent to become public.

"I also agree that a vote would be counter productive, for all the reasons that have been mentioned. ... It would be tragic for us, would it not, to do something that likely would invite criticism from FOREST and the like, and not even produce something meaningful? I had hoped in a prior posting to offer some 'talking points' framed in the form of questions which could be used by anyone, whether they agree with WHO's policy or not, in the event someone is confronted with a question about the policy and doesn't feel comfortable answering directly. You will also learn where the other person stands, rather than tipping your hand. As the person asking the questions controls the conversation uncomfortable conversations can be redirected towards the damage done by the tobacco industry."

Finding out how public health practitioners feel about an anti-smoking policy is tragic if it reveals that the policy is widely opposed. I am trying to provide those who oppose the WHO's policy with instructions on what to say if someone asks you how you feel about the policy. Rather than telling them that you oppose the policy, instead you must avoid the question and focus only on how terrible the tobacco industry is. Don't let on that you oppose any anti-smoking measure; simply repeat the dogma about how awful Big Tobacco is and move on.

"The fact is the WHO has adopted this policy at the highest levels. There are more productive things to do than fight with them."

We should not speak out against any anti-smoking policies that any group or organization promotes or adopts, even if we think that the policy is completely unjustified, discriminatory, and unduly intrusive and inappropriate from a public health perspective. Dissent interferes with the agenda and the movement and is therefore not productive.

The rest of the story is that there is a concerted effort in the tobacco control movement to promote policies that stigmatize smokers and to quell any dissent from those who disagree with this approach. The combination of these actions has led to a measurable negative impact on health care for smokers, in the form of a reluctance on the part of about six million smokers to disclose to their physicians that they smoke.

The Rest of the Story Will Return on Monday, January 9th; Happy New Year to All

2012-01-04T13:42:00.002-05:00

Lessons Learned in 2011: Reflections on the Year in Tobacco Control

2011-12-31T12:21:00.003-05:00

After reflecting on the events of 2011, here are the major lessons I've learned and their implications for public health:

1. Some anti-smoking groups really are lying to the public.

Previously, I was able to hold out hope that false statements being made by anti-smoking groups to the public were merely mistakes or oversights. It is now clear, however, that some anti-smoking groups really are lying to the public and the apparent intention is to mislead the public in some way.

For example, the American Cancer Society (winner of the 2011 Liar, Liar, Pants on Fire Award) lied to its constituents in telling them that the FDA Tobacco Act banned all flavored tobacco products. The ACS clearly understood that the legislation exempts menthol cigarettes because it was one of the groups that supported the legislation and was briefed on the bill by the Campaign for Tobacco-Free Kids, which negotiated the terms of the legislation. The false statement made by the ACS is therefore difficult to explain as a simple oversight.

Instead, it seems clear to me that the ACS is afraid to tell the public the truth - that while the bill bans all the flavorings in cigarette brands which are rarely used by youths - it exempts menthol, which is the chief flavoring present in the brands favored by 80% of African American youth smokers and 50% of all youth smokers. Telling the public the truth - that the bill exempted menthol - would be an embarrassing admission for the ACS, because it would reveal that the Tobacco Act is a scam, which allows health groups and politicians to boast about how they are fighting Big Tobacco but which actually failed to ban any flavored cigarettes manufactured by Big Tobacco and exempted the one flavoring in cigarettes which is favored by half of the nation's youth smokers.

As a second example, Americans for Nonsmokers' Rights (runner up for the 2011 Liar, Liar, Pants on Fire Award) lied to the public by stating that there are virtually no health disparities between active and passive smoking. This is clearly false, as there are many health disparities between the two. The apparent purpose of this lie is to mislead the public into thinking that secondhand smoke is more hazardous than it actually is. But of course, the adverse side effect of this is that it also misleads the public into thinking that active smoking is not as hazardous as they have been led to believe. Moreover, I discussed the issue with a staff member of ANR, explaining why the information is incorrect. That the organization apparently decided to retain the false claim suggests that this was an intentional decision rather than a mere oversight. It certainly does create a more alarming health scare: if secondhand smoke's health effects are every bit as severe as those of active smoking, then secondhand smoke is much more hazardous than even the scientific evidence demonstrates!

The implication of these lies for public health are that the anti-smoking movement is going to lose its public credibility. Like the "global warming movement," which has lost credibility (undeservedly) because of a few exaggerations, I fear that the tobacco control movement will similarly lose credibility because of its willingness to lie to the public. Eventually this is going to catch up with us. I don't want to see the tobacco control movement go the way of the global warming movement. But we risk that happening if we continue to lie to the public in this way.

2. The smoke-free aspect of the tobacco control movement has largely become an attack on smokers, rather than a battle against tobacco smoke.

Two trends that have picked up steam in 2011 are policies which ban smokers from potential employment and policies which ban smoking in large, wide-open outdoor areas such as Central Park or entire areas of a downtown. Both of these policies have left the realm of protecting the public from secondhand smoke to punishing smokers for their poor health behavior decisions. Banning smoking in the entirety of Central Park is obviously not necessary to protect the public from exposure to secondhand smoke. And banning smokers, rather than just tobacco smoke, from the workplace, is obviously not necessary to prevent exposure to tobacco smoke in the workplace.

These policies are instead intended to punish smokers by either: (1) making it more difficult for them to smoke outdoors; or (2) making it more difficult for them to find employment. The latter effect can be quite significant in communities in which a single hospital system is the major employer. If that hospital system refuses to consider applications from smokers, it truly does make it much more difficult for smokers to find employment. This is especially true with the job shortages we are facing today.

The implications of this development for public health is that we are now using employment discrimination as a strategy for health promotion. I find this a troubling development. In addition, we are now viewing smoking as a moral, rather than a health issue, and trying to protect people not only from tobacco smoke exposure, but from having to even see a smoker in public.

3. At a national level, the tobacco control movement has waged a war on smokers, rather than on the tobacco industry and its most hazardous products. It is working to help entrench the most risky existing tobacco products, protect existing cigarette market shares, and fend off Big Pharma from competition, all at the expense of the health of smokers.

The implementation of the FDA Tobacco Act has turned into a disaster because it has resulted in the protection and institutionalization of the most hazardous existing tobacco products - cigarettes - and the stifling of much safer alternatives such as electronic cigarettes, which could otherwise be helping many smokers who would not otherwise quit smoking to successfully discontinue smoking.

Rather than embrace products such as electronic cigarettes, which are being used successfully by thousands of ex-smokers to keep them off cigarettes, anti-smoking groups are making it difficult, if not impossible, for these products to compete with tobacco cigarettes. The recommendations of the Institute of Medicine committee reinforce this view. In fact, it is the very purpose of the FDA Tobacco Act.

The implication of this development for public health is that cigarettes now have the FDA seal of approval, while safer products - such as electronic cigarettes - have an almost insurmountable barrier in front of them if they want to promote themselves effectively in the marketplace (i.e., as safer alternatives to tobacco cigarettes).

The Rest of the Story

If this were a state-of-the-tobacco-control-movement address, I would be forced to give a quite negative report. The thrust of national tobacco control efforts is the exact opposite of what public health would call for: protection of the most hazardous products and the imposition of insurmountable barriers to much safer products that have the potential to save thousands of lives. At the local level, the goal of protecting the public from the hazards of secondhand smoke are being supplanted by policies designed to punish smokers. And for some reason, lying to the public has become an acceptable tactic that is supposedly justified based on the good ends which these lies are serving.

My hope is that 2012 will bring a re-examination of the public health practice of tobacco control and a return to the basic public health objectives that the movement is supposed to serve.

Winner of 2011 Liar, Liar, Pants on Fire Award: American Cancer Society

2011-12-29T17:07:00.006-05:00

Today I announce the first place winner in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter).

First Place - 2011 Liar, Liar, Pants on Fire Award: American Cancer Society

In a communication sent to the American Cancer Society's (ACS) network of advocates throughout the nation (including myself) and posted on the Society's web site, the ACS lied about the effects of the FDA tobacco legislation passed by Congress in 2009. Although this lie first appeared in print in 2009, the ACS has continued to mislead the public about this issue, and in 2011, lobbied for state legislation in New York that would have plugged the flavored cigar loophole, but failed to address the menthol cigarette exemption. The ACS incorrectly and deceptively referred to this legislation as a ban on flavored "tobacco products," when in fact, it merely banned flavored cigars and smokeless tobacco and left menthol cigarette untouched.

According to the American Cancer Society's statement: "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned."

The American Cancer Society thus claimed that the FDA tobacco legislation banned all flavored tobacco products.

The Rest of the Story

If the American Cancer Society had read the actual text of the legislation or read any of hundreds of newspaper articles about the bill, it would have easily found out that the bill did not ban all flavored tobacco cigarettes that seduce young smokers. The bill specifically exempted menthol from its ban on cigarette flavorings.

The key section of the bill about which the ACS lied is section 907(a)(1)(A), which reads: "Beginning 3 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, a cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke."

The American Cancer Society is well aware that menthol is a cigarette flavoring whose primary purpose is to help addict youths by making cigarette smoke less harsh. The ACS itself, in a special report on the topic, stated that cigarette companies use menthol flavoring to: "Numb throat so the smoker does not feel as much throat irritation."

In support of this assertion, the ACS cites a tobacco industry document which argues that a flavoring (such as menthol) which makes cigarette smoke less harsh will help entice youth smokers. According to the ACS report: "The Teague document details a number of product features that make smoking more tolerable for beginning and learning smokers. For example, it discusses methods of reducing harshness, making the flavor bland since new smokers don’t like the taste of the smoke, and improving the “mouth feel” by reducing negatives like hotness and dryness."

In fact, the ACS report goes into tremendous detail about how the tobacco companies are using menthol to entice young African Americans to smoke (whether you agree with this conclusion or not, my point is that the ACS has certainly concluded and argued to the public that menthol is used to entice young smokers):

"The tobacco companies’ success in using menthol cigarettes to target African American kids is exemplified by the disproportionate number of young blacks who smoke menthol cigarettes. Not only does menthol numb the throat to allow deeper inhaling, the companies know menthol is attractive to their African American targets: “Young blacks have found their thing, and it’s menthol in general and Kool in particular.” It is hardly surprising then that 80 percent of 12- to 17-year-old black smokers choose Newport, the leading menthol brand, compared to just 16 percent of young white smokers. Again, these product design decisions can have a terrible impact on health. Menthol cigarettes have higher carbon monoxide concentrations than non-menthol cigarettes and may be associated with a greater absorption of nicotine. Moreover, research indicates that mentholated cigarettes may increase the risk of both lung and bronchial cancer by promoting lung permeability and diffusability of smoke particles. African Americans are more likely to develop and die from cancer than persons of any other racial or ethnic group. Lung cancer is the second most common cancer in both African American men and women and it kills more African Americans than any other type of cancer."

So the ACS is aware that the bill exempts menthol and has also argued previously that menthol flavoring is used in order to entice young smokers by making the smoke less harsh and in particular, by enticing African American youths who are attracted by the menthol flavor.

Therefore, I am saddened but forced to conclude that the American Cancer Society lied to its constituents and the public in its communication stating that the FDA legislation banned all cigarette flavorings and thus ends the enticement of youths by these flavorings.

I should say that I am a long-time American Cancer Society supporter, volunteer, donor, and fund raiser and thus it greatly saddens me to see the ACS lie to the public like this.

But the reason for this lie is also clear. If the ACS were honest with the public, it would have to admit that the bill is a public scam which does little to protect children from addiction to cigarettes but lots to protect cigarette sales. Most notably, the bill bans all the flavorings that are not used very often (or at all), such as banana, pineapple, cherry, chocolate, and cherry, but exempts the one flavoring (menthol) which the ACS itself admits is used to entice huge numbers of young smokers, including a disproportionate number of African Americans. The ACS itself tells us that Newport - a menthol-flavored brand - is smoked by 80% of African American teenagers.

It's interesting that when it was trying to get this bill passed, the ACS had no problem featuring the problems of tobacco use in the African American community, but now that the legislation has been enacted, the ACS is pretending that the African American community doesn't exist and that the enticement and seduction of African American youth smokers by menthol-flavored brands is not a problem.

Clearly, the ACS is afraid to tell the public the truth - that while the bill bans all the flavorings in cigarette brands which are rarely used by youths - it exempts menthol, which is the chief flavoring present in the brands favored by 80% of African American youths. Moreover, menthol is the chief flavoring in the brands favored by about 50% of all youth smokers!

Telling the public the truth - that the bill exempted menthol - would be an embarrassing admission for the ACS, because it would reveal that the Tobacco Act is a scam, which allows health groups and politicians to boast about how they are fighting Big Tobacco but which actually failed to ban any flavored cigarettes manufactured by Big Tobacco and exempted the one flavoring in cigarettes which is favored by half of the nation's youth smokers.

Given that the American Cancer Society has focused so much effort on criticizing the tobacco industry for lying to the public, it seems hypocritical for the ACS to now engage in the same tactics, even though the Society might argue the lie is for a good purpose. I would argue that the lie is not only a lie, but it is for a bad purpose: protecting the menthol cigarette market to ensure that the Tobacco Act had no actual impact on cigarette sales and tobacco company profits.

The American Cancer Society is well-deserving of recognition as the first place finisher in the Rest of the Story's 2011 Liar, Liar, Pants on Fire Award competition.

Runner-Up for 2011 Liar, Liar, Pants on Fire Award: Americans for Nonsmokers' Rights

2011-12-28T12:10:00.003-05:00

Today I announce the 2nd place finisher in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter). The winner will be announced later this week.

Second Place - 2011 Liar, Liar, Pants on Fire Award: Americans for Nonsmokers' Rights

According to Americans for Nonsmokers' Rights (ANR) - a leading national smoke-free air advocacy group - active smoking is no worse than secondhand smoke exposure.

In a fact sheet entitled "Secondhand Smoke: The Science," the group claims that the health effects of secondhand smoke are virtually the same as those of active smoking. According to the fact sheet, "there are virtually no health disparities between active and passive smoking."

The fact sheet also states that active smoking only causes the same amount of heart damage as 30 minutes of exposure to secondhand smoke.

The precise statements made by ANR are as follows:

1. "A June 2004 study published in the British Medical Journal reaffirmed that there are virtually no health disparities between active and passive smoking. The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."

2. "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story

These false claims are damaging because they undermine decades of public education about the hazards of active smoking. They represent a lie that is every bit as false as anything the tobacco industry has fraudulently asserted in the historical annals of tobacco industry lies and deception.

The claims are particularly damaging because if believed by the public, they remove any incentive for smokers to quit. If smoking is only as bad as secondhand smoke exposure, then the hazards of active smoking are no where near as great as previously thought. Moreover, if smokers are going to be around people who smoke anyway, then there is no incentive for them to quit.

The health effects of active smoking are quite distinguishable from those of passive smoking. While passive smoking only increases the risk of lung cancer by a factor of about 1.3, active smoking increases lung cancer risk by a factor of about 17. That's more than an order of magnitude of difference in risk.

Similarly, the risk of COPD associated with active smoking is much greater than the risk associated with passive smoking.

While it is true that for heart disease, the risk associated with very heavy passive smoking approaches that associated with very light active smoking, it is simply not true to assert that the overall effects of secondhand smoke and active smoking are virtually indistinguishable and that "there are no health disparities between active and passive smoking."

Moreover, it is untrue that 30 minutes of secondhand smoke causes heart damage, much less the same degree of heart damage as observed in a chronic, active smoker. While it is true that 30 minutes of secondhand smoke exposure causes endothelial dysfunction, this is not equivalent to "heart damage." Heart damage implies damage to the heart muscle, such as observed in a myocardial infarction, or heart attack. Thus, a mere 30 minutes of secondhand smoke exposure does not cause heart damage. Clearly, it is false to assert that 30 minutes of secondhand smoke exposure causes "heart damage similar to that of habitual smokers."

The problem with these statements is not simply that they are untrue. They may be damaging to the public's appreciation of the hazards of active smoking. If the public believes that active smoking is only as dangerous as a mere 30 minutes of secondhand smoke exposure, then the public may believe that smoking is not as dangerous as they have been told. This is why this type of false propaganda can undermine years of public education about the hazards of smoking.

While the fact sheet was originally posted in 2006, it remains eligible for the 2011 Liar, Liar, Pants on Fire Award because it remains on the web site today, unchanged. This is despite my conversation with staff at ANR, explaining why these claims are false.

While lying to the public would be bad enough, lying in a way that is likely to undermine the public's appreciation of the hazards of smoking is particularly egregious. That makes this lie deserving of recognition as the second place finisher in the Rest of the Story's 2011 Liar, Liar, Pants on Fire Award competition.

Third Place Finisher of Liar, Liar, Pants on Fire Award: World Medical Association

2011-12-27T12:32:00.002-05:00

Today I announce the 3rd place finisher in my annual Liar, Liar, Pants on Fire Award for the worst public lie in the tobacco control field in 2011 (the Liar, Liar, Pants on Fire Award name is borrowed from PolitiFact, which uses the term in its truth-o-meter). The runner-up and winner will be announced in subsequent days.

Third Place - 2011 Liar, Liar, Pants on Fire Award: The World Medical Association

On October 4, 2011, the World Medical Association issued a press release in which it claimed that the tobacco industry was promoting electronic cigarettes in shops and on the internet in an effort to recruit young people.

According to the press release: "The World Medical Association will step up its fight against smoking with proposals to ban the production, distribution and sale of candy products that depict or resemble tobacco products. At their three-day Council meeting in Sydney, Australia, (April 7-9) WMA delegates agreed to recommend to their annual Assembly in October plans to strengthen the organisation's anti tobacco policy to combat moves by the tobacco industry to make their products more appealing to young people. Delegates argued that the WMA should extend its policy to include restrictions on smokeless tobacco and tobacco-derived products, including prohibiting all government subsidies for tobacco-derived products. Dr. Ardis Hoven, chair of the Board of the American Medical Association, said the tobacco industry was now involved in aggressively promoting new forms of cigarettes, such as smokeless tobacco and electronic cigarettes in shops and on the internet to attract and appeal to young people, and the WMA needed to respond strongly."

The Rest of the Story

The claim that the tobacco industry is promoting electronic cigarettes is a lie.

Tobacco companies have nothing to do with electronic cigarettes. They neither produce nor market these products.

The rest of the story, then, is that the Medical Association is lying. The problem is, it's not clear exactly which Medical Association is lying.

Either the American Medical Association is lying, or the World Medical Association is lying.

The Western Medical Association claims that the American Medical Association chair told the audience that tobacco companies are aggressively marketing electronic cigarettes. So there are two possibilities:

1. The American Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did actually make this claim.

2. The Western Medical Association is lying about tobacco companies marketing electronic cigarettes. This is the case if the AMA chair did not actually make this claim.

Either way, a physician's organization is lying to the public in order to cast electronic cigarettes in a negative light, and thus encourage smokers to stick with regular cigarettes and ex-smokers who have quit by virtue of e-cigs to return to tobacco cigarettes.

Moreover, it appears that both the World Medical Association and the American Medical Association are trying to eliminate the safer alternatives to cigarette smoking, while protecting existing cigarettes from any serious competition and ensuring that the hundreds of thousands of people who are using electronic cigarettes to help quit smoking will be forced to return to their Marlboros, Camels, Newports, Kools, and Salems.

Why are these physician organizations acting to protect the profits of cigarette companies at the expense of the public's health?

And why are they lying to the public in order to achieve that result?

While blatantly lying to the public would be bad enough, lying in a way that is going to encourage people to use a far more harmful product than a safer one is particularly egregious. That makes this lie deserving of recognition as the third place finisher in the Rest of the Story's 2011 Liar, Liar, Pants on Fire Award competition.

Campaign for Tobacco-Free Kids Exempts Cigars from Sports Sponsorship Ban, Then Complains that Cigar Company is Sponsoring Orange Bowl; More Hypocrisy

2011-12-26T07:31:00.000-05:00

The Campaign for Tobacco-Free Kids has joined Senator Dick Durbin in condemning the Orange Bowl for accepting sponsorship from a cigar company and urging the NCAA to prohibit such sponsorship. In a letter to the Orange Bowl and the NCAA, the Campaign writes: "As public health groups that combat the use of tobacco and its devastating toll on American families every day, we urge the Orange Bowl Committee and the NCAA to cancel a cigar company sponsorship of the Discover Orange Bowl. Tobacco has no place in sports, and the promotion of cigars at such a prestigious sporting event entices youth and young adults, putting them at risk of developing a deadly addiction."

The Rest of the Story

If it is the case that tobacco has no place in sports and promotion of cigars at sporting events entices youths to smoke, then why didn't the Campaign for Tobacco-Free Kids make sure to include a ban on cigar company sponsorship of sporting events when it helped craft the Family Smoking Prevention and Tobacco Control Act?

As the leading health group at the negotiating table with Philip Morris when this legislation was crafted, the Campaign for Tobacco-Free Kids could easily have demanded that the exemption of cigars from the sports sponsorship ban be eliminated. It would have taken just one additional sentence in the legislation to include cigars in the sports sponsorship ban. But the Campaign for Tobacco-Free Kids failed to act.

Instead of turning all of our criticism to the Orange Bowl and the NCAA, perhaps the public should direct its primary criticism at the Campaign for Tobacco-Free Kids for creating the loophole in the law which allowed this cigar sponsorship to take place in the first place.

Does it not seem mildly hypocritical for the Campaign to complain about the cigar sponsorship when it is responsible for allowing this sponsorship in the first place?

The Campaign for Tobacco-Free Kids now joins Senator Durbin as co-recipients of the Hypocrisy of the Year Award for 2011.

Senator Durbin Solidifies His Position As Hypocrisy of Year Winner

2011-12-23T13:52:00.002-05:00

Senator Dick Durbin yesterday called on the NCAA and the Orange Bowl to rescind sponsorship of the Bowl by Camacho Cigars.

Durbin and several other Senators wrote: "Tobacco has no place in sports, and the promotion of cigars at the Orange Bowl sends the wrong message to young fans. A tobacco company’s sponsorship of the Orange Bowl undermines a premier collegiate sporting event and promotes tobacco use to young fans, putting them at risk of developing an addictive and dangerous habit. Furthermore, Camacho Cigars’ sponsorship is at odds with the NCAA rules prohibiting tobacco use by student athletes and all game personnel in any form at practice and in competitions."

The letter to the Orange Bowl noted that: "The Family Smoking Prevention and Tobacco Control Act of 2009 bans sponsorship of sporting and entertainment events by cigarette and smokeless tobacco brands."

It then argued that: "Cigars contain the same toxic and cancer-causing chemicals found in cigarettes, and public health experts have warned that cigars are not a safe alternative to cigarettes."

The Rest of the Story

The rest of the story is that Senator Durbin has no one to blame but himself.

It was he who championed the legislation which exempted cigars from the sports sponsorship ban. If Senator Durbin felt so strongly that "tobacco has no place in sports," and that "cigars contain the same toxic and cancer-causing chemicals found in cigarettes," then why didn't he include a ban on cigar sponsorship of sporting events in the Family Smoking Prevention and Tobacco Control Act which he championed?

The same criticism that Durbin is leveling at the NCAA and the Orange Bowl could be leveled at Durbin himself for his failure to include cigars in the tobacco sports sponsorship ban. Why did he not heed his own warning that "cigars are not a safe alternative to cigarettes?"

The situation might be different if Senator Durbin had nothing to do with the tobacco legislation. If he were trying to clear up a loophole that others had inserted into the legislation, it would be one thing. But Durbin championed the legislation. He was certainly in a position to suggest that it be amended to include a ban on cigar sponsorship of sporting events. The loophole he is lambasting now is the very loophole he created!

This solidifies Senator Durbin's hold on the Rest of the Story's 2011 Hypocrisy of the Year Award.

2011 Hypocrisy of the Year Award

2011-12-22T12:53:00.002-05:00

As the holidays approach, The Rest of the Story will be posting a number of end-of-the-year features, including the eagerly-awaited annual Hypocrisy of the Year awards and the highly-anticipated Liar, Liar, Pants on Fire awards.

We kick off these end-of-year features, which are meant to provide a moment of reflection on the practice of tobacco control during the past year, with the announcement of the 2011 Hypocrisy of the Year Award.

The 2011 Hypocrisy of the Year Award

This year's award is presented to ...

... Senator Dick Durbin (D-IL), who closed out his 2011 political year by calling on the FDA to ban all flavored cigars. In a letter to the FDA Commissioner from Durbin and three other Senators, they wrote: "Cigars with candy-like flavorings such as strawberry, watermelon, vanilla and chocolate attract kids to smoking and help hook them on this addictive habit. Congress helped protect young people from the harmful effects of tobacco by banning flavored cigarettes. ... We urge FDA to immediately close the current regulatory loopholes and prohibit flavored cigars in the interest of public health."

Apparently, Senator Durbin is aware that flavorings in tobacco products may attract youth and believes that regulatory loopholes that allow tobacco companies to entice youth to smoke with the use of product flavorings should be banned. He also boasts about the fact that he voted for legislation that banned all flavored cigarettes.

Shall we congratulate the Senator for his principled stand in support of the nation's youth and his standing up to Big Tobacco to protect the health of our children?

The Rest of the Story

Not so much.

At the same time that Senator Durbin decries the loophole that allows flavored cigars to remain on the market, he remains silent about the loophole - for which he was partly responsible - that allows tobacco companies to continue to entice youth smokers by adding a flavoring to their cigarettes: menthol.

Senator Durbin is not telling the truth when he asserts that all flavored cigarettes have been banned. Not so. All flavored cigarettes with the exception of menthol cigarettes have been banned. And while the banned flavorings were found in no more than about 0.1% of the youth market (and in not a single brand manufactured by Big Tobacco), menthol cigarettes represent about half of the cigarettes smoked by our nation's youth.

Why did Senator Durbin agree to support legislation that contained a menthol exemption which put Big Tobacco profits ahead of the health of the nation's children? Because Philip Morris, the largest producer of menthol cigarettes, demanded that the menthol exemption remain in the bill. Thus, the rest of the story is that Senator Durbin caved in to the financial interests of Philip Morris, selling out the health of the nation's children, and especially the nation's African American children (of whom about 80% of smokers smoke menthol cigarette brands).

Senator Durbin supported the menthol exemption even though the National African American Tobacco Prevention Network (NAATPN) made its opposition to this exemption very clear:

"'It is a national disgrace and a tragedy that these lethal menthol products have been allowed to be marketed so disproportionately to African-American youth – or to any youth for that matter,' said John Payton, president of the NAACP Legal Defense and Educational Fund. 'The FDA should help millions of Americans avoid tobacco-related death and disease by banning menthol flavoring in cigarettes.' 'NAATPN raised the issue of menthol as a tobacco additive nearly three years ago, as the legislation was being developed to give authority to the FDA to regulate tobacco for the first time,' said William S. Robinson, NAATPN's executive director. 'We thought then, and still do now, that the exemption of menthol as a banned flavoring is wrong, discriminatory in its impact, and is a major factor in continuing the health-related disparities that currently exist.'"

When the Tobacco Act passed, Senator Durbin was quoted as saying: "This is a bill that will protect children and will protect America. Every day that we don't act, 3,500 American kids - children - will light up for the first time."

Certainly, Senator Durbin couldn't have been suggesting that by getting rid of cigarette flavorings that appeal to 0.1% of youth, we are going to be protecting 3500 children from lighting up for the first time. But the truth is that the legislation Durbin championed made it a point to prevent putting any serious dent in youth smoking by exempting the menthol flavorings which are enjoyed by a full 50% of youth. What Durbin did was ban the flavorings that no kids were using, and exempt the one flavoring which one in two were hooked on.

Today, how can Senator Durbin have the gall to stand in front of the American people and talk about the need to close legislative loopholes when he created a loophole that tobacco companies can drive a menthol cigarette-filled Mack truck through? And even if he now regrets including the menthol exemption, why is he now only calling on the FDA to ban flavored cigars? Where is his letter urging the FDA to close the menthol cigarette loophole that he created to appease Philip Morris?

For the starkness and boldness of this hypocrisy, The Rest of the Story presents the 2011 Hypocrisy of the Year Award to Senator Dick Durbin.

IN MY VIEW: IOM Report Essentially Recommends that Tobacco Research Funds Be Laundered Through Corporate-Influenced Third Parties

2011-12-21T07:16:00.001-05:00

In the last two days, I have commented on two aspects of the IOM report on modified risk tobacco products. First, I argued that the report recommends such stringent scientific standards for the approval of reduced risk products that it puts a nearly insurmountable obstacle in the path of these products and thus helps protect the most highly toxic existing tobacco products. Second, I argued that the report recommends another insurmountable obstacle in the path of reduced risk products: the need to conduct clinical trials with existing cigarettes as a control, which would be unethical.

Today, in the third in a three-part series on the IOM report, I address the IOM committee's suggestion that tobacco companies not be permitted to conduct their own studies in support of modified risk tobacco product applications, but that instead, they should provide funding to an "independent," "third-party" institution to conduct the research.

The reason for this requirement, according to the report, is that: "The history of public distrust and the absence of governance in the tobacco industry have created an isolated industry that lacks not only the expertise to produce the necessary range of credible and reliable data, but it also lacks the trustworthiness to acquire external expertise and avenues to disseminate acquired data."

The solution, according to the report, is: "To improve the credibility of the studies in support of an MRTP application under Section 911, tobacco product sponsors and the CTP should consider facilitating the creation of a third party or third parties for the conduct and oversight of these studies."

What might such a third party entity look like? The report suggests that a "possibility for an organizational model lies in the Reagan-Udall Foundation (RUF), which advises the FDA on modernizing regulatory science. It conducts and oversees studies on regulatory science, particularly in the emerging fields of pharmacogenomics and genomic-based prediction of drug response and adverse event risk."

The Rest of the Story

The IOM report is simplistic and naive in believing that by laundering money through a third-party, research funded by the tobacco industry magically becomes equivalent to research not funded by the industry or to research conducted independently of the industry. The research is still being funded by the tobacco companies and any influence of tobacco funding is not going to suddenly disappear. Instead, what the structure does is create the appearance that research is independent of the industry when in fact, that research is being funded directly by the industry.

In fact, what this could end up doing is reducing scrutiny of such research. Whereas work funded by the tobacco industry would undergo strict scrutiny, by laundering the money through an independent organization, the connection to the tobacco industry would no longer be apparent. The work would take on an automatic assumption of impartiality when such an assumption is not warranted.

An excellent example of this effect is a study conducted by Dr. Claudia Henschke of the use of CT scanning for the early detection of lung cancer.

In an October 26, 2006 article in the New England Journal of Medicine, Dr. Claudia Henschke of Weill Cornell Medical College and a group of other investigators reported the results of a study of the use of low-dose spiral CT scans as a screening tool to detect lung cancer among asymptomatic individuals. The article reported that 85% of patients with lung cancer detected had stage I cancer and the estimated 10-year survival among these patients was 88%. The study concluded that: "Annual spiral CT screening can detect lung cancer that is curable" and that "such screening could prevent some 80% of deaths from lung cancer."

The paper listed its funding sources at the end, one of which was the Foundation for Lung Cancer: Early Detection, Prevention & Treatment.

The New England Journal of Medicine has a policy of not publishing any paper supported with funds from the tobacco industry. Not seeing any disclosure of funding from the industry, the Journal published the paper.

The rest of the story is that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment was, according to a New York Times article, "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands. The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003."

According to the New York Times article and a concurrent article in The Cancer Letter, the Journal of the American Medical Association was also deceived by the absence of disclosure of Dr. Henschke's tobacco funding and would never have published her paper had they known that Henschke received tobacco industry money for her CT screening research.

Had the study been directly funded by Liggett, the article would have had to disclose this. Instead, the article was able to hide behind the Foundation sponsor's name, which sounded independent. Two major medical journals were deceived about the nature of the study's funding and the article did not receive the scrutiny that it would have if it were known that industry funding were behind the study.

The IOM report clearly views tobacco money as being tainted. But the committee is deceiving themselves if they believe that the money is magically cleansed just by passing hands from the tobacco industry to a third party.

Let's now look specifically at the entity which the IOM report puts forward as being an example of what an independent, third-party institution might look like: the Reagan-Udall Foundation.

Far from being an independent entity, the Reagan-Udall Foundation is heavily funded by and partly controlled by industry. On the Board of the Foundation are:

the President and CEO of the Grocery Manufacturers Association;
the President and CEO of GE Healthcare;
a senior adviser to the Genzyme Corporation; and
a group president of Johnson & Johnson.

Thus, the Reagan-Udall Foundation is partially controlled by Big Food, Big Pharma, and Big Biotechnology.

And by statute, the Foundation's Board must include "four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries."

Far from being an independent third-party scientific foundation, the Reagan-Udall Foundation serves as an institutionalized strategy to ensure that industry has a continuing influence on health policy, in spite of the science.

Moreover, it ensures that conflicts of interest abound and that scientific decisions are not made independently from corporate interests.

The Reagan-Udall Foundation has been criticized because it goes a long way toward turning the FDA into a drug company. It has been further criticized because of undue influence by corporate interests. As a Health Care Renewal article by Dr. Roy Poses pointed out, several of the Foundation's Board members who do not directly represent Big Food, Big Pharma, or Big Biotechnology have previously worked for those industries and/or have financial conflicts of interest with those industries. In fact, Dr. Poses notes that a majority (7 of 13) of the original Reagan-Udall Foundation Board members had "ties to the pharmaceutical, biotechnology, and medical device industries." The Health Care Renewal article concludes that: "There is reason for concern that this foundation, despite its relationship to the FDA, is apt to put the interests of these industries ahead of those of the general public."

The article concludes: "The pharmaceutical, biotechnology, and medical device industries already have astounding resources to market their wares and shape public opinion. They don’t need a government sponsored foundation to help them innovate or develop products. The public does deserve a government agency that protect its health and safety by making sure that drugs and devices are safe and effective, and that operates free of the influence of those with vested interests, especially in the drugs and devices the bureau is supposed to evaluate."

An article at 24-7 News summarizes the problem:

"Drug company executives are allowed to serve on a new Food and Drug Administration (FDA)-related board called the Reagan-Udall Foundation. ... The foundation is supposed to help improve the drug approval process, but with so many scandals involving defective drugs in recent years, is it wise to give the pharmaceutical industry so much say on the Reagan-Udall board? Does this just shriek conflict of interest? Well, this new food and drug research foundation, which is affiliated with FDA, brings private companies into a curiously close relationship with regulators like the FDA. Serving as chairman of the Reagan-Udall board is former FDA Commissioner Mark McClellan; executives from drug makers Johnson & Johnson and Genzyme, medical device maker General Electric Company, and the Grocery Manufacturers Association, which includes Hormel Food Corporation and Kellogg Company, were among those picked to lead the Foundation. ... consumer advocates and some lawmakers have criticized the relaxed partnership, stating that allowing companies to fund government-sanctioned research could increase the FDA’s vulnerability to industry clout. They also question how the FDA will be able to objectively review products that incorporate its own research and if this new collaboration will open potential for pressure on the FDA."

Byron Richards describes the Reagan-Udall Foundation in even more alarming terms: "Kennedy and Enzi are claiming that the Reagan-Udall Foundation for the FDA is nothing but a friendly non-governmental research foundation. I will fully document in a subsequent article that this is not the case. It is actually the tool by which Big Pharma and Big Biotech will lock in their profits for the next 50 years, as FDA joins them in the drug development and marketing business. This is one of the greatest safety threats in the history of America."

Representative Rose DeLauro (D-CT) criticized the legislation that created the Reagan-Udall Foundation, calling on the FDA "to cease all activities related to its creation." DeLauro argued that: "the Reagan-Udall Foundation will compromise FDA’s independence and favor the drug industry that will be funding it. Even FDA officials have acknowledged that the donors to the Foundation will have the primary say over how the funds are used."

The IOM committee is deceiving themselves if they think that a so-called "independent" third-party like the Reagan-Udall Foundation is going to use tobacco industry funding to produce unbiased scientific research.

The IOM report wants to have it both ways. It wants to view tobacco industry money as tainted and any tobacco-funded research as non-credible. But then it wants to make tobacco industry funding of research the basis for modified risk product applications. The only difference is that rather than conducting the research itself, the tobacco funding will be laundered through a third party. It just doesn't work. A horse of a different color is still a horse.

The bottom line is that if you are going to regulate the tobacco industry and require the industry to submit scientific research to support its applications for certain classifications of products, you cannot then tell the industry that it cannot conduct research and use that research in its applications.

The rest of the story is that the IOM report play along with the continuing hoax that is the Family Smoking Prevention and Tobacco Control Act. The Act was designed to protect today's highly toxic, existing cigarettes by putting huge obstacles in the way of the introduction of potentially safer products. The anti-smoking groups and politicians who supported the legislation want it to look like they are reforming the tobacco space and forever changing the landscape to favor the protection of the public's health. But the opposite is true. The Act institutionalizes the existing tobacco market and makes true reform almost impossible.

The IOM committee can hide behind the charade of having us believe that research funded by industry automatically becomes objective and unbiased when the money changes hands to a third-party. But the truth isn't all that difficult to see. It's not only the tobacco companies that have been deceptive. It's the anti-smoking movement as well.

IOM Recommendations Place Insurmountable Obstacle in the Way of New Reduced Risk Products By Requiring Research that Cannot Ethically Be Conducted

2011-12-20T07:43:00.000-05:00

Yesterday, I provided my evaluation of the IOM report on modified risk tobacco products, opining that the rigorous scientific standards recommended by the report to support a modified risk product application place a nearly insurmountable obstacle in the way of the development of truly reduced risk products, and therefore serve as a death knell for harm reduction as a viable strategy to reduce the disease and death caused by cigarettes in the United States. I noted that the report is consistent with the clear intentions of the politicians and anti-smoking groups which supported the Tobacco Act, which I believe was intended to protect the existing high-risk cigarette market.

Today, I reveal an additional reason why the IOM report recommendations place an insurmountable obstacle on the development and approval of new reduced risk tobacco products. This one is not a logistic or economic obstacle, but an ethical one.

The Rest of the Story

The IOM report recommends that a new tobacco product that wishes to be marketed as a reduced risk product must be tested in a clinical trial in comparison to a regular (existing) product. Specifically: "Any clinical trial should include at least two control conditions—usual brand use and cessation—to allow examination of the relative effects of the MRTP on biomarkers of exposure or risk."

Suppose that a company wishes to demonstrate that a new cigarette - Brand X - reduces individual risk. The IOM recommendations require it to conduct a clinical trial comparing Brand X to an existing cigarette brand. Thus, one group of subjects would be randomized to switch to brand X, and another group of subjects would be randomized to continue to smoke their usual brand.

In my view, this is an unethical research protocol, and I would hope that no IRB in the country would approve such a protocol. Because of the known severe risks of cigarette smoking, it is not ethical to randomize subjects to a condition characterized by smoking cigarettes as usual. No IRB would or should approve such a protocol.

In fact, the only condition in which a randomized clinical trial involving cigarettes is ethically appropriate is when the study is designed to assess smoking cessation (or at least reduction in smoking). For example, one could test a new product designed to help smokers quit by randomizing smokers to receive either the new product or usual cessation care (i.e., nicotine replacement therapy). But you can't include a control group which is instructed to continue to smoke their regular cigarettes.

You can easily see how the IOM report's basic strategy of requiring clinical trials to demonstrate reduced risk of tobacco products is fundamentally flawed. In order to compare a new product with an existing product in a randomized clinical trial, you need to randomize subjects to either smoke the new cigarette or their usual cigarette. But it is unethical to instruct subjects to continue to smoke regular cigarettes.

If the subjects don't continue to smoke their regular cigarettes, then the clinical trial falls apart because you need a large sample of subjects who continue to smoke their usual brand in order to maintain an adequately sized control group. That smokers quitting would harm the scientific value of the study is a serious ethical breach that cannot be tolerated.

Imagine a randomized clinical trial of electronic cigarettes compared to regular cigarettes. Such a study, according to the standards recommended by the IOM report, would be required. No IRB in its right mind would approve a trial in which subjects were randomized to either use electronic cigarettes or to smoke Marlboros. Clearly, such a study cannot be done. The IOM recommendations amount to a catch-22 by which companies can never produce the scientific evidence that is required to achieve reduced risk product status.

The rest of the story, then, is that the IOM report is recommending that in order to obtain approval of a tobacco product as a modified risk product, a company must conduct randomized clinical trials that are unethical. Elsewhere, of course, the report emphasizes that all scientific studies must meet basic ethical standards. Thus, the result is a recommendation which places an insurmountable obstacle before companies wishing to develop reduced risk products.

The IOM report proposes a system of scientific study of reduced risk cigarettes by which these products would be studied using the typical pharmaceutical drug model. Companies would have to apply for an IND (Investigational New Drug) application and after preclinical studies, conduct phase II and phase III clinical trials, which - as I noted above - would be unethical. Not only is this a catch-22, but this regulatory model makes a travesty of the FDA's regulation of pharmaceuticals by placing cigarettes in the same category as drugs.

The IOM report states: "In the case of a truly new product (where nothing similar is sold elsewhere) an Investigational New Drug application model could be the most appropriate approach. In such cases, then, the FDA could require that preclinical laboratory testing be completed before moving to animal or human studies (e.g., phase I), which would have to be justified by significant findings in the laboratory work. If preclinical findings pointed to potential reduced exposure, then the FDA could authorize phase II or III trials to explore the experience of reduced exposure in larger human populations under controlled conditions (e.g., RCTs)."

This proposal, in my view, would undermine the entire FDA system of drug regulation. Tobacco products are not drugs and they should not be treated as such, even if they are potentially lower risk compared to traditional cigarettes. The IND/randomized clinical trial approach is appropriate for pharmaceutical products that are going to be regulated under the federal Food, Drug, and Cosmetic Act (FDCA). But it is not appropriate for tobacco products, which are recreational products not intended to prevent or treat any disease. Putting them into that category does not make any sense.

It should seem pretty clear at this point that what the IOM report is doing is trying to fit a square peg into a round hole. The regulatory scheme created by the FDA Act for tobacco products simply doesn't fit these products. The scheme would be appropriate for pharmaceutical drugs, but it just doesn't fit for recreational (and inherently hazardous) tobacco products.

Now, I am convinced more than ever that the Tobacco Act must be amended by Congress if there is to be any meaningful and effective national harm reduction strategy to reduce the disease and death caused by cigarettes and other tobacco products.

IOM Report on Modified Risk Tobacco Products Interprets Tobacco Act as Putting Insurmountable Barriers in the Way of Reduced Risk Tobacco Products

2011-12-19T07:11:00.002-05:00

The Institute of Medicine last week released its long-awaited report on the scientific evidence required to support designation of tobacco products as modified risk products under the Family Smoking Prevention and Tobacco Control Act [the Tobacco Act].

The report recommends that extensive scientific evidence, including findings from randomized controlled trials and longitudinal cohort studies, be required to show that potential reduced risk products will reduce individual health risks and improve the public's health on a population basis.

The report summarizes the rigorous nature of the scientific evidence required as follows: "The evaluation of the effect of MRTPs on public health will require a wide range of evidence and therefore will require many different types of study designs, including studies of the composition of MRTPs and studies of human exposure, human health effects, the likelihood of addiction and abuse, and the perception and understanding of the product by the public. Furthermore, the evidence must be able to reliably support predictions about the effect of marketing the product on public health, and therefore these studies must be properly designed and rigorously conducted. Study designs will need to include all relevant populations including populations at a high risk for tobacco use. Study designs must be able to not only support inferences about the mechanisms of the products effects, but they must also be able to support predictions about the products’ effects in the real world."

The report makes it clear that demonstration of reduced risk cannot be made based simply on laboratory or pre-clinical studies, but requires the conduct of clinical trials and long-term longitudinal cohort studies.

As the report states: "there is no proof that any individual constituent or group of constituents is responsible for a given disease. For a biomarker of exposure to be accepted as a biomarker of risk or a surrogate endpoint of disease, there should be a strong biological rational as well as compelling data from clinical and epidemiologic studies. Experimental designs, in particular randomized controlled trials (RCTs), provide data that can support the strong inferences about the effect of an MRTP on human health relative to conventional tobacco products. The use of appropriately designed clinical trials will be important to establish whether the use of the MRTP reduces exposure to toxicants or induces positive changes in surrogate markers as claimed by the manufacturer. An RCT is an effective means of examining acceptability and use of the MRTP, the ability of the MRTP to increase cessation in users of conventional tobacco products, and the likelihood that availability of the MRTP will lead to dual use. RCT methods can also produce evidence on whether and how much individuals use an MRTP after they have used it to help them quit conventional products, changes in perception of the MRTP with its continued use, and the MRTP’s ability to suppress tobacco withdrawal symptoms. It is important to recognize that no single RCT can address all of these areas, and each study should have a focused objective with a primary endpoint."

"Long, intensive, and robust observational studies of actual health outcomes may be required to fully evaluate the net effects of MRTPs relative to conventional tobacco products. Prospective cohort studies are obvious candidates for the evaluation of MRTPs, and will also be an essential tool to validating anticipated or claimed effects of marketed MRTPs on both individuals and on the public’s health."

"It is clear that no single class of evidence (e.g., preclinical, RCTs, consumer perception, epidemiologic) in itself will be sufficient to support an MRTP application."

Thus, not only must the applicant demonstrate an improvement in individual and population health through randomized controlled trials and long-term longitudinal studies, but multiple clinical trials are required.

Moreover, the report recommends that tobacco companies not be allowed to submit their own research findings: "the committee concluded that the tobacco industry currently lacks not only the trustworthiness, but also lacks the expertise, infrastructure, and other resources needed to independently produce the scientific evidence necessary to meet the public health standards set by the law."

Instead, the report insists that tobacco companies must contract with independent third parties to conduct the required research.

The Rest of the Story

The scientific requirements recommended by the IOM report are so rigorous that I believe the implementation of such standards would place an insurmountable, or virtually insurmountable, obstacle in the way of the development and marketing of truly reduced risk tobacco products. I believe that these standards would be a de facto death knell for the strategy of harm reduction as a tool for controlling tobacco-related disease in the United States.

The requirements for conducting long-term epidemiologic studies and randomized clinical trials to demonstrate reduced individual and population risk are so burdensome that they remove most of the incentive to develop such products, especially since there is no guarantee that long-term studies will support the approval of such products. In addition, the length of time required to conduct these studies is prohibitive in most cases.

Consider the need to demonstrate a reduction in cancer risk. Cancer takes many years to develop so one cannot simply conduct a two-year cohort study to determine whether a new type of cigarette will reduce cancer risk. It would take a minimum of perhaps ten years to know whether the product reduces cancer risk. Very few companies are going to want to expend the amount of money required to carry out such long-term studies, with no guarantee of success.

Moreover, the requirements for randomized clinical trials that include a control group of regular cigarette users cannot be followed while still conducting ethical research. You cannot ethically randomize human subjects to smoke regular cigarettes. I will write more about this in a separate post tomorrow.

The Two Pathways for Modified Risk Products

There are two possible pathways for modified risk tobacco products: the reduced risk pathway and the reduced exposure pathway. Reduced risk products are those for which the manufacturer wishes to claim that the product is safer than other products on the market. Reduced exposure products are those for which the manufacturer will not make any explicit health claim, but will merely inform consumers that it contains less of a certain constituent, or is free of a particular constituent.

For the reduced risk pathway, the IOM report makes it clear that the manufacturer must show that the product will reduce health risks to individual users and to the population as a whole. This is a very high scientific standard, one that can only be met through long-term epidemiologic studies with thousands of product users in order to establish the long-term relative risks of using these products.

However, this produces a catch-22 situation: A manufacturer cannot market a product until it demonstrates that it reduces individual risk. But a manufacturer cannot demonstrate that the product reduces individual risk unless it first markets the product. Receiving special FDA permission to test market the product in a small population will not allow the large sample size necessary to examine the effects of these products on cancer risk. Such studies require perhaps hundreds of thousands of users in order to have enough power to detect differences in cancer risk.

Thus, it is virtually, if not literally impossible for any reduced risk product ever to be approved by the FDA under these scientific standards.

For the reduced exposure pathway, the manufacturer need only show that the product does indeed decrease exposure to a particular constituent or constituents and that a corresponding reduction in health risk is "reasonably likely." This is possible to do with laboratory studies, so it is feasible to make the necessary demonstrations to the Agency.

However, there is a third requirement: the manufacturer must show that as it plans to package and market the product, consumers will not believe that the product reduces their risk. In other words, even though consumers know that the product reduces exposure, they must not believe that it reduces risk.

This, again, creates a nearly impossible task. If consumers are aware that a product reduces exposure to one or more harmful substances, they are naturally going to believe that it reduces their risk of disease. The only way to avoid this perception would be not to tell consumers that the product reduces exposure. But in that case, the new product is no longer a reduced exposure product and so it cannot be approved for marketing in the United States.

Thus, the FDA Tobacco Act creates another catch-22: A manufacturer cannot market a product as reduced exposure unless it can show that consumers will not perceive it to be less harmful. But consumers will only perceive that the product is not any less harmful if it is not marketed as reduced exposure.

This provision, in other words, makes it virtually, if not literally impossible to market a reduced exposure product. One would have to make very limited claims that do not result in consumers believing the product is any safer. But if consumers don't believe the product is any safer, then why would they want to switch to that product? It would not be cost-effective to market the product, because it surely would not compete with existing products on the market in the absence of any consumer belief that the new product is safer.

Consistency of the IOM Report Recommendations with the Tobacco Act

I need to make it clear that I am not criticizing the IOM report for an overly stringent interpretation of the Tobacco Act. It is my opinion, which I expressed before the Tobacco Act was even enacted, that the above implications of the modified risk tobacco product provisions of the Tobacco Act were exactly what Congress and the anti-smoking groups which supported the legislation desired.

So I believe that the IOM report is accurately outlining the rigorous scientific evidence that the statute requires. I believe that a major purpose of the FDA Tobacco Act was specifically to put a huge barrier in the way of modified risk products, which have long been despised by the anti-smoking groups (and usually with good reason). But the climate has changed (e.g., consider the development of electronic cigarettes, which contain no tobacco) and the law needs to change with the climate. Unfortunately, the Tobacco Act employs an old picture of the tobacco product space and inhibits a true harm reduction approach in favor of preventing deceptive marketing that characterized the previous century, when there was no federal regulation of tobacco products. The times have changed, but the Act's view of the times has not. As a result, the Act essentially nixes harm reduction as a viable tobacco control strategy in favor of protecting the existing high-risk cigarette market. Even the tobacco companies recognize that this is an antiquated view; they desire to bring reduced risk products into their portfolios.

The rest of the story, then, is that the Tobacco Act's modified risk provisions simply make no sense. It is essentially a hoax, designed to make it look like the policy makers and health groups are interested in protecting the health of smokers, but instead, if you actually read the fine print, you'll find that the law sacrifices the health of smokers by making it impossible for tobacco companies or public health groups to pursue a harm reduction strategy. The Act preserves the existing market of the highest risk tobacco products and stifles competition from alternative products that might truly reduce health risks. The IOM report's interpretation of the Act is perfectly consistent with the statute.

This is not science-based policy. It is protectionism. Protection of the status quo. Protection of the existing tobacco market. The anti-smoking groups are not interested in actually protecting the health of smokers by encouraging them to use potentially less harmful alternatives. Instead, they are protecting the highest risk products and making sure that smokers continue smoking these high-risk products and that they do not switch to products that could potentially save their lives, or at least greatly reduce their risk of disease.

My Analysis of IOM Report on Modified Risk Tobacco Products Will Be Posted Monday and Tuesday

2011-12-16T09:07:00.002-05:00

I am not posting today, as I am busy digesting the very long IOM report on Modified Risk Tobacco Products. My commentaries on that report will be posted on Monday and Tuesday. If anyone has read the report and would like to comment, feel free to use this comment section to do so. In the mean time, I will be at work reading and analyzing the report.

2009 National Conference on Tobacco or Health Sacrifices Scientific Integrity By Accepting Sponsorship from Big Pharma

2011-12-14T07:50:00.000-05:00

The 2009 National Conference on Tobacco or Health, held in Phoenix from June 10-12, included two major program areas related to smoking cessation and the strategies used to promote cessation:

1. "Cessation (CESS)—Includes: reimbursement and insurance issues; telephone quitline services; innovative delivery methods; cessation programs in workplace, health care, or other settings; cessation programs for youth and adults; cessation interventions for specific populations; and cessation training programs and certification."

2. "Nicotine and the Science of Addiction (N&SCI)—Includes: research related to addiction; scientific rationale for tobacco control policies; current research in nicotine and other components of tobacco; and current research in addiction."

The Rest of the Story

The National Conference on Tobacco or Health sacrificed its scientific integrity for money. By accepting this sponsorship from Pfizer, the conference assured that no objective and unconflicted discussion of the effective strategies for smoking cessation could take place.

For example, how could an objective discussion of the risks of Chantix use possibly occur at the conference? To be sure, the conference was not going to highlight or even accept any talks on the deaths caused by Chantix. Doing so would risk future sponsorship.

How could one expect that the conference would include in the program a talk on the hundreds of cases of violent and often fatal adverse effects that have been reported with Chantix when the drug's manufacturer was a major sponsor of the conference?

The pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors. This bias does not necessarily have to be conscious. In fact, the most concerning bias is that which could arise subconsciously by virtue of the sponsorship of the conference by Big Pharma.

There were numerous papers presented about the effects of smoking cessation drugs. How can these papers present a completely objective picture of the efficacy of these medications when the manufacturers of these drugs are the very sponsors of the conference?

This is in no way to fault the individual scientists who presented on these issues at the conference. Nor is it to suggest that any wrongdoing occurred. It is merely to point out that the pharmaceutical sponsorship creates, by its very existence, an unavoidable bias that precludes a truly objective consideration of any scientific issue that may have significant implications for the profitability of smoking cessation drugs, and therefore, for their manufacturers who are conference sponsors.

The rest of the story is that the funding by Pfizer creates a substantial conflict of interest that precludes the objective consideration of many important scientific issues; in particular, the role of smoking cessation drugs as part of national tobacco control strategies.

Will the 2012 National Conference on Tobacco or Health accept pharmaceutical company sponsorship? I have put the odds of the Conference not accepting Big Pharma funding at 13:1, with the early over/under at $20,000. Readers are invited to place their bets on either the accept/not accept or over/under betting lines. Unlike wealthy political candidates, bets as large as $10,000 are not accepted. We'll stick with friendly bets for now.

Greek Health Ministry Will Reportedly Help Improve Cigarette Sales by Banning Electronic Cigarettes

2011-12-13T07:37:00.000-05:00

According to an article at ekathimerini.com, the Greek Health Ministry is in the process of banning the sale of electronic cigarettes because they contain nicotine and may pose a health risk. According to the article: "As electronic cigarettes are embraced by smokers trying to kick the habit or to abide by a ban on smoking in public places, the Health Ministry is reportedly planning to forbid the trade and use of the electrical device, noting that it contains nicotine and remains a health risk."

The Rest of the Story

Because electronic cigarettes are embraced by smokers trying to kick the habit, banning these products makes no public health sense. What the Greek Health Ministry is apparently saying is that they would rather smokers continue to smoke the well-proven to be deadly tobacco cigarettes rather than to quit smoking by using a product that is free of tobacco and produces no smoke.

This action will harm both smokers and nonsmokers. Smokers who have successfully quit or cut down significantly using electronic cigarettes will essentially be forced to return to smoking tobacco cigarettes full-time. Nonsmokers who were protected from secondhand smoke because the people they live with switched to electronic cigarettes will again be exposed to secondhand smoke. This is a lose-lose proposition.

There are two entities whose profits will increase as a result of the Greek government's action. First, the tobacco industry will regain sales from smokers who had switched over, in whole or in part, to electronic cigarettes. Second, the pharmaceutical industry will regain sales from smokers who used electronic cigarettes, rather than pharmaceutical products, in their efforts to quit smoking.

The fact that electronic cigarettes contain nicotine is no reason to ban the product. What sense is there in allowing nicotine to be sold when accompanied by over 10,000 other chemicals, including more than 60 carcinogens, but not allowing nicotine to be sold with only a few other chemicals, none of which have been demonstrated to be hazardous at the levels that occur in the vapor produced by electronic cigarettes?

As far as health risks beyond the nicotine, none of yet been identified. Tobacco-specific nitrosamines were found to be present only at trace levels, comparable to the levels in nicotine gum and nicotine patches, and at 1400 times lower a level than present in some cigarettes. Diethylene glycol has so far been identified in only one brand of electronic cigarettes, which I believe is no longer sold. Long-term inhalation of propylene glycol has been hypothesized to be potentially toxic, but preliminary studies have not substantiated this concern. Other than these three specific concerns, there are no other specific health risks that have been identified.

According to Action on Smoking and Health, other countries in which electronic cigarettes have been banned include Brazil, Australia, Canada, Israel, Mexico, and New Zealand.

Ironically, it is the health authorities in these countries which are protecting the profits of tobacco companies at the expense of the public's health.

Department of Health and Human Services Shows It is Driven by Politics, Not Science; Sibelius Overrules FDA and Bans Over-the-Counter Plan B Access

2011-12-12T07:25:00.000-05:00

In an unprecedented move, the Secretary of Health and Human Services - Kathleen Sibelius - overruled an FDA decision that would have removed the age restriction on over-the-counter sales of the morning after pill (also called plan B or emergency contraception), allowing access to the pill for girls below age 17 (the lower limit for sale would have been age 11).

It is thought that this is the first time that the Secretary of Health and Human Services has overruled an FDA action.

There is strong evidence that the morning after pill is safe and effective for girls between the ages of 11-16. Research has shown specifically that 11-16 year-old girls are able to read and understand the directions, use the product safely and effectively, and do both of these without physician consultation. The only significant side effect is nausea, which lasts a few hours (nausea associated with pregnancy can last months). There is no risk of overdose. Moreover, there is strong evidence that availability of the medication does not lead to increased unprotected sex among adolescents or young girls.

In other words, as the American Council on Science and Health emphasized in its Facts and Fears column last Thursday, there is no medical or scientific reason to overrule the FDA's decision.

What was Secretary Sebelius' reason for overturning the FDA's decision? According to several newspaper articles, the Secretary argued that young girls are unable to "understand the instructions." Sebelius noted that: "there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age."

The Rest of the Story

Secretary Sibelius argued that the cognitive differences between older and younger adolescent girls renders the younger girls incapable of understanding and following the instructions for the use of the morning after pill.

Let's examine, then, the instructions to see how hard it might be for an 11- or 12-year-old girl to follow them.

The instructions are as follows: "Take one white pill."

Now I can see where Dr. Sibelius is coming from. The instructions entail taking one pill. That seems far too difficult for an 11-year old to comprehend. Clearly, the girl would need to consult with her physician to understand what she is supposed to do.

For one thing, she may not understand the number one. Her doctor can review her numbers with her and explain what is meant by the number one.

For a second thing, she may not know her colors. The physician can explain to her what "white" means by giving examples of things that are white.

It's hard to fathom how an 11-year-old would be able to comprehend instructions as complicated as "take one white pill."

President Obama supported the Secretary's decision, arguing that the younger girls may not be able to use the pill properly.

I see the President's point here. A 14-year-old might mistakenly think that the pill is designed to be placed into the ear, rather than swallowed. Or she might think that, like snus, the pill is supposed to be placed in the nasal cavity. There are innumerable ways in which girls could use the pill improperly.

Clearly, the arguments being put forward by both Secretary Sibelius and President Obama are a smokescreen. They make no sense. It is quite evident that the real reason for their opposition to the pill are political. They are afraid that the decision to make the pill available could be used against the President in the 2012 presidential election campaign, especially since his opponent is certainly going to be a strong conservative candidate.

This is an egregious example of politics, rather than science, guiding federal public health policy. It is also the reason why I am not optimistic about the federal government - including the current administration - taking any major action that would actually put a dent in cigarette sales. When it comes down to it, politics will outweigh science and we're not going to see any major policy action that would substantially reduce the government's cigarette tax revenues. This is just one reason why I don't think a menthol cigarette ban will see the light of day, and certainly not before the 2012 election.

The rest of the story is that despite the promises when President Obama took office, politics - and not science - is still dictating federal public health policy. This is hardly what I imagine President Obama had in mind when in his inaugural address he called for "science to be restored to its rightful place."

Medical Scientists to Smokers: Keep Smoking, Don't Quit Using Electronic Cigarettes

2011-12-09T08:50:00.002-05:00

In their print and radio column entitled "Medical Discovery News," two biomedical scientists have urged smokers not to use electronic cigarettes to quit smoking, even though thousands of ex-smokers have successfully quit using these devices and many have experienced remarkable improvement in their health.

The scientists express four major concerns about electronic cigarettes:
1. Nicotine delivery is variable.
2. The products contain nitrosamines.
3. The products contain other toxic chemicals.
4. Youth may find the product appealing.

The authors write: "For scientists, those are enough reasons to not try an e-cigarette. At the very least, wait until science shows what is in them before smoking one, or better yet, choose not to smoke at all."

The Rest of the Story

Let's examine each of the four concerns:

1. Nicotine delivery is variable.

So what? In what way does this create harm to users? The effect of having variable nicotine delivery is simply that the product may be less effective in smoking cessation. But there is no harm to users. In fact, variable nicotine delivery would make the product less addictive than regular cigarettes.

2. The products contain nitrosamines.

The authors don't tell you the rest of the story, which is that the level of tobacco-specific nitrosamines in electronic cigarettes are orders of magnitude lower than in regular cigarettes (about 1400 times lower than in Marlboros). Moreover, the level of tobacco-specific nitrosamines are comparable to what is found in nicotine patches and nicotine gum. But the authors do not recommend that smokers refrain from using those products. If anything, the FDA laboratory finding of only trace levels of tobacco-specific nitrosamines in electronic cigarettes shows that these products are much safer than cigarettes in terms of their carcinogenic potential.

3. The products contain other toxic chemicals.

OK. What are they? And where is the evidence that they are harmful to users? And what health effects do they cause? The components of electronic cigarettes have been studied extensively, and so far no one has suggested a particular chemical delivered by these products that has been shown to be harmful. What we do know is that while there are only a handful of chemicals in electronic cigarettes, there are more than 10,000 in regular cigarettes, including more than 60 carcinogens. Which product do you think is likely to be safer?

4. Youth may find the product appealing.

This is a valid concern. However, to date there is no evidence that youth are actually using the product. This is certainly something that needs to monitored, and youth access to electronic cigarettes certainly has to be regulated, but this is not a reason to recommend that smokers not use electronic cigarettes to get off regular ones.

Unfortunately, what these scientists are recommending is essentially that smokers should keep smoking rather than switch to electronic cigarettes. I find this to be irresponsible medical advice. There's no question that smokers are much better off quitting smoking and switching to electronic cigarettes than continuing to smoke. There is strong evidence that electronic cigarettes are much safer and there is strong anecdotal evidence that there is an immediate health improvement among smokers who switch to electronic cigarettes.

The reality is that NRT and other smoking cessation drugs are ineffective, with failure rates of greater than 90% over the long-term. In that light, it seems irresponsible to tell smokers - most of whom have tried to quit and failed with NRT - that they should continue to try using this ineffective method that has already failed them. Essentially, that is tantamount to telling them to continue smoking. I find that to be really bad medical advice.

Menthol Cigarette Use Among Youths Soars While Anti-Smoking Groups and Policy Makers Congratulate Themselves for Getting Rid of Flavored Cigarettes

2011-12-08T08:54:00.000-05:00

According to an article on the Minnesota Public Radio web site, the Minnesota Department of Health reported this week that no progress has been made in recent years in reducing smoking among youth. According to the article: "Public health officials are disappointed with new findings that show there has been no significant change in tobacco usage among teenagers during the past few years. The Minnesota Department of Health survey shows that among high schoolers tobacco use remains stagnant, at around 26 percent."

Perhaps the most striking finding of the survey is that "the use of menthol cigarettes has more than doubled among teenage smokers in the past decade."

According to the Minnesota Department of Health's press release, in 2000, menthol cigarette use among high school students in Minnesota was 19.9%. In 2011, the prevalence of menthol cigarette use rose to 47.3%. There was a substantial increase in menthol cigarette use in the past three years, from 39.1% in 2008 to 47.3% in 2011.

The Rest of the Story

These findings stand in stark contrast to the proclamations of anti-smoking groups and policy makers that the Tobacco Act put an end to flavored cigarettes and eliminated the tobacco industry's ability to addict kids with flavored cigarettes.

For example, in a communication sent to the American Cancer Society's (ACS) network of advocates throughout the nation in June 2009, the American Cancer Society stated: "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned." Thus, the American Cancer Society claimed that the Tobacco Act bans all flavored tobacco products that might seduce children.

In a press release issued by the FDA in 2009, the U.S. Department of Health and Human Services Assistant Secretary for Health stated that: "Flavored cigarettes attract and allure kids into lifetime addiction. FDA's ban on these cigarettes will break that cycle for the more than 3,600 young people who start smoking daily." Thus, the Department was claiming that all flavored cigarettes were now banned and that this policy would have a major impact on reducing the use of flavored cigarettes among youth.

The truth is that the use of flavored cigarettes among youth has increased, not decreased since the implementation of the Tobacco Act.

The rest of the story is that while the national anti-smoking groups and policy makers congratulate themselves for having protected youths from addiction by flavored cigarettes, the proportion of youths smoking flavored cigarettes appear to be higher now than ever before.

CDC Seems to Know the Answer Before Starting the Research on Economic Effects of Smoke-Free Bars and Restaurants

2011-12-07T07:27:00.000-05:00

The Centers for Disease Control and Prevention (CDC) recently announced that it was partnering with Pfizer to conduct a study on the economic impact of smoke-free bar and restaurant laws. On Monday, I questioned whether this partnership with a pharmaceutical company, about whose products the CDC makes national policy recommendations, taints the agency's scientific objectivity. Today, I question whether CDC has answered the research question before actually conducting the study and therefore, I suggest that the agency may be wasting Pfizer's money since the answer seems to already be known.

The Rest of the Story

In the press release announcing the study, CDC Director Thomas Frieden states: "Making worksites, restaurants, and bars smoke-free saves lives, increases productivity, reduces health care costs, and doesn’t hurt business."

If smoke-free laws do not hurt business, then haven't we already answered the question? This statement by CDC's director seems to imply that we have answered the question before having started the research. If that's the case, then what's the point of doing the research? Isn't this a waste of Pfizer's money?

What's most interesting to me is not that CDC appears to have answered the question before starting the research, but that no one even attempted to hide that fact. The CDC director comes right out and tells us the answer to the research question, before Pfizer's money is even put to work.

This also raises the question of how objective the research process can be if the agency conducting the study has already drawn a conclusion.

(Thanks to Pam Parker for the tip.)

CDC Partnership with Pfizer Puts Question Mark on Its Scientific Objectivity

2011-12-05T07:24:00.000-05:00

According to a CDC Foundation press release, the CDC Foundation, the CDC, and Pfizer have formed a partnership, made possible by Pfizer funding, to conduct a study examining the economic impact of smoke-free bar and restaurant laws in nine states.

According to the press release: "As part of ongoing efforts to reduce disease and death caused by smoking and secondhand smoke exposure, the CDC Foundation and CDC have launched a new initiative to study the economic impact of smoke-free policies on restaurants and bars in nine states. ... This initiative, made possible by a partnership grant from Pfizer to the CDC Foundation, will assess the economic impact of local smoke-free laws on restaurants and bars by examining objective economic indicators." ...

"'We deeply appreciate our ongoing partnership with Pfizer to support CDC’s work to protect us all from dangerous and expensive health threats,' says Charles Stokes, president and CEO of the CDC Foundation. 'Each public-partnership forged through the CDC Foundation helps CDC put science into action to save lives. We believe this innovative partnership, which was made possible by Pfizer, could substantially improve health for many individuals and communities.'"

"'As part of Pfizer's commitment to addressing important public health needs, we are proud to partner with the CDC Foundation on this research initiative,' said Freda C. Lewis-Hall, M.D., FAPA, chief medical officer and executive vice president, Pfizer. 'Our goal is to help the CDC Foundation, working with CDC and other partners, provide state and local health groups with an independent, objective assessment of the economic impact of smoke-free policies on restaurants and bars. We hope that the results of this analysis will advance efforts to reduce secondhand smoke and the serious health risks it poses to nonsmokers.'"

The Rest of the Story

According to the CDC Foundation, it accepts partnerships only if they "present no conflict of interest for CDC or the CDC Foundation."

I do not understand how the CDC can argue that partnering with Pfizer is not a conflict of interest. If CDC conducted no work that related to the approval of disapproval of products manufactured by Pfizer, I would agree that the partnership does not represent a conflict of interest. But that is not the case. The CDC reviews and issues approval or disapproval to products manufactured by Pfizer and other pharmaceutical companies all the time.

For example, the CDC makes recommendations regarding the use of vaccines. One vaccine about which the CDC deliberated was Pfizer's Prevnar. The CDC Advisory Committee on Immunization Practices (ACIP) regularly makes recommendations regarding the use of vaccines.

Furthermore, CDC makes recommendations regarding a wide range of other drugs, related to the prevention and treatment of all sorts of infectious and chronic diseases.

Through its partnership with CDC and the CDC Foundation, Pfizer has the potential to gain an increased corporate image among CDC staff, and therefore, to influence decisions that the CDC makes about the approval or disapproval of Pfizer products. I am not arguing that the influence is a conscious one. I’m not saying that CDC will consciously say to itself: we received money from Pfizer so let’s be extra nice to them in our formulation of public recommendations. However, I do believe that the receipt of this funding from Pfizer, which the CDC Foundation praises heavily in its press release, will have the effect of improving the company’s image within the agency, and that it could potentially have a subconscious effect on the agency and therefore influence its actions. This is precisely how conflicts of interest work.

If this were an individual researcher rather than an agency, there is no question that the partnership with Pfizer and other pharmaceutical companies would represent a conflict of interest. I see no reason why it is not a conflict just because the CDC is an agency rather than an individual. The conflict of interest would be expected to work in exactly the same way.

The CDC Foundation has a large number of partnerships with Big Pharma companies, including GlaxoSmithKline, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Novartis, and Sanofi-Aventis. So the problem is not restricted to this one partnership with Pfizer.

The CDC Foundation also partners with the Coca-Cola Company. According to the CDC Foundation, partnerships are only accepted with "Corporations whose goals or philanthropic interests align with CDC’s work...".

In what way do Coca-Cola’s goals align with those of CDC? The CDC is in the business of trying to improve the public’s health. Coca-Cola is in the business of trying to market and sell sugar-laden soft drinks that contribute to the obesity epidemic. The CDC presumably favors school nutrition improvement. Coca-Cola has opposed virtually every piece of state legislation to improve school nutrition. The CDC presumably wants to decrease the consumption of sugar-laden soft drinks. Coca-Cola is working to sustain the sales of its sugar-laden soft drinks.

Don’t get me wrong. I’m not criticizing Coca-Cola. They are not in business to reduce obesity. They are in business to sell soft drinks and I wouldn’t argue that they should do otherwise. If anything, I commend Coca-Cola for being brilliant enough to use its money in a way that may soften the CDC’s stance on sugar-laden soft drinks.

The CDC Foundation also partners with Abbott Laboratories.

How could the CDC’s partnership with Abbott Laboratories not constitute a violation of its corporate partnership policy? Abbott Laboratories is one of the leading manufacturers of infant formula, which it is pushing to pregnant women through programs such as the giveaway of infant formula in hospitals. Presumably, the CDC has a vested interest in promoting increased breastfeeding and reduced use of infant formula. This certainly appears to represent a conflict of interest.

The CDC Foundation also partners with Georgia Pacific.

How could CDC’s partnership with Georgia Pacific not constitute a conflict of interest? Georgia Pacific is one of the nation's leading corporate polluters. In what way does that align with CDC's mission and goals?

The rest of the story is that through its corporate partnerships with companies which either produce products that are causing harm to the public or which are within the scope of CDC’s public recommendations, the CDC Foundation is creating significant conflict of interests that conflict with its stated policy of avoiding such conflicts. I believe that these partnerships taint the scientific objectivity of the agency, are inconsistent with the stated mission and policy of the CDC and CDC Foundation, and represent a disservice to the public’s interest.

In Defense of Investigators With Conflicts of Interest

2011-12-01T11:42:00.002-05:00

Over the course of the past several years, I have provided a number of critiques of research whose conclusions I believed were flawed and in which one or more investigators had a financial conflict of interest, leading me to suggest that the situation had the appearance of the conflict possibly affecting the interpretation and presentation of the research findings and conclusions. It has come to my attention that a number of readers have misinterpreted these commentaries as having questioned the integrity or character of the investigators with the conflicts of interest.

Today, I want to clarify and state explicitly that this is not the case. I do not believe that having a financial conflict of interest represents any wrongdoing, nor do I think that allowing such an interest to affect one's interpretation of the study findings represents any wrongdoing or reflects on the integrity, character, or honesty of the investigator.

Rather, I think that these situations involve bias, which is not related to wrongdoing, dishonesty, or lack of integrity. Bias is simply a perspective through which one sees, designs, conducts, interprets, and presents research. It has no moral value; it is simply the existence of a perspective, schema, or frame that tends to lead to the systematic interpretation of research data in a particular direction, or with a particular slant or angle. There is nothing wrong with it from the perspective of ethics, character, or integrity. In short, it is simply a reflection of being human.

Let me flesh this out a bit.

First, there is nothing wrong with an investigator having a conflict of interest. In fact, much of the great progress in the area of pharmaceuticals has been made specifically because researchers with relationships with pharmaceutical companies have been involved in the drug development process. Pharmaceutical funding of clinical trials is critical and without it significant advances in medical treatment would not occur. Researchers consulting for pharmaceutical companies is a natural offspring of these collaborative relationships and can contribute positively toward the identification and development of new and more effective medications. So there is nothing wrong with an investigator possessing a conflict of interest.

Second, if an investigator has a conflict of interest and conducts research despite that conflict, she is not doing anything wrong or unethical, assuming that the research is in compliance with her university's conflict of interest policies.

Third, even if a researcher is influenced by a conflict of interest in the conduct or presentation of research results, it is not wrongdoing. It does not necessarily reflect on the character or integrity or the investigator. Except in rare cases, the influence of conflicts of interest is subconscious. The concern is not that the investigator will intentionally and knowingly skew the presentation of results to favor the drug under study. That would be blatant investigator bias and would be unethical. However, in the overwhelming number of cases (and in all of the ones I've blogged in the past few months), the concern is that a conflict of interest could have a subconscious effect on the reporting of the results and the interpretation of findings. When this occurs, it is not a reflection of wrongdoing or lack of integrity; rather, it is simply a reflection of being human.

Several investigators have responded to my comments by stating things like: "I would never allow a conflict to affect my research." These comments show a misunderstanding of what I am arguing. I am not arguing that investigators are purposely skewing their results because they have a financial relationship with a company and want to make sure that the research doesn't hurt the financial value of the company. Instead, I believe that conflicts of interest operate beneath the consciousness of the investigator. By definition, the conflict would influence the investigator without his knowledge or awareness. You cannot be human and at the same time be completely immune from having a financial relationship affect the lens through which you view research. It's only human.

Let me illustrate this by being honest and disclosing bias in my own work. As my readers well know, I have been quite critical of the American Cancer Society for its role in supporting the FDA tobacco legislation which I believe is a huge victory for Philip Morris at the expense of the public's health. However, during the years that I held an ACS research grant, I would be willing to bet that I was less likely to criticize the ACS during that time. I am not aware of any situation in which I consciously decided not to criticize the ACS because of my grant funding from that organization. However, it is very likely that subconsciously, I avoided even becoming aware of ACS actions to potentially criticize. My eyes probably focused elsewhere during that time. So yes, my receipt of an ACS grant did create a bias: I was systematically less likely to criticize the ACS or to view the ACS' actions with as much critical analysis as I normally would. This was not a conscious effort on my part. But it occurred.

I would go so far as saying that I would (subconsciously) view any organization more positively if it were providing funding to me, funding that was helping me to support my family and kids. And if that organization was a company that manufactured drugs, I would (also subconsciously) also view those drugs in a more positive light.

So my previous criticism of studies involving conflicts of interest should not be interpreted by readers as asserting that the investigators did anything wrong or lacked integrity. In contrast, these are investigators with high standards of integrity who are human, and therefore are potentially influenced subconsciously by financial conflicts of interest.

Finally, I hope readers will understand that in my view, addressing issues such as the interpretation of the data and disclosure of conflicts is not an “attack” on anyone; rather, it is the opposite: it helps ensure the integrity of the science and the scientific process. In fact, rules about conflict of interest are set up not to penalize investigators for wrongdoing, but to protect them from potential questioning of the possible influence of the conflict on their work. My hope is that these commentaries will help advance the field, if nothing else by forcing us to re-think and reassess our current policies and programs (even if we end up making no changes, it still does us a service I think). I hope my commentary will be seen in that light.

I have the utmost respect for the work and integrity of scientists who have studied the effectiveness of NRT and view them as valuable colleagues in a common battle against tobacco-related disease and death. Helping to ensure that policy decisions are made based on unbiased, accurate, and free-from-financial conflict conclusions is not an attack on individuals; it is an attempt to improve our understanding of the scientific evidence and to protect scientists from having their work undermined because of the appearance of potential conflicts.

Should Researchers with Significant Conflicts of Interest Be Permitted to Conduct Clinical Trials on Products Made by the Relevant Company?

2011-12-01T07:52:00.000-05:00

Yesterday, I discussed a study which reported the results of a clinical trial in which nicotine replacement therapy [NRT] sampling produced no significant increase in smoking cessation at six-month follow-up. Nevertheless, the study touted NRT sampling as a promising strategy for smoking cessation. I also noted that one of the authors had significant conflicts of interest with Big Pharma, having served recently as a paid consultant for a number of companies that manufacture or sell smoking cessation drugs. I suggested that there is at least the appearance that the conflict of interest may have biased the interpretation and reporting of the study findings.

Today I address an even more difficult question: Should this type of research be allowed in the first place? More specifically, should an investigator with a significant conflict of interest with a company be permitted to conduct a clinical trial in which a product of that company is being tested?

I am not questioning the presence of conflicts of interest in early-stage research, especially lab research that does not involve human subjects and in which a drug or product is in the development rather than clinical testing phase. In such research, it seems reasonable to conclude that the conflict can be managed adequately with appropriate disclosures and other measures short of requiring that the conflict be eliminated.

However, in a clinical trial, the product is being tested among human subjects and the results of the trial have a direct effect on the profitability of the product and the financial value of the company. For example, after a clinical trial on a nicotine vaccine demonstrated a lack of effectiveness, the stock value of Nabi Pharmaceuticals plummeted by 70%. In this situation, the consequences of bias introduced by a significant conflict of interest can be substantial.

In addition, because human subjects are involved and there is often more than minimal risk, negative consequences of bias introduced by a significant conflict of interest could potentially be experienced by these human subjects. As I reported earlier this year, a clinical trial of CT scanning for lung cancer that involved a researcher with a significant conflict of interest was cited by the New York Times as not being able to document the receipt of informed consent from 90% of the patients. That study involved substantial risk to subjects, as they received high doses of radiation that could potentially increase their cancer risk. Failure to obtain informed consent from each patient would constitute a huge ethical breach.

Because of the gravity of these concerns, many universities do not allow investigators with significant conflicts of interest to participate as investigators in clinical trials where a product of the company of interest is being tested. For example, Harvard Medical School classifies this situation as being "Not Allowable." At Boston University Medical Center, investigators who consult for pharmaceutical companies and receive compensation of $10,000 or more per year are generally not permitted to engage in clinical trial research on drugs made by those companies.

I agree with the approach that medical centers such as Harvard and Boston University have taken. I do not think that conflicted investigators should be conducting clinical trials where drugs made by the companies who pay them are being tested on human subjects in the later stages of drug development and testing.

It does not appear to me that this approach is being taken in a large number of studies on the effectiveness of NRT. I think this is problematic, as there is abundant evidence that the research literature is heavily biased in the direction of recommending a focus on the use of NRT even though the data show that unassisted smoking cessation is more effective and is more commonly used in successful quit attempts. To the extent that such bias is related to conflicts of interest with pharmaceutical companies, it is quite unfortunate.

The rest of the story is that research such as the study on NRT sampling which I discussed yesterday presents serious potential problems because they involve a financially conflicted investigator taking part in a clinical trial of a drug manufactured by a company/industry in which they have a financial interest. I do not believe that such a situation should be allowable and hope that in the future, more universities will adopt policies similar to those in place at Harvard Medical School and Boston University Medical Center.

New Study Calls Nicotine Sampling Therapy a Promising Strategy for Smoking Cessation, Even Though Study Itself Found No Effect on Six-Month Abstinence

2011-11-30T07:49:00.003-05:00

A study published this week in the Archives of Internal Medicine concludes that nicotine sampling therapy (giving smokers samples of nicotine replacement therapy [NRT] to promote NRT use) is a promising strategy to promote smoking cessation.

The study involved a randomized clinical trial which compared a practice quit attempt intervention with or without the provision of nicotine lozenges to promote the use of NRT among a sample of smokers who were unmotivated to quit.

The methods, as describe in the study abstract, were as follows: "Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment."

The intervention was successful in getting smokers to make quit attempts and to use NRT (presumably in those quit attempts). While only 12.5% of those in the control group used NRT in the post-intervention follow-up period, 69.0% of those in the nicotine sampling therapy group used NRT (presumably to try to quit) during the post-intervention follow-up period.

The study concludes that the use of nicotine sampling therapy increases quit attempts and enhances NRT use and is therefore a promising strategy to promote smoking cessation.

The Rest of the Story

It might surprise readers to find out that the study actually found that nicotine sampling therapy was ultimately ineffective. At six months follow-up, there was no significant difference in the point prevalence of abstinence between the NRT group (16%) and the control group (14%).

Because the intervention had no effect on 6-month smoking cessation rates, it clearly had no effect on the bottom line: sustained cessation. For this reason, I disagree with the study conclusion. I do not conclude that NRT sampling is a promising strategy. I think this study demonstrates that it is a failed strategy. The bottom line is this: it didn't work. At six months, those in the intervention group were just as likely to be smoking as those in the control group. To me, that's a failure.

In fact, I believe the study provides strong evidence that NRT is quite ineffective in promoting smoking cessation, at least among smokers who are not motivated to quit. Since 69% of the smokers in the intervention group tried NRT and only 12.5% of smokers in the control group used NRT, the failure to find any difference in cessation at six months suggests that the use of NRT had no effect on smoking cessation.

The paper spins the results in an entirely different direction, calling NRT sampling a promising approach.

This at first seemed odd to me. However, it then occurred to me that what I see as an apparent bias in the interpretation of the study results could perhaps be a result of a financial conflict of interest, something I have observed time and again in the NRT literature. And in fact, in turns out that two of the study authors have or have had significant conflicts of interest with Big Pharma.

One author discloses the following: "Since January 1, 2008, Dr Hughes has received research grants from ... the National Institutes of Health and from Pfizer Pharmaceuticals; the latter
develops and sells smoking cessation medications. During this time, he has accepted honoraria or consulting fees from the following nonprofit and for-profit organizations and companies that develop, sell, or promote smoking cessation products or services or educate or advocate about smoking cessation: Abbott Pharmaceuticals, Aradigm, ... DLA Piper, EPI-Q, ... Evotec, Free and Clear, GlaxoSmithKline, Golin Harris, Healthwise, Integrated Communication, Invivodata, ... McNeil Pharmaceuticals, Novartis Pharmaceuticals, ... Pfizer Pharmaceuticals, Pinney Associates, Propagate Pharmaceuticals, Reckner Associates, Scientia."

Thus, this author has substantial financial conflicts of interest by virtue of his research funding and consulting income from a number of pharmaceutical companies that develop, sell, or promote smoking cessation medications.

A second author does not have any current conflict of interest, but previously, he reports having consulted for and received consulting payments from GlaxoSmithKline for helping the company market its Nicorette Fruit Chill gum. Though this financial relationship with the pharmaceutical company occurred in 2006, I explained earlier why I believe it is still very much relevant for the reader of the present study.

This is another example of a research study where I come to a very different conclusion than the article does about the effectiveness of NRT. And once again, the difference in interpretation has at least the appearance of potentially resulting from bias associated with a financial conflict of interest with Big Pharma.

I think this is a very serious issue because in my opinion, the obsession with NRT in smoking cessation treatment has been the greatest obstacle to finding an effective approach to helping smokers quit. Thus, it is an obsession that in my opinion has cost lives by diverting attention and resources from more effective potential approaches. I find it particularly unfortunate, therefore, that what I see as a skewed presentation of the science on NRT's effectiveness has the appearance of being influenced by financial conflicts of interest with pharmaceutical companies.

Medical Oncologist Claims that Smoking May Be Less Hazardous than Using Electronic Cigarettes

2011-11-29T07:04:00.000-05:00

A medical oncologist at the Palm Beach Cancer Institute has publicly claimed that smoking may be less hazardous than using electronic cigarettes, according to an article on the ABC Action News web site.

A physician spokesman for the local American Lung Association was quoted in the same article as declaring that we have no idea what chemicals are present in electronic cigarettes.

According to the article: "Touted as a safer alternative to traditional smoking, electronic cigarettes are supposed to give smokers their nicotine fix without the cancer-causing side effects of tobacco. But some have serious concerns that the battery-operated vaping devices may actually pose more dangers to users. ... Dr. Mike Feinstein, a spokesman for the American Lung Association said, 'People are inhaling some type of chemical vaporized compound into their lungs without really knowing what's in it.' Last year, The American Lung Association issued its own warning about e-cigarettes. 'This is a buyer stay away, a buyer health hazard, potentially.'"

"Doctor Robert Greene treats lung cancer patients at the Palm Beach Cancer Institute and said the product is potentially a health hazard. 'There really is no information about whether they're safe or not, and that's part of the problem.' He says with no real data on e-cigarettes, the three-year-old tobacco alternative may actually be more harmful that traditional cigarettes. 'The doses of nicotine that you get could conceivably be higher than what you would get in a typical cigarette.'"

The Rest of the Story

It is ludicrous to suggest that electronic cigarettes may be more hazardous than tobacco cigarettes. Tobacco cigarettes deliver tobacco smoke with more than 10,000 chemicals, including more than 60 carcinogens, and cause more than 400,000 deaths annually in the United States. In contrast, electronic cigarettes contain no tobacco, involve no combustion, produce no tobacco smoke, and have not been documented to cause any adverse health effects, despite their use by approximately 2.5 million people in the U.S.

Moreover, electronic cigarettes have been tested for carcinogens and have been found to contain more than one thousand times lower concentrations of tobacco-specific nitrosamines than regular cigarettes. They have also been extensively tested in the laboratory to identify the chemicals they contain and no other carcinogens have been detected. Thus, it seems beyond dispute that electronic cigarettes are much less hazardous than tobacco cigarettes in terms of cancer risk.

In fact, we know a lot more about the chemicals in electronic cigarettes than in tobacco cigarettes. While as many as 94% of the chemicals in tobacco smoke are unknown, the chemicals in multiple brands of electronic cigarettes have been identified using gas chromatography/mass spectrometry. So far, no chemicals of major concern have been identified at levels that would pose a substantial threat to health (other than the nicotine itself). The only real concern is the potential effect of the long-term inhalation of propylene glycol, but two initial animal studies have documented no health risks.

Furthermore, literally hundreds of thousands of Americans are using electronic cigarettes successfully to quit smoking or cut down significantly on the amount that they smoke, and despite four years of use, no serious adverse effects have been reported.

Given what he surely knows about the cancer risks of active tobacco smoking, it is mind-boggling that a medical oncologist would claim that smoking may be healthier than inhaling vapor from tobacco-free e-cigarettes that primarily deliver just nicotine, glycerin, and propylene glycol to the user, and with documented carcinogen levels (tobacco-specific nitrosamines) that are more than one thousand times lower than in tobacco cigarettes.

It is also surprising that a physician with the American Lung Association would falsely claim that we have no idea what is in electronic cigarettes, given the existence of at least 18 studies which have categorized the chemical constituents of e-cigarettes using gas chromatography/mass spectrometry.

That these individuals made these uninformed or ill-informed statements publicly I find to be irresponsible, because it misleads probably thousands of people about the relative health effects of smoking compared to vaping.

Would these physicians rather see hundreds of thousands of current e-cigarette users return to cigarette smoking because they believe that returning to cigarette smoking may be safer than continuing to stay smoke-free with the help of tobacco-free, electronic cigarettes?

This is perhaps the worst medical advice I have ever witnessed being delivered.

Mayo Clinic Researchers Deceiving the Public by Implying that 45% Reduction in Heart Attacks in Olmsted County Is Attributable to County Smoking Ban

2011-11-28T07:22:00.001-05:00

Researchers from the Mayo Clinic have reported finding a 45% reduction in the rate of admissions for heart attacks in Olmsted County, Minnesota from the 18 months prior to a workplace smoking ban implemented in 2002 to 18 months after a strengthened ban implemented in 2007.

These results are being presented to the media in a way that is implying that the observed 45% reduction in heart attack admissions is attributable to the county smoking bans.

For example, the headline of an ABC News article reads: "Smoking ban cuts cardiac events 45%, Mayo Clinic says."

A Procor headline reads: "Smoking ban cuts heart attacks in half."

A Thirdage.com article headline reads: "Smoking Ban Cuts Heart Attack Risk In Half."

The UPI headline about the research reads: "Smoking ban cut heart attacks risk in half."

The Minneapolis Star-Tribune headline reads: "Smoking bans cut cardiac events 45%."

The EMax Health headline is: "Smoking bans reduce heart attack rates by half, finds study."

The Business Insider headline reads: "Heart Attacks Decreased By 50% After These Workplaces Launched Smoking Bans."

These headlines appear to be consistent with the information being provided to reporters by the study investigators.

As a KAAL-TV article explains: "A new study from Mayo Clinic shows people who live in Olmsted County are nearly 50 percent less likely to suffer a heart attack than they were a decade ago. The study's main author claims the dramatic change is due entirely to the county's smoke-free laws. "We were absolutely shocked..." said Richard Hurt, M.D. Dr. Richard Hurt, the director of Mayo Clinic's Nicotine Dependence Center, is talking about the results of a recent second hand smoke study conducted in Olmsted County. In 2002, the county enacted a smoking ban in restaurants and expanded that to include work places in 2007. Since then, the study shows that heart attacks have dropped 45 percent. And sudden cardiac deaths have dropped 50 percent. Dr. Hurt says despite the numbers, all the other factors that cause heart attacks either stayed the same or got worse. 'So high cholesterol stayed the same, hypertension stayed the same, diabetes went up, obesity went up. So all the other risk factors for heart disease did not change,' he explained. 'So we don't have any explanation other than second hand smoke.'"

These findings were presented last week at the American Heart Association Scientific Sessions in Orlando, Florida. So far as I can tell, there is no actual study or report available for public review. Thus, the precise methodology used is not clear.

The Rest of the Story

Today's story illustrates the dangers of drawing conclusions from quasi-experimental studies without including a comparison group.

A quasi-experimental study is one in which investigators observe changes in an outcome variable (in this case, heart attacks) following the implementation of an intervention or " natural experiment" (in this case, the Olmsted County smoking ban). Because one never knows what would have occurred in the absence of the intervention, it is imperative in a quasi-experimental study design to include a comparison group to control for underlying secular changes taking place in the outcome variable over time in the absence of the intervention.

Unfortunately, it does not appear that the Olmsted County "study" employed any comparison group or attempted in any way to compare the 45% reduction in heart attack admissions in Olmsted County to the reduction in heart attack admissions that theoretically might have been occurring in the rest of the state of Minnesota.

Instead, the "study," the press release, and the researchers appear to have completely ignored secular changes in heart attacks occurring in Minnesota during the study period. From none of these sources is it revealed that heart attacks throughout the entire state of Minnesota also might have been declining during the study period, so that the 45% decline observed in Olmsted County might not be entirely attributable to the smoking ban.

Had the researchers examined the change in the heart attack admissions rate in Minnesota as a whole during the study period (2001 to 2008), which of the following do you think they would have found, according to the newspaper headlines:

A. No change in the heart attack admissions rate from 2001 to 2008.
B. A decrease of 3% in the heart attack admissions rate.
C. A decrease of 8% in the heart attack admissions rate.
D. A decrease of 14% in the heart attack admissions rate.
E. A decrease of 33% in the heart attack admissions rate.

According to the news articles, and according to the investigator's quote in the KAAL-TV article, one would have to assume that there was no change in the heart attack admissions rate for the state of Minnesota from 2001 to 2008 since the study and its presentation to the media and the public essentially attribute the entire 45% reduction in the heart attack admission rate to the smoking ban.

The truth, however, is that based on an analysis of data from the Healthcare Cost and Utilization Project (HCUP), the correct answer is:

E. A decrease of 33% in the heart attack admissions rate.

Therefore, even in the absence of any smoking ban, one would have expected the heart attack admission rate in Olmsted County to have declined by 33% from 2001 to 2008, simply based on the trend occurring throughout the state of Minnesota.

In light of the expectation of a 33% decline without a smoking ban, the finding of a 45% decline now doesn't seem nearly as dramatic, does it?

In fact, smoking prevalence in Olmsted County dropped sharply, by 23%, during the study period. It is conceivable that the additional 12% decline in heart attacks over the expected 33% decline was mostly attributable to the sharp decrease in smoking rates. Thus, it is entirely possible that the smoking ban - and specifically the decrease in secondhand smoke exposure - had very little impact on heart attack rates during the study period.

To answer that question would require a more rigorous analysis that adjusted not only for secular trends in heart attacks in Minnesota as a whole but also for changes in smoking prevalence that may not have been a result of the smoking ban.

Based on the only data presented in this "study" - the change in heart attack admissions rates in Olmsted County alone - one is unable to draw any conclusion about the impact of the smoking ban and secondhand smoke exposure on heart attacks, much less to be able to conclude that the observed 45% reduction in heart attacks was attributable to the smoking ban.

An honest press release would have revealed that while heart attack admissions in Olmsted County declined by 45% from 2001 to 2008, heart attack admission rates in the state of Minnesota as a whole declined by 33%.

Similarly, an honest presentation at the AHA conference would have disclosed that the 45% decline in heart attacks in Olmsted County must be interpreted in light of a 33% reduction in heart attacks in the state as a whole.

The rest of the story is that I believe the Mayo Clinic investigators have deceived the media and the public by failing to disclose the striking decrease in heart attack admission rates in Minnesota as a whole during the study period. It completely changes the public's and the media's interpretation of the meaning of the observed 45% decline in Olmsted County to know that heart attacks declined by 33% in the state of Minnesota as a whole during the same time period.

I want to make it clear to readers that I agree with the investigators' overall conclusions about smoking bans. I support these policies and I agree with their recommendation that people with heart disease avoid exposure to secondhand smoke. However, I do think that we need to support smoke-free policies with rigorous scientific evidence. Drawing causal conclusions from a quasi-experimental study without any comparison group is not, in my opinion, an example of rigorous scientific evidence, especially in a situation like this where the outcome variable is well known to be declining dramatically throughout the population.

Happy Thanksgiving to All; The Rest of the Story Will Return on Monday, November 28

2011-11-23T09:15:00.003-05:00

Note that there are two posts today: one on electronic cigarettes and the second on an anti-smoking advocate's call for censorship of opposing opinions.

Happy Thanksgiving!

Australia Health Authorities are Completely Missing the Point on E-Cigarettes

2011-11-23T08:48:00.002-05:00

Health authorities in Australia have banned the use of electronic cigarettes because, as they argue, vaping mimics smoking and encourages people to continue smoking.

According to an article in the Canberra Times: "Canberrans keen to try smokeless ''e-cigarettes'' are running a legal tightrope, with the product banned across Australia despite its increasing availability online. ... The Australian Medical Association said there was no evidence ''e-cigarettes'' helped people quit, and Victorian AMA president Harry Hemley warned the products posed a serious health risk. ... ACT Health said e-cigarettes also encouraged people to continue smoking behaviour. ''Because e-cigarettes mimic smoking in both design and use, the ACT Health Directorate does not support [their use],'' a spokeswoman said. ''The Health Directorate strongly advocates the de-normalisation of smoking and e-cigarettes are counterproductive to this goal.''"

The Rest of the Story

Australian health authorities are completely missing the point. Electronic cigarettes are helping thousands of vapers to stay off of cigarettes precisely because their use mimics smoking. Unlike nicotine replacement therapy or other "approved" drugs for smoking cessation, electronic cigarettes address both the pharmacologic and behavioral aspects of smoking addiction. They are effective specifically because they mimic smoking and thus replace many of the behavioral stimuli associated with cigarette smoking.

Moreover, contrary to the ACT Health Directorate statement, electronic cigarettes do not encourage continued smoking. They are overwhelmingly used by smokers to quit or substantially cut down on smoking. Every electronic cigarette that a smoker uses is one less tobacco cigarette smoked. There is no evidence to support the claim that e-cigarettes in any way inhibit smoking cessation. But there is abundant evidence that e-cigarettes are helping thousands of smokers to quit smoking or cut down on the amount they smoke.

A clinical trial of e-cigarettes among smokers with no interest in quitting found that 55% of subjects either cut down their consumption by 50% or more or quit smoking altogether at six months follow-up. This is remarkable, especially since these smokers had little motivation to quit. Imagine how effective e-cigarettes likely to be in reducing smoking among smokers who actually want to quit.

A further problem with the Australia health authorities assertions is that there is no evidence that e-cigarettes pose health risks (beyond the continued use of nicotine). The Australian Medical Association claims that e-cigarettes poses serious health risks, but does not reveal what those health risks are. That's because none have yet been identified. In fact, e-cigarettes reduce health risks because they usually eliminate or substantially reduce the amount of tobacco smoke that a smoker inhales. The Polosa study demonstrated this. Thus, the best current evidence is that e-cigarettes substantially reduce one's health risks.

The Australian health authorities have it all wrong. And it appears that they have tipped their hand as to why. Their opposition is purely ideological: "e-cigarettes mimic smoking in both design and use."

In other words, they oppose e-cigarettes simply because they look like and are used like regular cigarettes. The fact that they contain no tobacco and do not produce any smoke is irrelevant. The fact that they most likely greatly reduce health risks is irrelevant. The fact is that they look like regular cigarettes and therefore are bad and their use must be discouraged. This is no longer about health - it is about a moral principle: people should not do anything that looks like smoking.

In fact, the e-cigarette is effective (and probably more effective than NRT) specifically because it mimics smoking. My guess is that the smoking cessation product of the future is going to be some sort of device that mimics smoking but is not tobacco-based and produces no smoke (whether an electronic cigarette or some similar smoke-free, tobacco-free, nicotine-delivering device). Such a product could literally save millions of lives. But it doesn't matter, because it looks like smoking.

Anti-Smoking Researcher Urges Newspaper to Ban Opposing Comments from Public Forum

2011-11-23T07:22:00.000-05:00

A prominent anti-smoking researcher attempted to get a newspaper to ban comments from several individuals who disagreed with his position on the protection of residents of multi-unit dwellings from secondhand smoke exposure.

The anti-smoking advocate wrote: "The Greenbelt Patch that has carried several stories on the Schuman v. GHI & Popovic trial. The site has a Message Board, which has been attacked by semi-pro Tobacco Industry Spammers with the obvious intent of drowning out support for Schuman. These spammers, who go by the names of Michael J. McFadden, a FORCES.org columnist, as well as Kevin Mulvina, and Magnetic, among several others, invariably pollute the message boards relating to on-line tobacco-related stories with the clear intent of drowning out alternative opinion with their fanatical flat-earth pseudo-science. Some webmasters have become wise to this, and some moderated sites have banned these industry moles. Unfortunately this has not happened with the Patch blog."

In response, the newspaper wrote: "Free speech allows for dissenting opinions, no matter what any individual thinks about each one, or collectively all of them. When we start talking "bans," we really are saying "censorship." That's the thing about free speech, we can't have it both ways."

The Rest of the Story

While I happen to agree with the advocate's position on secondhand smoke in multi-unit dwellings and I believe that nonsmokers deserve a remedy in the case that smoke is polluting the air in their apartments and causing health effects, I do not believe that censorship of opposing comments from private individuals is appropriate. So I agree with the position that the newspaper took.

I believe that public health is just that: "public." It involves regulating the behavior of the public and we should therefore be willing to listen to what the public has to say, even if we disagree. Censorship does not advance our interests, even if it silences the "opposition."

The advocate would have a point if these individuals were actually tobacco industry representatives or if they were being paid by the tobacco industry to state these opinions. In that case, it would not be unreasonable to restrict the comments or to require that the authors disclose their tobacco industry affiliations. However, the advocate provides no evidence that these individuals are paid by the tobacco industry and the truth is that they are indeed private individuals and not industry representatives.

So there are actually two problems here. One is the promotion of censorship. The second is the making of false public accusations about individuals in an attempt to discredit them. Discredit all you want but do not base it on false and unsupported public accusations.

Anti-Smoking Community Still Being Guided by Ideology Rather than Science on Electronic Cigarettes

2011-11-22T13:37:00.003-05:00

In a letter to the editor published last week in the New York Times, the director of smoking cessation services at Columbia University Medical Center urges smokers not to quit using electronic cigarettes because it involves "directly inhaling heated nicotine into the delicate tissue of smokers’ lungs." He praises nicotine replacement therapy as a "proven" aid to smoking cessation.

The Rest of the Story

I have news for you. Smoking cigarettes involves "directly inhaling heated nicotine into the delicate tissue of smokers’ lungs." Would we rather that smokers directly inhale heated nicotine plus 10,000 other chemicals or that they just inhale the nicotine?

For literally thousands of ex-smokers, electronic cigarettes have helped them to stop or greatly cut down on their cigarette smoking. Many of these are smokers who tried to quit with NRT but failed. Telling them that they should not use electronic cigarettes is tantamount to recommending that they return to cigarette smoking instead of continuing to stay smoke-free with the help of electronic cigarettes.

Moreover, to call NRT a "proven" strategy for smoking cessation is misleading. What NRT has been "proven" to do is to fail in about 92% of quit attempts.

For a while, I was baffled by why a physician would offer this strange advice to smokers, and based on such flawed reasoning. I reasoned that like many other opponents of electronic cigarettes, he must have a financial tie to pharmaceutical companies. This was not the case. However, I did discover that the author appears to have an interest in opposing e-cigarettes, as he has written a book on quitting smoking that relies heavily upon the use of traditional pharmacotherapy and his web site solicits speaking engagements for the presentation of his smoking cessation method. He even has his own publicist and literary agent.

While I am not claiming that there is a financial interest involved (I believe that the author should have disclosed whether or not he receives any money from the sale of his book and/or from speaking engagements), there does appear to be a major conflict of interest.

The rest of the story is that this is yet another example of an anti-smoking professional who is publicly opposing electronic cigarettes, but without revealing that he has a conflict of interest. The public deserves unbiased and unconflicted, science-based recommendations on strategies to improve their health, especially when the advice may potentially lead to harm for thousands of individuals.

Anti-Smoking Researcher Criticizes Ruling on Graphic Warning Labels

2011-11-21T11:51:00.003-05:00

In a commentary on the UCSF Center for Tobacco Control Research & Education web site, Professor Stan Glantz criticizes Judge Leon's ruling, in which the D.C. district court issued a preliminary injunction against the implementation of the FDA's graphic cigarette warning labels.

The basis of Dr. Glantz' criticism of the decision is that the imposition of the warning labels is justified because they "will certainly reduce smoking." He calls this a "public health justification" for the warning labels and chastises Judge Leon for his "blithe disregard for public health."

The central point of Dr. Glantz' argument is as follows: "Accomplishing the goal of protecting public health requires providing warning labels that will affect behavior (preventing people from starting to smoke or convincing them to quit), something that Judge Leon asserts goes beyond “providing objective information” into the forbidden (political) realm of “advocacy.” If one takes Judge Leon’s position to its logical conclusion, the only warning labels that would be constitutionally permitted would be ones that would not stimulate a behavior change (since those would not be “advocating” for anything)."

The Rest of the Story

Unfortunately, Dr. Glantz' argument is flawed. He misinterprets Judge Leon's ruling. The Court did not hold that the graphic cigarette warning labels are unconstitutional because they would stimulate a behavior change. Instead, what the Court ruled was that the graphic warning labels go beyond the provision of simply factual and uncontroversial information and are therefore subject to a higher level of scrutiny. And under that higher level of scrutiny, the warning labels violate the tobacco company's First Amendment rights because they are much broader than necessary to advance the government's interest of informing smokers about the health effects of cigarettes.

Dr. Glantz argues that under Judge Leon's logic, the only warning labels that would be allowed are ones which do not stimulate a behavior change (i.e., quitting smoking). This is not the case. Any warning label that construes factual and uncontroversial information would be allowed, regardless of its effects on consumer behavior.

For example, if the FDA chose to require a warning that said: "Cigarettes contain radioactive polonium-210" and the FDA had conducted formative research suggesting that such a factual warning would result in 25% of smokers quitting, such a warning would still be allowable under Leon's logic. As long as the warning is factual and uncontroversial, then it is not subject to strict scrutiny and would be allowable, even if it covers half of the cigarette pack.

The primary flaw in Glantz' argument is that it is not the effect of the warning label that makes it unconstitutional, it is the nature of the warning label. Regardless of how many people will quit smoking because of it, a warning label that is purely factual is permitted.

Where the FDA's mandated warnings cross the line (into requiring stricter scrutiny under the Court's holding in Zauderer [Zauderer v. Office of Disciplinary Counsel for Sup. Ct. of Ohio, 471 U.S. 626,651 (1985)] is in their failure to stick to factual and uncontroversial information, and instead, to directly and primarily attempt to get consumers to quit smoking. For example, the requirement that the smoking quitline number be prominently displayed on the package is, according to Leon, evidence that the purpose of the warning labels is to directly promote smoking cessation, not just to warn smokers of the health effects of cigarettes. And further, "it is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start, smoking: an objective wholly apart from disseminating purely factual and uncontroversial information."

While one could make an argument to counter the Court's ruling, such an argument would have to provide a rationale for either: (1) why the cigarette warning labels are not subject to strict scrutiny; or (2) why the cigarette warning labels can survive a strict scrutiny analysis. Dr. Glantz' argument fails to address either of these.

Because public health regulations must adhere to the Constitution, it is not as simple as arguing that the graphic cigarette warning labels are justified because they will certainly reduce smoking. The standard that the courts must use in determining whether the required warnings violate the cigarette companies' First Amendment rights is not simply whether they will advance the government's interest in protecting or improving the public's health. Instead, the question is first, to what level of scrutiny is this regulation subject and second, does the regulation pass such scrutiny?

If Judge Leon is wrong, it is not because of a "blithe disregard for public health." He could be wrong because of a blithe misinterpretation of Zauderer or a flawed assessment of the narrowness of the warning labels under Central Hudson. But the fact that his ruling blocks implementation of a regulation that would decrease smoking rates is not due to any failure of the court to consider the impact of the regulation on the public's health. In fact, Leon's consideration of the public health effects of the regulation played a role in his decision (he accepted the FDA's own analysis showing that there was no statistically significant predicted reduction in smoking).

Under Glantz' argument, we could and should be requiring graphic warning labels on all unhealthy consumer products -- warnings that directly implore consumers not to use those products. McDonalds could be required to post disgusting pictures of people with diseases caused by obesity at the point of purchase. Beer bottles could be required to include the phone number of Alcoholics Anonymous. My beloved Vienna Fingers could be required to include a graphic depiction of diseases related to increased fat intake.

There needs to be some limit on the degree to which the government can interfere with the free speech of companies, especially when those companies are being required to make statements which directly implore their consumers not to use those products. While my personal opinion is that the courts have been overly generous in granting First Amendment protection to corporations, I would never go so far as to argue that compulsion of speech by corporations is always justified if that speech would advance the public's health. This is, however, precisely the argument that Dr. Glantz is making when he asserts that the graphic warning labels are justified because they will certainly reduce smoking.

New Study Estimates That There are 2.5 Million Electronic Cigarette Users in the United States

2011-11-18T07:44:00.000-05:00

According to an article by CDC researchers published online ahead of print in Tobacco Control, the proportion of U.S. adults who have ever used electronic cigarettes more than quadrupled from 0.6% in 2009 to 2.7% in 2010. The overall proportion of adults who had used electronic cigarettes in the past 30 days in 2010 was 1.2%.

Since the adult U.S. population in 2010 was approximately 209 million, the estimated number of current (past-month) electronic cigarette users is about 2.5 million.

The Rest of the Story

These data are important for three reasons. First, to the best of my knowledge, this is the first scientific estimate of the number of electronic cigarette users in the U.S. It helps to define the magnitude of electronic cigarette use, which is useful in public policy discussions regarding vaping and its regulation.

Second, these data demonstrate that taking electronic cigarettes off the market - as recommended by a number of anti-smoking groups - would have devastating effects on the public's health. We now know that there are literally hundreds of thousands of vapers who are using electronic cigarettes to reduce their cigarette consumption or to quit smoking entirely. Taking electronic cigarettes off the market would force most of these individuals to return to smoking, which would have devastating health effects.

Third, the fact that the number of electronic cigarette users has more than quadrupled in just one year suggests that smokers are finding these devices helpful. If they were ineffective - as suggested by some anti-smoking researchers - one would not expect the market to take off as it is.

Anti-Smoking Advocates are Defending Defamatory Attacks Against Private Citizens

2011-11-17T07:17:00.001-05:00

In response to yesterday's post in which I revealed that an anti-smoking researcher posted a defamatory comment on the Smokefree DC web site which falsely accuses Michael McFadden of being paid by the tobacco industry to oppose tobacco control measures, I received a number of responses from tobacco control advocates defending the defamatory comment.

The advocates who defended the defamatory comment had two main arguments. First, McFadden has published on the FORCES site and FORCES is known to be a tobacco industry front group. Second, there is no proof that McFadden has not taken tobacco industry money.

The advocates have it wrong on both accounts. Taking the second argument first, the burden of proof is upon the one making an accusation to provide evidence to support that accusation. If someone writes on my blog that I have taken tobacco money to write posts that oppose outdoor smoking bans, the burden of proof is on that individual to provide the evidence to back up his claim.

As far as the first argument goes, it is simply not true that FORCES is a tobacco front group, and no evidence has ever been put forward to support that claim. More than five years ago - on February 28, 2006 to be exact - I issued a challenge to all anti-smoking groups and advocates to produce evidence that FORCES had received major funding from tobacco companies. There was no response, and to date, I have still not received or seen any evidence to support the front group assertion.

Americans for Nonsmokers' Rights continues to insinuate that FORCES is a tobacco industry front group, but has yet to provide any evidence. The only relevant fact that ANR provides is that: "a 1999 Philip Morris (PM) memo indicated that FORCES did not accept tobacco industry funding." So in fact, ANR knows that FORCES is not a Big Tobacco front group but continues to make the false accusation anyway.

This is exactly why I parted ways with ANR (I was at one time a member of ANR's Board of Directors). In my book, you don't make accusations or insinuate that a group is being funded by someone unless you have documentation to back it up.

The rest of the story is that ANR and a number of anti-smoking advocates continue to accuse FORCES of being an ally/front group of Big Tobacco without documenting any current relationship between the two and in light of the admission that there is in fact no evidence to link the two. Even worse, some anti-smoking advocates are falsely accusing private citizens like Michael McFadden of being tobacco industry-funded "moles" in an effort to discredit them.

It is high time that we acknowledge that there are reasons why some individuals and groups to which they belong are unhappy with smoke-free laws, and that they don't have to be operating under the direction or funding of Big Tobacco to have these opinions. Opposing smoke-free laws doesn't necessarily make you a Big Tobacco front group.

FORCES is a great illustration of this. FORCES is a genuine group without funding from Big Tobacco which opposes smoke-free laws not because they are trying to protect the tobacco industry's profits, but because they don't want government telling them what to do and they don't believe that secondhand smoke is a health hazard that would justify government intrusion into the rights of businesses and individuals. I don't necessarily agree with that viewpoint, but I acknowledge it as a legitimate and genuine point of view that reflects the feelings of its membership and does not mean that the group is connected with Big Tobacco.

It seems to me that this trend in making statements without having documentation is occurring both in how we treat opponents of smoke-free laws as well as in how we communicate to the public about the health effects of secondhand smoke. We have become much less concerned about having documentation to support our attacks against opposition groups and much less concerned about having documentation to support our scientific claims as well.

It just seems to me that we are unable to allow the truth and documentation of the facts to get in the way of pursuing our agenda. I think it violates a basic ethical principle of public health practice to operate in this way.

ADDENDUM - November 17, 2011 - 8:55 a.m.: I have just been informed that the defamatory comment has been removed from the Smokefree DC web site. I applaud this action and hope that it will usher in a new era in which we can treat members of the public with respect, even if they oppose our policies, and in which we can stick to the truth and to documented facts.

IN MY VIEW: Anti-Smoking Advocates Should Not Post Defamatory Accusations Against Private Citizens, Even the "Opposition"

2011-11-15T15:37:00.002-05:00

On the Smokefree DC web site, an anti-smoking researcher/advocate posted a comment which claims that Michael McFadden is a tobacco industry mole, meaning an individual affiliated with the tobacco companies who repeats Big Tobacco propaganda without revealing his connections to the industry.

Specifically, the anti-smoking researcher claimed as follows: "MOLE WARNING: There’s a Greenbelt Community On-line newsletter operated by the Greenbelt Patch that has carried several stories on the Schuman v. GHI & Popovic trial. The site has a Message Board, which has been attacked by semi-pro Tobacco Industry Spammers with the obvious intent of drowning out support for Schuman. According to Gene Borio, who operates an extremely informative daily tobacco newsletter, these spammers, who go by the names of Michael J. McFadden, a FORCES.org columnist, as well as Kevin Mulvina, and Magnetic, among several others, invariably pollute the message boards relating to on-line tobacco-related stories with the clear intent of drowning out alternative opinion with their fanatical flat-earth pseudo-science. Some webmasters have become wise to this, and some moderated sites have banned these industry moles."

The term "tobacco industry mole" has been used in the tobacco control literature to denote tobacco industry "spies" who essentially pose as private citizens who oppose tobacco control measures but who are really tobacco industry representatives or otherwise financially connected with the industry.

By calling McFadden a tobacco industry mole and by also calling him a semi-professional tobacco industry spammer, the clear connotation of this attack is that McFadden is not a private citizen who opposes smoking bans, but a paid tobacco industry representative with a tobacco company affiliation.

The Rest of the Story

To the best of my knowledge, Michael McFadden is neither a tobacco industry mole nor a semi-professional tobacco industry representative. In fact, I do not believe that he has any affiliation with the tobacco industry, nor do I believe that he has received tobacco industry payments to express his opinions.

In other words, I believe the claim being made by the anti-smoking researcher in his accusation is a lie.

Because the comment was made in an attempt to discredit McFadden by falsely tying him to the tobacco industry, I believe the comment is a defamatory one. If made on my blog, I would have deleted it for legal reasons. I am surprised that the Smokefree DC web site allows such a defamatory comment, especially when no evidence is presented to support the accusation that McFadden is working for the tobacco industry.

In my opinion, anti-smoking advocates should not be attacking private citizens with defamatory accusations such as this one. It is below us and reflects poorly on our character as public health professionals.

Hopefully, the accusation will either be removed with an apology offered to Michael, or else evidence of Michael's financial relationship with one or more tobacco companies will be provided in timely fashion. If the latter, I am sure that Michael will share some of his earnings with his old friend at the Rest of the Story.

Data from Oregon Show No Change in Rate of Decline in Heart Attack Admissions Following Statewide Bar and Restaurant Smoking Ban

2011-11-14T07:09:00.000-05:00

Last week, I revealed that a new report out of North Carolina concluded that the statewide smoking ban resulted in a 21% decline in heart attack admissions, although the actual data showed a 21% increase in heart attack admissions among women and a slowing of the overall rate of decline in heart attacks in the state.

Today, I share data first reported by Jacob Grier over at Liquidity Preference which demonstrated that the statewide smoking ban in Oregon was not associated with any significant increase in the rate of decline in heart attack admission rates in that state.

The following data and graph are copied directly from Jacob Grier's blog Liquidity Preference. Credit goes to Jacob Grier for obtaining these data from the Oregon state health department and for producing the figure.

The data below show age-adjusted rates of heart attack admissions for the state of Oregon. The percentage change from year-to-year is shown in parentheses:

2003 198.4
2004 181.2 (8.67)
2005 166.8 (7.95)
2006 166.6 (0.12)
2007 163.4 (1.92)
2008 152.5 (6.67)
2009 141.5 (7.21)
2010 137.1 (3.11)

Here is the same data in graph form (note that the statewide ban on smoking in bars and restaurants went into effect on January 1, 2009, so the data points for 2009 and 2010 reflect the implementation of the statewide smoking ban):

Source: Jacob Grier. Whatever Happened to Oregon's Heart Miracle. Liquidity Preference blog. November 2, 2011 [link].

As you can see from the figure, there was no change in the rate of decline in heart attacks in Oregon during the first year of the implementation of the smoking ban. If anything, the rate of decline in heart attacks slowed during the second year of the smoking ban. The heart attack admission rate fell by about 7% in the year prior to the smoking ban and by about 7% in the first year following the smoking ban's implementation. However, the rate of decline slowed to just above 3% in the second year following the smoking ban's implementation.

The Rest of the Story

Jacob Grier summarizes this analysis in a commentary published at OregonLive.com.

Grier writes: "When Oregon's smoking ban took effect in 2009, we were promised that it would usher in drastic reductions in heart attacks. A January 2009 story in this paper reported that even brief exposure to secondhand smoke could set the stage for heart attacks and cited research claiming that banning smoking in bars and restaurants could reduce them by 41 percent over three years. Later in 2009 cardiologist Ty Gluckman suggested in The Oregonian Commentary section that we might see a drop in heart attacks of 17 percent in the first year, saving the state $40 million. So, how's that working out for us?"

"I contacted the Oregon Public Health Division to ask for the latest data. The good news is that heart attack rates in Oregon have been in steady decline since 2003, the earliest year for which I have data. The bad news for smoking ban advocates is that the ban hasn't noticeably affected this rate and certainly hasn't resulted in the large declines that they predicted. The heart attack rate fell by 7.21 percent in 2009, the first year of the smoking ban. That sounds impressive, but it's in line with drops in recent years. 2004 and 2005 saw greater declines -- 8.67 percent and 7.95 percent, respectively -- and 2008, 6.67 percent. Given this existing trend, it would be spurious to credit the ban for the similar drop in 2009. The ban doesn't fare any better if you include data from 2010. In the two years since the ban took effect, rates have dropped only 10 percent, a much smaller decline than we were told to expect in just one year."

In response, a representative of the Greater Portland and Vancouver American Heart and Stroke Association acknowledges that the data presented by Grier are accurate but argues that heart attack rates wouldn't have been expected to decline in Oregon because many cities in the state had already enacted smoking bans. As he writes: "Most published studies of heart attack rates following smoking bans have looked at communities that went smoke-free nearly overnight. This is not Oregon's story."

The truth, however, is that according to Americans for Nonsmokers' Rights, there were only 4 communities in Oregon that enacted smoke-free bar or restaurant laws prior to the statewide smoking ban: Corvallis, Eugene, Independence, and Philomath. This is clearly not enough of the state's population to explain why the smoking ban would not lead to an immediate decrease in heart attacks if that is indeed the expected effect of a statewide ban on smoking in all bars and restaurants.

The rest of the story is that the data from Oregon do not support the conclusion that the statewide smoking ban led to an immediate and significant decline in heart attacks, as claimed by anti-smoking researchers and groups. This does not mean that the ban is unjustified, because it will eventually reduce cardiovascular disease. But remember, it takes many years for secondhand smoke exposure to result in heart disease. It does not happen overnight. Moreover, the ban has immediate effects on respiratory symptoms of nonsmokers, especially those with asthma or other respiratory conditions.

By continuing to rely upon shoddy science to support its conclusions that smoking bans immediately and dramatically reduce heart attacks, the anti-smoking movement is risking losing its scientific credibility. Once that is lost, it will be much more difficult to enact smoking bans. Any short-term gains to be had by touting these Helena-like studies will, in my opinion, be overshadowed by the long-term damage to the scientific credibility of the tobacco control movement.

Tobacco Control Science as Shoddy as It Gets: The North Carolina Smoking Ban - Heart Attack Report

2011-11-10T16:12:00.005-05:00

Believe it or not, the following data - which show a 21% increase in heart attacks among women during the first year following North Carolina's smoking ban - are the actual data behind the report out of the North Carolina Department of Health and Human Services which concludes that the smoking ban led to a 21% decline in heart attacks in the state.

Figure 1. Annual Heart Attack Admissions Among Females -- North Carolina, 2008-2010

These data are taken directly from the report.

Despite what the report calls a 21% reduction in heart attack admissions during the first year of the smoking ban, the number of heart attack admissions among women was higher after the smoking ban than before. The number of heart attack admissions among women, which dropped from 4182 in 2008 to 3521 in 2009, increased to 4273 in 2010, so that it reached its highest level in three years!

It is simply mind-boggling to me how the report, and anti-smoking groups and advocates which have been disseminating the conclusions of the report, can draw the conclusion that the smoking ban reduced heart attacks by 21% when the actual number of heart attacks among women increased by 21% during the first year after the smoking ban was implemented.

Apparently, the model used in the report failed to include a time trend and therefore attributed the lower number of heart attacks overall in 2010 to the smoking ban, rather than to the existing trend of decreasing heart attacks in the state. Properly adjusting for the secular time trend in heart attacks would have negated the finding of a 21% decline in heart attacks associated with the smoking ban and instead would have led to the conclusion that heart attacks were higher than expected in 2010.

To be clear, I am not suggesting that researchers intentionally omitted the time trend to create this finding. However, I do believe there may have been a subconscious bias toward finding and showing an effect of the smoking ban. We all want to be able to demonstrate the positive results of our enacted policies on the public's health. Here, that bias appears to have clouded the interpretation of otherwise very clear data which fail to show any significant decline in heart attacks attributable to the smoking ban during its first year of implementation.

I continue to be boggled by the poor science coming out of the anti-smoking movement in the specific area of the effect of smoking bans on heart attacks. If these were tobacco industry studies purporting to show a negative effect of smoking bans on restaurant sales, but using the exact same methodology, we would be blasting them.

Interestingly, in his note to tobacco control advocates, Dr. Glantz argues that the tobacco industry has been criticizing the smoking ban - heart attack studies and insinuates that the only ones criticizing these studies are tobacco company employees or tobacco "sympathizers." Clearly, that is not true. For one, I have been quite critical of these studies and I am not affiliated in any way with the tobacco industry. Additionally, I am not aware that the tobacco companies have publicly opined either way on these studies.

The rest of the story is that anti-smoking groups have jumped on to a study which concludes that the North Carolina smoking ban decreased heart attacks by 21% in its first year, when in fact heart attacks among women increased by 21% during that year and the rate of decline in heart attacks overall slowed significantly. This is shoddy science and I believe it threatens to undermine the integrity of the tobacco control movement, risking the loss of our ability to effectively advocate for these and other important public health policies.

Data Show No Effect of Smoking Ban on Heart Attack Admissions in North Carolina, But That Doesn't Stop Anti-Smoking Groups from Claiming a 21% Decline

2011-11-10T07:31:00.001-05:00

Frank Increase in Heart Attack Admissions Among Women Makes Anti-Smoking Groups' Conclusions Completely Untenable

A new report out of the North Carolina Department of Health concludes that the statewide smoking ban, implemented on January 1, 2010, caused a 21% decline in heart attack admissions during 2010.

The report assessed age-adjusted rates for weekly heart attack admissions during the two years prior to the smoking ban (2008 and 2009) and one year after the ban (2010). The effect of the ban was estimated using "generalized estimating equation (GEE) Poisson regression models with an autoregressive correlation matrix to adjust for short-term autocorrelations within clusters of gender, age, and county" (i.e., using a fancy statistical model).

The study results were as follows: "Comparison of QIC statistics suggested that the model that provided the best fit to the data was that which only adjusted for the weekly average temperature and for county. This model indicated that the rate of ED visits for AMI was 21 percent lower following the implementation of the smoke-free restaurant and bars legislation. (Rate Ratio [RR] Estimate was 0.79 ; 95% CI: 0.75-0.83)."

The study goes further. It then calculates the health care savings due to the smoking ban's reduction of heart attacks. A North Carolina Department of Health and Human Services press release boasts that: "Emergency room visits by North Carolinians experiencing heart attacks have declined by 21 percent since the January 2010 start of the state’s Smoke-Free Restaurants and Bars Law. ... the decline in heart attacks in North Carolina in 2010 represents an estimated $3.3 to $4.8 million in health care cost savings."

An immediate announcement by Dr. Stan Glantz, following the release of the report, boasted that heart attacks in North Carolina are "down 21 percent in the first year after the North Carolina smokefree restuarant and bar law took effect."

The Rest of the Story

The rest of the story is the actual data, which show quite clearly that the rate of decline in heart attack admissions in North Carolina has slowed since the smoking ban went into effect and that among women, the number of heart attacks has increased.

Moreover, the health department's report acknowledges both of these findings!

The combination of these two facts leads me to question whether the conclusion of the report is attributable to bias on the part of the anti-smoking groups involved in the research, which (like me) desperately want to see the health effects of their policies.

Here are the actual data, which show the rate of decline in heart attack admissions observed in North Carolina during the year before and the year after the smoking ban:

Year Before the Smoking Ban (change from 2008 to 2009): 10.5% decline in heart attacks
Year After Smoking Ban (change from 2009 to 2010): 5.5% decline in heart attacks

Thus, the actual data show that the rate of decline in heart attacks slowed in the first year after the smoking ban went into effect.

The study acknowledges this finding, admitting that: "Interestingly, the rates appear to have consistently declined between the year 2008 and 2009; after that period the rates leveled off at a consistently lower level in the year 2010 (Figure 1)."

In other words, the report readily admits that the data demonstrate an increase in the expected number of heart attacks following the smoking ban. Based on the existing secular trend, one would have expected to see about a 10% decline in heart attack admissions. However, the actual decline was only 5.5%. As the report itself acknowledges, the heart attack rates, which were declining prior to the smoking ban, "leveled off" in 2010.

Now let's examine what the so-called 21% decline in heart attack admissions meant for the number of heart attack admissions among women in North Carolina:

Question: From 2008 to 2009 (the year prior to the smoking ban), the number of heart attack admissions among women in North Carolina decreased by 661, from 4182 to 3521, representing a decline of 15.8%. Given the anti-smoking groups' conclusion that the smoking ban led to a 21% reduction in heart attacks, which of the following is the observed reduction in heart attack admissions among women in North Carolina from 2009 to 2010 (the first year of the smoking ban)?

a. From 3521 to 2678, a decline of 23.9%
b. From 3521 to 2790, a decline of 20.8%
c. From 3521 to 3012, a decline of 14.5%
d. From 3521 to 3245, a decline of 7.8%
e. From 3521 to 3456, a decline of 1.8%

The answer is:

...

...

f. None of the above.

The number of heart attack admissions among women increased from 3521 to 4273, an increase of 21.4%.

Do you see how ridiculous it is to conclude that the smoking ban in North Carolina led to a 21% decline in heart attack admissions when the actual data show that heart attack admissions among women increased by 21%?

Moreover, the report readily acknowledges this finding: "the number of ED visits for AMI increased slightly from 2009 to 2010 in younger and older women."

Now you can see why I cannot help but wonder whether there is a bias taking place here: researchers and policy makers are eager to find an effect of their interventions. I, too, share this bias, as I have testified in favor of smoking bans in many states and cities, and would like nothing more than to be able to document a substantial reduction in heart attacks due to these policies.

However, if the data don't show it, then the data don't show it and we shouldn't be disseminating these ridiculous, unsupported conclusions.

Frankly, the actual data come much closer to showing a 21% increase in heart attack admissions in North Carolina during the first year of the smoking ban than they do to showing a 21% decline in admissions.

By the way, if you don't believe me, look at the data yourself. In particular, look at Figure 1, which shows the raw data. You'll see that there was a decline in heart attack admissions prior to the smoking ban but that the decline leveled off somewhat after the ban went into effect. Even the authors of the report do not dispute this.

How then, does the report come up with the conclusion that there was a 21% decline in heart attacks due to the smoking ban? It appears to me that this is the result of a flaw in the methodology: the analysis fails to control for the secular trend in heart attacks. In other words, the analysis simply compares the number of heart attacks in 2010 to the number in 2008 and 2009 and finds that it is about 21% lower. If you don't control for the baseline trend in heart attacks, you are going to create an effect that doesn't actually exist.

The rest of the story is that instead of a 21% decline in heart attacks due to the smoking ban, there was actually a 21% increase in heart attack admissions among women and a decrease in the rate of decline in heart attacks overall from 10.5% to 5.5%. These data are not consistent with the conclusion in the report, in the press release, or in the announcement being disseminated by Dr. Glantz.

My readers understand that I support smoking bans and that this support does not hinge on demonstrating an immediate effect of such bans on heart attacks. The inability to demonstrate such an immediate effect is not a reason to stop protecting workers from secondhand smoke exposure. However, by disseminating these unsupported conclusions and adopting shoddy science to support our policies, I believe that the tobacco control movement is risking its credibility. And if that is lost or undermined, then we will lose our ability to continue to pass laws that protect workers from the dangers of secondhand smoke exposure. And that's the real shame with the rest of the story.

New York Times Article Highlights Absurdity of Anti-Smoking Groups' Opposition to Smoking Cessation Via Electronic Cigarettes

2011-11-09T11:48:00.002-05:00

An article by John Tierney in yesterday's New York Times highlights the absurdity of anti-smoking groups' opposition to smoking cessation via the use of electronic cigarettes.

Tierney first notes the results of a clinical trial on the use of electronic cigarettes as a smoking alternative. In that trial, which involved smokers who had little interest in quitting: "After six months, more than half the subjects in Dr. Polosa’s experiment had cut their regular cigarette consumption by at least 50 percent. Nearly a quarter had stopped altogether."

Tierney then notes that: "Though this was just a small pilot study, the results fit with other encouraging evidence and bolster hopes that these e-cigarettes could be the most effective tool yet for reducing the global death toll from smoking."

However, as Tierney reveals: "there’s a powerful group working against this innovation — and it’s not Big Tobacco. It’s a coalition of government officials and antismoking groups who have been warning about the dangers of e-cigarettes and trying to ban their sale. The controversy is part of a long-running philosophical debate about public health policy, but with an odd role reversal. In the past, conservatives have leaned toward “abstinence only” policies for dealing with problems like teenage pregnancy and heroin addiction, while liberals have been open to “harm reduction” strategies like encouraging birth control and dispensing methadone. When it comes to nicotine, though, the abstinence forces tend to be more liberal, including Democratic officials at the state and national level who have been trying to stop the sale of e-cigarettes and ban their use in smoke-free places. They’ve argued that smokers who want an alternative source of nicotine should use only thoroughly tested products like Nicorette gum and prescription patches — and use them only briefly, as a way to get off nicotine altogether."

"The Food and Drug Administration tried to stop the sale of e-cigarettes by treating them as a “drug delivery device” that could not be marketed until its safety and efficacy could be demonstrated in clinical trials. The agency was backed by the American Cancer Society, the American Heart Association, Action on Smoking and Health, and the Center for Tobacco-Free Kids. ... they cite an F.D.A. warning that several chemicals in the vapor of e-cigarettes may be “harmful” and “toxic.” But the agency has never presented evidence that the trace amounts actually cause any harm, and it has neglected to mention that similar traces of these chemicals have been found in other F.D.A.-approved products, including nicotine patches and gum."

The article cites me as stating: "It boggles my mind why there is a bias against e-cigarettes among antismoking groups."

The Rest of the Story

While it does continue to boggle my mind, I have come upon two potential influences that may at least explain the anti-smoking groups' positions.

First, they appear to share an ideology by which it is impossible to acknowledge that anything good could come out of the use of something called a "cigarette" or by an action that looks just like "smoking." Even when abundant evidence suggests that such a product is helping thousands of ex-smokers to stay off of cigarettes and that the product is much safer than smoking, the ideology of these groups appears to blind them to the overall public health benefits of these products.

Second, nearly every one of the anti-smoking groups which opposes e-cigarettes and which called for their removal from the market has received money from pharmaceutical companies that manufacture competing smoking cessation drugs. This bias is, I think, acting subconsciously to cloud these groups' perspectives on the data, the science, and the policy issues. Electronic cigarettes represent a substantial potential threat to the profitability of existing smoking cessation medications and could have implications for sales of these existing products on the order of billions of dollars.

Preliminary Injunction Issued Against Graphic Cigarette Warning Labels; Court Finds Tobacco Companies Likely to Prevail on First Amendment Grounds

2011-11-07T14:49:00.002-05:00

A federal district court judge today issued a preliminary injunction against the FDA's graphic cigarette warning label requirements, which were scheduled to go into effect next September. Unless overturned on appeal, this means that the FDA will not be able to implement this graphic warning label requirement pending the outcome of the lawsuit, which was filed on First Amendment grounds by R.J. Reynolds, Lorillard, and three smaller tobacco companies.

The primary argument of the tobacco company plaintiffs was that while requiring factual and uncontroversial information on cigarette packs is permissible, the large graphic warnings which are intended to solicit an emotional response along with a telephone hotline number for smoking cessation service go beyond this and essentially require the tobacco companies to place an anti-smoking billboard on their packages.

Judge Richard Leon of the District Court of the D.C. Circuit agreed with the plaintiffs, finding that the graphic warning labels are intended and designed not to convey factual information about smoking and health, but to discourage people from smoking.

Leon writes: "Unfortunately for the Government, the evidence here overwhelmingly suggests that the Rule's graphic-image requirements are not the type of purely factual and uncontroversial disclosures that are reviewable under this less stringent standard. Indeed, the fact alone that some of the graphic images here appear to be cartoons, and others appear to be digitally enhanced or manipulated, would seem to contravene the very definition of "purely factual." That the images were unquestionably designed to evoke emotion - or, at the very least, that their efficacy was measured by their "salience," which the FDA defines in large part as a viewer's emotional reaction ... further undercuts the Government's argument that the images are purely factual and not controversial ... . Moreover, it is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start, smoking: an objective wholly apart from disseminating purely factual and uncontroversial information."

Judge Leon then analyzes the graphic warning label requirement under strict scrutiny and fails to find that the government has either demonstrated that it will advance a legitimate and significant government interest or that it is tailored as narrowly as possible to advance that interest.

Leon writes: "In short, the Government has neither carried its burden of demonstrating a compelling interest, nor demonstrated how the Rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech."

Because he finds that the tobacco companies are likely to prevail on the merits of their First Amendment challenge and because they are likely to suffer irreparable harm if the requirement is implemented, Judge Leon issued a preliminary injunction, barring implementation and enforcement of the requirement while the Court considers and decides the case.

The Rest of the Story

I predicted in an August post that Judge Leon would rule in favor of the plaintiffs on two major grounds. As I wrote:

"There are two problems with the required graphic warning labels that I believe renders them subject to potential violation of the First Amendment. First, as the tobacco companies argue, it is going to be difficult for the FDA to assert that requiring tobacco companies to put the smoking cessation hot line number on their packs is merely a health warning, rather than a smoking cessation message."

"Second, it is going to be difficult for the FDA to argue that the required warnings are the least restrictive interference with free speech that could accomplish the government's intended purpose in requiring that tobacco companies warn their consumers of the health hazards of smoking."

Each of these points played a central role in Judge Leon's ruling.

First, Leon found that the requirement for a smoking cessation hotline number on the cigarette pack made it abundantly clear that the purpose of the warning label requirement was not merely to provide factual information on health risks, but to advocate for smoking cessation.

As he writes: "Thus, while the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company's advertising space for Government advocacy can be frustratingly blurry, here - where these emotion-provoking images are coupled with text extolling consumers to call the phone number "1-800-QUIT" - the line seems quite clear."

Second, Leon found that the graphic warning labels are not even close to being narrowly tailored to advance the government's purpose: "it is quite clear that the Rule's graphic-image requirements in no way suggest the slightest attempt to narrowly tailor the display or presentation of the graphic images Congress mandated."

Also, as I noted in more recent commentaries, the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups actually undermined the government's case. While the FDA tried to achieve a lesser degree of scrutiny by arguing that the purpose of the graphic images was to more effectively communicate health information, the amicus brief makes it eminently clear that the real purpose of the labels is to create a tobacco industry-funded anti-smoking campaign on the cigarette packs.

Indeed, the fact that Judge Leon had difficulty discerning and articulating the government's primary interest in his opinion is a testament to the sneaky tactics of the FDA in trying to design a smoking cessation campaign under the guise of an information campaign. Had the FDA simply been honest and stated that its purpose was to save lives by deterring smoking, it would have at least been able to meet one of the prongs of the Central Hudson test. Sure, it would have had to give up on lesser scrutiny, but at least it could have tried to make a compelling case for why the government has a substantial interest in lowering smoking rates, something it failed to do in its arguments because it was unwilling to admit that the purpose of the warning labels was to deter smoking.

Predictably, the Campaign for Tobacco-Free Kids responded to the ruling by issuing a press release calling the decision "wrong on the science" and "wrong on the law" but failing to point out either how the ruling is wrong on the science or how it is wrong on the law. In fact, the press release fails to address any of the relevant legal issues involved in the case.

Professor Stanton Glantz responded to the ruling by issuing an email entitled "Bush appointed judge rules against FDA graphic warning labels." This implies that the decision was a purely political one and like the Campaign's response, fails to address any of the substantive issues of the case, or even to admit that it involves any substantive legal issues.

Despite the anti-smoking groups' apparent confidence that this ruling will be overturned on appeal, I do not share that confidence. I do think there is a valid First Amendment issue of whether the government can compel speech by a company which is not purely factual but which is instead primarily intended to discourage sales of that company's own products.

It would be one thing to require the Clorox company to place a warning on Clorox bleach that says: "Corrosive. Do not allow to touch your skin." It would be quite another, however, to require that 50% of a Clorox bottle contain a picture of a dead fish and urge consumers to call a hotline that promotes the use of natural products instead of household chemicals.

New Study Confirms Suicide Risk from Chantix and Argues It Should Not Be Used as First-Line Therapy for Smoking Cessation

2011-11-07T11:38:00.004-05:00

Story Demonstrates Why Conflicts of Interest Are Unacceptable on NIH Expert Smoking Cessation Panel

A new study published this week in the journal PLoS Medicine confirms that Chantix (varenicline) is associated with a substantial increase in suicide, suicidal behavior, and depression, and to a much greater degree than nicotine replacement therapy even though Chantix was available during only four of the 13 study years.

Of the total of 3,249 reported cases of suicidal/self-injurious behavior or depression during the study period, only 3% of cases occurred among NRT users, compared to 90% for varenicline. The authors adjusted the observed increased risk of these adverse outcomes among varenicline users for a number of potential confounders. However, they found that "varenicline has markedly higher reported risk than any of the comparators, a risk that was not reduced regardless of the form of adjustment used."

The study concludes: "Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior. Bupropion for smoking cessation had smaller increased risks. The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation."

The study also recommends that:

1. "varenicline should not be prescribed for sensitive occupations such as airline pilots, air controllers, active duty military, police officers, truck and bus drivers, and emergency medical workers."; and

2. "the FDA should consider revising the suicidal behavior and depression language in the Boxed Warning and Highlights of Prescribing Information to state clearly that the risks of suicidal behavior and depression are higher with varenicline than with other smoking cessation treatments."

These results conflict with those of an earlier FDA study which found no increased risk of hospitalization for depression or suicidal ideation among users of Chantix.

According to an article at WebMD.com: "The FDA is standing by its Oct. 24 review of two FDA-sponsored studies that examined hospitalizations for psychiatric reasons in users of Chantix and nicotine-replacement therapy."

According to the article, Pfizer also denounced the new study's conclusions: "In a written statement, Pfizer spokesman MacKay Jimeson was highly critical of the reliance of Moore and colleagues on reports that came out after the drug went to market. 'Post-marketing reports can come from any source ranging from patients to health care providers, and from phone calls to Internet postings and lawyers,' he tells WebMD. 'Because of the many limitations of post-marketing reports, the conclusions made by the authors are not supported by the data.'"

The Rest of the Story

There is a good reason why the results of this new study conflict with those of the FDA-sponsored studies. In those studies, the outcome variable was hospitalization for suicidal ideation or depression. But hospitalization for these symptoms are quite uncommon (it takes a lot these days to get yourself admitted acutely for depressive symptoms). Moreover, the study would miss any suicides because persons are not admitted to the hospital for suicide. Furthermore, most of the serious adverse effects of Chantix are sudden and acute and would not necessarily be expected to lead to hospitalization.

For this reason, I find the FDA's defense of its study and its apparent dismissal of these new results to be quite worrisome.

It is also discouraging to see Pfizer criticizing this study on the grounds that it relies on post-marketing reports. It is precisely those reports which resulted in revelations about the adverse effects of drugs like Vioxx and which led to their removal from the market. Does Pfizer really want to be on record as arguing that post-marketing surveillance is not a valid source of information about possible unforeseen drug adverse effects?

But the real rest of the story here is what it says about the participation of conflicted researchers (namely, those with financial relationships with Pfizer) on the FDA expert panel which recommended that drugs be used for every smoking patient and which listed Chantix as a legitimate first-line therapy.

Clearly, that expert panel's recommendation is now in direct conflict with that of the Institute for Safe Medical Practices along with expert researchers from Harvard Medical School, Wake Forest University School of Medicine, and the Johns Hopkins University School of Medicine.

The shame, however, is that as I reported in May 2008, the panel chair and eight members had financial conflicts of interest with Big Pharma. In particular, the panel chair received funding from Pfizer, the manufacturer of Chantix, at about the same time as his panel crafted the recommendation that this drug should be considered as first-line therapy for smoking cessation.

Note that as of the writing of the report, the FDA had already issued a black box warning noting that agitation, depression, suicidal ideation, and suicide had been associated with the use of varenicline. The panel apparently downplayed this risk in its recommendations. Differences in clinical judgment are acceptable when they are genuine, but to have a disagreement like this which has the appearance of potentially being associated with a financial conflict of interest is, in my view, unacceptable.

Moreover, from what I can tell, the 2008 guideline has not been updated to note the subsequent reports of Chantix's adverse effects, including to quantify the number of suicides reported with the use of this drug. No mention is made of the results from the new study above. Thus, physicians relying on the 2008 update do not have the information they need regarding the potential risks of varenicline. At very least, I think they deserve to know that the Institute for Safe Medical Practices along with expert researchers from Harvard Medical School, Wake Forest University School of Medicine, and the Johns Hopkins University School of Medicine do not believe that Chantix should be considered as first-line therapy for smoking cessation.

Bias Against Cold Turkey Quitting is Apparent in Literature; Possibly Influenced by Financial Conflicts of Interest?

2011-11-03T15:57:00.006-04:00

Imagine that you were doing a study on whether nicotine replacement therapy (NRT) is more effective than cold turkey quitting in smoking cessation. You ask a bunch of successful quitters (ex-smokers) and unsuccessful quitters (current smokers who have made a quit attempt) what strategy for smoking cessation they used in their most recent quit attempt. You might structure the question something like this:

During your last quit attempt, what was the primary method you used to try to quit?
1. NRT
2. Buproprion
3. Chantix
4. Cold Turkey
5. Other

In comparing the effectiveness of each approach, you might compare the reported use of each strategy between successful and unsuccessful quitters.

Suppose, instead, that you had a vested interest, or a bias towards not finding that cold turkey approaches are superior to NRT. What might you do?

A clever approach would be to simply not list "cold turkey" as a potential answer. Instead, you might provide a very long list of potential smoking cessation aids, including books, web sites, group sessions, phone lines, group sessions, etc. Let the respondent check off all the strategies that they used. Then, at the end of the long list, include a category entitled "Nothing." This category would only apply to people who not only tried to quit unaided by medication, but who also failed to even look at a smoking cessation web site, make a phone call, watch a video, attend a group session, etc. This doesn't sound like a very motivated group of smokers, does it?

What happens if you then use this category to classify smokers as "unaided" quitters (a very loose and inaccurate proxy for cold turkey quitters)?

My guess is that you are going to get an artificially low estimate of the cessation rate for cold turkey quitters. Rather than a direct comparison of cold turkey quitting vs. the use of NRT, this provides a comparison of NRT against a loosely defined group of people who don't appear to have been very motivated to quit in the first place.

Unfortunately, this appears to be the method used to ascertain the quit strategies used by smokers in the Smoking Toolkit Study, a series of monthly annual surveys in the UK which are designed to examine smoking cessation and the effectiveness of various cessation strategies.

The actual question that appears in the February 2010 questionnaire is as follows:

"Which, if any, of the following did you try to help you stop smoking during the most recent serious quit attempt?" (Please code all that apply)

"Nicotine replacement product (eg. patches/gum/inhaler) without a prescription
Nicotine replacement product on prescription or given to you by a health professional
Zyban (bupropion)
Champix (varenicline)
Attended an NHS Stop Smoking group
Attended a non-NHS smoking support group Attended one or more NHS Stop Smoking one-to-one counselling/advice/support session/s
Attended a non-NHS one-to-one counselling/advice/support session/s
Phoned NHS Smoking Helpline
Phoned a non- NHS Smoking Helpline Allen Carr Easyway session
Allen Carr Easyway book
Another book or booklet
Visited www.nhs.uk/smokefree website
Visited a website other than Smokefree
Hypnotherapy
Acupuncture
Don't Know
Nothing
Other"

Despite this bias against cold turkey quitting, the results of a recent report from the study found that NRT was no more effective than "unaided quitting." This almost assuredly indicates that had cold turkey been pitted against NRT, it would have won hands down.

Why this tremendous bias in what is supposed to be objective scientific research?

The Rest of the Story

Perhaps the apparent bias is less astonishing when one finds out the rest of the story: The study was funded by the pharmaceutical industry.

According to a background study document: "The Smoking Toolkit Study is currently funded
by Cancer Research UK, Pfizer and GSK [GlaxoSmithKline]."

Moreover, two of the researchers working on the Smoking Toolkit Study also have financial conflicts of interest with Big Pharma.

As disclosed in a recent paper: "RW undertakes research and consultancy for the following developers and manufacturers of smoking cessation treatments; Pfizer, J&J, McNeil, GSK, Nabi, Novartis and Sanofi-Aventis. RW also has a share in the patent of a novel nicotine delivery device. AMC has received travel funding, honorariums and consultancy payments from manufacturers of smoking cessation products (Pfizer, J&J, McNeil, GSK, Nabi, Novartis and Sanofi-Aventis). He also receives payment for providing training to smoking cessation specialists; receives royalties from books on smoking cessation and has a share in a patent of a nicotine delivery device."

That paper also acknowledges that the Smoking Toolkit Study is funded by: "Pfizer, GlaxoSmithKline and Johnson and Johnson."

Perhaps worst of all, in the recent paper that reports the results of the Smoking Toolkit Study, the author (RW above) fails to disclose any financial conflicts of interest and the report fails to disclose that the study is funded by several pharmaceutical companies.

The rest of the story is that there does indeed appear to be a bias in favor of pharmaceutical smoking cessation aids, and there is at least the appearance that this bias is at least in part related to the receipt of money from pharmaceutical companies.

(Thanks to John Polito for the tip.)

When is a Financial Conflict of Interest No Longer a Conflict?

2011-11-02T15:23:00.003-04:00

In the past two sets of commentaries, I have revealed examples of tobacco control researchers who failed to disclose past conflicts of interest with the pharmaceutical industry. Although failing to report these "prior" conflicts was in compliance with the journal or professional organization policy, I opined that although they occurred in the past, these conflicts were still significant and relevant and therefore should have been disclosed to readers nonetheless.

Today, I address the tricky issue of: When is a conflict no longer a conflict?

Let's start with two examples:

Example 1: Professor X is a chemist at the University of Louisville. He studies the levels of particulate matter and other chemicals in ambient air for use in exposure assessment. In 2011, he publishes a paper entitled "Levels of Secondhand Smoke in Owensboro Bars: No Evidence that Regulation is Necessary." For the past 3 years, he has been employed at the University of Louisville and hasn't had any funding or consulting income from any corporations. The journal requires disclosure of any financial conflicts of interest within the past 3 years.

Is it acceptable for Professor X to file a "no" disclosure (i.e., not to disclose any financial conflicts of interest)?

According to the reasoning being used by Dr. Fiore, Dr. Carpenter, and many others in tobacco control (and according to numerous comments I received from tobacco control colleagues in response to my commentaries), the answer is a resounding "No." Since the journal only requires the disclosure of conflicts within the past 3 years, Professor X need not disclose any financial conflicts of interest. There is nothing wrong with him claiming that he has no financial conflicts of interest, and there is no reason for journal readers to have any more information about past potential conflicts.

Example 2: Professor Y is an epidemiologist at the Health Policy Institute. He studies the effects of various exposures on disease risk, as he has done for decades. In 2011, he publishes a paper entitled "No Evidence of Increased Heart Disease Risk among Secondhand Smoke-Exposed Workers. For the past 3 years, he has been employed at the Health Policy Institute and neither he nor the Institute had any funding or consulting income from any corporations during that time period. The journal requires disclosure of any financial conflicts of interest within the past 3 years.

Is it acceptable for Professor Y to file a "no" disclosure (i.e., not to disclose any financial conflicts of interest)?

According to the reasoning being used by Dr. Fiore, Dr. Carpenter, and many others in tobacco control (and according to numerous comments I received from tobacco control colleagues in response to my commentaries), the answer is a resounding "No." Since the journal only requires the disclosure of conflicts within the past 3 years, Professor Y need not disclose any financial conflicts of interest. There is nothing wrong with him claiming that he has no financial conflicts of interest, and there is no reason for journal readers to have any more information about past potential conflicts.

The Rest of the Story

Here is the rest of the story about Professor X. As it turns out, Professor X spent most of his career as a research chemist in the Laboratory Division of Brown & Williamson. He worked there for 34 years, during which time he produced articles that helped the company deny that nicotine is addictive, that secondhand smoke is hazardous, and that active smoking is as harmful as public health authorities claim. Four years ago, he "retired" from Brown & Williamson and took a position at the University of Louisville.

How many people in tobacco control still think that Professor X has no obligation to disclose his prior conflicts of interest? I would venture to say none. Moreover, I would venture to say that if this occurred in real life, a contingent of anti-smoking groups would publicly attack Professor X for failing to disclose his prior employment at Brown & Williamson and that they would attempt to discredit the study on that basis.

Now here is the rest of the story about Professor Y. As it turns out, in 1985 Professor Y became Vice President of the Thomas Institute Policy Analysis Center (TIPAC), a consulting firm funded initially by a $400,000 grant from the Brown & Williamson Tobacco Corporation. Following its initial formation, TIPAC continued to receive hundreds of thousands of dollars in funding annually from a number of tobacco companies. Professor Y worked on Research & Development projects for B&W Tobacco, such as analysis of the sensory perception of smoke and how to reduce the amount of tobacco in cigarettes. By 1995, Professor Y was a full-time consultant on environmental tobacco smoke issues for the Tobacco Institute. In 2005, he took a position with the Health Policy Institute. Both his initial salary and the Institute's start-up costs were paid for by Philip Morris. For the last four years, however, the Institute has found private donors and has not had to rely on any tobacco industry funding.

How many people in tobacco control still think that Professor Y has no obligation to disclose his prior conflicts of interest? I would venture to say none. Moreover, I would venture to say that if this occurred in real life, a contingent of anti-smoking groups would publicly attack Professor Y for failing to disclose his prior history of involvement with the tobacco industry and that they would attempt to discredit the study on that basis.

It is clear from these examples, I hope, that past conflicts of interest are indeed critical for readers to know about. Just because Professor X and Professor Y had nothing to disclose during the past three years does not indicate that they have no financial conflicts of interest that need to be disclosed in their current publications, the journal's requirements notwithstanding.

Furthermore, it would be hypocritical and inconsistent to argue that past conflicts are only relevant when it comes to tobacco. If past conflicts are relevant, then past conflicts are relevant.

Therefore, it is my feeling that researchers do need to disclose their past conflicts (albeit briefly). A financial conflict of interest does not disappear simply because the conflict is no longer active.

Let me reinforce this point with one further example:

In 2007, a tobacco researcher who is near and dear to you (actually, despised by many may be closer to the truth) - Dr. Michael Siegel - accepted $400,000 from a start-up electronic cigarette company to advise the company on how to best market its products, deal with potential FDA and other regulatory matters, and conduct valid scientific studies to test the safety and effectiveness of the product. The consulting work concluded by the end of 2007, Dr. Siegel was paid in full in that year, and has not had occasion to do any further paid consulting for electronic cigarette companies.

Now, in 2011, Dr. Siegel is (I am indeed) about to publish a study in which he reports the results of qualitative research with electronic cigarette users to determine the effectiveness of the product. How many of you believe that there is no need to disclose my 2007 receipt of nearly a half million dollars from an electronic cigarette company because it was more than 3 years ago? (the journal to which I am submitting the paper requires only conflicts within the past 3 years to be revealed)

I would be willing to bet (up to $400,000 in fact) that if I did not disclose my prior financial relationship with an e-cigarette company, anti-smoking advocates would grill me over the coals for failing to disclose that fact, even though it occurred four years ago and I am not required to report it by the journal. I am sure I would be attacked even though I would be in full compliance with journal and institutional policies.

Clearly, past conflicts of interest are relevant and I believe that researchers have the obligation to disclose past conflicts that are related to the research in question.

Is there any circumstance in which a past conflict of interest does indeed "disappear" or become inactive to the point that it need not be disclosed?

I can think of just one. If a researcher were to renounce his past involvement with a particular industry, vow to never accept money from that industry in the future (whether in the form of grants, employment, honoraria, consulting, lecture fees, etc.), to make this vow public (by publishing it on a personal or institutional web site), and to demonstrate the commitment by going a certain period of time (e.g., 5 years) in compliance, then one could potentially argue that the investigator has truly put the financial relationship in the past. As there is no opportunity for any funds to be received from that industry ever again, this could in fact put an end to the potential influence of the previous conflict.

Short of that, there is simply no way to argue that a past conflict is no longer present. For example, in the example above, I accepted e-cigarette money in 2007. I then write a paper in 2011 about the effectiveness of e-cigarettes and I don't disclose any conflicts since none are "current." Then, the day after the paper is published, I get a call from "Heavy Metal Cigs," which wants to pay me $1 million for helping them plan a definitive clinical trial on the effectiveness of electronic cigarettes (note: my phone lines are open). So was I really unconflicted in 2011 when I published my paper, or was I just waiting for the right offer to come along? And how could we ever know the willingness of any particular researcher to take corporate money in the future, short of a public vow?

The rest of the story is that prior conflicts of interest - even if "active" before a journal's "disclosure period" - need to be disclosed if they are directly related to the topic of the research, as they are still potentially relevant to the reader. If the conflicts are small in magnitude and unlikely to affect the appearance of impartiality, then that is a judgment that the reader is free to make. But without the information, then we clearly lack the information we need to be able to make an informed judgment.

Unfortunately, the last example was only an example. Had I actually received $400,000 in 2007, I would certainly not still be driving my 120,000+-mile 1998 Saturn SL.

Study Finds Cold Turkey Quitting More Effective than NRT, But Concludes the Opposite

2011-11-01T14:31:00.010-04:00

According to a study presented at the 2011 CHEST (American College of Chest Physicians) annual meeting, physicians who recommend cold turkey smoking cessation are giving bad advice as they should instead recommend the use of nicotine replacement therapy (NRT) or other medications.

The study is summarized in a press release as follows:

"Clinicians frequently recommend patients stop smoking but do not always provide them with appropriate tools to ensure their success. Researchers from the Medical University of South Carolina in Charleston conducted a survey of 777 current and ex-smokers, asking questions about patient demographics, smoking status, smoking cessation attempts, physician recommendations regarding approaches, and methods used to stop smoking, as well as cessation treatments. Among current smokers, 66% were advised by a physician to stop smoking. A cold turkey approach was advised 19% of the time, while nicotine replacement therapy was advised 52% of the time, and medications were advised 40% of the time. Of those who received a recommendation to quit cold turkey, the success rate was less than 10% a year. Greater efforts may be required by clinicians to ensure patients receive appropriate evidence-based therapy for smoking cessation."

The study abstract concludes as follows:

"Patients report that that clinicians make inquiries regarding patient smoking status and recommend smoking cessation; however, it appears that many patients are given improper cessation techniques. According to participants, clinicians recommend a 'cold turkey' approach to smoking cessation in 19% of cases, but its success rate is less than 10% at 1 year. Based on the survey results, it is unclear if patient's are receiving appropriate information and/or education regarding smoking cessation therapy.

The Rest of the Story

Readers may be surprised to find out that the study, according to the abstract, actually found that cold turkey quitting is more effective than the use of the so-called "evidence-based" therapy.

If you read the results section of the abstract, you will note that the authors report the following finding: "Former smokers reported that they were significantly more likely to have attempted a cold turkey approach to smoking cessation (p<0.0001) and less likely to have tried evidence-based therapies to stop smoking compared to current smokers (p<0.0001). "

This finding indicates that successful quitters - the former smokers - were more likely to have used a cold turkey approach, while the unsuccessful quitters - the current smokers - were more likely than the quitters to have used "evidence-based" therapies.

In other words, these data provide evidence that cold turkey smoking cessation is more effective in achieving sustained smoking cessation than the use of NRT or other medications.

While I hold out hope that this is simply a typo and that the actual finding was the opposite, if not a mistake it means that the authors drew the opposite conclusion from what their data showed and suggests that they have some sort of bias in favor of medication over cold turkey quitting.

Interestingly, while the press release and abstract report that the cessation rate was below 10% with cold turkey quit attempts, neither reports the cessation rate with the so-called "evidence-based" approaches: NRT and other medication. This is a curious omission in a study that purports to have demonstrated that NRT and medication are more effective than cold turkey quit attempts.

Of note, these study findings are consistent with those of several previous studies which have also found that cold turkey, unplanned quit attempts tend to be more effective than planned attempts that often involve the use of medications (example 1; example 2; example 3).

The odd apparent discrepancy between the study results and the study conclusion may seem difficult to explain until one considers the financial disclosure statement at the end of the abstract. It states that all of the authors "have nothing to disclose."

However, a quick internet search revealed that one of the authors does indeed have an apparent conflict of interest, as he reports (elsewhere) having consulted for and received consulting payments from GlaxoSmithKline for helping the company market its Nicorette Fruit Chill gum. Though this financial relationship with the pharmaceutical company occurred in 2006, I explained last week why I believe it is still very much relevant for the reader of the present study.

If the published abstract is printed correctly, then the rest of the story is that the research appears to be biased, with an admonition against the use of cold turkey cessation that runs counter to the data presented in the paper itself. Moreover, there appears to be a significant financial conflict of interest among one of the study authors that is not disclosed in the paper and which I believe should have been disclosed. This author's history of a past financial relationship with Big Pharma and his apparently paid role in having helped market Nicorette gum certainly has the appearance of potentially influencing the reporting of the results of the present research.

If the published abstract was printed with a mistake (which seems unlikely but possible), then the rest of the story is simply that there appears to be a significant financial conflict of interest among one of the study authors that is not disclosed in the paper and which I believe should have been disclosed. Again, this author's history of a past financial relationship with Big Pharma and his apparently paid role in having helped market Nicorette gum certainly has the appearance of potentially influencing the reporting of the results of the present research.

Please note that I am not arguing that the co-author with what I believe is a conflict violated any policy of CHEST. They presumably do not ask authors to disclose "past" conflicts. However, my personal opinion is that these types of "past" conflicts should be disclosed to readers.

Do Significant Conflicts of Interest Disappear Overnight? Researcher Fails to Disclose Previous 12-Year Big Pharma Financial Relationship

2011-10-31T07:31:00.000-04:00

How long is a financial conflict of interest still a conflict? And for how long after a conflict "ceases to exist" should a researcher continue to disclose that conflict? These intriguing questions are raised in today's Rest of the Story.

Last week, I discussed how a researcher who has made substantial contributions to the field of treatment of patients for smoking cessation - Dr. Michael Fiore - had a significant conflict of interest with Big Pharma by virtue of his position as a chair endowed by GlaxoSmithKline, which he acknowledged gave him "access to up to $50,000 per year to support [his] University approved and sanctioned educational, research, and policy activities."

This chair position was apparently held by Dr. Fiore from 1997 until February 2010, when he resigned the position.

It appears that in at least some of his current publications, Dr. Fiore has stopped disclosing this conflict of interest to readers.

In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore states only that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals." These articles give no indication that as of the start of 2010, and for the previous 13 years, Dr. Fiore held a chair position endowed by GlaxoSmithKline.

In August 2011, an erratum to the latter article was published. This would have been an opportunity to correct the disclosure statement had the omission of mention of the Big Pharma endowed chair position had merely been an oversight.

In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore states only that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals." Again, the article gives no indication that as of the start of 2010, and for the previous 13 years, Dr. Fiore held a chair position endowed by GlaxoSmithKline.

The Rest of the Story

In my opinion, a conflict of interest does not disappear overnight. In the present case, I believe that the existence of a 13 year period during which the researcher held a Big Pharma endowed chair position is absolutely relevant today, even though the researcher has resigned that position. I believe that readers deserve to be informed about that 13-year financial relationship between the researcher and the pharmaceutical industry and that this relationship is relevant to the evaluation of potential bias in the conduct and reporting of the research, even though the relationship ceased to exist in early 2010. Thus, I believe that the conflict should continue to be reported and that the investigator has an obligation to inform journal readers of the past financial relationship.

Imagine if a scientist at Philip Morris resigned his position to take a job at an academic institution. Now imagine that scientist published a tobacco-related paper in a scientific journal but failed to disclose his past employment by Philip Morris. I can guarantee that we in the tobacco control community would be attacking that scientist for failing to disclose his prior employment at Philip Morris.

Clearly, a significant conflict of interest does not simply disappear overnight. And I would argue that the forthrightness which we would expect from tobacco industry researchers is the same that we should expect from tobacco control researchers. Past conflicts of interest should be disclosed if they are significant and relevant. Certainly, a 13-year financial relationship with a pharmaceutical company, in which a researcher holds a chair position endowed by that company and has access to tens of thousands of dollars to support his work constitutes a significant and relevant financial conflict of interest.

And no, that conflict does not simply disappear overnight.

Panel Chair's Disclosure Emphasizes No Personal Receipt of Funds from Endowed Chair, But Hides from Readers His Access to Tens of Thousands of Dollars

2011-10-25T07:51:00.001-04:00

In his disclosure statement in a recent article in the New England Journal of Medicine about the treatment of smokers in the health care setting, Dr. Michael Fiore - chair of a panel that advised the Joint Commission on standards for hospital treatment of smoking - discloses the existence of his previous endowed chair position (which he recently resigned) which was funded by GlaxoSmithKline.

In the disclosure, Dr. Fiore emphasizes that no money from GlaxoSmithKline's gift was ever paid directly to him. He discloses as follows: "In 1997, the University of Wisconsin (UW) appointed me to a named Chair for the study of Nicotine Dependence made possible by a gift from GlaxoWellcome. No funds from that Chair have ever been paid directly to me and no funds from that Chair were used to pay my UW salary over the last 10 years."

The Rest of the Story

Unfortunately, this disclosure is quite misleading and if you ask me, a bit sneaky. Dr. Fiore emphasizes that he never personally received money from the endowment and that no funds from the pharmaceutical company were used to pay his salary. However, he fails to explain that under the terms of the endowed chair position, he had "access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

Thus, although he may not have received funds to himself directly, he admits in sworn testimony that he had access to up to $50,000 a year of GlaxoSmithKline money to support his work, but fails to disclose as much in the "disclosure." It does not appear that he adhered to the form's directions: "err on the side of full disclosure."

Why would one hide from readers the fact that one had access to such a huge amount of pharmaceutical company money each year to support one's work. If one is going to mention this endowed chair position, it seems important to disclose that. In fact, as Dr. Fiore told the Court in the DOJ tobacco lawsuit, that is exactly the way the endowed chairmanships work: the very idea is apparently that the interest on the endowment is accessible to the professor to support his work.

Why is this important? Because it creates the appearance that Dr. Fiore has something to hide. Why the need to deceive readers about the extent of his financial relationship with Big Pharma?

It is problematic enough to have a financially conflicted panel chair writing accreditation standards. But when that individual appears not to be forthright in disclosing the full nature of the potential conflict and appears to be hiding the full nature of his financial relationships with the pharmaceutical industry, I believe it is not only problematic, but antithetical to objective science and policy.

Joint Commission Smoking Cessation Panel Chair's Disclosure in NEJM Article is Deceiving; History of Past Conflicts with Big Pharma are Not Revealed

2011-10-24T07:37:00.000-04:00

Last week, I revealed that the Joint Commission's new tobacco treatment accreditation standard was created by a panel whose chair is financially conflicted by virtue of current and multiple past financial relationships with pharmaceutical companies that market or are developing smoking cessation drugs. As I noted, the standard requires hospitals to offer smoking cessation drugs to every smoking patient upon discharge. I also explained why such a requirement is inappropriate since it violates physician autonomy.

Today, I note that the financial disclosure statement submitted by the panel chair is deceiving, because it reports only the most recent conflicts, hiding from the reader the long history of the chair's financial relationships with multiple pharmaceutical companies.

As I reported:

In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

The Rest of the Story

In his disclosure statement in a recent article in the New England Journal of Medicine about the treatment of smokers in the health care setting, Dr. Fiore discloses only his current funding from Nabi Pharmaceuticals, not his prior funding by or consultancies/lectures for Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome.

He discloses the existence of his endowed chair position (which he has resigned), but fails to explain that he had "access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Instead, he emphasizes that no funds from that endowment were ever paid "directly to him."

The disclosure is therefore deceiving to readers and does not reveal the full extent of his past financial relationships with pharmaceutical companies that manufacture smoking cessation medications.

Importantly, it is not that Dr. Fiore is being untruthful. The form instructs authors to report financial conflicts within the past 3 years, and Dr. Fiore does just that. The problem is that disclosing current conflicts may not paint an accurate picture of an investigator's potential biases when there is a long history of previous conflicts of interest, as there is in this case. Thus, I believe that investigators should voluntarily disclose significant past conflicts, even if the disclosure form does not require it. Otherwise, readers may not get an accurate picture of the potential biases that may be operating and could have the appearance of influencing the conduct or reporting of the research.

Why Requirement That All Smokers Be Prescribed Medication is Inappropriate: It Violates Basic Medical Principles for Benefit of Pharmaceutical Profits

2011-10-18T13:17:00.004-04:00

Yesterday, I revealed that the Joint Commission's new tobacco treatment accreditation standard was created by a panel whose chair is financially conflicted by virtue of current and multiple past financial relationships with pharmaceutical companies that market or are developing smoking cessation drugs. As I noted, the standard requires hospitals to offer smoking cessation drugs to every smoking patient upon discharge.

The purpose of yesterday's post was not necessarily to criticize the requirement itself, but to criticize the fact that the standard was set by a severely conflicted panel: one whose chair has and has had financial conflicts of interest with Big Pharma.

Today, I explain why this requirement is inappropriate.

The Rest of the Story

Quite simply, the requirement is inappropriate because it requires hospitals to offer smoking cessation medication to every smoking patient, even if in the judgment of the treating physician, prescribing a smoking cessation drug is not the most appropriate and effective treatment for his or her patient.

There are many available treatments for smoking dependence and the most effective treatment plan should be individualized. As with most other aspects of medicine, there is no room for a one-size-fits-all, strictly prescribed treatment plan for every patient, regardless of individual circumstances.

Take the example of type II diabetes. One would not set a standard that requires every patient diagnosed with type II diabetes to be treated with an FDA-approved diabetes medication. In fact, 90% of cases of type II diabetes can be adequately treated with exercise and diet alone. To require every hospital to prescribe a diabetes medication to every type II diabetes patient upon discharge would be inappropriate. The appropriate treatment depends on the individual circumstances.

However, the Joint Commission panel's requirement ignores individual circumstances and undermines the judgment of the treating physician in favor of setting a one-size-fits-all mandate that every smoker be prescribed an FDA-approved smoking cessation drug. In many cases, this will not be the most appropriate choice of treatment. Yet hospitals may risk losing accreditation if they fail to follow the standard.

For example, consider a patient with the following history:

Patient X is admitted and treated for a kidney stone. She has a 25 year history of smoking. She has tried nicotine replacement therapy on six different occasions and failed to quit smoking on any of those occasions. She tried Chantix once but discontinued the drug because of severe side effects. Two years ago, she tried hypnotherapy which was very successful. She kept off cigarettes for nearly two years. However, she resumed smoking one month prior to admission due to the stress related to the loss of her job. She is now employed at a new position which she loves, but she hasn't tried to quit smoking since she resumed working.

In this case, the treating physician might legitimately and appropriately believe that the best treatment for the patient would be to try hypnotherapy again. She tried NRT six times and failed so prescribing NRT does not seem likely to be effective. Prescribing Chantix is probably not appropriate given the severe side effects the patient experienced. However, the patient has already been quite successful with hypnotherapy and her sustained period of cessation was interrupted only because of severe stress, which has now been relieved. It seems that a second trial of hypnotherapy might be the most effective and appropriate approach. At very least, it would be reasonable for a physician to so opine.

The Joint Commission panel's standard, however, would find this physician and this hospital in non-compliance. The patient must be offered an FDA-approved smoking cessation drug. Hypnosis doesn't cut it. Acupuncture doesn't cut it. Electronic cigarettes do not cut it. Even if the patient has previously had success with one of these approaches and no success with FDA-approved cessation drugs.

In many ways, this violates a basic principle of medicine: that each patient should be treated in that patient's best interests, without regard to the financial profits of corporations. In this case, the decision is being made not based on what is best for the patient, but what is best for the pharmaceutical companies.

That such a requirement was developed by a panel whose chair has a history of financial conflicts of interest with Big Pharma makes it completely unacceptable.

Chair of Panel Setting Joint Commission Standards on Smoking Cessation for Hospitals is Financially Conflicted

2011-10-17T06:37:00.001-04:00

The Joint Commission is a body that sets standards for the accreditation of hospitals and health care facilities. Since most states require hospitals to be accredited to receive Medicaid reimbursement, following the standards set by the Joint Commission is quite important for most hospitals.

Recently, a panel of the Joint Commission developed standards regarding tobacco use screening and treatment. These standards go into effect in January 2012 and they therefore become a part of the accreditation assessment for hospitals.

While some aspects of the standards set by the panel are straightforward and non-controversial (e.g., all patients should be screened for tobacco use), one striking aspect of the standards is that every patient should be treated with smoking cessation drugs, unless there is a specific contraindication.

As stated by the panel, the smoking treatment standards are "consistent with the 2008 United States Public Health Service Guideline, Treating Tobacco Use and Dependence" and require "that all tobacco users be identified, that tobacco users be provided or offered both evidence-based counseling and medications during the hospitalization and upon discharge, and that tobacco use status be assessed post-discharge."

According to the panel's standards, not only must every patient be treated with smoking drugs during hospitalization (unless contraindicated), but every patient should be prescribed an FDA-approved smoking cessation drug upon discharge.

This recommendation is not exactly evidence-based, because there is a large body of research showing that FDA-approved smoking cessation drugs are highly ineffective, failing to work in the overwhelming majority of patients who are treated with them. Long-term success rates with these drugs are on the order of about 8%. Thus, they have about a 92% failure rate. This makes the recommendation that every patient be prescribed one of these drugs upon discharge quite curious.

The Rest of the Story

Perhaps the recommendation that every patient be prescribed one of the dismally effective FDA-approved smoking cessation drugs is not so mysterious when one learns that the chair of the Joint Commission panel that set this standard has a conflict of interest by virtue of his receiving grant funding from a pharmaceutical company that is in the late stages of developing what it hopes will soon be ...

... an FDA-approved smoking cessation drug.

Moreover, panel chair has a long history of financial conflicts of interest with pharmaceutical companies that manufacture FDA-approved smoking cessation drugs.

The panel chair is Dr. Michael Fiore, who is currently receiving grant funding from Nabi Pharmaceuticals, which has a smoking cessation drug in the late stages of development. The drug is a nicotine vaccine which has been given fast track status by the FDA "for use as a therapeutic for smoking cessation."

Clearly, it is to Nabi Pharmaceutical's great financial interest to have in place as it begins to market this drug a hospital standard requiring all smokers to be prescribed at discharge and FDA-approved smoking cessation drug.

We are talking about an enormous amount of money here. Nabi Pharmaceuticals estimates that the nicotine vaccine market will be $2.1 billion in sales: "The smoking cessation Rx market is young and growing. Datamonitor estimates that the market will grow at a compound annual growth rate of 11% and will reach approximately $3.8 billion by 2018. Datamonitor forecasts that nicotine vaccines will account for $2.1 billion of these sales."

Thus, NicVAX is projected to be the most prescribed smoking cessation medication and the drug to benefit most from the Joint Commission panel's recommendation that every smoking patient leave the hospital with a smoking cessation drug prescription in hand. In fact, giving patients the nicotine vaccine prior to discharge will become the easiest way for hospitals to meet the Joint Commission panel's standards.

On top of the current financial conflict of interest with Big Pharma, Dr. Fiore has a long history of similar conflicts: In 2008, Dr. Fiore "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

In 2008, Dr. Fiore reported "that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

According to Dr. Fiore's testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities." Dr. Fiore recently gave up this endowed Chair position, but the past conflict is enormous and it appears that much of the panel's work occurred during a time when this conflict was still present.

In his 2005 testimony, Dr. Fiore also admits that he did "consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

In 2000, Dr. Fiore reported that he "has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome."

I have no problem with researchers receiving pharmaceutical funding to conduct clinical research. However, scientists with financial conflicts of interest should not be put in a position of making national recommendations regarding the use of those medications. And they absolutely should not be in the position of setting standards for hospital accreditation when those standards involve the use of medications made by companies with which they have financial conflicts of interest.

This is not an issue of small potatoes. We're talking about potentially $2.1 billion of sales for Nabi Pharmaceuticals. Having Dr. Fiore as chair of the technical advisory panel for the Joint Commission on smoking cessation treatment standards is like giving Big Pharma a seat at the table. Why not just allow the pharmaceutical companies to write the standards that dictate hospitals' prescribing patterns for smoking cessation drugs? Frankly, such a process would have resulted in precisely the same recommendation as this expert panel.

It's a shame that the Joint Commission allowed financially conflicted scientists to participate in the setting of standards for hospitals. It gives pharmaceutical company interests an undue influence - albeit indirectly - on drug prescription policy.

First Clinical Trial of Electronic Cigarettes Suggests They May Be More Effective Than Traditional NRT Products

2011-10-12T13:58:00.004-04:00

The results of the first clinical trial of electronic cigarettes, reported yesterday in the journal BMC Public Health, suggest that these devices may be more effective than traditional NRT products for smoking cessation and may be particularly effective in smokers who are unmotivated to quit.

(see: Polosa R, et al. Effect of an Electronic Nicotine Delivery Device [e-Cigarette] on Smoking Reduction and Cessation: A Prospective 6-Month Pilot Study. BMC Public Health 2011; 11:786 doi:10.1186/1471-2458-11-786)

The subjects were 40 healthy, adult, regular smokers with no interest in quitting. They were provided with electronic cigarettes and minimal intervention (a baseline and four follow-up clinic visits). They were not instructed to try to quit smoking, but were simply allowed to use the electronic cigarettes however they wished.

The sustained smoking abstinence rate at six-month follow-up was 22.5%.

The proportion of subjects who experienced a sustained reduction in the amount smoked by at least 50% was 32.5%.

Thus, 55% of subjects either cut down their consumption by 50% or more or quit smoking altogether at six months follow-up.

No serious adverse events were reported in the study.

The authors conclude: "Although not formally regulated as a pharmaceutical product, the e-Cigarette can help smokers to remain abstinent or reduce their cigarette consumption. By replacing tobacco cigarettes, the e-cigarette can only save lives. Here we show for the first time that e-Cigarettes can substantially decrease cigarette consumption without causing significant side effects in smokers not intending to quit."

The Rest of the Story

Based on a Cochrane review of seven studies that measured smoking cessation using nicotine replacement therapy (NRT), the average 6-month point prevalence of smoking abstinence is only 17.8%, and the 6-month point prevalence of smoking abstinence in the pooled data from these studies is only 11.9%. However, these were generally studies of smokers who were motivated to quit. The fact that this trial found a 6-month abstinence rate of 22.5% among a sample of smokers who were not motivated to quit is quite encouraging.

Moreover, the NRT clinical trials generally involved substantial intervention and encouragement to quit smoking. This trial simulated a real-life experience, where no motivation or support was offered to subjects to quit smoking. In fact, smokers who expressed interest in cessation services were withdrawn from the study. The fact that 22.5% of smokers quit and an additional 32.5% reduced their cigarette consumption by at least half suggests that electronic cigarettes are a promising strategy for both harm reduction (reduction in cigarette consumption) and smoking cessation.

Further trials are necessary to confirm these results and especially, to try electronic cigarettes as a strategy for smoking cessation among smokers who are motivated to quit. Nevertheless, the results of this initial clinical trial are encouraging. Electronic cigarettes appear to be a promising strategy for smoking cessation. Use of these devices among smokers who are unable to quit with other available methods (such as NRT) should be encouraged by health professionals, anti-smoking groups, and the FDA.

If Anti-Smoking Groups Want Electronic Cigarettes Off the Market, Why Aren't They Calling for FDA to Remove Propylene Glycol from Cigarettes?

2011-10-11T07:39:00.002-04:00

And Why is FDA Scaring Ex-Smokers About Use of Electronic Cigarettes But Failing to Remove Propylene Glycol from Regular Cigarettes?

Most electronic cigarettes involve the vaporization of a liquid containing nicotine dissolved in glycerin and/or propylene glycol. The major question regarding the long-term safety of these devices is whether or not long-term inhalation of propylene glycol may have adverse respiratory effects. Two initial studies, one conducted recently by Philip Morris, suggest that propylene glycol appears to be safe for long-term inhalation. Nevertheless, the chief health concern regarding e-cigarettes remains the long-term effects of inhalation of propylene glycol and any other chemicals resulting from the heating of propylene glycol.

Other than that (and the effects of nicotine exposure itself), there are really no outstanding health concerns regarding electronic cigarettes, since the issue of diethylene glycol seems to have been solved and the levels of carcinogens (tobacco-specific nitrosamines) in electronic cigarettes are only trace levels, comparable to those in nicotine patches and nicotine gum.

With this as background, consider that at least eight anti-smoking and health groups have called for the removal of electronic cigarettes from the market, because they do not feel that these products have been deemed safe for use. Presumably, these groups are concerned about the long-term effects of propylene glycol inhalation, and the inhalation of byproducts resulting from the heating of propylene glycol.

Similarly, the FDA has scared ex-smokers about the toxins in electronic cigarettes, encouraging them to return to cigarette smoking rather than remain smoke-free using e-cigarettes, presumably also because of concerns over the effects of the long-term inhalation of propylene glycol and any associated byproducts of the heating of propylene glycol.

The Rest of the Story

If the FDA and the anti-smoking and health groups are so concerned about the effects of long-term inhalation of propylene glycol and any byproducts that result from heating propylene glycol, then these very same groups ought to be immediately banning (or calling for a ban on) the use of propylene glycol in regular cigarettes.

After all, if the concerns about the safety of long-term inhalation of propylene glycol are serious enough that we need to discourage smokers from switching from regular cigarettes to electronic cigarettes, then certainly we must have enough concern about long-term inhalation of propylene glycol to require the elimination of this additive from all cigarettes.

And if we are concerned enough about the potential effects of byproducts that result from the simple heating of propylene glycol, then certainly we must be even more concerned about the health effects of combusted propylene glycol, as occurs in many cigarettes.

Since propylene glycol is an additive, the FDA could easily ban its use in regular cigarettes.

Why aren't the anti-smoking groups calling for a ban on propylene glycol in cigarettes? Why hasn't the FDA taken rule-making action to prohibit the use of propylene glycol in cigarettes?

The answer, I believe, is that the FDA's regulation of tobacco products is a sham. It is essentially a Congressional hoax -- a deal set up between politicians and Philip Morris -- to achieve the dual purposes of providing a political victory to the politicians (making it look like they were standing up to Big Tobacco) and an economic victory to Philip Morris (institutionalization of its dominant market share and the elimination of the most serious potential threats to cigarette regulation that could otherwise substantially put a dent in its profits).

Not only is the entire idea of FDA regulation of tobacco products a sham, but the way in which the agency is implemented the law is as well. The approach so far has been to give the most scrutiny to the safest of the spectrum of products on the market (a.k.a, the initial agency ban on electronic cigarettes, the focus on dissolvable tobacco products) and to let the most hazardous products continue to kill hundreds of thousands of Americans, unfettered by meaningful and significant regulation (a.k.a., no ban on menthol cigarettes, no ban on propylene glycol in cigarettes, no regulation of any other hazardous chemicals in cigarettes, no regulation of carcinogens in cigarettes, etc).

In other words, so far the FDA has done absolutely nothing to reduce cigarette use or to make cigarettes safer. It has, however, undermined successful smoking cessation for thousands of successful ex-smokers by urging them to return to regular cigarettes rather than use electronic cigarettes which are loaded with "toxins," "carcinogens," and "anti-freeze."

The anti-smoking groups, for their part, are playing right along with the scam. On the one hand, they are apparently concerned about the effects of long-term inhalation of propylene glycol, demanding that it be shown to be safe before being allowed to be used to help get smokers off of regular cigarettes. On the other hand, they are unwilling to step up and apply the same principle to the real cigarettes, as not a single one of them has called for the FDA to remove propylene glycol as an additive to regular cigarettes.

To be clear, I am not myself calling for a ban on propylene glycol in cigarettes. In fact, I disapprove of the entire idea of regulating the safety of this product by controlling the levels of individual constituents, when there are between 10,000 and 100,000 of those constituents in tobacco smoke. I think the entire process - the entire regulatory scheme - is absurd.

However, I do expect some consistency from anti-smoking groups and from the FDA. I do expect regulation and policy to be guided by science, rather than by politics and ideology. So far, science is taking a back seat. To be exact, the back row of seats in a long, stretch limousine.

NOTE: R.J. Reynolds has responsibly disclosed the ingredients and additives it uses in its products. It lists propylene glycol as an additive in numerous brands of cigarettes, including (but not limited to): Camel Crush, Camel Filters 99 Hard Pack, Camel Filters Hard Pack, Camel Filters Soft Pack, Camel Filters Menthol, Camel Menthol Silver Hard Pack, Camel Blues, Camel No. 9, Camel Turkish, Camel Wides, Kool (all sub-brands), Salem (all sub-brands), Doral (all sub-brands), Newport (all sub-brands), and Lucky Strike non-filter soft pack.

Rest of the Story Puts Odds of National Tobacco Conference Not Taking Big Pharma Money at 13:1

2011-10-05T07:20:00.000-04:00

The 2012 National Conference on Tobacco or Health will be held next July in Kansas City.

Among the program areas to be discussed are:

1. Cessation: "Includes reimbursement and insurance issues; telephone quitline services; innovative methods; cessation programs in the workplace, health care, or other settings; cessation programs for youth and adults; cessation interventions for specific populations; and cessation training programs and certification."

2. Non-Cigarette Tobacco and Nicotine Products: "Includes smokeless tobacco prevention strategies of smokeless tobacco industry strategies; e.g. rodeo sponsorships; alternative nicotine delivery devices and related products; and smokeless tobacco and alternative products as harm reduction."

In my view, it is impossible for an objective discussion of smoking cessation treatment (e.g., the effectiveness of pharmaceuticals) and alternative nicotine delivery products (such as electronic cigarettes) to take place at a conference sponsored by pharmaceutical companies.

For example, imagine that the conference were being sponsored by an electronic cigarette company. Arguably, tobacco control advocates from across the country would vigorously protest, demanding that the sponsorship be rescinded because no objective consideration of the role of electronic cigarettes in tobacco control can take place at a conference where money is coming in from the electronic cigarette companies.

Well the same is true with pharmaceutical sponsorship. How can the role of smoking cessation drugs be objectively considered at a conference sponsored by the manufacturers of those very products?

The Rest of the Story

While the 2012 sponsors of the National Conference on Tobacco or Health have not yet been announced, I put the early odd of the conference not accepting Big Pharma sponsorship at 13:1. On its web site page seeking sponsors, the conference is highlighting its past sponsorship by pharmaceutical companies, including Pfizer and GlaxoSmithKline. This seems to indicate a willingness, if not a desire, to obtain pharmaceutical sponsorship again this year for the 2012 conference.

For the betters among you, I have the over-under at $20,000.

Boston Public Health Commission Considering Regulation to Ban Electronic Cigarette Use in the Workplace

2011-10-03T07:38:00.000-04:00

The Boston Public Health Commission is considering a new regulation which would ban the use of electronic cigarettes in the workplace. The regulation would also restrict the sale of electronic cigarettes to minors and require a permit for selling these products.

The proposed regulation cites as a justification for the ban on electronic cigarette use (vaping) in the workplace: "the U.S. Food and Drug Administration has conducted laboratory tests that found e-cigarettes contain toxic chemicals and carcinogens; and the health effects of involuntary exposure to e-cigarette vapors containing these chemicals and carcinogens is unknown."

The Rest of the Story

The FDA scared the public and implied that electronic cigarettes present a substantial risk of cancer to users by reporting its laboratory finding that electronic cigarettes are dangerous because they contain carcinogens. The FDA failed to inform the public about the level of carcinogens they detected and how it compares to the level of tobacco-specific nitrosamines in regular cigarettes and in nicotine replacement products. The truth is that the FDA found only trace levels of carcinogens, comparable to those found in nicotine patches and nicotine gum, and orders of magnitude below the levels of these same carcinogens in regular cigarettes.

The rest of the story is that:

The FDA found only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to those found in FDA-approved nicotine replacement products like nicotine patches and nicotine gum.
The levels of carcinogens that have been detected in electronic cigarettes are orders of magnitude lower than in regular cigarettes, indicating that electronic cigarettes are likely much safer than regular cigarettes in terms of cancer risk.
The minute levels of tobacco-specific nitrosamines in electronic cigarettes are a necessary result of the extraction of nicotine from tobacco. Overall, these devices deliver nicotine with only a few other chemicals, compared to the delivery of nicotine plus tens of thousands of chemicals and more than 60 proven carcinogens in regular cigarettes.
There is no evidence, and little reason to believe, that there would be any significant exposure to carcinogens among bystanders in the proximity of electronic cigarette users.

As far as the presence of "toxic chemicals" goes, the FDA reported only one such chemical (diethylene glycol) and it was present in just one cartridge of one brand of electronic cigarettes. Subsequent to that investigation, multiple brands of electronic cigarettes have been tested for diethylene glycol and not a single brand has been found to contain this chemical. It appears that this was an anomaly caused by one company's use of a non-pharmaceutical grade of propylene glycol. The use of pharmaceutical grade propylene glycol should not result in the presence of diethylene glycol in the electronic cigarette, which appears to be the case with every other brand of electronic cigarettes that has been tested subsequently.

The public needs to understand that there is presently no more scientific justification for banning electronic cigarette use in the workplace than there is for banning the use of the nicotine inhaler, which many smokers are using in an attempt to quit smoking. Both contain similar levels of tobacco-specific nitrosamines, and there is no evidence that the use of these inhaled products results in any significant carcinogenic exposure among bystanders.

Moreover, the statement that we don't know what vapers are inhaling is a myth. Electronic cigarette emissions have been tested in numerous laboratory studies. Cahn and I reviewed these studies in our review article published in the Journal of Public Health Policy.

We concluded as follows:

"As ~5300 of the estimated 10 000–100 000 chemicals in cigarette smoke have ever been identified,[4] we already have more comprehensive knowledge of the chemical constituents of electronic cigarettes than tobacco ones. We were able to identify 16 studies[5–17] that have characterized, quite extensively, the components contained in electronic cigarette liquid and vapor using gas chromatography mass spectrometry (GC-MS) (Table 1). These studies demonstrate that the primary components of electronic cigarette cartridges are propylene glycol (PG), glycerin, and nicotine. Of the other chemicals identified, the FDA has focused on potential health hazards associated with two: tobacco-specific nitrosamines (TSNAs) and diethylene glycol (DEG).[5]

TSNAs have been detected in two studies at trace levels.[5,6] The maximum level of total TSNAs reported was 8.2 ng/g.[6] This compares with a similar level of 8.0 ng in a nicotine patch, and it is orders of magnitude lower than TSNA levels in regular cigarettes.[18] Table 2 shows that electronic cigarettes contain only 0.07–0.2 per cent of the TSNAs present in cigarettes, a 500-fold to 1400-fold reduction in concentration. The presence of DEG in one of the 18 cartridges studied by the US Food and Drug Administration (FDA) is worrisome, yet none of the other 15 studies found any DEG. The use of a non-pharmaceutical grade of PG may explain this
contamination.

Other than TSNAs and DEG, few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products."

In summary then, there is presently no evidence that electronic cigarettes pose any known health threat to bystanders. In other words, there is no evidence that secondhand vaping poses any health hazards.

Perhaps it would be helpful here for me to present my philosophy regarding the criterion that justifies government action to ban a personal behavior in order to protect the health of bystanders. The criterion I have always adhered to is that the burden of proof is on the government to demonstrate that the behavior in question endangers the health of others. There must be substantial evidence, in other words, that a health hazard exists. The mere possibility of a health hazard is not, in my opinion, sufficient to justify banning a widespread public behavior.

For example, when I have lobbied for laws and regulations to ban smoking in the workplace, my testimony has always been based on substantial evidence of the health hazards associated with secondhand smoke exposure. I never asked any city council or state legislative body to ban smoking in workplaces simply because of the "possibility" that secondhand smoke exposure might be harmful. I, and other anti-smoking advocates, did not demand government intervention until sufficient scientific evidence had accumulated to support the contention that secondhand smoke exposure in the workplace was a cause of health harm among exposed nonsmoking workers.

There are many exposures, which, from time to time, the media or the public associate with potential harm to the public. If government agencies banned these exposures every time there was mere speculation that the exposure might be harmful, it would prove to be an undue and overly burdensome level of intervention in the workplace.

For example, Action on Smoking and Health has argued that the breathe of smokers is itself toxic and has promoted the idea of banning smokers from the workplace simply because of speculation that exhaled toxins could threaten the health of nonsmokers. Would we not all agree that for the government to take such an intrusive action without actual evidence of harms to nonsmokers caused by exhaled chemicals from smoking employees would be inappropriate?

I have two other concerns about setting a precedent of the government banning behaviors in the absence of scientific evidence that those behaviors are causing health harm. First, might it undermine efforts to protect the public in situations where we really do have evidence of harm? In this case, I fear that basing a non-vaping regulation on no scientific evidence of harm could undermine efforts in other states - which do not yet have workplace smoking laws - to protect the public from the hazards of secondhand smoke in the workplace.

Second, banning electronic cigarette use in the workplace could place an undue burden on smokers who are trying to quit smoking using electronic cigarettes or ex-smokers who have successfully quit using e-cigarettes and who are trying to stay smoke-free.

Finally, I want to make it clear that I do not oppose the aspect of the proposed regulation regarding the sale of electronic cigarettes to minors. Certainly it is reasonable to make sure that electronic cigarettes cannot be easily purchased by minors. My comments relate solely to the portion of the proposed regulation that bans vaping in the workplace.

Baylor Health Care System Will Not Hire Smokers Trying to Quit or Ex-Smokers Who Remain Off Cigarettes Using Nicotine Replacement Therapy

2011-09-29T09:44:00.002-04:00

The Baylor Health Care System has announced that it will no longer hire smokers. But the policy goes far beyond that. The hospital system will not consider for employment smokers who are trying to quit using nicotine replacement therapy or electronic cigarettes. Nor will it hire ex-smokers who are successfully keeping themselves off of cigarettes by using NRT products or electronic cigarettes.

The policy is not simply an anti-smoker policy. It is an anti-nicotine policy. It forbids the employment of anyone who uses nicotine in any form, even if the person is using a product like electronic cigarettes in order to successfully keep away from cigarette smoking.

The Rest of the Story

This policy is making a moral statement, not a public health statement. In fact, in some ways the policy deters the improvement of the public's health by casting a dark cloud on the millions of smokers who are making or have successfully made quit attempts using nicotine replacement therapy, whether in the form of nicotine patches, gum, inhalers, or electronic cigarettes.

Why would a health care system want to discourage people from quitting smoking using nicotine-containing products?

The Baylor Health Care System appears to have joined the abstinence-only movement which has proven so counterproductive in public health.

Hearing on Cigarette Warnings Reveals Key Issue: Are Proposed Labels Warnings or Advocacy Statements?

2011-09-27T08:49:00.002-04:00

I have been writing for the past several weeks about what I see as a key issue in the lawsuit regarding the FDA's proposed cigarette warning labels: whether the proposed labels represent merely warnings about the health effects of smoking or whether they are really anti-smoking advertisements designed primarily to promote smoking cessation. According to an Associated Press article regarding last week's hearing before the District Court judge, this does appear to be a key issue in the case and Judge Richard Leon directly questioned the government attorney about this.

According to the article: "A federal judge peppered a government lawyer with questions Wednesday expressing doubts about whether the Food and Drug Administration can force tobacco companies to post graphic images on their cigarette packages showing the health effects of smoking. In a two-hour hearing, U.S. District Judge Richard Leon closely questioned Justice Department lawyer Mark Stern on whether the nine graphic images proposed by the FDA convey just the facts about the health risks of smoking or go beyond that into advocacy — a critical distinction in a case over free speech. ... Lawyers for the tobacco companies argued that the government is free to tell people how to live — through steps such as enacting smoking bans on teenagers and by requiring written, factual warnings on the sides of cigarette packages from the surgeon general about the effects of smoking. But what the government cannot do is "conscript" the companies "into an anti-smoking brigade," noted First Amendment lawyer Floyd Abrams told the judge. The judge questioned Stern about why the images did not amount to advocacy. "What do you say is the line" between advocacy and fact? he asked Stern. "This is not an ordinary product" and the images coupled with written warnings are designed to communicate the dangers to the public — including youngsters as well as adults, Stern replied."

The Rest of the Story

You can see why I argued yesterday that the amicus brief submitted by the Campaign for Tobacco-Free Kids and other anti-smoking groups hurts the government's case. In the hearing, government lawyer Mark Stern was very careful to insist that the purpose of the graphic warning labels is to "communicate the dangers to the public." He apparently argued that the graphic nature of the warnings is necessary in order to effectively communicate the dangers, as evidence shows that the current warnings are not effectively doing so.

In contrast, the amicus brief argues that the purpose of the graphic warnings is to send an anti-smoking message, encouraging smokers to quit by referring them to a telephonic counseling service, which the groups assert has proven effective in promoting smoking cessation.

Now, the FDA is in the awkward position of having to counter the amicus brief and convince the judge that the reasons for the graphic warning labels set forward in the brief by the anti-smoking groups are not the real reasons that the FDA has proposed these warnings.

While it is true that tobacco is not an ordinary product and that the type of warning that might be sufficient for a typical consumer product may not be effective for cigarettes, this would still not seem to explain why the 1-800-QUIT-NOW message needs to be included on the label. To me, the inclusion of that requirement is the chief legal problem with the proposed labels, as it appears difficult to assert that the inclusion of the smoking cessation number is intended and necessary to effectively convey a health warning, rather than intended to promote smoking cessation and help smokers quit by referring them for telephonic counseling.

According to the AP, Judge Leon indicated that he hopes to issue a ruling by the end of October.

Amicus Brief Submitted by Anti-Smoking Groups Undermines Case for Graphic Cigarette Warning Labels

2011-09-25T20:34:00.000-04:00

A consortium of anti-smoking and health groups - including the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society, American Lung Association, American Medical Association, and the American Academy of Pediatrics - has submitted an amicus brief with the D.C. District Court to support the FDA's proposed graphic cigarette warning labels, which have been challenged by R.J. Reynolds, Lorillard, and several smaller tobacco companies.

The brief begins by making several strong points. First, it establishes that warning consumers about the health effects of smoking is a legitimate government interest. Second, it establishes that the current warning labels are insufficient for this purpose (there is abundant evidence to support this contention). Third, it provides evidence that the revised, graphic warning labels represent an improvement and that consumers are more likely to pay attention to them.

The Rest of the Story

At this point, however, the brief makes a surprising blunder. Rather than sticking to the argument that the revised warning labels will be more effective by virtue of more effectively delivering information about the adverse health effects of cigarette smoking, the brief essentially shows its hand of cards: it puts forward the argument that including the national quitline number on the cigarette pack will encourage individuals to quit smoking and help them quit by offering them assistance to do so about which they would not otherwise have known.

The brief argues: "Finally, there is also strong scientific evidence demonstrating the value of including the national quitline number, 1-800-QUIT-NOW, in the graphic warnings to inform consumers about the availability of assistance if they want to quit. As the Institute of Medicine found, quitlines have proven “effective … in helping individuals to stop smoking”—increasing smoking abstinence by as much as 30 to 50 percent. Id. at 237. Based on a careful review of the evidence, the U.S. Public Health Service similarly concluded that smokers who use telephone quitlines are significantly more successful at quitting than those who get little or no counseling. U.S. Pub. Health Serv., Clinical Practice Guidelines, Treating Tobacco Use and Dependence: 2008 Update 91-92 (2008).14 The Public Health Service’s guidelines accordingly recommend that “clinicians and health care delivery systems should both ensure patient access to quitlines and promote quitline use.” Id. at vii. These conclusions are consistent with well-established evidence confirming that by providing a direct and immediate cue for action, quitlines significantly increase the likelihood of changes in behavior. See, e.g., David B. Abrams, et al., Boosting Population Quits Through Evidence-Based Cessation Treatment and Policy, 38 Am J. Prev. Med. Supp. S351-363 (2010)."

This argument goes beyond the need to improve the warning message to make it more effective. First, it speaks to a desire not only to warn people about the health effects of smoking, but to encourage then to quit (beyond any desire to quit that might be associated with knowledge of health effects). Second, it demonstrates that the purpose of the revised warning labels is not merely to communicate health information more effectively, but to serve as an anti-smoking advertisement that promotes smoking cessation. Third, the argument acknowledges that an additional purpose of the warning label, beyond informing consumers about the health effects of the product, is to make them aware of a particular smoking cessation quitline service: in essence, to refer them for telephonic smoking cessation counseling. The brief essentially admits that a major purpose of the new warning labels is to "ensure patient access to quitlines and promote quitline use." The warning label is intended to serve as a "direct and immediate cue for action."

These purposes go far beyond the legitimate government interest in effectively communicating to the public a warning about the health effects of cigarette smoking. In the exact words of the interveners, a major purpose of the revised warning labels is to provide an anti-smoking advertisement that will promote smoking cessation by referring potential customers to a smoking cessation hotline number that will provide telephonic counseling as a direct and immediate intervention to try to get the customer to quit smoking.

It is not difficult to see that forcing a tobacco company to put an advertisement on its cigarette package which goes so far as referring a potential customer for a telephonic counseling intervention as a direct intervention to get the customer to discontinue the use of that product goes far beyond the permissible actions of the government under the First Amendment, even as accepted in Commonwealth Brands, Inc. v. United States (678 F. Supp. 2d 512, 528-32 [2010]). The district court in that case merely upheld the legitimacy of the government's interest in improving warnings in order to "convey relevant information in an effective way" (678 F. Supp. 2d at 530-31). However, provision of a referral for telephonic counseling to encourage discontinuation of the use of the product seems far beyond the conveying of "relevant information" to improve the effectiveness of the health warning.

This seems to be a rather strange situation where an intervener's amicus brief actually appears to help the other side. In this case, the anti-smoking groups' brief aids the plaintiffs by helping to establish that the purpose of the revised warning labels goes far beyond the desire to simply improve the effectiveness of the conveying of relevant health information to the consumer. If anything, the brief helps establish that the true underlying motive behind the revised warning labels is to achieve a large-scale, telephonic counseling intervention on cigarette purchasers by using the cigarette pack as a billboard to advertise, promote cessation, and refer the smoker for a telephonic counseling intervention.

To be clear, I am not in any way criticizing the intervention itself or the desire of these anti-smoking groups to aim to reduce smoking prevalence by using the cigarette pack as a form of an anti-smoking advertisement with a direct referral to the smoking cessation hotline. In fact, I applaud them for suggesting such an intervention. The problem, however, is that the intervention is almost certainly not constitutional, as it appears to violate the tobacco companies' free speech rights by compelling them to use their own cigarette packages as a referral system to initiate a process with each customer that is designed to ultimately lead to discontinuation of product use.

That is going to be a tall order for the FDA to defend. And ironically, I think this amicus brief actually makes it more likely that the judge will grant the plaintiff's request for a preliminary injunction.

Two Advertising Industry Groups Join Lawsuit Against FDA's Graphic Cigarette Warning Requirement

2011-09-20T07:44:00.000-04:00

Two advertising industry groups have filed amicus briefs with the D.C. District Court, seeking to join the lawsuit by several tobacco companies, which seek an injunction against the FDA's proposal to require graphic warning labels on cigarette packages.

According to an article in the Richmond Times-Dispatch: "'The new cigarette warnings are expressly designed to be propagandistic rather than informative,' wrote the groups who represent hundreds of U.S. companies and thousands of advertising professionals. 'If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things — and history shows it will not hesitate to do so.'"

The Rest of the Story

The advertising groups' comments mirror my own observations about the case. The central question is whether the "warning labels" are simply health warnings or whether they are actually advertisements that directly discourage product purchase. While the government has a legitimate interest in warning consumers about the health hazards of consumer products, it would be a violation of free speech rights to require those companies to go beyond warning labels and actively and directly discourage product purchase on the product labels.

The advertising groups raise this legitimate question: if the court rules that the FDA is justified in requiring anti-smoking advertisements on cigarette packages, then doesn't such a decision open the door to a floodgate of state actions to require all sorts of anti-product advertising on consumer product labels?

For example, could the New York City Health Department not then require that McDonalds display prominent anti-obesity posters at point of purchase of Big Macs, with gross pictures of fat-laden arteries and a message urging consumers not to consume this fat-laden product?

Could the Boston Public Health Commission not require that coffee containers include a graphic picture of a person suffering a cardiac arrhythmia, with a warning discouraging consumers from drinking coffee out of fear of suffering such an arrhythmia?

Clearly, the court must preserve the demarcation between a legitimate health warning message designed to inform consumers of non-controversial, factual information and persuasive advertising that goes beyond a mere warning message and directly discourages purchase of the product.

I think the FDA is going to have a difficult time convincing the court that graphic ads which display a stop-smoking quitline number are merely health warning messages, and that they do not cross the line into being persuasive advertisements intended to directly discourage the use of the product by consumers.

Philadelphia Board of Health Considering Requiring Graphic Anti-Smoking Posters at Point of Tobacco Purchase

2011-09-15T08:21:00.001-04:00

According to an article in the Philadelphia Inquirer, the Philadelphia Board of Health is considering an ordinance that would require retail tobacco stores to display graphic anti-smoking advertisements at the point of purchase.

According to the article, one aspect of the advertisements would be a smoking cessation hotline number.

The Rest of the Story

Quite simply, the rest of the story is that the proposed regulation is almost certainly unconstitutional because it violates the free speech rights of retail stores by compelling them to engage in speech with which they disagree and which is intended to directly harm their business by discouraging the purchase of the items in question.

Consider, for example, the requirement that McDonalds post, at the point of purchase, a graphic advertisement that shows a clogged artery with a message discouraging consumers from eating Big Macs. This would clearly be viewed as violating McDonalds' free speech rights.

Similarly, consider a requirement that a store selling light bulbs post an advertisement with a picture of environmental damage urging customers to purchase fluorescent bulbs in order to save energy and lessen the carbon blueprint. This, too, would clearly be unconstitutional.

The government does have a legitimate right to require health warning labels at point of purchase of products that may be hazardous. However, the proposed posters are not merely warning labels. They are advertisements that promote smoking cessation. In other words, they go beyond warning about health consequences and proceed to encourage smokers to quit. They discourage consumers from purchasing the very products that are being sold by the retail stores which are being required to display the posters.

A similar ordinance enacted by the New York City Council was struck down by a federal judge, although the ruling is under appeal.