Tuesday, January 31, 2012

By Arguing that Hiring Smokers "Supports" Smoking, Cleveland Clinic Destroys Its Own Argument

In an "opposing view" published today in USA Today, Dr. Paul Terpeluk - Cleveland Clinic's medical director of Employee Health Services - defends the Cleveland Clinic's policy of not hiring smokers.

His main argument: "As a health care institution, whose inherent mission is healing the sick and cultivating a healthier community, does it make sense to support a habit that leads to disease, disability and death? ... At Cleveland Clinic, we have a unique perspective on the burden of chronic disease. We not only treat disease, but we also play a vital role in educating patients and employees about lifestyle choices. It is only right to practice what we preach. Banning smoking and smokers is a crucial part of that, and part of a broader theme that includes banning transfats, offering free gym memberships, removing sugar-laden drinks from campus vending machines, and rewarding employees who make healthy decisions with lower insurance premiums."

The Rest of the Story

There are four major problems with Dr. Terpeluk's argument:

1. The Cleveland Clinic is, by the same reasoning, a supporter of physical inactivity, overeating, reckless driving, and promiscuity.

If hiring smokers is supporting the habit of smoking, then hiring overweight individuals is supporting physical inactivity and lousy diets. Since the Cleveland Clinic hires overweight individuals, by its own admission, the Cleveland Clinic supports physical inactivity, overeating, poor nutrition, consumption of high-fat food, and a couch potato lifestyle.

Moreover, since the Cleveland Clinic is willing to hire people who do not wear seat belts, who speed on the roadways, who have unsafe sex, and who use tanning salons, the Cleveland Clinic is therefore a supporter of reckless driving, promiscuity, and skin cancer.

2. The Cleveland Clinic apparently does support smoking - a habit that leads to disease, disability and death.

The Cleveland Clinic does hire smokers. In fact, a large number of smokers are employed at its hospitals and medical centers. The only smokers who are not allowed to work at the Cleveland Clinic are new applicants. By continuing to employ smokers, the Cleveland Clinic, by its own argument, is supporting smoking, and with that, disease, disability, and death.

3. The Cleveland Clinic apparently does not support smoking cessation using nicotine replacement therapy.

By its own argument, since the Cleveland Clinic will not hire ex-smokers who have quit using NRT and are still using the NRT to stay off cigarettes, the Cleveland Clinic does not support smoking cessation using NRT.

4. The Cleveland Clinic apparently supports white collar crime and pornography.

Since the Cleveland Clinic is willing to hire an individual who is suspected of having committed crime, including the viewing of pornography on his work computer, the Cleveland Clinic apparently supports crime and pornography. As I revealed yesterday, the Cleveland Clinic has hired the former director of the Kansas Bioscience Authority, who is under criminal investigation and has had to hire a leading white collar criminal defense lawyer to defend him.

The rest of the story is that the Cleveland Clinic should have been more careful in its frantic search for arguments to support its unjustified policy of employment discrimination. Sometimes the arguments you make can come back to haunt you.

(Thanks to Harry for the tip).

Monday, January 30, 2012

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

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.)

Thursday, January 26, 2012

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

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.

Wednesday, January 25, 2012

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?

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.

Tuesday, January 24, 2012

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

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:
  1. Abbott Laboratories;
  2. AstraZeneca;
  3. Bristol-Myers Squibb;
  4. Eli Lilly and Company;
  5. The Johnson & Johnson Family of Companies;
  6. Merck & Co., Inc.;
  7. Novartis;
  8. Novo Nordisk;
  9. Pfizer;
  10. Roche;
  11. Sanofi-Aventis;
  12. Takeda Pharmaceuticals UK; and
  13. 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.

Monday, January 23, 2012

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

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?

Thursday, January 19, 2012

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

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.

Wednesday, January 18, 2012

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

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.

Tuesday, January 17, 2012

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

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.

Friday, January 13, 2012

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

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.

Thursday, January 12, 2012

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

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.

Tuesday, January 10, 2012

New Study Finds Nicotine Replacement Therapy Ineffective in Smoking Cessation

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

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.

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.

Monday, January 09, 2012

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

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.