Friday, September 23, 2016

FDA Violated Ethics Rules to Censor Dissenting Opinions about Its E-Cigarette Regulations

According to a shocking exposé in the October 16th issue of Scientific American written by Charles Seife, the FDA censored dissenting opinions about its e-cigarette regulations by prohibiting journalists covering the release of these regulations from speaking with anyone who might oppose them.

The FDA's e-cigarette regulations were initially released on April 24, 2014. On April 23, the FDA's Center for Tobacco Products held a press briefing for a select group of reporters to provide information so that they could publish news stories about the regulations at the expiration of the embargo, which was set for April 24th. It is not uncommon to set an embargo date and time for the release of a story by media outlets. It helps ensure that all media outlets have an equal opportunity to publish the story in a timely fashion and not to get "scooped" by one favored media outlet.

However, the FDA went beyond the simple step of setting an embargo date and time for the publication of media stories. First, the agency only invited a select group of reporters to the media briefing, ensuring that only reporters who were "friendly" to the FDA's position would be able to cover the story in a timely fashion and that such "friendly" reporters would get a scoop on the story.

Second, the FDA prohibited the reporters at the media briefing from talking to anyone else about the regulations prior to the embargo, meaning that in the articles coming out about the regulations at the expiration of the embargo, there was no possible way for reporters to provide quotes from individuals who might have dissenting opinions about the regulations. In other words, the FDA ensured that only its own position could be presented to the public.

The article explains that reporters at the briefing were told: "You will not be able to reach out to third parties for comment on this announcement."

In addition, reporters were sent an email stating that: "Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this. ... We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency."

The FDA thought that its little scheme to prevent the public from reading dissenting opinions about the regulations had worked to perfection. It apparently did work to perfection in terms of the nature of the media coverage, which of course failed to present any dissenting opinions from experts. However, one courageous reporter exposed the fact that the FDA was censoring media coverage by not allowing reporters to seek comments from experts who might have dissenting opinions. In  her article, she noted that:

"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."

According to Scientific American: "'I felt like I wanted to be clear with readers,' Sabrina Tavernise, the author of the story, later told Sullivan, the New York Times' public editor at the time. 'Usually you would have reaction in a story like this, but in this case, there wasn't going to be any.'"

The FDA then blasted Tavernise in an email to her, stating: "I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way."

The FDA was apparently not only prohibiting reporters from presenting an alternative perspective on its regulations but also prohibiting them from informing readers that they were not allowed to seek out alternative opinions. So the FDA was engaging not only in censorship but in a cover-up of that censorship.

At the time, Eric Boehm of Watchdog.org wrote about the FDA's censorship: "Essentially, the Times agreed to feed the public information about new regulations, but without being able to talk to any of the people affected by the regulations. What did that leave them in terms of perspective? Only those who favored the new regulations, of course."

According to Seife, the FDA is violating its own ethics policy, established in 2011, which states that: "A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo."

In a revealing section of his article, Seife explains that:

"Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies."

Seife concludes that: "By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs."

The Rest of the Story

The rest of the story is that the FDA, including the Center for Tobacco Products, used censorship to ensure one-sided coverage of its e-cigarette regulations, thus denying the public the opportunity to receive a balanced perspective on the important public health issues at stake. In spite of the First Amendment, this censorship was successfully achieved by offering select reporters a sneak preview of the regulations and an opportunity to "scoop" other reporters, but forcing them to agree not to seek third party comments in order to secure this privileged status. In doing so, it appears that the FDA and CTP violated their own ethics rules. The end result was censoring any dissenting views on the e-cigarette regulations and ensuring that the public would only be presented with the FDA's side of the issue.

In my view, this is a clear violation of scientific ethics as well as the public health code of conduct. This is something you might expect out of the playbook of Big Tobacco or other corporations, not out of a federal agency charged with protecting the public's health.

Wednesday, September 21, 2016

Helena Miracle? Not So Much; New Study Casts Doubt on Conclusions of Anti-Smoking Groups

For many years, anti-smoking groups have been claiming that smoking bans result in an immediate and dramatic decline in hospitalizations for heart attacks. This claim is based on studies like that conducted in Helena, in which the authors concluded that there was a 40% reduction in heart attack admissions within 6-18 months after a bar and restaurant smoking ban was implemented.

When these studies were first published, I warned anti-smoking groups not to use these conclusions to promote smoking bans because I believed that the conclusions were not adequately supported by the data. In particular, I criticized these studies and questioned their conclusions because they did not adequately account for secular trends in heart attack rates that were occurring even in the absence of smoking bans.

I also argued that it was not plausible to see such large effects in so short a time span because it takes many years for heart disease to develop. In contrast, I noted that respiratory effects might be observed immediately.

Finally, I argued that these findings were largely a result of publication bias. Cities for study were not chosen randomly. Instead, in places where there appeared to be a dramatic decline in heart attacks, that community was chosen for study. The few studies that did systematically examine this research question failed to find an immediate effect of smoking bans on heart attack hospitalization rates.

This week, a new study was published in the journal Medical Care Research and Review which re-examines the relationship between smoking bans and heart attack hospitalization rates.

(See: Ho V, et al. A nationwide assessment of the association of smoking bans and cigarette taxes with hospitalizations for acute myocardial infarction, heart failure, and pneumonia. Medical Care Research and Review 2016. Published online ahead of print on September 12, 2016. DOI: 10.1177/10775587/16668646.)

The authors summarize the study as follows:

"We examine the association between county-level smoking-related hospitalization rates and comprehensive smoking bans in 28 states from 2001 to 2008. Differences-in-differences analysis measures changes in hospitalization rates before versus after introducing bans in bars, restaurants, and workplaces, controlling for cigarette taxes, adjusting for local health and provider characteristics. Smoking bans were not associated with acute myocardial infarction or heart failure hospitalizations, but lowered pneumonia hospitalization rates for persons ages 60 to 74 years."

The Rest of the Story

The results of this study support the arguments that I made back in 2006, and which I have continued to emphasize on this blog over the past 10 years. The key finding of the study is that once you account for time-specific local trends in heart attack hospitalization rates, there is no longer a significant observed decline in heart attack rates associated with the implementation of these smoking bans.

The key data are in Table 2. Helpfully, this table provides regression estimates both with and without the inclusion of region-specific (in this case, county-specific) time trends in the rate of hospitalization for heart attacks. Note that without the county-specific time trends, the authors do find a significant decrease in hospitalizations for heart attacks associated with the implementation of smoking bans. But once they control for these local time trends, there is no longer a significant effect.

What this suggests is that communities that implemented smoking bans happened to be those which had a higher pre-existing rate of decline in heart attacks and that once you adjust for that, there is no difference associated with the implementation of the smoking bans.

The authors further demonstrate that the previous conclusions were spurious by showing that when you examine the impact of smoking bans on hospitalizations for hip fractures (which are not plausibly related to smoking bans), you find a significant effect of smoking bans when you don't include regional time trends. That spurious effect disappears once you control for the regional time trends.

The regional time trends are important to consider in these models because without them, you are making the assumption that the secular rates of decline in heart attacks at baseline were the same in communities with and without smoking bans. Apparently, this is not a fair assumption because the nature of cities that enacted smoking bans differed from that of cities which did not enact such laws. And those differences were reflected in higher rates of decline in heart attacks in the intervention communities.

It is interesting to note that it was my expression of the above opinions about these studies back in the mid-2000's that led to my "expulsion" from the tobacco control movement, including being thrown off several list-serves, ostracized by many of my colleagues, accused of being a "tobacco mole," being characterized by my hero and mentor - Stan Glantz - as being "a tragic figure," having copyright to one of my articles violated by an anti-smoking organization, no longer being invited to speak at tobacco conferences, not being able to present at tobacco control conferences anymore, not being able to obtain further research grants, and having colleagues refuse to appear with me at conferences to discuss these or any other scientific issues. In fact, it was this censorship that led to the creation of the Rest of the Story in the first place.

Nearly three million page views later, perhaps these groups knew what they were doing because it appears that I may have been right all along. By silencing me, these groups were able to disseminate their pre-determined conclusions widely to the public through the media long enough for the conclusions to be generally accepted. Now, it is too late to undo the damage. The media and the public have already made up their minds, and one article noting the results of this new study is not going to correct or undo 10 years of dissemination of unsupported and errant scientific conclusions.

To be clear, this issue has nothing to do with my support for smoking bans. My readers understand that I have and continue to support 100% smoke-free policies for all workplaces (including bars, restaurants, and casinos). However, I do believe that we can advocate for such policies without misrepresenting scientific evidence or exaggerating findings beyond what is scientifically defensible.

Tuesday, September 20, 2016

FDA-Induced Crumbling of E-Cigarette Market Begins: NJOY Files for Bankruptcy

It didn't take long after the FDA enacted its deeming regulations for the first of many e-cigarette companies to lose their ability to stay in the market. Just one and a half months after the FDA's deeming regulations went into effect, NJOY - one of the largest independent e-cigarette manufacturers in the U.S. - has filed for bankruptcy.

While a major reason for NJOY's inability to stay afloat was the failure of its King cig-a-like product, the company also cites the "substantial expenses of preparing for the Food and Drug Administration (FDA) deeming regulations."

As I have argued for some time, the capital costs involved in preparing pre-market applications under the deeming regulations are prohibitive for all but the tobacco companies and perhaps the largest independent manufacturers. With the loss of NJOY, it is not even clear whether any of the independent companies will survive, and even if they do, whether there will be any significant diversity in the e-cigarette market that remains.

The result will be the devastation of the overall e-cigarette market and the squandering of an amazing opportunity to substantially reduce smoking-related disease and death.

Today's story illustrates how the change in the e-cigarette market away from cig-a-likes and toward more advanced vaping products - including open systems - has been the key to the growth of the market. By essentially making it impossible for the smaller companies that manufacture more advanced products like open systems to survive and restricting the market to the more traditional cig-a-likes, the FDA has ensured that market growth will be stunted, essentially blocking the shift from combustible cigarettes to safer alternatives.

It is a sad day for public health because the FDA has contributed toward putting an anti-smoking company out of business. NJOY's value proposition was to make smoking obsolete," which is exactly what the FDA should be trying to do.

The Rest of the Story

The rest of the story is that the FDA is perversely pursuing the exact opposite of what it should be doing. The FDA is committed to the preservation of cigarette smoking and to the protection of cigarettes from competition from much safer products. The agency's obsession with the pre-market approval process - which was never intended for e-cigarettes - is destroying the long-term potential to replace combustible tobacco products with much safer tobacco-free and smoke-free products, at the expense of the protection of the public's health.

The result of the FDA's actions will be the re-normalization of smoking as the predominant vehicle for nicotine use in the United States. It is becoming clear that this really could be about "a billion lives."

Monday, September 19, 2016

Deciding Vote in FDA Advisory Committee Recommendation to Remove Black Box Warning for Chantix is Cast by Pharmaceutical Company President; FDA Review Process is Badly Tainted

Last Wednesday, a pair of FDA advisory committees - meeting jointly - voted 10-9 to recommend that the FDA remove the black box warning for Chantix (varenicline). Currently, the black box warns about the potential for severe psychiatric side effects of Chantix, including depression and suicidal ideation. The recommendation is not binding, and the FDA is free to follow or ignore the advisory panel's vote.

According to an article at MedPage Today: "a few of those who voted to remove the warning said the study supplied the evidence needed to make them comfortable using Varenicline to address a major public health problem. 'The risk-benefit ratio is as clear as anything I have ever seen,' said David Pickar, MD, a Johns Hopkins Medical School psychiatry professor who said he works with psychiatric patients. Looking at his fellow committee members, Pickar added: 'For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive.'"

The Rest of the Story

What this article and similar ones are not telling you is that the advisory committee member mentioned above - who cast the deciding vote - is, believe it or not, the president of a pharmaceutical company!

In a whopping conflict of interest that is apparently not disclosed in the article, it turns out that Dr. Pickar, according to his own web site, is "Founder and President of Gabriel Sciences, a company whose mission is advancing the development of a novel treatment for schizophrenia." Prior to that, he was "Co-Founder of Comprehensive Neuroscience, Inc., a clinical trials and medical communication company where he served as a Director, Executive Vice-President and Chief Science Officer." On top of that, he "is the inventor on two US patents."

Dr. Pickar's curriculum vitae confirms that he is the founder and president of a pharmaceutical company (Gabriel Sciences). Prior to that (going back to 2001), he was the founder and president of Potomac Pharma, Inc., a biopharmaceutical company which has transferred assets to Gabriel Sciences. Thus, it appears that Dr. Pickar has been a pharmaceutical company president for the past 15 years.  Dr. Pickar's patents appear to be related to strategies for the pharmacological treatment of schizophrenia. The patents were licensed exclusively to Potomac Pharma, Inc.

I have previously pointed out the problems inherent in having advisory panel members who have personal conflicts of interest with Big Pharma, but here you actually have a pharmaceutical company president serving on the advisory panel!

I view this as an enormous conflict of interest. This pharmaceutical company president, whose company specializes in research and development of psychopharmacologic drugs, is serving on an FDA advisory board to evaluate psychopharmacologic drugs! The name of the advisory committee is the "Psychopharmacologic Drugs Advisory Committee." I can't think of a more pertinent conflict of interest. If you are going to allow this type of a conflict, then you might as well throw conflict of interest policies out the window completely and just let the CEO's of various pharmaceutical companies serve as the advisory committee. I do not understand how the FDA can possibly allow this type of a conflict of interest.

Even in decisions regarding drugs that are not used for treatment of psychiatric illnesses - such as Chantix - the conflict is still present because the way that the FDA deals with one drug is relevant to how it deals with other drugs. In this case, the decision sets a precedent that could benefit drugs that are subsequently developed by Gabriel Sciences. For one thing, the decision accepts the principle that it is acceptable to have conflicted investigators conducting clinical trials on drugs, even when their financial conflict of interest is with the company that manufactures the very drug being tested.

As I reported last week, investigators at 32 of the 139 study sites involved in the recent study of adverse psychiatric effects related to Chantix had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. To be very clear, at my institution, investigators with such a conflict of interest would not be permitted to conduct such research.

I should point out that I am not criticizing Dr. Pickar here. My criticism is directed at the agency for allowing members of its advisory committees to have these kind of conflicts. 

The rest of the story is that in my view, the FDA is in violation of the regulations issued by the Office of Government Ethics related to conflicts of interest among FDA advisory committee members (5 CFR part 2640), which state that financial conflicts are disqualifying for committee membership unless a waiver is granted and that to grant a waiver, it must be determined that "the disqualifying financial interest is not so substantial that it is likely to affect the integrity of an employee's services to the government." In this case, the FDA is clearly in violation of these regulations.

By the way, the statement that Dr. Pickar made, as quoted by MedPage Today, is not relevant to the issue of whether or not the black box warning should be maintained. He was quoted as stating: "The risk-benefit ratio is as clear as anything I have ever seen. For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive." These expressed concerns are relevant to the question of whether Chantix should remain on the market, but the decision about whether or not to require a black box warning should not be based on the risk-benefit ratio of the drug, but on the evidence related to the drug's adverse effects.

In my view, there needs to be a serious review of the FDA's adherence to federal conflict of interest regulations because it appears that the agency is blatantly violating these rules and that the public is being placed at potential risk because of it.

Wednesday, September 14, 2016

Pfizer Study of Psychiatric Risks of Chantix Marred by Financial Conflicts of Interest and Under-Reporting of Adverse Events

According to a briefing document for today's joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the black box warning for Chantix (varenicline), Pfizer's study of the potential serious psychiatric side effects of Chantix, which reported no significant increased risk of adverse events, was marred by financial conflicts of interests of many of the study investigators and by under-reporting of adverse events, including potential episodes of suicidal ideation and depression that could have been drug-related.

According to the document, investigators at 32 of the 139 study sites had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. Moreover, at the sites with financially conflicted investigators, the reporting of adverse drug events was substantially lower than at non-conflicted sites. For example, while the rate of adverse neuropsychiatric events was 6.4% at non-conflicted sites, the rate was only 1.8% at sites at which an investigator had a conflict of interest.

In some cases, the under-reporting of adverse events seems quite blatant. For example, the document cites one patient, who was coded as not having an adverse neuropsychiatric event, as having reported: "I think I am having a major depression. I am worried. I cry easily. I have apathy, I have no desire to do things, insomnia, increased appetite, guilt, I have death thoughts (without suicidal ideation)."

The Rest of the Story

This story illustrates why investigators with personal financial interests in a drug company should not be conducting clinical trials on drugs manufactured by that company. The conflict of interest taints the research and could easily be seen as having influenced the conduct, analysis, or reporting of the research.

In this investigation by the FDA, not only did the agency find financial conflicts of interest of a large number of study researchers, but it also found significant under-reporting of adverse events which was highly correlated with whether a site had a conflicted researcher. This certainly creates the appearance that personal financial conflicts of interest with Pfizer created a bias in the conduct of the study and that the results may therefore be tainted and not trustworthy.

This story also explains my concern about an unreported financial conflict of interest in a newspaper article summarizing the results of an in vitro study in which the conflicted investigator improperly extrapolated the results to have clinical significance in humans and made what I see as a negligent medical recommendation to the public. In that case, the study showed that e-cigarette aerosol caused damage to respiratory cells in culture yet the investigator concluded that vaping can cause fatal lung disease and advised vapers to get vaccinated for bacterial lung infections, even though he failed to make the same recommendation for smokers.

In my opinion, investigators with personal financial conflicts of interest should not be conducting clinical research on products that are manufactured by the relevant company or its competitors. This is not just to protect the integrity of the research, but to protect the investigators and their institutions.

Tuesday, September 13, 2016

Unlike Samsung Galaxy, FDA Regulations Don't Allow E-Cigarette Companies to Fix their Exploding Batteries

Last week, Samsung temporarily took its Galaxy Note 7 smartphone off the market while it works to solve the problem of exploding batteries, which occurred while the devices were charging. A Samsung investigation found that the problem was a battery cell made by one of its two battery suppliers. The problem stemmed from a defect in the manufacturing process, which is now being corrected.

At the same time, a number of e-cigarette companies have noted a similar problem with batteries in their devices, possibly related to a similar manufacturing defect. However, in contrast to Samsung, these companies are actually not allowed to fix the problem.

Why?

Because the FDA has prohibited e-cigarette companies from fixing exploding batteries - or any other manufacturing defect - in their products.

This unprecedented consumer "safety" regulation actually puts the public at great risk. No matter how many manufacturing defects are discovered, no matter how severe they are, no matter how easy they are to fix, and no matter how much the companies want to fix the problem to ensure the safety of their products, these safety improvements are simply not allowed, due to the stupidity of the FDA's e-cigarette deeming regulations.

The only thing worse than the FDA issuing such inane regulations is the fact that the major anti-tobacco groups supported this absurd approach to tobacco and nicotine product regulation.

The Rest of the Story

The FDA is completely butchering the intent of Congress in including new product applications as part of its Family Smoking Prevention and Tobacco Control Act of 2009. The only reason the requirement for pre-market tobacco applications was included in the law is that tobacco companies had a history of altering their products in a way that increased public health harm. For example, they might increase nicotine delivery by adding ammonia to change the pH, market low-nicotine cigarettes which don't actually reduce risk, or alter the blend of tobacco types which might increase the level of certain carcinogens. From the perspective of Congress (a perspective with which I don't happen to agree but that is irrelevant to this commentary), the tobacco companies simply couldn't be trusted. Any changes they made to their products could potentially place the public at increased risk while at the same time giving them the false impression that the products were safer.

This justification does not hold for applying the same requirement to electronic cigarettes and vaping products. There is absolutely no history of the companies making product changes designed to make the products more dangerous while giving consumers the impression that the product is safer. In fact, the opposite is the case. There is a long history of product improvements over time, such that the safety of vaping devices has substantially improved from when they were first introduced into the market.

One example of this is the problem of diethylene glycol contamination. In 2009, the FDA found diethylene glycol contamination in two brands of electronic cigarettes. This problem probably resulted from the use of non-pharmaceutical grade propylene glycol. Apparently, the problem was corrected because since that time, I am not aware of any further testing that has revealed diethylene glycol in e-liquids of any manufacturer.

The companies have also consistently made quality improvements over time, resulting in more effective products. More effective products have a greater public health impact because the better these devices are in helping smokers quit, the greater their contribution to improving the public's health.

Therefore, it makes absolutely no sense to prevent the e-cigarette companies from making safety and quality improvements to their products.

The rest of the story is that in its application of the law to e-cigarettes, the FDA has completely run afoul of the intent of Congress in enacting the Family Smoking Prevention and Tobacco Control Act. The result is a set of regulations that not only fail to protect the public's health, but which place the public at imminent and substantial risk.

Monday, September 12, 2016

Anti-Vaping Researcher Gives Negligent Advice to the Public

An anti-vaping researcher, citing findings solely from an in-vitro cell culture study without clear clinical significance, has claimed that vaping can cause fatal respiratory infections. Based on his extrapolation from an in-vitro study to human disease, this researcher has advised all vapers to be vaccinated for serious bacterial lung infections. However, at the same time, he failed to advise smokers to be vaccinated against these same serious infections.

According to an article in the Times of London, a professor of pediatric respiratory and environmental medicine at Queen Mary University of London "has found that the chemical propellants and nicotine used in ecigarettes both have a powerful effect on lung cells,effectively opening them up to infection by the bacteria that cause pneumonia." Based on this finding, he has warned that "Vaping may raise people’s risk of pneumonia and other deadly bacterial infections."

Despite the fact that these findings related only to a cell culture and cannot be extrapolated to living humans, the researcher nevertheless recommended that "People who vape should consider vaccination against bacterial pneumonia." The researcher did not make a similar recommendation for smokers.

The researcher presented these results at the annual meeting of the European Respiratory Society, although they have not yet been published in a medical journal.

The Rest of the Story

Lipinski and Hopkins explained that the findings of in vitro (or ex vivo, as in this case) study cannot be extrapolated to have clinical significance in humans: "Whether the aim is to discover drugs or to gain knowledge of biological systems, the nature and properties of a chemical tool cannot be considered independently of the system it is to be tested in. Compounds that bind to isolated recombinant proteins are one thing; chemical tools that can perturb cell function another; and pharmacological agents that can be tolerated by a live organism and perturb its systems are yet another. If it were simple to ascertain the properties required to develop a lead discovered in vitro to one that is active in vivo, drug discovery would be as reliable as drug manufacturing."

Extrapolating from in vitro studies to humans can actually be quite dangerous. For example, anthrax was not found to cause problems when derived in vitro, but the same extract derived from living animals was highly toxic.

Clinical experience actually suggests that switching from smoking to vaping decreases the risk of pneumonia and severe lung infection and does not support the contention that vaping significantly increases the risk of fatal lung infections. Despite the millions of people using electronic cigarettes, including many nonsmokers, I am not aware of a single case of a fatal lung infection attributable to vaping.

Therefore, the advice being given by this researcher is negligent. It is negligent not only because there is as yet no evidence supporting a clinical indication for vaccination among people who vape, but also because he fails to recommend vaccination among smokers, who in many cases are at increased risk of serious respiratory infections.

Many people reading this article might conclude that vaping is more dangerous than smoking, since vaccination is only recommended for vaping, but not for smoking. What the researcher has done here in misleadingly communicating the implications of his research is, in my view, negligent because it is unsupported by credible scientific evidence, contradicted by clinical experience, and damaging to the public health.

To make matters worse, that smokers are at risk of serious respiratory infections and in some cases should be vaccinated is not the only thing that the researcher hides from the public in this article. He also hides his financial conflict of interest with Big Pharma, and specifically, with GlaxoSmithKline, a company which stands to lose financially if electronic cigarettes become increasingly popular, as they are a competitor to Glaxo's nicotine gum, lozenges, and patches. The researcher has apparently served as a paid consultant for GlaxoSmithKline, a fact that is not revealed in the newspaper article, thus hiding from readers knowledge of this important conflict of interest which has the appearance of biasing the researcher's reporting of the significance of his study findings.

And to add insult to the injury done by this misleading communication of scientific findings, the European Respiratory Society annual meeting itself is financially conflicted, since it received support from Big Pharma, including Pfizer, GlaxoSmithKline, Novartis, CSL Behring, Hoffman LaRoche, Astra Zeneca, Pneum-Rx, Bayer, Merck, and many more.

This story encompasses the conglomeration of what is wrong with the reporting of science in the area of tobacco control today.

Friday, September 09, 2016

Conde Nast Promotes Cancer Research ... and Cancer: A Guest Commentary and Open Letter by Alan Blum, MD

"Glamour. This is one of the many publications whose chief function is to publish ads for cosmetics, clothes, and other items for young women.  The tobacco industry, having almost reached the saturation point of male smoking, is out to get a majority of women. Glamour hired Dr. Henry C. Link to write an article (Jan '46) saying that smoking cigarets is one of the most important of all bad habits."
--George Seldes, In Fact, July 28, 1947

Nearly 70 years later, Glamour is still ignoring the dangers of smoking and running cigarette ads.  And now Glamour is published by Conde Nast, which also publishes influential magazines like The New Yorker, Wired, and Vanity Fair.

Tonight Stand Up To Cancer holds its fifth fundraising telethon for cancer research.  Its slogan is "This is where the end of cancer begins."  But several of SU2C's Publishing Partners still accept advertising for the leading cause of cancer, cigarettes.  Because The New Yorker prides itself on exposing the hypocrisy of  public figures and trusted institutions, it is only fair to ask its editor how the magazine can ignore the hypocrisy of its publisher, whose slogan could well be "This is where cancer begins."


An open letter to David Remnick: 

Sent: Sunday, September 04, 2016 3:39 PM
Subject: In the spirit of Thomas Whiteside...
David Remnick
Editor, The New Yorker

Dear Mr. Remnick,

Since as a longstanding subscriber to The New Yorker I receive a weekly email from you, I hope you will be interested in a letter from a loyal reader with a suggestion for an editor's note.

The late Thomas Whiteside, most well known for his expose in The New Yorker of the use of the herbicide Agent Orange in the Viet Nam War, also wrote two scathing articles for the magazine in 1963 and 1970 (plus a third in The New Republic) about the tobacco industry and cigarette advertising that were published as a book, Selling Death.

By this time The New Yorker had stopped accepting cigarette advertising.  But nearly half a century later The New Yorker's publisher Conde Nast is still running cigarette ads in several of its magazines, notably Vanity Fair, Wired, and Glamour. That's certainly its prerogative, as it is of the tobacco companies under the First Amendment to advertise cigarettes, a legal, albeit lethal, product.

However, Conde Nast is also a Publishing Partner of Stand Up To Cancer (SU2C), the cancer cure research fund-raising organization whose fifth national telethon is September 9. The publication by Conde Nast of advertisements for SU2C, including in The New Yorker, that call for the public to support research to find a cure for cancer, strikes me as the epitome of hypocrisy.  I believe that Thomas Whiteside would have called out Conde Nast.  I think you should do so now.

Even while it no longer published cigarette ads per se, throughout the 1980s, 1990s, and well into the 2000s The New Yorker published countless 2-page image-burnishing advertisements byPhilip Morris USA (subsumed, since 2003, under its newly named parent, Altria) touting its support for the arts and various charitable causes from food banks and minority-hiring programs to efforts to end illiteracy and domestic violence.  More recently, Altria was a co-sponsor of The New Yorker's Aspen Ideas Festival, and the Altria logo was featured in advertisements in the magazine.  All of these ads were aimed at opinion leaders among The New Yorker's readership. Altria/Philip Morris is the manufacturer of the world's top-selling brand of cigarettes, Marlboro.

I have heard your interview with Terry Gross on "Fresh Air," in which you praise Sy Newhouse for the free hand he has given you at the helm of The New Yorker.  I also admire Mr. Newhouse for his commitment to the print medium and for his contributions to education (my son is a graduate of the Newhouse School at Syracuse).

But it should be a no-brainer to point out the egregious contradiction of a publisher promoting a foundation that seeks to find cures for cancer while still promoting the leading preventable cause of cancer, cigarettes, which are responsible for upwards of a third of all cancer deaths.

As a regular op-ed contributor to The Birmingham News, I first wrote about your publisher's (and others')  hypocrisy in a column in 2014, which was picked up by The Cancer Letter (attachment) and other outlets including Fair Warning (an investigative journalism group) and the Knight Science Journalism Tracker.  I wrote about it again a few weeks ago:

http://www.al.com/opinion/index.ssf/2014/09/stand_up_to_cancer_not_standin.html

But such local columns are trees falling in the forest, and here we are nearly half a century after Thomas Whiteside's condemnation of the cigarette makers in The New Yorker. I hope you will raise concerns about Conde Nast's wanting to appear to be an ardent foe of cancer while still accepting a considerable
amount of money to advertise cigarettes--and will also forward my letter to Mr. Newhouse for his consideration.

I look forward to hearing from you.

Sincerely,

Alan Blum, MD
Professor and Gerald Leon Wallace, MD, Endowed Chair in Family Medicine
Director, The University of Alabama Center for the Study of Tobacco and Society
University of Alabama School of Medicine
Phone: 205.348.2880  ablum@cchs.ua.edu

_______________________________________________________
Publishing Partners of Stand Up To Cancer that still publish cigarette advertisements

http://www.standup2cancer.org/supporters/publishing

American Media, Inc. (AMI) owns and operates the leading celebrity and health & fitness media brands in the country. Our magazines have a combined total circulation of 5.9+ million and reach 53+ million men and women each month. Our digital properties reach a total of 41+ million unique visitors and 313+ million page views monthly.
http://www.americanmediainc.com

AMI's most well known publication THE NATIONAL ENQUIRER still runs cigarette ads.  The company cultivates an image of health with some magazines as Men's Fitness, Muscle & Fitness, and Muscle & Fitness Hers.

Bonnier Corporation is one of the largest consumer-publishing groups in America and is the leading media company serving passionate, highly engaged audiences through 50 special-interest magazines and related multimedia projects and events. Popular brands include Saveur, Parenting, Popular Science, Field & Stream and TransWorld SKATEboarding. Bonnier Corp. is the U.S. division of the Bonnier Group, a 200-year-old family-owned media group based in Sweden with business operations in 25 countries.
http://www.bonniercorp.com/

FIELD & STREAM and POPULAR SCIENCE feature cigarette and smokeless tobacco advertisements in every issue.

Condé Nast is a premier media company renowned for producing the highest quality content for the world’s most influential audiences.  Attracting 95 million consumers across its industry-leading print, digital and video brands, the company’s portfolio includes some of the most iconic titles in media: Vogue, Vanity Fair, Glamour, Brides, Self, GQ, The New Yorker, Condé Nast Traveler, Details, Allure, Architectural Digest, Bon Appétit, Epicurious, Wired, W, Lucky, Golf Digest, Golf World, Teen Vogue and Ars Technica.
http://www.condenast.com/

VOGUE, VANITY FAIR, GQ, CONDE NAST TRAVELER, and WIRED all regularly feature advertisements for cigarettes and smokeless tobacco.

Hearst Magazines is one of the world’s largest publishers of monthly magazines, with 21 U.S. titles and close to 300 international editions. Hearst Magazines also publishes 19 magazines in the United Kingdom through its wholly owned subsidiary, Hearst Magazines UK. Hearst’s properties include, among others, Cosmopolitan, Good Housekeeping, O the Oprah Magazine, Redbook, Town&Country, and the newly launched Food Network Magazine. Hearst is pleased to support the Entertainment Industry Foundation and its efforts to Stand Up to Cancer.
http://central.hearstmags.com/

COSMOPOLITAN still accepts advertisements for cigarettes and smokeless tobacco.

Time Inc., a Time Warner company, is a world class branded content company, investing in the future and engaging more than 138 million consumers monthly; whenever, however, and wherever they are. With 22 magazines and 26 web sites in the U.S., it is the country’s largest consumer publisher. Each month, one out of every two American adults reads a Time Inc. magazine, and one out of every five, who are online, visits a company web site (more than 52 million monthly unique visitors). Time Inc.’s popular brands and successful franchises extend to online, mobile and digital reading devices, television, events and branded products.
www.timeinc.com

TIME and SPORTS ILLUSTRATED feature advertisements for cigarettes and smokeless tobacco in almost every issue.

Thursday, September 08, 2016

More Shoddy Research on E-Cigarettes by Big Pharma-Funded Scientists

A study recently published online in the journal Nicotine & Tobacco Research purports to show that the use of e-cigarettes inhibits smoking cessation. In the study, smokers were recruited from 187 primary care clinics in Ontario. Some of these smokers had not used e-cigarettes and some were dual users (of both cigarettes and e-cigarettes). The study followed these smokers for six months and found that the smoking cessation rate among the non-e-cigarette-users was significantly higher than among the dual users. Based on this finding, the paper concludes that e-cigarette use inhibits smoking cessation.

The paper's conclusion is as follows: "This study confirms previous findings from observational studies regarding the negative association between e-cigarette use and smoking cessation, but in a large cohort of smokers enrolled in an evidence-based treatment program. The implications of these findings are that concurrent use of e-cigarettes during a quit attempt utilizing cost-free evidence-based treatment (nicotine replacement therapy plus behavioural counselling) does not confer any added benefit and may hamper successful quitting."

The Rest of the Story

The major flaw in this study is that it is very likely that the smokers who were dual users became dual users because they were unable to quit smoking. Had they been successful in quitting smoking, they would not have become dual users (and thus their success would not have been observed in the study). This means that what the study is really comparing is smoking cessation rates among smokers who have failed to quit versus those who have not necessarily failed to quit. It would be shocking if the study did not find higher quit rates among the non-dual users.

While the study controlled for confidence in ability to quit using a crude measure, this is clearly not as sensitive a measure as whether the person had actually failed to quit smoking, which is of course going to be much more productive than any self-reported attitudinal measure. Apparently, one question that was not asked of study subjects was their history of failed quit attempts. And another important question that was not asked was whether or not the subjects had previously tried NRT and failed. Without either of these two variables, the study was unable to control for the sampling bias that is inherent in this study design.

Most smokers who use e-cigarettes for cessation are doing so specifically because they failed to quit using traditional methods in the past and/or because they don't think they can (or don't want to) completely eliminate nicotine or the "smoking" behavior. On top of this, of these smokers, it is only the ones who fail to quit who become dual users. Skimmed off the top are all the successful quitters who, according to this study, do not exist. Their experiences are not considered at all in the analysis of whether or not e-cigarettes can help smokers quit.

Moreover, smokers who try e-cigarettes are likely to have failed in previous quit attempts using NRT. Having a history of failed quit attempts using NRT is obviously a very strong predictor of future failure to quit using NRT. Many of the dual users who were given NRT probably knew that it was a waste of time, since they did not previously find this method useful. In our focus groups with vapers, we found that nearly all of them chose to try e-cigarettes because they were unhappy with, and unsuccessful with the FDA-approved cessation strategies, such as NRT.

What could explain such a biased interpretation of the study results?

Unfortunately, two of the major authors of the article have significant conflicts of interest with Big Pharma, leading to the appearance that these conflicts might have been associated with the apparent bias in the interpretation and reporting of the study findings and conclusions.

Both the lead author and the senior author of the study disclosed that they have received funding from Pfizer. The senior author also disclosed having received honoraria and consulting fees from Johnson & Johnson, Pfizer, and NABI Pharmaceuticals.

These are significant conflicts of interest because all of these pharmaceutical companies are developing or marketing smoking cessation products. They stand to lose financially if e-cigarettes are found to be effective cessation products. Therefore, these conflicts of interest create an appearance that the apparent bias in the interpretation of study results and in the design of the study itself may be related to financial interests in these pharmaceutical companies.

A more detailed summary of the conflicts of interest of the senior author reveals a host of financial interests related to pharmaceutical companies: "He has received funds from Schering Canada to provide buprenorphine training (2000). He has acted as a paid consultant for Johnson and Johnson Consumer Health Care Canada; Pfizer Inc. Canada; Pfizer Global; Sanofi-Synthelabo, Canada; GlaxoSmithKline, Canada; Genpharm and Prepharm Canada; NABI Pharmaceuticals: V-CC Systems Inc. & EHealth Bahaviour Change Software Co.; and Schering Canada. He has also received honoraria or been part of a speakers bureau for Schering Canada; Johnson and Johnson Consumer Health Care, Canada, Pfizer Inc. Canada; Pfizer Global; Sanofi-Synthelabo Canada; Glaxo Smith Kine Canada; Genpharm & Premfarm Canada and NABI Pharmaceuticals."

There is a real need for clinical research on the effectiveness of electronic cigarettes that is conducted by unconflicted investigators. I do not believe that much of the work done by conflicted investigators can be trusted because it has been improperly designed in a way that has introduced serious sampling bias which has not been adequately accounted for. At some institutions, including my own, investigators with conflicts of interest like this are not allowed to conduct this kind of research in the first place. Seeing the problems apparent in work like the present study, these policies may be appropriate.

Tuesday, September 06, 2016

New Study Refutes E-Cigarette Gateway Hypothesis

A new study published in the American Journal of Preventive Medicine refutes the hypothesis that e-cigarettes serve as a gateway to smoking among nonsmoking youth.

In the study, Dr. Kenneth Warner of the University of Michigan analyzed data from the 2014 Monitoring the Future survey. While previous studies, conducted by the Centers for Disease Control and Prevention (CDC) have only considered whether youth had used an e-cigarette in the past month, Dr. Warner examined the actual frequency of e-cigarette use during the past month.

The study found that among 12th grade never smokers, 6.5% had used e-cigarettes in the past month. However, only 0.7% of never smokers reported vaping on 20 or more days in the past month. The predominant pattern of e-cigarette use among nonsmoking youth was vaping about once a week or less.

The study concludes that: "Never smokers were highly unlikely to have used e-cigarettes, and of those who did, the majority used e-cigarettes only 1-2 days."

The Rest of the Story

This study should help ease the concerns of those worried about e-cigarettes addicting youth nonsmokers and leading them along a gateway which ends with life-long smoking addiction. Only a very small percentage of nonsmokers were found to be vaping regularly, with only 0.7% vaping at a level that could potentially represent addiction. These findings provide no support for the theory that e-cigarettes are a gateway to smoking. Combined with the fact that youth smoking has dramatically fallen during a period when e-cigarette use among youth is skyrocketing, these findings refute the gateway hypothesis and show that the claims being made by many anti-smoking groups and agencies, including the CDC, are false.

The rest of the story is that it is time for CDC director Dr. Thomas Frieden to retract his statement that: "Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes." It is high time that the CDC stop lying to the public about this critical issue.