Friday, June 18, 2010

Former FDA Commissioner Calls for Agency to Mandate 90% Reduction in Nicotine Levels in Cigarettes - Michael Siegel

Former FDA Commissioner Dr. David Kessler, speaking at a forum on the impact of the FDA tobacco law, urged the Agency to mandate significantly lower levels of nicotine in cigarettes. According to an article in the New York Times, he called for a reduction from the current level of about 10 mg per cigarette to less than 1 mg, which would be a reduction of just over 90%.

According to Kessler, mandating this reduction in nicotine levels would bring the nicotine to "non-addictive levels" and would save 200,000 to 300,000 lives a year.

The FDA tobacco law does not allow the Agency to eliminate the nicotine in cigarettes.

The Rest of the Story

Dr. Kessler's recommendation is flawed because of three basic scientific myths inherent in his reasoning:

Myth #1. Nicotine is not addictive below 1 mg per cigarette.

There is no evidence to support the contention that below 1 mg, nicotine-laden cigarettes cease being addictive. This has never been tested in real-life setting, so there is simply no evidence to support the assertion. This assumption flies in the face of what we know about other addictive drugs. For example, addiction specialists who treat alcoholics do not recommend that they cut the amount of alcohol they consume by 90%. They call for complete abstinence. Anything short of this is going to result in activation of brain receptors that are involved in addiction to alcohol. Even at a level of less than 1 mg, there is almost certainly going to be some uptake of nicotine, and some binding to receptor sites in the brain, resulting in at least some activation of the neurochemical systems that produce psychoactive effects that contribute to nicotine addiction.

The only studies that have been conducted on very-low nicotine cigarettes have found that consumers will not maintain smoking these products, but will switch to regular cigarettes. This is not relevant to the mandated reduction of nicotine levels, however, because in that situation, there will be no "regular" cigarettes. There will be no other choice, and it is not clear that smokers will be more likely to quit smoking entirely.

Myth #2: The addiction to smoking is solely due to nicotine.

As I have revealed over the past months in relation to the apparent effectiveness of electronic cigarettes in suppressing the craving to smoke, high levels of nicotine delivery are not necessary to maintain cigarette addiction. A large component of the addiction is behavioral. Many anti-smoking groups are failing to recognize that smoking addiction is more than just addiction to nicotine. In fact, many electronic cigarette users are successful in quitting smoking even with 0 mg nicotine cartridges. There is substantial scientific evidence to suggest that the behavioral aspects of smoking contribute heavily to the addictiveness of smoking. Replacing the nicotine alone is not sufficient to suppress the craving to smoke. Replacing the behavioral aspects of smoking, in the absence of nicotine, can actually suppress the craving. So it is clear that there are both pharmacologic and behavioral aspects to smoking addiction.

Myth #3: Cigarettes would not be smoked if they contained less than 1 mg of nicotine. Many smokers would quit and youth would not initiate smoking.

Myths #1 and #2 lead to the conclusion that if only nicotine levels in cigarettes were cut by 90%, cigarettes would no longer be addictive and therefore most smokers would quit and most youth would not start smoking. Hence, Dr. Kessler's estimate of a reduction in smoking-attributable mortality by a whopping 50 to 75% if nicotine levels are lowered.

Unfortunately, there is no evidence to support this prediction. A 90% reduction in nicotine levels would most likely not result in a non-addictive product, both because there is no evidence that a level below 1 mg is non-addictive and because the nicotine is just one aspect of the addiction to smoking.

What the scientific evidence suggests is the most likely outcome is that cigarette smokers will substantially increase their cigarette consumption in an attempt to try to maintain their current nicotine levels. This increased cigarette consumption will, of course, result in increased disease and deaths -- the exact opposite of what Dr. Kessler promises with his proposed policy.

If you addict rats to nicotine by hooking them up to an infusion mechanism by which they can press a lever to administer a nicotine dose, and then you substantially lower the nicotine level, the rats will not cease pressing the lever. Instead, they will start pressing the lever more often, and more frantically. The same behavior occurs when the dose of any addictive drug is lowered. It is unclear what evidence supports the contention that in the face of a uniform reduction in nicotine levels, cigarette smokers will behave in the exact opposite way of what a scientific knowledge of addiction behavior predicts.

There is abundant scientific evidence that reductions in nicotine levels are associated with compensation -- the phenomenon by which smokers will increase their cigarette consumption (and puffing intensity) to compensate for lower nicotine delivery. This is one of the major reasons why the low-nicotine cigarette myth is a myth.

Let me emphasize that this flawed policy proposal is not Dr. Kessler's fault. It is the result of a flawed law: one that precluded the FDA from eliminating the nicotine in cigarettes. While I am not arguing that elimination of nicotine in cigarettes is a policy that should have been adopted (I have made it clear that I do not favor cigarette ingredient regulation as an appropriate way to tackle the problem at all), the anti-smoking groups should never have agreed to legislation that was intended to lower nicotine levels, but not eliminate the nicotine. Such a policy is exactly what cigarette companies would want because it would increase cigarette consumption as smokers struggle to compensate for the reduced nicotine delivery. Moreover, there is no evidence that lowering the nicotine levels in cigarettes would substantially reduce youth smoking either. The scientific base is simply not existent to support the contention that there is a level below which nicotine would not contribute toward cigarette addiction, or that if there is a level, we know what it is.

The biggest tragedy would be if the FDA adopted Dr. Kessler's advice, reduced nicotine levels by 90%, and it turned out that cigarette consumption greatly increased. It would be even worse if such a policy resulted in a lowering of the public's appreciation of the addictive potential of smoking (it most certainly would have that effect). Such an effect would itself increase smoking rates and could perhaps encourage smoking experimentation among youth because they would mistakenly believe that smoking is no longer addictive and so it is less of a danger to experiment.

Unfortunately, the FDA tobacco law puts forth a regulatory approach that is misguided and cannot actually achieve a significant reduction in smoking-related mortality. Instead, the FDA should concentrate its resources on the only proven way of substantially reducing smoking: by putting all of its tobacco-related resources into a national anti-smoking media campaign, along the lines of the "truth" campaign.

Tuesday, June 8, 2010

Washington Ethics Group Calls for Investigation of Two FDA Tobacco Panelists, Citing Conflicts of Interest with Big Pharma - Michael Siegel

On Monday, the group Citizens for Responsibility and Ethics in Washington (CREW) - which focuses on government ethics and accountability - wrote to the Inspector General of the Department of Health and Human Services, urging him to investigate the participation of Dr. Jack Henningfield and Dr. Neal Benowitz on the FDA Tobacco Products Scientific Advisory Committee. The letter cites the financial conflicts of interest of Drs. Henningfield and Benowitz, who have both received money from pharmaceutical companies that make smoking cessation products.

According to the letter, Henningfield and Benowitz have "received millions of dollars in grants from pharmaceutical companies that stand to profit from decisions made by the committee. Specifically, Drs. Neal Benowitz and Jack Henningfield have received money from companies that actively market products designed to help people quit smoking."

According to CREW: "the business interests of two members of the panel, Dr. Neal L. Benowitz and Dr. Jack L. Henningfield create significant conflicts of interest. As a result, CREW requests that the Office of the Inspector General investigate to determine whether these conflicts should disqualify them from serving on the TPSAC [Tobacco Products Scientific Advisory Committee]."

Specifically, CREW notes that "Dr. Benowitz has served as a paid consultant for pharmaceutical companies, including Pfizer, GlaxoSmithKline, Novartis and Aradigm, assisting with the design, development, and marketing of smoking cessation products. ... Dr. Henningfield serves as a paid consultant for pharmaceutical companies seeking approval of smoking cessation products. The firm [Pinney Associates] has received over $2 million a year from pharmaceutical companies, over half of which is directly attributable to its work on smoking cessation products. Finally, Dr. Henningfield is a partner in a company that holds at least one patent for a nicotine replacement product -- a potential nicotine-gum delivery system -- and he has estimated that if he is successful in licensing this patent, it may be worth over a million dollars to him as a partner in that company."

The letter notes that the FDA has been widely criticized for allowing scientific panelists with conflicts of interests, but that the Agency responded by issuing new policies. However, CREW says, the appointments of Dr. Benowitz and Dr. Henningfield do not follow these policies. CREW writes: "In the wake of these systemic problems, the FDA issued new transparency and public disclosure policies for advisory committees in August 2008. ... Beyond these policies, the Federal Advisory Committee Act (FACA), under which the TPSAC was formed, mandates that any advisory committee put in place 'appropriate provisions to assure that the advice and recommendations of the advisory committee will not be inappropriately influenced by the appointing authority or any special interest...' ... The FDA's selection of membership in the TPSAC does not follow these legal mandates and the FDA's implementing guidance."

While CREW is only asking for an investigation, it makes it very clear that it believes the Inspector General should disqualify Drs. Benowitz and Henningfield from participation on the TPSAC: "Drs. Benowitz and Henningfield have clear financial conflicts of interest as defined by statute and FDA guidance. As outlined above, both stand to receive direct financial benefits from teh TPSAC's recommendations on smoking cessation products. ... Their outside financial interests will be directly and predictably affected by the recommendations from TPSAC on particular matters within its assigned jurisdiction. These conflicts unquestionably disqualify Drs. Benowitz and Henningfield from serving as members of the TPSAC."

The CREW letter follows a similar request to the FDA from Philip Morris to reconsider the appointment of Drs. Benowitz and Henningfield to the TPSAC because of their Big Pharma financial ties. In its response denying that request, the FDA fails to even acknowledge the financial conflicts of interest with Big Pharma and fails to explain whether it had determined that the conflicts of interest with pharmaceutical companies were non-disqualifying.

According to an article in the New York Times, Dr. Benowitz fails to even see any conflict of interest. He is quoted as stating: "I really don’t see any conflict. My involvement with pharmaceutical companies is aimed at reducing the risk of smoking, quitting smoking. The aim of the committee is also to reduce the adverse health consequences of tobacco use."

CREW was disappointed that FDA failed to directly address the pharmaceutical conflict of interest issue, stating: "We just thought the financial conflicts were clear. The FDA has not explained how these are unavoidable conflicts."

The Rest of the Story

The financial conflicts of interest that are the subject of Monday's letter from CREW were first highlighted here at The Rest of the Story on March 1 and March 2, as soon as the TPSAC membership was announced. I argued that these conflicts were substantial because the TPSAC will be making decisions that directly affect the profitability of pharmaceutical smoking cessation products.

I argued: "Given that the FDA has already been under siege for complaints about the undue influence of politics over science, due to the influence of industry, it is unclear why the Agency would want to compound the problem by crafting a highly conflicted panel to advise it on tobacco issues. There is enough bias in this field to begin with; we don't need to add to it by appointing a panel with numerous members who have severe, personal financial conflicts of interest."

"The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats). The ... pharmaceutical industr[y] must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors."

It seems to me that two things are indisputable in this case. First, there is no question that there is a financial conflict of interest. Both Dr. Benowitz and Dr. Henningfield have significant financial interests in pharmaceutical companies that manufacture smoking cessation products whose profitability will be directly impacted by the decisions of the TPSAC about how to regulate the potential competitors to these products.

Second, there is no question that the products the TPSAC will be advising the FDA about how to regulate include direct competitors to the smoking cessation products made by these pharmaceutical companies. For example, products like electronic cigarettes (which could well fall under the jurisdiction of the FDA tobacco law, and therefore, the TPSAC), are potentially fierce competitors of pharmaceutical smoking cessation products. If electronic cigarettes prove to be effective, they could put a huge dent in the market share of pharmaceutical products and could irreversibly alter the profitability of those products.

Thus, I fail to see how one can credibly argue that there is no financial conflict of interest here or that the conflict is not relevant to the subject matter that will be considered by the Advisory Committee.

At best, the FDA could argue that there is a relevant conflict of interest, but that the Agency has carefully considered it and decided that it need not disqualify the pharmaceutical consultants from participation on the panel. Obviously, I wouldn't agree with such reasoning; however, it is imperative that the FDA directly address the issue.

I agree with CREW that the FDA's response so far has been inadequate. It can't simply ignore the conflict and pretend that it doesn't exist. It must directly answer the question: "Given this clear conflict of interest, how can the continued participation of these two pharmaceutical consultants on the advisory committee be justified?"

Perhaps most troublesome is the response of Dr. Benowitz that he fails to see any conflict of interest. If that is the case, then the conflict is even more worrisome. Conflicts of interest that are out in the open can at least be managed. But when the consultant doesn't even acknowledge that there is a conflict, then that signals trouble. You can't manage something when you're not even aware of it, and don't even acknowledge that it exists.

In light of the rest of the story, I believe that Drs. Benowitz and Henningfield should voluntarily step down from their seats on the TPSAC panel and allow the FDA to appoint two unconflicted scientists to serve.

Saturday, June 5, 2010

Why FDA Regulation of Tobacco Constituents Makes No Sense, and Will Transfer Fraudulent Deception from Tobacco Industry to Government - Michael Siegel

A number of health groups - such as the Campaign for Tobacco-Free Kids - contend that the new FDA tobacco law will save lives by allowing the FDA to mandate reductions in certain constituents of tobacco smoke. In fact, the basic regulatory structure of the Family Smoking Prevention and Tobacco Control Act is the task - given to the FDA - of requiring safer cigarettes by mandating the reduction or elimination of certain chemicals in cigarette smoke.

While that might sound beneficial for the public's health on first glance, a more careful analysis of the science reveals that the idea is actually an absurd one that makes no sense and will - rather than protect public health - simply transfer the fraudulent deception of American consumers from the tobacco industry over to the federal government.

The Rest of the Story

The FDA's regulatory approach to tobacco products is hampered by four critical, but often unrecognized facts:

1. We currently have no idea what constituents in cigarette smoke, at what levels and combinations, result in the observed health effects of smoking.

Without knowing the specific constituents that are responsible for the harmful effects of smoking, there is simply no way that the FDA can produce a cigarette that it knows will be safer.

2. We have only identified 4,000 of what may be as many as 100,000 chemicals in cigarette smoke. Thus, there are as many as 96,000 unknown chemicals.

With 96,000 unknown chemicals in tobacco smoke, it is clear that we cannot determine the risk of cigarettes simply by knowing the levels of the 4,000 known chemicals.

3. Research has demonstrated that risk analysis of the known constituents in cigarette smoke explains less than 4% of observed lung cancer risk. In other words, even if all identified carcinogens were removed from cigarettes, there is no evidence that the incidence of lung cancer among smokers would be reduced.

An article published in the March 2007 issue of Cancer Epidemiology, Biomarkers & Prevention concludes that even if all currently known and measured carcinogens in tobacco smoke were completely removed, there would be little reason to believe that there would be any observable reduction in smoking-related cancers (see: Pankow JF, Watanabe KH, Toccalino PL, Luo W, Austin DF. Calculated cancer risks for conventional and 'potentially reduced exposure product' cigarettes. Cancer Epidemiology, Biomarkers & Prevention 2007; 16:584-592).

Using data on per-cigarette smoke yields of a large number of known carcinogens and the known cancer risks posed by those carcinogens, the researchers assessed the lung cancer risk posed by regular, light, ultralight, and a number of PREP (potentially reduced exposure product) cigarettes using a mathematical model. They found that neither light, ultralight, or any available PREP was predicted to offer any substantial reduction in cancer.

Moreover, the researchers found that knowledge of the yields of all currently known lung carcinogens in cigarettes was able to account for less than 4% of the observed lung cancer risk of cigarette smoking. This inability to account for observed cancer risk means, they conclude, that even if all currently known and measured carcinogens were completely removed from cigarette smoke, there would be no reason to believe that actual human cancer risk would be decreased.

The authors conclude: "The current inability to account for the observed health risks of smoking based on existing data indicates that current expressed/implied marketing promises of reduced harm from PREPs are unverified: there is little reason to be confident that total removal of the currently measured human lung carcinogens would reduce the incidence of lung cancer among smokers by any noticeable amount."

"Expressed another way, even if a PREP design were to succeed in removing all currently measured known human lung carcinogens from cigarette smoke (and even perhaps all other currently measured carcinogens), there would be little reason to be confident that such removal would by itself lead to any observable reduction in smoking related lung cancer."

In perhaps easier to understand terms, Dr. Pankow summarized his key conclusion as follows: "Since we can't account for the risks from smoking conventional cigarettes, it does not accomplish much to just remove a few of the known toxins. An analogy might be someone who abuses alcohol by drinking 10 beers a day, but says they are going to cut down to 9."

And Dr. Pamela Clark, a senior research scientist at the Battelle Centers for Public Health Research and Evaluation, explained that "Dr. Pankow's study shows that simply lowering the levels of a few known harmful compounds from tobacco smoke may not significantly reduce the risks of smoking."

This is a critically important study and it has vital implications for the consideration of the FDA tobacco law. Specifically, the study demonstrates the complete folly of the regulatory approach and the ridiculous nature of the claims being made by the Campaign for Tobacco-Free Kids, American Medical Association, and other organizations that the legislation is going to "save countless lives."

Quite the opposite. This research demonstrates that a regulatory approach based on asking the FDA to require the reduction or elimination of various constituents of cigarette smoke is an absurd approach that offers no known or expected health benefits. Any claim that this legislation is going to save lives by requiring safer cigarettes is completely undocumented and unsupported.

As the research shows, there is no reason to believe that requiring the reduction or elimination of even a large number of the known harmful and carcinogenic constituents in tobacco smoke would result in any reduction in the risks of smoking.

In some ways, I find that the health groups are making claims that are more baseless and deceptive than anything the tobacco companies have stated about the risks of low-yield cigarette products. The cigarette companies have certainly deceived the public by implying that low-yield products offer a health advantage over conventional products. But they have never gone so far as to claim that they would save countless lives - a claim being made about the FDA legislation by the Campaign for Tobacco-Free Kids. Nor have they pinned a specific number on the lives saved, something the American Medical Association has done by suggesting that the FDA legislation will save millions of lives.

I don't really understand why it is that if the tobacco companies make such baseless, undocumented, and deceptive claims, it represents fraud and engenders attacks on the companies for their unscrupulous actions, but when anti-smoking groups make even more baseless, undocumented, and deceptive claims, it is now magically acceptable because we are working towards an allegedly noble cause.

The FDA tobacco legislation is really a mechanism to transfer the deception about low-yield cigarettes from the tobacco companies to the government. It takes the tobacco companies off the hook, allowing them to smile all the way to the bank as the very low-yield health claims they have been found guilty of making are now made by the federal government. And to boot, the companies no longer will have to face a liability risk for making such undocumented claims. The government is going to be doing all the dirty work for them. What a brilliant scheme!

The rest of the story is that there is absolutely no evidence to support the law supporters' contention that by reducing or eliminating specific constituents of the smoke, we will produce a safer cigarette that will save countless lives, millions of lives, or even any lives. In fact, the science shows that even if every known carcinogen in cigarettes were removed, we'd be in no position to be confident that the actual cancer risk of smoking had been reduced. And you can be sure that the FDA is not going to enact regulations that require the removal of every known carcinogen from cigarettes!

Realistically, the best the FDA could do under the proposed legislation would be to require the reduction or elimination of a number of specific tobacco smoke constituents. This research demonstrates that there is no basis to believe that such an approach would result in a measurable decline in smoking-related mortality.

Moreover, the only way to know whether a reduction in specific constituents would reduce the risks of smoking would be to mandate those changes and then conduct long-term epidemiologic studies. In other words, smokers would have to be used as guinea pigs. The FDA would have to set so-called "safety standards" without knowing whether those standards actually reduce the product's risk. It would take years to find out.

In the mean time, smokers would be misled into believing that by virtue of the FDA's promulgation of a "safety standard," the product has been made safer. This will certainly undermine the public's appreciation of the hazards of smoking and will cause many smokers who would otherwise have quit entirely to instead continue to smoke, thinking that the FDA-mandated changes to cigarettes have made them safer.

The end result will likely be harm to the public's health, due to an increase in smoking caused by deterrence of smoking cessation because of the perception that cigarettes are now safer. In other words, it will be the "low-tar" fiasco all over again, except now it will be the federal government perpetrating this fraud instead of the tobacco companies.

It is critically important to understand that there is no way of determining cigarette risk based solely on studying the product in the laboratory. Epidemiologic studies of the actual use of the product in the population is necessary to determine whether a change in the constituents of cigarettes will lessen their health risks.

To repeat the important conclusion of Pankow et al.: "The current inability to use toxicant-specific methods to account for the observed cancer risks of smoking carries an important implication for PREP cigarettes. Namely, all expressed and implied promises of 'reduced harm' ... of PREPs (including ostensible PREPs) must be viewed as speculative and unverified. Indeed, because does considerations for known tobacco smoke lung carcinogens account for <4% of the lung cancer risk of conventional cigarettes as they are smoked by North American populations, then lowered levels of these toxicants in PREPs still leave PREPs in the possible position of being as harmful as conventional cigarettes."

This means that the FDA has been put in the absurd position of being asked to promulgate "tobacco product safety standards" for which it will have no way of knowing whether they will improve, have no effect on, or harm human health. This is an untenable to position to be in, and it needs to be rejected outright.

The FDA tobacco law has been enacted, but there is no requirement that the FDA adopt any "product safety standards." Instead, I recommend that the FDA take an entirely different approach, and devote all of its time and resources not to regulating the product, but to trying to decrease the demand for the product and actually make a dent in smoking rates by funding anti-smoking education and prevention programs, including media campaigns, throughout the country. Unlike product regulation, which has no science to back it up, the use of media campaigns to reduce smoking is supported by solid scientific evidence.

The rest of the story is that in their zeal to put a feather in their cap by being able to claim that they achieved FDA regulation of tobacco products, the major anti-smoking and health groups actually deceived the public about the potential health benefits of lower-yield cigarettes to a greater degree than anything the tobacco companies have ever done. Frankly, the tobacco companies wouldn't even dream of deceiving the public to this extent. They remained somewhat subtle in their deception, by merely implying that there is some health value to reduced yield cigarettes. I can only imagine the scorn and ridicule the companies would have received had they claimed that their lower-yield cigarettes were going to save countless lives.

Friday, June 4, 2010

Chair of FDA Tobacco Advisory Committee Took Tobacco Industry Money to Help Craft Fraudulent Research Agenda - Alan Blum and Michael Siegel

Two Prominent Anti-Smoking Researchers Call on Chair to Resign

Two prominent anti-smoking researchers – Dr. Michael Siegel of the Boston University School of Public Health and Dr. Alan Blum of the University of Alabama – are calling for the resignation of Dr. Jonathan Samet, the chair of the newly appointed FDA Tobacco Products Scientific Advisory Committee.

Dr. Samet received tobacco industry funding to help craft the scientific agenda for the now-defunct industry front group: the Center for Indoor Air Research. To the best of our knowledge, he has never publicly acknowledged and apologized for having played this role for the industry and he failed to even mention his history of tobacco funding when he published an article which scolded other scientists for accepting tobacco money to help the industry disseminate “junk science” to foster its opposition to smoke-free policies. Dr. Samet refused to answer our questions about his past involvement with the tobacco industry, instead referring our questions to the FDA.

Dr. Siegel and Dr. Blum’s statement calling for Dr. Samet’s resignation is as follows:

The chairman of the newly created FDA scientific advisory panel on tobacco products, which held its first meeting on March 30, helped the tobacco industry set a research agenda aimed at casting doubt on the harm caused by secondhand cigarette smoke. Dr. Jonathan Samet, a professor of preventive medicine at the University of Southern California, was one of six scientists enlisted in 1989 by the Center for Indoor Air Research (CIAR), a tobacco industry front group.

In the 1980s mounting scientific evidence of the harmfulness of secondhand smoke led to the passage of numerous state and local smoking bans in public places, culminating in the 1988 ban by Congress on smoking on all domestic airlines. Moreover, the Environmental Protection Agency (EPA) was about to consider whether to name secondhand smoke as a cause of cancer.

In response, America's three leading cigarette companies, Philip Morris USA (maker of the top-selling US brand, Marlboro), RJ Reynolds Tobacco Company (Winston, Camel), and Lorillard Inc (Newport) teamed up to establish CIAR. Tobacco company lawyers were present at all meetings of CIAR's Board of Directors and were involved in all of its decisions. In her scathing, 2000-page opinion in the Department of Justice lawsuit against the tobacco industry for racketeering, Judge Gladys Kessler exposed the fraudulent nature of CIAR: "During the entire existence of CIAR (1988-1999) only cigarette company executives/scientists sat on the Board of Directors...Despite the establishment of a functioning Scientific Advisory Board (SAB), only the CIAR Board of Directors had authority to approve the funding of any CIAR project." Judge Kessler also noted that in none of the 19 issues of CIAR's quarterly newsletter was it disclosed that the Center was funded and controlled by the tobacco industry.

Dr. Samet's relationship with the industry surfaced in 1990, when the Associated Press reported that he and five other members of a 16-person EPA scientific advisory panel charged with evaluating studies on the health effects of secondhand smoke were identified as having ties to CIAR. In its 1989-1990 Request for Applications (RFA) from researchers, CIAR acknowledged Samet and others "for their assistance in the development of the Center's first research agenda by making presentations at the Scientific Advisory Board Workshop." CIAR's 1991 RFA thanks Samet and others "for their intense efforts and active participation." Samet accepted payment from the tobacco industry for his participation in the workshop, including travel expenses and an honorarium paid to his academic institution, the University of New Mexico, where he served as a professor in the Department of Family, Community, and Emergency Medicine.

Samet has previously acknowledged: "With regard to the Center for Indoor Air Research, I participated for one day in a workshop at which I gave my opinions concerning research needs on indoor air pollution. On one occasion I have served as an external peer reviewer of grants by mail. For these activities I received reimbursement for expenses. I did not accept honoraria, but submitted them to my institution." Yet the fact remains that the newly appointed chair of the first scientific panel appointed to advise the FDA on the regulation of tobacco products accepted tobacco money to help craft the research agenda for an organization that proved to be a fraudulent scientific enterprise.

Ironically, in 2001 Samet published a paper in the American Journal of Public Health in which he criticized the tobacco industry's use of "junk science" to undermine the scientific evidence linking secondhand smoke and adverse health effects. Samet wrote: "The lesson? The stakes are high in the public policy arena. Public health scientists will continue to be called on to research society's most vexing issues, and to inform and shape the public policy response. We need to be aware of the competing interests and to work for greater transparency to assure ourselves that we understand the purposes and funding sources of potentially invidious meetings and other activities." The junk science and corruption he was condemning was precisely the enterprise in which he had participated at a time when the tobacco industry was redoubling its efforts to cast doubt on the impact of secondhand smoke.

Yet nowhere in Samet's paper does he acknowledge having played a role, even inadvertently, in this scheme. Nor did this inhibit Samet from calling for greater awareness of competing interests and transparency, scolding other scientists, and according to a published article by Dr. Carl Phillips (in the journal Epidemiologic Perspectives and Innovations), even urging attendees at a conference to boycott a session of a scientific meeting at which a tobacco industry-funded scientist was to present a paper on the effects of secondhand tobacco smoke.

In light of these revelations about Dr. Samet, he should end his participation in the FDA Tobacco Products Scientific Advisory Committee.

Numerous scientists have worked for decades to address tobacco problems without the need to accept funding from cigarette manufacturers or to associate themselves with the tobacco industry's obfuscatory research agenda. Surely, in its first try at ending the smoking pandemic, the FDA should be able to identify a scientist free of the taint of Big Tobacco to serve as chair of its scientific advisory committee.

Michael Siegel, MD, MPH - Professor, Boston University School of Public Health

Alan Blum, MD - Professor and Endowed Chair in Family Medicine and Director of the University of Alabama Center for the Study of Tobacco and Society

Dr. Michael Siegel is a long-time tobacco control researcher and advocate for tobacco control policies, fairly well known in the tobacco control area. He is a physician who specializes in preventive medicine and public health. He is now a professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 23 years of experience in tobacco control, primarily as a researcher. He has over 60 published, peer-reviewed articles on tobacco control policy in such journals as the New England Journal of Medicine, JAMA, American Journal of Public Health, Tobacco Control, Journal of Marketing, and the American Journal of Epidemiology. He is author of three previous op-eds on tobacco policy published in the Washington Post, New York Times, and USA Today. His work on the health effects of secondhand smoke on bar and restaurant workers is widely cited in public policy debates over smoke-free bar and restaurant policies. He has been a long-term advocate for smoke-free bar and restaurant policies, and have testified on behalf of such laws in more than 50 cities throughout the country. His areas of research interest include the health effects of secondhand smoke, policy aspects of regulating smoking in public places, effects of cigarette marketing on youth smoking behavior, and the evaluation of tobacco control program and policy interventions.

Dr. Alan Blum is a family medicine physician and a long-time veteran of the anti-tobacco movement. He is now Professor and Director of the Center for the Study of Tobacco and Society at the University of Alabama. Dr. Blum formerly served as Editor of the New York State Journal of Medicine, where he published the first journal issue dedicated to tobacco articles. Dr. Blum has published extensively on tobacco policy, with a specialty in tobacco marketing and advertising. He is the founder of Doctors Ought to Care, a national organization which has involved physicians in tobacco control advocacy, an effort for which he received the first National Public Health Award from the American Academy of Family Physicians.

Thursday, June 3, 2010

Four Members of FDA Tobacco Products Scientific Advisory Committee Have Received Pharmaceutical Money; Industry Influence Grows - Michael Siegel

My previous post reported that the FDA appointed GlaxoSmithKline to sit on its Tobacco Products Scientific Advisory Committee, by virtue of its appointment of a Glaxo consultant and expert witness to the panel.

Today, I report that the influence of the pharmaceutical industry on FDA policy will be even greater than I suggested yesterday, because three additional members of the Committee have also received pharmaceutical money.

First, the chair of the Committee - Dr. Jonathan Samet - has received grant support from GlaxoSmithKline. In addition, the organization that he directed - the Institute for Global Tobacco Control - is funded by GlaxoSmithKline and Pfizer.

Second, an additional panel member - Dr. Dorothy Hatsukami - has received grant support from a pharmaceutical company to study the nicotine vaccine for use in smoking cessation.

Third, an additional panel member - Dr. Neal Benowitz - co-authored a study on the use of Chantix in smoking cessation which was funded by Pfizer and has also served as a Pfizer consultant. In particular, Dr. Benowitz served as a Pfizer consultant on how to develop a scientific base to support the use of Chantix in smoking cessation. Benowitz has also consulted for GlaxoSmithKline and Nabi Pharmaceuticals.

The Rest of the Story

The FDA Tobacco Products Scientific Advisory Panel is a virtual smorgasbord of tobacco and pharmaceutical financial interests. This is hardly what I imagine President Obama had in mind when in his inaugural address he called for "science to be restored to its rightful place."

The FDA has now given a seat on the panel to GlaxoSmithKline, Pfizer, and Nabi Pharmaceuticals, alongside the tobacco companies, through their paid consultants or grantees.

There is no way this panel can objectively consider tobacco product regulation and policy - based purely on the science - in the midst of such a potpourri of pharmaceutical financial interests and conflicts of interest.

The conflicts of interest of two of the panel members were highlighted in an article in today's Wall Street Journal.

Given that the FDA has already been under siege for complaints about the undue influence of politics over science, due to the influence of industry, it is unclear why the Agency would want to compound the problem by crafting a highly conflicted panel to advise it on tobacco issues. There is enough bias in this field to begin with; we don't need to add to it by appointing a panel with numerous members who have severe, personal financial conflicts of interest.

The rest of the story is that by virtue of its appointment of numerous members with financial conflicts of interest with Big Pharma, the FDA Tobacco Products Scientific Advisory Committee has now become a literal extension of pharmaceutical company financial interests. These companies have been given the gift of a seat at the table (actually, four seats).

This means that 7 of the 12 seats on the panel are now industry seats:

Big Tobacco: 3
Big Pharma: 4
Total Industry Seats: 7

The tobacco and pharmaceutical industries must be laughing all the way to the bank. There's nothing like sitting on the panel of the Agency that regulates your products or makes decisions about the regulation of the products of your chief competitors.

Wednesday, June 2, 2010

GlaxoSmithKline Given a Seat on FDA Tobacco Products Scientific Advisory Committee - Michael Siegel

While it seems bad enough that the tobacco industry is given three seats on a supposed "scientific" advisory committee to guide the FDA in its implementation of the regulation of tobacco products, the FDA made the situation worse by providing a major pharmaceutical company with a vested, multi-million dollar interest in smoking cessation products a seat at the table as well.

The FDA appointed a GlaxoSmithKline consultant - Dr. Jack Henningfield of Pinney Associates - to the Tobacco Products Scientific Advisory Committee.

Pinney Associates is a pharmaceutical consulting firm that provides consulting support to GlaxoSmithKline on an exclusive basis regarding tobacco dependence treatment. GlaxoSmithKline is the manufacturer of Zyban and NiQuitin.

In addition to his serving as an exclusive consultant to GlaxoSmithKline specifically on the issue of tobacco dependence treatment, Dr. Henningfield also has a personal financial interest in smoking cessation treatment, as he has a financial interest in a potential new oral nicotine replacement therapy product.

To make matters even worse, Dr. Henningfield has testified in court as an expert witness on behalf of GlaxoSmithKline.

The Rest of the Story

The rest of the story is that Big Pharma now joins Big Tobacco with a seat at the table on the supposedly objective and scientific FDA advisory committee that will guide the Agency in its decisions about the regulation of tobacco products. These regulations will have a major impact on the future profitability of smoking cessation medications. The last individual in the world who you would want to serve on such a panel would be a Big Pharma consultant, especially one who consults specifically in the area of smoking cessation medications. The fact that this individual also has a personal financial interest in such medication and who also has testified in court on behalf of Big Pharma simply adds insult to the public's injury.

That GlaxoSmithKline joins the tobacco companies in having a seat at a supposedly "scientific advisory" table undermines the entire point of the panel and turns the whole thing into a joke, rather than a serious scientific and policy undertaking for the benefit of the public's health.

These type of panels should consist of individual scientists who are impartial and do not have personal financial conflicts of interest with industry, especially if that industry is to be directly regulated by the FDA and if the use and profitability of its products will be directly affected by the national policy decisions that the Agency makes.

For example, one issue that the FDA is going to have to deal with immediately is the regulation of electronic cigarettes. As these products are a tremendous threat to GlaxoSmithKline profits (not to mention Big Tobacco profits), there is no way that the Scientific Advisory Committee can have an objective discussion about this issue.

Unfortunately, the FDA has chosen to invite Big Pharma to the table.

So much for an objective scientific panel. Industry's influence on the FDA just became even bigger, and in a major way.