Federal Judge to FDA: Tobacco Advisory Panel Tainted by Conflicts of Interest

“The presence of conflicted members on [FDA Tobacco Products Scientific Advisory Committee, TPSAC] irrevocably tainted its very composition and its work product” and “the Committee’s findings and recommendations…are, at a minimum, suspect, and, at worst, untrustworthy.”  So ruled federal judge Richard Leon this week (here).

A lawsuit by Lorillard et al. claimed that the FDA appointment of TPSAC members Neal Benowitz, Jack Henningfield and Jonathan Samet was “arbitrary, capricious, an abuse of discretion, and otherwise not in compliance with the law” because they had conflicts of interest.  The evidence was abundant and uncontested.  Here are excerpts from the judge’s opinion:

“Since the 1980s, Dr. Benowitz has consulted for numerous pharmaceutical companies about the design of the NRT and other smoking-cessation drugs.  He consulted for affiliates of Pfizer, Inc. and GlaxoSmithKline (GSK) as to such products, even while serving on the TPSAC…Dr. Benowitz has also served as a paid witness for lawyers suing tobacco-product manufacturers.  He testified as a paid expert witness while serving on the TPSAC, and…he was designated to testify in 585 pending tobacco cases.”

“Before and while serving on the TPSAC, Dr. Henningfield consulted for GSK and other drug companies as to NRT and other smoking-cessation drugs.  He also had ownership interest in a company that was developing a patented NRT drug.  Dr. Henningfield has testified as an expert for GSK and for lawyers suing tobacco-product manufacturers… he was designated to testify in 350 pending tobacco cases.”

“Dr. Samet received grant support from GSK at least six times, including in 2010.  He also led the Institute for Global Tobacco Control, funded by GSK and Pfizer.  Dr. Samet also testified for lawyers suing tobacco-product manufacturers…he was designated to testify in two pending tobacco cases.”

Judge Leon’s ruling notes that the composition of TPSAC is different from other FDA advisory committees, because the enabling legislation bans any expert “who received ‘any salary, grants, or other payment or support’ from any tobacco company in the 18-month period prior to serving on the TPSAC.”  

TPSAC was structured to exclude qualified authorities who have had industry support.  Experts with industry support are not precluded from serving on other FDA advisory committees, in which scientific issues are more important than industry demonization.   

Judge Leon noted that the provision should apply evenly to any conflict of interest: “If Congress deemed that past remuneration from tobacco companies constituted a conflict of interest, it stands to reason that past remuneration from direct competitors of those companies, such as manufacturers of smoking-cessation drugs, would also constitute a conflict of interest.”

Judge Leon’s ruling bars the FDA from using a 2011 TPSAC report on menthol, and it also “enjoins the FDA to reconstitute TPSAC’s membership so that it complies with the applicable ethics laws.”  Dr. Samet is the only conflicted member remaining on TPSAC, as chair (until 2016).  Another member, Claudia Barone, may have a conflict, because she received a Pfizer Educational Grant through 2013 and was appointed to the TPSAC on April 1, 2014 (here).

Although the ruling applies specifically to committee actions on menthol cigarettes and dissolvable products, it is relevant to all TPSAC activities until conflicted members are removed.

It is common for experts to be co-opted by financial support from organizations committed to a tobacco free society, a euphemism for the obliteration of the tobacco industry (an objective that is at odds with the principle of regulation).  Any individual who is funded by organizations such as the American Cancer Society, the American Heart Association, the American Lung Association, the National Cancer Institute, the Centers for Disease Control and Prevention, or the Robert Wood Johnson Foundation should be ineligible for membership on TPSAC.

(Updated July 23)

Kudos to the FDA: E-Cigarettes Are Tobacco Products

On April 25, the FDA abandoned its claim that e-cigarettes are drug delivery devices. In an open letter published on the agency’s website (here), Tobacco Center Director Lawrence Deyton and Drug Center Director Janet Woodcock acknowledged that e-cigarettes are tobacco products and would be subject to regulations under the 2009 Tobacco Act. This is consistent with the January 2010 decision by federal judge Richard Leon (discussed here).

This is a victory on several counts for smokers and for our nation’s public health. First, the FDA decision guarantees that e-cigarettes, which have helped many smokers quit, will remain on the market.

Second, as the Deyton-Woodcock letter indicates, FDA regulation of e-cigarettes will subject them “to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for ‘new tobacco products’ and ‘modified risk tobacco products.’” These requirements will promote the marketing of safe and quality-controlled products.

Finally, this decision could allow pharmaceutical companies to reposition nicotine medicines as recreational alternatives to cigarettes. Today, these products are sold with a therapeutic claim for smoking cessation, but they are expensive, unsatisfying and FDA-approved only for temporary use (10-12 weeks). That accounts for their dismal success rate of only seven percent among smokers (evidence here). I believe pharmaceutical companies should enter the recreational nicotine market with products that satisfy smokers indefinitely and are cheap enough to compete directly with cigarettes. Clearly, the tobacco industry is poised to compete in this new market -- Reynolds American owns Niconovum (here) and British American Tobacco recently formed Nicoventures (here).

In my 1995 book “For Smokers Only” (description here), I shared my perspective on recreational nicotine for smokers:

“Smokers derive a lot of pleasure from smoking tobacco. You may be reading this book because you or your loved one actually enjoys lighting up a cigarette and taking several deep puffs. A smoke may be especially welcome when you are in a stressful situation or when you need to relax. Or you may enjoy smoking when you need to concentrate on a difficult problem at work or at home. Cigarette smoking can activate that mental pressure-relief valve, which is followed by the feeling that the problem can be solved, the crisis will pass. These feelings are real, and not just a figment of your imagination.

“Many tobacco opponents claim that these sensations are not truly pleasurable, but are merely the satisfying of induced cravings and avoidance of withdrawal symptoms. One of the big advantages of the smokeless tobacco solution is that it addresses either view of smoking equally well. That is, it doesn't matter if you are a smoker who is unwilling to quit because you enjoy tobacco, or if you are unable to quit because of nicotine craving and withdrawal. Because in either case you recognize the potential life-shortening effects of this nicotine delivery system. In either case the smokeless tobacco solution can work for you.”

Smoking has been the problem; smoke-free tobacco and nicotine can be the solution. In making the right call on e-cigarettes, the FDA has facilitated that solution.

Federal Appeals Court to FDA: E-Cigarettes Are Tobacco Products, Not Medicines

One month ago a federal appeals court affirmed Judge Richard Leon’s decision requiring the FDA to regulate e-cigarettes as tobacco products, rather than as drug-delivery devices, as the agency had attempted to do. This week the appellate court rejected the FDA’s request to review the decision, so the only remaining option for the agency is to appeal to the Supreme Court (here).

The FDA had decided that e-cigarettes were being sold without sufficient evidence of safety and efficacy – the expensive and time-consuming regulatory challenge that all drug manufacturers must address. The agency had begun seizing shipments, triggering the suit.

As I noted one year ago (here), Judge Leon found that the 2009 “Tobacco Act applies to ‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.”

The reaction from nicotine prohibitionists has been predictable. Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the decision “wrong on the law, wrong on the facts…” and he urged “the government to appeal this ruling.”

Why is Mr. Myers so upset? According to the New York Times, he was a primary author of the Tobacco Act (link here). The legislation placed “any product made or derived from tobacco that is intended for human consumption” under FDA control.

It is wonderful irony that the courts have interpreted Myers’ legislation to free a potentially broad array of recreational nicotine products from drug regulation. It is also a dramatic, positive development for tobacco harm reduction, public health and millions of inveterate smokers, effectively accomplishing what I first advocated in 1995 – deregulation of nicotine. (link here)

This week I was interviewed about the e-cigarette issue by www.AllTreatment.com, which focuses on ways of making treatment and recovery more accessible to anyone struggling with addiction. That interview is available here.

Physicians Who Genuinely Care About Public Health

The American Association of Public Health Physicians, the national voice of directors of state and local health departments and of other public health physicians, has filed two citizens’ petitions with the FDA regarding regulation of e-cigarettes. Both are available for review and comment at the federal Regulations.gov website.

The first petition urges the FDA to classify and regulate e-cigarettes as tobacco products, rather than drug delivery devices. It presents several justifications for this position, including:

Legal - AAPHP agrees with federal Judge Richard Leon, who recently found that “Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.” Unfortunately, Judge Leon’s decision was challenged by the FDA and is currently under review by a federal appeals court.

Ethical - The AAPHP observes that “[t]he new FDA/Tobacco law…forces FDA to grandfather-in currently marketed conventional cigarettes – the most hazardous of tobacco products, while placing formidable barriers to lower risk products,” which conflicts “with the ethical responsibility of FDA to protect the health of the American public and FDA commitment to base their decisions on the best available scientific data.”

Medical Science and Epidemiology - The AAPHP observes that “[t]he risk of death attributable to tobacco use from smokeless tobacco products is less than 5%, and, for some products, less than 0.1 % the risk of death from conventional cigarettes. The risk of death from E-cigarettes, as best we can estimate from available data, should be about the same as for long term use of pharmaceutical nicotine replacement therapy products.”

The second petition urges the FDA to correct inaccurate and misleading claims about electronic cigarettes made at its July 22, 2009, press conference, and to truthfully inform the public about these products.

I was also critical of the agency’s press conference, noting in a blog post that “the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.”

The AAPHP petitions urge FDA actions that would enormously benefit public health, but I am not confident that the agency will pay any attention. Over two years ago, New York State Health Commissioner Richard Daines filed a petition requesting minor revisions in package labeling and the sale of pharmaceutical nicotine that would greatly expand consumer awareness and availability. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA never responded.

FDA: E-cigarettes Are Harmful

In a dramatic turn of events, the FDA convinced a federal appeals court to temporarily suspend federal judge Richard J. Leon’s ruling that the agency must regulate e-cigarettes as tobacco products rather than drug-delivery devices. The lower court ruling was discussed in a previous post, here.

If e-cigarettes are regulated as drug-delivery devices, the FDA would effectively ban them until manufacturers conduct clinical trials costing millions of dollars, delaying availability for 5 to 10 years. If the FDA prevails, all those e-cigarette users who are former smokers will have to quit nicotine, smoke regular cigarettes, or buy e-cigarette replacement units and cartridges on a black market that is sure to arise.

According to the media, Judge Leon based his decision on a 2000 case (FDA v. Brown & Williamson) in which the Supreme Court ruled that cigarettes and smokeless tobacco products could not be regulated as drugs or devices. But that is only part of the story. Judge Leon demonstrated that e-cigarettes are appropriately regulated under the 2009 Tobacco Act, which was written by tobacco prohibitionists. Leon ruled that they are “‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use.”

The news report quoted the FDA as saying that Judge Leon was “quite wrong to believe that no injury would result from the use of these harmful and addictive products.” This statement is wholly unfounded. Tobacco harm reduction experts have been monitoring use of e-cigarettes -- there have been no reports of adverse health effects. This is in stark contrast to a mountain of evidence that cigarette smoking is associated with diseases killing 400,000 Americans every year.

FDA officials apparently believe that banning e-cigarettes is much more important than saving the lives of American smokers. The federal appeals court should put a stop to this travesty by affirming Judge Leon’s decision.

Federal Judge to FDA: E-Cigarettes Are Tobacco Products, Not Drugs or Devices

On January 14, federal judge Richard J. Leon ruled that the FDA does not have the authority to regulate e-cigarettes as drug-delivery devices. (The 32-page opinion, available here is required reading for anyone interested in American tobacco policy). In addition to being a victory for e-cigarette manufacturers, this decision has enormous positive implications for tobacco harm reduction and for American smokers.

In 2008 and 2009, the FDA detained e-cigarette shipments being imported by two American distributors, Smoking Everywhere and NJoy, on the grounds that the items were unapproved drug-delivery devices. Judge Leon ordered that “the FDA shall not detain or refuse admission into the United States of [Smoking Everywhere's and NJoy’s] electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations.”

The judge found that the 2009 “Tobacco Act applies to ‘tobacco products,’ which Congress defined expansively as ‘any product made or derived from tobacco that is intended for human consumption’…Congress enacted the Tobacco Act to confer FDA
jurisdiction over any tobacco product – whether traditional or not – that is sold for
customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.”

Finding that e-cigarettes, like all tobacco products, are subject to FDA oversight but fall outside of both drug and device categorization, Judge Leon characterized the FDA’s attempt to apply pharmaceutical standards to e-cigarettes as “bootstrapping run amuck.”

Judge Leon’s decision was not popular with tobacco prohibitionists. Matt Myers, president of the Campaign for Tobacco-Free Kids, seethed: “"Nicotine in products currently regulated as drugs and devices is derived from tobacco products, but that doesn't make them tobacco products.” The federal court, thankfully, found otherwise.

According to the New York Times, Myers was a primary author of the Tobacco Act. His goal was to cast the regulatory net widely and subject all tobacco-related products to FDA control. It is therefore ironic that the court has interpreted his legislation to free a potentially broad array of recreational nicotine products from the most stringent categories of regulation.

Judge Leon’s opinion may open up other commercial opportunities for recreational nicotine. Currently, pharmaceutical companies market nicotine gum, patch and lozenges as temporary “medications” for smokers who are attempting to achieve nicotine abstinence, the holy grail of tobacco prohibition. This has been an utter disaster, since the products are successful for only about 7% of smokers who try them, as I explained in a previous post. In addition, the FDA has refused to respond to a petition by New York State Commissioner of Health Richard Daines to revise package labeling and sale of nicotine that would greatly expand consumer awareness and availability.

But Judge Leon’s decision removes nicotine from FDA jurisdiction as a medicine as long as no therapeutic claims are made. If this ruling stands, it will allow pharmaceutical companies to reposition nicotine gum, patches and lozenges as recreational devices with higher doses that satisfy smokers, and sell them at prices competitive with cigarettes. This would liberate nicotine from the onerous and unnecessary restrictions and warnings currently mandated by the FDA.

This would be a revolutionary development for tobacco harm reduction. It would in effect accomplish what I first advocated in 1995 – deregulation of nicotine.