Tuesday, July 22, 2014

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)


Brad Rodu said...

Comment from a reader:

EXCELLENT!!! now if only someone would do something about RWJF's illegal funding of lobbying alphabet "non profit charities" for profit....
The Robert Wood Johnson Foundation, owner of Johnson and Johnson, maker of repeatedly proven ineffective nicotine replacement products has been illegally lobbying for smoke free air laws around the planet and no one will stop them.
"In 1991 the Robert Wood Johnson Foundation (RWJF) began to tackle one of the most intractable problems in the field of public health—tobacco addiction. Over the next two decades, it invested significant funds and talent and joined forces with advocates and researchers, promoting coalitions and facilitating the work of collaborators. The work focused on policy and systems changes, such as higher tobacco excise taxes, smoke-free indoor air laws, access to cessation treatments and the federal regulation of tobacco."
It is illegal for RWJF to lobby or fund lobbying for smoke free air laws. I note on their 990 reports they check the box that says they do no lobbying. That, in itself, is a flat out lie on their federal report.
The over $700,000,000 that RWJF invested in "tobacco control" started at about the same time that J&J started selling the patches and gums.
RWJF created the Champagne Tower of Tobacco Control when it started grant funding illegal lobbying by other "non profits", including the ACS and ALA, and the non profits they themselves created for the purpose of getting smoking bans passed, including the Campaign For Tobacco Free Kids and the Smokeless States program. The former executive director of the CTFK is now deputy secretary of HHS William Corr. RWJF is laughing all the way to the bank.
The groups funded by RWJF are actively lobbying municipalities right NOW. Repeated phone calls, email and letters to the IRS, prosecutors and etc as well as many politicians at all levels of government go unanswered and nothing is done. The same applies to Canada where we are just shut out and ignored.

Hillary said...

Judge Leon to the rescue again! He's the judge who, back in 2010 ruled in favor of ecig companies when the FDA seized their shipments.

FXR said...

The Judge unfortunately was unable to rule on the activities of the funding agencies, responsible for this predicament. The primary and almost exclusive focus of these promoters, resides in the social stigmatization of those they claim to be "protecting" Taxation, cigarette porn and smoking bans, all exist in the realm of harms inflicted, to solidify an agenda. The trickle down of judgements and peer review research in support of negative stereotype building activities, has no doubt had a profound effect in judgments deeming smoking "more addictive than the most powerful street drugs", moving medicine from an encouraging position with "you can do it" to the more conflicted position that provides the newer "you can't do it alone". Job discrimination, cat calls being taught to children and housing restrictions, complete with legal advice and forms to file all provided to nget rid of your neighbors. Again in aid of those who according to the gospel were "duped by tobacco companies", experiencing a punishing effect as a prescription, of protecting the perpetrators and adding more layers of harms and violence against the victims.

Judgmental medicine [call it; tough love, preventative, or what ever sound bite you wish to attach] is a crime. It should be treated as such and convicted to the full extent of the law.

The Judge did start what should be a long process; back to inclusive communities by de-legitimatizing conflicted big Pharma funding. Suggesting Doctors will have to decide, ethically between pursuing medicine, or oppressive and hateful politics. With one negating a standing, in the pursuit of the other.