Commentary - the FDA CTR Scientific Advisory Committee..

Center for Tobacco Products

June 27, 2010 - At Altria's 2010 Annual Meeting of Shareholders on May 20, 2010 one of the company's critics scolded Michael E. Szymanczyk, Chairman of the Board, President, and CEO for seeking the removal of four of the 12 members of a scientific Food and Drug Administration (FDA) Center for Tobacco Products (CTR) scientific advisory board. (
Altria Adds a Dime Increases wholesale prices on smokeless brands 10 cents , Convenience Store/Petroleum (CSP) Daily, 5/24/2010) The CTR has an unique role for the FDA -- regulating a product that, when used as intended, causes disease and death for more than 400,000 of its consumers in the U.S. each year. (The Tobacco Products Scientific Advisory Committee was formed to review and evaluate “safety, dependence and health issues” concerning tobacco products.)

Altria's president had every right to criticize the members selected to serve on this committee. Afterall, we know that the legislation to regulate tobacco signed by President Obama the Family Smoking Prevention and Tobacco Control Act represents the results of negotiations between the tobacco control group Campaign for Tobacco-Free Kids and Philip Morris (PMUSA) - is a subsidiary of the Altria Group. In fact, U.S. Senator Michael B. Enzi (R-WY) points out, "Poison peddlers shouldn’t get to decide how we as responsible legislators fight the war against their deadly products."

For members of the FDA scientific advisory committee, the FDA indicated they wanted to recruit qualified experts with minimal conflicts of interest. PMUSA and U.S. Smokeless Tobacco Co., another unit of Altria, requested that the agency remove as panelists Neal Benowitz, Gregory Connolly, Jack Henningfield and Jonathan Samet.

In its request to the FDA, Altria argued that the four panel members had conflicts of interest, including having served as paid experts for plaintiffs in lawsuits against tobacco companies. The FDA denied the company's request to remove them from the board, said the report.

On June 7th an ethics watchdog group, Citizens for Responsibility and Ethics, filed a challenge against two members of a new scientific advisory committee, saying they should be disqualified because they are consultants for drug companies that make smoking cessation products. Drs. Neal Benowitz and Jack Henningfield are experts who consult for drug companies that make stop-smoking products. “Everybody hates the tobacco companies, but favoring the drug companies can’t be the answer,” Melanie Sloan, executive director of this watchdog group. She said the two panelists’ ties to smoking cessation businesses would undermine public confidence in regulation of the tobacco industry.

These same committee members were two of the four challenged by PMUSA. The FDA rejected Altria’s complaint, saying it had selected qualified members and would manage any potential conflicts case by case as it did on other federal advisory committees. Meghan Scott, an FDA spokeswoman said, “Tobacco cessation drugs are not regulated by the Center for Tobacco Products.” This happened to be the same reasoning offered by that Dr. Benowitz.

Dr. Benowitz said he doesn’t “see a direct conflict of interest” because the board deals with tobacco products, not drugs that are aimed at helping people quit smoking. “Now, if this group gains jurisdiction over drugs as well, I think that would be something different,” he said. Mr. Benowitz said he still consults Pfizer, but not GlaxoSmithKline.

But there is a major conflict brewing between between drug companies smoking cessation products and harm reduction tobacco products the tobacco companies are development - they will be competing for the same limited market. As pointed out by Washington Examiner columnist Timothy Carney noted several of the experts appointed to the committee have financial ties to pharmaceutical companies that manufacture nicotine replacement products, which compete not only with cigarettes but with various safer alternatives that the FDA is deciding how to regulate. (Big Pharma rumbles with Big Tobacco by Timothy P. Carney, Washington Examiner, 5/14/2010)

The pharmaceutical companies have a lot riding on the FDA's decisions about whether to tolerate and how to regulate alternatives to their nicotine gum, lozenges, patches, and inhalers. The aim of tobacco companies is to reduce the adverse health consequences of tobacco use, and make a profit doing so. How is that fundamentally different from what Novartis or GlaxoSmithKline, Pfizer does?

Who do you think is behind this request.. Two smoking-cessation groups are urging the FDA to relax restrictions on nicotine patches, lozenges and gums amid concerns the agency's regulations go too far and make it harder for people to quit smoking. The groups say nicotine-replacement therapies such as GSK's Nicoderm CQ and Nicorette gum should be available everywhere cigarettes are sold, so people who want to quit can find the products easily without having to go to a pharmacy. They also want the FDA to tone down warnings on the products that say they shouldn't be used when people continue to smoke or in those who have heart conditions. (Groups Urge FDA To Relax Restrictions On Nicotine Patches, 2/11/2010)

A Statement From GlaxoSmithKline Consumer Healthcare on the Petition to FDA to Help People Quit Smoking

We were shocked to learn, Dr. Benowitz, in an interview in 2004 with Los Angeles Times reporter Valerie Reitman, stated, "If someone can’t quit smoking, there is no question that smokeless is much safer. It doesn’t cause heart or lung disease, and if it does cause cancer, it does slow at a much lower rate." (Is smokeless safer? Tobacco products that give hard-core smokers an alternative to quitting fuel debate;, Valerie Reitman Times Staff Writer, Los Angeles Times, 6/14/2004)

Most likely the FDA had a hard time trying to find a person qualified to serve on the committee that did not have ties to the pharmaceutical industry.

Does anyone really think that use of these smoking cessation drugs doubles the chance of the smoker totally quitting? (United Kingdom's NHS spending more to stop smoking less people quitting..)

We know that some of the advisory committee members (Drs. Samet, Benowitz, Hatsukami) have worked for Pfizer, the maker of the smoking cessation drug, Chantix (Champix) which has topped the FDA’s list of most dangerous drugs. In 2009 in the the U.S. use of this drug included 98 reports of suicide, and 188 attempted suicides and many other untoward reactions. Champix (Chantix) - the risks are greater then the benefits..)

If any member of the scientific advisory committee was involved with the safety studies needed for the FDA approval of Chantix then they should be removed. (FDA, Pfizer Told of Chantix Safety Concerns a Year Ago by DAN CHILDS, ABC News Medical Unit, 6/12/2008)



June 27, 2010 at 9:14 PM