According to an article in yesterday's Wall Street Journal, the pharmaceutical company GlaxoSmithKline urged the FDA to remove dissolvable tobacco products from the market.
According to the article: "GlaxoSmithKline PLC called for the U.S. government to remove so-called dissolvable smokeless-tobacco products from the market, a move that shows emerging battle lines between pharmaceutical and tobacco companies aiming to sell alternatives to cigarettes. GlaxoSmithKline, which markets quit-smoking aids such as Nicorette gum, said Monday that it urged the Food and Drug Administration to take oral dissolvable tobacco products from store shelves until companies that make such products, including tobacco giant Reynolds American Inc., 'can demonstrate to the FDA that their marketing is appropriate for the protection of public health.'"
The Rest of the Story
This story demonstrates that Big Pharma views alternative tobacco products - such as dissolvable smokeless tobacco - as a threat to its profits because such products may be used as an alternative to nicotine replacement therapy among smokers who want to quit or cut down on their smoking and reduce their health risks.
But a more important implication of the story, and one which is not generally being reported elsewhere, is that it demonstrates why it is inexcusable to have individuals on the Tobacco Products Scientific Advisory Committee (TPSAC) who have financial conflicts of interest with Big Pharma.
The next major issue that TPSAC will consider (after menthol), in fact, is dissolvable tobacco products. Now that GlaxoSmithKline has come out in strong opposition to these products and directly petitioned the FDA to remove these products from the market, it is not possible for any TPSAC member who has a financial conflict of interest with Glaxo (or similar companies that manufacture smoking cessation products) to impartially participate in discussions on this matter.
Due to the FDA's ignoring financial conflicts of interest in appointing the TPSAC panel, however, it turns out that Glaxo essentially has a seat on the panel.
A GlaxoSmithKline consultant - Dr. Jack Henningfield of Pinney Associates - was appointed 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.
To make matters worse still, 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.
And to make matters even more unacceptable, a third member of the panel - Dr. Neal Benowitz - has consulted for GlaxoSmithKline.
Dr. Benowitz also co-authored a study on the use of Chantix in smoking cessation which was funded by Pfizer and has 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. In addition to consulting for Glaxo, Benowitz has also consulted for Nabi Pharmaceuticals.
To make matters downright ugly, a fourth member of the panel - Dr. Dorothy Hatsukami - has received grant support from a pharmaceutical company to study the nicotine vaccine for use in smoking cessation.
Given GlaxoSmithKline's direct request to the FDA and given these four panel members' significant conflicts of interest with Big Pharma, I call on these panel members to withdraw from the Tobacco Products Scientific Advisory Committee.
Short of that, I call on the FDA to remove these members from the Committee and to replace them with unconflicted scientists who can make unbiased decisions about federal regulatory policy.
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