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Dr. Michael Siegel Exposes "Experts" on Big Tobacco & Big Pharm Payroll

Posted on 14th Apr 2009 @ 10:25 PM

 

Initial National Expert Panel on Smoking Cessation Also Had Severe Conflicts of Interest with Big Pharma; Repeating the Mistake: Inexcusable


I have heavily criticized the most recent national expert panel on smoking cessation for issuing guidelines for the clinical treatment of nicotine dependence by physicians despite the existence of severe conflicts of interest among the chair of the panel and eight of the panel members. Any panel, however, can make a mistake and a first-time mistake may be excusable.

Today, I reveal that this was not a first-time mistake. In fact, I expose the presence of conflicts of interest among themajority of members of the first expert panel, which issued the initial clinical practice guideline for treating tobacco use and dependence in 2000.

I argue that while one might excuse the initial mistake in 2000, to have the panel repeat this mistake in 2008 is inexcusable and can really be viewed as an intentional decision to allow conflicts of interest to bias its recommendations.

The Rest of the Story


Treating Tobacco Use and Dependence is a Clinical Practice Guideline sponsored by the United States Public Health Service. The most recent update was published in 2008, but an earlier version was published in June 2000.

The original expert panel (for the 2000 version of the guideline) was chaired by Dr. Michael Fiore and consisted of a total of 18 members. The panel concluded that: "Numerous effective pharmacotherapies for smoking cessation now exist. Except in the presence of contraindications, these should be used with all patients attempting to quit smoking." In other words, the panel recommended to physicians throughout the nation that cold turkey smoking cessation should never be used (unless pharmaceuticals are specifically contraindicated).

Like the conclusion in the 2008 update, this recommendation goes against the evidence base, which documents that nicotine replacement therapy is dismal for the treatment of nicotine dependence and that long-term abstinence rates are extremely low. The research also shows that unplanned quit attempts are more successful than planned attempts, and that cold turkey quitting remains the most successful means of smoking cessation in the population.

Not surprisingly, the 2000 expert panel contained a chair and members with severe financial conflicts of interest by virtue of their financial relationships with Big Pharma. What is perhaps surprising is the magnitude of the conflicts. A total of 11 of the 18 panelists - the clear majority - had financial conflicts of interest with pharmaceutical companies.

Here is the listing of the panelists with conflicts of interest:

"Michael C. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil, Elan Pharmaceutical, and Glaxo Wellcome.

William C. Bailey has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome, SmithKline Beecham, Schering-Plough, 3M Pharmaceuticals, Pfizer, and Sepracor.

Sally Faith Dorfman has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by various pharmaceutical companies.

Michael G. Goldstein, in addition to being an employee of the Bayer Corporation, has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome, McNeil, Ciba-Geigy, SmithKline Beecham, Boehringer Ingelheim, Sano Corporation, Dupont Pharmaceuticals, and Eli Lilly.

Ellen R. Gritz has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Bristol Myers Squibb, SmithKline Beecham, and Glaxo Wellcome.

Carlos Roberto Jaén has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome Pharmaceuticals.

Thomas E. Kottke has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by McNeil Consumer Healthcare.

Harry A. Lando has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Glaxo Wellcome and SmithKline Beecham.

Robert Mecklenburg has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by SmithKline Beecham and Glaxo Wellcome.

Maxine L. Stitzer has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by McNeil and SmithKline Beecham.

Louise Villejo has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ortho Biotech."

To make matters even worse, 3 of the 5 consultants to the panel also had financial conflicts of interest with pharmaceutical companies:

"Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle.

Victor Hasselblad has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by CorTheraputics, Skinceuticals, Merck, Novartis, AstraZeneca, AstraCharnwood, The Medicines, Pfizer, Daiichi, Hoffman-LaRoche, RhonePolenc Rorer, Alexion, SmithKline Beecham, Dade, Quad-C, and Centocor Lilly.

David L. Schriger has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Pfizer Corporation and the MedAmerica Corporation."

In other words, the panel and consultant list looks like a virtual directory of pharmaceutical company consultants.

It was ridiculous and irresponsible to have a panel of pharmaceutical company consultants put together national recommendations for the treatment of tobacco use.

However, if nothing else, this mistake should have taught a lesson to the panel and its members. It should have taught them that this type of prostitution of objective science to financial interests is wrong and should not be repeated.

What happened?

When the panel re-convened in 2008, its chair and eight other members had severe financial conflicts of interest with pharmaceutical companies.

While one might excuse the initial mistake in 2000, to have the panel repeat this mistake in 2008 is inexcusable and can really be viewed as an intentional decision to allow conflicts of interest to bias its recommendations.

This increasing practice in tobacco control of prostitution of objective science to financial interests must come to an end.


(Note: For an extensive discussion of these issues, see John Polito's Why Quit site.)
See Article Here...

New Study Demonstrates How Conflicts of Interest with Big Pharma Influence Reporting of the Effectiveness of Smoking Cessation Drug Treatment


A new study published online ahead of print in BMJ reviews the evidence on the effectiveness of nicotine replacement therapy (NRT) in smoking cessation and concludes that: "Available trials indicate that nicotine replacement therapy is an effective intervention in achieving sustained smoking abstinence for smokers who have no intention or are unable to attempt an abrupt quit." (Moore D, Aveyard P, Connock M, Wang D, Fry-Smith A, Barton P. Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis. BMJ2009;338:b1024 doi:10.1136/bmj.b1024).

The article is based on a review and meta-analysis or nicotine replacement therapy treatment of smokers who were unable or unwilling to stop smoking abruptly. The outcome was continuous abstinence from smoking which was generally measured at six month and twelve month follow-up. A secondary outcome was sustained smoking reduction, which was defined as reducing cigarette consumption by more than 50%.

The results were as follows:

The proportion of smokers achieving sustained abstinence at six months with nicotine replacement therapy was 6.75%, compared to 3.28% for placebo, yielding a significant relative risk of 2.06.

The proportion of smokers achieving sustained abstinence at final follow-up (generally one year) was 1.6% for the nicotine replacement therapy group, compared to 0.4% for the placebo group.

The proportion of smokers achieving sustained reduction at six months was 21.8% in the intervention group compared to 16.5% in the placebo group.

The proportion of smokers achieving sustained reduction at final follow-up was 6.3% for the NRT group and 1.6% for the placebo group.

The Rest of the Story

As you can from the actual study results, the conclusions of this paper are highly slanted. With a long-term smoking cessation percentage of only 1.6%, one can hardly call NRT treatment an "effective" intervention. Even though the 1.6% abstinence rate is better than the 0.4% achieved with placebo, no one in their right mind would consider a 1.6% success rate with NRT to be "effective."

In fact, the logical conclusion from this paper is that NRT was a dismal intervention. The overwhelming majority of smokers - 98.4% - failed to achieve long-term sustained abstinence with NRT treatment.

The slanting of the paper's conclusions is also evident with the smoking reduction findings. While getting 6.3% of smokers to reduce their cigarette consumption is a dismal result indicating that NRT is quite ineffective for this purpose, the study authors use the fact that 6.3% is greater than 1.6% to argue that the intervention is effective. That's quite a job of "spinning" the results.

When I read this paper and saw how slanted the study conclusions are in light of the actual data presented, my first thought was: I wonder what the chances are that one of the study authors has a financial conflict of interest with Big Pharma?

Lo and behold, the rest of the story is that study author Paul Aveyard acknowledges that he has been paid by McNeil, a pharmaceutical company located in Sweden that is associated with the Johnson & Johnson family of companies. According to the paper, Aveyard "has accepted hospitality and money from McNeil (Helsinborg, Sweden), which sponsored the trials in the report."

Among other things, McNeil is the manufacturer of Nicorette tablets, Nicorette nasal spray, Nicorette gum, Nicorette inhalator cartridges, and Nicotrol.

Clearly, McNeil has a huge stake in the nicotine replacement therapy market and so there is the appearance that the financial conflict of interest of one of the study authors by virtue of his funding by McNeil affected the slanted way in which the results of this article were reported.