Thursday, May 08, 2008

NIH Expert Panel Recommends Smoking Cessation Pharmaceuticals for Every Smoking Patient; Panel Chair and 8 Members Have Financial Ties to Big Pharma

An NIH expert panel this week released a 2008 update of the clinical practice guideline regarding the treatment of tobacco use and dependence (see: Fiore MC, JaƩn CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008).

The guideline recommends that every patient who wishes to quit be treated with pharmaceuticals, unless medically contraindicated. The guideline also recommends the use of Chantix, despite concerns about its potential suicide risk, a risk that is currently being investigated by the FDA. Among the pharmaceuticals recommended by the panel are:
  • buproprion;
  • nicotine gum;
  • nicotine patch;
  • nicotine nasal spray;
  • nicotine lozenge;
  • nicotine inhaler;
  • Chantix; and
  • combinations of the above.
The Rest of the Story

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore: "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.

As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.

According to the article: "Lois Biener, a researcher of tobacco use and control efforts at the University of Massachusetts in Boston, said most people who quit do so without smoking-cessation drugs. There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's 'way less than what is claimed' by medication advocates, Biener said."

One national expert on smoking cessation who was not on the panel - John Polito - suggested in the article that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.

According to the article: "Fiore's views are shaped by his past ties to the drug industry, and those ties still pose a conflict, at least one consumer advocate said. John Polito, a smoking cessation educator who runs the site advocating quitting 'cold turkey,' called the revised guidelines 'a sales pitch' for the drug industry. The task force overlooked research showing that quitting cold turkey works, Polito said, and studies showing Chantix is superior don't reflect how it's used 'in the real world.' 'People are quitting smoking to save their lives,' Polito said. If Chantix's risks outweigh its benefits, 'then it's insane for people to risk their lives' by using it, he said."

Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.

What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.

The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.

It may come as a surprise to many in tobacco control, but this type of science is just as bad. Bad science is bad science. Conflicts of interest are conflicts of interest. Believe me, the science doesn't get any stronger just because it is a less detestable industry. As a field which has literally helped to ruin the careers of scientists with tobacco industry connections, we should be beyond reproach in not allowing similar conflicts of interest to degrade and poison our science.

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