Wednesday, January 24, 2007

NIH Cancels Meeting Because of Researchers' Conflicts of Interest; Same Policy Should Apply to Smoking Cessation Panels

According to an article in Friday's Wall Street Journal, the National Institutes of Health has canceled a meeting of a panel of experts to discuss approaches to treating pregnant women and babies with herpes infection and to draft guidelines because of concerns of financial conflicts of interest among several of the panel members (see Armstrong D. NIH cancels meeting on herpes. The Wall Street Journal, January 19, 2007, section B, page 2).

It turns out that several of these physicians were paid consultants or speakers for GlaxoSmithKline, which manufactures a herpes drug - Valtrex. Treatment of pregnant women with Valtrex to prevent herpes infection of the newborn is a controversial issue.

Apparently, the concern was that the financial conflict of interest would preclude the panel experts from developing, in a purely scientific and unbiased way, recommendations for the most appropriate approach to prevent herpes infection in the newborn. These researchers potentially stand to benefit financially from the increased use of Valtrex, and this was apparently deemed to be inappropriate for their participation on this panel which would be developing guidelines to be followed by medical practitioners throughout the country.

The Rest of the Story

In 2000, the U.S. Public Health Service put out a clinical practice guideline for treating tobacco use and dependence (encouraging and promoting smoking cessation among smoking patients). According to the introduction of the guidelines: "The panel employed an explicit, science-based methodology and expert clinical judgment to develop recommendations on the treatment of tobacco use and dependence."

The guideline demonstrates an obsession with the use of pharmaceutical products to treat smoking cessation. In fact, it goes so far as to demand the use of nicotine replacement therapy or other pharmaceuticals with every patient who the physician is helping to quit smoking. The idea of quitting cold turkey, long the mainstay of successful smoking cessation, is completely dismissed.

At the end of the guideline, after the summary, the text, the references, and the glossary, is a biography of each of the panel members. Nowhere in these biographies is it mentioned that there is any financial conflict of interest for any of the panel members.

It is only if you read all the way to the 3rd appendix that you find out the following shocking revelations:
  • the chair of the panel which developed the guideline is a pharmaceutical collaborator, consultant, and grant recipient. Dr. Michael Fiore, the panel chair, collaborated with Glaxo Wellcome and received research funding from Glaxo at the time the CPG was released in 2000.
  • In addition, as of 2001, Dr. Fiore had "served as a consultant for, given lectures sponsored by, or ... conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."
  • 11 of the 18 panel members who developed the guideline acknowledged financial relationships with one or more pharmaceutical companies (see page 173 and 174 of the guideline).
  • Three out of the five project consultants had financial relationships with Big Pharma.
  • To make matters even worse, one of the peer reviewers of the report was the head of Psychiatry Clinical Development at Glaxo Wellcome (see page 159).
In other words, the head of the panel that produced this clinical practice guideline as well as 10 of the other 17 members had an extensive financial interest in the pharmaceutical industry and between them, they had in fact a financial relationship with most, if not all, of the pharmaceutical companies that manufacture drugs whose use is recommended in the guideline.

Thus, the guideline is anything but an independent review of the evidence and an objective assessment of the most effective approaches to smoking cessation in the population. It is a strategy that was put together largely by individuals with a vested financial interest in promoting pharmacotherapeutic treatment (and not cold-turkey treatment) of smoking cessation.

In my view, this is irresponsible and unethical public policy. You simply cannot allow these kinds of financial conflicts of interest to enter into the promulgation of national medical and public health policy recommendations.

Just as the NIH has canceled the panel meeting of the herpes experts who have a financial conflict of interest because they receive or have received money from the manufacturer of a herpes treatment drug, the Public Health Service should have canceled the meeting of this panel of so-called independent experts who used nothing but so-called expert clinical judgment.

In fact, I would go so far as to say that the guideline itself should be retracted and a new panel, consisting of experts without a financial conflict of interest, should be assembled to consider the issue in an unbiased and impartial way.

And I think the same thing is true of the National Action Plan for Tobacco Cessation that was developed by a panel of experts in 2003. These recommendations are also guided by an obsessive focus on pharmaceutical treatment.

And it is no surprise. If you read beyond the text of the plan and go all the way past the references to the appendices at the end, you'll note the following conflicts of interest:

"Dr. Fiore [the Chair of the panel] has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Pharmacia, Pfizer, and Sanofi-Synthelabo. In 1998, the University of Wisconsin (UW) appointed Dr. Fiore to a named Chair, made possible by an unrestricted gift to UW from GlaxoWellcome."

"Dr. Richling has received honoraria for speaking engagements from Pfizer and Merck. On February 1, 2003, Dr. Richling joined the Midwest Business Group on Health as COO. The following organizations are members of this organization: Abbott Laboratories; AstraZeneca; Aventis; Bristol-Myers Squibb; Genentech; GlaxoSmithKline; Lilly; Pfizer; Pharmacia; Roche; and Schering-Plough."

In my opinion, these financial conflicts of interest are so egregious for panel members who are supposed to be objectively developing a national smoking cessation strategy that the entire recommendation is thrown into question. I think it should be retracted and a new, truly independent panel be convened to consider the issue.

The NIH is wise to cancel this meeting of experts, who were to develop national guidelines, in the presence of panel members with substantial financial conflicts of interest. But those of us in the tobacco control movement need to learn something from this. We need to follow suit. Smoking cessation treatment guidelines and national cessation strategy guidelines need to be developed by experts who are not conflicted because of financial relationships with Big Pharma. It's time to throw out the bath water completely and start over with a new baby.

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