When I wrote yesterday about the financial conflicts of interest inherent in the pharmaceutical industry connections of a number of panelists on the groups that developed the Public Health Service's clinical practice guideline on the treatment of tobacco use and dependence and the national smoking cessation action plan, I wasn't aware of just how deep those connections were.
Today, I reveal the extent of these financial ties with regards to the chair of these two panels and argue that it is unethical and irresponsible to have such an individual developing what is supposed to be independent, objective, and unbiased national guidelines to the clinical and public health approaches to addressing tobacco use cessation.
The Rest of the Story
According to his testimony in the Department of Justice tobacco lawsuit, the chair of the panels which put together the clinical practice guideline and the national smoking cessation plan runs a tobacco research center which receives or has received funding from GlaxoSmithKline, Pfizer, Sanofi, Ciba-Geigy, and Elan. The center had a budget of about $6 million in 2004, with about 16% coming from pharmaceutical companies. This means that the center received close to $1 million from Big Pharma in that year alone.
In addition, the panel chair does consulting work for pharmaceutical companies, for which his annual income is between $10,000 and $40,000.
To top it off, his position as chair for the treatment of tobacco dependence at his university was endowed by none other than GlaxoSmithKline, which produces a range of smoking cessation products, including Zyban, Commit, NicoDerm CQ, and Nicorette. It is unclear how much money GlaxoSmithKline provided for this endowed chair position, but the panel chair disclosed that he has "access to up to $50,000 per year" - which is the "revenue generated from the investment on the initial grant."
If the pharmaceutical companies - or any companies - endowed a position for me, giving me access to up to $50,000 per year, paid me between $10,000 and $40,000 per year in consulting fees, and provided research funding to the tune of up to $1 million per year to my institution, I would gladly develop national guidelines that called for the use of those companies' products.
If it were the pharmaceutical companies who were paying, I would gladly make pharmaceutical treatment of nicotine dependence the cornerstone of my national smoking cessation action plan and my clinical practice guidelines. I would happily throw the most successful quitting strategy - cold turkey - to the wind and call for "free FDA-approved pharmacotherapy" for all smokers who seek help from the national quitline and to opine that a "key feature of a quitline is having counselors who are trained to work with smokers to establish a detailed quitting plan, including the provision of specific advice on the types of medication that are most appropriate for the smoker in making the quit attempt."
That leaves no room for even considering the idea that quitting cold turkey might be the best approach for an individual smoker, and it also assures a continued stream of pharmaceutical funding to my institution by incentivizing the pharmaceutical companies to compete vigorously to be sure that their products are the ones recommended by the national quitline.
Yes - I do think it is unethical and irresponsible to have individuals with these kind of ties to the pharmaceutical companies sitting on, or worse - chairing - national panels of experts to make recommendations and develop guidelines for national policy on smoking cessation.
This really makes a farce of the whole process of providing a so-called independent and entirely science-based and objective review of the evidence and formulation of the most sound and appropriate recommendations. So I renew and strengthen my call for the retraction of both the clinical practice guideline and the national smoking cessation action plan. I think both need to be re-developed by panels whose members and chair do not have severe financial conflicts of interest.
I don't know if this type of thing goes on with other clinical and public health recommendations, but if it does, the problem needs to be addressed. Would we really want researchers with strong financial ties to Big Pharma making national decisions regarding the appropriate treatment for various medical problems? If someone is going to recommend that all patients in the country take a particular drug for a particular problem, I want that recommendation to be based on the most objective review of the science, not based on a financial conflict of interest because the panelists making the recommendation were receiving consulting fees from pharmaceutical companies.
Of course, the most basic element of protecting the public from the effects of these types of financial conflicts of interest is disclosure of the conflicts. Unfortunately, my review of the panel chair's center website suggests that the ties of the center to Big Pharma are not prominently disclosed. If this observation is correct, I think this failure is unethical.
Please correct me if I'm wrong, but it appears to me that the financial ties to the pharmaceutical companies are not disclosed on the main web site pages: you have to actually go and read the center's annual report(s) to find out that it receives major funding from pharmaceutical companies.
For example, the 2005 annual report does disclose that the center received $400,000 from Big Pharma in 2005. The 2004 annual report discloses $1 million of pharmaceutical company funding.
But on the main pages, and in particular, the About Us pages, this funding does not appear to be disclosed (see About Us 1; About Us 2; About Us 3; About Us 4; About Us 5). In fact, on the main About Us page, it states: "Through its federal and foundation grants and its clinical trials, the Center has brought more than $30.4 million into the state of Wisconsin from outside sources." Nothing is disclosed about pharmaceutical company funding - only federal and foundation grants are mentioned. It mentions the clinical trials but doesn't disclose that at least some of these are being funded by pharmaceutical companies.
I find this very problematic, especially since at least a part of the role of the website is to play some role in the potential recruitment of human subjects who may take part in a pharmaceutical company-sponsored clinical trial.
I could be wrong, and maybe I'm missing something (and let me know if I am), but I can't seem to find any prominent disclosure of the financial conflict of interest - the funding of the center, in part, by pharmaceutical companies. It is not the case that the center is completely failing to disclose the funding - it is openly acknowledged in the annual reports - but I question how many website readers are going to go to the trouble of opening the annual reports and reading the financial disclosures at the end.
The rest of the story is that the tobacco control movement appears to be plagued by a severe financial conflict of interest problem. I do not think that we as a movement have done enough to guard against financial conflicts caused by pharmaceutical company funding of tobacco control research, and more importantly - the development of tobacco control guidelines, recommendations, and strategies. I do not even think that we are doing what we should be doing in terms of the disclosure of these conflicts of interest.
This wouldn't necessarily be as much of a problem if it weren't a fact that we as a movement spend a lot of our time complaining about tobacco industry-related conflicts of interest and that we skewer any individual who so much as accepts a free lunch from the tobacco companies. If we want to retain credibility in attacking those with tobacco industry ties and the role of tobacco company funding of research and influence on policy, then we need to clean our own house first.