Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers
BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6989 (Published 21 November 2013) Cite this as: BMJ 2013;347:f6989All rapid responses
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Dr. Jessup and Dr. Harold, presidents of perhaps the most influential professional medical society in the world, respond to concerns about conflicts of interest (COI) in their cholesterol guideline panel by asserting three points.
First, they feel that for the panel chair "a conflict does not exist." They base this on the NIH COI policy which asks members to "voluntarily verbally disclose" COIs to each other, with no further direction.(1) In the peer-reviewed scientific community (and using common sense) direct financial relationships with statin manufacturers in the years immediately prior to joining a guideline panel represent a conspicuous point of potential bias and COI.
Second, they believe that because generic formulations are available for most statins the guideline is not a boon to the pharmaceutical industry, despite the increase (by more than 10 million in the U.S.) in eligible patients.(2) At the lowest, and seldom seen, price of $50 per year for each prescription this would represent over $500 million dollars per year in sales.
Finally, and most disturbing, the presidents of the American College of Cardiology appear not to be aware of the effect of guidelines, suggesting they "are simply a tool" to help patients and physicians decide. For reasons ranging from professional standing to medico-legal fear to simple faith in 'expertise', guidelines in practice are much more than a simple tool. Moreover, this advisory view ignores their impact on quality markers, reimbursement schedules, local practice pathways, and malpractice claims.
Patients and physicians seek counsel from professional societies that is scientific, i.e. untouched by outside influence. A 15-person panel that includes eight with active or recent financial ties to makers of the drugs being evaluated does not measure up.
These defensive assertions do not befit the leadership of a scientific organization, and they represent poor advocacy for patients.
1) http://www.nhlbi.nih.gov/guidelines/about.htm#conflict
2) http://www.nytimes.com/2013/11/14/opinion/dont-give-more-patients-statin...
Competing interests: No competing interests
Re: Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers (BMJ, November, 21, 2013)
A BMJ story implying that conflicts of interest of authors affected the new ACC/AHA cholesterol guidelines misses several key points.
First, the National Institutes of Health established a disclosure policy to help prevent industry influence in guideline development. Dr. Neil Stone who chaired the writing panel, and his fellow panelists, completely and precisely followed the policy—in some cases, going beyond what the policy requires to further establish the panel’s integrity. The failure in your story to acknowledge full compliance with the policy implies a conflict that does not exist.
Critics also implied that the new guidelines will result in a dramatic increase in statin prescriptions, benefitting industry. Statins can help many patients live healthier lives. But almost all statins, including high potency ones, are now available as generics, and the guidelines call for newer agents to prove their benefit for outcomes rather than simply on surrogate markers like LDL - hardly a boon to the pharmaceutical industry.
But most importantly, the writing committee has clearly pointed out the guidelines do not determine treatment. Physicians and patients determine treatment together. The guidelines are simply a tool, based on the best evidence available, to help them make those decisions.
JOHN G. HAROLD
MARIELL JESSUP
The writers are presidents of the American College of Cardiology and the American Heart Association, respectively.
Competing interests: No competing interests
Re: Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers
I thank Drs Harold and Jessup for their response. However, whether or not the panel met its own guidelines for how it should be constituted is beside the point; most guideline authors have financial and professional conflicts of interest even though virtually all meet their own criteria for avoiding or “managing” conflicts, as appears to be the case for NIH criteria. Do Drs Jessup and Harold assert that panels in which a majority has current or recent ties to industry is disinterested, objective and independent?
While Dr Stone, chair of the panel, did put his ties on hold once he was appointed, are we to presume that this means he was suddenly free of any pre-existing bias in favor of industry?
Finally, the suggestion that panelists’ industry ties are insignificant since many generic statins are on the market is hardly credible: statins have been and remain the best-selling and most profitable class of drugs in the history of the world. Given a new generation of statins already in the pipeline, and the fact that there are in many examples of continued blockbuster status for brand-name and highly profitable drugs long after generic formulations become available (including for statins themselves), it seems rather unlikely that a guideline expected to lead to many millions more people being put on this class of drugs is of no consequence to the drug's manufacturers.
For independent analyses of the cholesterol conundrum, I suggest readers turn to sources like Therapeutics Initiative,1 John P.A. Ioannidis,2 Rita F. Redberg,3,4 and David Newman.5,6
1. Wright JM. Do statins have a role in primary prevention? An update.2010. http://www.ti.ubc.ca/sites/ti.ubc.ca/files/77.pdf.
2. Ioannidis JA. More than a billion people taking statins?: Potential implications of the new cardiovascular guidelines. JAMA. 2013: http://dx.doi.org/10.1001/jama.2013.284657.
3. Redberg RF. Reassessing Benefits and Risks of Statins. New England Journal of Medicine. 2012;367(8):776-776. http://www.nejm.org/doi/full/10.1056/NEJMc1207079.
4. Redberg RF, Katz MH. Healthy men should not take statins. JAMA. Apr 11 2012;307(14):1491-1492. http://www.ncbi.nlm.nih.gov/pubmed/22496261.
5. Newman D. The Guideline, The Science, and The Gap. Scientific Medicine and Research Translation, Emergency Medicine. 2013. http://www.smartem.org/content/guideline-science-and-gap.http://www.smar....
6. Newman DH, Saini V, Brody H, et al. Statins for people at low risk of cardiovascular disease. Lancet. Nov 24 2012;380(9856):1814; author reply 1817-1818. http://www.ncbi.nlm.nih.gov/pubmed/23177692.
Competing interests: author of article