In response to Dr. Adrianne Fugh-Berman, who worte:
Actually, Hargrove's article is both fair and accurate, in stark contrast to Dr. Roseman's unwarranted attack on a journalist. Regarding the cardiovascular effects of Avandia, a small absolute increase in risk in people with diabetes - not a rare disease - translates to a large number of drug-induced heart attacks and deaths, especially when diabetics already have a higher risk of cardiovascular disease. Sure, Avandia lowers blood sugar, and if it were the only drug that did so, its use just might be justified. But the goal of diabetes treatment is to prevent long-term complications , including cardiovascular disease, kidney disease, and blindness. Why should someone with a disease that increases cardiovascular risk take a drug that increases cardiovascular risk when many other safer drugs are available?
As it relates to Dr. Fugh-Berman, she obviously did not read my blog carefully. The summary of my view on the Avandia controversy follows:
As it relates to his reporting of my defense of Avandia (rosiglitazone), I just wish the reporter would get his facts straight. It should be emphasized that the scientific information surrounding this contentious issue is complex and confusing. A definitive consensus about the safety of Avandia has yet to be established; the recent actions of the FDA to severely limit the distribution of Avandia were taken as a prudent measure given this uncertainty. My statements, which have been taken out of context in this and the ProPublica articles, have been consistent. The scientific evidence for affirming a cardiovascular risk to Avandia is incomplete and conflicting. In fact, in the FDA statement explaining its ruling on Avandia, Dr. Woodcock, the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) stated that “the cardiovascular safety profile of rosiglitazone is still an open question because there are conflicting data on the existence and magnitude of the risk.” If interested, please refer to Dr. Woodcock's complete statement that has been published on FDA’s website: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. Finally, my opinions comport with that of the American College of Cardiology and American Heart Association: http://circ.ahajournals.org/cgi/reprint/CIR.0b013e3181d34114. Contrary to the representation of me in this article, I believe that my viewpoint is credible and defensible, regardless of the appearance of bias related to my GSK association.
I have always made it clear that a signal suggesting cardiovascular risk associated with Avandia is present in some, but not all, of the observational studies. However, the more exacting six randomized clinical trials whose treatment protocols included Avandia, which represent a higher level of evidence, failed to show a risk! In fact, two trials, the BARI-2D and VADT, suggested a benefit. (By the way, contrary to his report, three of the these six trials were not sponsored by industry, but by the United States government!) Although the reporter refers to my July 14, 2010 presentation to the joint FDA advisory board: (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM224749.pdf),he failed to acknowledge that my main point at the meeting was to demonstrate the lack of conclusive evidence to take Avandia off the market. (By the way, contrary to the insinuation of the reporter, I was not compensated by GSK in any way for going to the meeting or provided with any support to make my presentation.) Guess what, the FDA agreed with me! Admittedly, the restriction of Avandia use is prudent, until the uncertainty of its safety profile can be reassessed following re-analysis of the singly dedicated safety trial RECORD trial. As it relates to reporter’s comments that RECORD trial was “viscerated”, he should check the record. None other than Dr. Unger, FDA Deputy Chief, came to aid of the trial, reporting that his division within the FDA still had confidence in the results, especially the mortality end-point.
I am offering a more complete analysis of this article on my blog. Please read it carefully for a better explanation of my perspective and my "flawed reasoning": http://cardiologist-on-call.blogspot.com/2010/12/my-formal-response-to-nashville-scene.html. Hopefully, you will pay particular attention to my comments of the two experts mentioned in the article who allege harm from the industry-physician relationship of which I have been identified and stigmatized by this article.
As I have stated, no industry is spared from legitimate charges of excesses and malfeasance. In a similar vein, no one person can be shielded from the charge of prejudice and bias emanating from relationships with an employer, institution, company, or other agency. The true test of the individual, emanating from his moral constitution, comes from recognizing the potential of bias, being circumspect about it, and taking steps to ensure that the influence is limited and one’s judgment is unimpaired by it.
So, let’s take the example of Dr. Fugh-Berman, one of the experts used to support the main point of subtle corruption of individual physicians participating with industry. In her defense of the reporter, she claimed that my attacks were “unwarranted”, despite that I take offense to his false characterization of my views.
So, Dr. Fugh-Berman, please explain why you chose not to expose your potential biases in your interview for this article. As a side, your expose of ghost-writing was admirable. However, your active promotion of natural herbal remedies and dietary supplements, which I do not professionally oppose and actually support within reason, seem to present as a major conflict of interest, which was not exposed in the article. Is it not possible that either directly or indirectly you benefit from creating uncertainty around allopathic pharmaceutical agents by criticizing the industry? You have written a book on the promotion of such products. Your website also lists you as a paid plaintiff expert against the pharmaceutical industry. Did the advertising of your perspective in this article increase your recognition that may contribute in the future to more lucrative consulting assignments for plaintiff lawyers?
You are right, Dr. Fugh-Berman, there are subtle influences that can creep into any type of relationship. When one lives in a glass house, one should not throw stones.
I do not pretend to be free of criticism or fault. However, I can claim that I am conscious and attempt to live life in a moral and ethical way. As it relates to my practice, I do strive to offer the best for my patients, which for me, has been facilitated through my contact with industry. Certainly, there are other channels of information of which I avail myself. In the end, the question of influence is one that begins in the heart. That is why I became a cardiologist. Contrary to the comments and the insinuations of this article, life is not always about money. As Dan Millman stated, “Money is neither my god nor my devil. It is a form of energy that tends to make us more of who we are already, whether it’s greedy or loving.”
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