Dear Charlie Ornstein:
Thanks for presenting a fair balanced story. Let's look at my portrayal of me, as an example. "Roseman is not a researcher with published peer-reviewed studies to his name. Nor is he on the staff of a top academic medical center." If you had done further research about me, you would realize that you have misrepresented my credentials. As discussed, I have significant standing both academically and clinically. My education was discussed with you: BA, University of Pennsylvania (your alma mater), MD, University of Tennessee; MPH, Yale University; Clinical Training at Yale and Brown University. I was one of the first in the country to be selected to take the National Lipid Boards, an inspiring subspecialty board under the Board of Internal Medicine. I am a specialist with the American Society of Hypertension. I have fellowship standing with at least three major societies, including the American College of Internal Medicine and Cardiovascular Diseases. I am well regarded as a thought leader in my field of preventive cardiology, at least regionally, if not nationally. I have been offered academic positions, but I chose to remain in clinical practice. I have published, although minimally. A second paper on lipid treatment has been submitted and is awaiting approval. My lack of publication does not mean that I carry no authority nor provide credible knowledge. Furthermore, it does not indicate anything about my capacity as an educator.
In discussing my position on rosiglitazone (Avandia), you reported that after all of the controversy around Avandia that I still have confidence in the agent. The article insinuated that my confidence in the agent followed from a bias as a direct result of my association with GSK, the pharmaceutical company that manufactures and markets Avandia. You failed to use any of my three position papers on the decision by the FDA in clarifying this statement. Furthermore, you failed to mention that FDA's own Woodcock recent statement about the uncertainty of harm imposed by rosiglitazone: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. The issue of Avandia causing heart attacks is not settled. The absolute risk of Avandia causing heart attacks is low, as I reported!
Your characterization of me was unfair. You failed to include my background, despite our having discussed it. You misrepresented that I had no publication to my name, which I do (article included). Now I am aware why journalists are so aptly painted. Your main aim is to get out a controversial story; you characterize situations to make a good story line. Based upon this involvement with you, you failed your own ethics tests: http://www.spj.org/ethicscode.asp.
My issue with you is not from a position of anger but disappointment. During the initial conversation with me, you portrayed yourself as being open-minded and unbiased, but the perspective of the story for which you were gathering information had already been formulated. You failed to print much of which I shared with you that defended my participation as well as that of many other well-qualified physicians in lecture bureaus of the pharmaceutical companies. In other words, you and your fellow journalists print information that suits the purpose of your story line and diminish or suppress information that doesn't fit. As in this case, your headlines "Docs on Pharma Payroll Have Blemished Records, Limited Credentials", dramatize a situation that represents only a minority of the physicians involved in the educational efforts of the pharmaceutical industry.
The purpose of the lecture bureau is to educate individual physicians about disease states and treatments. For many of the practicing physicians and health care providers in the country, especially primary care providers, their educational update on new products and on new concepts about disease mechanisms and pathophysiology stem from efforts by the pharmaceutical industry. The FDA has certainly curtailed the potential of misrepresenting the claim of a medication. A presentation has to be fair balanced, avoiding erroneous claims or unscientific information. The presentations must not contain overly exuberant statements about the use of the medication and must stay within the context of the prescribing guidelines as set forth by the FDA. Furthermore, unfair comparisons with other competing medications cannot be presented. Finally, a full disclosure of side-effects of a medication must be included. A world without these promotional programs would certainly limit access of these physicians to some of the latest scientific information that can have potentially important consequences to their patients. Finally, although I have confidence in the medications, which I represent, I regularly discuss the option of other medications, some even in the same treatment class, when appropriate in discussing clinical problems.
The stigmatization of the pharmaceutical industry implicit in your report fails to take into account the extreme challenges of bringing a new drug, many life affirming and disease modifying, to market. Usually the intellectual assets or patents of these new drugs are only protected for 10-14 years. Because of the stringent requirements of bringing a drug to market, the average cost approaches $1 billion dollars. Of course, there is significant pressure to make the medical system aware of these newer treatments. Education, from peer-to-peer, is one method by which health care providers are familiarized with these agents. What is wrong with promotion of new drugs, many of which supplant less efficacious and legacy medications?
By the way, certain drugs that were approved for one condition have proven after entering the market place to have significant benefits for another disease. A good example is carvedilol (Coreg), which revolutionized the medical treatment of heart failure, although its first indication was hypertension. It was only through the revenue from the product that research was able to expose this drug's superior benefit in treating heart failure.
I would certainly challenge you and your colleagues to research and write about the benefits of these educational programs. You insinuate that these programs are part of insidious marketing scheme by the pharmaceutical companies to sell drugs for profit sake only. Of course, we do live in a capitalistic society that favors and rewards innovation. However, contrary to a widget company, the pharmaceutical industry’s ultimate aim is to make medications to help people. Certainly there are examples are overly zealous and avaricious businessmen that overstepped the promotion of their products. But generally, the pharmaceutical industry is in the service of providing safe and efficacious treatments. Even if greed was the main motivation, the current climate is highly punitive of companies that abuse their mandated role in providing effective and novel medications within the regulatory boundaries set forth by Congress and the FDA. Educating the medical personnel on the appropriate use of these medications is an important step to ensure that the health care provider has the most relevant and up-to-date information to make informed decisions about the treatment options for his/her patients.
Best regards,
Hal Roseman, MD. MPH, FACC, FACP
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