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Aug29
Briefly Noted: The Politics Of Disclosure; The Off-Label Promotion Debate; The Art & Science Of Evidence-Based Medicine
The Politics Of Disclosure: In recent weeks, there has been a great deal of conversation about the need for drug firms and academic researchers to disclose their ties to the pharmaceutical industry.  For example, supporters of full disclosure argue that it would help readers of journals ferret out the subtle biases of industry-supported scientists.  I anticipate that the focus on full disclosure will only increase as drug firms move from the mass marketing of products to targeted educational campaigns.

However, shouldn't people on both sides of the debate be required to practice full disclosure?  In an interesting article that appeared on Drug Wonks a couple of weeks ago, the blog's co-author Peter Pitts suggests that critics of the pharmaceutical industry should be held to the same standards as drug company supporters.  He argues they should report conflicts of interest that may influence how they view the industry and its marketing activities.  More On The Off-Label Promotion Debate:  On August 15, the Annals of Internal Medicine published an article focusing on Parke-Davis’ (now owned by Pfizer) off-label promotion of gabapentin (Neurontin).  The article’s authors analyzed information from a public directory of company documents outlining how it worked with thought leaders, conducted clinical trials and paid medical education companies to educate physicians on Food and Drug Administration (FDA) approved and non-approved uses for the product. 

The article has accelerated the debate surrounding the development and dissemination of medical information.  Physicians have long defended their right to educate their peers on the off-label use of medications.  For example, this practice is very common in cancer care.  Oncologists develop and use their own “cocktails of anti-cancer medications based on the results of small studies or anecdotal evidence.  They tell other physicians about their efforts.  Drug firms sometimes decide to conduct follow-up studies confirming the benefits of an off-label use of a medication.  Companies then submit a Supplemental New Drug Application (sNDA) to the FDA seeking permission from the agency to market the product for a new indication.

The key questions in this debate are:

1.    Should (and can) the FDA step in to regulate off-label promotion of medications?

2.    What role should physicians play?

3.    Should drug companies refrain from educating medical professionals on off-label uses for their medications? 

The authors of the Annals article (three of them participated in the whistleblower lawsuit against Parke-Davis) would answer "yes" to many of these questions.  They assert that “new strategies are needed to ensure a clear separation between scientific and commercial activity.”

Evidence-Based Medicine: Dr. Robert Centor, author of DB’s Medical Rants, posted an interesting article recently on evidence-based medicine (EBM).  He says that supporters of EBM “should not expect [it] to solve all of the problems in medicine."  Physicians should understand the biases and limitations of thought leaders evaluating medical data and making treatment recommendations.  

EBM has had a significant influence on medicine.  It is used to decide lawsuits, what drugs third party payers will cover and how pharmaceutical companies promote their medications.  For example, Pfizer has conducted a number of studies on its cholesterol medicine Lipitor that have changed treatment guidelines.  Drug firms then use these studies to secure FDA approval to market their products. 

Centor argues that physicians should not overly rely on EBM when making decisions about how to treat patients.  They should remember that a patient’s medical history should have as much bearing on diagnosis and treatment as a clinical trial. 

Centor’s remarks are relevant to the debate over off-label education.  If  physicians rely on past experience and individual patients to make medical decisions shouldn’t they be aware of approved and unapproved uses for medications?  If pharmaceutical companies do not  conduct and support clinical studies and educate medical professionals will government or nonprofits pick up the slack? 

All of these are tough questions with few easy answers. 

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