More Sour Grapes

More Sour Grapes

It seems that the folks who wanted the FDA to pull Avandia from the market will never be happy. This overly zealous group of researchers has been unhappy since the FDA panel meeting where panel member voted to keep Avandia on the market with additional restrictions and warnings.  For this group the only acceptable solution to the Avandia was for the FDA to pull the drug from the market or put more simply it was there way or the highway no matter what anyone else had to say. Since the panel meeting took place back in July, these folks have mounted an aggressive campaign which basically states we’re right and everyone else is wrong.

Not content to accept the FDA decision and move on this group continues to bash the FDA’s decision every chance they get. The latest example comes from an article published on-line by the New England Journal of Medicine (NEJM) entitled; “Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone” by Nilay D. Shah, Ph.D., Victor M. Montori, M.D., Harlan M. Krumholz, M.D., Karen Tu, M.D., G. Caleb Alexander, M.D., and Cynthia A. Jackevicius, Pharm.D.

The author’s state: “The FDA uses boxed warnings to express concern about a drug’s safety. Research has shown, however, that the response by clinicians to boxed warnings is inadequate, which results in significant exposure of patients to potentially unsafe medications.” This statement alone tells Diabetic Investor that this group of distinguished researchers has lost all touch with reality.  Worse still is the author’s presumption that physicians cannot look at the evidence, consider all the facts and make a decision based on what they see as the drugs overall risk/reward profile. Basically what the authors are saying is that a black box warning is the equivalent of pulling the drug from the market and physicians should not use any drug that carries such a warning. (Wonder how the people at Novo Nordisk (NYSE:NVO) fell about this given Victoza® carries a black box warning yet is performing quite nicely in the marketplace.)

The authors go on – “It seems that, in general, FDA warnings do not provide adequate guidance for providers about how to incorporate the warning into clinical decision making. Warnings can be interpreted in a variety of ways, and patient protection may be inconsistent as a result. Variations in responsiveness to warnings within the United States should be of critical interest to the FDA, since patients may be exposed to risk differentially depending on where they live. Specifically, if the use of rosiglitazone varies widely throughout the country and thus can potentially cause differential harm, the best way for the FDA to protect the public’s health may be to remove the drug from the market. Alternatively, if the FDA values the practice of offering patients and clinicians as great a range of options as possible, it may need to provide decision-making tools for incorporating information about patients’ context and preferences to better align residual use with informed patient choice.” (Highlighting, italic and underling added by Diabetic Investor)

What the authors are trying to say in the nicest, most politically correct way is that the average physician is not smart enough to make up their own mind and the government should take away their ability to make a decision. While Diabetic Investor believes any physician who continues to prescribe Avandia is taking on a great risk, we do not advocate taking away their ability to prescribe a drug just because it carries a black box warning.  Given the evidence against Avandia is not clear cut and open to wide interpretation it is quite plausible to believe the physicians who continue to prescribe Avandia have look at all the evidence and concluded that for a certain group of patients the risk/reward profile of Avandia is acceptable.

The authors conclude by stating; “Our finding of substantial variation, along with notable levels of residual rosiglitazone use even in the face of a boxed warning, challenges the apparent regulatory assumption that patient–clinician deliberation about the risks and benefits of the available agents will ensue when a boxed warning is issued. This same assumption underlies the FDA’s reliance on a new Risk Evaluation and Mitigation Strategy to justify ongoing rosiglitazone use. But given the lack of tools available to clinicians for translating these additional warnings into practice, the warnings are likely to be translated inconsistently throughout the country.” (Highlighting added by Diabetic Investor)

Again what the authors are trying to say in their PC way is “if you continue to prescribe Avandia, a drug approved by the FDA, extensively reviewed by the FDA but a drug the FDA chose to leave on the market, you are an idiot.”  Or put more simply what the authors are saying is “how dare you disagree with us and make up your own mind.”

The reality here is that Avandia has been studied, debated and reviewed more than any diabetes drug ever to be approved by the FDA. Experts have weighed in from all sides and countless hours and dollars have spent to determine whether or not Avandia should remain on the market. Finally after reviewing all the evidence, listening to hours of testimony, reading study after study – the FDA concluded that Avandia should remain on the market with additional restrictions.

Unless a physician has been living in a cave, cut off from the world for the past two years it’s unlikely they would have not read something about this debate. It is equally unlikely that these physicians who actually work with real patients with diabetes have not seen firsthand what happens when patients do not properly control their diabetes. Each day they must deal with real world concerns such as what medications their patients insurance pays for and the declining options available to treat diabetes. They see the FDA preventing new drugs that would help them more effectively treat diabetes from reaching the market and what new drugs which are approved carry with them a host of warnings.

On top of all this they must now deal with a group of arrogant researchers who cannot accept the FDA’s decision and wish to force their belief on everyone else. These zealots who believe they are more informed than everyone else and they know better. This anti-Avandia group is not even willing to consider an alternate viewpoint. It’s their way or the highway no matter what.

This position seems at odds with the fundamental tenets of scientific research which is designed to foster debate and allow people to make informed decisions based on all available evidence. Scientific research presumes that people have the freedom to make up their own minds. It does not presume that in the absence of clear cut evidence to the contrary that an opinion becomes fact.  As Bergen Evans wrote; “Freedom of speech and freedom of action are meaningless without freedom to think.”