When will the madness end?
Someone needs to explain to Diabetic Investor why everyone is still fixated on Avandia. Agree or disagree with the results of the now famous meta-analysis that started this whole mess, the market has spoken and done what the FDA and researchers could never do; take real action. Why any physician would still be prescribing Avandia is anyone’s guess and quite frankly most are not. As Avandia sales numbers clearly indicate, physicians and their patients have moved on switching to alternate medications.
Yet this fact hasn’t stopped researchers from doing what they do best; over-analyzing a problem when the problem has already been solved by the market. Other than strengthening the many class action lawsuits against GlaxoSmithKline (NYSE:GSK) would it really make any difference if the FDA came out tomorrow and pulled the drug off the market? And just what will these researchers prove if they complete the ongoing TIDE trails? Will physicians all of sudden start prescribing Avandia again or has the decisions already been made regarding Avandia? (Just in case any researchers or FDA are reading this is a rhetorical question, if you’re not sure what that is please consult a dictionary.)
To illustrate just how nutty this whole situation has become (and frankly Diabetic Investor didn’t think it could become even nuttier) take a look at an article published in today’s Wall Street Journal which stated; “In a letter in late March to ranking Senate Finance Committee Republican Chuck Grassley of Iowa, whose two year investigation into Avandia led to a critical report released in February, FDA Commissioner Margaret Hamburg wrote that the agency is reassessing the trial involving Avandia versus Actos “based on expert input and our own analysis.”
Dr. Hamburg’s principal deputy, Joshua Sharfstein, said the decision on the trial “cannot be de-linked from the agency’s view of Avandia,” suggesting that if the trial must be halted, the agency would also consider asking Glaxo to halt sales of the drug.”
Later in that same article it states; “In her letter to Sen. Grassley, Dr. Hamburg said, “I recognize that head-to-head safety trials can pose challenging ethical questions.” She noted that if one drug is inferior to another, “such a trial should not be conducted because it would place one group of patients at unnecessary risk.”
Curt Furberg, an expert in clinical trials at Wake Forest University, said the informed-consent form for the TIDE trial is unethical because it doesn’t spell out the magnitude of the cardiovascular risk tied to Avandia. “How the FDA could approve TIDE is beyond me,” Dr. Furberg said.”
The fact that we are still even talking about Avandia is evidence of just who screwed up this whole process is. The reality is even after all this research and debate we will still be in the same place when this whole mess started namely; more than two-thirds of all patients are not achieving control and we need more and not less therapy options.
The bottom line here is that the market has spoken when it comes to Avandia and it seems rather pointless to continue pilling on Avandia as nothing of real value will be gained here. The fact is the FDA is looking for someone to blame and the researchers who are foolishly pursuing this subject appear to be looking for personal recognition rather than advancing knowledge. Diabetic Investor thinks it’s about time everyone moves on, the FDA should pull Avandia from the market and researchers should get back to the business of providing information that will actually help patients and the physicians that treat them.