Healthy Skepticism Library item: 18981

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Meyer R
Avandia: Did Science Triumph Over Fear?
World of DTC Marketing 2010 July 14
http://www.pharma-marketer.com/avandia-did-science-triumph-over-fear/

Full text:

I have to say that I was quite surprised that the FDA agreed to let Avandia stay on the market. Given the increase in media coverage with story headlines like “GSK hid clinical trial data” one has to wonder how could they trust that the data they were reviewing was accurate ?
There is a bigger issue here and that is the “perception” that the FDA is the back pocket of the drug industry and and is not looking out for the best interests of patients. The credibility of the FDA has taken a nose dive in recent years but frankly consumers are reluctant to believe anything today after the bank failures and a recession that 70& believe is still going on.
As someone who is in the industry what I really want to know is “did GSK hide/underreport data for Avandia clinical trials ? If they did then how can people within the FDA agree to keep it on the market ?
Will this issue cast a shadow on the whole drug industry ? I doubt it. I believe the ones who are really going to take a hard look at ALL data now are health care professionals. If, as Dr Mintz says in his blog “despite the panel’s concerns about Avandia safety, the clear majority felt that there was simply not enough data” one has to wonder how they could vote to keep it on the market and how patients feel about taking a drug without ‘enough data” behind it ?
The FDA will probably now add stern warnings to Avandia decreasing its sales to the point that it won’t be a blockbuster anymore. GSK may try and blow their horn but there is a lot of mud in that horn right now. As Dr Mintz said:
Despite all the holes that Avandia’s opponents poked in the data, I remained convinved that the preponderance of the data points in Avandia’s favor. It doesn’t appear to cause increased heart attacks, it certainly doesn’t cause increased death, seems to decrease stroke, and clearly decreases the use of insulin. I will continue to write for the product unless it is pulled from the market, newer restrictions make it virtually impossible to prescribe, or my patients request being placed on a different medicine.