Well the ADA is over and it’s safe to say when it comes to the Avandia controversy there are no winners, many losers and plenty of blame to go around. The most well attending meeting at the conference occurred late Monday afternoon. In packed Arie Crown theater Steven E. Nissen, MD and Philip Home, MA, DPhil, DM, FRCP each presented their views on Avandia. Sadly the presentations and ensuing panel discussion did little to answer the question whether Avandia is safe and actually created more questions. The most relevant point came from Dr. Home when he stated that he disagreed with Dr. Nissen when it came to how physicians and their patients should deal with the controversy. Dr. Home correctly pointed out that its time for someone to step up and give physicians and their patients clear guidance on what to do with Avandia. Diabetic Investor couldn’t agree more.
Unfortunately the FDA and ADA have left physicians and their patients dangling in the wind. These are the very organizations that are supposed to provide guidance. The fact is primary care physicians who treat the majority of patients with diabetes rely on these organizations for direction.
As everyone knows there is FDA panel meeting on July 30th that will examine Avandia and Actos. Diabetic Investor is not optimistic that this meeting will do much to quell the controversy. At the meeting everyone will have their say and present their data and in the end the FDA will require black box warnings for both drugs. In essence nothing really will change; physicians and their patients will still be left holding the bag on what to do.
In the end everyone, patients, physicians, GlaxoSmithKline (NYSE:GSK) and Takeda all come up big losers. Because no one appears willing to take a stand patients are now reluctant to take their medications. Physicians are losing faith in the FDA and the drug approval process. Glaxo and Takeda are losing millions in sales and market cap.
One has to wonder if any good can come from this mess. Will the FDA change the drug approval process? Will companies be required to release all study data no matter whether it was published or not? Will Congress give the FDA the power to force companies to conduct post-market studies? Will an independent board be set up to oversee the design of these studies to insure that they actually provide relevant information? About the only thing Dr. Nissen and Dr. Home agreed on is that the RECORD study is flawed. This begs the question why would you continue a study when everyone appears to agree that it won’t tell us what we need to know.
The reality here is that there are no easy answers or guarantees. However, it would be refreshing if everyone stopped trying to protect their turf and realized that millions of people are suffering and need straight answers. Diabetes is a serious public health issue that is only getting worse. However as we have learned from Vioxx the more things change the more they stay the same. How many people have to suffer or die to make this clear?