ADA Day One
Yesterday results of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) were presented and published. And just what did this major study find? Well it really depends on who you ask. If you ask the people at GlaxoSmithKline (NYSE:GSK), the people who make Avandia, they will tell you the study shows that the drug is safe and concerns over cardiovascular events are over blown. Ask many of the researchers who listened to the results and you would come away feeling the entire study was flawed.
Given that sales of Avandia have fallen into the abyss ever since Dr. Nissen ambushed GSK with his now famous meta-analysis, the results of RECORD really don’t matter all that much. It’s understandable that GSK would try and show that Dr. Nissen’s analysis was flawed but the fact of the matter is sales of Avandia won’t be resurrected. Patients and physicians have moved on as evidenced by sales of Januvia from Merck (NYSE:MRK).
What Diabetic Investor finds just a little ironic here is the attention this study has garnered. Even if the study had proved conclusively that Avandia was not associated with adverse cardiovascular events, it’s unlikely that sales would increase. The fact of the matter is Avandia sales were doomed the day the Nissen meta-analysis was published. Being a billion dollar drug the main stream media quickly picked up on the story making it front page news. Like so many stories that involve popular drugs and adverse events, the main stream media went for the headline without fully investigating all the facts. GSK was put in an unwinnable situation as the story took on a life of its own.
The real lesson here is for every drug company involved in the diabetes market is no drug is safe from scrutiny. A lesson also learned by the folks at Amylin (NASDAQ:AMLN) who experienced a similar situation with Byetta and pancreatitis and Novo Nordisk (NYSE:NVO) who is currently dealing with concerns about liraglutide and thyroid cancer.
Moving a drug through the FDA is tough enough as it is and it doesn’t help matters any when issues are blown out of proportion. The fact is GSK never had the chance to address the concerns over Avandia as nearly half the participants of the RECORD study dropped out after the meta-analysis became public. Truth be told, we’ll never really know if Avandia was the cause of adverse cardiovascular events or just how big this problem really is. The reality is a comprehensive study of Avandia and cardiovascular events is next to impossible as the drug has been forever tainted.
Diabetic Investor commends GSK for trying but we think it’s time for everyone to move on.