AP GlaxoSmithKline's Avandia

The huge auditorium at the McCormick Place Convention Center was packed to the rafters. It was standing room only in the 45-hundred seat theater, although the fire department wouldn't let people stand. The doctors, scientists, and educators at the American Diabetes Association's Annual Meeting came to see the rock stars of their world--Dr. Steven Nissen who wrote the controversial New England Journal of Medicine report questioning the safety of GlaxoSmithKline's Avandia and Dr. Phillip Home who wrote--also in NEJM--the subsequent interim analysis of a GSK

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[GSK  Loading...      ()   ]  sponsored study that, so far, supports Avandia's safety.

Because of the predicament the conflicting reports have put doctors in, the ADA added this symposium to the convention program at nearly the last minute. Drs. Home and Nissen were the main attraction, but the ADA put three other prominent diabetes doctors on the dais to participate in a follow-up panel discussion. The ADA had its own TV cameras in the auditorium to project the speakers and their Power Point presentations onto big screens, but it did not do a live webcast of the event or allow our camera--or anyone else's--into the room.

The ADA told my producer, Ruth, that it will take two days to make the event available via the web. While much of the discussion would be Greek to the layman, it seems to me that given the patient fears the situation has created that it would be a public health service to disseminate the event as widely and as freely as possible.

The symposium started with the moderator ticking off the long list of disclosures about relationships with drug companies for each of the docs. The recitation took so long that people in the audience started to laugh. At which point the moderator interrupted himself to remind the crowd that many of them probably have even more disclosures to make than those sitting on the dais. That also drew laughs.

But then they got down to the serious business at hand. Dr. Nissen went first. He began with a bit of an apology: "I know I've made life more difficult for you over the past few months," he said. "Let me tell you why." And then he proceeded to give the backstory of his Avandia analysis.

Ahead of the panel discussion I interviewed him live on the "Closing Bell". You can watch it here:

Dr. Nissen is one of the world's leading cardiologists from The Cleveland Clinic. He did what's called a meta-analysis (looking at results of more than 40 clinical trials) to glean that Avandia may increase the risk of heart attack and death.

GSK, on the other hand, is in the middle of what's considered to be a gold standard clinical trial designed specifically to measure the cardiovascular side effects of its $3 billion dollar-a-year diabetes drug, Avandia.

But Dr. Nissen told the crowd yesterday he doesn't think that study, known by the acronym RECORD, is up to snuff. "Major errors in design have likely rendered the study futile," he said.

When Dr. Home got up to make his presentation his Power Point wouldn't work and his "opponent", Dr. Nissen, had to go back up to the podium and give Home a technical assist. Dr. Home acknowledged that the main goal of the RECORD study is "broad and, in some ways, unsatisfactory." But that's where any bit of agreement between him and Nissen begins and ends.

Dr. Home told the audience that Nissen's analysis is "statistically unacceptable". He argued that Nissen's findings are "hypothesis generating" and inconclusive. "There is no reason (Avandia) should not still have a role in our glucose monitoring armory," he concluded.

Meantime, Deutsche Bank big pharma analyst Barbara Ryan in her weekly note to clients about prescription trends says compared to the week before Dr. Nissen's report was published new Avandia prescriptions are down 42%. Scripts for Merck's

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[MRK  Loading...      ()   ]  Januvia are up 31%, Takeda and Lilly's

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[LLY  Loading...      ()   ] Actos up 30% and Lilly and Amylin's

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[AMLN  Loading...      ()   ] Byetta 4%.

The next major event for GSK and Avandia will be the company's earnings report on July 25th. Then, five days later is the big FDA Advisory Committee meeting on Avandia safety. We'll be there.

Questions?  Comments?