According to a story that appeared in today’s Wall Street Journal one of the panel members who voted in favor of keeping Avandia on the market with no additional restrictions received speaking fees from GlaxoSmithKline (NYSE:GSK). The story states that Dr. David Capuzzi received “$3,750 from the company as a speaker between April 2009 and March 2010. A Glaxo spokesman said Dr. Capuzzi also received about $8,000 in speaking fees from the company before that period and an additional $3,000 in the second quarter of this year, making the total payments about $14,750.”
This story is just more fallout from a meeting that did not yield the results some members of the FDA wanted. It also reinforces Diabetic Investor’s belief that the FDA will ignore the panel’s vote and move to have Avandia withdrawn from the market.
It’s important to note that even had Dr. Capuzzi voted for Avandia to be withdrawn from the market; his vote would not have affected the outcome. It should be further noted that as Diabetic Investor pointed out before the meeting even began the FDA stacked the deck in Avandia’s favor by the way they structured the critical question where four of the five possible answers allowed Avandia to remain on the market.
As Diabetic Investor stated previously the FDA could have avoided this whole issue by splitting the critical question into two questions; the first asking whether or not Avandia should be remain on the market and the second, if it should remain on the market what additional restrictions, if any, are needed.
Frankly the FDA got what they deserved and should honor the recommendation of the panel. Think of the precedent it would set should the FDA ignore the panel’s vote. If the FDA’s intent all along was to pull the drug then they should have avoided the expense and time of a panel. Why the circus? The fact is the FDA was looking towards the panel to do what they seem incapable of doing; making a tough decision. Like the politicians who oversee the agency, they have become very good at passing the buck, ducking their responsibility and then when things don’t go the way they wanted acting like a spoiled child who did not get ice cream after dinner. What a bunch of sore losers.
In desperate attempt to save face they now are trying to muddy the waters by stating that the panel was tainted. Excuse me, but are there no computers with internet access at the FDA. As it clearly states in the Journal article this information is posted on the Glaxo web site, www.gsk.com. Also did the FDA not read the disclosure forms submitted by the panel members and even if they did were they just plan lazy by not having someone check the backgrounds of the panel members?
The truth here is from the very start of this whole mess, when the meta-analysis was leaked before publication, it never passed the smell test. The fact is someone or group of people had it in for Avandia and was willing to use any means necessary to accomplish this objective. They painted themselves as patient advocates when their true colors were more self-centered. Granted GSK is not free of guilt here but what GSK did does not hold a candle to what these people are capable of. These despicable tactics have no place in a debate that affects the lives of real people with diabetes and the physicians that treat them.
Now after two days of meetings, contentious debate and a public vote that didn’t go their way what do they do. Accept the results and graciously accept defeat. No, they claim fool play after the fact and try and taint the vote as if the panel members were akin to a two bit third world country that just re-elected a ruthless dictator.
At least Glaxo had the decency not to gloat when the vote went their way. They understood that while the vote may have been favorable for Avandia this will not undo the damage already done to their reputation. As Diabetic Investor stated previously there is enough blame to go around here and no one is coming out of this whole mess looking very good.
Hopefully GSK will begin the healing process by doing what the FDA wants but seems to thin skinned to do and pull Avandia voluntarily. The majority of the lawsuits are settled, they have already set aside the money to cover everything and for all practical purposes Avandia is already a dead drug. The thing to do now is give Avandia a proper burial and move on. This will make the FDA happy, it will get the critics off their back and we can then await the next drug disaster.
It will also save this group of sore losers from further embarrassment. Diabetic Investor would expect this type of behavior from a group of spoiled children who don’t know any better and not a group of adults who should know better. It’s time to grow up already this is beyond ridiculous.