Time to Man Up and Move On
This past Sunday the Detroit Lions lost their opening game based on a new rule put in place by the NFL. For anyone who watched the game for all practical purposes it appeared the Lions won the game on a late touchdown, even the players on Chicago Bears, the Lions opponents, thought they had lost. Yet, to the surprise of anyone at the game or watching on TV the pass was ruled incomplete and the Bears miraculously won the game. While the Lion players and coaches were obviously disappointed and upset over the call, to their credit they did not blame the loss on the officials who made the call or the NFL for coming up with a stupid rule. Simply put the Lions accepted defeat and moved on to prepare for their next game.
Diabetic Investor thinks Dr. David Graham and Dr. Kate Gelperin who wrote a letter to the British Medical Journal accusing the members of the FDA panel on Avandia with bias learn a lesson from the Lions, learn to accept defeat and move on. In this letter they write; “In an unprecedented move, the FDA’s Center for Drug Evaluation and Research (CDER), which originally approved rosiglitazone and has defended its continued marketing, invited not only the current members of these committees [the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee] but also all members from the 2007 meeting, even though they were no longer active members of either committee. Of the 32 advisers who voted at the 2010 meeting, 16 (50%) attended the 2007 meeting, and 15 of them had voted that rosiglitazone remain on the market (one attendee was a temporary nonvoting invitee).”
Joining Drs Graham and Gelperin in their accusations against the panel members was Dr. Steven Nissen, who’s now famous meta-analysis, set this chain of events in motion, noted in an interview with heartwire; “The outcome of FDA advisory panels is significantly influenced by who is on the panel. When I saw the roster, I knew it was going to be an uphill struggle. I was very surprised that they had invited back people who had already voted to keep the drug on the market in 2007. Once you have opined publicly, it is very difficult to turn around and admit you made a mistake.”
70 years ago Helen Keller wrote; “Defeat is simply a signal to press onward.” A sentiment apparently shared by Drs Graham, Gelperin and Nissen. Unable to accept the panel’s decision and get on with their lives, they have made it their quest to convince anyone who will listen that they are right about Avandia and everyone else is wrong or biased.
The fact is too much time, effort and money have been wasted on Avandia and nothing substantive has come from it. Physicians now have fewer weapons to fight diabetes; patient’s fears that approved medications cannot be trusted have been reinforced leading to even greater therapy non-compliance. The drug approval process has slowed to a crawl as the FDA has become preoccupied with Avandia. Drug companies now must deal with an every change set of rules, conduct even more studies and have no clue what the FDA will do or why they will do it. The new drugs that do make it through are put under such a microscope that even the smallest flaw draws the dreaded black box warning even when there is little if any scientific evidence to support such this action.
As Diabetic Investor noted before the panel meeting even took place, the likely outcome was staked in Avandia’s favor based solely on how the questions were worded. Instead of a simple yes or no vote on whether or not Avandia should remain on the market, the FDA made it easy for the panel members to vote against Avandia but without pulling the drug from the market. Had the question been a simple yes or no these claims of bias may have merit, but in reality the FDA gave the panel an easy out.
Some may admire these doctors zeal in the mistaken belief they are truly concerned about patients. They could see this as mass injustice and feel it is their duty to correct the FDA’s mistake. Diabetic Investor obviously doesn’t see that way based on the simple reality that there isn’t human living on this planet who does not know about the possible risks associated with Avandia. Given that Avandia sales have fallen into the abyss, GlaxoSmithKline (NYSE:GSK) is facing numerous class-action lawsuits and no physician with a working brain cell would prescribe Avandia ever again- for all practical purposes these zealots have already won their fight. Yet, not content with this real world victory they continue to press forward seeking complete and unabated capitulation to their viewpoint. Put another way they have enjoyed their time in the spotlight and want their fifteen minutes of fame to last a little longer.
As we have noted too many times little, if any, good has come from this whole mess. Isn’t it time we put this issue where it belongs and move onto some real issues like how we can help the two thirds of patients who are not properly controlling their diabetes and now have even fewer therapy options available to them. Wouldn’t that be a better allocation of resources than living in the past fighting over an issue that for all practical purposes has already been decided?