Welcome to the circus
This morning the FDA posted the draft meeting materials for the upcoming advisory panel on Avandia (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm191113.htm) and as Diabetic Investor suspected this meeting is going to be nothing more than a three ring circus. Taking a quick look at the various presentations, there are 16 sets of presentations, it’s obvious that all these experts, whether they are from the FDA, academia, research, etc. are like dogs looking to mark their territory. Also as anticipated the debate will center on meta-analysis and what data should or should not have been included in the meta-analysis.
Besides the presentations Diabetic Investor recommends taking a look at the questions the committee is supposed to answer. Read through each question and ask yourself how after two days of circus acts, will the committee be able to digest all the “facts” and reach a reasonable conclusion. Diabetic Investor also has a suggestion for anyone attending the circus – don’t expect to catch an earlier flight home as this meeting which is scheduled to end at around 5pm EST next Wednesday will likely run well over.
As we noted yesterday Diabetic Investor sees little good coming out of this meeting and looking over the material posted today only reinforces that view. No one, not the FDA, not Dr. Nissen or Dr. Graham and not GlaxoSmithKline (NYSE:GSK) will come out of this meeting looking any better than when they went in. There will accusations against GSK painting them as the big, bad pharma company concerned only with profits and ignoring the interest of the patients. There will counter claims that analytical methods used by Nissen and Graham are flawed therefore making their complete analysis flawed. As we noted before everyone is stacking out their territory and protecting their turf.
Normally Diabetic Investor would have little sympathy for anyone who would participate in this circus but our hearts go out to the 33 voting members of the committee. No matter what you think of this process these people have the daunting task of shifting through all this data, spending two days listening to all the rancor and then have to vote. A vote, which should be noted, that may or may not be taken into consideration by the full FDA. Sources have told Diabetic Investor that the division within the FDA is so strong that it really won’t make a difference what the panel recommends.
The reality here is that this whole meeting is more for show than substance. Even after all the data is presented and the various experts make their respective points no one in that room will have a clear answer to the central question; should Avandia be pulled from the market. In essence two years after the initial meta-analysis was leaked to the public we’ll be in the exact same place. Frankly this whole process has accomplished nothing more than long term harm to drug development and the drug approval process. The FDA is more cautious than ever before and drug companies have to play a game where the rules keep changing while the game is being played.
These so-called patient advocates, who claim to be doing this to protect the public have actually pushed back patient care as studies have shown that as a direct result of this controversy patients are even less compliant with their therapy regimen. Wonder how these so-called “experts” feel about that? Diabetic Investor would like to ask them but they seem pretty busy doing television interviews and promoting themselves for bigger and more lucrative opportunities.
Meanwhile outside the circus, in the real world, there is a glimmer of hope as most physicians have been smart enough to ignore all the noise and switched their patients from Avandia to alternate medications; that is until the next meta-analysis comes along and this process starts all over. If there is one thing we can bank on in the diabetes drug world its controversy.
Hopefully patients with diabetes will have better things to do and see this circus for what it truly is a bunch of so-called experts who have nothing better to do than to waste taxpayer’s money. Diabetic Investor has no doubt these “experts” are true believers that they are right and this mess will somehow make drugs safer and the FDA will become a better agency as a result. Sadly this will not be the case. When it’s all over and the dust settles we’ll be no better off than we were before. Even more unfortunate diabetes continues to grow at epidemic rates and the majority of patients are not properly controlling their diabetes. This fact won’t change and that’s the saddest fact of all.