A real Turkey

A real Turkey

Just in time for the Thanksgiving holiday the FDA has cooked up their own turkey for the wacky world of diabetes with their announcement   that they are removing the restrictions placed on Avandia. According to Janet Woodcock, the agency’s drug czar; “Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug.  Given these new results, our level of concern is considerably less reduced; thus, we are requiring the removal of certain prescribing restrictions.”

Not surprisingly Dr. Steven Nissen the crusading cardiologist whose infamous meta-analysis started this whole mess is not pleased with this decision stating; “I do not think this decision is in the public interest.”

Shaking their heads are the folks at GlaxoSmithKline (NYSE:GSK), the makers of Avandia, who have witnessed their drug go from a multi-billion dollar blockbuster to multi-billion dollar headache.

Diabetic Investor would like to say that this move by the FDA puts an end once and for all to the controversy but we cannot. The fact is the fallout from the controversy continues to impact the diabetes drug approval process and has placed unnecessary burdens on companies that are developing new diabetes medications. As we have witnessed time and time again because of the controversy new medications are being subjected to overly stringent standards, standards that have caused several new drugs to be rejected or seriously delayed from reaching the market.

Diabetic Investor would like to think that everyone has learned from this experience but here too we are not optimistic. As we have noted since this controversy burst onto the scene years ago there really are no winners here and as has become standard operating procedure patients with diabetes and the physicians that treat them are the ones who got the shaft.  Even worse because of the controversy patients are being denied new medications while physicians are even more hesitant to prescribe newly approved drugs worried they too might become the target of a witch hunt.

In fact this process is playing itself out all over with the recent attacks on GLP-1 therapies.  Once again a group of zealots have raised concerns over these increasingly popular and effective therapies. Once again the supposed science behind these concerns is not definitive or clear by any stretch of the imagination. Once again these zealots have taken to the press to air their concerns making the media and unwitting ally in their attempt to gain notoriety. Once again these zealots claim to have the patient’s best interest at heart but in reality want nothing more than their 15 minutes of fame.

And just who do we have to thank for this, none other than the most famous zealot of all, that crusading cardiologist Dr. Nissen.  Thanks to the good doctor the diabetes drug world has been turned upside down and unfortunately will never be the same. Thanks to the good doctor patients must wait a longer than reasonable amount of time to see new drugs reach the market. Thanks to the good doctor the physicians that treat these patients can no longer answer a simple question; “Is this drug safe?” with any degree of certainty. Thanks to the good doctor companies like GSK must live in constant fear that any zealot armed with a data set, even when that data set is inconclusive, will become the target of class action attorneys.

Diabetic Investor realizes that Thanksgiving is supposed to be a time when we all give thanks, to appreciate the good things in life. A time to spend with family, watch some football, shop at crazy hours and turn our attention to the coming of Christmas and the New Year.  It’s also a time for that traditional Thanksgiving turkey dinner and all the fixings that go with it.  Yet this year it’s the good doctor who has severed up one big bad bird, a true turkey.  Hope your happy Dr. Nissen with the mess you started, nurtured and used to push yourself into the limelight.

To everyone other than the good doctor, Diabetic Investor would like to wish a Happy Thanksgiving.