Off The Deep End

Off The Deep End

Late this afternoon Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) announced they have received a complete response letter from the FDA for Bydureon. According to a press release issued by the companies:

“In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA’s March 15 complete response letter. REMS and product labeling discussions will continue following submission of the additional data. The companies’ goal is to submit their reply to the complete response letter by the end of 2011, pending discussions with the FDA. Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.”

Needless to say this not the news anyone had hoped for and shares of Amylin, Lilly and Alkermes were hammered in afterhours trading.

Listening to a replay of the conference call conducted by Amylin late this afternoon and talking with major leaders in the diabetes community it’s obvious the complete response letter is further confirmation of just how far off the deep end the FDA has a fallen.  As Diabetic Investor has been reporting the FDA has become ultraconservative since the Avandia controversy became public and this action shows just how much the FDA has lost total touch with reality.

While Bydureon is not a perfect drug, after reviewing all relevant data there is no question the benefits of Bydureon far outweigh possible risks. However, the FDA has once again shown they are actively looking for any issue, no matter how farfetched, not to approve new treatments for diabetes.

Given that two-thirds of all patients with diabetes are not achieving adequate control, the cost of poorly controlled diabetes is spiraling out of control and that millions of patients will needless suffer, Diabetic Investor is now convinced the FDA has lost all touch with reality.  This is not paralysis by analysis; this is an agency totally out of touch with reality, which has strayed a million miles from their mission, a mission which states they should use scientific evidence when making their decisions.

Since the Avandia controversy started Diabetic Investor has looked at this issue from a very simple view point; what good, if any, will come from it. We have wondered how Dr. Nissen and his publicity seeking cohorts feel today. Are they pleased with the mess they have created? Are they proud of the fact that patients have to wait longer and possibly never have new treatments that could save their lives? Do they believe patients are being better served by their efforts? Are they pleased that internally the FDA is at odds with each other?

According to sources inside the FDA, the fallout from the Avandia controversy isn’t over. While the agency has tried to put forth a public show of unity, internally the members of the agency are at odds with each other. Rather than put up with all this bickering, backstabbing and power plays Diabetic Investor is hearing that several key members of the agency are about to call it quits and take their talents to the private sector. Given what’s going on at the agency and the way our elected officials rake these people over the coals any chance they get, Diabetic Investor can’t blame them.

Still there is no excuse for the agency’s action with Bydureon. This is more than a travesty; this is an outright example of how badly our system is broken.  Frankly ever member of the FDA and those elected officials who are more concerned with how they look on TV should be ashamed of themselves. You can also add to this list Dr. Nissen and his followers who care more about remaining in the spotlight than helping patients.

In the real world all drugs carry some degree of risk and there is no such thing as truly adverse event free drug. In the real world there is risk/reward analysis is used every day and using scientific evidence, not fear of making a mistake, is used to make decisions. In the real world two thirds of patients with diabetes are not achieving control and are in desperate need of new therapies that will help them achieve control. In the real world therapy non-compliance is major reason these patients are not achieving control and drugs like Bydureon would help stem this problem.

The bottom line here is the blood of millions of patients with diabetes is now on the hands of the FDA, those fat cat elected officials who care only about looking like they doing good than actually doing good and Dr. Nissen and his supporters who could care less about helping patients and more about being on TV.  This entire group should be ashamed of themselves as they do not know the damage they have created and even worse, they could don’t really care. This is truly a sad day.