August 26, 2008
As expected this evenings conference call on Byetta from Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) was comprehensive, replete with facts and informative. The main areas addressed during the question and answer session were:
1. Is there a casual relationship between Byetta and Pancreatitis?
2. Will there be a Black Box Warning?
3. Will this affect the submission of Byetta LAR to the FDA?
4. Has there been any noticeable change in prescriptions?
1. While it is always possible that Byetta usage causes pancreatitis, the facts indicate there is not a causal relationship.
2. This is possibility but also unlikely based on all available evidence.
The real question is where we go from here. Diabetic Investor considers it highly unlikely that the FDA would require a Black Box warning for the Byetta label. Frankly the evidence just isn’t there and this move would create even more problems than it would solve. Already physicians and patients have been told of the danger of using Avandia and as Diabetic Investor pointed out in earlier alerts on this subject that each therapy option for diabetes carries known adverse events. While some may point out that a Black Box warning does not indicate a causal relationship, in the real world it would effectively kill the drug in the mind of physicians and patients.
Perhaps the best news coming out of this evenings call was there have no cases of pancreatitis in over 600 patients that have used Byetta LAR. It was equally good news to hear that in discussions with the FDA over Byetta LAR’s submission the pancreatitis issue was not brought up. The company restated what they had indicated earlier that the FDA was more concerned with manufacturing LAR in commercial scale.
Truth be told Amylin and Lilly did a fine job dealing with this issue. In reality there was little they could do as the information was already in the public domain and many have already made up their minds on the issue. Now we are left to wait for what label changes are worked out between the FDA, Lilly and Amylin.
The problem is here is while patients, physicians and investors have suffered due to the FDA’s irresponsible action, what happens to the FDA. While the FDA will claim they were just doing their job and protecting the public, the facts do not support this claim. The FDA publicly stated the there was no indication of causation here and that the events were “rare and uncommon.”
The truth is the FDA is hyper-sensitive to any possible issue after Rezulin, Avandia and Vioxx – just to name a few of the agency’s more recent blunders. Rather than fully investigate and follow their mission to use evidence based medicine, the FDA over-reacted.
Unfortunately the FDA will not pay for their careless actions and the real people who get hurt here are the patients and the physicians who treat them. Once again government bureaucrats drop the ball and it lands where it does the most damage. Even if the FDA did the unthinkable and actually issue some sort of statement clearing Byetta, the mercury is already out of the thermometer. They cannot undo the numerous press reports on their action or change public perception. The jury may have acquitted O J but in the minds of many he is guilty of murder.
When it comes to the law someone is supposed to be presumed innocent and proven guilty. The FDA however, appears to be following a different path inferring guilt without even conducting a full, fair and complete investigation. As Robert Ingersoll stated, “There is but one blasphemy, and that is injustice.”