rosey...
Reflecting on the "poison" scene in "The Princess Bride"...If someone knew the fix was in, they would not likely tell AF. If AF really had this information, why would he go public with it. The less in on it, the greater the shock value on the price.
Grand conspiracies are more fragile than kites in a hurricane. The sad truth here is the AdCom needed no conspiracy. What it did require was an opinion held at FDA. The AdCom panel members, the voters, were hardly experts on the topic they were convened to make judgement on. Half the members were not practicing MDs. Of the members that should of had some knowledge of the field, there were only six including a specialist in pediatrics. At least four of the cardiologist had conflicts which might have made them less than warm to the idea of a new n-3 drug. None of them had real expertise about n-3s and likely looked at Vascepa as medical grade "Fish Oil".
Of the panel, the only one I would have questioned about a possible agenda was Hiatt. He did his best to control the morning session and introduced stupid arguments regarding V's safety (bleeding and blood sugar alterations) that had absolutely no validity, but were enough to worry anyone who did not understand them. Later in the afternoon he shed a few "crocodile tears" over poor Amarin (after trying to bury it in the AM.).
The meeting was carefully orchestrated by the FDA. There were clinicians brought in by Amarin including Dr. Marvin Miller who did a great job explaining V's wonderful properties, but these were simply ignored by FDA. It was perfectly clear how the FDA felt about the drug and also clear the meeting was designed to get the result FDA wanted which was a negative vote. The famous "question" basically asked how much confidence do you have that the changes in lipid parameters (trig lowering), seen in ANCHOR, will translate into reduced CVD risk. Well the assumptions leading into the development of V was lowering trigs and non HDL without raising LDL-C would lead to lower CVD risk. But the ANCHOR trial itself was not designed in any fashion as a statement on lowering CVD risk. So considering ANCHOR alone, it offered zero proof that lower trigs mean lower risk...So this question was really a "yes or no question" and the correct answers was..no proof. Two of the panel actually got the answer wrong.
Was the AdCom rigged? IMO..yes..no doubt about it. Was this a conspiracy in the FDA...Possibly. The problem is the number of people involved in the FDA would be substantial. Maybe I'm underestimating the hierarchy factor, the "Eichmann" factor. We do know Hiatt was getting money from AZN. Colman is dead. Hamburg would not be in on this. Early on I assumed the SPA decision occurred at top level, I now believe FDA's arrogance starts right from the basement level and the higher ups are not really keeping an eye on their juniors. The operating mantra in FDA.."Don't rock the boat"..basic principle..united we stand.
Question...is a congressional investigation in FDA's future.
":>) JL
