to bog and birz...
I have never been a conspiracy buff. Stupidity has proven itself to be the greatest force dictating the course of history. Stupidity has all the advantages over brilliance, simply because it does not need to justify itself by logic or fact.
There is however an important interval in the Vascepa story. This was the period from the spring of 2012 to the October fest Adcomm.. The facts are the FDA's attitude toward Vascepa changed radically and inexplicidly towards the company after accepting the company's SNDA application, without comment or qualification. Almost forgotten at this late date was the reason why AMR101 (Vascepa) was being celebrated. The reason was the drug lowered Trigs, acknowledged by the FDA at that time as a CVD risk factor, but did not raise LDL-C, considered then as now by the FDA as the most important risk marker.
This raises some questions. Important studies such as the Framingham study had already put LDL-C in fourth or fifth place behind such factors as LDL-P, APOb..The most likely explanation why the LDL-C remained on top was that statins lower LDL-C. Statins generate more revenues than almost any other drugs and the manufacturers form a cartel empowered by money and dedicated to maintaining their position at the top of the legal drug business. The truth is there is actually only luke warm proof that statins are effective in treating secondarty intervention CVD risk, and almost no credible evidence they are effective in primary intervention, including the embarrassing fact that over 50% of first time heart attacks occur in people with normal or low LDL-C. These ( stupidity) facts have been virtually ignored by the FDA which clammers down its own pathway, blandly ignoring the facts and inventing its own Alice in Wonderland picture of cardio vascular disease. It should not escape anyones attention that the statin cartel is the beneficiary of the FDA's "crazy ideas"
So..I guess I'm saying what I want is to go for the juglar here..Stupidity does not 'butter the turnips". IMO we can make a very good case, not necessarily against individuals, but against organizations. We have some important questions to ask. Why did the FDA wait until the last minute when all their arguments were based information that was years old. How could the FDA use information derived from drugs which do not even tangentially relate to Vascepa, and trials that clearly do not say anything about the effects of trig lowering? Why has the FDA ignored recent scientific evidence that puts trig lowering in a favorable light. Why is the FDA so obtuse when it comes to the vast scientific literature and the population studies that support the AA/EPA ratio as a CVD risk factor? Why did they ignore JELIS, the only trial that did use EPA? JELIS had some pimples, but nothing like the total body sores of ACCORD or THRIVE..
We want to get FDA personal up in front of the cameras and ask them about these questions...Americans, like me would like to find out the answers to these questions...There are lives in the balance.
":>) JL
AI
