Wow, a thumbs down for stating fact, the detractors are really out now. Vera Bittner, the other cardio on the panel seems to be most concerned with safety. She recently voted against the combo with bupropion and naltrexone for the treatment of obesity and weight management in January 2011. She stated: “Despite the fact that the company has done an excellent job putting data together, I’m just not convinced that the benefits of this drug outweigh the cardiovascular risks". One of the risks was increased blood pressure, (note the overall panel approved the combo). In reviewing decision after decision is has become clear that nearly all no votes from doctors like Bittner are the result of safety concerns. That is why the ADCOMM is such a slam dunk for Vascepa since it does nothing except help patients and has zero safety concerns. All of the angst about the ADCOMM is FUD with literally no basis in fact.
He's on the ADCOMM and is a cardiologist so one of the votes and biggest voices to worry about. In 2009 he voted for expanded Crestor use in a population less than 130 mg/DL of cholesterol but with elevated hs-CRP. His reasoning: “I voted yes, because I’m concerned about the ethical issue of denying a majority of the population [preventive treatment]…But I do believe there are patients in this study who really shouldn’t receive this drug. Should we add CRP to the decision making? I think the study and the population convincingly say to me that we should, but I’m not sure how far with this we should go.” Just a quick note: Vascepa on top of statin therapy reduces hs-CRP 22% more. Dr. Hiatt also noted about the panel, "I have tremendous respect for the FDA and the advisory committee process. It is rigorous, free of conflicts, and I believe serves the American public. I have no criticism of the process and only admiration for those who serve in the FDA and my colleagues who participate in the process".
Vascepa helps people and doesn't cause concern. It provably reduces inflammation and reduces LDL-C on statins. It has no side effects for anybody. V reduces LDL-C levels on statins and reduces triglycerides to more normal levels; Lovaza raises LDL-C and lowers triglycerides less on optimized statin therapy than V. Vasepsa reduces inflammation far beyond Lovaza. Vascepa is proceeding into a multi-billion dollar market with ANCHOR approval. That approval is uncertain but with a track record of an 86% chance based on the 97-17 FDA approval rate in SPA history. Having the safest drug of all time doesn't hurt that equation. Betting against AMRN is weird. .
Scary, the crowd likes GSK and others so much that they'll deny patients the best treatment. That's not the way it works I hope. He compares a poorly run study with perfectly run studies, but who cares, let's scare everybody.