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On October 16th 2013, the FDA hosted an advisory committee meeting (ADCOM) for what most everyone expected to be nothing less than a coronation event for Vascepa, a new drug to treat high triglycerides and dyslipidemia, both considered significant risk factors for cardiovascular disease (CVD). In Japan, a large outcomes study of the same compound as Vascepa showed a 53% reduction in CVD events in 18,000 subjects over 5 years. The U.S. spends $300 billion a year treating CVD and 800,000 U.S. citizens die each year from CVD. A 25% reduction in CVD events would shrink treatment costs by $50 - $75 billion, not to mention the 100,000 and 200,000 lives that would be saved each year.
The FDA had previously made an agreement with Amarin, the drug's sponsor, called a special protocol assessment (SPA), which outlined the steps Vascepa would have to achieve to win approval. These milestones included: (1) successful clinical trials and (2) the creation of a large outcomes study - similar to what was conducted in Japan, but to FDA specifications - with at least 50% enrollment. Both of these requirements were exceeded by Amarin.
For these reasons, Vascepa was among the most anticipated new preventive therapies for cardiovascular disease in over 20 years. What made Vascepa unique was that it lowered every key lipid marker for CVD, including Triglycerides, LDLs, and inflammation. It did so without any side effects and a safety profile equal to placebo. With such a remarkable safety profile and proven efficacy, the FDA would surely grant Vascepa approval, or least that's what everyone anticipated.
In an unprecedented move, the FDA systematically disparaged Vascepa to the ADCOM panel, first casting doubt on its efficacy by pointing to the 4 grams mineral oil used in the trials as "possibly" affecting the statin potency. No such effect has been observed anywhere in the world and the mere fact the FDA approved the use of mineral oil as placebo in the clinical trials is inherently contradictory.
After its attempt to diminish the drug's efficacy, the FDA pulled out studies of Fibrate and Niacin drugs that had failed to reduce CVD events, arguing if these drugs had failed, so too would Vascepa. For a Government agency founded on scientific principle, it's unconscionable to rely on such "pseudo-science" when so much is at stake. Putting the fact that these are entirely different compounds aside, consider the subjects studied in these failed trials had normal triglyceride levels. If Statin drugs were evaluated in the same manner, they would not have reached the market for 15 years - it only takes common sense to understand CVD risk is difficult to lower if your LDL-C levels are already in the normal range.
The use of surrogate markers such as LDL-C levels in clinical trials, and not 5 year outcomes studies, has long been the basis used by the FDA as a means to approve current CVD drugs - all of which have serious side effects. But it appears the FDA is now saying a different standard of approval is needed for a drug that is as safe as a placebo.
The EPA Drug Initiative was formed in reaction to what was seen as a smear campaign and an arbitrary "moving of the goal posts", designed to prevent Vascepa from reaching the market at all costs. Thirteen days following the ADCOM, the FDA rescinded their agreement with Amarin for approving Vascepa, on the grounds that lowering high triglycerides was not considered to be associated with lowering CVD risk; this, despite lowering triglycerides and dyslipidemia being considered the standard of care throughout the United States.
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