“All the talk about God and all the books about God will never give you a single breath.”

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According to Sathya Sai Baba …

“Breath is God: the name of God and the form of God.”

A California physician treated a woman who developed a large gash in her esophagus from swallowing a half-chewed chip.

“Icosapent ethyl (Vascepa) is a purified preparation of the omega-3 fatty acid eicosapentaenoic acid, which is marketed by Amarin Pharma based in Ireland. The product was initially approved by the US Food and Drug Administration for the use of a high dose (4g/day) in the treatment of hypertriglyceridaemia. On the basis of the results of the REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl Intervention Trial), the agency later granted a label extension to include the additional indication of a reduction in risk of cardiovascular events in persons with serum triglyceride levels of 150mg/dL or greater and established cardiovascular disease or diabetes. Data supporting the efficacy of omega-3 fatty acids in the prevention of cardiovascular disease have been inconsistent and controversial. The story of the development of icosapent ethyl has been fraught with challenges, including the invalidation of six core patents on the product, and recently, the completion of a new clinical trial, STRENGTH (Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia), that directly contradicts REDUCE-IT and calls into question whether icosapent ethyl is actually effective in the secondary prevention of cardiovascular events.”

According to the same source …

“The story of Vascepa, which is still unfolding, is a telling example of the intersection between drug development and the law. In this circumstance, the Irish company Amarin prevailed in an important lawsuit against the FDA involving off-label promotion of Vascepa, a case that has had significant ramifications for First Amendment coverage of commercial free speech. Success in that lawsuit, however, was followed by a major setback in a separate lawsuit resulting in invalidation of Amarin’s core patents on Vascepa. The patent invalidation, along with the results of the STRENGTH trial, which call into question the very efficacy of the drug, has placed the future of this product in considerable jeopardy.”

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“Oh, but the pusher is a monster. Good God, he’s not a natural man.”