Friday, May 26, 2017 8:10:10 AM
The error the FDA made was granting a SPA for ANCHOR in the first place.
I am in agreement with the conclusion of the ACCELERATE trial investigators. That trial, testing a CETP inhibitor and published last week, showed a 35% reduction in LDL-C and a 130% increase in HDL. No benefit in actual outcomes were observed. They concluded:
"The negative results of the current trial therefore reinforce the principle that biologic plausibility and beneficial effects on surrogate end points do not obviate the need for adequately powered outcome trials of new therapeutic agents".
As much as I hate to admit it, the FDA made the correct call. As a tax payer and insured person, I don't want to see my rates go up because people are being treated with ineffective drugs. Not only would it raise health care costs, it would stymie new advancements.
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