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What We're Reading: Government Wants Clinical Trial Findings More Widely Available
September 19, 2016 – AJMC Staff
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What We're Reading: Government Wants Clinical Trial Findings More Widely Available

AJMC Staff
What we're reading, September 19, 2016: the government update rules on reporting clinical trial findings; hospitals say they aren't receiving discounts for Valeant's heart drugs; and the FDA approved the first treatment for Duchenne muscular dystrophy.
Universities and institutions that do not comply with new policies to make findings from clinical trials more widely available could find they are losing out on funding. According to The Washington Post, the government has unveiled new rules to encourage more participation in research and to spread those findings faster. The updated rules echo a threat Vice President Joe Biden made in June regarding the research findings for the Cancer Moonshot initiative. The new rules from HHS also include a need for more information on research that failed to achieve goals.

Valeant Pharmaceuticals said it would give discounts to hospitals for 2 heart drugs, but some hospitals say they haven’t seen a reduction in cost for these expensive treatments. Hospitals have reported a number of issues including not knowing to negotiate for the discounts instead of receiving them automatically, reported Bloomberg. Valeant’s CEO said it possible some hospitals using group purchasing organizations simply haven’t had the discounts passed along to them yet, but that all hospitals are eligible for the discounts and should be receiving them.

The FDA has approved the first drug to treat Duchenne muscular dystrophy. The agency overruled medical staffers who earlier this year questioned the effectiveness of the drug, according to STAT. However, the FDA has acknowledged the unmet need of patients with this rare disease. Sarepta Therapeutics will have to conduct a 2-year trial to verify the clinical benefit, and the FDA could withdraw approval if the trial ultimately fails.

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