Tech Times, September 20, 2016. The U.S. Food and Drug Administration (FDA) has approved the first drug for treating patients with Duchenne muscular dystrophy. “The agency has set a dangerous precedent,” said National Center for Health Research president Diana Zuckerman. “To prove something works, you have to compare it to something else — a placebo or a treatment. They didn’t do that.”
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FDA Approves First Drug to Treat Rare Form of Muscular Dystrophy
Kaiser Health News, September 19, 2016. The Food and Drug Administration Monday approved the first drug to treat Duchenne muscular dystrophy, a rare and lethal muscle weakening disorder that affects about 15,000 Americans. Diana Zuckerman, president of the National Center for Health Research, said “it sets a dangerous precedent if the FDA is going to start approving drugs that aren’t compared to anything.”
Read More »Did the FDA Set ‘a Dangerous Precedent’ With Its Latest Drug Approval?
STAT, September 19, 2016. The approval sets “a dangerous precedent,” said Diana Zuckerman, president of the National Center for Health Research. “A decade from now, will we look back at this approval as a turning point when the FDA ceased to function as a public health agency?”
Read More »FDA Grants Accelerated Approval to Controversial Muscular Dystrophy Drug
Washington Post, September 19, 2016. Despite lack of proof that the drug will help patients, FDA approves a controversial drug. NCHR president Diana Zuckerman asks “is there any drug the FDA won’t approve?”
Read More »Feds to Crack Down on Those Who Fail to Report Clinical Trials
Politico Pro, September 16, 2016. Drug companies and research institutions will have to publicly report more clinical trial data, including results that show their products or experiments failed, under new policies rolled out Friday by HHS. But NCHR president criticizes their decision not to provide summaries of treatment results that patients can understand.
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