Boston Globe, May 22, 2023: Boston Globe quotes NCHR and other experts explaining why we are concerned that Sarepta’s gene therapy for Duchenne Muscular Dystrophy isn’t proven to work and has substantial risks. If it doesn’t work, patients who use it will not be able to try other, potentially better gene therapies in the future.Read More »
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Unproven Drugs Reap Billions for Years After Taking FDA Shortcut
Bloomberg News, May 12, 2023: Accelerated approval of Sarepta drugs for Duchenne muscular dystrophy makes billions of dollars for the company even though the drugs aren’t proven to work. We call Sarepta decisions a poster child for inexcusable FDA lack of oversight or enforcement.Read More »
FDA advisers recommend accelerated approval of a Sarepta gene therapy
Boston Globe, May 12, 2023: FDA advisers recommended accelerated approval of Sarepta gene therapy for Duchenne Muscular Dystrophy, despite questionable results and worrisome risks. We testified that lowering FDA standards harms all families, and that Duchenne patients deserve free access to affordable treatments until drugs are proven to work.Read More »
Alzheimer’s drug donanemab: what promising trial means for treatments
Nature, May 4, 2023: Nature news article quotes Eli Lilly’s press release claiming donanemab delays cognitive decline from Alzheimer’s Disease, but we ask if the small benefit is meaningful to patients with mild cognitive impairment compared to the risk of death or brain swelling or bleeding.Read More »
FDA’s new plan to study opioids’ effectiveness faces resistance
STAT, April 19, 2023: An FDA proposal to study whether opioids are effective as a chronic pain treatment is facing major resistance from addiction and pain care experts who are not paid by industry. We told STAT that the proposed clinical trial is unethical because it will provide no new information and would make some patients more dependent on opioids.Read More »