Huge Part Of Potential Patient Pool Excluded In Aduhelm Clinical Trials
A study found as many as 92% of Medicare beneficiaries, who'd comprise a key portion of potential patients, would have been excluded from Biogen's Alzheimer's drug trials. Meanwhile, an analysis of drug labeling says a third of the uses for cancer drugs stay on labels after being unconfirmed.
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Biogen Trials For Alzheimer's Drug Excluded Much Of Targeted Population
A new analysis finds that the clinical trials conducted by Biogen (BIIB) for its controversial Alzheimer’s treatment would have excluded as many as 92% of Medicare beneficiaries — a key portion of the targeted patient population — based on their age or existing medical conditions. Breaking it down, a total of 92% of patients with Alzheimer’s and related disorders, 91% with Alzheimer’s specifically, and 85.5% with mild cognitive impairment met at least one of the criteria for exclusion from the studies, according to the analysis published in JAMA. (Silverman, 9/10)
In other pharmaceutical industry news —
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Cancer Drug Indications Remain On Labels After Trials Fail To Confirm Benefits
One-third of the uses for cancer drugs granted speedy approvals remained on product labeling even after follow-up studies failed to confirm their benefits, according to a new analysis in BMJ. And at the same time, widely-read guidelines for physicians also continued to recommend these treatments. At issue is the accelerated approval program created nearly three decades ago to hasten availability of drugs for serious conditions with unmet medical needs. However, since the program allows regulators to rely on surrogate measures that are likely to prove effectiveness in exchange for access, drug makers must run trials to later verify the medicines are benefiting patients as intended. (Silverman, 9/13)
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A Former Facebook Exec Tries His Hand At Drug Development
After building Facebook’s search bar into a pivotal part of its platform, Tom Stocky is setting his sights on a new target: biology. The onetime tech executive decided to switch tracks after taking a weekly biotech class at Stanford. “I was inspired. I thought, maybe there’s something I can do to deliver medications faster to people,” Stocky, who recently joined AI-powered drug development startup Insitro as vice president of product, told STAT. (Brodwin, 9/13)
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Aubrey De Grey Made Sexual Comments To Two Scientists, Investigator Finds
Aubrey de Grey, the anti-aging research pioneer who was removed last month as chief scientific officer of the SENS Research Foundation, made offensive sexual comments to two prominent, young entrepreneurs in the longevity community, according to the findings of an independent investigation conducted at the request of the organization. Released Friday night, an 18-page executive summary of the report from the law firm Van Dermyden Makus gave corroborating evidence for previous allegations made by Laura Deming and Celine Halioua. Though they are not named in the report, the women confirmed to STAT that they are the two complainants. (Molteni, 9/11)
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A Vaccine Veteran Steps Away From The NIH, Looking Out Toward The World
In early January 2020, most of the world hadn’t yet awakened to the fact that life was soon to change profoundly. But Barney Graham saw a possible need coming, and set out to fill it. Graham was deputy director of the National Institutes of Health’s Vaccine Research Center and chief of the viral pathogenesis laboratory. Mere days after Chinese scientists posted to an international database the genetic sequence of a new, as yet unnamed coronavirus that was causing a fast-expanding outbreak in Wuhan, Graham and his colleague Kizzmekia Corbett had designed the structure for a vaccine that later became the prototype for Moderna’s Covid-19 shot and laid the foundation for Covid vaccines made by Johnson & Johnson, Novavax, and others. (Branswell, 9/13)
