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Aducanumab & FDA transparency in the news. @US_FDA appears on the cusp of approval, & Biogen's market cap surged >$10B, but does the drug actually work? At least one expert FDA statistician isn't convinced. If the drug is approved, will FDA keep that expert's analysis secret? 1/ https://twitter.com/jsross119/status/1324029550431473664
Per STAT, FDA statistician Tristan Massie concluded that “there is no compelling, substantial evidence of treatment effect or disease slowing and that another study is needed to confirm or deny the positive study and the negative study.” 2/ https://www.statnews.com/2020/11/04/fda-scientists-appear-to-offer-major-endorsement-of-biogens-controversial-alzheimers-treatment/
In years past, we could have felt confident that FDA would disclose Massie's (& all experts') full analyses upon approval. For years, FDA published the analyses of each expert reviewer & review team, a vital source of data, & insights into concerns & dissent within FDA 3/
In fact, federal law requires FDA to publish its experts' individual "reviews." Statute even specifies, "[a] scientific review of an application is considered the work of the reviewer and shall not be altered by management or the reviewer once final." 4/ https://www.law.cornell.edu/uscode/text/21/355
Yet in recent months, FDA announced it will cease publishing its experts' individual reviews as a matter of course. It will shift to an "integrated review" format that consolidates all reviewers analyses into a single document approved by FDA management 5/ https://www.fda.gov/drugs/regulatory-science-research-and-education/modernizing-fdas-new-drugs-regulatory-program
FDA insists no meaningful information will be lost in the move to integrated reviews, but I have deep concerns, summarized in a short paper with @cmrherder & Peter Doshi: less transparency, possible suppression of dissent within FDA, & possibly illegal 7/7 https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2762578
Oops, the preceding tweet is 6/6, not 7/7. Will I ever successfully proofread a tweet? It is as if I have face blindness, but for recognizing typos in tweets. I swear, prospective co-authors and collaborators, I'm not like this in other formats.
