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[Slashdot] - Unsealed Emails Show How J&J Shaped Report On Talc's Links To Cancer


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An anonymous reader quotes a report from Bloomberg: Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer. The emails -- unsealed in the state of Mississippi's lawsuit against J&J over its refusal to add a safety warning -- show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powders' health risks. They also show the researchers changed the final version of their report at the companies' behest. The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product. The emails among executives of J&J and Rio Tinto Minerals, its supplier at the time, provide a behind-the-scenes glimpse of dealings between companies and their industry group that successfully fended off a cancer warning on talc-based powders for nearly 40 years. Now, almost 39,000 users and their families are suing J&J, most claiming their ovarian cancers and those of loved ones were linked to asbestos, the potent carcinogen in the products pulled from U.S. and Canadian shelves in May 2020. Dependence on industry data creates a situation that's ripe for lobbyists to exert pressure on the FDA. The unsealed emails pull back the curtain on how such efforts get launched, who pays for them, and who has a hand in delivering the final product to regulators. While the practice of companies having a say in industry group submissions to the FDA isn't new or illegal, the emails reveal just how involved J&J got in a report meant to assess product safety -- down to selecting individual scientists to produce it and having them write an executive summary. J&J denied any wrongdoing in its decision not to acknowledge its input to the report that the PCPC lobbying group sent to the FDA. [...] FDA officials acknowledged they weighed the PCPC's response to the citizens' petitions demanding a warning for talc-based powders before finding there was "inconclusive evidence" the mineral caused ovarian and other forms of cancer. "The FDA reviewed and considered all of the information submitted to us in the two petitions, the comments received in response to the petitions, and additional scientific information," said Tara Rabin, a spokeswoman.

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