geoffrey modest medical blogs

  The FDA is currently seeking a review of their very recent recommendations approving the new Biogen drug aducanumab, which purportedly helps treat Alzheimer’s disease. This FDA review request was engendered by a STAT analysis suggesting significant drug company shenanigans (see  https://edition.pagesuite.com/popovers/dynamic_article_popover.aspx?artguid=a5dc1cb2-8885-45ed-97ed-c0736cd1d87f&appid=1165   )    Details:  -- acting FDA Commissioner Janet Woodcock just asked the independent Office of Inspector General (OIG) for an investigation into the approval of aducanumab by the FDA, within just one month of its approval  -- the OIG does have broad power to subpoena internal documents and conduct interviews under oath as well as pursue potential criminal violations through the Department of Justice  -- this current potential investigation is quite unusual in the FDA, though the OIG is currently assessing the monitoring of the sa...

  A French study documented an improved immunologic response after a third dose of the Pfizer vaccine in immunocompromised patients (see  covid immunocomp getting 3rd dose nejm2021  in dropbox or DOI: 10.1056/NEJMc2108861 )    Details:  -- 101 consecutive solid organ transplant recipients were given a third dose of the Pfizer vaccine  -- mean age 58, 62% men, in a retrospective study  -- transplant recipients: 78 kidney, 12 liver, 8 lung or heart, and 3 pancreas   -- time from transplant to initiating vaccination was 98 months  -- first two doses were given one month apart, third dose was 61 days after the second dose  -- medications: glucocorticoids 87%, calcineurin inhibitors 79%, mycophenolic acid 63%, mammalian target of rapamycin inhibitors 30%, belatacept 12%  -- antibody levels were assessed against the SARS-CoV-2 spike protein    Results:  -- prevalence of anti-SARS-CoV-2 antibodies:   ...