1984 was not supposed to be an instruction manual. First posted 2014

Recall that FDA’s Device Center was recently shown to make political decisions re medical device approvals, and to grandfather in devices on the basis of earlier approvals of very different devices.  GAO wrote several damning reports including this one from June 2009: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments. …

CDC published a report October 1 on its very expensive, 43 month-long trial of anthrax vaccine, but inexplicably discussed only the first 7 months and only 65% of the subjects. No explanation was given for why only partial data were provided in this important paper. Bloomberg may provide the reason; the selected data discussed in…

From the NY Times: In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, federal prosecutors announced Monday. The agreement also…

I have been meaning to update the information on Covid-19 testing, since it has been such a confusing subject. This post will only cover antibody (aka serology) tests.  And most of the post will be direct quotes from the FDA and CDC websites, because you would probably not believe me if I simply paraphrased the…

Scientist’s Working Group on Chemical and Biologic Weapons  Center for Arms Control and Nonproliferation  February 17, 2014  Introduction: The danger to world or regional public health from the escape from microbiology laboratories of pathogens capable of causing pandemics, or Potentially Pandemic Pathogens (PPPs) has been the subject of considerable discussion1,2,3,4 including mathematical modeling of the…

DoD produced and distributed a long memo alleging that both short and long-term safety of anthrax vaccine have been established: “There are no known long-term patterns of side effects from the anthrax vaccine, based on an ongoing series of studies…” I decided to annotate the document to correct many of its errors and omissions.