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One reason drugs may be used for years before risks become evident is that we have no active drug surveillance system-Mark McClellan, FDA Commissioner
Although no significant improvements in drug safety occurred while he was FDA Commissioner from 2002 to 2004, Dr. McClellan now acknowledges the need for improved safety surveillance at FDA, in a commentary in the April 26, 2007 New England Journal of Medicine. This issue contains several articles on FDA assessment of drug safety. Jerry Avorn,…
Then and Now: Parallels and Lessons for COVID vaccines from the Anthrax vaccine program
In March of 2021, Dr. Simone Gold of AFLDS asked me to write weekly short articles on the parallels between the anthrax vaccine debacle twenty years earlier and the COVID vaccine debacle today, titled “Then and Now.” AFLDS was getting itself organized, used a lot of volunteer labor, and it never got around to setting…
Sweden and Denmark say no Moderna for those under 30: Too Risky/ Bloomberg
https://www.bloomberg.com/news/articles/2021-10-06/sweden-halts-moderna-s-covid-vaccine-for-people-aged-30-or-under Sweden and Denmark decided to pause vaccinations with Moderna Inc.’s Covid-19 shot for younger people because of potential side effects. The Swedish health authority Wednesday cited new data on the increased risk of heart inflammation as a reason for the pause for those aged 30 and under. Denmark will stop giving the shot to…
Editorial: Anthrax Attacks Still A Mystery After 10 Years/ Hartford Courant
From the Courant: October 5, 2011 After the World Trade Center was destroyed 10 years ago, death arrived once again — in the mail. Anthrax, a terrifying and deadly bacterium that multiplies rapidly when inhaled, began to appear in letters sent to a variety of places. Among these were the New York Post, the offices…
The US is not an honest broker: a) impenetrable last-minute legalese, b) a history of making reservations that enable the US to dodge compliance, and c) scuttling carefully negotiated agreements
3 Examples of how the US avoids the traps it sets for others Meryl Nass May 29, 2024 Example #1. Here is a resolution the US and a handful of its hangers-on proposed for the WHA to approve today. It is so full of references to other documents (by number) that it is impossible to…
Anthrax vaccine – To the victor, the spoils / Scientific American blogs
From infectious disease MD Judith Stone at Scientific American comes this comprehensive look at what is behind the push to keep buying anthrax vaccine and even give it to children: In my last post, we began to play “Follow the Money” to better understand the history of the anthrax vaccine and the current proposal to…