by Dale | Feb 17, 2020 | Articles, DoD AVIP, Veteran
Mary PENDERGAST (FDA): As I indicated to you, it was not the type or quantity of information we would have hoped for. SHAYS (R-CT): That’s an understatement. PENDERGAST: It – it was. We don’t disagree with you. This was war. This was the first time, and...
by Dale | Feb 4, 2020 | Articles, DoD AVIP, Law, Science, Veteran
The manufacturing process for Anthrax Vaccine is not validated.[i] The anthrax vaccine’s manufacturer has had an interesting ownership history, beginning in 1968 as the Michigan Department of Public Health (MDPH), a public entity that manufactured the earliest vaccine...
by Dale | Jan 28, 2020 | Articles, DoD AVIP, ethics, Veteran
The first use of a human anthrax vaccine took place in 1954.[i] The primary purpose, like all vaccines, was to provide some prophylaxis for human beings from contracting the anthrax bacteria, which is typically found in cattle. Those most likely to come into contact...
by Dale | Jan 20, 2020 | Articles, DoD AVIP, Law, Marines, politics, Veteran
I didn’t even knock on Justin’s door, I busted in like Kreamer on a Seinfeld episode. Justin had a client sitting in front of his desk. “Sir–” Justin began as a young lance corporal turned around to see who had just come in. “Oh, shit. Sorry. When you’re done, could...
by Dale | Jan 13, 2020 | DoD AVIP, ethics, Philosophy, politics, tort law, Veteran
More can and must be done, however, to rebuild trust, to avoid repeating past mistakes, and to prevent future health consequences similar to those experienced during and after the Gulf War. Our troops must be assured that when we send them into battle, they will be...
by Dale | Jan 6, 2020 | Articles, DoD AVIP, Philosophy, politics, Veteran
The current regulations do not permit a determination that obtaining informed consent is otherwise not feasible or is contrary to the best interest of the subject . . . II. DOD’s Request . . .FDA assistance is also needed on the issue of informed consent. Under...