DANGEROUS DRUG LICENSING GAME THE FDA PLAYS
Thu, 6 Mar 2003
In her column on Red Flags Weekly, Dr. Meryl Nass describes how the FDA in concert with the Justice Department have been lowering the bar for safety of drugs and vaccines used on military personnel. The significance is that soldiers are uninformed participants in an undeclared human experiment. Whereas civilians exposed to similarly unlicensed experimental products would be at least be able to seek compensation if injured, military personnel cannot.
Dr. Nass describes 3 examples: Pyridostigmine bromide, smallpox vaccine and anthrax vaccine.
Did you think the FDA’s job IS to protect the public from dangerous drugs and vaccines? Well, yes, sometimes – as long as the federal government doesn’t want to administer those self-same dangerous products.
FDA has been helped along by the 1997 FDA Modernization Act (FDAMA), which lowered the evidence bar for new drug approvals, and by the so-called “animal rule” of 2002, which allows drugs and vaccines to be approved without checking out their effectiveness in humans. (The rule does not omit safety testing in humans, however.) This lowering of standards was used to expedite licensing for the first two examples below.