MERYL NASS, MD

March 5, 2003

THE DANGEROUS DRUG LICENSING GAME THE FDA PLAYS WITH THE DEPARTMENT OF DEFENSE

By Meryl Nass

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.

Example 1: Pyridostigmine bromide (aka PB or NAPS tablets). May help survive exposure to certain nerve gases, if ingested 8 hours before exposure.

Although PB when used alone may not cause serious side-effects, research has shown that when PB is used in a setting like the Gulf War, things get a lot more complicated. There, soldiers wore permethrin-impregnated uniforms to repel insects, used additional insect repellents like DEET on their skin, and were exposed to sarin when Iraqi weapons depots were blown up.

Several researchers have shown that PB, when ingested while simultaneously exposed to various combinations of DEET, permethrin, sarin (another nerve gas to which it offers no protection) or jet fuel, caused brain and testicular injury in experimental animals. Despite this, FDA went ahead, ignored all the evidence, and approved PB as a licensed drug for "nerve gas pretreatment."

PB was used in the Gulf War as an experimental drug under a waiver from FDA, which allowed the military to mandate its use. FDA is no longer giving out those waivers, since the Defense Department never kept its agreement for the use of experimental products. You know, stuff like refusing to keep records of who received the experimental drug or vaccine, and whether the recipients became ill. Not in the Gulf War, nor in the Bosnia theater would DOD keep track of these human experiments.

Had PB remained an experimental or investigational drug for nerve gas pretreatment, the military would have had to give soldiers informed consent and the option of whether to take it, or invoke a direct order from the President. Licensing PB saves the President any political cost, and allows the military to avoid what is anathema to them: giving troops a choice. Who cares about sterile or brain-damaged guinea pigs, anyway?

Example 2: Smallpox vaccine. A decades-old stash of Dryvax smallpox vaccine, owned by the federal government, had been tested and readied for use. Never mind that expired drugs and vaccines are considered adulterated, and cannot be licensed. Last October, FDA went ahead and licensed old Dryvax anyway. But they didn’t license the identical vaccine for civilians.

That makes no sense, you say. Think again. The military can only force it on soldiers if it is licensed, or ordered by the President. Soldiers cannot sue the government for injuries sustained as a result of vaccination. (Thank the Feres Doctrine, a body of law that got the government off the hook for injuries to uniformed subjects of its LSD experiments.)

Civilians, on the other hand, need sign no informed consent if the vaccine is fully licensed. And if they are injured, they can sue the manufacturer. Or perhaps the government, which owned the stockpile. Knowing what we know of this vaccine, a lot of folks were going to get injured. Neither Wyeth, the original manufacturer, nor the government wanted to pay for injuries. By not licensing the vaccine for civilians, recipients must sign a consent form before vaccination that prevents them from suing. Pretty clever, eh?

Example 3: Anthrax vaccine. "Fully licensed" for the first 520,000 military recipients, said FDA. A small stockpile of licensed vaccine remained available in late 2001, when it was decided to offer the vaccine to civilians who had been exposed to anthrax spores. (Vaccine had been saved for a pending clinical trial to be performed by CDC.)

But that wasn’t what the civilians were offered. They got "experimental" vaccine, unlicensed because it came from the new plant, and also because it was being used after exposure, which was not an FDA-approved use at the time. Despite this, the military had recommended post-exposure vaccination for decades.

You guessed right! The civilians had to sign an informed consent for this "fully licensed" vaccine, and signed away their right to both medical care and a lawsuit, were they to be injured as a result.

The civilians weren’t so dumb as Uncle Sam thought. Only 2% of those offered anthrax vaccine by CDC accepted. And less than 2% of health care workers took up the government’s offer of smallpox vaccination. The result: a safer smallpox vaccine is now being developed, and Congress is working on a plan to compensate civilians made ill by the current smallpox vaccine. But both remedies only appeared after the public said "NO."

On the other hand, close to 100% of our military troops slated for either vaccination have accepted. Do they have any real choice, facing threats of court martial and 1-2 years in the brig for refusing a vaccine?