Clinton Orders Human Experiments

Executive Order 13139 is requiring military personnel to receive experimental vaccines not approved by the Food and Drug Administration. Courts-martial are pending.

A day after Republican Rep. Chris Shays of Connecticut ended congressional hearings on the controversial decision mandating the inoculation of 2.4 million U.S. troops against anthrax, President Clinton quietly signed an executive order, or EO, that denies soldiers the right to refuse experimental vaccines.

E013139, titled "Improving Health Protection of Military Personnel Participating in Particular Military Operations," caught Congress off guard as it directed the Pentagon to disregard the authority of the Food and Drug Administration, or FDA. The order authorized use of experimental vaccines -- those not approved by the FDA and therefore illegal -- to be administered to members of the armed forces without informed consent.

Some congressmen saw this as an attack by the president on the House Government Reform subcommittee on National Security, Veterans Affairs and International Relations, where testimony indicated the Pentagon had violated the FDA's procedures on how to administer the anthrax vaccine. Those hearings -- as well as others held by the full House Committee on Government Reform -- had put the FDA on the spot for letting the Pentagon disregard sensible FDA regulations. The Pentagon wanted to administer the shots now and, as a result, long-range studies were not conducted and an inadequate reporting system was set up to hide the large number of adverse effects, critics charged.

As a result of the unprecedented implementation of the vaccination program, more than 1,000 troops are awaiting trial on a felony charge of refusing to obey, hundreds more have left the armed forces and dozens have been prosecuted.

The FDA's failure to take a stand against the Pentagon has prompted a group of concerned congressmen, led by Republican Rep. Walter Jones Jr. of North Carolina, formally to complain to the agency. "The FDA didn't do its job," says Jones, a member of the House Armed Services Committee. "Our men and women are too valuable and they're not going to be guinea pigs."

Jones, who has asked the Pentagon's inspector general to launch a probe into the growing anthrax controversy, warns that Clinton's executive order "might encourage more men and women to get out of the military. I think Clinton did it to give cover to what the DOD [or Department of Defense] is doing." And with the FDA having rolled over, Jones says, he is even more determined to learn why the White House and the Pentagon doubled the contract of Michigan-based BioPort Corp., which manufactures the vaccine, from $25.7 million to $49.8 million and at the same time reduced the volume to be delivered by 2.3 million shots (see "Why BioPort Got a Shot in the Arm," Sept. 20).

The Pentagon has claimed the inoculation protects against all anthrax strains, and BioPort made the same claim to Insight -- despite the fact that an experiment at the Fort Detrick chemical and biological warfare center in Maryland using guinea pigs showed nine of the 27 anthrax strains tested killed 50 percent of the vaccinated subjects.

Kwai-Cheung Chan, the director of the special studies and evaluations, national-security and international-affairs division of the General Accounting Office, testified before the House Government Reform Committee that there have been no studies to "determine the optimum number of doses of the anthrax vaccine. Although annual boosters are given, the needs for a six-shot regimen and annual booster shots have not been evaluated."

Chan's biggest criticism, however, involves the process in which the vaccine was made. He notes the deficiencies that FDA identified in its February 1998 inspection. "These fell into two categories: those that might affect only one or a limited number of batches, and those that could compromise the safety and efficacy of any or all batches." The facility was as a result shut down in early 1998. BioPort is addressing the processing problems, but the FDA has yet to approve its laboratory to produce the controversial vaccine.

Meanwhile, since Insight last reported on the anthrax vaccination, still more troops and civilians have fallen ill after receiving the shots, according to the FDA. From 1990 to Oct. 1, 1999, 425 reports of adverse events associated with the anthrax vaccine have been reported. Critics argue the incidents are being underreported because, unless the side effects involve chills or fatigue, some doctors say they can't report the symptoms (see "A Dose of Reality," Sept. 20).

Mark Zaid, an attorney representing dozens of troops who refused to take the mandatory anthrax inoculation, says, "There are big problems. Why, all of a sudden out of nowhere, especially when the opposition to the program is getting so much steam and criticism of the Department of Defense was running rampant, does Clinton sign an executive order that assures DOD can implement any experimental program it wants? This whole thing is DOD doing an end run around the FDA. The FDA should step up to plate and do its job."