Timothy W. Maier
Insight on the News Magazine, Vol. 15, No. 42, November 15, 1999
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.
EO13139, 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.”
The FDA may be starting to take note, according to a September letter from the agency obtained by Insight. The letter was written the day Shays’ hearing ended. Katheryn Zoon, director of the Center for Biologics Evaluation and Research, wrote to Assistant Secretary of Defense Sue Bailey:
“Recently it has come to the agency’s attention through congressional sources that some troops may not be receiving the vaccine in accordance with the schedule found in the approved labeling. As you know, the approved anthrax labeling states that full immunization involves six doses of the vaccine to be administered following the first dose at two and four weeks, six months, 12 months and 18 months, with yearly boosters thereafter. This schedule is the only regimen shown to be effective in protecting humans against anthrax and is the only schedule approved by the FDA. Data received by FDA from congressional sources indicate that a number of reserve and active military personnel are receiving their anthrax vaccine dose significantly later than the FDA approved schedule.”
In his order Clinton calls attention to the biological threat to which troops might be subjected, saying soldiers could “potentially be exposed to a range of chemical, biological and radiological weapons, as well as disease endemic to an area of operations.” Defense Secretary William Cohen warned recently on ABC’s Nightline that it is not a question of whether we could face a biological attack, it’s a question of when.
But neither the president’s top intelligence expert in this field nor the State Department are impressed by these claims. Richard Clarke, the bioterrorism expert with the National Security Council, also said on Nightline that he doesn’t expect terrorists will turn to biological weapons. “I don’t believe it’s a certainty at all,” he said. “I know that there are people who say it will eventually happen. But I think you have to remember, there has to be motivation. Someone has to do it. And that someone has to believe they can get away with it. They’re not going to. If you look at our history in the last five years, after every major terrorist incident we have discovered the people who were involved. And even if they were on the other side of the earth, and even if it was four years later or 10 years later, we reached out and got them.”
In addition, the State Department has posted this statement on its Website: “The Department of State has no information to indicate that there is a likelihood of use of chemical or biological agent release in the immediate future. The Department believes the risk of the use of chemical/biological warfare is remote, although it cannot be excluded.”
Meanwhile, even though U.S. embassies are prime targets of terrorists, the State Department isn’t requiring its employees to have the anthrax shot before deployment. Jones called on the State Department to explain why it was not mandating the shot, and promptly was told it will take “four years to get that information.” He then turned to House International Relations Committee Chairman Ben Gilman of New York, who quickly fired off a letter to State demanding action.
Yet Clinton signed EO13139 to use experimental vaccines on U.S. troops despite the scandals created by exposure of the secret use of experimental vaccines ranging from administering LSD in the 1950s to the drug pyriostigmine bromide, or PB, given to troops bound for the Persian Gulf War. PB, which protects against nerve gas, may be linked to some of the gulf-war illnesses, according to the Rand Corp., a California-based think tank that recently published a 385-page review of the drug.
Maj. Thomas “Buzz” Rempfer of the Air Force Reserve says there may be times when use of vaccines that have not been fully tested and FDA-approved may be necessary and appropriate during great crisis. “But this capability for our president is currently being jeopardized by the reckless mandatory vaccination of all service members against anthrax,” he says. “The threat is not imminent and the integrity of the military institution is being compromised to implement a strategic or blanket program that is doctrinally unprecedented and unsound. The lack of trust we are breeding in the force today could sacrifice our military’s capability to protect our troops on a tactical basis when threatened in the future.”