Military Guinea Pigs Under Bill Clinton: Executive Order 13139
Executive Order 13139, AKA Improving Health Protection of Military Personnel Participating in Particular Military Operations, was an EO signed by President Bill Clinton on September 30th, 1999. The EO allowed for FDA approved products to be used off label "when the Secretary considers an investigational new drug or a drug unapproved for its intended use to represent the most appropriate countermeasure" to chemical, biological, or radiological weapons.
Normally, before a drug or antidote is administered, informed consent must be obtained from the individual service member. Executive Order 13139 allowed for informed consent to be waived by the POTUS upon request of one and only one individual - the Secretary of Defense. Three conditions were required for the rule waiver :
1. Informed consent is not feasible,
2. Informed consent is contrary to the best interests of the service member,
3. Obtaining informed consent is not in the best interests of national security.
Some have argued that the order allowed for our military servicemen to be used as human test subjects for experimental drugs. This claim is based on the number of reported side effects, and actions that were taken against those who refused the vaccinations.
The same anthrax vaccine that was forced on the US Military was also used by the Australian, British and Canadian military but on a volunteer basis. Additionally, U.S. Department of State employees were given the choice to opt out of taking the vaccine even though they were located in the same geographical regions, and faced the same chemical, biological, or radiological weapon threats as the service members.
Former Chairman of the Joint Chiefs of Staff Admiral William Crowe personally vouched for Bill Clinton when charges were made that he was a draft dodger during Clinton's bid for the presidency in 1992. Crowe was also arguably the biggest beneficiary of the executive order that mandated the use of the anthrax vaccine: President Clinton appointed the Chief of Staff as Ambassador to England after his election. Clinton also awarded the exclusive military contract for the production of the vaccine to BioPort - a corporation where Crowe was a director and a stockholder. The contract was worth millions.
There were significant concerns about the safety of the vaccine which Clinton and then Secretary of Defense William James Perry ignored: the FDA had repeatedly cited BioPort for quality deficiencies, and the company failed numerous federal inspections. Army Secretary Louis Caldera admitted the vaccine was "unusually hazardous" for certain recipients, but despite the questions about safety and manufacturing processes BioPort was indemnified against all potential liability related to adverse reactions to the anthrax vaccine.
BioPort was founded on September 5, 1998 and the company purchased the rights to manufacture the anthrax vaccine for the U.S. military, and a facility to produce it, from the Michigan Department of Public Health. The Pentagon had previously awarded Michigan more than $20 million to repair the facility and purchase new equipment. The facility also had been handed $100 million in guaranteed contracts during the previous decade. BioPort purchased the rights to all operations and licenses in a $25 million package of cash, loans and promises of future payments.
The contract to supply the vaccine for military use was originally worth $25.7 million. A year after the original contract was awarded to BioPort, the Clinton Administration nearly doubled the commitment to $49.8 million. The contract required the government to pay for vaccine even if the drugs weren't licensed for use. The contract also stipulated that all the company's debts would be paid, and increased the payment for each anthrax vaccine dose from $4.36 to $10.64 - a 144 percent increase.
Despite the healthy contract the company was going under. In June 1999, BioPort said it was running out of money and needed more help. A Pentagon audit showed millions unaccounted for, but auditors were overruled and in September, 1999 a $24.1 million bailout was approved citing "the interests of national security".
It has been reported that Crowe received substantial stock in BioPort's parent company without paying for it. He received about 10% of the stock in the company. In April 2000, it was reported in a Pentagon audit that BioPort wasted funds on "excessive travel costs, excessive severance pay and unsubstantiated consulting costs," that amounted to $1.28 million in "unreasonable" bonuses for senior management. Crowe undoubtedly reaped the rewards of the windfall, and his partnership with Clinton.
BioPort has operated under the name of Emergent BioSolutions since 2004. The company produces and manufactures pharmaceuticals for infectious diseases like cholera and typhoid, as well as Narcan which is used in the emergency treatment of opioid overdose. It continues to produce the only FDA approved anthrax vaccine called BioThrax - an intramuscular injection.
Motivations behind Executive Order 13139 appear to be politically, and financially, driven. Despite concerns about the manufacturing process and the safety of the vaccine, it was forced upon military service men who feared the long term effects of the injections.
Those who refused the mandatory anthrax vaccinations were threatened with disciplinary action. Captain John Buck, an emergency medicine physician at Keesler Air Force base in Mississippi, chose to face a court-martial rather than be injected with the vaccine stating "a red lump on the arm is not something that scares me," adding "but an autoimmune disorder for the rest of my life is".
One Air Force pilot, Maj. Sonnie Bates, was ordered take a six-shot regimen of the drug after testifying against its use. He faced imprisonment on the charge of disobeying the order and was ultimately fined $3,200 for refusing to take the shots. Bates was also threatened that his training and relocation pay would be taken away.
According to the Association of American Physicians and Surgeons, 500 active-duty service-members refused the vaccine, resulting in more than 100 being court-martialed. A 2002 General Accounting Office (GAO) report stated that significant numbers of National Guard and Reserve pilots were leaving their positions as a result of adverse side effects from the anthrax vaccine that was administered under Clinton's order. 500-1000 pilots and flight crew members quit, resigned or transferred to avoid taking the vaccine. In all, 86 percent of those who were given the shots reported adverse side effects.
Two Connecticut Air Force Reserve pilots filed a suit which asserted that the vaccine was never properly tested. The Food and Drug Administration's (FDA) responded by halting use of existing stocks of the vaccine. When Clinton signed Executive Order 13139, it was stated that adverse reaction occurred in 0.2% of cases. This was an outright lie, and the FDA's own warning label on doses given to the military stated 5 to 35 percent of people who get the injection would see a reaction. .
Another suit was filed in the United States District Court on behalf of all military service members and civilians. It requested that the anthrax vaccine be declared an experimental drug and illegal by a federal judge. A separate motion sought a Temporary Restraining Order or Preliminary Injunction to prevent further anthrax inoculations without informed consent or a presidential waiver.