« Home | Defense seeks emergency authority to resume anthra... » | FDA asked to regulate advertising of anthrax vacci... » | Vaccine role in gulf illness proposed for more stu... » | Spacing out the shots may get harder look » | Too many vaccines, too quickly? » | Acambis suffers as US cuts drug order » | Smallpox vaccine linked to heart inflammation » | U.S. Defense Department Accused of ‘Disinformation... » | The Rutherford Institute (TRI) Sues Donald Rumsfel... » | Federal Court Orders Pentagon to Stop Anthrax Immu... »

Pentagon Looks to Declare Anthrax Risk Emergency, Resume Mandatory Vaccinations

By David Ruppe
Global Security Newswire

WASHINGTON — A senior Republican congressman is investigating a U.S. Defense Department claim that an emergency exists requiring it to resume mandatory military anthrax vaccinations, which were blocked by a federal judge in October (see GSN, Nov. 11).

Deputy Defense Secretary Paul Wolfowitz in a letter last Friday asked Health and Human Services Secretary Tommy Thompson to declare a state of emergency with the aim of resuming anthrax vaccinations, apparently without first informing the soldiers to be vaccinated of the risks of side effects and obtaining their consent.

In making his request, Wolfowitz cited “a classified November 2004 Intelligence Community assessment” of a threat to U.S. forces in South Korea and the U.S. Central Command region, which includes Iraq and stretches from the horn of Africa to Central Asia.

“I have determined there is a significant potential for a military emergency involving heightened risk to United States military forces of attack with anthrax. … This heightened risk has been and continues to be the basis for the DOD program of vaccinating personnel serving in areas of the Central Command and Korea,” he wrote.

The military suspended the vaccinations after a U.S. District Court judge ruled in October that a prior Food and Drug Administration approval for the drug’s use against inhalation anthrax was invalid, that the drug therefore remained experimental for that purpose, and so troops should be given it only with informed consent.

The Defense Department appears unwilling to provide the vaccinations to soldiers with informed consent, apparently out of concern a voluntary vaccination program would result in refusals, increasing U.S. military vulnerability to an attack.

In a letter last night obtained by Global Security Newswire, Representative Christopher Shays (R-Conn.) asked the Central Intelligence Agency to provide him with the intelligence assessment cited by Wolfowitz and a briefing on the perceived danger.

“The basis for any determination of emergency use of a biological warfare countermeasure should be as clear as possible to those who take the vaccine and to their elected representatives,” wrote Shays, who chairs the House Subcommittee on National Security, Emerging Threats, and International Relations of the Committee on Government Reform.

Shays also sent a letter to Thompson, asking whether his agency views Wolfowitz’s letter as a valid emergency determination under statutory requirements. The Federal Food, Drug and Cosmetic Act “explicitly requires” a determination by the defense secretary and publication of such a determination in the Federal Register for emergency use, along with the concurrence of the Health and Human Services Department, he wrote.

The Defense Department request “presents a number of unique, potentially troubling legal and procedural issues,” he wrote.

Shays furthermore urged Health and Human Services to review Wolfowitz’s request “deliberately and openly … with maximum public input to avoid even the implication HHS will rubber stamp or give unquestioning, and underserved, deference to DOD determinations on medical matters.”

“Hundreds of military personnel have suffered adverse reactions to the vaccine,” he wrote.

The military has maintained the drug is relatively safe and effective against inhalation anthrax and that the Food and Drug Administration rule was legitimate.

Defense Department Strategy Uncertain

Observers say they are uncertain what Wolfowitz was trying to accomplish with his letter, noting as Shays did that federal law requires the defense secretary to determine a state of emergency and to publish the determination in the Federal Register prior to emergency use of an unapproved vaccine.

The emergency-use provision was contained in the Project Bioshield Act of 2004 passed by Congress in July and this appears to be its first invocation.

Furthermore, another U.S. law requires the military to obtain a presidential waiver to resume the anthrax vaccinations without informed consent, in light of the judicial ruling on the status of the vaccine, and whether there is an emergency or not, said John Michels, a partner in the Chicago office of McGuireWoods LLP representing plaintiffs in a lawsuit that pushed for the injunction.

“We are not exactly clear on the meaning of the Wolfowitz letter,” Michaels said.

The law “says you can’t use investigational drugs without the consent of the soldier or a presidential waiver. That’s the bottom line right there,” he said.

U.S. officials appear unwilling to pursue a presidential waiver.

Officials with the Health and Human Services and Defense departments had not returned requests for comment by press time.