Lawmaker questions Pentagon’s plan to resume anthrax vaccinations

By Chris Strohm

December 17, 2004

The vice chairman of the House Government Reform Committee has raised questions about the Pentagon's recent request for emergency authority to resume its anthrax vaccination program, Government Executive has learned.

Rep. Christopher Shays, R-Conn., sent letters on Thursday to the Health and Human Services Department and CIA concerning the Pentagon's request. Shays also is chairman of the House Government Reform Subcommittee on National Security, Emerging Threats and International Relations.

"The Department of Defense request presents a number of unique, potentially troubling legal and procedural issues, and the subcommittee requests information on how the Department of Health and Human Services will approach this precedent-setting matter," Shays wrote in a letter to HHS Secretary Tommy Thompson.

Deputy Defense Secretary Paul Wolfowitz asked Thompson on Dec. 10 to declare an emergency so the Pentagon could begin giving all military personnel anthrax inoculations again. Wolfowitz said a classified November 2004 intelligence community assessment raised concerns about a heightened risk to U.S. military forces of attack with anthrax.

Shays said the Pentagon's request represents the first use of emergency authority under the 2004 Project Bioshield Act.

"It is essential that HHS consider this first request for Project Bioshield Act authority carefully and with maximum public input to avoid even the implication HHS will rubber stamp or give unquestioning, and undeserved, deference to DoD determinations on medical matters," Shays wrote.

Shays sent another letter to CIA Director Porter Goss requesting access to the November 2004 assessment of the anthrax threat.

The Pentagon's anthrax vaccination program was suspended in late October by a federal judge in response to a lawsuit filed by six anonymous plaintiffs. The lawsuit argued that the vaccine was not proven to protect against inhaled anthrax, and led to health problems.

Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled Oct. 27 that the military must stop administering the BioThrax vaccine, also known as Anthrax Vaccine Adsorbed, to service members. The vaccine is produced by BioPort Corp. of Lansing, Mich.

The Food and Drug Administration issued a final rule and order in December 2003 that licensed the vaccine as safe and effective for anthrax, regardless of the route of exposure. The judge, however, vacated that ruling, saying the FDA did not follow proper procedures to determine whether the vaccine is safe and effective against inhaled anthrax.

The ruling has created controversy over whether the anthrax vaccine is approved for use against inhaled anthrax. BioPort maintains that the vaccine is the only FDA-approved anthrax vaccine, regardless of the route of exposure. Lawyers for the plaintiffs, however, argue that the FDA should prevent BioPort and the Pentagon from advertising that the vaccine is approved for protection against inhaled anthrax.

Shays raised several questions concerning how HHS will handle the Pentagon's request.

"If the emergency use authorization is granted, how will [HHS] monitor DoD compliance with legal requirements to inform health care practitioners and recipients of the emergency use determination, the benefits and risks of the vaccine, alternatives to inoculation, and the option to refuse?" Shays asked.

Shays also asked if HHS now considers the anthrax vaccine product labeling to be incomplete or misleading because it fails to differentiate between approved use for exposure on the skin compared to "as yet unapproved use for inhalational exposure."

HHS spokesman Marc Wolfson confirmed that the department received Shays' letter but declined to comment further.

The Defense Department issued a short statement regarding the matter.

"We are concerned for the health and safety of our service members, particularly in worldwide operations involving the war on terrorism," said the statement, attributed to William Winkenwerder, assistant secretary of Defense for health affairs. "Intelligence indicates an ongoing threat of anthrax against our military forces. America's best scientists say the anthrax vaccine is safe and effective. It provides significant protection in addition to other measures."

By Chris Strohm

December 17, 2004