Originally created 11/10/99

Troops to be given experimental drugs only rarely



WASHINGTON -- Only in rare instances will U.S. forces be required to take drugs not approved by the Food and Drug Administration, the Clinton administration told Congress Tuesday. A Pentagon official said these could include exposure to lethal biological-chemical weapons for which there are no approved vaccines.

But members of a congressional panel suggested the authority could be abused. "I happen to believe such requests will not be rare," said Rep. Christopher Shays, R-Conn., chairman of a House Government Reform subcommittee looking into Defense Department vaccination programs.

On Sept. 30, President Clinton signed an executive order setting forth the process under which a mandatory vaccination program could be administered under terms of a 1998 law. Essentially, the defense secretary would have to request such a program. It would then have to be approved by the president.

"The United States faces the monumental challenge of establishing a credible medical defense against chemical and biological weapons in contexts of both military operations and civilian terrorist response," said Dr. Sue Bailey, assistant secretary of defense for health affairs, told the subcommittee on national security, veterans affairs and international relations.

She said it will take many years for some new drugs to be developed and approved by the FDA. In the meantime, Bailey testified, it may become necessary to use "investigational" new drugs, those not yet approved by the FDA, to protect troops who might be exposed to certain chemical or biological substances.

"We will make every effort to obtain appropriate informed consent" from troops. There might be times, however, when the Pentagon would want to make the program mandatory.

By contrast, the current vaccine program designed to eventually protect all 2.4 million members of the military is a product already approved by the FDA, Bailey said. Some 300,000 servicemen and women have received it already, she said.

John Spotila, an official with the Office of Management and Budget, told the panel the Pentagon would generally only administer products approved by the FDA. "Under certain circumstances, however, and with strict controls, it may need to administer such products without obtaining an individual's consent in order to preserve military capability ... and to protect the health and well-being of our deployed troops."

During the Persian Gulf War, the Pentagon was given approval to use two investigational products -- pyridostigmine bromide, a drug believe to protect against certain nerve gases, and botulinum toxoid, a vaccine to protect against botulism. Only the pyridostigmine was used.

Charles R. McCarthy, a senior research fellow at Georgetown University, told the panel that more safeguards need to be imposed to ensure that mandatory vaccination programs are used only in the most rare and serious instances.

"Military personnel do not surrender all of their rights," he said. They must "not be ordered to participate in biomedical or behavioral research."