Law could allow military to keep drug information from personnel

Congressional leaders may soon address a proposed law that critics say would reduce the U.S. military's obligation to inform soldiers about the health risks of unlicensed biological defense drugs and vaccines they might be required to receive in an emergency.

The provision, contained in the House version of the Project Bioshield Act of 2003, would allow officials to respond to some emergencies by administering drugs to the nation that have not been approved by the Food and Drug Administration.

The law would require officials to inform potential drug recipients of the drug's potential health risks and to get the recipients' consent to administer the drug, but it would also permit the president and other senior officials to waive these requirements when delivering the drugs to U.S. military personnel.

Rep. Christopher Shays, R-Conn., recently criticized that provision.

"I am concerned that certain provisions of Section 4 of the bill will unfairly treat the men and women of our armed services," he said in a July dialogue with House Energy and Commerce Committee Chairman Billy Tauzin, R-La.

Existing federal law, that Shays helped draft following the 1991 Gulf War, already permits the president to waive the consent requirement for military personnel if obtaining consent is infeasible, contrary to the best interests of the individual, or not in the interests of national security. In addition, the law requires that potential recipients must be told that they have the right to refuse the drug, although they might be discharged from the military or jailed if they do so. It further requires that all recipients be first informed of the product's unapproved status and of its potential side effects.

Under the proposed changes, the president would continue to be able to waive the consent requirement, but he would also be able to waive the requirement to notify potential recipients that they may refuse the drug. Furthermore, the Health and Human Services secretary could authorize delaying the notification of recipients of their potential health risks. The proposed law says the information would be provided to the drug recipient, or next-of-kin in case of a death, no later than 30 days after the individual received the drug.

Steve Robinson of the National Gulf War Resource Center, a veterans group, opposes the new language.

The military will say it's "for the cause of good order and discipline, because if one person said 'no,' a thousand could. But we're supposed to be the kind of society that evolves and I think our soldiers are smart enough to at least be told of the risks and, in certain cases for certain drugs, have a choice," he said.

Tauzin said the disputed provision was intended only to eliminate an individual's right to refuse a drug, not to deny drug recipients information on potential health risks, except in "extraordinary circumstances."

Tauzin said his committee reviewed the language and found it could be confusing.

"We intend the waiver authority in this bill to be used only in the very extraordinary circumstances that we describe in the bill," he said.

Tauzin said he would work with Shays "to make sure that the final version of this bill from the conference that we will have with the Senate, I am sure, provides that our military are informed of the drugs that are given before these drugs are administered."