Executive order gives DOD power to use investigational
drugs on military
Feds say rules improve safeguards, critics say it will erode their rights
J. Stryker Meyer
WASHINGTON ---- President Clinton signed Executive Order 13139 on Sept. 30 authorizing the Department of Defense to administer "new investigational drugs" to troops ---- with or without their consent ---- to protect them from biological, chemical or radiological agents during military actions.
The executive order modified a Defense Department policy to issue pyridostigmine bromide tablets to U.S. troops during Operation Desert Storm in Iraq in 1991 to protect them from possible chemical attacks from the Iraqi army.
The 1991 action was criticized by some veterans groups.
On Oct. 5, the Food and Drug Administration adopted a companion measure to the president's order. The FDA measure lays out the ground rules under which the Defense Department can unilaterally administer "new investigational drugs" to its troops ---- rules the federal government maintains has new safeguards for the military while critics worry that they will erode their rights.
In hearings last month before the House Subcommittee on National Security, Veterans Affairs and International Relations, two "bio-ethicists" and representatives from the FDA and Department of Health and Human Services talked about scenarios in which the president can have soldiers take new or unlicensed drugs without their consent.
The president's executive order, the FDA's companion measure and the House subcommittee hearings all grew out of the Defense Department's "failure to provide basic information or (to) maintain individual medical records for 'investigational' products used in the Persian Gulf (War in 1991)," said subcommittee Chairman Rep. Christopher Shays, R-Conn., at the November hearing.
During Operation Desert Storm, the secretary of defense had the authority to give soldiers two new unlicensed drugs ---- pyridostigmine bromide, in 30-milligram tablets, and botulinum toxoid vaccine ---- Dr. William Raub told
Shay's subcommittee. Raub is deputy assistant secretary for science policy at the Department of Health and Human Services.
"Pyridostigmine bromide was considered a potentially useful pre-treatment against certain nerve gases (and) botulinum toxoid vaccine is widely accepted as offering potential protection against ... botulism," Raub testified.
The FDA approved the Defense Department's request to administer the tablets and vaccine on Dec. 31, 1990, and Jan. 8, 1991, respectively, Raub said.
"Both products," he said, "were administered to portions of the military personnel who participated in Operation Desert Storm."
A drug that is "investigational" ---- a drug that hasn't gone completely through the FDA's lengthy approval process ---- isn't necessarily experimental or unsafe, said Defense Department spokesman James D. Turner.
"Rather, it means that a particular product has not been approved by FDA for general commercial marketing, but rather for a particularly stated medical purpose," Turner said last week. The "investigational" drugs were tested on primates, but not on people "because it would be unethical to give a test group drugs that would kill people ... so we do tests on primates."
Pyridostigmine bromide tablets were given to Desert Storm troops as pre-treatment for possible exposure to the nerve agent soman that Iraqi troops had in their arsenal, Turner said. He said soman is "a rapidly lethal nerve agent" that can kill in minutes. It was developed by Russia before the Gulf War, Turner said.
Turner said pyridostigmine bromide was listed by the FDA as a "new investigational drug" largely because tests of the drug were conducted on primates but not on humans. Even so, he said, it was still the drug that held the most promise against nerve agents.
He has some support for that position from Dr. Sue Bailey, assistant secretary of defense for health affairs, who testified before the subcommittees on Health and Oversight and Investigations Committee on Veteran's Affairs on Nov. 16.
"The results of animal tests suggest that (the) use of pyridostigmine bromide as a pre-treatment adjunct, coupled with standard post-exposure treatments, may be effective," Bailey testified. She said she would still recommend pyridostigmine bromide today as the best drug for exposure to the nerve agent soman.
U.S. Rep. Randy "Duke" Cunningham, R-Escondido, said he is aware of the order and is receiving a briefing from the Pentagon on it on Monday.
"As I understand it, the intent is to tighten the restrictions against the government using experimental drugs," Cunningham said. "That could be good. ... I want our troops going into combat being protected against chemical or germ or nuclear agents."
Military spokesmen from the Navy, Air Force, Army and Marines said last week that they had not heard about Executive Order 13139.
"It usually takes some time for an order like that to roll down the chain of command," said Camp Pendleton's Lt. Col. Carol McBride.
Veterans groups don't trust 13139
Two veterans groups said they're worried that Executive Order 13139 will eventually erode the rights of soldiers.
"It's ridiculous," said Arthur Bernklau, executive director of the New York-based Veterans for Constitutional Law Limited. "We're not serving under the King of England.
"(The executive order) should be rescinded immediately. ... I think it'll have a tremendous negative impact on re-enlistments, because slowly the word is spreading among military personnel today about the risks of (Defense Department) and FDA-sanctioned vaccines, including (pyridostigmine bromide)."
"This new executive order requires that we again trust that our Defense Department will do us no harm," said Joyce Riley vonKleist, a spokeswoman for the national organization Gulf War Veterans Association. "We can no longer trust it."
VonKleist, of the Gulf War Veterans Association, said Executive Order 13139 "comes at a time when the Pentagon's credibility with its military is at an all-time low."
She said Gulf War veterans returned home suffering maladies from both the toxicological and radiological elements they encountered in Iraq and Kuwait and from the pyridostigmine bromide tablets.
"It appears as though the drugs issued to military troops during the Gulf War were not adequately researched and that (soldiers) were used as guinea pigs," said vonKleist, a registered nurse and a captain in the inactive Air Force reserves. "We believe that 75 percent of the Gulf War veterans who are sick are ill from the vaccine."
Turner, in an interview with the North County Times, and Shays in his November testimony, said, however, that the tablets and vaccine were used as preventive measures, not as part of an experiment of some sort.
"Some Gulf War veterans believe they are suffering illnesses that were caused by (pyridostigmine bromide)," Turner said. "To date, no research has found a proven tie between (pyridostigmine bromide) and illnesses suffered by Gulf War veterans."
VonKleist said veterans who believe their maladies have been caused by unlicensed tablets and vaccine have the burden of proof in proving the link from being exposed to chemical agents in Iraq or Kuwait, to having an illness from service there. The veterans' task of proving their beliefs is difficult, vonKleist said, because the Department of Defense did a poor job of maintaining medical records for the administration of unlicensed drugs while refusing to give veterans their medical records.
Federal officials testified in the November hearings that the president's executive order and the FDA's companion measure offer specific guidelines that must be met before the president can waive the rights of soldiers and administer investigational drugs. Turner, in an interview, agreed with them.
The federal officials said the guidelines were set up in part to respond to critics' concerns that there weren't any safeguards in place.
John T. Spotila of the Office of Management and Budget testified that 13139 "establishes a process for waiver decisions to be carefully evaluated in a timely manner and used only when absolutely necessary."
Spotila, who testified in the Nov. 9 hearing, said the order "creates multiple layers of oversight to ensure accountability, ensures that necessary safeguards for military troops are met, and builds in additional procedures and safeguards to protect the health and well-being of our military troops prior to and after a particular military operation."
There are three conditions under which the secretary of defense can request, in writing, that the president waive consent requirements for soldiers so the department can administer drugs without their consent. They are:
1. When obtaining consent is not feasible.
2. When it is contrary to the best interest of the soldier.
3. When it is not in the interests of national security.
A waiver can last for up to a year and can be renewed only after the secretary applies for an extension to the president in writing.
Moreover, Raub testified in November that before the secretary can ask the president for a waiver he must follow the FDA's companion measure that requires the following:
1. The safety and effectiveness of the drug in relation to medical risk that could be encountered during the military operation supports the drug's administration under an investigational new drug application.
2. The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear or other exposure likely to produce death or serious or life-threatening injury or illness.
3. There is no available satisfactory alternative therapeutic or preventive treatment.
Additionally, Raub testified that under the FDA's companion measure, military personnel must be given a "specific written information sheet" detailing why the drug is being used and "the risks and benefits of the drug's use, potential side effects and other pertinent information."
The Department of Defense must provide public notice in the Federal Register describing each waiver of informed consent, a summary of the most updated scientific information on the products used "as soon as practicable," he testified.
The Department of Defense must document and certify that its record-keeping system is capable of tracking military personnel who have been given "new investigational drugs," Raub testified.
Department of Defense spokesman Turner said in a telephone interview last week that in 1990 and after Operation Desert Storm, the department "admitted some difficulties in administering the conditions of the waiver, such as poor record-keeping and providing information to military personnel."
The Department of Defense must also establish an Institutional Review Board to oversee the department's compliance with FDA rules. Defense officials point to this review board as one more "safeguard" to protect military members.
Dr. Charles R. McCarthy, a senior research fellow with the Kennedy Institute of Ethics at Georgetown University, testified on Nov. 9 that the Institutional Review Board "should be created by FDA" and not the Department of Defense. He said the president should receive a briefing from members of that board before deciding on whether to authorize the use of investigational drugs.
McCarthy recommended that a Date and Safety Monitoring Board be created to track each given drug and that its reports and evaluations be forwarded to the Institutional Review Board and the president "at regular intervals."
Raub said that in 1997, notice was printed in the Federal Register seeking comments on the use of "investigational drugs" in military personnel and other "emergency settings to treat or prevent toxicity of chemical or biological substances."
In response to the Federal Register inquiry, the FDA says it received 134 comments on the Pentagon's use of pyridostigmine bromide and on the issue of waiving military members' consent. The FDA says 114 respondents filed those 134 comments, which "stated that informed consent was absolutely essential and that military personnel, like other nonmilitary citizens, should receive adequate information about an investigational product before its use and the right to refuse to receive it."
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