DOD AND RAND RELEASE REVIEW OF THE LITERATURE AS IT PERTAINS TO GULF WAR ILLNESSES AND PYRIDOSTIGMINE BROMIDE
Today the Department of Defense and RAND Corporation released the latest in a series of scientific literature reviews on potential health issues affecting Gulf War veterans.
"The Defense Department has provided an important service to Gulf War vets by commissioning this work," said Bernard Rostker, special assistant for Gulf War illnesses. "This work breaks new ground, presenting a great deal of information that wasn't available to decision makers during the Gulf War. It is a most thorough review of an important issue in the search for answers to Gulf War illnesses. I believe this information will be invaluable both to Gulf War veterans and in the continued research on pyridostigmine bromide (PB)."
The RAND paper examines the safety and effectiveness of PB used during the Gulf War as a pretreatment to protect military personnel from the nerve agent Soman. The work was performed to identify hypotheses or theories that might link PB to illnesses in Gulf War veterans.
According to the paper, "Two major conclusions emerge from this review of the scientific literature, one pertaining to the safety and one to the effectiveness of PB." Although medical research has not established PB as a cause of Gulf War illnesses, it "cannot be ruled out as a possible contributor to the development of unexplained or undiagnosed illnesses in some PGW veterans." The paper goes on to say that further research is needed to determine the effectiveness of the current dose of PB against Soman.
"We need to complete research regarding PB to resolve remaining questions," said Dr. Sue Bailey, assistant secretary of Defense for health affairs. "A very active research program is continuing on all of the hypotheses identified by RAND. I have asked the Armed Forces Epidemiology Board, an ouside panel of distinguished medical experts, to evaluate the RAND review and advise DoD on whether present research directions should be altered." Bailey added, "We have followed and will continue to follow research leads wherever they go."
From fiscal 94 through fiscal 99 more than $133.5 million has been invested for research on illnesses among Gulf War veterans. To date, more than 25 peer-reviewed studies with funding in excess of $20 million, address the health consequences of PB use for nerve agent pretreatment. The Persian Gulf Veterans Coordinating Board has given priority to studies on PB, either alone or in combination with other exposures.
"In addition to the ongoing research, this RAND review will be evaluated by the Institute of Medicine as part of its charter to review and assess all information related to health concerns of our veterans, " said Rostker.
There is no FDA-approved, effective protection against the deadly nerve agent Soman, which was thought to be a threat during the Gulf War. Based on animal research, DoD believes PB, used in combination with other antidotes, may be effective in preventing human casualties. Most U.S. troops received packets containing PB pills during the war. DoD estimates that approximately 250,000 personnel took at least some PB.
Pyridostigmine bromide is an FDA-approved drug for two civilian uses: treatment of myasthenia gravis, a neuro-muscular disorder, and for reversing the effects of some anesthetic drugs. However, PB is considered to be an investigational, not experimental, drug when used as a pre-treatment against chemical warfare agents. Evidence of the effectiveness of PB as the pre-treatment for Soman was based solely on animal studies because it is unethical to intentionally expose people to lethal nerve agents in order to test the effectiveness of a drug.
"The DoD must always balance the risks of war, to include the potential for use of deadly nerve agents such as Soman with the possible side effects from drugs such as PB," according to Bailey. "Currently, PB is thought to be an essential part of the medical protection our troops have for Soman, which is extremely lethal. Pyridostigmine bromide does have known short-term side-effects however, we need to continue our efforts to protect our troops against deadly nerve agents."
The policy for using PB is covered in detail in the RAND report, "Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense," published earlier this year. This report chronicles the complex nature of the approval process for using the drug during the Gulf War.
This paper, as well as the other RAND literature reviews on oil well fires, stress and depleted uranium, is posted on the GulfLINK website ( http//www.gulflink.osd.mil ). We expect literature reviews dealing with chemical and biological weapons, pesticides, immunizations and infectious diseases to be released over the next year. As each review is released, it will be posted on GulfLINK.