Drug Tested in Gulf War Is Approved for Troops_NYT
Thu, 6 Feb 2003
The New York Times reports that FDA has approved the drug, pyridostigmine bromide for use by the military. The drug had been used experimentally during the Gulf War in 1991. It has been the center of controversy as it is thought by some to be the cause of Gulf War Syndrome.
Although there have been no clinical trials in human volunteers to test the safety of the drug, FDA claims postwar studies “all assert that you can’t attribute any aspects of gulf war syndrome to this drug.”
By invoking bioterrorism as a risk, the government is institutionalizing a two track standard for approving drugs. Those meant for civilians must undergo testing in clinical trials for safety and efficacy. When efficacy cannot be tested in human beings–as in the case of vaccines and antidotes against deadly agents–such as nerve gas, anthrax, smallpox– those drugs / vaccines should be tested in human volunteers *for SAFETY alone* before they can be approved for legitimate use in the population.
Instead, the government is attempting to by-pass safety trial requiremtnes for drugs / vaccines that will mostly be used by military servicepersons. Essentially the government is using service personnel as non-consenting human guinea pigs. Military personnel don’t have the luxury of saying NO.
Is there reason to suspect that the troops are likely to face soman nerve gas as opposed to another, such as sarin? Since pyridostigmine bromide does not even protect against sarin, but only against soman, it may have no protective value.
On January 28 BNA had reported that a DOD memo proposed a similar two-track policy–one for the military, another for civilians. [see http://www.ahrp.org/infomail/0103/28.php ]
We believe that by applying a double standard for drug approval FDA and DOD are dismantling ethical research standards and leading us down the slippery slope.
The New York Times
February 6, 2003
Drug Tested in Gulf War Is Approved for Troops
By DONALD G. McNEIL Jr.
The Food and Drug Administration gave final approval yesterday to a drug used to help protect troops against one type of nerve gas that might be used in any war with Iraq.
The drug, pyridostigmine bromide, was used, on an experimental basis, in the Persian Gulf war in 1991, and some groups argued that it could have been a cause of gulf war syndrome. The syndrome is vaguely defined, but veterans complained of fatigue, rashes, headaches, muscle pains and memory loss.
But an F.D.A. spokesman said several postwar studies “all assert that you can’t attribute any aspects of gulf war syndrome to this drug.”
Much higher doses of the drug are used to treat myasthenia gravis, a neuromuscular disease, the spokesman, Dr. Robert Temple, said, adding that the drug does not pass the blood-brain barrier, which protects the brain. It was approved for myasthenia gravis in 1955.
At the front, pyridostigmine bromide is taken in tablets three times a day by troops in danger of being exposed to soman nerve gas. Soman is one of several nerve gases that kill by paralyzing the breathing muscles. The drug does not protect against sarin, a better-known, slower-acting gas in the same family.
The pills protect the periphery of the body. If troops are exposed to gas, they must immediately stop using them and inject themselves with atropine and pralidoxime, drugs that can reach the central nervous system and that already have F.D.A. approval. Troops are also supposed to wear gas masks and chemical protection suits.
In the gulf war, pyridostigmine bromide was considered an investigational drug. Yesterday’s agency approval was based on tests in guinea pigs and monkeys. The drug cannot ethically be studied in humans because they would have to be exposed to nerve gas.
F.D.A. rules issued last June allow for approval of drugs for humans based on their effectiveness in animals when it is not feasible to do human tests, Dr. Temple said.
Because of the possibility of war with Iraq, “there was interest in having the drug approved,” he said.
Dr. Mark B. McClellan, the F.D.A. commissioner, said the approval would “help protect American troops and others from nerve agent attacks.”
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