Nerve-gas drug OK'd for troops despite fear

[thedrifter]

Subj: FDA's OK, in spite of perceived link to gulf-war illnesses
Date: 2/7/2003 1:39:15 PM Eastern Standard Time
From: LPGulfvet
BCC: VetCenter




Nerve-gas drug OK'd for troops despite fear

FDA's OK, in spite of perceived link to gulf-war illnesses, boosts ICN.
By BERNARD J. WOLFSON
The Orange County Register

The U.S. Food and Drug Administration has approved a nerve-gas antidote that's been linked in medical studies to the undiagnosed chronic illnesses sustained by veterans of the 1991 gulf war.

The FDA's formal approval Wednesday of pyridostigmine bromide is a boon for Costa Mesa-based ICN Pharmaceuticals Inc., which manufactures it under the brand name Mestinon.

The FDA approved the drug solely for U.S. combat troops as pretreatment in case of exposure to the nerve agent soman, which triggers loss of muscle control and can cause death through respiratory failure.

Pyridostigmine bromide's effectiveness against soman has only been tested in monkeys and guinea pigs. It is the first drug approved under a recent ruling that allows the use of animal data for evidence of efficacy when testing on humans is unethical.

The drug has been approved since 1955 for treatment of myasthenia gravis, a neuromuscular disease. The FDA allowed it to be used on soldiers in 1991 under a special exemption for "investigational" drugs, though it was not officially approved at that time. Some U.S. officials believe that during the gulf war Iraq may have used soman obtained from the Soviet Union.

The FDA on Thursday said it has found no convincing connection between pyridostigmine bromide and so-called gulf war syndrome, whose symptoms include muscle pain, memory loss, diarrhea, respiratory problems, rashes and sleep loss. Its potential benefits – preventing deaths in a soman attack â–outweigh the unproved risks, the agency decided.

Gulf war veterans fumed at the decision, citing scientific evidence they believe proves a link.

"I'm mad as a hornet," said Steve Robinson, executive director of the National Gulf War Resource Center. "Citizens and soldiers alike should demand an explanation of this ruling."

An ICN spokesman wouldn't comment on the drug's alleged link to gulf war syndrome or say whether the company has received orders for the drug from the Pentagon.

But Assistant Secretary of Defense William Winkenwerder Jr. said the Pentagon was pleased by the FDA's move. "We have a responsibility to protect the health and safety of our service members."

Robert Temple, director of one of the FDA's five drug- evaluation offices, said the agency looked at three significant studies, by the Rand Corp., the Institute of Medicine and the U.S. Army, and that none found strong evidence of a link between pyridostigmine bromide and Gulf War Syndrome – thoough they couldn't rule it out.

"You never say never. But on the basis of evidence available now, we concluded there was no relationship established," Temple said.

But Beatrice Golomb, author of the Rand report, said her view has shifted since it was published in 1999. "I now believe there is substantially more compelling evidence of a relationship between pyridostigmine bromide and illness in gulf war veterans," said Golomb, a professor of medicine at UC San Diego and scientific director for the Department of Veterans Affairs Research Advisory Committee on Gulf War Illnesses.

"I am concerned there will be people who will be receiving this agent and will potentially have long-term health effects from it," she said.

Golomb said a strong connection has emerged between veterans who reported taking pyridostigmine bromide in 1991 and those having gulf-war illnesses. And veterans who took more of the drug are more likely to be ill, she said.

Moreover, laboratory animals who got low, short-term doses of the drug showed nerve-cell death and changes in brain chemistry, Golomb said. She added that it is not effective against other nerve agents, such as sarin and VX, and could even exacerbate their sometimes-deadly effects.

Temple countered the studies of veterans who reported having taken pyridostigmine bromide, saying their recollections could have been biased by subsequent reports about the drug. And he noted that people with myasthenia gravis have taken the drug in much higher doses and over many years with no apparent ill effects. "That's reasonably good evidence," he said.

But weighing risks vs. benefits is a far different calculation for healthy soldiers than for people with a long-term disabling disease, said Felicia Cohn, director of medical ethics at U.C. Irvine's College of Medicine. "They're already living with a chronic illness, so if there's a drug that can counteract that, the benefits might still outweigh the risks," she said.

Soldiers, on the other hand, might take the drug and never be exposed to soman – or worse yet, get hit with another nerve agent whose effects arre aggravated by the drug, Cohn said. "So it seems to me that regardless of what the military says and what the FDA says, our soldiers deserve the right to decide for themselves whether the potential benefits still outweigh the potential risks."

Sempers,

Roger

[eddief]

The FDA is using our troops as lab rats again, and it stinks to high hell.