[MC_USA] Business as Usual,

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Wayne Fugitt

Wed, 26 May 2004 21:25:06 -0500

[MC_USA] Business as Usual,

 

Drug causing GIs permanent brain damage

 

By Mark Benjamin and Dan Olmsted

United Press International

Published 5/26/2004 4:19 PM

 

WASHINGTON, May 26 (UPI) -- Six U.S. soldiers have been diagnosed by the

military with permanent brain damage from an anti-malaria drug used in Iraq and

Afghanistan, and health officials must reassess its safety, a U.S. senator said.

 

Sen. Dianne Feinstein, D-Calif., in a letter to Health and Human Services

Secretary Tommy Thompson, said the drug, called mefloquine, has " serious risks "

that have not been adequately tracked by the Pentagon, the Peace Corps and other

government agencies that distribute it.

 

" I ask that you work with the Food and Drug Administration to reassess the

safety of mefloquine, " Feinstein wrote Thompson in a letter dated May 24.

 

Feinstein told Thompson she is concerned that " six service members have been

diagnosed with permanent brainstem and vestibular damage from being given this

drug despite the fact that alternative drugs might have been chosen to prevent

infection. "

 

The FDA last year warned that the drug, also called Lariam, is linked to reports

of suicide, though a connection has not been established. It also said some

psychiatric and neurological side effects have been reported to last long after

taking it. The Pentagon this year announced a new safety study of the drug,

which has been used by some 20 million people worldwide, and the Department of

Veterans Affairs said it will look at possible long-term effects on veterans.

 

According to people familiar with the situation, the six service members were

diagnosed in recent weeks by doctors at Naval Medical Center San Diego. Its

Spatial Orientation Lab, a Department of Defense facility, specializes in

balance disorders.

 

One service member who received a diagnosis is former Navy Reserve Cmdr. William

Manofsky, who became severely ill after taking mefloquine in Iraq and Kuwait

while deployed for Operation Iraqi Freedom. Another soldier with a mefloquine

diagnosis is a Green Beret who served in Afghanistan.

 

UPI reviewed a copy of Manofsky's medical report from the San Diego lab, which

includes the notation, " Lariam induced, " with the word Lariam underlined.

 

Earlier this month, Manofsky filed suit against Lariam's manufacturer, Swiss

drug giant Hoffmann-La Roche, for alleged failure to warn of the drug's risks

and marketing a product it knows is unsafe.

 

Asked for comment about the suit, Roche spokesman Terence Hurley told UPI: " We

don't comment on pending litigation. Roche believes that the labeling that

accompanies Lariam, and which has been approved by the FDA, is adequate.

Information about the use of Lariam and neuropsychiatric events has appeared in

the product's label since it was approved by the FDA in 1989.

 

" Roche takes issues of safety very seriously and works with regulatory

authorities on an ongoing basis to ensure recommendations on product use take

into account current scientific and medical evidence. "

 

Manofsky said he became mentally and physically ill after taking the drug, at

one point taking his gun apart because he was afraid he was going to kill

himself. A year after he stopped taking the drug, he still suffers from severe

balance problems, trembling and memory loss.

 

The diagnoses appear to put the Pentagon, and particularly the Army, in an

unusual position: Military health officials continue to insist the drug is safe

and to prescribe it widely. Army Surgeon General James Peake told a House

subcommittee in February that " we don't think it is as big a problem as has been

made out. "

 

Peake also dismissed any association between the drug and a string of

murder-suicides at Fort Bragg, N.C., in the summer of 2002 by U.S. soldiers who

took Lariam while assigned to units in Afghanistan.

 

" There was absolutely no statistical correlation between Lariam use and those

suicides, " Peake said.

 

But the Army announced it will study possible Lariam side effects, including

suicide, as a result of the controversy. The study could take up to two years,

according to William Winkerwerder Jr., assistant secretary of defense for health

affairs.

 

In March another Special Forces soldier committed suicide after taking Lariam in

Iraq and returning home to Monument, Colo. William Howell's wife believes Lariam

triggered his bizarre behavior, in which he stuck a gun in her face and

threatened to kill her before shooting himself. She accused the Army of not

looking into whether the drug had played a role -- the same charge made by

friends of the soldiers involved in the Fort Bragg incidents.

 

Howell's death in Colorado brought the number of suicides among Special Forces

soldiers during the war on terrorism to five. At least four of the five took

Lariam on deployments just prior to committing suicide, according to the Army.

 

 

 

 

 

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