PFPC Daily - February 17, 2005

Side-effect reports cast shadow over malaria drug

Associated Press - Feb. 16, 2005

By Seth Hettena

SAN DIEGO — As a volunteer firefighter, Georg-Andreas Pogany had
seen disfigured bodies pulled from wrecked cars. But something very
different happened when the Army interrogator saw the mangled remains
of an Iraqi soldier.

He became panicked, disoriented and that night reached for both his
loaded pistol and rifle as he thought he saw the enemy bursting into
his room. Pogany asked his superiors for help; the Army packed him
home to face charges of cowardice — the first such case since
Vietnam.

None of it made sense to Pogany until he learned more about the white
pills the Army gave him each week to prevent malaria.

The drug's manufacturer warned of rare but severe side effects
including paranoia and hallucinations. It became his defense: The
pills made him snap. The Army dropped all charges, a spokesman later
saying that Pogany "may have a medical problem that requires care
and treatment."

Pogany is among the current or former troops sent to Iraq who claim
that Lariam, the commercial name for the anti-malarial drug
mefloquine, provoked disturbing and dangerous behavior. The families
of some troops blame the drug for the suicides of their loved ones.
Though the evidence is largely anecdotal, their stories have raised
alarm in Congress, and the Pentagon has stopped giving out a pill it
probably never needed to give to tens of thousands of troops in Iraq
in the first place.

"What are we doing giving drugs that cause hallucinations,
confusion, psychotic behavior to people that carry weapons and hold
secret clearances?" asked Pogany, 33, who is now seeking a medical
discharge. "It doesn't pass the common-sense test."

The U.S. military, which developed the drug after the Vietnam War,
maintains that Lariam is safe and effective, though officials have
expressed some concern and the military tells its pilots not to take
Lariam.

In written guidance on the drug last year, the military urged
commanders to send for a medical evaluation anyone who showed
behavioral changes after taking the drug, "especially ... if they
carry a weapon" — a description of nearly all U.S. troops in
Iraq.

"Delay could put the service member or your unit at risk,"
the guide said.

Lariam is among the drugs recommended by the U.S. Centers for Disease
Control and Prevention for treatment and prevention of malaria, which
kills about 1 million people worldwide each year. The drug's New
Jersey-based manufacturer, Roche Pharmaceuticals, points out that
more than 30 million people worldwide have used Lariam over 20 years.

"There is no reliable scientific evidence that Lariam is
associated with violent acts or criminal conduct," Roche
spokesman Terence Hurley wrote in an e-mailed response to questions.

Further blurring the issue, the side effects associated with Lariam
closely mirror symptoms of stress disorders related to combat, making
diagnosis difficult.

Still, the pill has dedicated critics who believe it is causing
problems that are only beginning to be understood. A review by the
Department of Veterans Affairs found 34 articles in medical journals
about patients who took Lariam and became paranoid, psychotic or
behaved strangely.

Within the civilian medical community, faith in the drug is mixed
among doctors who specialize in tropical diseases. Two said they
routinely prescribe it to travelers and believe troop complaints are
overblown. Another criticized the military's use of a drug with a
known history of psychiatric complications.

Dr. G. Richard Olds, professor and chairman of medicine at the
Medical College of Wisconsin, is among Lariam's critics.

"There's a strong recommendation not to use Lariam for those
who depend on fine motor skills," he said. "Do you call
firing an M-16 a fine motor skill? I do."

Doctors at the Naval Medical Center in San Diego have diagnosed a
disorder in the region of the brain that controls balance in 18
service members who took Lariam, among them Pogany.

The Pentagon's records show the number of Lariam prescriptions
issued to active-duty personnel nearly doubled from 18,704 in 2002 to
36,451 the next year, said Lt. Col. Stephen Phillips, a program
director for deployment medicine. Since prescriptions issued at
remote locations aren't counted, actual numbers may be higher.

Shortly after the March 2003 invasion, military doctors determined
another malaria drug would do the job with fewer side effects. Around
the same time, the U.S. Food and Drug Administration announced that
doctors should give patients revised information, underscoring that
some Lariam users experience severe anxiety, paranoia,
hallucinations, depression and think about killing themselves.

Troops were supposed to receive those kinds of warnings, but several
current and former soldiers interviewed for this story said they did
not — and that they continued taking the drug in Iraq as recently
as 2004. In that year, Phillips said, the number of prescriptions fell
to 12,363.

Concerns about those taking the drug weren't new. Some U.S. and
Canadian forces deployed to Somalia in the early 1990s reported
strange behavior. Lariam came up as a possible explanation after four
Fort Bragg, North Carolina, soldiers killed their wives over 43 days
in 2002. An Army probe ruled out Lariam, which was only prescribed to
two of the soldiers.

Last year, the assistant defense secretary for health affairs ordered
a review of the drug's use based on troop concerns. Many who
complained came from the 3rd Armored Cavalry Regiment at Fort Carson,
Colo. A base spokesman referred all questions to the Pentagon.

In a letter last month, Sen. Dianne Feinstein, D-Calif., pressed
Defense Secretary Donald Rumsfeld to release results of the
Pentagon's investigation. Feinstein has said there is enough
evidence in the warnings from Lariam's maker "to make the
causal link between the drug and many of the serious adverse events
experienced by service members."

Military officials now concede Lariam wasn't needed in Iraq —
and not just because, according to the Pentagon, no malaria
infections have been reported among U.S. forces there.

Troops sent to Kuwait in 1991 for Operation Desert Storm were given
another anti-malarial, chloroquine. Before the Iraq invasion, the
Armed Forces Medical Intelligence Center in Fort Detrick, Md., which
is charged with evaluating medical risks, was concerned that a deadly
malaria strain in the region might have become resistant to
chloroquine. They relied on reports from the World Health
Organization and U.S. Special Operations units sent to northern Iraq.

In a series of reports before the invasion, the intelligence center
extrapolated that — without bug spray, mosquito nets or other
preventive measures — about 1 in 2,000 troops could pick up a
deadly chloroquine-resistant malaria strain, according to a
spokesman, Army Lt. Col. Michael Birmingham.

In March 2003, U.S. Central Command recommended the use of Lariam or
another drug, doxycycline, in high-risk areas in Iraq. The idea was
"to err on the side of caution," rather than assume
chloroquine would work, said Phillips of the Pentagon's
deployment medicine program.

Some commanders chose Lariam because it could be taken once a week
rather than daily like doxycycline, whose main side effects included
sensitivity to sunlight.

By July 2003, the military had determined the chloroquine-resistant
strain wasn't in Iraq. Chloroquine then became the drug of choice.

"That's the saddest part," said Laura Howell, a widow
with two children after her husband killed himself in Colorado
Springs, Colo. "There was never a need."

Howell blames Lariam for what happened a few weeks after her husband,
a veteran Green Beret, returned home. In March 2004, Chief Warrant
Officer William Howell went from "normal to murderous" in a
half-hour, his wife said, and ended his life in his front yard with a
bullet to the head.

Critics of the drug in organizations such as Lariam Action USA and
the National Gulf War Resources Center believe Lariam is connected to
the surge in military suicides in 2003, when 23 people deployed to
Iraq and Kuwait took their lives. The suicide rate dropped after
Lariam's use was halted in Iraq.

Former Army Spc. Don Dills and his wife say he grew anxious, paranoid
and depressed after taking Lariam for seven months in Iraq. Dills,
22, says he "went crazy" on a family visit to Mississippi last
year and wound up jailed for robbery. When Dills' wife called her
husband's first sergeant about the arrest, he told her: Look into
Lariam.

Dills, who like Pogany and Howell was based at Fort Carson, was
kicked out of the military shortly after he wound up in a psychiatric
ward for problems he and his wife contend are linked to Lariam.

"The bottom line is they know what's going on," said
Elicia Dills, 25, of Pueblo, Colo. "They just don't know how
to deal with the can of worms they opened."

SOURCE:
http://www.armytimes.com/story.php?f=1-292925-663413.php