PFPC Daily - October 11, 2004

Lariam: The New Agent Orange?

October 9, 2004 - Alliance for Security

If science was going to design a drug not to give troops going into a
war zone, it might look a lot like Mefloquine hydrochloride known by
the brand name Lariam. Approved in 1983 by the Food and Drug
Administration, this anti-malarial product was developed by the Walter
Reed Army Institute of Research in collaboration with the World Bank,
the World Health Organization (WHO) and the pharmaceutical giant, F.
Hoffman-La Roche (Roche) of Basel, Switzerland.

Since its introduction 20 years ago, millions of people have taken the
drug as both a prophylaxis (preventative) against malaria and also as
a therapy (treatment) for those who have contacted the
life-threatening disease which is carried by mosquitoes in many
regions of the world. Ten of thousands of American troops deployed to
Afghanistan and

Iraq were ordered to take Lariam, a scored white pill, three times a
week.

Not long after the war in Afghanistan got underway, stories of strange
and violent behavior and lingering neurological side effects began
emerging, many of them reported by United Press International's
Mark Benjamin and Dan Olmsted . A growing anecdotal chorus born of
both soldier suicides and homicides, perhaps connected to Lariam use,
have some veterans and their advocates concerned that troops are
victims of a drug they should never have been given in the first
place.

A string of homicides by soldiers in the summer of 2002 near Fort
Bragg may have been fueled by the drug, although the Army has denied
it. Three soldiers involved also committed suicide. A cluster of
suicides last summer in Iraq, (malaria season) had the Army scrambling
to determine why our soldiers were killing themselves.

Last August, right about the time the suicide cluster in Iraq was
peaking, the pharmaceutical company Roche, issued this warning in a
patient information sheet : "People taking Lariam occasionally
experience severe anxiety, feelings that people are against them,
hallucinations, depression, unusual behavior or feeling disoriented.
Some patients taking Lariam think about killing themselves and there
have been rare reports of suicides. It is not known whether Lariam was
responsible for these suicides."

A review of the medical literature raises a number of questions about
why the military would use this drug in the first place. In 1991, WHO
published a paper that stated that in 1989 "serious neurological
and psychiatric adverse events attributed to the drug were brought to
the attention of the pharmaceutical company and of WHO." That
paper, after looking at the science to date, noted that of the
patients who had reported negative side effects, "...38 % were
reported to have had neurological and psychiatric adverse
events."

For those with symptoms who had taken the drug as a prophylactic, 41 %
had taken only a "single 250-mg dose prior to the onset of
symptoms."

It also reported this scary statistic: "There were 22 (30%)
patients whose neurological or psychiatric disorder did not resolve
for many months" after they stopped taking Lariam. Some of these
patients "continued to have adverse events for four or more
months."

The WHO review also discussed a number of neurological symptoms that
can occur in people taking Lariam. They include:
Seizure Disturbances in the level of consciousness
Dizziness
Vertigo
Neuropathies
Sensory disturbances
Headache
Other neurological disorders

It stated there is concern that "life-threatening trauma could
arise from neurological events such as dizziness or from psychiatric
disturbances. Both WHO and Roche thus continue to advise that persons
involved with precision activities requiring fine coordination (such
as airline pilots) should not take Mefloquine (Lariam)."

Over the years, a number of studies drew similar conclusions. In July
2002, a Dutch team reported that "In conclusion,
Mefloquine-associated neuropsychiatric adverse effects were
demonstrated during the run-in period of 3 weeks of the use of a
prophylactic dose of 250 mg weekly."

In September of 2002, Roche issued a "Dear Doctor" letter
warning clinicians among other things that "During prophylactic
use, if psychiatric symptoms such as acute anxiety, depression,
restlessness or confusion occur, these may be considered prodromal
(predictive) to a more serious event. In these cases the drug must be
discontinued and an alternative medication should be substituted."

The letter also said "Lariam should not be prescribed for
prophylaxis in patients with active depression, a recent history of
depression, generalized anxiety disorder, psychosis or schizophrenia
or other major psychiatric disorders, or with a history of
convulsions."

Effects of Lariam on U.S. Troops

It is still to be sorted out whether the Army actually headed any of
these warnings when it ordered our soldiers to take Lariam. Alliance
for Security, in researching this issue knows of two Iraq suicide
cases, young soldiers both, who were struggling with depression before
they went to Iraq. Both died of self-inflicted gunshot wounds. We have
not yet been able to determine if they were given Lariam.

Georg-Andreas Pogany, a soldier who was charged with cowardice after
reporting an anxiety attack to his commander, tells us he was not
instructed to stop taking his Lariam pills, even though it's clear
that it had become contraindicated.

Another suicide, of a soldier known to have taken the drug, occurred
just outside of Fort Carson, three weeks after the Green Beret
returned from Iraq. William Howell was a Special Forces sergeant with
no history of psychiatric trouble. Even so he shot himself, after days
of paranoid and delusional behavior as described by his wife.

Recently, the Naval Medical Center, in San Diego diagnosed Pogany and
several other soldiers with "likely Lariam toxicity". In
Pogany's case the tests showed eye and ear abnormalities and
balance problems linked to brain stem damage.

In June of this year, the Veteran's Administration warned its own
doctors that Lariam "may rarely be associated with certain chronic
health problems that persist for weeks, months and even years after
the drug is stopped."

Given that Lariam is contraindicated in people who are anxious or
depressed and given that combat naturally induces those states in
soldiers, one has to wonder how much thought went into the Army's
Lariam decision. Why would they choose to prescribe this drug when an
alternative, doxycycline, was available? We could be watching a
preventable tragedy unfold.

SOURCE:
http://bellaciao.org/en/article.php3?id_article=3647