Unintended Damage

Transcript of Webcast from Voice of America

by Carolyn Weaver
April 7, 2001

INTRODUCTION
April seventh marks World Health Day… a day the World Health
Organization selects to highlight a public health issue. We’re going
to take this opportunity to highlight a highly dangerous
infection–malaria–which still threatens the health of millions.
But, ironically, some say the cures may be as devastating as the
disease itself.

U.S. health officials say the drug “Lariam” has prevented millions
of infections, especially in countries where malaria is resistant to
other drugs. But in some people, the drug causes severe
neuro-psychiatric side effects.
VOA’s Carolyn Weaver reports on a life-saving medicine that may also
be a prescription for “unintended damage.”

NARRATOR
Kristi Anderson was a federal criminal investigator when she
traveled to South Africa on vacation in 1991. To protect her against
malaria — a potentially fatal disease carried by mosquitoes — Ms.
Anderson’s doctor prescribed a drug called mefloquine, sold in the
United States under the brand name Lariam. After the third pill, she
began having constant dizziness, nausea, and panic attacks.

KRISTI ANDERSON
“I would sweat, I would have chills, I’d shake. Almost, always,
there was nausea, but sometimes it was a wave of dizziness or
vertigo, and then I would start having this feeling of impending
doom. I wanted to get out of where I was, I just wanted to get back
home or someplace where I felt safe because I was afraid something
terrible might happen.”

NARRATOR
Nauseated and losing weight — and tormented by anxiety and phobias
— Kristi Anderson quit her job and moved back home to California
for a year and a half, until she was well enough to go back to work.
But in 1996, she returned to South Africa – and again took Lariam –
and again became violently ill. Only then did she begin to suspect
the drug was the cause.

KRISTI ANDERSON
“He said the damage was in my brain stem.”

NARRATOR
Neurological tests at Stanford University’s California Ear
Institute, confirmed Kristi’s suspicion finding damage to a part of
the brain, the vestibular system, that controls balance.

KRISTI ANDERSON
“He told me, from the Lariam patients he had seen and what his tests
showed, he believed that Lariam was the cause of my vestibular
problems and he thought it was the cause of the earlier problems as
well.”

NARRATOR
A spokesman for the Roche pharmaceutical company, which makes
Lariam, declined VOA’s requests for an interview, saying the company
saw no advantage to participating. In the 12 years since Lariam was
approved for use in the United States, Roche has twice added new
warnings of possible adverse effects in the package insert given to
doctors. It’s a long list, including, among other things, nausea,
vomiting, dizziness, convulsions, depression, hallucinations,
psychotic or paranoid reactions, and anxiety.
But few patients ever see the package insert. And many tropical
health and travel doctors, like former State Department consultant
Martin Wolfe, prescribe Lariam routinely. They’re acting on the
guidance of the Centers for Disease Control and Prevention, which
recommends Lariam as one of the most effective drugs for preventing
malaria. It’s a disease endemic in many parts of Africa and Asia,
where it kills more than one million people, most of them children,
every year.

MARTIN WOLFE
“We do prescribe it very frequently because it only has to be taken
once a week, and we believe the compliance is better with a drug
taken once a week than one taken daily. And since we are protecting
against a potentially life threatening illness, we want to do the
very best we can to encourage people to take their medication.”

NARRATOR
It’s impossible to pin down the incidence, but some experts say the
rate of severe reactions is far higher than the one in ten-thousand
cited in early research by Roche. A study presented at an infectious
disease conference last fall reported mild to serious
neuropsychiatric adverse effects in 29% of travelers on Lariam.

RAYMOND WOOSLEY
“There are some very serious reactions that appear to be happening
more commonly.”

NARRATOR
Dr. Raymond Woosley is the head of pharmacology at Georgetown
University in Washington, D.C.

RAYMOND WOOSLEY
“You look in the package insert, they’re listed there. So they are
real, there is no doubt about that. But the true incidence is
something we don’t understand, and it really doesn’t matter, because
they’re such severe reactions that patients need to be warned about
this.”

NARRATOR
Colonel Wilbur Milhous was among the military scientists who first
developed Lariam at the Walter Reed Army Institute for Medical
Research — and then gave the rights to make and sell the drug to
the Roche company. But as reports of severe reactions to Lariam
began to emerge — and as lawsuits were filed over illness and
violence allegedly linked to the drug — he says the government
feared that Roche would pull the drug off the market.

WILBUR MILHOUS
“There was clearly an unmet medical need which the drug fulfilled.
We were frightened from a U.S. perspective, in terms of national
contingencies, what would happen if it were withdrawn?”

NARRATOR
So, Colonel Milhous says, top government health officials promised
Roche they would continue to back Lariam, despite the growing
reports of adverse effects.

Officials at the Centers for Disease Control and the Food and Drug
Administration, which approved the Lariam, declined VOA’s request
for an interview. But earlier this year, the CDC updated its malaria
protection guidelines, offering alternative drugs, including
doxycycline and Malarone, for those who do not wish to take Lariam.

WILBUR MILHOUS
“This is essentially the type of laboratory where this all started.”

NARRATOR
Colonel Wilbur Milhous says American health officials now are
looking ahead, to the next generation of drugs –largely because of
growing resistance to Lariam in some strains of malaria. But there
is little doubt that Lariam will continue to be prescribed for
months…and years to come, to Peace Corps volunteers, soldiers, and
ordinary travelers.

Despite bouts of dizziness, Kristi Anderson has resumed her career,
and tends her California flower farm on weekends. She says she’s
felt more at peace since she came upon a newspaper article about
Lariam that explained her mental symptoms.

KRISTI ANDERSON
“Reading that article released me from this shame of ‘Kristi, you’re
some kind of weak person and you better watch out because you’re
going to have a nervous breakdown again sometime, you just better be
careful. I realized, that’s what made me sick — that’s what
happened to me — that’s why I became a different person.”

NARRATOR
Carolyn Weaver, VOA-TV.

More Information on Malaria, Treatment, and Side Effects