LARIAM MISERY: THE FDA WON'T LISTEN

Palo Alto -- A RECENT column by Examiner reporter Scott Winokur on the perils of
Lariam is the first ever aimed at a general audience.

Otherwise, you would need to subscribe to special-interest publications
where underwater divers, photographers and outdoor sports enthusiasts have
contributed "traveler's advisories" about this toxic anti-malarial drug.

Those of us who have tried to alert the U.S. Food and Drug Administration
find our reports uniformly discounted. I sent then-FDA Commissioner David
Kessler an account of what happened to me years ago in Uganda after I took
a precautionary dose of Lariam. (I then fantasized jumping from my
eighth-floor room in Kampala to experience the sensation of flying. I had
strange sensations in my legs. And so forth.)

I received a characteristic FDA reply. It questioned my observations,
chided me for being unwilling to suffer a few "minor" side-effects and
lectured me, a health economist, on cost / benefits analysis.

I sent the same account five years ago to The Lancet, the British medical
journal, trying to alert health and medical professionals to Lariam's
relatively high incidence of serious, long-lasting side-effects. Since
then, manufacturer Hoffmann-La Roche has expanded the Lariam Product
Warning Sheet in the United Kingdom. And the British government no longer
recommends Lariam to the general traveler.

Meanwhile, the U.S. Food and Drug Administration still pronounces Lariam
"safe." The U.S. Centers for Disease Control still designates Lariam as its
preferred anti-malarial drug.

The FDA's and CDC's sluggish reaction to the cascade of Lariam critiques
reflects weakness in its adverse drug reaction reporting system.

Doctors or users are required first to identify as a drug reaction problems
that may have been omitted from the product warning sheet. Next, they must
obtain and file the "Medwatch" form.

According to University of Pennsylvania biostatistics chair Brian Strom,
more than two-thirds of the doctors in his audiences fail to file Medwatch
forms.

More than 225 persons this past year have contacted Lariam Action-U.S.A. -
LariamUSA@aol.com- an informal clearinghouse I manage for people who have
used Lariam or have questions about it. But few had filed Medwatch reports
of disabling side-effects they experienced.

Some users, completing our questionnaire, reply that our information sheet
alerted them for the first time to link Lariam to their neuro-psychiatric
symptoms, panic and anxiety attacks, skin rashes, insomnia, circulatory and
respiratory upsets and so forth. Others had deprecated their own
experience, saying, "I thought it was just me" or, "I took only one pill,
so why should I bother the FDA?"

This known underreporting bias explains Dr. Philip Lee's caution when
addressing a Stanford audience: "We do not have adequate authority for
post-marketing surveillance of new drugs."

Dr. Lee, now with the FDA, is founder of the UC-San Francisco Institute for
Health Policy Studies. He was assistant secretary for health in both the
Clinton and Johnson administrations.

Donald Kennedy, FDA commissioner (1977-79) and Stanford president emeritus,
concurred. He has since told me that he doesn't know anyone "intimately
familiar with the FDA's adverse drug reaction reporting system" who
believes it is performing adequately.

Last fall Dr. Murray Lumpkin, deputy director of the FDA's Center for Drug
Evaluation, stated he felt "very good about our system" of drug reaction
tracking.

This reassurance was directed at those who questioned the FDA capability to
monitor thalidomide, a notorious teratogen associated with fetal limb
reductions.

Consider: An FDA lacking funds to conduct its own outreach studies first
maintains full trust in its drug reaction system.

Next, it attacks the credibility of those users who conscientiously
self-report side effects.

The agency consistently ignores the Medwatch reports and letters from me
and other sufferers, not to mention assessments in two British medical
journal reports that Lariam is "toxic."

Finally, it has not called for experts with no financial ties to Roche to
evaluate these overseas studies. Where Lariam is concerned, the FDA's motto
seems to be: "Don't tell; we won't ask."

Can we trust this is the only drug the agency treats so cavalierly?

Examiner contributor B. Meredith Burke is a former research associate at
Stanford Medical School, and director of Lariam Action-U.S.A.

1998 San Francisco Examiner Page A 17

Checked-by: (Joel W. Johnson)