Drug used in malaria fight deserves closer scrutiny 
USA  Today.com
Tue Mar 9, 2004

 
After months of questions from veterans groups and members of Congress, the Pentagon (news - web sites) announced last week it would set up a panel of experts to dispel safety "myths" about an anti-malaria pill dispensed weekly to troops in Iraq (news - web sites) and Afghanistan (news - web sites). Among them: fears the prescription drug Lariam causes suicide and neurological problems.

Developed by the U.S. Army in the 1970s, Lariam was licensed to the Swiss company Hoffmann-La Roche and approved for use in the U.S. in 1989. In the 12 months through last October, Defense Department statistics show the military filled about 45,000 Lariam prescriptions. Defense officials say adverse reactions are rare, and Lariam is easier to dispense and more effective than three other anti-malaria drugs they prescribe. But that confidence is hardly universal.

In the face of growing reports of problems, the Food and Drug Administration (news - web sites) (FDA) ordered La Roche last year to provide written warnings with every Lariam prescription that the drug causes side effects in a small number of cases. They include anxiety, suicidal thoughts, hallucinations and depression, which can continue after Lariam use is discontinued.

Lawmakers and a group opposed to the drug, Lariam Action USA, say they have received more than 100 complaints from troops and veterans who describe dangerous reactions caused by Lariam.

Sen. Dianne Feinstein, D-Calif., found the reports so disturbing that she asked the Pentagon last October to reassess its continued use of the drug. A La Roche spokesman said numerous studies showed that severe reactions were rare - as few as one in 13,000. But a study published in 2001 in the journal Clinical Infectious Diseases reported "mild to serious neuropsychiatric reactions" in nearly a third of civilians on Lariam.

The Pentagon's new study, which will track the number and severity of adverse reactions, could clear up much of the fear surrounding Lariam. Equally crucial is demonstrating that the drug is properly dispensed and that troops' health problems are being studied. On those counts, the military's actions still fall short.


Among the concerns:

•Warnings. The Pentagon says all troops using Lariam are given the FDA-mandated warnings. But the National Gulf War (news - web sites) Research Center, a veterans group, and Lariam Action USA dispute that claim. Naval Reserve Cmdr. Bill Manofsky of Ridgecrest, Calif., who is receiving a medical discharge related to Lariam use, says neither he nor other troops he knows were warned. One simple solution: Require troops to sign a form stating they have read the warnings.


•Monitoring. The Pentagon says Lariam use is noted in health screenings before and after tours in Iraq, and troops are encouraged to report reactions. But the veterans group says the information often isn't recorded. A Pentagon spokesman acknowledged that many paper records haven't yet been added to a central database that Congress required to track medical problems better.

The Pentagon says Lariam is safe, the Centers for Disease Control and Prevention (news - web sites) recommend it as an effective anti-malaria drug, and the only common bad reaction is unfounded fear. La Roche says more than 20 million people worldwide have taken it.

Though Lariam is the Pentagon's first choice, it now says it may shift to another drug for troops in Iraq.

That's a reasonable first step. A thorough inquiry can separate facts from myths about Lariam - and dispel impressions that the Pentagon exposes its forces to health risks.