(Article changed on April 8, 2014 at 09:26)
The malaria drug Lariam (mefloquine) is linked to grisly
crimes like Army Staff Sgt. Robert Bales' 2012 murder
of 16 Afghan civilians, the murders of four wives of Fort
Bragg soldiers in 2002 and other extreme violence. While the FDA beefed up
warnings for mefloquine last summer, especially about the drug's neurotoxic
effects, and users are now given a medication guide and wallet card,
Lariam and its generic versions are still the third most
prescribed malaria medication in the US. Last year there were 119,000
prescriptions between January and June. Though Lariam/mefloquine is banned in
Air Force pilots, until 2011, it was on
the increase in the Navy and Marine Corps.
A drug that doesn't feel right by Martha Rosenberg
The negative neurotoxic side effects of mefloquine can last for "weeks, months, and even years," after someone stops using it, warns the VA. Medical and military authorities say the drug "should not be given to anyone with symptoms of a brain injury, depression or anxiety disorder," reported Army Times--which is, of course the demographic that encompasses "many troops who have deployed to Iraq or Afghanistan." In addition to mefloquine's wide us in the military, the civilian population taking malaria drugs includes Peace Corps and aid workers, business travelers, news media, students, NGO workers, industrial contractors, missionaries and families visiting relatives, often bringing children.
What makes mefloquine so deadly? It has the same features that made the street drug PCP/angel dust such an urban legend in the 1970s and 1980s. It can produce extreme panic, paranoia and rage in the user along with out-of-body "dissociative" and dream-like sensations so that someone performing a criminal act often thinks someone else is doing it . ("Dust" users were also reportedly impervious to pain and anecdotally, could pop their own handcuffs.) An example of such "dissociative" effects is seen in Staff Sgt. Robert Bales' rampage; according to prosecutors at his trial, Bales slipped away from his remote Afghanistan post, Camp Belambay, in a T-shirt, cape and night vision goggles and no body armor to attack his first victims. He then returned to the base and "woke a fellow soldier, reported what he'd done, and said he was headed out to kill more." What?
In addition to Army Staff Sgt. Robert Bales' 2012 attacks and the 2002 Fort Bragg attacks, Lariam/mefloquine was linked, in news reports, to extreme side effects in an army Staff Sergeant in Iraq in 2005 and to the suicide of an Army Reservist in 2008.
Former Army psychiatrist Elspeth Cameron Ritchie, former U.S. Army Major and Preventive Medicine Officer Remington Nevin and Jerald Block with the Portland Veterans Affairs Medical Center agree in a recent paper that mefloquine may be behind "seemingly spectacular and impulsive suicides." It can produce "derealization and depersonalization, compulsions toward dangerous objects, and morbid curiosity about death," they write, describing frequent hallucinations "involving religious or morbid themes" and "a sense of the presence of a nearby nondescript figure." The researchers refer to two reports of people jumping out of windows on mefloquine under the false belief that their rooms were on fire.
In 2009, the Army Surgeon General and Deputy Assistant Secretary of Defense sent directives making Lariam a last choice drug for troops and last fall the Army banned it for the approximately 25,000 Green Berets , Rangers, Civil Affairs and Psychological Operations soldiers. But since the neurological effects of Lariam can continue indefinitely, troops and veterans may still be under its effects even if the drug has stopped being prescribed.
Lariam/mefloquine is one of five malaria drugs listed by the CDC for people who will be exposed to malaria. Other drugs include Malarone, a combination of the drugs atovaquone and Proguanil, Aralen (chloroquine,) primaquine and the antibiotic doxycycline marketed as Vibramycin. None of the drugs are ideal--Malarone can, for example have renal effects, and Aralen can have liver, blood and skin effects. Some do not work right away or are ineffective against resistant malaria strains. But the main reason for mefloquine's historic popularity is that it is taken weekly unlike all the other drugs (except chloroquine) which are taken daily. Some travelers also report that mefloquine is cheaper than other malaria drugs and say they only experience symptoms like memory loss and vivid nightmares. Still, since awareness of mefloquine's dangers, many users are now required to read and sign an informed consent form.
An Early Example of Public Funding of Pharma Profits
Lariam/mefloquine was an early example of "technology-transfer" between publicly-funded and academic research and Big Pharma, driven by the Bayh-Dole Act of 1980. The Bayh-Dole Act dangled the riches of "industry" before medical institutions just as the former were floundering and the latter was booming, observes Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine. Turning universities into think tanks for Big Pharma has been so profitable, Northwestern University made $700 million when it sold Lyrica, discovered by one of its chemists, to Pfizer enabling it to build a new research building.
Lariam/mefloquine was developed by the Walter Reed Army Institute of Research (WRAIR) in the 1960's and 1970's after a drug resistant strain of malaria did not respond to medications and sickened troops during the Vietnam War. Though Lariam/mefloquine was developed with our tax dollars, all phase I and phase II clinical trial data were given to Hoffman LaRoche and Smith Kline free of charge in what was the first private public partnership between the U.S. Department of Defense and Big Pharma . You're welcome! It was approved by the FDA in 1989.
Roche, who retained the patent, did well with the government largesse. In 2009, it spent $46.8 billion to buy Genentech (for comparison the entire yearly budget of the National Institutes of Health is $60 billion a year) and its cancer drug, Avastin, makes up to $100,000 per patient per year, despite reports of its limited effectiveness for some cancers for which it is used.
Nor was the testing of Lariam/mefloquine kosher. It was first tested on prisoners and soldiers who are not necessarily able or willing to refuse participation in clinical trials and it was also widely given to Guantanamo detainees. Phase III trials, that are supposed to be conducted on larger patient groups of up to 3,000 people, were not conducted at all, wrote the Journal of the Royal Society of Medicine in 2007 and "there was no serious attempt prior to licensing to explore the potential drug-drug interactions." In fact, all users of "have been involved in a natural experiment to determine the true safety margin," says the journal, because " Consumers have been unwitting recruits to this longitudinal study, rather than informed partners." No wonder mefloquine causes adverse effects in as many as 67 percent of users .
As seen with other drugs that have neuropsychiatric effects, like the antidepressant Cymbalta and seizure drug Neurontin, the military, government and Big Pharma blamed the effects on the patients not the drugs. When wives of four Fort Bragg soldiers were murdered during the summer of 2002--one was stabbed 50 times and set on fire-- military investigators blamed "existing marital problems and the stress of separation while soldiers are away on duty," not mefloquine. Right. Three of the four soldiers also took their own lives.