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New concerns rising over antimalaria drug

Apr. 11, 2012 - 06:22AM   |   Last Updated: Apr. 11, 2012 - 06:22AM  |  
Navy Sonar Technician Seaman Douglas Corrigan and wife Nicki are seen in an undated photo.
Navy Sonar Technician Seaman Douglas Corrigan and wife Nicki are seen in an undated photo. (Courtesy of Nicki Corrigan)
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Navy Sonar Technician (Surface) Seaman Douglas Corrigan placed a Skype call to his wife March 25, 2011, from Rota, Spain, shortly after taking his first dose of the antimalaria medication mefloquine.

Preparing for a mission to a malaria-endemic region, his unit watched a video on the illness, and corpsmen dispensed two drugs: daily-dose doxycycline, and mefloquine, taken weekly.

Corrigan doesn't remember getting a choice. He received a blister pack of mefloquine and was told it could cause nightmares.

"He told me he didn't feel good," recalled Nicki Corrigan, his wife of three years. "He said, ‘I don't feel like myself anymore.' It was a really weird thing for him to say."

Corrigan's personality changed radically, she said. The straight-laced husband and father began chewing tobacco, drinking and carousing. He climbed outside a three-story building to see whether he would feel fear.

Months later, at home, he was found tiptoeing around his basement, pursuing imagined intruders. He ranted psychotically and complained of daily headaches.

Medical tests showed no traumatic brain injury, nor did doctors believe he had post-traumatic stress disorder. They began suggesting he had a personality disorder or was a malingerer, faking his problems to get out of the military.

Finally, an ear, nose and throat doctor at National Naval Medical Center Bethesda, Md., offered another diagnosis: "multifocal brain stem injury" — brain damage — likely caused by mefloquine.

"He has a lesion. On his brain," said Nicki, a registered nurse.

Back in the spotlight

Mefloquine has drawn attention since the Army's former top psychiatrist, retired Col. Elspeth Cameron Ritchie, wrote a http://battleland.blogs.time.com/2012/04/02/afghan-massacre-the-link-to-lariam-remains-open/">column in Time magazine listing it among several drugs that may have induced psychoses in Army Staff Sgt. Robert Bales, charged in the shootings deaths of 17 Afghan civilians March 11.

But Defense Department concerns about mefloquine date back further — and some close to the issue say the most recent bout of scrutiny, which began with a meeting last Aug. 24-25 of DoD's Joint Prevention Medicine Group to discuss mefloquine policy, stems from the Corrigan case.

"You have a sailor with permanent brain damage," said an Army doctor familiar with the debate. "It's very serious."

The Navy would not confirm a link between Corrigan and the current DoD review, citing privacy laws. But on Jan. 17, two months before Bales' alleged spree, the Pentagon's top doctor, Jonathan Woodson, directed the Army, Navy and Air Force and the commander of Joint Task Force National Capital Region Medical to give him all data and policies related to mefloquine.

DoD "wants to ensure each service conducts proper screening, patient education and medical documentation," said Cynthia Smith, a Pentagon spokeswoman.

Mefloquine was developed under the Army's malaria drug discovery program, which ran from 1963 to 1976. The Food and Drug Administration approved it for preventive use in 1989 and it was marketed under the brand name Lariam.

But no safety and efficacy reviews were ever done on a normal civilian population. The Army performed tests on prisoners in Illinois and Maryland in 1975 and 1976.

Shortly after commercial use began, anecdotes surfaced about side effects including hallucinations, delirium and psychoses.

According to the FDA, the most common side effects are nausea and vomiting, seen in less than 3 percent of users. Side effects occurring in less than 1 percent include emotional disturbances, seizures, hair loss, headache, tinnitus, pain and fatigue.

A 2004 Veterans Affairs Department memo urged doctors to refrain from prescribing mefloquine, citing individual cases of hallucinations, paranoia, suicidal thoughts, psychoses and more.

That same year, then-Assistant Defense Secretary for Health Affairs Dr. William Winkenwerder ordered a study to assess the rate of adverse side effects associated with antimalaria medications.

He ordered the study after questions arose over its possible role in several murder-suicides at Fort Bragg, N.C., in 2002 and suicides in Iraq among deployed troops.

The Army in 2009 issued a policy listing mefloquine as a third choice behind doxycycline and another antimalarial, chloroquine. DoD followed with a memo later that year stating that doxycylcine and mefloquine may be used in areas where malaria is resistant to chloroquine, but doxycycline is the preferred choice.

The Air Force and the Navy have similar policies, officials said.

The DoD memo says troops given mefloquine must be counseled on its possible effects and must not be suspected of having any mental health concerns.

In 2011, U.S. Central Command and U.S. Africa Command issued memos barring mefloquine use except when doxycycline or another preventive drug called Malarone cannot be taken.

Roche, the manufacturer of Lariam, stopped marketing it in the U.S. in 2008, but it is still available in more than 50 countries. The mefloquine now taken by U.S. troops is a generic version.

Other drugs also have issues

Doxycycline is not without its drawbacks. It can make patients photo-sensitive, causing debilitating sunburn; has a poor compliance rate, since it must be taken daily; and has side effects, including nausea and vomiting.

And Malarone costs much more than the other drugs — about $30 a week, compared with $3 a week for mefloquine and less than 25 cents a week for doxycycline.

Navy Cmdr. Bill Manofsky — who was medically retired in 2004 for PTSD and neurological problems, including loss of balance, that he said were documented in his medical records as mefloquine-related — said if cost concerns are an issue, they shouldn't be.

He said if DoD wants to protect the troops from malaria as well as mefloquine's potential side effects, it should ban mefloquine and pay the higher cost of Malarone.

"How much does a .50-caliber round cost? They're worried about $4 a pill and they're willing to spend $5 for a round?" he said.

There's no question malaria poses a risk. In 2011, 124 service members contracted the potentially fatal disease — 91 in Afghanistan, 24 in Africa and nine elsewhere. The year before, 113 troops contracted malaria; one died.

But mefloquine continues to be used in part because it is taken weekly while the alternatives must be taken daily, and some physicians believe that troops are more likely to take a weekly dose.

The services have 90 days to respond to Woodson's order for details of their mefloquine policies.

Nicki Corrigan and others have contacted lawmakers, including Sens. Dianne Feinstein, D-Calif., and Jim Webb, D-Va., to press for congressional hearings.

Douglas Corrigan is currently undergoing a Medical Evaluation Board to determine if he is still fit for military service.

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