Malaria drug overused on Guantanamo Bay prisoners?
FDA slaps strongest warning on potentially mind-altering drug administered to inmates in large doses
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FDA slaps strongest warning on potentially mind-altering drug administered to inmates in large doses
The U.S. Department of Defense has been urged to rescreen all Guantanamo prisoners to determine whether heavy doses of an anti-malarial drug administered at the facility between January 2002 and mid-2005 caused brain damage. The drug, mefloquine, was tagged last month with an FDA warning of possible side effects that range from depression and anxiety to psychosis and even suicide.
Dr. Remington Nevin, a former U.S. Army major and leading researcher into the effects of anti-malarial drugs, said the military should review seven prisoner suicides at Gitmo over the past decade to determine if their deaths may be linked to mefloquine, a controversial medication known to cause severe neurological and psychological disorders.
"Careful evaluation by specialists … trained in the recognition and diagnosis of mefloquine toxicity would aid in correctly identifying detainees suffering potentially disabling effects from the drug," Nevin told Al Jazeera.
His comments come on the heels of a black-box warning label ordered last month by the Food and Drug Administration to alert patients to potentially serious and permanent neurological side effects that can result from even a single dose of mefloquine. The FDA issued the warning — the agency's strongest — after an extensive review of adverse-reaction reports and mefloquine studies, including Nevin’s work.
The FDA's updated warning states:
Neurologic symptoms such as dizziness or vertigo, tinnitus, and loss of balance have been reported. These adverse reactions may occur early in the course of mefloquine use and in some cases have been reported to continue for months or years after mefloquine has been stopped. Psychiatric symptoms ranging from anxiety, paranoia, and depression, to hallucinations and psychotic behavior, can occur with mefloquine use … Cases of suicidal ideation and suicide have been reported.
While the recommended prophylactic dose for an adult is 250 milligrams, each prisoner transferred to Guantanamo between January 2002 and July 2005 was administered 1,250 milligrams of the powerful drug — the full treatment dose for someone who has already contracted malaria — within 24 hours of being transferred to the detention facility, regardless of whether he had the disease, according to a military document.
In January 2002, CNN reported two detainees were treated for malaria. The Pentagon said there were no other cases among the 779 prisoners transferred there.
“A majority of those detainees administered mefloquine at treatment doses will experience symptoms which the FDA’s product insert warns could precede permanent neurologic or long-term psychiatric symptoms,” Nevin said.
The Pentagon said someone made a decision "to presumptively treat each arriving Guantanamo detainee for malaria to prevent the possibility of having mosquito-borne (sic) spread from an infected individual to uninfected individuals in the Guantanamo population, the guard force, the population at the Naval base or the broader Cuban population."
But the Centers for Disease Control makes no mention of malaria in its travel advice for extended stays in Cuba. A September 2002 Department of Defense (DOD) memo and enclosure issued by then–Assistant Secretary of Defense for Health Affairs William Winkenwerder Jr. reads, "Malaria is not a threat in Guantanamo Bay."
A Freedom of Information Act request has been filed with the Pentagon and United States Southern Command, which has oversight of the joint task force that operates Guantanamo, to discover who made the decision to administer treatment doses of mefloquine to prisoners without medical evaluations.
There are now 166 prisoners at Guantanamo. In July 2005 there were 510 prisoners at the facility, and 249 of them had been transferred between January 2002 and July 2005. For the most part, transfers to Guantanamo ended by July 2005.
Hajji Nassim was one of the last prisoners sent to Guantanamo, in 2007. He committed suicide in 2011. It is unknown whether he was given an alternative to mefloquine. The Defense Department would not say whether its standard operating procedures had changed. In September 2006, 14 high-value detainees were transferred to Guantanamo. Because they are former CIA captives, information about their detention and treatment remains classified.
The U.S. military developed mefloquine in the 1970s at the Walter Reed Army Institute of Research. It was licensed by the FDA in 1989 to the Swiss pharmaceutical company F. Hoffmann–La Roche, which marketed the drug under the brand name Lariam. For three decades, it was the military’s drug of choice for troops who were deployed to malaria-prone regions.
In 2009, after the publication of news reports and medical studies that linked mefloquine to a series of suicides and murders involving U.S. service members, then–Army Surgeon General Eric Schoomaker removed mefloquine (PDF) as a first-line drug. He revised Army policy so that mefloquine would not be prescribed to U.S. service members unless they had a medical reason not to take a newly preferred malaria-prevention drug, doxycycline. His policy memo also said mefloquine should not be prescribed to any service member who had a history of traumatic brain injury or mental illness.
Two years later, Sen. Dianne Feinstein, D-Calif., sent a letter to Secretary of Veterans Affairs Eric Shinseki and then–Secretary of Defense Leon Panetta expressing concern that mefloquine was still being administered to military personnel and that troops "are now suffering from the preventable neurological side effects" despite the policy change.
Al Jazeera spent two weeks trying to obtain a comment from Feinstein, whose concerns about mefloquine use date back to 2004, about mefloquine administration at Guantanamo. But her spokesman, Brian Weiss, said he was unable to obtain a comment from the senator because of the summer legislative recess.
In 2010, when Nevin learned mefloquine had been given to Guantanamo prisoners, he said he believed it was, at best, an "egregious malpractice." But with the FDA’s new warning and after conducting additional research, he now believes it is "plausible" that mefloquine was used as an interrogation tool. Nevin said the physician who ordered mefloquine to be used "in this potentially negligent manner" needs to be held accountable.
"It should have been reasonably known to DOD that this drug was neurotoxic and would have caused irreversible harm," said Nevin, who has testified before the Senate about mefloquine's neurological side effects. "The disturbing possibility was that the drug was used due to the knowledge of its adverse effects. It seems implausible to me those with knowledge of the drug's effects would not have recognized this inadvertent utility. We know there was no medically justifiable reason to give these detainees this drug. Therefore, it is likely the true intention was to exploit the drug’s toxic effects in a manner that could be plausibly denied."
There is no evidence to support the use of mefloquine at Guantanamo as an interrogation tool, and Army Lt. Col. Todd Breasseale, a Pentagon spokesman, adamantly refuted the notion.
"The anti-malarial prophylaxis mefloquine is absolutely not used in any other way than its intended medical purpose," Breasseale said. "Hypothetical suppositions to the contrary are both reckless and wildly unprofessional."
Mefloquine is not the first drug administered to Guantanamo prisoners to come under scrutiny by the FDA, nor is it the first that may cause irreversible brain disorders.
A military document obtained by Al Jazeera in May confirmed that hunger-striking prisoners who are subjected to force-feedings may be given a drug to enhance digestion. The drug, Reglan, has been linked to tardive dyskinesia, a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue or extremities.
In February 2009, medical studies prompted the FDA to slap Reglan with a black-box label. According to the FDA's medication guide, additional side effects include depression, thoughts about depression and, in extreme cases, suicidal thoughts and suicide.
Cori Crider, strategic director of Reprieve, a U.K.-based human-rights organization, filed an incident report with the FDA in June calling for an investigation into the use of Reglan on Guantanamo prisoners. The Justice Department, responding to a lawsuit filed by Reprieve, said Reglan has rarely been used during force-feedings. Reprieve filed a citizen’s petition last week asking the FDA to investigate whether any Reglan's use in force-feedings broke any regulations and to suspend approval during the investigation.
With regard to mefloquine, Crider told Al Jazeera the military should conduct an investigation.
"It's obviously concerning to know that our clients were drugged and that those drugs may cause permanent damage," Crider said.
She added that there are dozens of Guantanamo prisoners who have some form of mental illness. But it's impossible to determine whether indefinite detention, isolation, drugs or previous conditions are to blame.
"What I would want, ideally, is someone who has some real qualifications conducting an investigation," she said.
Nevin said, "It would be appropriate for DOD to re-evaluate Guantanamo detainees," given the FDA’s new warning.
"Similarly, as psychiatric symptoms caused by mefloquine use may significantly contribute to a risk of suicide, these [seven] detainee deaths should be re-examined for evidence of preceding symptoms consistent with drug toxicity," he added. "It would also be appropriate for DOD to consider rescreening every detainee for evidence of subtle but lasting neurologic and psychiatric effects."
"It is premature to take the course of action [Nevin] is advising," the Pentagon spokesman said. "We provide exemplary medical care to detainees at Guantanamo Bay. If there were neurological problems detected in any of the current population, they would certainly receive appropriate attention and treatment."
However, a military document recently obtained by Al Jazeera — a commander's inquiry into the death of a prisoner who is said to have overdosed on antipsychotic medications — states that guards and medical personnel repeatedly violated various protocols.
According to the report, "in some cases, the guards and medical personnel are unfamiliar with the [standard operating procedures]. In other cases, the guards and medical personnel are familiar with the requirements but for various reasons, fail to follow them."
Nevin said he is teaching a class in the fall at Johns Hopkins University on U.S. military policy and public health. One of his lectures will center on "detainee public-health practices at Guantanamo."
"In particular, we will be focusing on the use of the anti-malarial drug mefloquine," he said, "and reviewing its use with reference to the current standard of care."
The Washington Post and Guardian won a Pulitzer Prize for reporting on NSA surveillance programs