On April 6, 2009, 21-year-old Army Specialist Adam Kuligowski took his rifle into a bathroom stall at Bagram Air Base in Afghanistan and shot himself. His last words were found in a suicide note to his father, Michael Kuligowski: "Sorry to be a disappointment."
Just weeks earlier, Adam had visited his dad in Thailand. Michael Kuligowski works as an information officer at the U.S. Embassy in Bangkok. During his 18-day visit, Adam had complained of sleeplessness. He had mentioned being late for work, and the push-ups he had to do as punishment. And he had talked about some extra guard duty. Michael Kuligowski is an Army veteran and saw all of that as standard-issue Army life.
There had been problems the father didn't hear about. In the fall of 2008, Adam had been ordered to kitchen duty on his days off, after he threw his gun on the ground and told his commander to send him to jail. Michael Kuligowski later learned that his son had been suffering from depression. Sleeplessness at night had left Adam exhausted during the day, when he needed to be sharp. Adam was attached to the 101st Airborne's Special Troops Battalion, tracking enemy communications as a signals-intelligence analyst.
In a report about Adam's last disciplinary meeting, a commanding officer noted that the young soldier was falling asleep in front of him. The same report showed a photo of an overturned footlocker in Adam's quarters. It noted that Adam was awake at all hours, playing online video games.
A toxicology report on Adam's death mentioned the presence of an anti-malaria medication known as mefloquine hydrochloride. The report attached no special significance to this result, though in February 2009, just a few months earlier, Army Surgeon General Eric Schoomaker had issued a directive removing mefloquine as the Army's malaria drug of choice. Schoomaker's directive had said the drug could induce "anxiety, paranoia, depression, hallucination, psychotic behavior" and restlessness in "one per 2,000 to 13,000 persons."
Five months after Adam Kuligowski died, the military went a step further. Ellen P. Embrey, deputy assistant secretary of defense, ordered all branches of the armed forces to replace mefloquine as their top malaria drug. The national Centers for Disease Control had already established that policy with regard to the civilian population, relegating mefloquine to last among all treatment options.
Roche(RHHBY) stopped distributing mefloquine in 2008—its version had been marketed as Lariam—but the drug remains available today, in generic versions produced by Novartis(NVS) subsidiary Sandoz, Barr Pharmaceuticals(BRL) and Boehringer Ingelheim's Roxane Laboratories. Michael Kuligowski says Adam's comrades at Fort Campbell in Kentucky told him of mass distribution of the drug. The soldiers were given mefloquine in bags containing a six-month supply. They were given no information about proper use of the drug, or its well-known side effects, or potential interactions with other drugs.
"My whole issue with mefloquine is that my son's death was entirely preventable," Kuligowski says. "Everything was entirely preventable, had military medical command done its job and briefed everyone they were giving mefloquine to before they gave them mefloquine."
Kuligowski and others are concerned about the military's management of psychoactive drugs in an era of extreme stress on troops and mounting soldier suicide rates. While medical advances have provided new treatment options, they have also introduced new levels of complexity regarding treatments for malaria, depression, insomnia and post-traumatic stress disorder. The Army's critics claim it is behind the curve, and that its medical lapses continue to cost troops their lives.
A trail of human wreckage
The record of problems relating to mefloquine is a long one.
In December 2002, Naval Lt. Cmdr. Bill Manofsky was given Lariam, the Roche version, during his deployment to Kuwait. There was no prescription and no warning about side effects, as far as Manofsky can recall.
Three days before the Iraq War began, in March 2003, Manofsky experienced uncontrolled vomiting and vertigo while operating in the Kuwaiti desert. Two months later, back home in China Lake, Calif., he had a panic attack on the way to a local restaurant. He tried to jump out of the truck his wife was driving and, when they arrived at the restaurant, threatened to kill himself, ending the evening at an emergency clinic.
Today, Manofsky is a veterans' advocate who questions the quality of medical care given to active-duty soldiers and veterans.
"There is a tremendous amount of dysfunctionality in Army medical, to the point that the Army surgeon general can put a directive out and it can be ignored," Manofsky says, referring to the Schoomaker advisory. "I would never go into the Army the way it is now. I am telling them, 'People, don't send your kids to the Army until the medical stuff gets fixed.' "
About the same time Manofsky first experienced problems, four soldiers at Fort Bragg, N.C., killed their wives before three of them took their own lives. Three of the four had been taking Lariam before the shootings.
As evidence of problems associated with mefloquine mounted, the Army seemed slow to recognize the pattern. In February 2004, the Army surgeon general at the time, James Peake, testified before a House Armed Services subcommittee that an Army investigation had found no link between Lariam and soldier suicides. A month later, U.S. Chief Warrant Officer Bill Howell, who had taken Lariam while deployed with Special Forces in Iraq, shot and killed himself in the front yard of his Colorado home. His wife suspected Lariam had a role in his death.
A study released that same month by doctors at the Walter Reed Army Institute of Research bolstered her claim, finding that a quarter of the individuals taking Lariam to prevent disease and nearly three-quarters of those taking it as a treatment experienced damage to their central nervous systems. That report cited psychological disorders such as hallucination and insomnia, and neurological disorders like seizures and dizziness.
On July, 11, 2004, 25-year-old Army reservist John Torres killed himself with an M-16 while stationed at Bagram, where Adam Kuligowski would later die. A report that mentioned the presence of Lariam in Torres' system, together with a bit of strange phrasing in Roche's medication guide on the drug, were among Michael Kuligowski's first clues that mefloquine may have played a role in his son's death. Roche's guide said: "Some people who take Lariam think about suicide. Some people who were taking Lariam committed suicide. It is not known whether Lariam was responsible for those suicides."
By the military, for the military
If the military has been slow to recognize the ill effects of mefloquine, the reluctance doubtless relates to the unusual history of the drug, and to its special efficacy in the fight against malaria. Mefloquine was developed by researchers in the Experimental Therapeutics division of the Walter Reed Army Institute of Research during the 1960s. At the time, malaria struck as many as 1% of the U.S. combat troops then deployed in Vietnam. The researchers were seeking a replacement for the anti-malaria medication chloroquine, having discovered that malaria strains in several regions of the globe had developed a resistance.
The researchers at Walter Reed identified some 250,000 anti-malarial compounds. They found that mefloquine was the most effective.
Malaria, an infection of parasites spread by mosquitoes, remains a major health threat in warm climates throughout the world. Each year, a quarter of a billion people contract the disease and about a million die from it. Those facts alone might explain the military's enthusiasm for a drug that prevents malaria. But there was more to the appeal of mefloquine. The drug could prevent malaria even when taken only once a week, making it "idiot proof," in the words of military health-care providers and veterans interviewed for this article.
The U.S. military is legally barred from manufacturing commercial pharmaceutical products, so Walter Reed enlisted Roche to produce and distribute mefloquine. Roche's Lariam gained Food and Drug Administration approval in 1989, following a review that did not include complete analysis of side effects and did not fully explore the drug's interactions with other medications.
Dr. Donald H. Marks, a 13-year Army veteran, was then director of clinical research in Roche's anti-infectives department in Nutley, N.J. In that role, he monitored reports of adverse affects associated with Lariam. Based on his experience with mefloquine—and the knowledge that there are other anti-malaria medications available, including the once-a-day antibiotic doxycyclene (which includes skin sensitivity among its side effects) and GlaxoSmithKline's(GSK) milder alternative Malarone—Marks says today that he "wouldn't recommend it, generally speaking," especially not for use in combat.
"With Lariam, you can have convulsions, agitation, restlessness, anxiety, depression, mood swings, panic attacks, memory impairment, confusion, hallucinations, aggression and psychotic or paranoid reactions," Marks says.
While the Army and its doctors at Walter Reed acknowledge that the exact interactions with the brain and central nervous system that lead to mefloquine's side effects remain a mystery, the reasons for their reluctance to pull the drug are somewhat clearer. When asked what the Army is doing to stop potential contraindications and drug interactions with mefloquine, Army spokespersons point to Surgeon General Schoomaker's directive removing mefloquine as its anti-malaria drug of choice. Still, the Army and some of its critics note the drug's efficacy against malaria and its importance to the formulary—especially as a treatment—in light of increasing global resistance to anti-malaria medications.
Roche documents say side effects like vertigo, dizziness and loss of balance "may continue for months" after use of the drug stops. The wallet card that Roche included with its Lariam prescriptions advised against "activities such as driving a car or using heavy machinery or other activities requiring alertness or careful movements." When asked recently whether the military's continued use of mefloquine in combat conditions was advisable, considering the side effects, Roche said that "we cannot comment on the Army's choice for malaria prevention."
Roche's former employee, Marks, points out that rank-and-file soldiers are generally not able to evaluate the risks and benefits of drugs for themselves.
"What happens in the military is that you have a lot of young people in the range of 17 to 20 years old who are very impressionable going into combat theaters," Marks says. "Their days are very regimented, and they're told what to eat and what to wear, so when an officer comes along and tells them to take Lariam because it will prevent malaria, they're going to take it because it's not an atmosphere that is conducive to questioning authority."
The drug fair
Manofsky argues that a modern battlefield is no place for a drug that can damage the nervous system. He questions the Army's sensitivity to the issue. One of his first cases as a veterans' advocate was that of Army Special Forces Staff Sergeant Georg-Andreas Pogany. In September 2003, while stationed in Iraq, Pogany experienced panic attacks and hallucinations and told Army doctors he was on his way to a nervous breakdown. He was given Sanofi-Aventis'(SNY) Ambien to help him relax. An Army psychologist told him to rest.
Then the Army sent Pogany back to his base at Fort Carson, Colo., and charged him with cowardice, a rare charge that is punishable by death under the Uniform Code of Military Justice. Pogany and his attorneys established that his mental condition was likely attributable to Lariam and to that drug's known interaction with Ambien's core drug, zolpidem. Consequently, the Army finally dropped the charges. He went on to serve as an attorney for veterans with mental-health issues and today works with the nonprofit military mental health service provider Give an Hour.
In Pogany's eyes, military policy on psychotropic and antipsychotic drugs is a disaster, and U.S. soldiers are the victims. Not only has the Army lost track of the psychological side effects of drugs like mefloquine, Pogany says, it is also over-using other psychoactive drugs, particularly sedatives and anti-depressants.
"They medicate people for two reasons: One is to calm down and the other is to sleep, so they put you on anti-anxiety meds and sleep meds so you can perform your mission," Pogany says. "The way one soldier described it to me is that they are constantly on uppers and downers."
A March hearing conducted by the Military Personnel Subcommittee of the Senate Armed Services Committee supported Pogany's view. At the hearing, Sen. Jim Webb (D-Va.) estimated that one in six service members is now taking some form of psychiatric drug. Army Surgeon General Schoomaker says between 3% and 6% of the 550,000 troops currently deployed are taking drugs for mental health or stress, that 8.6% have been given antidepressants, anxiety medications or sleep aids, and that 34% have two or more prescriptions.
As a result, the U.S. Defense Department has plenty of data on prescription drugs. It tracks all prescriptions through the Military Health System's Pharmacy Data Transaction Service. But the data haven't been helpful in regard to problems plaguing combat troops, because the transaction service "has no visibility of pharmacy data for prescriptions dispensed in forward operating areas." In other words, the military doesn't know which drugs combat troops are getting.
Another problem has to do with the massive scale of military operations and the obvious difficulties involved in taking the situations of individuals into account. According to a March 2008 study by Army doctors published in Malaria Journal, just less than 10% of 11,725 active-duty military personnel who took Lariam in Afghanistan in early 2007 did so despite contraindications that included depression, anxiety and epilepsy.
The potential for drug interaction is another problem requiring individual attention. The Army's formulary—its list of approved and available prescriptions—mentions several drugs that have negative interactions with mefloquine, among them Ambien, from Sanofi-Aventis, and GlaxoSmithKline's Wellbutrin.
Manofsky says that wise use of drugs like mefloquine depends on the individual decisions of Army doctors and corpsmen, with uneven results.
"A lot of these doctors and corpsmen have a lot of autonomy in the field," says Manofsky. "It all has to do with chain of command, or lack thereof."
In recent years, the Army has been increasing the number of mental-health professionals who support combat troops, but still has work to do, even by its own standards. The latest findings from the Army's Mental Health Advisory Team show that the ratio of mental-health professionals to military personnel in Afghanistan now stands at 1 to 1,123, well short of the 1-to-700 ratio thought to be adequate.
Controversy over drug policies is increasing in tandem with the military suicide rate. Last year, the Army recorded 162 active-duty suicides, a number that has steadily increased every year since 2004. That number jumps to 239 when non-active duty personnel are included. And the total doesn't factor in the 1,713 known suicide attempts that took place during the same period. The suicide rate in the Army has exceeded that of the civilian population in recent years, a reversal of the historic relationship.
By mid-July 2010, the total number of soldier suicides for the year had already climbed to 140. It was in July that the Army released a far-reaching report on military suicides and measures that might reverse the recent upward trend. The report noted that, of the soldiers who committed suicide in 2009, 16.7% seemed to have been motivated by a desire for "emotional relief," while 11.1% cited "hopelessness and depression" in discussing their problems.
The Army report recognized the toll that stress takes on combat troops. Among the known stressors for active-duty suicides, diagnosis of a behavioral or mental-health problem was cited in 48% of cases. Those diagnoses included the vague "adjustment disorder" (26%), substance abuse (18%) and post-traumatic stress disorder (9.1%).
The report said the number of soldiers prescribed antidepressants jumped from 1.1% in 2005 to 5% in 2008. The Army has acknowledged that antidepressants can increase suicidal behavior in soldiers ages 18 to 29. But the report blamed the suicide spike largely on the "high-risk behavior" of soldiers -- including heavy use of illegal drugs and "suicidal behavior" —not on the drugs themselves or those prescribing them.
Pogany, the veterans advocate, was not appeased. He is incredulous that mefloquine is still affecting families like the Kuligowskis.
"This kid was killed by mefloquine, and that happened seven years after my incident happened," Pogany says. "The fact that, seven years later, this drug is still in use and Congress has never done anything or called anyone to testify, and that they tried to criminalize my reaction to the side effects of this drug by court-martialing me is absolutely ridiculous."
Michael Kuligowski knows he can't sue the Army, as Supreme Court precedent effectively prevents the families of military personnel from filing wrongful-death claims against the U.S. government. Yet he feels the Army owes him something.
"I really feel like it was medical malpractice on their part," Kuligowski says. "Whoever the physician was who handed him this stuff wasn't trained about mefloquine, and it opened my eyes to the fact that you can't assume everything's going to be OK. I learned not to trust the military."
Critics say the Army remains partially blind.
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