INVESTIGATION: Vets say anti-malaria drugs they were ordered to take caused devastating side effects

Service members believe suicides are linked to use of anti-malaria drug

If you served in the United States military or traveled to a part of the world that's prone to malaria, you may have been prescribed a small white pill called Mefloquine, sold under the brand name, Lariam.

Many veterans, former Peace Corps volunteers and other world travelers now say that weekly anti-malarial pill ravaged their lives, causing psychiatric and physical damage that is getting progressively worse each year.

An Army veteran named Sean, who asked us to withhold his last name, said he took mefloquine while serving in Afghanistan from 2003 to 2004. He was 21 years old and didn't consider questioning orders.

What Sean didn't expect was that weekly dosage over the course of his deployment wouldn't show up in his medical records. He said he's "100% sure" he took mefloquine.

That disconnect has left him frustrated and angry when he's sought VA benefits related to the depression, anxiety, insomnia and vertigo that plague his life now, at the age of 35.

"I’ve resubmitted claims multiple times to the VA and they’re saying, 'Oh, well, it’s not in your medical record,' said Sean.

Sean attributed all those symptoms to the side effects of mefloquine. He insisted that no one in the military warned him of any potential drawbacks of taking the drug, although he recalled service members were alerted to the dangers of contracting malaria.

"We attempted to give folks the best possible agent to protect them to the highest degree. To do any less would have done them a disservice," said Col. Andrew Wiesen, the Director of Preventive Health for the Office of the Deputy Assistant Secretary of Defense for Health Affairs. Col. Wiesen acknowledged though that the Department of Defense protocol mandates all medications to be logged into a service member's records.

"If that did in fact occur that was not within the DOD policy and it should not have occurred," he said.

Commander Bill Manofsky, a Navy veteran who deployed to Iraq and Kuwait, said that lack of record-keeping was not uncommon.

"Before 2012, few people got it in their medical records. It was just handed out like candy," said Cdr. Manofsky, who did mission planning for Special Forces in Baghdad and Southern Iraq.

"I didn’t get a prescription, I had no pre-screenings, I had no warning," he said. Like many veterans, there was no evidence in his records that he took the drug.

He contends mefloquine caused him multiple adverse effects, both psychiatric and physical. Eventually, Cdr. Manofsky became the first veteran awarded a partial disability rating of 30% by the VA for his exposure to the drug.

"I was ordered to take a mefloquine pill every single day," said Staff Sgt. Marty Brown, an Army veteran whose deployments included tours in Afghanistan and Iraq. No one informed him that the drug was supposed to be taken weekly, not daily. And like so many others we interviewed, not a single pill was reflected in his medical records. Sgt. Brown said he's suffered permanent, debilitating injuries as a result.

In 2004, even the VA warned of mefloquine's possible long-term health effects. Yet the drug was still dispensed for nearly a decade until the Food and Drug Administration issued a black box warning in 2013. After that, the military was supposed to issue mefloquine only as a last resort, but we found service members who apparently slipped through the cracks.

"They just handed me a bottle and said hey, if you have dreams, just push through 'em," said Sergeant First Class Sheryll Lander, who deployed to Afghanistan in 2013 and took mefloquine from March through December of that year. The FDA issued its black box warning in July of 2013. Sgt. Lander said there was no prescription and her name wasn't on the bottle of small white pills.

She attributed her depression, anxiety, vertigo and tinnitus to mefloquine and admitted she struggled to lead her Georgia National Guard troops. In an emotional, tear-filled interview, she offered words of support to fellow service members who may have suffered side effects after taking mefloquine.

"I just want to let my brothers and sisters know that they’re not alone. To not give up. We’ve got to be stronger than the side effects and the damage," she said.

Many service members believe the high suicide rate among veterans may be linked to the use of this drug. If they were misdiagnosed with PTSD or traumatic brain injury, there's widespread concern that veterans didn't receive proper treatment.

It's believed that the military ordered more than 150,000 service men and women to take the controversial drug since the 1980s, although the numbers are difficult if not impossible to quantify because of potential lapses in record-keeping.

Late last year, the VA awarded its first--and only--100% permanent and total disability rating to a Marine Corps veteran who served in Somalia. VA doctors attributed all 15 of his psychiatric and physical symptoms to mefloquine. That rating ensured he'll get full benefits for his severe, service-related injuries.

"We’re looking for answers in solid science. So that it’s not the flavor of the week or a rush of emotion, but that it’s rooted in good science," said Dr. Ralph Erickson, Chief Consultant for Post-Deployment Health Services at the U.S. Department of Veterans Affairs.

Dr. Erickson noted that by late 2018, the VA hoped to release a survey of 30,000 veterans who served in Iraq and Afghanistan. Although the study is not focused on the impact of mefloquine, he confirmed it did include questions about the drug.

Since the FDA's black box warning of 2013, the Department of Defense rarely prescribed mefloquine. But multiple sources told us a replacment drug called Tafenoquine is being fast-tracked for approval by the FDA. That has prompted an outcry from as far away as Australia, where it was tested on that nation's military. Many Australian veterans said tafenoquine proved to be as harmful, if not worse than mefloquine.

A WUSA9 investigation has focused on an anti-malarial drug called mefloquine.

Since the 1980s, tens of thousands of American service members have been ordered to take the drug. That included men and women who served in Somalia, Iraq and Afghanistan. It was intended to prevent malaria, a potentially fatal mosquito-borne disease. Pentagon officials say it is now used only as a drug of last resort.

Many veterans insist that small white pill destroyed their lives and abruptly ended their military careers. They blame mefloquine for everything from severe and permanent physical side effects, to gruesome, ongoing night terrors and other psychiatric issues.

Now, a new anti-malarial drug called tafenoquine is being fast-tracked for approval by the Food and Drug Administration, according to one of its developers. That’s raised some serious concerns among service members from as far away as Australia.

“It’s not neurotoxic and it is safe,” said Dr. Geoffrey Dow, the CEO and Founder of 60 Degrees Pharmaceuticals, or 60P. His company is seeking expedited FDA approval of tafenoquine here in the United States. Like mefloquine, it was created in the DC area, at the Walter Reed Army Institute of Research.

If tafenoquine is approved by the FDA, it could be administered to American service members at some point in the future, according to Dr. Dow.

“If you look at the evidence from 25 clinical studies, over 3,000 patients in rigorously conducted clinical trials, there is no evidence of neuropsychiatric adverse event risk,” said Dr. Stephen Toovey, a malaria expert and member of the scientific advisory board of 60P
Roughly 10,000 miles away, many veterans of the Australian Defence Force beg to differ. Between 1998 and 2002, they were used for clinical trials of both made-in-America drugs, mefloquine and tafenoquine.

“While over in Timor, I was on the drug tafenoquine,” said Sgt. Andre Kerp, an Australian veteran. “And I was told there were no side effects, nothing wrong with it.”

Sgt. Kerp was one of 3,000 troops ordered to take one of the two anti-malarial drugs or, in some cases, both. The pills were administered on a weekly basis for at least six months, or for shorter periods at very high “loading” doses.

“I’m just a shadow of the person I once was. I was so happy, outgoing, loved fitness, loved the gym. And now I just stay home,” said Sgt. Kerp, whose medical records confirm he took tafenoquine only.

“I am so withdrawn from society. I’m not happy anymore. I have developed PTSD, I have very bad mood swings. I have now been diagnosed with depression, anxiety,” he said. “The side effects from taking that drug have greatly impacted my life.”

Veterans in Australia are caught in a bureaucratic quandary, just as they are here in the United States. Much like our Department of Veterans Affairs, the Australian government does not yet recognize a medical diagnosis directly related to either of these drugs.

“I’ve had spiraling mental health issues. I had suicide attempts. I’ve had anger management therapy. My biggest problem is coping with stress,” said Army Corporal Mick Kruizinga. Nearly two decades ago, he was ordered to take both drugs. So it’s difficult, if not impossible, to determine whether it was tafenoquine, mefloquine, a combination of both drugs, or something else that caused his severe, life-changing symptoms.

“My memory has suffered badly,” said Cpl. Kruizinga. “I repeat myself often. One time I told the same story to some family friends three times in the same evening. I’ve had tests for dementia but all returned negative.”

There are countless similar stories from other Australian veterans.

“People just haven’t been able to cope and they’ve taken their own lives,” said Major Stuart McCarthy, an Australian Army veteran who was ordered to take tafenoquine and mefloquine.
“I would rather live with malaria…which is treatable, than have to live with a permanent brain injury,” he said.

WUSA9 asked 60P CEO Dr. Geoffrey Dow if he would be willing to take the drug for at least six months, as the Australian service members did.

He responded, “The simple answer to that is yes” and added, “Without hesitation.”

“I think what we can clearly say is that tafenoquine is not behind what these unfortunate people might be suffering,” Dr. Toovey concluded. “Am I surprised that veterans have post traumatic stress disorder? No."

Drs. Toovey and Dow say military service, not anti-malarial drugs, caused the veterans’ psychiatric and physical conditions.

“We know post-traumatic stress disorder is a risk of deployment. It is a risk of military service,” asserted Dr. Toovey.

Echoed Dr. Dow, “It’s well documented in the literature that deployment specifically and then combat even more than that is a major risk factor for mental health disorders.”

Australian government documents obtained by WUSA9 reveal that 1,331 service members who took tafenoquine and deployed to the East Timor peacekeeping mission were later diagnosed with PTSD. That’s more than 1,300 veterans out of just five thousand military personnel, few of whom saw combat.

Tafenoquine and mefloquine are from the same broad class of drugs that have proven to be neurotoxic in animals. The term “neurotoxic” means the drug can cause adverse effects on the central nervous system and even permanent brain and brainstem damage. Symptoms of neurotoxicity can include: limb weakness or numbness, dizziness, memory loss, and mood and behavioral changes.

“The development of tafenoquine should be raising red flags all through the drug safety community,” said Dr. Remington Nevin. The former Army Medic founded the Quinism Foundation to study the potential side effects posed by these anti-malarial drugs and push for more research. He’s documented how many of the symptoms of toxicity mimic post-traumatic stress disorder, or PTSD.

“There’s been a systematic pattern of almost intentional ignorance among those in the military drug development community associated with this drug,” he said.

Dr. Nevin pointed out research done by Walter Reed’s own scientists in 2007 which revealed that “Tafenoquine is the only antimalarial more neurotoxic than mefloquine.”

Some experts disagree.

“Mefloquine and tafenoquine are very different drugs,” said Dr. Toovey. “Each has to be judged on its own merits.”

A 2010 study noted that “92% of tafenoquine subjects and 88% of mefloquine subjects” reported one or more adverse events. The majority of those side effects were described as mild or moderate in severity and included vertigo, diarrhea and abnormal dreams.

But what about the potential long-term effects of tafenoquine? In Australia, there is lingering concern among veterans that not enough research has been done.

Insisted Dr. Toovey, “We would not expect to see side effects emerging 20 years later. And nobody has gone and looked for that. It would be… it doesn’t make any sense scientifically.”

According to 60P’s Dr. Dow, tafenoquine could be approved by the United States Food and Drug Administration by the end of this year.

FDA officials won’t comment on pending applications, but emphasized that the agency would only approve a new drug after finding that it’s safe and effective.

Drugmaker Glaxo Smith Kline has developed a different variety of tafenoquine. Unlike the 60P version which is designed to prevent malaria, this would be a one-time dose intended to treat the disease. Company officials indicated it would not be marketed in the United States.

If you've taken tafenoquine and believe you suffered psychiatric or physical side effects as a result, we'd like to hear from you. Please email Andrea McCarren and put "Tafenoquine" in the subject line. Let us know when and where you took the drug, for how long and under what circumstances.

Lawyers are claiming an anti-malaria drug, called mefloquine may be the reason behind why an Army Staff Sergeant murdered 16 civilians while deployed in Afghanistan.

In a brief filed Wednesday, lawyers are arguing Army Staff Sergeant Robert Bales did not have a fair trial and are taking his case to the United States Supreme Court. During Sgt. Bales' trial, government prosecutors did not disclose that he was ordered to take mefloquine before and during his deployment, lawyers said.

"Mefloquine is a potential game changer in the Bales case because like in any criminal prosecution, one of the main, important pieces of the case is the accused’s state of mind," said one of his Bales' lawyers, John Maher.

For decades, American service members were ordered to take the controversial drug, mefloquine while deployed in countries where malaria is a threat.

WUSA9's investigation revealed that many veterans blame mefloquine for severe psychiatric and physical conditions that persist years later. Paranoia, depression, anxiety, gruesome night terrors, including homicidal and suicidal thoughts are among the side effects.

Sgt. Bales wandered off his base in March of 2012 and confessed to shooting 22 villagers in the middle of the night. Sixteen of them died, including nine children as young as two years old. Four women and three men were also killed. He pleaded guilty in 2013 to avoid the death penalty.

His lawyers are blaming “involuntary mefloquine toxicity” as a significant factor in the case. They believe the outcome of Sgt. Bales’ case may have been dramatically different had it been known he was on mefloquine at the time of the massacre. Like many veterans, the drug was never logged in his medical records.

"And if Bob Bales were under a drug, a prescription drug that compromised his state of mind, that means by law, he can’t be guilty," said Maher.

The case attracted international attention and condemnation. President Hamid Karzai, who was the president of Afghanistan at the time wanted Bales tried and hanged.

At the time of the attack, Sgt. Bales was on his fourth combat tour, with a total of 42 months in a combat zone. The legal brief reveals that after his first deployment to Iraq in 2004, he complained about memory loss and depression. After subsequent deployments, according to the brief, he suffered from insomnia, irritability, anger, and memory impairment. The United States sent him on a fourth combat tour, despite these complaints.

180504 Petition for E-Filing by WUSA9-TV on Scribd

An Australian Member of Parliament has called for a formal inquiry into two antimalarial drugs developed at the Walter Reed Army Institute of Research in Maryland: mefloquine and tafenoquine.

This follows a series of WUSA9 investigative reports on the two drugs. Veterans around the world allege the weekly pills caused serious and lasting psychiatric and physical side effects.

"We're now seeing a really significant issue emerging about the effects of those experimental drugs known as the quinolones family, including tafenoquine,” said MP Mike Kelly, who is himself a veteran. "We should draw on the examples and evidence emerging from overseas, but we need to do our own inquiry on this, and we need to do it deep and we need to do it fast. We need to see that happening now. "

Mefloquine, under the brand name Lariam, was ordered for tens of thousands of American service members deployed to malaria-prone parts of the world from the 1980s until 2013, when the United States Food and Drug Administration issued a black box warning.

That’s the FDA’s strictest measure, put on prescription drug labels when there’s evidence of a serious side effect. The drug is now used as a last resort, according to Pentagon officials, reserved for service members who cannot take one of the alternative antimalarials.

From 1998 to 2002, members of the Australian Defence Force were used as trial subjects for mefloquine and tafenoquine.

“We need Defence to be really careful with this stuff in the future,” said Kelly. “We're talking about people here, not guinea pigs, and I think we're united across the aisles here on wanting to see something happen urgently in this space.

He added, ”This is very serious, because we've had issues of perhaps an interconnection with suicides and other neurological problems as well as physiological problems. "

"It’s not neurotoxic and it is safe," said Dr. Geoffrey Dow, the CEO of 60 Degrees Pharmaceuticals, the DC company that developed tafenoquine. He told us the United States Food and Drug Administration has fast-tracked it for approval.

Dr. Dow said the safety of the drug is "supported by the clinical trials that the Army and 60P have conducted and have submitted to the FDA for evaluation."

Two drug makers are seeking approval by the FDA for tafenoquine. 60P has a pill that would be used to prevent malaria. Glaxo Smith Kline has developed a version that would be used to treat malaria, and would only be marketed and administered overseas, according to the company.

The FDA action could come by the end of this year.

A retired United States Army General is now calling on the Department of Veterans’ Affairs and other senior military leaders to step up and take responsibility for any psychiatric or physical side effects caused by the antimalarial drug, mefloquine.

Veterans from around the world have told WUSA9 the drug they were ordered to take caused devastating side effects.

"You hear many presidents and many leaders say what we owe them, we can never pay them back. Well, here’s a way to pay them back," said Brigadier General Donald Bolduc.

The highly decorated veteran led ten deployments, survived a bomb blast, a helicopter crash and several firefights. He received two combat valor awards, five Bronze Stars and two Purple Hearts.

But his most challenging battle may lie ahead: holding the United States government accountable for any life-changing side effects that may have been caused by mefloquine. It was ordered for tens of thousands of American service members.

"We owe it to those who served our country to treat them properly when they have side effects," said General Bolduc.

Veterans allege the drug caused life-changing, career-ending symptoms. Side effects that have lasted for decades. Among them: gruesome night terrors. Depression, anxiety, and paranoia that mimic symptoms of PTSD. Ringing in the ears. Memory loss. Hand tremors. Balance issues. And gastrointestinal distress that often comes without warning.

As a Brigadier General, Bolduc was the Commander of Special Operations across the entire continent of Africa. In that role, he was responsible for more than 1,700 military personnel operating in 28 countries throughout Africa and Europe.

Of our military leadership at the Department of Veterans' Affairs and the Department of Defense, he said, "Well, I hope they have the moral courage to own up to it. Whatever the liability is, we need to own up to it. It’s about taking care of the health and welfare of our citizens and particularly those who served our country."

From the 1980s to 2013, the Department of Defense ordered service members deployed to Somalia, Iraq, Afghanistan and elsewhere to take mefloquine to prevent malaria. The mosquito-borne disease can be fatal.

In an interview at the Pentagon earlier this year, Colonel Andrew Wiesen said, "We attempted to give folks the best possible agent to protect them to the highest degree. To do any less would have done them a disservice."

But starting in 2013, the DOD backed off mefloquine, using it only as a last resort. That was after the Food and Drug Administration issued a black box warning. That’s the FDA’s strictest alert on a drug label when there’s evidence of a serious hazard.

General Bolduc knows the side effects firsthand. He took the drug during multiple deployments and experienced devastating symptoms including night terrors and paranoia, even after he returned home.

"I couldn’t drive. The reason I couldn’t drive was because of hypervigilance," he recalled. "I thought that I had to drive like I was in Afghanistan. Every stimulus around me was a threat."

In 2008, drugmaker Roche stopped producing the brand name version of mefloquine, called Lariam. Two generic forms are still available in the United States by prescription only. Three other generics have been discontinued.

So, how does our government make this right? General Bolduc says the VA should start by contacting every single veteran that took the drug and letting them know they may be experiencing some symptoms. VA doctors need to be trained to recognize them. And, he believes, every health assessment done on a service member or veteran should include questions about mefloquine.

"Please, please senior leaders, take this on. It has to do with the health of the current force and the health of our veterans, later on in life. And that’s hugely important for our country," he said.

The General is one of a growing chorus of voices demanding government accountability on this issue.

Largest veterans orgs want hearings on mefloquine

​​​​​​​

Five of the nation’s largest and most influential veterans organizations are calling for action from the Department of Defense, the Department of Veterans Affairs and Congress.

They want to know how many veterans were ordered to take an antimalarial drug called mefloquine, and whether they are suffering from any lasting side effects.

Their battle cry comes in the wake of our WUSA9 investigation into side effects caused by the weekly pill. Tens of thousands of American service members were ordered to take it between the 1980s and 2013 to prevent or treat malaria.

The American Legion, Veterans of Foreign Wars (VFW), American Veterans (AMVETS), Vietnam Veterans of America (VVA) and Iraq and Afghanistan Veterans of America (IAVA) want:

• Congressional hearings to investigate physical and psychiatric side effects caused by mefloquine
• The Department of Defense to acknowledge that mefloquine caused some service members lasting side effects
• A change in protocol for the Department of Veterans Affairs, so that every veteran who goes through a health assessment is asked whether he or she was ordered to take mefloquine, and if so, whether they have experienced specific symptoms
• A thorough accounting of all service members who took the antimalarial drug and targeted outreach to alert them to potential side effects

Members of the Veterans' Affairs Committee Spreadsheet by WUSA9-TV on Scribd

"This is not the first time veterans experience severe side effects on being exposed to something," said Lana McKenzie, the Chief Medical Executive for AMVETS. "We’re talking about Agent Orange and we’re not learning our lessons?"

INVESTIGATION: Vets say anti-malaria drugs they were ordered to take caused devastating side effects

Agent Orange was the powerful herbicide sprayed by U.S. military during Vietnam War. It caused serious health issues, including cancer and birth defects.

Echoed Carlos Fuentes of the VFW, "Learn from past mistakes to make sure that you don’t jeopardize the lives of our brave men and women in uniform."

Vietnam Veterans of America's co-founder Rick Weidman was more blunt. "It’s criminal!" he said. "It’s treating people who serve like second class or third class citizens."

He added that top military officials should have taken the drug too.

"If you’re making troops take anything, the SECDEF and every other civilian appointee and military brass, in the chain of command ought to take the same damn thing at the same time," he said.

Many veterans say mefloquine caused lasting side effects, including anxiety, depression, paranoia, vertigo, tremors, irritable bowel syndrome and ringing in the ears.

"Many of them don’t even know that it’s connected to their use of mefloquine when they were over in Iraq or Afghanistan," said the VFW's Fuentes.

The Department of Defense has never acknowledged that the drug was the cause of these wide-ranging ailments.

"The DoD first needs to acknowledge that these drugs are very harmful," said Melissa Bryant, of IAVA.

"If the government does something to harm an active duty service member, then the American people have more responsibility to make that veteran whole, or as whole as they can, for the rest of their lives," said Joe Plenzler of The American Legion.

The Department of Veterans Affairs has no diagnosis or treatment for mefloquine side effects. The five organizations interviewed by WUSA9, representing millions of veterans, believe our government can take some basic measures to make this right. They suggest starting by asking veterans whether they took mefloquine. In many cases, our investigation revealed it was never logged in their medical records.

"Every veteran should be asked. A lot of people took it even if they were on a stateside base or they were stationed in South America or someplace else. Certainly, the Philippines," said Weidman of the VVA.

Letter to VA from The Quinism Foundation by WUSA9 TV on Scribd

Added McKenzie, "I always question the reason people don’t want to jump on board and do the right thing. For me, as a society, we pay one way or another."

Drug manufacturer Roche stopped making mefloquine (brand name: Lariam) in 2008. Three of the five generic manufacturers have also discontinued the drug.

"It takes the folks on Capitol Hill and it takes the folks in the White House and the Administration to make this right," said Plenzler.

Every one of these organizations agrees, it will take Congressional action to effect any change. They believe there should be hearings on Capitol Hill to determine how many veterans are suffering and how best to get them the help they need.

"We’re adamant," said Weidman. "Simply what we’re interested in is justice."

If you’d like to contact members of the House and Senate Veterans Affairs Committees to ask for hearings into mefloquine, please click HERE for a full list of contacts.

Major Staurt McCarthy

Col. Andrew Wiesen

Sgt. Andre Kerp

Dr. Geoffrey Dow

Dr. Toovey

Greg Harris

Jane Quinn

Mark Armstrong

Army Corporal Mick Kruizinga

Dr. Ralph Erickson

Staff Sgt. Marty Brown

Dr. Remington Nevin

Sean

Sheryll Lander

Commander Bill Manofsky

Constance Hardy

Michael Hughes

In-Vitro Toxicity Assessment of Antimalarial Drugs on Cultured Embryonic Rat Neurons, Macrophage (RAW 264.7... by WUSA9 TV on Scribd

Historical insights into the chronic neurological sequelae of mefloquine by WUSA9 TV on Scribd

1951 - Schmidt, Schmidt - Neurotoxicity of the 8-Aminoquinolines. III. the Effects of Pentaquine, Isopentaq... by WUSA9 TV on Scribd

1949 - Schmidt, Schmidt - Neurotoxicity of the 8-Aminoquinolines. II. Reactions of Various Experimental Ani... by WUSA9 TV on Scribd

1948 - Schmidt, Schmidt - Neurotoxicity of the 8-Aminoquinolines. I. Lesions in the Central Nervous System... by WUSA9 TV on Scribd

Australian Government Department of Veterans' Affairs - Accepted Conditions for Veterans of Selected Confli... by WUSA9 TV on Scribd

Radical curative efficacy of tafenoquine combination regimens in Plasmodium cynomolgiinfected Rhesus monkey... by WUSA9 TV on Scribd