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During the 1990s,
it was common for military personnel to be prescribed Mefloquine, an
antimalarial medication, when deployed to areas around the world
where malaria was prevalent. However, issues with the drug have
since been discovered causing some to be concerned. In fact, in
2016, Health Canada updated the warning labels for mefloquine,
highlighting serious side effects – anxiety, paranoia, depression,
hallucinations, psychotic behaviour and thoughts of suicide –which
can persist for months or years after taking the drug.
A
class action was commenced in 2000 against the Canadian Government;
the case was dismissed for delay in April 2018.
HSH has
partnered with Waddell Phillips as Co-Counsel to bring forth
individual claims for any member, or former member, of Canadian
Armed Forces who was ordered to take Mefloquine from years 1989 to
present.
If you or a loved one is taking or has taken Mefloquine and
has experienced harmful side effects associated with its use, HSH
personal injury lawyers Paul Miller and Michael Henry can help you
to identify whether you may benefit from taking part in this legal
action.
Side Effects of Mefloquine
Mefloquine has been
reported to cause a number of symptoms in those who’ve taken the
drug, including anxiety, depression, suicidal and homicidal
thoughts, paranoia, delusions and hallucinations. Health Canada
recently updated its warning labels to reflect those side effects.
Though the Canadian military conducted its own review which
determined that the drug doesn’t have any long-term effects, it now
only prescribes mefloquine as a drug of last resort.
The
Problem
A number of veterans claim they have suffered
significant side effects from mefloquine which they say they were
forced to take when deployed to Somalia in 1992 and 1993. They say
the anti-malaria drug was prescribed as part of a clinical trial
which didn’t follow proper procedure. According to the rules of
clinical trials, soldiers must provide consent before taking a new
drug and be made aware of possible side effects. They should also be
advised to avoid alcohol when taking the drug and must be monitored
and treated for any negative side effects.
By not following
those rules, the veterans claim the federal government hasn’t
effectively met its duty of care. As a result, many are now
suffering from a variety of side effects from mefloquine, including
depression, anxiety, aggressive behaviour, paranoia, psychiatric
symptoms, brain damage and suicidal thoughts.
Today the
Canadian military seldom prescribes mefloquine. In June of 2017 the
Department of National Defence announced that Mefloquine would only
be recommended for use if a CAF member requests it, or if there are
contraindications to the member being prescribed other
anti-malarials.
What’s Being Done?
By prescribing
mefloquine without following proper procedure for a clinical trial,
and failing to inform our forces of the side effects, members of the
military have suffered debilitating medical symptoms, some serious
with long-term impact. HSH lawyers Paul Miller and Michael Henry,
along with Waddell Phillips, want to hold the Canadian Government
accountable.
The objective of the mefloquine lawsuit in
Canada is to help its victims receive compensation for the drug’s
harmful effects and for being part of a clinical trial that didn’t
follow proper procedure despite potential risks. As a mass tort
litigation, cases proceed on an individual basis.
Helping You
HSH lawyers can help you create a claim for compensation and
damages based on the pain, suffering and losses you have experienced
after experiencing side effects from a drug. If you or a loved one
has been prescribed mefloquine and have experienced harm as a
result, HSH can explain your rights and determine whether you may
benefit from participating in this mass tort litigation.
Call
us today at 1-877-771-7006 for a free consultation.
GLORIA
GALLOWAY PARLIAMENTARY REPORTER PUBLISHED JUNE 1, 2017 UPDATED
JUNE 2, 2017
Chief of the Defence Staff General Jonathan Vance working in his
office at DND Headquarter November 13, 2015 in Ottawa. The Canadian
Forces on Thursday released a report from a task force on mefloquine
that was ordered last fall by General Vance.
Canadian
soldiers who are deployed to regions where malaria is prevalent will
no longer be offered mefloquine as a first option for preventing the
disease, the military has decided after a completing a study
prompted by veterans who say the drug caused permanent brain damage.
The Canadian Forces on Thursday released a report from a task
force on mefloquine that was ordered last fall by General Jonathan
Vance, the Chief of Defence Staff. Health Canada simultaneously made
public its own findings about the safety of the drug. Both studies
conclude there is no evidence that the drug causes long-lasting and
permanent neurological and psychiatric problems.
That angers
some veterans, who say they experience debilitating mood issues,
sleep disorders, aggression, depression and memory loss as a result
of mefloquine toxicity.
"There is no doubt in my mind that
this drug caused, and causes, serious, serious issues for a lot of
us," former soldier Dave Bona said.
The military's report
recommends that the two most commonly prescribed alternatives –
Malarone and doxycycline – be considered preferred options for
soldiers deploying to countries where malaria is a risk, and that
mefloquine be used only when the other drugs are not tolerated or
when a soldier has taken it previously, had no problems with it, and
chooses to take it again.
The change closely aligns the
policy of the Canadian Forces with that of the Australian, U.S. and
British military, which have declared mefloquine a drug of last
resort. Germany has banned it for its soldiers.
The Canadian
military study did not involve original scientific research, but
analyzed available studies on the medication and reviewed the
Canadian Forces' experience with it.
"It just infuriates me.
It's like they have cherry-picked the reports they want to use to
support their own agenda," said Mr. Bona, who took mefloquine during
the Somalia mission of the early 1990s as part of an unorthodox and
possibly illegal clinical trial run by the Department of National
Defence and Health Canada. Some blame the drug for the violence in
which Canadian troops beat a 16-year-old Somali to death.
Mr.
Bona's partner, Teresa Untereiner, said it is is both dangerous and
irresponsible to say mefloquine causes no permanent neurological
harm. "When they deny that it has an effect, they're able to deny
the people who have been affected any services," she said.
Health Canada updated the warning labels for mefloquine in August to
emphasize that certain side effects can persist for months or years
after the drug is discontinued and may be permanent in some
patients. The department said the reported symptoms include anxiety,
paranoia, depression, hallucinations, psychotic behaviour and, in
rare cases, thoughts of suicide.
How such side effects might
affect soldiers when they are deployed to dangerous parts of the
world was part of the study released by the military on Thursday,
said Lieutenant-Colonel Andrew Currie, the head of the communicable
disease prevention program for the Canadian Forces. "At the end of
the day," Lt.-Col. Currie said, "that was certainly part of the
decision-making that the surgeon-general had when he proposed the
new policy on mefloquine."
It is important to point out that
the number of soldiers who have been using mefloquine has diminished
significantly, he said.
In fact, task force could find just
111 military patients who had been prescribed mefloquine between
December, 2013, and December, 2016, a time when there was no large
deployment to a country where malaria is prevalent. Of those cases,
however, it was discovered that 12 per cent were given the drug even
though they had a history with anxiety, depression or PTSD that
meant it was was not recommended. The report advises the military to
develop better screening procedures.
The Commons Veterans
Affairs Committee, which has been studying mental health and suicide
among veterans, had heard much testimony from veterans such as Mr.
Bona who believe they were injured by mefloquine.
Cathay
Wagantall, a Conservative MP who is a member of that committee,
commended the military for making mefloquine a second-line drug. But
by declaring there is no evidence of permanent neurological and
psychiatric damage, she said, "I think they are trying to dismiss
themselves now from having to deal with the fact that, for years,
soldiers have suffered, and veterans have suffered, with the use of
this drug."
Remington Nevin, a doctor at the Johns Hopkins
University Bloomberg School of Public Health in Maryland, who has
studied the drug's effects for nearly a decade, was harsh in his
assessment of Health's Canada's conclusions. The federal department
"shamefully appears to be taking a page from the playbook of tobacco
company executives in attempting to manufacture doubt about the
known chronic effects of mefloquine which are clearly acknowledged
by international drug regulators," Dr. Nevin said.
As for the
report of the Canadian military, the recommendation to further
restrict use of mefloquine is a tacit acknowledgment that the Forces
have failed to use mefloquine safely, and that its continued use
poses a risk to its members, Dr. Nevin said.
"While this
report is a step in the right direction for serving members of the
Canadian Armed Forces," he said, "it does a disservice to Canadian
veterans. Canadian mefloquine veterans deserve to have the
government acknowledge that their health has been placed at risk by
Canadian Armed Forces' misuse of mefloquine."
Cpl. Timothy Dobson, a fire team leader with second platoon, Ground
Combat Element, Security Cooperation Task Force Africa Partnership
Station 2011 takes doxycycline once per day in accordance with a
weekly dosage of mefloquine to prevent the spread of Malaria. The
daily routine is supervised by 1st Sgt. Jason Moffit and one of the
second platoon corpsmen to ensure that meds are taken each day while
APS-11 conducts its mission of security cooperation through
military-to-military exchanges. (U.S. Marine Corps photo by Lance
Cpl. Timothy L. Solano)
The case of a service member
diagnosed with post-traumatic stress disorder but found instead to
have brain damage caused by a malaria drug raises questions about
the origin of similar symptoms in other post-9/11 veterans.
According to the case study
published online in Drug Safety Case Reports in June, a U.S.
military member sought treatment at Walter Reed National Military
Medical Center in Bethesda, Maryland, for uncontrolled anger,
insomnia, nightmares and memory loss.
The once-active sailor, who
ran marathons and deployed in 2009 to East Africa, reported
stumbling frequently, arguing with his family and needing
significant support from his staff while on the job due to cognitive
issues.
Physicians diagnosed the
service member with anxiety, PTSD and a thiamine deficiency. But
after months of treatment, including medication, behavioral therapy
and daily doses of vitamins, little changed.
The patient continued to be
hobbled by his symptoms, eventually leaving the military on a
medical discharge and questioning his abilities to function or take
care of his children.
It wasn’t until physicians
took a hard look at his medical history, which included vertigo that
began two months after his Africa deployment, that they suspected
mefloquine poisoning: The medication once used widely by the U.S.
armed forces to prevent and treat malaria has been linked to brain
stem lesions and psychiatric symptoms.
While no test is available to
prove the sailor suffered what is called "mefloquine toxicity," he
scored high enough on an adverse drug reaction probability survey to
tie his symptoms to the drug, also known as Lariam.
The sailor told his Walter
Reed doctors that he began experiencing vivid dreams and
disequilibrium within two months of starting the required deployment
protocol.
Symptoms can last years
Case reports of mefloquine
side effects have been published before, but the authors of
"Prolonged Neuropsychiatric Symptoms in a Military Service Member
Exposed to Mefloquine" say their example is unusual because it shows
that symptoms can last years after a person stops taking the drug.
And since the symptoms are so
similar to PTSD, the researchers add, they serve to "confound the
diagnosis" of either condition.
"It demonstrates the
difficulty in distinguishing from possible mefloquine-induced
toxicity versus PTSD and raises some questions regarding possible
linkages between the two diagnoses," wrote Army Maj. Jeffrey
Livezey, chief of clinical pharmacology at the Walter Reed Army
Institute of Research, Silver Spring, Maryland.
Once the U.S. military's
malaria prophylactic of choice, favored for its once-a-week dosage
regimen, mefloquine was designated the drug of last resort in 2013
by the Defense Department after the Food and Drug Administration
slapped a boxed warning on its label, noting it can cause permanent
psychiatric and neurological side effects,
50,000 prescriptions in 2003
At the peak of mefloquine's
use in 2003, nearly 50,000 prescriptions were written by military
doctors.
That figure dropped to 216
prescriptions in 2015, according to data provided by the Defense
Department. According to DoD policy, mefloquine is prescribed only
to personnel who can't tolerate other preventives.
But Dr. Remington Nevin, a
former Army epidemiologist and researcher at the Johns Hopkins
Bloomberg School of Public Health in Baltimore, said any
distribution of the drug, which was developed by the Army in the
late 1970s, is too much.
"This new finding should
motivate the U.S. military to consider further revising its
mefloquine policy to ban use of the drug altogether," Nevin told
Military Times.
While a case study is a
snapshot of one patient's experience and not an indication that
everyone who took or takes mefloquine has similar issues, one
randomized study conducted in 2001 — more than a decade after the
medication was adopted by the military for malaria prevention —
showed that 67 percent of study participants reported more than one
adverse side effect, such as nightmares and hallucinations, and 6
percent needed medical treatment after taking the drug.
Yet mefloquine remains on the
market while Walter Reed Army Institute of Research conducts
research on medications in the same family as mefloquine, including
tafenoquine, hoping to find a malarial preventive that is less toxic
but as effective.
Mefloquine was developed under
the Army's malaria drug discovery program and approved for use as a
malaria prophylactic in 1989. Shortly after commercial production
began, stories surfaced about side effects, including
hallucinations, delirium and psychoses.
Once considered
'well-tolerated'
Military researchers
maintained, however, that it was a "well-tolerated drug," with one
WRAIR scientist attributing reports of mefloquine-associated
psychoses to a "herd mentality."
"Growing controversies over
neurological side effects, though, are appearing in the literature,
from journal articles to traveler's magazines and resulting legal
ramifications threaten global availability," wrote researcher Army
Col. Wilbur Milhous in 2001. "As the 'herd mentality' of mefloquine
associated psychoses continues to gain momentum, it will certainly
affect operational compliance and readiness. ... The need for a
replacement drug for weekly prophylaxis will continue to escalate."
Mefloquine was implicated in a
series of murder-suicides at Fort Bragg, North Carolina, in 2002,
and media reports also tied it to an uptick in military suicides in
2003.
A 2004 Veterans Affairs
Department memo urged doctors to refrain from prescribing
mefloquine, citing individual cases of hallucinations, paranoia,
suicidal thoughts, psychoses and more.
The FDA black box warning nine
years later led to a sharp decline in demand for the medication. But
while the drug is no longer widely used, it has left damage in its
wake, with an unknown number of troops and veterans affected,
according to retired Navy Cmdr. Bill Manofsky, who was discharged
from the military in 2004 for PTSD and later documented to have
mefloquine toxicity.
He said the Defense Department
and VA should do more to understand the scope of the problem and
reach out to those who have been affected.
"I'm kind of the patient zero
for this and I now spend my life trying to help other veterans who
have health problems that may have been caused by mefloquine. More
needs to be done," Manofsky said.
He said while there is no cure
for the vertigo and vestibular damage or the psychiatric symptoms
caused by mefloquine, treatments for such symptoms, such as behavior
and vestibular therapy help.
And, he added, simply having a
diagnosis is comforting.
Veterans can seek help
"Veterans need to come
forward," he said. "The VA's War Related Illness and Injury Study
Center can help."
The patient in the case study
written by Livezey continues to see a behavioral therapist weekly
but takes no medications besides vitamins and fish oil.
He sleeps just three to four
hours a night, has vivid dreams and nightmares and vertigo that
causes him to fall frequently, and continues to report depression,
restlessness and a lack of motivation.
The sailor's experience with
mefloquine has been "severely life debilitating" and Livezey notes
that the case should alert physicians to the challenges of
diagnosing patients with similar symptoms.
"This case documents the
potential long-term and varied mefloquine-induced neuropsychiatric
side effects," he wrote.
Patricia Kime covers
military health care and medicine for Military Times. She can be
reached at
pkime@militarytimes.com.
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