Translate

Monday, December 5, 2016

Canadian Forces firm on anti-malaria drug ahead of Africa mission

By: Gloria Galloway, The Globe and Mail 

Val Reyes-Santiesteban is convinced she lost a military son to the neuropsychotic side effects of the anti-malarial drug mefloquine, and she fears some of the Canadian soldiers who are about to deploy to Africa could meet the same fate.

Members of the Canadian Airborne Regiment get into position as they arrive to assume responsibility for the airport at Bali Dogle, Somalia, on December 15, 1992. Senior medical officials in the Canadian Forces say there is not enough scientific evidence to remove mefloquine as an option for troops who go to countries where malaria is a threat. (Andrew Vaughan/Canadian Press)
Members of the Canadian Airborne Regiment get into position as they arrive to assume responsibility for the airport at Bali Dogle, Somalia, on December 15, 1992. Senior medical officials in the Canadian Forces say there is not enough scientific evidence to remove mefloquine as an option for troops who go to countries where malaria is a threat.
(Andrew Vaughan/Canadian Press)
“It makes me sick. They’ve got to stop them from taking this drug,” Ms. Reyes-Santiesteban, of Welland, Ont., told The Globe and Mail. “Everyone in the government should take this pill once a week for a month and let them see what happens.”

Her son, Corporal Scott Smith, died of a self-inflicted gunshot wound on Christmas Day of 1994 in Rwanda, where he had been sent after taking part in the 1992 Somalia peacekeeping mission. Military doctors prescribed mefloquine for him on both deployments.

The army says he was “killed in action” even though his death, at the age of 23, was clearly suicide.

But, more than two decades later, as the government determines where its next peacekeeping mission in Africa will be, senior medical officials in the Canadian Forces say there is not enough scientific evidence to remove mefloquine as an option for troops who go to countries where malaria is a threat. They remain dubious of claims it can cause permanent damage, despite a Health Canada warning and veterans who say the medication ruined their lives.

Military brass said the same after allowing more than 1,000 Canadian Forces members in Somalia to be part of a poorly monitored clinical trial. Two of the soldiers on that mission were charged in the beating death of a Somali teen, and many others complained of alarming dreams, hallucinations and depression.

Even after doctors on the front lines implicated mefloquine in the troops’ violent behaviour, officers in Canada reassured the commission of inquiry into the Somalia affair that the drug could not cause the psychotic side effects being reported.

The current Liberal government has rejected calls from an all-party committee of the House of Commons and Somalia veterans for more research on mefloquine. And a previous Liberal government shut down the Somalia commission just before the issue of mefloquine was to be addressed.

As a result of recent media coverage, the chief of defence staff asked the military’s surgeon-general to take another look at the scientific literature about the drug. It is now prescribed to just a small fraction of Canadian troops.

The use of mefloquine in Somalia was unorthodox and possibly illegal. The drug had not been approved in Canada in 1992, but National Defence obtained it from Health Canada as part of a clinical trial in which military personnel were supposed to receive the informed consent of the users and to monitor the efficacy and the adverse reactions. They did neither.

The military chose mefloquine over other options because, unlike most anti-malarial drugs, it is taken once a week instead of daily and the Forces determined it was the best option for the Somalia theatre.

Ms. Reyes-Santiesteban does not doubt the drug killed her son.

As he was on his way to Rwanda in the fall of 1994, Cpl. Smith told a reporter for what is now called Canadian Shipper magazine that the malaria medication gave him hallucinations. A few months later, he was dead.

In the hours before he shot himself, Cpl. Smith took part in a convoy in which he was laughing and joking with his colleagues. Then he called his mother, his father and his best friend to wish them a Merry Christmas.

“He was coming home, we were going to have a late Christmas in February,” Ms. Reyes-Santiesteban said. “Nothing seemed to add up.”

Ms. Reyes-Santiesteban wrote to the military and politicians to demand they examine the role mefloquine may have played in the tragedy but, she said, she was never taken seriously.

That was also the response when Barry Armstrong, one of the military doctors who took part in the Somalia mission, expressed concerns about the drug’s effects on the troops.

In a post-deployment analysis he wrote for a 1993 conference, Dr. Armstrong said the failure of the United Nations forces in Somalia was “rather exceptional,” and “I believe that a simple reason may exist. Canadian and American troops may have been impaired by the use of mefloquine.”

Of the three military people who presented papers about the Somalia mission at the conference, “two of us had minor neuropsychiatric problems which occurred regularly in the 24 to 48 hours after our weekly mefloquine doses. If there are two of us, these reactions aren’t so rare.”

Greg Passey, a military doctor who was deployed to Rwanda in 1994, had similar concerns, and wanted to make them known to the Somalia inquiry. Despite a forces-wide communication that said any member of the military who had pertinent information should step forward, Dr. Passey said his decision to testify drew anger from senior officers.

Dr. Passey said one of his colleagues told him “the surgeon-general [then Major-General Wendy Clay] was very upset with me.” He said he decided to testify at the commission anyway, but it was shut down the week before his scheduled appearance.

Dr. Clay said in a telephone interview that she has no recollection of the incident, given that it took place nearly 20 years ago, and it would not have been her place to stop someone from testifying.

She was deputy surgeon-general during the Somalia mission and “certainly, at the time, you weighed the risks and the benefits and there seemed to be no doubt that mefloquine was an appropriate drug to give at that time,” Dr. Clay said. “Whether I would say the same thing now, I don’t know.”

Additional background material for the Somali inquiry includes a 1994 memo from Dr. Clay to the chief of defence staff saying she did not mean to “deny the perceptions of those who served in Somalia,” but the weight of scientific evidence suggests “that the probability of there being adverse effects severe enough to have an impact on the behaviour of our troops, and to constitute a contributing factor to the tragic events that occurred, is very low indeed.”

Some of the troops who believe they suffer long-lasting effects from the drug have started a class-action suit against the government and Hoffman-LaRoche, the drug’s manufacturer.

“The management of the soldiers’ mefloquine use was not at all what would constitute an approved trial,” Dr. Armstrong said in an e-mail. “Considering the dangers of mefloquine, its unapproved status in 1992 and the promise of our Charter of Rights and Freedoms, to guarantee Canadians’ rights to life, liberty and security of the person, I consider the military orders about taking mefloquine to be wrong.”

Early studies of mefloquine conducted by Hoffman-LaRoche put the risk of even mild side effects at about one in 10,000. Those statistics were recently quoted to The Globe and Mail by Brigadier-General Hugh MacKay, the current military surgeon-general.

But Hervey Blois, a medic on the Somalia mission, estimates that 300 or 400 troops who took part in that deployment were affected in one way or another.

“It was an extreme topic of conversation,” Mr. Blois said. The soldiers would say: “Holy cow, was I ever loopy the other night,” he said. “I would have some really vivid and real dreams. I got into a state of paranoia later on.”

A medical report from HMCS Preserver, a navy support ship stationed off the coast of Somalia at the time, said mefloquine was a problem. “Ten patients experienced nightmares with one patient having feelings of unease and paranoia,” it said. “One patient heard voices and talked to himself. All were switched to Doxycycline with no subsequent problems.”

In March, 1993, Clayton Matchee and Kyle Brown were charged in the beating death of Shidane Arone, a 16-year-old Somali. Mr. Brown was convicted of manslaughter and served a third of a five-year sentence. Mr. Matchee suffered brain damage when he tried to hang himself and was found unfit to stand trial.

When news of the crime hit the papers, an employee of the drug approvals branch of Health Canada walked into the office of Michele Brill-Edwards looking worried. Dr. Brill-Edwards was the senior physician at the department in the late 1980s, when Hoffman-LaRoche began the process of obtaining approval for mefloquine in Canada and, although she was no longer in that role, her former staff still came to her for advice.

“He said: ‘We allowed access under a clinical trial and all of this is going on and it clearly reflects possible mental derangement and we’re not getting any information back. We have no idea whether they are following the protocol that’s been set up and this is basically a big mess,’” Dr. Brill-Edwards said.

Several years later, Dr. Brill-Edwards decided to check the claim that just one in 10,000 people experience mefloquine’s side effects. She said she found those results were obtained from questionnaires handed to travellers on airplanes returning from Africa.

That is no way to collect data, she said, because those who had killed themselves or were in jail over a mefloquine-induced crime would not be counted, and people who had a psychotic episode abroad might be reluctant to divulge it on a card collected by a flight attendant. “If you think about it,” Dr. Brill-Edwards said, “it is the perfect way not to collect the experience of people who have had adverse effects of a mental nature.”

Health Canada, which still says “the benefits of mefloquine outweigh its risks when it is used as directed,” updated its warning labels in August. The department says mefloquine can cause adverse neuropsychiatric reactions that can persist after it is discontinued, and that permanent damage has been seen in some cases.

Nearly 1,000 British soldiers have required psychiatric treatment after taking the drug.

And the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency says that, due to the long half-life of mefloquine, adverse reactions may occur or persist up to several months after discontinuation, or become permanent.

Val Reyes-Santiesteban, who found her son riding a bicycle down a hallway of her home in the middle of the night while he was on leave from his deployment to Somalia, does not need more proof of mefloquine’s long-term psychiatric damage.

“I blame it now. I blamed it then,” she said. The government and the defence department “don’t admit fault. It’s not their job to admit fault. But I knew right away.”

No comments:

Post a Comment