Clinical trials of controversial MS therapy still not OK’d

Hey there, time traveller!
This article was published 06/03/2012 (5342 days ago), so information in it may no longer be current.

MANITOBA is likely still months away from a decision on whether to proceed with clinical trials for a controversial multiple sclerosis treatment.

The province and the Manitoba Health Research Council (MHRC) had hoped trials to assess liberation therapy, which involves opening up blocked neck veins, would begin early this year.

Premier Greg Selinger announced $5 million in funding toward the research last April. The deadline for research proposals was Sept. 30.

Christina Weise, executive director of the MHRC, which would oversee the trials, said her organization hopes to make an announcement by spring. “The review is ongoing and a final decision has not been made,” she said in an interview.

Weise said the review is being done by a committee of experts who will determine which proposal, if any, best meets the council’s criteria. Those include expertise in designing and managing clinical trials, providing care for MS patients and leading a multi-disciplinary, multi-site research team.

The task is onerous and there are ethical hurdles, Weise said. To test the procedure, researchers would do a double-blind study consisting of patients who are receiving the treatment and those who aren’t but think they are, she said. “It’s very, very complex.”

Saskatchewan, the first jurisdiction in Canada to announce it would fund home-based clinical research trials, abandoned that plan last summer when the single research proposal it received failed to meet criteria set out by the province’s health research foundation.

Saskatchewan has opted instead to spend $2.2 million to send 86 MS sufferers to participate in a clinical trial at the Albany Medical Center in New York state. But even those trials have yet to receive the official green light.

The fact Manitoba has fallen behind its original schedule for launching clinical trials is exasperating some MS sufferers, who are anxious to undergo the procedure in Canada.

The liberation procedure, also known by the acronym CCSVI, is frowned upon by many in the Canadian medical community and is unavailable in this country. An untold number of Manitobans have travelled abroad at great expense to receive it. For some, the procedure has changed their lives, freeing them from their symptoms. Others have received only temporary relief.

Sharlene Garlinski, a Winnipegger who received the treatment in Costa Rica a year-and-a-half ago, said it’s changed her life. She is now contemplating a return to work.

Garlinski is impatient with the time it’s taken to launch the Manitoba-sponsored trials. She said MS patients are suffering and desperate for help.

Asked this week if she was confident there would be a Manitoba-based CCSVI trial, Health Minister Theresa Oswald admitted she did not know: “MHRC will be the ones that decide if indeed the proposals they receive meet all of the criteria that they’ve set out.”

larry.kusch@freepress.mb.ca