Drug trial likely to be approved
Health Canada promises to ‘ expedite the approval of the compassionate clinical trial’ to help five men with AIDS
OTTAWA — Health Canada could strike a deal as early as today to fast-track the approval of a special trial that will get new AIDS drugs to five dying B.C. men, including celebrated artist Tiko Kerr and Anglican priest Rev. Michael Forshaw.
Dr. Julio Montaner, one of Canada’s best-known HIV/ AIDS researchers, said he has obtained a written commitment from a senior federal bureaucrat that he believes will help assure the drug trials start soon.
The commitment came from Health Canada’s Dr. Supriya Sharma, who gave assurances that the federal department won’t let red tape stop Montaner from offering an innovative new treatment to the five desperate men.
That promise, according to Montaner, was virtually identical to a statement issued to the media late Friday on behalf of Sharma.
“Health Canada understands the urgency of the situation,” wrote Health Canada’s Christopher Williams in an e-mail.
“Health Canada will expedite the approval of the compassionate clinical trial.”
Montaner, who was initially critical of the department's offer to approve a quick trial, said on the weekend he’s arranged a conference call for today with officials at Tibotec Inc., the Belgium-based manufacturer of the antiretroviral drugs TMC114 and TMC125.
“ Depending what they say, I could put this back to Dr. Sharma [later today],” wrote Montaner, head of the B. C. Centre for Excellence in HIV/ AIDS at Vancouver’s St. Paul's Hospital, in an e-mail.
“I am confident that my Institutional Review Board [ at St. Paul’s] will cooperate.”
Montaner, recognized internationally for his early advocacy of the use of antiretroviral drugs in combination to treat AIDS sufferers with severely weakened immune systems, wants to be one of the first in the world to use the new drugs together on patients.
But his application earlier this year was rejected in August by officials at the Special Access Program ( SAP), which is supposed to help dying Canadians obtain otherwise- unavailable drugs on a “ compassionate” basis. An appeal to Health Minister Ujjal Dosanjh’s office was rejected in October.
Both Kerr and Forshaw went public as part of a campaign that has emerged as an early election issue in B. C., particularly in the Vancouver Centre riding that has one of Canada’s largest concentration of gays and lesbians – and a sizable group of people with AIDS.
Liberal MP Hedy Fry, her highprofile opponent Svend Robinson of the New Democratic Party, and Conservative Tony Fogarassy have all criticized Health Canada’s stand.
Even Dosanjh went public to say it isn’t logical for his department to deny Montaner the drugs under SAP.
Dosanjh, however, has said he’s forbidden under legislation to overrule on the matter.
Sharma has countered that SAP is for drugs close to the final approval process in Canada or overseas, after having undergone formal trials. SAP isn’t meant to circumvent the drug trials process, which is in the broader interest of all Canadians, she has said.
As a result, Sharma is fasttracking approval under a separate program that regulates the trials system.
“The government has laws in place to protect the health and safety of all Canadians. We must respect these laws,” Williams wrote.
“The best option for the five patients is a ‘ compassionate use trial’ that would require the overview of an ethics board, and would produce scientific results that can benefit all HIV patients in the future.” poneil1@hotmail. com