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Special Access Request for TMC114 & 125
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"Decision expected today on AIDS drug clinical trial"
By JONATHAN WOODWARD
Tuesday, December 6, 2005
Posted at 4:13 PM EST
theglobeandmail.com
VANCOUVER -- A European drug manufacturer could decide as early as today whether to work with Health Canada to provide unapproved AIDS drugs to five men in a rare clinical trial.
The decision on whether the company will supply the drug under Health Canada's rules for the trial is the final hurdle for Dr. Julio Montaner, who has been trying to get his patients the drugs for months after a request to get them through a different Health Canada program was denied.
The decision by Belgium-based Tibotec Inc. could set in motion a chain of events that will give the patients, including B.C. artist Tiko Kerr and Anglican priest Michael Forshaw, two cutting-edge antiretroviral drugs within a week.
"The moment the company says yes, we'll approve the mechanism; then I'm ready to roll," Dr. Montaner said yesterday.
If Tibotec decides to supply AIDS drugs TMC 114 and TMC 125, Dr. Montaner said he'll submit his plan for the clinical trial to Health Canada for formal approval.
Both the government department and Dr. Montaner's ethics board at St. Paul's hospital have said they can review the proposal and approve it within days.
It's good news, says Dr. Montaner, but it's unnecessary paperwork for a company that had already agreed to provide drugs to the patients under Health Canada's special-access program, which provides drugs to Canadians with deadly ailments for which approved drugs offer no help.
Health Canada denied the request this year, saying that although the six men were dying and although there was information about how the two drugs worked independently, no study shows how they work together -- and that could be toxic.
One of the six men has since died. Dr. Montaner and two of the patients went public to press the department to act.
Health Minister Ujjal Dosanjh said the department should provide the drugs, although critics say he didn't do enough.
Under pressure, Health Canada proposed a rarely used compassionate clinical trial, which gives the drugs to the patients but requires more oversight and data collection than the special-access program.
Although 30,000 requests are granted each year under the program, only one person last year got drugs through a compassionate clinical trial, Dr. Supriya Sharma of Health Canada said.
Dr. Sharma sent Dr. Montaner a letter on the weekend to promise the department would approve the trial as quickly as it could.
But Mr. Kerr, the ailing artist, said the process was taking too long and the bureaucracy was making more delays by forcing the patients to go through extra paperwork."
He said Health Canada is making Dr. Montaner jump through hoops to deal with a protocol he's already completed.
"Health Canada is playing the coward, here," he said. "It's laughable that these people who aren't elected officials are playing games with people's lives. They're shirking all of their responsibility in absolutely every direction here.
"It's such a futile situation, and I'm glad things are moving. But things are only moving because we're applying political pressure, and they're only moving for us because we've gone public. It shouldn't have to take that."
Tibotec's Canadian spokeswoman, Alexandra Gillespie, said the company is considering the request. "We'll do what we can to the extent Health Canada allows," she said.
Ms. Gillespie said both drugs are in the process of phase-three testing, during which a large number of test subjects are randomly given the new treatment and their reaction is compared to people taking an old treatment.
The two drugs will be tested in combination early next year, she said.
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