After months of denying a group of men dying of AIDS special access to unapproved drugs, Health Canada yesterday gave them the medication in a rare clinical trial.
Politicians of all stripes called for a review of the regulations that some say prevented elected officials from overruling the department's earlier decision, while the doctor who originally sought the drugs for six patients blasted the process that entangled them in red tape.
"We started nine months ago looking for treatment," said Julio Montaner, an AIDS drugs specialist with the B.C. Centre for Excellence in HIV/AIDS at St. Paul's Hospital. "In that time, unfortunately, one [of the six men]has died.
"We need to make sure we do the best for the patients at all times and not get hung up on unnecessary bureaucratic delays."
Dr. Montaner applied earlier this year to bring two unapproved anti-retroviral drugs into Canada -- TMC 114 and TMC 125 -- through Health Canada's special access program, which is designed to get unapproved drugs to otherwise terminal patients.
But Health Canada denied that request, saying that while there were data on how the two drugs worked independently, not enough information was available on how they worked together.
In early December, Dr. Montaner and three of his patients went public with their demands. Under pressure from the media and politicians, the department wrote to them saying it would use a different mechanism: a clinical trial.
That way, Health Canada could gather that data while the drugs were administered together, spokesman Christopher Williams said.
"This is about protecting the patients involved," he said.
But Dr. Montaner said he would have monitored his patients anyway. "This is a special access program in all but name," he said.
The chair of St. Paul's ethical-review board has approved Dr. Montaner's protocol, but has asked for minor changes to patient consent forms that hospital representatives say could be completed in a day.
The company that supplies the drugs, Belgian-based Tibotec Inc., has said it will provide them free, but still has to sign a contract with the hospital and ship them from the United States.
Dr. Montaner estimated the patients would start taking the drugs in the new year.
One of the five men, B.C. artist Tiko Kerr, said he is elated.
"I've been listening to 'any day now, any day now,' so I'm not holding my breath," he said. "But really, it could be any day now."
Mr. Kerr said the disease has attacked his nervous system and robbed him of feeling in his feet. In the months since Dr. Montaner told him his AIDS drugs weren't working, he has lost the feeling in one hand as well -- but not the hand that he paints with, he said.
"Thank God, I've been able to do my art," he said. "Maybe this will stop the disintegration and turn it around."
Health Minister Ujjal Dosanjh has said he couldn't order his ministry to give the drugs because the power rested in the assistant deputy minister.
"Politicians aren't medical scientists. Some of their staff are," he said.
Earlier in the day, Mr. Dosanjh met another patient, Paul Lewand, chairman of the B.C. Persons with AIDS Society, outside his campaign office in Vancouver.
Mr. Lewand led a protest at which Santa and his elves laid five coffins at the doorstep of the office to symbolize the men whose lives were at stake.
Hedy Fry, the Liberal candidate for Vancouver Centre, said that it's a clinical decision to mix two drugs, not a bureaucratic one, and that decision should be left to doctors.
"We will change the procedure that's in place . . . to let the Minister of Health override where necessary and only with very clear expert clinical advice . . . so this won't happen again," she said.
Svend Robinson, the NDP candidate for Vancouver Centre, said that the special access program wasn't doing what it was designed to do in the 1980s: give AIDS patients access to new drugs.
"If I'm elected in Vancouver Centre, the first thing I will do is ask the standing committee on health to look at how this SAP program is working and how it isn't," he said.
Mr. Dosanjh could have stepped in earlier under the existing laws, he said.
Mr. Kerr says he's glad to get the drugs, but knows what he's going to do if they don't change his deteriorating condition.
"I'll keep going as I have been for 20 years," he said. "Live every moment, give what I can to the community, and enjoy my life."