About six months ago Paul Lewand, chair of BC Persons with AIDS Society (BCPWA), learned from Dr Julio Montaner, clinical director of the BC Centre for Excellence in HIV/AIDS, that his drug treatment plan was not working.
Montaner told Lewand that he was very hopeful a new drug combination would help. All they needed was to wait for Health Canada to approve the new therapy. Lewand was prepared to wait, but was confounded when he learned that the application for access to the drugs was rejected.
“[Health Canada’s] final reason really was that because there isn’t proof that this is a safe combination to use, they will simply not even allow us to try,” he remembers. “That [decision] made absolutely no sense.”
The ruling equally confuses Montaner. “I would ask them what’s the worst side effect that an HIV person can expect, dying from HIV or taking a chance with drugs that otherwise have done very well in preliminary clinical trials?” he poses seriously. “It baffles me why at this time, they are not willing to make these drugs available on compassionate grounds to people whose lives are in danger.”
On World AIDS Day, Montaner carefully wends his way through a crowded room of reporters and news cameras at The Dr Peter Centre. He joins Lewand; Svend Robinson, the New Democratic Party candidate for Vancouver Centre; and Tiko Kerr, an internationally renowned Vancouver artist. They’re holding a news conference to publicly demand that federal Minister of Health Ujjal Dosanjh overturn the ruling by members of his staff at Health Canada to deny access to the drugs.
The minister has not yet overturned his department’s ruling. “Much as he’s sympathetic, much as he supports the request of Dr Montaner, he said his hands are tied,” Robinson outlines.
The federal Food and Drugs Act contains a specific provision that gives physicians the right to ask for access to experimental drugs. It’s called the Special Access Program (SAP).
According to the Ministry of Health, this program allows medical practitioners to request access to drugs that are unavailable for sale in Canada. The access is limited to patients with a serious or life-threatening condition on a compassionate or emergency basis when conventional therapies have failed, are unsuitable or unavailable.
Montaner requested access to the drugs in the spring of this year under SAP. “In all honesty this has been a very frustrating process,” he says.
“What is the purpose of the Special Access Program if not to respond precisely to Dr Montaner’s request for Tiko Kerr, Paul Lewand and three other people who are living with AIDS?” questions Robinson.
The drugs under consideration are both in phase two of their clinical development. One, TMC 114 is a protease inhibitor, and the other TMC 125 is a non-nucleoside reverse transcriptase inhibitor. Montaner thinks combining these drugs are the best chance left to help these men. It has never been done before in Canada, but he believes that it may make a difference.
To illustrate the urgency of this request Montaner recounts that, “these individuals over the last year have run out of options. Their lives are in danger. The proof of that is that one of [them] has already died from [the disease’s] progression.”
“The song and dance that Health Canada has brought up has confused everyone involved because their reasoning has been unreasonable,” offers Kerr who earlier in the day made a donation of one of his paintings to The Dr Peter Centre.
“I would like to continue to do good deeds in my community. Now that I have no drugs to ward off a very good possibility of certain death with AIDS, what do I do now Mr Dosanjh?” an anguished Kerr enquires.
Reached by telephone, Dosanjh responds, “Look, from my perspective as a lay person, I believe that these two individuals should get the drugs that they are asking for under the supervision of the doctor in question. I have said that to Dr Montaner, and I have said that for several days.”
“[Receiving the medication is] the logical thing to do. These people are facing certain death over time, and if these two medications together help them even a little bit, who are we to say it might endanger their lives? Their lives are in danger in any event,” he states.
However, he then adds that, “I have been given a legal opinion that the authority for the Special Access Program is embedded in the legislation, therefore, [the decision] at this point is impossible to change.”
He then explains that, “If I had been given a different legal opinion, you would have seen some action. No one should believe that I am any less sensitive to these fundamental issues of life and death than anybody else.”
Montaner demonstrates his frustration by offering, “that after a lengthy discussion with the bureaucracy, and the ministry, we are now hearing that the political arm of the government is saying that the request is sound, and they would like to see a mechanism for the drugs to become available. The actual mechanism that is in place, for some reason, is being blocked by the bureaucracy in a way that is unacceptable.”
He then includes, “that this is no longer about Tiko and Paul. This is an issue that goes beyond them and is of interest to all Canadians. We need to wonder to ourselves, ‘Who is running the show?'”
Robinson believes that, “The minister is wrong. He has the power to tell his assistant deputy minister to issue these drugs. If there is any remaining doubt, here’s what [The Department of Health Act] says, ‘The powers of the minister include the administration of acts, orders and regulations relating in any way to the health of the people of Canada.'”
“What do we have to lose here?’ he queries. “The minister has to show leadership. The lives of five British Columbians are on the line.”