A group of five AIDS victims who have been trying to gain special access to the much sought unapproved anti- HIV drugs (TMC 114 and TMC 125) can now rejoice as the Health Canada has now issued the medication in what can be considered as a rare clinical trial.
Dr. Montaner, an AIDS drugs specialist with the B.C. Centre for Excellence in HIV/AIDS at St. Paul's Hospital has been trying hard to bring the two unapproved drugs into Canada as a special case. He had even submitted an application to Health Canada in this regard. A special access program that is designed to get unapproved drugs to terminally ill patients was his only hope.
Advertisement"We started nine months ago looking for treatment. 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," said Montaner.
Health Canada however refused the request on grounds of inadequate data regarding the synergistic effect of the two drugs. Following this, the doctor and his team sought the help of media and politicians. Unable to withstand the pressure, it has been decided to provide the patients with the drug under a unique approach, a clinical trial.
The chair of St. Paul's ethical-review board that approved the protocol has requested for minor changes to be incorporated in the patient consent forms. The clinical trail is believed to ensure better monitoring of the five patients. A contract would soon by signed between the hospital and the drug supplier, Tibotec Inc., which has agreed to provide the drug free of cost.
The drug is hoped to reach the patients in the coming year. One of the proposed recipient, B.C. artist Tiko Kerr has expressed his feelings of joy following the announcement. He his nervous system has already been affected. Infact he has already lost sensation in his feet and one hand. He manages to do painting with the other hand in which there is some sensation preserved.
Health Minister Ujjal Dosanjh has also been very active in ensuring drug supply to the victims. He met another patient, Paul Lewand, chairman of the B.C. Persons with AIDS Society. While the whole world visualises a hopeless end for AIDS victims, this move is expected to infuse an endless hope amongst the five victims.