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AIDS Activists to Ottawa:  Shorten drug approval time.
 

AIDS activists are challenging the federal government to reduce the time required to approve new drugs and make the approval process more transparent.

"The government has turned a blind eye to those of us with AIDS by not allowing us to have the drugs we need," Louise Binder, Chair of the Canadian Treatment Advocates Council, told Reuters.

"Unlike the US, the government here is secretive and won't give us any information about their drug approval process, or account for the months of 'dead time' where drug applications sit and collect dust.  Meanwhile, our lives could be slipping away," she continued.

The comments were made during an international pharmaceutical conference in Ottawa.

But people in need of treatment were not the only ones issuing the challenge to Health Canada.  AIDS physicians and bureaucrats within the Ministry itself spoke out as well at the summit.

"Can you imagine that Canadian AIDS patients were using nevirapine during clinical trials conducted in Canada by Canadian researchers?" asked specialist Dr. Mark Wainberg of Montreal.  "Yet filing dates for the compound were made in Canada 110 days after they were in the US, and the drug was approved here 28 months after it was already available in the US," he added.

"That is not helping the morale of the patients or scientists," the physician, who is president of the International AIDS society, declared.

Dr. Wainberg went on to state that the time take by Health Canada's approval process for new drugs such as protease inhibitors is almost double that of the American Food and Drug Administration (FDA).  He accused the federal government of creating a "scientific brain drain" through indifference and lack of support.

Dann Michols, head of the Therapeutic Products Program at Health Canada, agreed.

"What am I supposed to do when our budget was cut 50%?" he asked.  He claimed that the increase in staff by the American FDA, as part of that agency's successful effort to reduce approval time, represents a cost greater than his entire budget.

Jane Axelrad, Associate Director for Drug Evaluation and Research with the FDA, attended the conference and presented the methods that agency used to reduce its drug approval time from 2-years to 1-year without endangering consumers or resulting in a rise in recall rates.  'Fast track' drug applications can now be processed in 6-months' time.

She explained, however, that the changes in process methods required 5-years to complete and that the improvements are partially financed by filing fees levied to the pharmaceutical companies.

Mr. Michols of Health Canada said a restoration of the budget from the ministry and Health Minister Allen Rock was necessary.