MEDICINE

An abrupt reversal

People with AIDS can get untested drugs

MARK NICHOLS March 13 1989
MEDICINE

An abrupt reversal

People with AIDS can get untested drugs

MARK NICHOLS March 13 1989

An abrupt reversal

MEDICINE

People with AIDS can get untested drugs

Since scientists first diagnosed AIDS eight years ago, only two drugs— alpha-interferon and pentamidine— that can be used to treat the deadly disease or its related conditions have received approval for use in Canada, both only since the start of the year. When people with AIDS tried to obtain drugs used in other countries—but not yet approved for use in Canada—officials in Ottawa’s emergency drug-release program routinely rejected their appeals. But now, in a dramatic reversal, federal officials have announced that patients with AIDS will be able to obtain drugs before they are officially approved—provided that manufacturers are willing to donate or at least sell them from their scarce supplies. While AIDS patients hailed the new policy, it raised issues about practices within the federal department of health and welfare. In Ottawa, officials said that under an existing 22-year-old policy, patients with any potentially fatal disease should have been able

to obtain drugs before they were officially approved. In fact, more than 2,000 requests for such drugs were approved last year for heartdisease and cancer sufferers. But Michèle BrillEdwards, acting assistant director of the emergency drug-release program, acknowledged that in the past officials responsible for releasing AIDS drugs were too “bureaucratic.”

The policy change—announced in the health protection branch’s newsletter last month— will likely mean the end of car pools organized by Canadians with AIDS who travelled to U.S. border cities with prescriptions written by Canadian doctors for AIDS drugs that were unavailable in Canada. The policy shift also represented a victory for Canadian AIDS groups, which have been lobbying since February, 1988, for federal officials to make available drugs that have proven effective in treating Europeans with AIDS but that had been held up by clinical testing procedures in Canada.

The past refusal of federal officials to release unapproved AIDS drugs to patients appeared to have been based on bureaucratic caution—as well as concerns about undermining existing drug trials. Brill-Edwards said that to test most new drugs, medical researchers administer the drug to some patients and a placebo—a nonmedicinal capsule—to others, without the patients knowing which they are receiving. AIDS spokesmen argued

that it was unethical to give placebos to dying people. But in the past, federal officials said that they were worried that if people with AIDS could obtain new drugs through their doctors, fewer volunteers would be available for testing. At the same time, Dr. Philip Berger, a Toronto physician who treats AIDS patients, said that federal officials tended to be “extremely conservative and they assume that a patient has no right of access to medication.”

For her part, Brill-Edwards said that Ottawa’s policy shift followed a shakeup of officials in the emergency drug-release program, with some personnel who had been handling the program being given new jobs. She said that under the 22-year-old policy that allowed unapproved drugs to be released to some patients, actual decisions were at the discretion of federal officials. The denial of such requests, she said, “may also have become a routine thing rather than each case being treated individually.” She added, “There is a problem of being scientifically rational when you have an illness that may be fatal.”

The issue of Ottawa’s policy on unapproved drugs came to a head partly as a result of a campaign by AIDS groups that wanted the drug pentamidine made available in Canada after U.S. and European studies showed that in aerosol form it could help prevent pneumocystis carinii pneumonia, an infection that has killed more than half of the 1,338 Canadians who have died of AIDS. Dr. Michael Hulton, a Toronto anesthetist, said that when he tried to get permission from Health and Welfare to use the drug for the prevention of that strain of pneumonia, he was always denied. Federal officials finally approved pentamidine for use in Canada last month, and the drug is expected to be for sale in most parts of Canada by April 10.

The thrust of last month’s federal letter clearly showed the growing influence of those lobbying on behalf of people with AIDS. The letter said that physicians requesting use of an unapproved drug for their patients would only have to provide the initials, age, sex and diagnosis of the victims. As well as the policy reversal, the newsletter announced a series of measures to expedite the clinical testing of anti-AIDS drugs. “This is highly significant,” said Hulton. “It not only makes drugs available, it means that people are not forced into clinical trials using placebos. AIDS is tragic enough.”

Spokesmen for AIDS groups expressed relief that victims would now be able to obtain drugs not yet approved in Canada, including ansamycin and dextran sulphate, which are both used to treat AIDS, “AIDS is potentially fatal,” said Timothy McCaskell, chairman of Torontobased AIDS Action Now. “But it is also potentially only chronic and potentially controllable.” Still, Brill-Edwards cautioned that patients who use an unapproved drug will do so at their own risk. “If you wish to use it,” said Brill-Edwards, “that’s your medical judgment.” For patients locked in a losing battle with AIDS, those risks will likely prove well worth taking.

MARK NICHOLS with NORA UNDERWOOD in Toronto

NORA UNDERWOOD