DRUG AGENCY SECRECY BLASTED

'Open the books' on pharmaceutical approvals, doctor says

OTTAWA (CP) - Tight secrecy at Health Canada's protection branch is
fuelling suspicion that drug companies have too much influence over drug
approvals in Canada, a prominent researcher says.

It is almost impossible for doctors or consumers to obtain information used
to assess the safety and effectiveness of new drugs, says Dr. Joel Lexchin
in the current issue of the Canadian Medical Association Journal.

The information void could lead to inappropriate and hazardous usage of
medicines, says Lexchin, who is affiliated with Toronto Hospital and the
University of Toronto.

"We have created a system whereby nobody can get access to the data -
health professionals, patients or anybody," he said in an interview.

The therapeutic products directorate, the arm of the health protection
branch that regulates drugs, gets 70 per cent of its financing from fees
paid by pharmaceutical firms and other companies, he noted.

"Right now, if you're a cynic, you could say: 'Whenever this agency makes a
questionable decision, they're going to favour the drug companies because
of the golden rule - he who has the gold makes the rules.' If the (health
protection branch) wants to counter that argument, the best way they can do
it is by opening the books."

Dann Michols, director-general of the therapeutic products directorate,
said he has sympathy for Lexchin's concerns, but the agency must comply
with the federal Access to Information Act.

Under the act, data submitted to government by a drug manufacturer is
considered proprietary information and can be released only with the
manufacturer's consent.

"The feeling from Dr. Lexchin's article is that we are not interested in
more openness and transparency and that is the farthest thing from the
truth," said Michols.

"There are quite legitimate reasons for some of the protections offered by
the system and our activities have been to see if we can't work out some
compromise."

Michols said the people who conduct drug reviews have nothing to do with
agency financing and every major drug regulatory authority in the world
uses a similar approach to recover costs from manufacturers.

Michele Brill-Edwards, who resigned from the agency in 1996, said Lexchin's
concerns are well-founded.

When she was there, she said, staffers were told to consider drug
manufacturers as clients.

She said she resigned because she believed the agency was ignoring evidence
that cast doubt on the effectiveness of a widely used heart drug.

"My concern was that neither the public nor Canadian doctors had any way of
knowing that the reassurances of Health Canada (about the effectiveness of
the drug) were hollow."

Derek Kent, a spokesperson for Health Minister Allan Rock, noted the future
of the health protection branch is under review.

He said access to drug information will be one of the issues up for public
consultation this fall.

Checked-by: Pat Dolan