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Report clears researcher who broke
drug company agreement
by David Spurgeon, Quebec
November 10, 2001
A new report has urged Canada's federal government to do more to curb
attempts by pharmaceutical companies to influence the conduct and publication
of clinical studies carried out by researchers into their products.
The report, commissioned by the Canadian Association of University Teachers,
follows a four year dispute at the Toronto Hospital for Sick Children,
centring on attempts by a drug company to prevent publication of results of a
trial that were unfavourable in relation to one of its products.
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The dispute began after researcher Dr Nancy Olivieri decided to break a
confidentiality agreement with Apotex, a Toronto based pharmaceutical company
that was sponsoring her research. She published results critical of the drug
deferiprone, which she was testing in young patients with thalassaemia, in
the New England Journal of Medicine (1998;339:417-23).
Dr Olivieri, former head of the hospital's haemoglobinopathy programme, was
threatened with legal action by Apotex and also removed from her hospital
post, though she was later reinstated (BMJ 1999;318:351).
Now a report into the affair, commissioned by the academic tenure and freedom
committee of the Canadian Association of University Teachers in 1999, has
exonerated her. It concluded that Dr Olivieri's academic freedom was violated
when the pharmaceutical firm Apotex stopped the trials and threatened legal
action if she went public with her fears about deferiprone.
Reacting to the report, Dr Olivieri said in an article in the Toronto
Globe and Mail newspaper that neither the hospital nor the university,
"both anticipating large donations from Apotex, supported me in
fulfilling my ethical obligations to my patients or my scientific obligations
to the public."
She said the report confirmed that, after her announcement of her findings,
she experienced "five years of personal vilifications, reprisals and
harassment."
In major respects the report contradicts a previous report commissioned by
the Hospital for Sick Children that said that the hospital had done nothing
wrong, although it called for changes in hospital policies and procedures
(BMJ 1999; 318:77).
In a news release (www.caut.ca) James Turk, executive director of the
university teachers association, called for immediate action so that
researchers' ethical duties, academic freedom, the rights of patients, and
the public interest should "never again be compromised in this
way."
Mr Turk said it was essential that medical faculty be given the same rights
of academic freedom as all other faculties. He charged that the University of
Toronto was currently in negotiations with its teaching hospitals over an
alternative funding arrangement "that would strip clinical faculty of
academic freedom."
One of the study's three authors, Jocelyn Downie of Dalhousie University,
said her greatest concern was "the fact that this is not an isolated
incident." She added: "These incidents are happening across the
country. We have a clear need for national standards to be implemented and
applied... so that people can be protected."
The Hospital for Sick Children issued a statement saying that it had already
conducted "a full, thorough investigation" of the issues arising
from the affair and noting that neither it nor the University of Toronto
participated in the association's review.
"This dispute is closed and attempts to revive it are
counterproductive," the hospital wrote in its statement
(www.sickkids.on.ca). In the three years since the completion of its own
investigation the hospital had "implemented an entirely new policy
structure governing clinical research in the hospital," it said.
"The new policies ensure that the relationship between clinicians and
those who provide financial support for research is clear."
The hospital said that the Canadian Association of University Teachers was an
association representing faculty unions and did not represent doctors at the
hospital. It added that the Canadian university teachers' association did not
"have any standing when it comes to clinical research, patient care,
personnel or human resources issues at Sick Kids or any other teaching
hospital." The University of Toronto's statement said the new study
"does not add any substantial information on the case."
Susan Bloch-Nevitte, the university's public affairs director, said that
since the report was commissioned by the hospital, the university had moved
forward to implement its recommendations (www.newsandevents.utoronto.ca)
The University of Toronto "reached an agreement in March with its
teaching hospitals to harmonise research policies and enforce stringent
ethical guidelines and public accountability in research. Under the new
agreement, peer review remains the cornerstone of excellence in research, and
it notes that scientists should have the right to disseminate the results of
their findings. No agreements will be negotiated that allow research sponsors
to suppress or censor research results."
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