Whistleblower vows to fight on
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《英国医生杂志》
BMJ
A Canadian haematologist at the centre of a cause célèbre over academic freedom and research funded by a drug company vowed this week to continue her crusade after failing in her attempt to challenge the European marketing authorisation granted for the thalassaemia drug deferiprone.
Nancy Olivieri, professor of paediatrics and medicine at the University of Toronto, asked the European court of justice in Luxembourg to suspend the authorisation granted by the committee for proprietary and medicinal products (CPMP), the drug licensing body for the European Union.
Dr Olivieri, a specialist in thalassaemia, had been conducting trials on the drug in young patients when she broke a confidentiality agreement with Apotex, the Toronto based pharmaceutical company that owns the commercial rights to the drug. She went public with her belief that it was insufficiently effective and could cause liver damage in some patients.
In 1999 she launched proceedings to try to get the European marketing halted, but last month the court ruled she had no standing to challenge it and rejected her claim as inadmissible.
"The court did not proceed to an adjudication of any merits of the case but noted only that it finds that I lack sufficient `interest'—legally speaking—to challenge the completeness of the company's submission, or the correctness of any scientific assessment submitted by the CPMP," said Dr Olivieri.
"This ruling guarantees that only a drug company attempting to sell a drug will control the content of the scientific data submitted or not submitted to the European CPMP," she said. "It no longer matters whether drug companies tell the truth, the whole truth and nothing but the truth, because it's unchallengeable now."
Apotex removed her from the trials, and she was sacked from her job at the Hospital for Sick Children in Toronto, an appointment she held jointly with her academic post at the university. She was eventually reinstated at the hospital, but with a five year leave of absence.
Nancy Olivieri may appeal
Credit: TIBOR KOLLEY/THE GLOBE AND MAIL
Neither the hospital nor the university backed her in the dispute, but in 2001 a report into the affair, commissioned by the Canadian Association of University Teachers, concluded that her academic freedom was violated when the company stopped the trials and threatened legal action if she made her concerns public ( BMJ 2001;323: 1085; BMJ 1999;318: 77, BMJ 1999;318: 351).
Dr Olivieri said she was considering an appeal against the European court ruling. She has also launched a campaign against proposed changes to Canadian drug regulation laws, which she says will weaken the protections that Canadians now enjoy.
She is asking colleagues to sign an open letter urging the new Canadian prime minister, Paul Martin, to shelve plans for sweeping changes to regulatory laws. She argues that the changes would shift the existing burden of proof from the drug industry having to prove that products are safe to a presumption that they are safe unless harm has been proved.
Deferiprone is on the market in 29 countries, but not so far in the United States or Canada. It is marketed in the United Kingdom as Ferriprox. Fernando Tricta, medical director of Apotex, said: "The court's decision is a major victory for the treatment of thalassaemia patients."(Clare Dyer, legal corresp)
A Canadian haematologist at the centre of a cause célèbre over academic freedom and research funded by a drug company vowed this week to continue her crusade after failing in her attempt to challenge the European marketing authorisation granted for the thalassaemia drug deferiprone.
Nancy Olivieri, professor of paediatrics and medicine at the University of Toronto, asked the European court of justice in Luxembourg to suspend the authorisation granted by the committee for proprietary and medicinal products (CPMP), the drug licensing body for the European Union.
Dr Olivieri, a specialist in thalassaemia, had been conducting trials on the drug in young patients when she broke a confidentiality agreement with Apotex, the Toronto based pharmaceutical company that owns the commercial rights to the drug. She went public with her belief that it was insufficiently effective and could cause liver damage in some patients.
In 1999 she launched proceedings to try to get the European marketing halted, but last month the court ruled she had no standing to challenge it and rejected her claim as inadmissible.
"The court did not proceed to an adjudication of any merits of the case but noted only that it finds that I lack sufficient `interest'—legally speaking—to challenge the completeness of the company's submission, or the correctness of any scientific assessment submitted by the CPMP," said Dr Olivieri.
"This ruling guarantees that only a drug company attempting to sell a drug will control the content of the scientific data submitted or not submitted to the European CPMP," she said. "It no longer matters whether drug companies tell the truth, the whole truth and nothing but the truth, because it's unchallengeable now."
Apotex removed her from the trials, and she was sacked from her job at the Hospital for Sick Children in Toronto, an appointment she held jointly with her academic post at the university. She was eventually reinstated at the hospital, but with a five year leave of absence.
Nancy Olivieri may appeal
Credit: TIBOR KOLLEY/THE GLOBE AND MAIL
Neither the hospital nor the university backed her in the dispute, but in 2001 a report into the affair, commissioned by the Canadian Association of University Teachers, concluded that her academic freedom was violated when the company stopped the trials and threatened legal action if she made her concerns public ( BMJ 2001;323: 1085; BMJ 1999;318: 77, BMJ 1999;318: 351).
Dr Olivieri said she was considering an appeal against the European court ruling. She has also launched a campaign against proposed changes to Canadian drug regulation laws, which she says will weaken the protections that Canadians now enjoy.
She is asking colleagues to sign an open letter urging the new Canadian prime minister, Paul Martin, to shelve plans for sweeping changes to regulatory laws. She argues that the changes would shift the existing burden of proof from the drug industry having to prove that products are safe to a presumption that they are safe unless harm has been proved.
Deferiprone is on the market in 29 countries, but not so far in the United States or Canada. It is marketed in the United Kingdom as Ferriprox. Fernando Tricta, medical director of Apotex, said: "The court's decision is a major victory for the treatment of thalassaemia patients."(Clare Dyer, legal corresp)