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Vioxx makers 'perplexed' by Dosanjh's remarks

MEDICAL REPORTER

The makers of the popular painkiller Vioxx say they are "perplexed" by harsh allegations from the federal Health Minister that they have withheld safety data from the Canadian government.

A day after Ujjal Dosanjh criticized Merck Frosst Canada in The Globe and Mail, saying it failed to turn over safety data related to Vioxx, the company said in a statement that "it has at all times and continues to co-operate with Health Canada."

The controversy involves the raw data from the study that prompted Merck to pull Vioxx from world markets last September after finding it increased the risk of heart attacks and strokes twofold.

Health Canada officials say they have been waiting since last November for the information.

But Merck Frosst spokeswoman Marlene Gauthier said yesterday that Health Canada asked for information it already had, such as monthly adverse-event reports, as well as information that is not yet available.

She said the raw data from the study that led to the Vioxx withdrawal will not be fully compiled until April.

In a statement, Ms. Gauthier added: "The Company responded in writing to Health Canada's request for information and has offered to meet with Health Canada officials at their convenience. We had not received any verbal or written feedback to our letter until we saw the Minister's comments in the newspaper."

Mr. Dosanjh had told The Globe that he is considering boosting Health Canada's legal authority to force a drug company to turn over information the department requests.

Relations between Merck and federal drug regulators could become important should the company ever try to return Vioxx to the Canadian market, where more than 15 million prescriptions were dispensed since it was introduced in 1999. Health Canada has not yet determined if it would allow such a move.

But a panel of the U.S. Food and Drug Administration voted last week to allow the possible return of Vioxx provided it carries a striking black-box warning on its label about its cardiovascular risks, and patients who take it sign consent forms.

The panel also voted to allow other painkillers manufactured in the same class of medication as Vioxx, known as cox-2 drugs, such as Celebrex and Bextra, to remain on the market in the United States despite their known heart risks, so long as they also carry a black-box warning on their labels.

The New York Times reported yesterday that 10 of the 32 panel members who endorsed continued marketing of the drugs had consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records.

The 10 advisers with company ties voted 9-1 to keep Bextra on the market and 9-1 for Vioxx's return. The votes of the 10 did not substantially influence the committee's decision on Celebrex because only one committee member voted that it should be withdrawn.

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