Theglobeandmail.com
By CAROLYN ABRAHAM MEDICAL REPORTER
Friday, February 25, 2005 Updated at 2:57 PM EST
Dosanjh says Merck withheld safety data
Canada’s Health Minister has accused the makers of Vioxx of holding back safety data from drug regulators in the months after the company yanked its blockbuster painkiller off the market.
“I can tell you that I am extremely concerned and disappointed with Merck [Frosst Canada] withholding data from Health Canada, even after it pulled the drug. I think they have an obligation and they have some explaining to do,” Ujjal Dosanjh said yesterday in an interview with The Globe and Mail.
The minister said that as a result he is contemplating new legislation to give Health Canada the power to force companies to hand over information as the drug regulator requests it.
“I am not satisfied with the responses that Merck has given,” he said. “I want to make sure that they understand that I take it very seriously, and I will, in fact, regardless of whether or not they provide us with information, I would try and have legislation developed . . . to deal with that vacuum of authority.”
Mr. Dosanjh slammed Merck for its “attitude” in correspondence related to Vioxx, citing letters and conversation between the company and the federal department in recent efforts to gain access to safety information.
“I was very, very concerned at the attitude that Merck had taken,” the minister said. “They have not provided us the details that we have sought from them, the information that we have sought from them.”
Mr. Dosanjh was speaking in reference to data Health Canada has sought after Merck’s withdrawal of Vioxx from the market worldwide on Sept. 30.
That decision came after the company learned that one of its clinical trials showed the drug doubled the risk of heart attack and stroke.
Last November, Health Canada sent Merck a lengthy request for the raw study data that led to the withdrawal. But department spokeswoman Jirina Vlk said yesterday the data still have not been received.
Only a study summary, she said, arrived last week in the run-up to the U.S. Food and Drug Administration hearings into the heart safety of Vioxx and similar pain relievers.
A spokesperson from Merck could not be reached for comment yesterday. “We need to take a look at what new authority we need to compel information like that when co-operation is not readily forthcoming,” the Health Minister said.
Mr. Dosanjh explained that what he saw as a stalemate between Merck and Health Canada troubled him from a broad perspective: “When we say to a pharmaceutical [company] you can come into our market, we will give you the patent and the patent protection, you can sell within our jurisdiction, then they have an obligation to provide us with information that we require from time to time. . . .”
The minister’s comments offer important insight into how negotiations between Merck and Health Canada may have proceeded before the withdrawal of Vioxx, which was among the top 10 selling drugs in the country during its five years on the market.
A recent Globe investigation into the events that preceded the Vioxx withdrawal showed Merck had protracted debates about the cardiovascular side effects of its drug with FDA regulators in the United States. FDA documents show the agency repeatedly, and unsuccessfully, calling for a heart-safety study of the drug.
Exactly how Health Canada, which waited two years before issuing any public advisory about the drug’s heart-attack risks, handled the file so far remains a mystery. The department has said Vioxx-related lawsuits against it prevent it from answering key questions.
But Mr. Dosanjh said yesterday that he believes in “the public right to know.”
He said he asked last week for Health Canada to reconsider releasing its files on the matter, which he noted he has not seen.
“I have asked them to take a look at their whole file and release all of what they can release,” he said. “They’re looking at it, they’re working on it.”
The minister said that this week’s budget gives Health Canada $170-million (out of a total of $805-million) to spend on drug safety.
He said he plans a sweeping overhaul of the way the department handles drugs, from how they are approved, to the prospect of conditional drug approvals, to post-market surveillance of adverse side effects.
“I want to defend the department while I prepare to challenge it as well. I think it’s important that we recognize that these are difficult issues and there are good people who work in the department, who work very hard, but we need to do things differently.”
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