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By CAROLYN ABRAHAM
Friday, February 25, 2005 - Page A2
Ottawa: 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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