Health Minister attacks makers of Vioxx

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Health Minister attacks makers of Vioxx

Dosanjh says Merck withheld safety data

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By CAROLYN ABRAHAM

 

Friday, February 25, 2005 Updated at 2:57 PM EST

 

MEDICAL REPORTER

 

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. "