New FDA review of NSAID cardiovascular risk inconclusive

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New FDA review of NSAID cardiovascular risk inconclusive



Feb 10, 2006



Gandey



Gaithersburg, MD - Presenting findings from its latest review of

nonsteroidal anti-inflammatory drug (NSAID) data, the US Food and

Drug Administration reported today that the cardiovascular risks

associated with traditional NSAIDs are unclear. But the agency stands

behind recent black-box warnings on the products, arguing that the

move was based on stronger evidence than this new analysis.

The data, newly collected by the agency from NSAID manufacturers, was

presented this morning during a meeting of the drug safety and risk

management advisory committee. The agency's Dr Sharon Hertz admitted

that none of the studies evaluated in this new review were designed

to assess cardiovascular risk, the duration of study was short, and

the samples were small.

" You can't conclude very much on the basis of these data, " Dr Curt

Furberg (Wake Forest University, Winston-Salem, NC) said during the

meeting. " It would seem that the scientific data on traditional

NSAIDs are weak. "

Hertz responded that this new review was an effort by the FDA to

update and further clarify the issue, but the data were admittedly

limited. " In previous analyses, we were able to look at the largest

studies, which had traditional NSAIDs as comparators. " It is on the

basis of these studies that the agency recommended subsequent black-

box warnings.



" You can't conclude very much on the basis of these data. "



This decision has been hotly contested by the American College of

Rheumatology (ACR). " This FDA decision has caused unnecessary alarm

on the part of the public and necessitated hours of time from

physicians and other healthcare providers, who must reassure and

educate their patients, " members of the ACR executive committee wrote

in a letter to the agency last April. " Much more research is needed

in this area before such strong warnings are included with these

medications. "

Responding to physician concerns around the time the ACR letter was

written, FDA committee member Dr Hoffman (Cleveland Clinic, OH)

said, " Before we feel that the FDA has done an injustice in

responding to public pressure, my perspective is a little different.

I think the FDA has responded to the data, and I think it made a

conservative and informed decision. And the next steps, in terms of

whether that's good or bad for patients, I think we'll have to see—

and our impressions really should be data based. "

Make new drug safety oversight board more transparent, committee urges

The advisory committee heard from the new Drug Safety Oversight

Board, which was convened in the wake of the Vioxx scandal. " You are

doing a good, competent job, but you are setting yourself up for

failure, " warned committee chair Dr Gross (Hackensack

University Medical School, NJ). " In an age of transparency, you have

no public representatives. "



" It seems to me that we could do with some sunshine on the activities

of this board. "



Committee members also complained about the board's closed-door

policy. Board presenter Dr Cummins said that her group deals

with sensitive issues and confidential proprietary information that

make it impossible for public meetings.

" It is unfortunate that proprietary information would inhibit public

participation, " said Dr Arthur Levin (Center for Medical Consumers,

NY). " It seems to me that we could do with some sunshine on the

activities of this board. "

The committee also questioned whether the board should be given a new

name. According to Cummins, her group focuses on the internal

workings of the FDA's Center for Drug Evaluation and weighs how

messages are communicated to the public. Since it is focused on

central management, committee members wondered why the board is

referred to as a drug safety initiative. " I agree that the name is

misleading, " Levin said.

Bolster FDA authority, others say

Furberg argues that regulators need more power to address safety

concerns. He calls the current situation " disturbing. " Under the

present system, regulators negotiate with manufacturers to make changes.

" The agency really has no authority to go after companies, " Furberg

said. " Discussions over safety issues can go on for a month or a

year, and that's unacceptable. " He adds that the situation is even

worse for postmarketing studies, which, more often than not, are

never completed.

Dr Sheldon Krimsky (Tufts University, Medford, MA), an outspoken

critic of the FDA, agrees that reform is needed. " This a federal

agency, and it shouldn't be in the business of negotiating with

companies. " Krimsky says he would like to see the agency

depoliticized and stiffer regulations put in place for the reporting

of adverse effects. " Japan has a national law on adverse effects in

place that we should be looking at. "

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