FDA conflicts screened, but not removed

[Guest guest]

[Even though there were people with clear conflicts of interest on the

Vioxx review panel, they were still allowed to participate.]

 

FDA Says It Screened Merck, Pfizer Drug Panelists for Conflicts

http://www.bloomberg.com/apps/news?pid=10000103 & sid=anvrTAdDIXrU & refer=us

 

Feb. 26 2005 (Bloomberg) -- The U.S. Food and Drug Administration said it

screened doctors and scientists for conflicts of interest when the agency

named a committee to rule on the safety of pain drugs made by Merck & Co.

and Pfizer Inc.

 

A 32-member committee voted Feb. 18 that the benefits of Merck's Vioxx and

Pfizer's Celebrex and Bextra outweighed the risk of cardiac damage for

patients taking them. The New York Times reported yesterday that 10

panelists had financial ties to the two companies and a third maker of

similar medicines, Novartis AG. Without their votes, the findings would

have been reversed for Vioxx and Bextra, the newspaper said.

 

``The advisory committee members and expert consultants were screened for

conflicts of interest according to the same strict ethics guidelines FDA

applies to all its advisory committees,'' said Sheila Dearybury Walcoff,

the FDA's associate commissioner for external relations, in an e-mailed

statement yesterday.

 

The Center for Science in the Public Interest, a Washington consumer

advocacy group, said it evaluated affiliations disclosed by the 32

committee members at the request of the Times, which didn't name all of

those identified as having ties to the companies. The analysis found 17

additional panelists with other links to drugmakers, including three to

Merck or Pfizer that ``were deemed to be too old to be relevant,'' the

center said.

 

In a list made available to Bloomberg, the group named the 27 advisers and

their links to New York-based Pfizer, the world's biggest drugmaker;

Whitehouse Station, New Jersey-based Merck, which withdrew Vioxx Sept. 30;

Basel, Switzerland-based Novartis, maker of the painkiller Prexige; and

other drugmakers.

 

FDA Process

 

Inclusion of the 10 with financial ties to the makers of pain drugs ``would

appear to be a direct violation of the Federal Advisory Committee Act,

which prohibits scientists with direct conflicts of interest from serving

on panels offering advise to federal regulatory agencies,'' the center said

in a statement.

 

The FDA spokeswoman said the agency followed its rules for complying with

U.S. law. As the committee meetings opened Feb. 16, 17 and 18 in

Gaithersburg, Maryland, an FDA official verbally listed members with

connections to health-care companies.

 

``This transparent process requires the agency to carefully weigh any

potential financial interest with the need for essential scientific

expertise,'' Walcoff said.

 

``In our view, the FDA clearly discussed conflict issues at the start of

the meeting in a very clear and forthright manner, so it was public,''

Pfizer spokesman Andy McCormick said yesterday in a telephone interview.

``We had no role in the selection of the FDA panel, and the membership

wasn't publicly announced until very close to the hearing.''

 

`No Merck Involvement'

 

``The composition of the committee is a process that is left completely to

the FDA with no Merck involvement,'' said Tony Plohoros, a Merck spokesman,

in a telephone interview.

 

Senator Edward M. Kennedy, a Massachusetts Democrat, said yesterday that

the report of panel members' conflicts ``emphasizes the need to restore

public confidence in the FDA and its ability to protect the public health

and safety of the American people.''

 

Senate and House Committees have been probing the FDA's monitoring of drug

safety since a Merck study showed a link to heart attacks and strokes in

patients taking Vioxx, leading to the biggest drug recall ever, and since

antidepressants were linked to elevated suicidal behavior in children.

 

``The FDA needs to stop including people on its panels who have conflicts

of interest, period, end of story,'' said Merrill Goozner, director of the

consumer group's Integrity in Science project, yesterday in a telephone

interview. ``I don't believe this country is so small the FDA can't find

unconflicted scientists who have the requisite expertise.''

 

Ties to Drugmakers

 

Those invited to sit on FDA advisory committees must disclose details of

all speaking and consulting fees, contracts, grants, patents, investments

and spouses' employment, according to a 2002 guidance document on the

agency's Web site.

 

Among the 10 pain-drug panelists listed by the consumer group as having

financial ties to Pfizer, Merck or Novartis were Robert H. Dworkin of

Boston University and Richard Platt of Harvard University's Medical School.

Both said yesterday that their votes weren't influenced by links to the

companies. The eight others named by the center didn't respond to phone or

e-mail messages.

 

``I provided the FDA with the detailed information that they requested

before the meeting, and, as was announced each morning, they granted

waivers for those of us with potential conflicts of interest so that we

could participate in the meeting,'' Dworkin said in an e-mail. ``I do not

believe that the things I said at the FDA meeting last week or my votes

were influenced by research grants and compensation received from Novartis

or Pfizer.''

 

`Very Mad at Me'

 

``I'm quite certain that the relationship with Pfizer didn't make a

difference to the decision I made at the meeting,'' Harvard's Platt said in

a telephone interview yesterday. His Pfizer- funded research is to develop

a mathematical model to detect signals of drug-related adverse events. ``I

voted same way for all three drugs. That's the critical piece.''

 

The center's list of 17 panelists with other links to health- care

companies included Steven L. Shafer, a Stanford University

anesthesiologist, and Ralph D'Agostino, a biostatistician from Boston

University.

 

``The FDA pretty much knows everything that I do, and I suspect that's the

case for the others,'' Shafer said in a telephone interview yesterday. The

consumer group didn't assess his ownership of 1.3 percent of Mountain View,

California-based biotechnology company Pharsight Corp. as a conflict of

interest.

 

``I voted to keep Vioxx and Bextra off the market,'' D'Agostino said in

telephone interview yesterday. The center reported he disclosed holding

interests in and consulting for health-care companies that didn't include

the makers of pain drugs. ``If I had industry ties, they must be very mad

at me.''

 

To contact the reporter on this story:

Geraldine Ryerson-Cruz in Washington at gryerson

 

To contact the editor responsible for this story:

Robert Simison at rsimison.

 

Last Updated: February 26, 2005 12:25 EST