10 Voters on Panel Backing Pain Pills Had Industry Ties

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The New York TImes

 

February 25, 2005

 

10 Voters on Panel Backing Pain Pills Had Industry Ties

 

By GARDINER HARRIS and ALEX BERENSON

 

en of the 32 government drug advisers who last week endorsed continued marketing

of the

 

huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent

years for the

 

drugs' makers, according to disclosures in medical journals and other public

records.

 

If the 10 advisers had not cast their votes, the committee would have voted 12

to 8 that Bextra

 

should be withdrawn and 14 to 8 that Vioxx should not return to the market. The

10 advisers with

 

company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's

return.

 

The votes of the 10 did not substantially influence the committee's decision on

Celebrex because

 

only one committee member voted that Celebrex should be withdrawn.

 

Eight of the 10 members said in interviews that their past relationships with

the drug companies had

 

not influenced their votes. The two others did not respond to phone or e-mail

messages.

 

Researchers with ties to industry commonly serve on Food and Drug Administration

advisory

 

panels, but their presence has long been a contentious issue.

 

The agency has said it tries to balance expertise - often found among those who

have conducted

 

clinical trials of the drugs in question or otherwise studied them - with

potential conflicts of interest.

 

Several of the panel members flagged with conflicts said most or all of the

money went not to

 

themselves but to their universities or institutions.

 

The Center for Science in the Public Interest, an advocacy group in Washington

that maintains a

 

large database of scientists' industry ties culled from disclosures in medical

journals and other public

 

documents, analyzed the panel members' affiliations at the request of The New

York Times.

 

The center has been a frequent critic of the F.D.A. and of the pharmaceutical

industry. The center's

 

analysis may understate the industry ties of the panel participants because some

ties may not have

 

been previously disclosed publicly.

 

Dr. Sheldon Krimsky, a science policy expert at Tufts University, said such

conflicts were common

 

on F.D.A. advisory panels. The agency often conceals these conflicts, and

studies have shown that,

 

taken as a whole, money does influence scientific judgments, Dr. Krimsky said.

 

He added, " F.D.A. has to work harder to fill panels with people without

conflicts, and if they feel

 

they have the best committee, they at least ought to make it transparent. "

 

But Dan Troy, a Washington lawyer who was until last year the agency's general

counsel, said that

 

finding knowledgeable experts without financial conflicts was difficult.

Suggesting that such

 

conflicts skew a panel's decisions " buys into an overly conspiratorial view of

the world, " Mr. Troy

 

said.

 

A spokeswoman for the F.D.A. said no one at the agency would comment on specific

panel

 

members' industry ties.

 

Before each of three meetings of the advisory board last week, an agency

secretary read a statement

 

absolving panel members of conflicts of interest because the committee's agenda

involved " issues of

 

broad applicability and there are no products being approved. "

 

The secretary also said, " The Food and Drug Administration acknowledges that

there may be

 

potential conflicts of interest, but because of the general nature of the

discussions before the

 

committee, these potential conflicts are mitigated. "

 

But the committee took nine votes, three for each drug, on whether Celebrex,

Bextra or Vioxx hurt

 

the heart, should continue to be marketed and, if so, under what restrictions.

These votes were

 

deeply important to the three companies - Merck, Pfizer and Novartis - that came

before the

 

committee. Indeed, shares of Merck and Pfizer soared last Friday after the

panel's votes.

 

Ten members of the panel have worked in some capacity in recent years for Merck,

the maker of

 

Vioxx; Pfizer, the maker of Celebrex and Bextra; or Novartis, which is applying

to sell Prexige, a

 

very similar pill discussed by the panel, according to the public disclosures.

 

An 11th panel member, Dr. Jack Cush, a rheumatologist at Presbyterian Hospital

in Dallas, said a

 

disclosure that he once consulted for Pfizer was incorrect, so he was excluded

from the analysis.

 

Of the 30 votes cast by the 10 panel members on whether Celebrex, Bextra and

Vioxx should

 

continue to be marketed, 28 favored the drugs. Among the 66 votes cast by the

remaining 22

 

members of the panel, just 37 favored the drugs.

 

Dr. Steven Abramson, a rheumatologist at New York University School of Medicine

who was on

 

the panel, has consulted for Pfizer and Novartis. " The F.D.A. is looking for

people who understand

 

the science behind these medicines, " and such an understanding often results

from working with

 

drug makers, he said.

 

Dr. John Farrar, a neurologist at the University of Pennsylvania who has

received research support

 

from Pfizer and is a panel member, agreed. " I think F.D.A. would have a hard

time finding people

 

who are good at what they do who never spoke to a pharmaceutical company, " he

said.

 

But Dr. Curt Furberg, a panel member and an epidemiologist at Wake Forest

University who had no

 

ties to any of the drug companies, said he was " uncomfortable with the

Pfizer-friendly undertone " at

 

the meeting. And he worried that Pfizer's financial relationships with some

panel members might

 

have played a role in setting that tone.

 

Joan Wainwright, a spokeswoman for Merck, said the company had had no role in

choosing any of

 

the scientists on the panel.

 

Merck has made no decision on whether it will reintroduce Vioxx, Ms. Wainwright

said. " We look

 

forward to discussing the outcomes of the meeting with the F.D.A. and other

regulatory authorities, "

 

she said.

 

Andy McCormick, a spokesman for Pfizer, said the company had no plans to

withdraw Bextra from

 

the market. He also said that Pfizer had played no role in helping to choose the

panel.

 

Critics of the drug industry said they were not surprised that the panel's

decisions would have been

 

different if scientists with financial ties to the companies had recused

themselves from the votes.

 

" My employees usually vote for me as well, " said W. Mark Lanier, a lawyer in

Houston who

 

represents people who have sued Merck after taking Vioxx and suffering heart

attacks or strokes.

 

Some lawyers and Wall Street analysts said last week that the panel's decision

would help to protect

 

Merck and Pfizer from lawsuits. But juries will be more skeptical of the

decision after they learn

 

about the composition of the panel, Mr. Lanier said.

 

Christopher A. Seeger, a lawyer in New York with many Vioxx clients, said the

fact that scientists

 

had not recused themselves simply highlighted the close ties between the drug

industry and

 

academic researchers. He said researchers were afraid to say anything negative

about new drugs

 

because doing so might jeopardize their chances of participating in clinical

trials and publishing

 

papers.

 

Several panel members said the important split on the committee was not so much

between those

 

with industry ties and those who did not have those ties but between experts who

treat arthritis

 

patients and those who do not.

 

Dr. Cush was angry that the voices of the panel's rheumatologists were nearly

drowned out by

 

statisticians and others who do not have to cope with anguished patients every

day.

 

Dr. Furberg said clinicians often wanted access to therapies without

understanding the devastating

 

public health consequences of their prescribing decisions. Celebrex, Bextra and

Vioxx have never

 

been proved in clinical trials to cure pain any better than ibuprofen or more

than a dozen other, older

 

pain pills.

 

" Fifty patients a day probably die from those drugs, and who is speaking for

them? " Dr. Furberg

 

said.

 

Dr. Alastair Wood, an associate dean at Vanderbilt University and the panel's

chairman, said he was

 

disappointed that the F.D.A. failed to disclose the financial conflicts of the

panel's participants

 

before each day's meeting.

 

" I'm a great believer in letting it all hang out, " he said.

 

Still, Dr. Wood said that even with its conflicts the panel was a tough critic

of the drugs. Many of

 

the panel members who were among the narrow majorities approving continued

marketing of Bextra

 

and Vioxx did so only with the stipulation that severe restrictions be imposed

on their uses, he

 

noted.

 

He said he expected that the uses of the drugs would be confined to very limited

patient populations.

 

 

<alonmarcus wrote:FDA Panel: Merck's Vioxx Safe Enough

to Be Sold

A panel of experts, by a narrow margin, said on Friday that Merck & Co.

Inc.'s now-withdrawn painkiller Vioxx was safe enough to be sold in the

United States despite an increased risk of heart attack and stroke.

Reuters Health Information 2005

http://mp.medscape.com/cgi-bin1/DM/y/emXI0EDHzl0DzC0GSIR0Ek