Scientist Who Cited Drug's Risks Is Barred From F.D.A. Panel

[Guest guest]

" Dr. Furberg was asked not to participate when it took up an issue in

which he was seen to have an intellectual conflict of interest. " but

most panels are packed with people who have a conflict of a financial

or pro interest bias.

 

 

http://www.nytimes.com/2004/11/13/politics/13fda.html?oref=login

 

November 13, 2004

Scientist Who Cited Drug's Risks Is Barred From F.D.A. Panel

By GINA KOLATA

 

The Food and Drug Administration has told a researcher that he cannot

be part of an advisory panel that will meet early next year to review

the safety of a class of drugs, COX-2 inhibitors, used to treat

arthritis and pain. The reason, the agency said, is he publicly stated

that he thought one of these drugs caused heart problems and that

Pfizer, its maker, knew that and was covering it up.

 

The scientist, Dr. Curt D. Furberg, a professor of public health

sciences at Wake Forest University School of Medicine in

Winston-Salem, N.C., was not barred forever from the panel, an F.D.A.

spokeswoman said. Instead, Dr. Furberg was asked not to participate

when it took up an issue in which he was seen to have an intellectual

conflict of interest.

 

" This is a routine procedure, " said Victoria Kao, the spokeswoman.

" They look at the members that will make up the committee, and they

review them for each case to see whether they have a conflict of

interest, financial or intellectual. "

 

In September, Merck announced that it was withdrawing its COX-2

inhibitor, Vioxx, from the market after a clinical trial it was

conducting showed an increased risk of heart attacks and strokes when

patients took it for 18 months or longer. That raised questions about

similar drugs made by Pfizer, Celebrex and Bextra, and the F.D.A.

panel was charged with reviewing what is known about them.

 

The Vioxx findings were based on the strongest evidence - a clinical

trial comparing the drug with a placebo. But no such evidence on heart

attacks and strokes has been reported for Celebrex and Bextra.

 

There is, however, a scientifically weaker study, pooling data from 12

clinical trials, that Dr. Furberg and Dr. Garret A. FitzGerald, a

cardiologist and pharmacologist at the University of Pennsylvania,

completed recently. " Basically, we showed that Bextra is no different

than Vioxx, and Pfizer is trying to suppress that information,'' Dr.

Furberg told The New York Times this week.

 

Dr. Furberg said yesterday that he was surprised to be removed from

the advisory committee.

 

" I had a call yesterday, out of the blue, " from the F.D.A.,

" disinviting me, " he said. The agency, he said, told him " the reason

is that I have publicly expressed my views. "

 

The F.D.A.'s decision is not unreasonable, said Dr. David Orentlicher,

a physician, lawyer and ethicist at Indiana University. It is

analogous to situations in which potential jurors with strong opinions

about a case are excluded from juries, and judges with such opinions

are recused from hearing cases. " It's a concern about open minds if

you are asked to be a neutral, detached observer, " he said.

 

There is a risk, however, Dr. Orentlicher said, and it is the same one

that arises in death penalty trials, which exclude jurors who are

strongly opposed to capital punishment.

 

" You have to be careful that you don't skew the panel, " he said.

 

Dr. Furberg said he did not object to being removed from the panel,

" if it's the same rule they apply to others. " He still has the option

of presenting his data, and his opinions, in a public comment period

at the meeting. " I haven't decided yet, but several people have said,

'You should,' " Dr. Furberg said.

 

Copyright 2004 The New York Times Company