Panel Backing Pain Pills
10 Voters on Panel Backing Pain Pills Had Industry Ties
By GARDINER HARRIS and ALEX BERENSON
Published: February 25, 2005
Ten 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If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market.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influence the committee's decision on Celebrex because only one committee member voted that Celebrex should be withdrawn.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.
By GARDINER HARRIS and ALEX BERENSON
Published: February 25, 2005
Ten 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.
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