Part 2: Did Merck Try to Censor Vioxx Critics?

Med Schools & Drug Firm Funds

An informal survey of medical schools by NPR found that some schools rely on funding from pharmaceutical and other health-industry sources.

The issue is taking on increasing importance. Government funding for medical research is not expected to increase in coming years and could decline. Medical schools will be more reliant on private, for-profit industry for funding. That raises concerns about academic freedom and restrictions on what researchers can and cannot say in print and in public

Because of intense interest in this report, NPR has decided to present a full transcript.

Introduction: NPR's story about Merck and its efforts to suppress safety concerns about the painkiller Vioxx continues with a look at how Merck exerted its influence in the world of top medical institutions. NPR's Snighda Prakash presents part two of her report.

Transcript: Dr. Louis Sherwood's campaign to "fix" Vioxx critic Gurkirpal Singh began with a series of phone calls to Singh's bosses at Stanford University.

"I don't usually receive phone calls on a Saturday at home from representatives of drug companies," says James Fries, a professor of medicine at Stanford. "So it was definitely unusual."

The call came on Oct. 28, 2000. " I received a call from a medical director at Merck, stating that someone on my staff had been making wild and irresponsible public statements about the cardiovascular side effects of Vioxx," Fries says. He says Sherwood hinted there would be repercussions for Fries and Stanford if Singh's statements didn't stop. He was left with the sense that Merck's financial support to Stanford was at risk.

Fries started making calls of his own and learned that researchers at seven other institutions, including the University of Minnesota, the University of Texas Southwestern and a Harvard teaching hospital, had also raised doubts about Vioxx's safety. Sherwood had placed calls to those institutions as well.

"A number of investigators who had spoken publicly had been called or the chairs of their departments had been called, "Fries says. "The deans of their medical schools, and a variety of veiled and not so veiled threats had been made — that they were saying bad things about the drug company, and that the people to whom they reported should take steps to see that this stopped."

At Merck, Medical Director Sherwood wrote an e-mail to bring the marketing department up to speed. NPR has obtained that e-mail. It suggests that part of Merck's strategy to suppress criticism was intimidation. The e-mail, dated Nov. 7, 2000, reads:

"Fries and I discussed getting Singh to stop making the outrageous comments he has in the past few months... I will keep the pressure on and get others at Stanford to help."

Sherwood advises one of the marketing executives how to pressure Singh himself. He says: "Tell Singh that we've told his boss about his Merck-bashing." And tell him, " should it continue, further actions will be necessary (don't define it.) "

Lisa Bero is a professor of clinical pharmacy and health policy at the University of California, San Francisco. She's done extensive research showing how funding from drug companies influences academic science. She reviewed Sherwood's email at NPR's request.

"I didn't realize how powerful the drug companies thought they were," Bero said. "For example, having enough influence over a department to say 'change what your faculty member is saying.' I haven't ever seen that documented before."

Another document written by Sherwood shows Merck tried to use that influence on several occasions. After Stanford Professor James Fries learned about Sherwood's calls to other medical institutions, he sent a strongly worded letter to Merck's CEO. The letter questioned the propriety of Sherwood's calls. Sherwood wrote an internal memo in response. NPR has obtained that memo.

In it, Sherwood writes there was no "orchestrated campaign or specific program" to deal with what he calls '"problem individuals." Yet, he lists groups of Merck executives who managed those critics. The memo, dated Jan. 23, 2001, reads in part:

"I will only get involved when our representatives... regional medical directors, Merck research lab physicians... or key individuals in the therapeutic business group have felt frustrated by their inability to reach out or to 'balance' selected individuals."

And Sherwood implies that when that happened, he did lean on Vioxx critics — and on their institutions: "Without trying to appear immodest, I believe I am the most respected physician in the pharmaceutical industry among academic chairs and deans... Therefore, when I call them on a matter of urgent concern, they generally take it seriously... This has been a source of strength ... as I have been able to exert balanced leverage in some difficult situations."

UCSF's Bero says, "Well, the first thing I thought is, 'What kind of leverage are we talking about?' And the first thing I thought of was money, in all the various ways that it can come to departments."

In 2004, Stanford's medical school got 9 percent of its research budget — $29 million — from drug companies. NPR surveyed several medical schools and found that's not unusual.

David Rothman is at the Columbia University College of Physicians and Surgeons.

"Look, medical research is expensive," says David Rothman of the Columbia University College of Physicians and Surgeons. "No one can take a call from a drug company high official, critical of an investigator, and not realize that behind that call is the implicit reminder, implicit threat — 'If you can't control your folks, how do you expect us to continue to do business with you?''"

Merck and Sherwood deny the allegations in this story. Ted Mayer, a lawyer representing Merck, says, "Merck was not trying to silence critics. The scientific or the safety profile of this product was very well known in data that was available to the public, and it was vigorously debated in the public, and it's perfectly appropriate to have that vigorous debate."

Mayer says Merck was concerned about Dr. Singh because many of his talks went far beyond that vigorous debate: "The number of people who heard those talks and who were physicians and understood the data well believed that those talks contained unbalanced and inaccurate information, and that the views weren't supported by the data and were kind of at the extreme end among hundreds of scientists who were making these kinds of presentations."

In an interview with NPR, Dr. Louis Sherwood says it was rare for him to complain to department heads. He says he firmly believes in academic freedom. He says he only made calls when faculty members were being unfair to Merck and acting unprofessionally.

"I never, never made any threats to withdraw funding or hamper anyone's faculty appointment," Sherwood said. "Under no circumstances did I ever do that."

Then why did Stanford's James Fries feel threatened when Sherwood called?

"No one likes to be criticized," Sherwood said. "Now sometimes, when an academic physician is criticized for his or her actions, they may interpret that as a threat. But under no circumstances did I threaten Stanford or Dr. Fries or anyone with funding issues or anything else. That would've been inappropriate."

FDA whistleblower Doctor David Graham estimates that at least 38,000 people died from taking Vioxx. Drummond Rennie, deputy editor of the Journal of the American Medical Association, notes that "each one of those is somebody, is a real person, with a real family, real people who grieve for them."

"I think it's the job of a physician, physicians who're doing research, physicians who work in drug companies — all physicians — to care about that," Rennie said.

Merck says its physicians strongly believed in the safety and benefits of Vioxx. The company says the risks of Vioxx weren't clear until just last fall, when, it says, Merck acted promptly and voluntarily withdrew Vioxx.

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