Because of intense interest in this report, NPR has decided to present a full transcript.
Introduction: At least 38,000 Americans are believed to have died from taking the pain pill Vioxx before it was withdrawn last year. Drug maker Merck is now facing thousands of lawsuits.
Over the past few months, it has emerged that the company was aware for years that Vioxx might be dangerous. Now, new documents obtained by NPR suggest that even as Merck was making Vioxx into a bestseller, the company was putting pressure on independent doctors. The company's apparent aim: to keep them from discussing evidence of Vioxx's potential safety problems. The documents show that Merck exerted pressure not only on individual doctors, but also on several of the nation's top medical schools.
Merck tells NPR it did nothing wrong. NPR's Snigdha Prakash has the first story in a two-part report.
Transcript: When a drug company wants to sell a pill to a doctor, its best salesperson is usually another doctor.
Of course, drug companies don't call that selling. They call it "medical education." Or even medical research.
Well before Merck launched Vioxx, the company was targeting influential doctors who could help it build Vioxx's sales.
When they located a prospect, they entered the details about that doctor into a spreadsheet at headquarters. Spreadsheet entries included items such as:
"...treats all of the major sports teams, including the Lakers basketball team and the Dodgers baseball team, as well as the high-profile members of our society."
"... 2,4OO prescriptions per year... also known nationally... Writes for a lot of rheumatology textbooks."
Merck's vast army of sales representatives gathered intelligence on what it would take to win over individual doctors. Their notes included the following strategic observations:
"Use in many speaking engagements... At least $20,000 for speaking engagements for the remainder of the year."
"Will speak for us only at certain restaurants and high honorarium... Likes to feel important... He needs the VIP treatment."
One of the physicians whom Merck recruited to promote Vioxx was Gurkirpal Singh of Stanford University.
Merck wanted Singh on board because he was a senior researcher on a seminal study of arthritis patients. The study showed that older painkillers, such as Naproxen, commonly caused gastrointestinal bleeding. It established the need for new painkillers, such as Vioxx and its rival, Celebrex, that were gentler on the stomach.
NPR has examined Merck documents provided by sources working with individuals and families who allege Vioxx harmed them. They're now suing Merck.
Among those documents is a memo that shows Merck started to focus on Singh in April or May of 1998 -- almost two years before Vioxx was ready for market. The overture was successful. A year later, Merck was launching Vioxx, and Singh was an important spokesman.
One document reads: "March-May 1999. Aggressively scheduled Dr. Singh for talk in preparation for launch... Reviews and feedback of Dr. Singh's presentations were generally positive." And it notes that "Dr. Singh commanded relatively large honoraria."
Merck paid Singh fees of up to $2,500 for each talk. He gave 40 talks over seven months.
Singh described the system in an interview with NPR:
"One setting which is where I was speaking predominantly was in the grand round situation in hospitals, or in medical schools, or in the universities, where like you're giving a formal lecture to the physicians," Singh said. "It's always lectures to physicians. And then the other set is usually these evening programs that drug companies arrange, where you also present your research, and then there's often a dinner with it."
Merck was pushing hard to catch up with rival drug maker Pfizer. Pfizer's new painkiller, Celebrex, had beaten Vioxx to market by a few months. It was gobbling up market share.
Then in early 2000, Merck got news of a potential problem. A large study commissioned by the company showed that patients on Vioxx suffered more heart attacks, strokes and deaths than those on the older pain pill Naproxen.
For some researchers, the results were a red flag that Vioxx might be dangerous. But according to the company, the new evidence was outweighed by many previous studies that showed the drug was safe.
Merck scientists interpreted the study in a postive way. In a series of press releases, Merck said the study showed that the older drug protected against heart attacks -- not that Vioxx caused them. The company confirmed that Vioxx was safe for the heart.
Merck gave the study data to the Food and Drug Administration, and the two began a protracted debate over what the study meant, and what to tell doctors and patients about it.
Meanwhile, despite the positive spin of Merck's press releases, Singh was uneasy about the new study.
"I was worried, because obviously this was something new," Singh said. "This was something we had never seen before."
As an independent scientific expert, Gurkirpal Singh wanted to evaluate the study for himself.
Singh asked Merck repeatedly for the data. "I wanted to know how many heart attacks, how many strokes, how many deaths were occurring in each one of the groups, and what were these actual number of patients at risk, and how many ended up having an event," he said.
Singh says for months, Merck's scientific education department assured him that the results would be available soon -- at one scientific meeting, then another. They never were.
Singh got tired of waiting. He shared his concerns with at least one prominent European scientist, and he began to allude to his concerns in talks.
Inside Merck, Susan Baumgartner, a Vioxx marketing manager, wrote this e-mail:
"June 19, 2000: Dr. Singh continues to play up the cardiovascular adverse events associated with Vioxx... I think there are many other speakers who deliver good messages, and we should not risk supporting the negative messages that he continues to deliver."
The Merck sales machine, which included the departments of marketing, scientific education and physician outreach, had begun to show its other face. It had paid Singh fat speaking fees. Now it was canceling many of his educational lectures.
The documents obtained by NPR show that for much of June 2000, Merck executives conferred on how to rein in their skeptical consultant. At least 23 local, regional and national executives took part in the discussions. They feared that just as Singh's credibility had opened doors for Merck, it could close them.
Singh was widely respected at the FDA. He also had connections with large institutional buyers that were vital to Vioxx's sales.
Terry Strombom, who was senior business director for the San Francisco region, sent an e-mail on June 5, 2000, that shows Merck was walking a tight rope -- it wanted to censor Singh, but was afraid of alienating him. The e-mail read:
"The one thing I am pretty sure of is that Dr. Singh could impact us negatively if he chose to do so... I would recommend we handle this very carefully... I just don't think canceling all the programs and walking away completely will serve us well in the long term."
The e-mails show that at the same time that Merck was trying to censor Singh, at least one Merck official acknowledged that Singh's concerns about Vioxx were legitimate.
Heather Robertson, the coordinator of health education liaisons for the San Francisco region, reported on a conversation with Singh's main scientific contact at Merck, who has since left the company. Her e-mail of June 5, 2000, read:
"I spoke to Kirsten directly for the first time this past week to learn that Dr. Singh makes a balanced presentation (he must since he is an FDA advisor) but reports product information that is not favorable to Merck... Kirsten feels that no amount of work would change Dr. Singh's position, and although we may not like to hear about it, his information is scientifically accurate."
Later, Merck would advise its sales representatives not to discuss Vioxx's risks to the heart, and to have doctors send their questions to headquarters.
We showed the Merck documents to David Rothman, director of the Center on Medicine as a Profession at the Columbia University College of Physicians and Surgeons. He says the Merck documents consistently show a disregard for the substance of the scientific arguments about Vioxx.
"The drug companies will use the language of objective neutral science," Rothman says. "But what speaks much louder is 'You're for us, or you're again' us. And if you're again' us, we're going to try to get you.'"
Merck's surveillance system had many ways to pick up who was for them or against them. Physicians, including advocates with financial ties to Merck, contacted the company when they heard criticism.
A document from July 21, 2000, reads: "Communication from advocate regarding a program given by Dr. Singh... It was hyper-inflammatory."
Singh's allegiance was shifting. He was now promoting Vioxx's rival, Celebrex. He was being paid by Pfizer, and he was telling his audiences that Merck had refused to answer his questions about Vioxx's safety. A July 2000 document notes: "Received reports that Dr. Singh showed a cartoon of a character hiding under a blanket and asked the audience to speculate about what it is that Merck is trying to hide."
Merck's sales force was also keeping tabs on the buzz in doctors' offices. As sales representatives gave out free Vioxx samples, they asked doctors if they'd heard anything new about Vioxx. The sales reps would transmit this intelligence via voicemail to the company's National Service Center. Another Merck document, from July 26, 2000, notes:
"NSC report that at nine meetings in the L.A. area over the last three days, Singh presented sessions that were very unfavorable to Vioxx."
A week later, Singh would convey his concerns to one of the country's largest and most influential drug purchasers, the Department of Veterans Affairs. The VA started asking Merck if Vioxx was safe for the heart. The company's most senior scientists were brought in to answer the VA's questions. It was clearer than ever that Singh had become a major liability for the company.
Dealing with Singh was now a job for Merck's senior vice president for medical and scientific affairs -- Dr. Louis Sherwood. Sherwood was a former academic and had been chief of medicine at a top medical school.
Merck documents obtained by NPR show that a detailed account of Singh's activities was now prepared for Sherwood. Almost a dozen Merck executives were involved. A senior regional executive who had supervised Singh's scientific handlers sent this Oct. 4, 2000, e-mail:
"I have in excess of 80 e-mails pertaining to interactions with Dr. Singh from March 1999 to present. The following is my best recollection of what has happened. Because of the sensitive nature of the following, I strongly encourage you not to share with anyone unless they clearly have a need to know."
The profile of Dr. Singh is remarkably complete," says Columbia's David Rothman, who reviewed the final document for NPR. "One can't help but almost frame it in terms of an FBI dossier, except here Dr. Singh is not cavorting with possible communists, or possible gangsters. Here the dossier is filled with Dr. Singh's take on Vioxx, who is Dr. Singh talking to. It's scrupulously watched and very, very carefully recorded."
The profile was dispatched to Sherwood and six other executives. Around the same time, Singh heard from a friend inside Merck: "I was told that Dr. Lou Sherwood, who was then vice president at Merck, had become 'very interested,' in quotes, in what I was doing, and that Dr. Sherwood is "very powerful, and he's going to crush you and he's going to fix you.'"
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