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February 11, 2005
Marketing of Vioxx: How Merck Played Game of Catch-Up
t times, it is necessary to "neutralize" the opposition, or at least Merck & Company executives seemedto think so.
In 1999, the company's new pain drug, Vioxx, was beaten to pharmacy shelves by a competing drug,Celebrex. Merck apparently hoped that nationally known rheumatologists like Dr. Roy Altman could help itcatch up.
At a dinner that year in Miami, a Merck executive asked Dr. Altman what it would take to win his support,the doctor recalled. Dr. Altman said he told the executive that he wanted to run a clinical trial involvingVioxx, and, later, Merck put up $25,000 for it.
"Show me the money," appeared on an internal Merck document near Dr. Altman's name. He said those wereneither his words nor his intent. He also said his involvement in the trial did not affect his prescribing.
Merck's dinner with Dr. Altman, internal company documents show, was a brief stop in a long-runningcampaign by Merck to enlist the support of doctors for Vioxx or, at the least, to defuse their support forCelebrex - to "neutralize" them as the documents put it.
"We were all aware that there was a great deal of marketing" at the time, said one doctor who was named inthe Merck "neutralize" documents, Dr. Robert Ettlinger, a rheumatologist in Tacoma, Wash. "Like a Coke-Pepsi war." The company's campaign was one part of a broader marketing effort that helped propel Vioxx to annual salesof $2.5 billion, until it was with-drawn from the market last September after a clinical trial found that itincreased the risk of heart attacks and strokes. And next week, an advisory panel to the Food and DrugAdministration will review whether the agency should add warnings or restrictions on the use of Celebrexand other drugs known as COX-2 inhibitors, a category that also includes Vioxx.
In a statement, Merck said that it stood behind its marketing programs and added that all were intended toprovide accurate information about its products.
With respect to references to a program to "neutralize" physicians, Merck said that when doctors had"misinformation" or a "lack of information" about a drug, it "provided information to bring them back to abalanced or neutral position." Drug companies routinely try to woo doctors to prescribe or promote their drugs, taking them out to fancymeals, hiring them as speakers, or contributing to medical schools. But the internal Merck documents offer arare, behind-the-scenes look into the extremes of this process - one that may have blurred the line betweenlegitimate promotion and offering inducements to doctors to prescribe a drug.
In recent months, federal investigators, state officials, Congressional committees and lawyers for plaintiffshave obtained thousands of internal Merck documents while pursuing investigations and lawsuits related toVioxx.
The New York Times obtained the documents cited in this article - records that include e-mail messages,memorandums and spreadsheets - through a public official. Some of those records involved physicians Mercksought to "neutralize," while others described promotional activities aimed at doctors not on that list.
In the "neutralize" documents written by a Merck marketing executive, company officials identified dozensof influential but "problem" physicians whom the company believed had either a negative view of Merck orVioxx or were active boosters of Celebrex.
To win them over, the documents show, Merck officials planned to offer them carrots like clinical trials, postsas consultants or give them grants.
"Attached is the complete list of 36 physicians to neutralize with background information and recommendedtactics," the marketing official wrote in an e-mail message.
Merck officials insisted that all the activities they financed were "educational." But one part of a standardizedform requesting payments to doctors had a somewhat less erudite tone. It read "Expected Outcome/Return onInvestment." To be sure, some claims made in the Merck internal documents and other company memos might havereflected idle boasts by company sales officials seeking to impress their superiors. In addition, the Merckdocuments indicated that some of tactics were meant to counter moves by Celebrex.
As part of the COX-2 marketing war, Merck monitored its competitors' activities, regularly compiling digestsof instances in which physicians speaking on behalf of Celebrex made statements that it viewed as misleadingor false. Many of those internal complaints involved claims that some academic researchers were inflatingCelebrex's benefits while exaggerating Vioxx's side effects.
In a statement, Pfizer, which now makes and markets Celebrex, said that it always strived to provide abalanced picture of Celebrex's risks and benefits and that it could not comment on specific incidents thatmight have involved other companies that were once part of Celebrex's promotion. Over the years, Merck andPfizer or its marketing partners all received warning letters admonishing them for misleading claims.
Both Celebrex and Vioxx were marketed as a safer alternative to traditional pain relievers like Advil andAleve, which can cause ulcers and stomach bleeding.
The "neutralize" list reflected the battle for the hearts and minds of doctors in the COX-2 wars. Onephysician on the list - Dr. Ettlinger from Tacoma - was described in Merck documents as an adviser to theformulary board of a regional insurer who was being "heavily courted by Searle and Pfizer." At the time, Searle was the manufacturer of Celebrex, and Pfizer helped market it.
A Merck document recommended that Dr. Ettlinger be giving more paid speeches, be invited to moremeetings and be asked to do more drug trials. "He is participating in a number of clinical trials," the Merckmemo noted. "Keep him busy." In bold letters beneath Dr. Ettlinger's name was the term "neutralized." The physician said in an interview that he was "absolutely shocked" that he had been singled out forattention, saying he regularly gave speeches for many drug companies. Such work never affected the drugs heprescribed, including Vioxx or Celebrex, he said.
But in some cases, Merck sales officials apparently hoped that showering physicians with favors would bringsome returns, the records indicate. For example, one Merck representative requested in 1999 that thecompany make a $25,000 donation to the West Coast Sports Medicine Foundation, a nonprofit organizationfounded by Dr. Keith Feder, a Los Angeles-area orthopedic surgeon. The foundation helps pay medicalinsurance for low-income students in California so they can have the coverage required by the state toparticipate in team sports.
A Merck sales representative said in the document that the $25,000 payment to the foundation was needed to"be competitive with Searle," which, had also made such a grant. In a form requesting the payment, theMerck representative listed the "Expected Outcome/Return on Investment" as "51 percent share of COX-2market in 2000." In an interview, Dr. Feder confirmed that the foundation had received money from both Searle and Merck,but said that the grants helped support a continuing medical education program and were not intended toinfluence his prescribing habits and did not do so.
"It had nothing to do with their product in any way, shape or form," he said.
Concerns about the sales of Celebrex and Vioxx also came up in connection with Dr. Max Hamburger, arheumatologist in Melville, N.Y. Dr. Hamburger, who was also on Merck's "neutralize" list, headed a largeconsortium of physicians in the New York metropolitan area who, by the time Vioxx went on the market,were "high-volume prescribers and huge adopters of Celebrex." At the time, Dr. Hamburger was approaching drug companies to subsidize retreats for his group during whichthe physicians would put together guidelines on what drugs to prescribe.
"Companies that provide funding will receive preferred status with its members and those that do not willhave trouble accessing" the group, the Merck memo stated. "Price tag is $25,000." Merck officials stated in the internal document that Pfizer and Searle had already agreed to pay. And Merckdid so, too, the document shows. On the "neutralize" list, Dr. Hamburger was described as having been"turned around" and the word "advocate" appears.
In an interview, Dr. Hamburger said that his group solicited funds from a large number of pharmaceuticalcompanies to support its educational meetings and that payments from those drug makers did not influencethe medications prescribed.
As for his description as an advocate, Dr. Hamburger said he was a strong believer in the value of COX-2drugs but not a champion of any company's medication.
James Sheehan, a federal prosecutor in Philadelphia who specializes in health care fraud, did not review thedocuments. But, speaking generally, he said that while drug companies can give money to doctors foreducational or scientific purposes, payments intended to influence whether a physician prescribes a drugmight qualify as an illegal kickback.
Asked about the propriety of the company's marketing program, Merck said in a statement that it stoodbehind its marketing and would defend it.
"Merck believes that the provision of educational grants to support the exchange of information in a medicalor scientific form is not only proper but is a valuable contribution," the company said.
Merck also said that the documents reviewed by The Times reflected only a selection of the company'smarketing materials and so might misrepresent its activities.
In the end, Merck's efforts might not have been needed in some cases and failed to work in others. Severaldoctors on the company's list of "problem" physicians said they had no problem with Merck or Vioxx, whileothers said they felt that the drug, while frequently killing pain better than Celebrex, did have its ownproblematic side effects like increasing blood pressure and fluid retention.
As for Dr. Altman, who is now a professor of medicine at the University of California, Los Angeles, he neverspoke for Merck or said he felt any more pressure from the company after the dinner in Miami. As for the$25,000 study Merck financed to look for the drug's value in the treatment of gout, he said he nevercompleted it. He could not recruit enough patients for it.
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