Merck Attempted to Quash Vioxx Criticism

Score another hit for NPR. Besides their selenium exposé (Below: “Making Molehills out of Mountains“), they’ve also punched Merck and its product Vioxx right in the solar plexus:

Morning Edition, June 10, 2005 · Drug maker Merck attempted to censor critics of Vioxx as early as 2000, an investigation by NPR finds. That year, a study indicated that the painkiller might cause heart problems. The story raises larger issues about the role of pharmaceutical firms’ funding of medical schools and independent doctors. (Listen)


“At least 38,000 Americans are believed to have died from taking the pain pill Vioxx before it was withdrawn last year,” reports NPR. “Merck [faces] thousands of lawsuits.”


And, PRWatch points out that we can’t count on the FDA’s new drug safety board to protect us from more Vioxx disasters. The board is “severely biased in favor of industry.”


Morning Edition’s report today is a coda to NPR’s stunning series of true muckracker journalism.


Next thing you know, Guy Noir will be investigating the Downing Street minutes.


Below, audio links and transcript excerpts:

From PRWatch:

“The new drug safety board established by the Food and Drug Administration to restore confidence in the nation’s drug supply will actually set back efforts to improve the safety of the medications Americans take and will not make it any easier to take dangerous drugs off the market,” the Washington Post reports. FDA safety officer David Graham criticized the Drug Safety Oversight Board (DSB) for being “severely biased in favor of industry.” He told the Post, “Ironically, drug safety in the U.S. is worse off today than it was in November.” Senator Chuck Grassley (R-Iowa) sent a letter to the FDA critical of the agency’s decision that the DSB will have private deliberations, requesting improved transparency and accountability and for the FDA to “explain in detail how it will ensure that the DSB is truly independent and objective.”

NPR’s series:

  1. Part 1: Documents Suggest Merck Tried to Censor Vioxx Critics (Listen)
  2. Part 2: Did Merck Try to Censor Vioxx Critics? (Listen)
  3. June 10, 2005 More on Merck’s Attempts to Quash Criticism (Listen)

All Things Considered, June 9, 2005 · 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Introduction: At least 38,000 Americans are believed to have died from taking the pain pill Vioxx before it was withdrawn last year.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.


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:


[………………]


[I]n 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.


[………………]

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. …


[………………]


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. …


Keep reading. It gets MUCH WORSE. Full transcript,