Healthy Skepticism Library item: 7457

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Berenson A.
In Training Video, Merck Said Vioxx Did Not Increase Risk of Heart Attack
New York Times 2005 Jul 21Business
http://www.nytimes.com/2005/07/21/business/21vioxx.html?ex=1279598400&en=408e6e6a800498b2&ei=5088&partner=rssnyt&emc=rss

Full text:

ANGLETON, Tex., July 20 – Merck told its sales representatives that its painkiller Vioxx did not increase the risk of heart attacks, according to a Merck training video played on Wednesday for jurors in the first Vioxx lawsuit to reach trial.

The video, which had never before been publicly shown, also depicts actors playing Merck representatives avoiding a question about Vioxx’s potential to increase blood pressure – a documented side effect.

While the training tape was never shown to doctors or consumers, its existence may further undercut Merck’s claim that the company properly disclosed Vioxx’s risks during the five years the drug was on the market.

In the video, an actress playing “an obstacle” to Vioxx sales says, “I’m afraid Vioxx causes M.I.‘s” – a reference to myocardial infarctions, or heart attacks.

In response, an actress playing a Merck sales representative says, “That’s not true.”

After playing a portion of the videotape to the jury, W. Mark Lanier, a lawyer for plaintiffs in the case, asked Dr. Nancy Santanello, a senior Merck scientist, why Merck had told its sales representatives that Vioxx did not cause heart attacks or raise blood pressure.

Dr. Santanello responded that at the time the training video was made, Merck did not know if Vioxx raised the risk of heart attacks. In addition, the tape does not show the actress actually denying that Vioxx raises blood pressure, Dr. Santanello said.

Instead, the actress merely sidesteps the issue, she said. Dr. Santanello’s response appeared to take the jury aback.

“Is that how you train people to sell your product?” Mr. Lanier said.

Merck made the videotape in 2000, as it struggled to increase Vioxx sales despite concerns by doctors and independent scientists that the drug might damage the heart.

Merck stopped selling Vioxx last September after a clinical trial showed patients taking Vioxx had a substantially higher risk of heart attacks and strokes than those taking a placebo.

In the suit, which is being heard in the Brazoria County Courthouse in Angleton, a town of 18,000 about 45 miles south of downtown Houston, the widow and children of Robert Ernst charge that Vioxx caused Mr. Ernst’s death.

Mr. Ernst, a marathoner and triathlete, died suddenly at age 59 in May 2001 after taking Vioxx for eight months.

Jonathan B. Skidmore, a lawyer for Merck, said the videotape was irrelevant to the case because there was no evidence that the company’s sales representatives who called on Mr. Ernst’s doctor had ever seen it.

The training video was the highlight of another contentious day in the trial, in which Mr. Lanier also began to lay the groundwork for his theory that Vioxx caused Mr. Ernst’s death – even though a coroner found that Mr. Ernst died of an arrhythmia, or irregular heartbeat, not a heart attack. Clinical trials have not linked Vioxx to arrhythmias.

But Mr. Lanier noted that the Merck Manual, a reference book for doctors, says that more than 90 percent of heart attacks lead to arrhythmias. Mr. Lanier argues that Mr. Ernst died of a heart attack that killed him so quickly that his heart muscle did not show the classic characteristics of heart attack damage. Cardiologists say such a scenario is possible, although it is not clear whether Mr. Lanier has evidence to support his claim.

“If someone dies relatively quickly of a heart attack, you’re not going to see damage to the heart muscle?” Mr. Lanier asked Dr. Santanello. In a rare moment of agreement, she said that in some circumstances he might be correct.

But Dr. Santanello and Mr. Lanier sparred vigorously for much of the day, as Mr. Lanier pressed Dr. Santanello about when Merck became aware that Vioxx might be dangerous. Mr. Lanier criticized Dr. Santanello for offering long answers to yes-or-no questions, while lawyers for Merck objected frequently to his questions as argumentative.

At one point, Mr. Lanier presented the jury an e-mail message written in March 2000 by Dr. Edward M. Scolnick, who was then Merck’s head of research, saying that a large clinical trial of Vioxx had shown that the drug increased heart risks, or cardiovascular events.

“The CV events were clearly there,” Dr. Scolnick wrote.

Dr. Santanello said that Dr. Scolnick and Merck had decided later that Vioxx did not increase heart risks. Instead, naproxen, an older painkiller sold under the brand name Aleve and taken by other patients in the clinical trial, had decreased its users’ heart risks, Dr. Santanello said.

As Dr. Santanello offered a long explanation of Merck’s rationale, Mr. Lanier whispered to a member of his staff about a possible exhibit. When Dr. Santanello finished, he said: “I wasn’t listening to what you were saying, but I don’t think you were answering my question. That’s the one time I don’t mind you going on and on.”

Later, Dr. Santanello appeared to grow irritated as Mr. Lanier asked her whether Mr. Ernst had risk factors for heart attacks beyond his use of Vioxx. “You’re playing this game,” she said.

“This is not a game,” he responded. “My client’s dead.”