The Evidence Against Merck

The verdict in the Vioxx case is a clear example of how our civil justice system works to protect our rights as American citizens, allowing ordinary Americans to hold even the largest and wealthiest corporations accountable when they put their bottom line before the health and safety of the public. The facts presented during the Vioxx trial showed that Merck distributed and promoted Vioxx without properly disclosing the dangers of the drug. The following document summarizes some of these key facts that were highlighted by the media during the course of the trial.

Early scientific studies indicated that Vioxx increased heart risks

Internal Merck documents indicated that the company was aware of the problems with Vioxx as early as 1997. In fact, the company's top scientist stated in March of 2000 that a clinical trial of Vioxx confirmed that the drug had heart risks. Despite their knowledge of these problems, Merck aggressively marketed the drug.

• "Mr. Lanier [the plaintiffs attorney] offered jurors a trove of company documents and e-mail messages that revealed how Merck researched Vioxx's heart risks and presented what it knew to doctors and consumers. The documents showed that scientists at Merck were worried about Vioxx's potential cardiovascular risks as early as 1997, two years before Merck began selling the drug. 'The possibility of increased C.V. events is of great concern,' Dr. Alise Reicin, a Merck scientist, wrote in a 1997 e-mail message; 'C.V. events' is scientific shorthand for cardiovascular problems like strokes or heart attacks. 'I just can't wait to be the one to present those results to senior management,' Dr. Reicin's message continued. The documents also revealed that Dr. Edward M. Scolnick, who at the time was Merck's top scientist, said in March 2000 that the largest clinical trial ever conducted of Vioxx confirmed that Vioxx had heart risks, as he had feared." [The New York Times, 8/21/05; emphasis added]



• "Dr. Jerry Avorn, a professor at Harvard Medical School and frequent critic of the drug industry, said he was not surprised that the jury responded as vehemently as it did. 'Even as a seasoned observer of drug company affairs, I have been surprised at the way Merck handled the emerging evidence about cardiac risk with this drug,' Dr. Avorn said. 'There was an element of the Watergate tapes that I was reminded of: many people had been critical of Nixon for a long time, but even Nixon's critics did not expect to find the documentation of their worst fears made so clearly evident.'" [The New York Times, 8/21/05; emphasis added]



• "With the help of Dr. David Egilman, another of his expert witnesses, Mr. Lanier also clarified the chronology of Merck's evolving knowledge of Vioxx and its risks. By presenting company documents and e-mail messages among top Merck scientists, Mr. Lanier has shown that Merck was concerned about Vioxx's possible heart risks even before a 2000 clinical trial -- called Vigor -- showed Vioxx caused five times as many heart attacks as naproxen, an older painkiller." [The New York Times, 8/6/05; emphasis added]

Despite problems, Merck appeared to have rushed approval for Vioxx

Even though Merck was aware of the problems with Vioxx, the company tried to rush federal approval of the drug. Documents presented during the trial seem to indicate that the company was more concerned about competition from rival drug makers than they were with health and safety of consumers.

• "On Friday, for example, Mr. Lanier staged a withering examination of Dr. Alan S. Nies, a retired Merck scientist who led the Vioxx development program in the 1990's. The lawyer presented documents that appeared to show that Merck tried to rush federal approval for Vioxx because it feared that Celebrex, a competing drug by Pfizer, would get approval first." [The New York Times, 8/6/05; emphasis added]



• "Before Lanier began drilling Nies, he told Merck lawyer Joseph Piorkowski that there was no race to get Vioxx on the market before Celebrex. Nies, who retired from Merck in 2002 three years after Vioxx went on the market, also told Piorkowski it was 'absolutely false' that Merck minimized safety to rush Vioxx to consumers. However, Nies' 1996 plan identified the Celebrex market goal of late 1998 and set the same goal for Vioxx. The document also noted an 'accelerated and compressed' drug development strategy, or beginning some studies before others were finished. 'That's called efficiency,' Nies said. 'It's called recklessness,' Lanier countered. 'It's not reckless,' Nies said." [Associated Press, 8/5/05; emphasis added]

Merck's aggressive marketing practices were highly misleading

In a misleading 2001 letter to doctors, the company clearly understated the risks that patents would be exposed to by using Vioxx. Merck even produced a game called "dodgeball" to teach pharmaceutical representatives how to avoid answering tough questions about their new blockbuster drug.

• "In a 2001 letter to doctors, Merck seriously understated the heart risks faced by patients taking its painkiller Vioxx, according to evidence presented Tuesday in the first Vioxx lawsuit to reach trial. In the letter, Merck reported that patients taking Vioxx in the largest clinical trial of the drug ever, only 0.5 percent had incurred 'cardiovascular events,' or heart and circulation problems. That would mean only about 20 patients among the more than 4,000 who took Vioxx during the study. But in fact, 14.6 percent of the Vioxx patients -- or 590 people -- had cardiovascular troubles while taking the drug, according to Merck's own report on the study to federal regulators. And 2.5 percent, or 101 people, had serious problems, like heart attacks. Merck sent the letter to thousands of doctors, including in April 2001 to Dr. Brent Wallace, who had prescribed Vioxx to Robert Ernst. Mr. Ernst, who was 59, died suddenly in May 2001 after taking Vioxx for eight months, and his family is suing Merck, claiming the drug caused his death. ...The gap between Merck's internal analysis of the study and its letter to physicians may undercut a crucial aspect of the company's defense: that Merck fully disclosed Vioxx's potential heart risks to doctors and patients during the five years the drug was on the market." [The New York Times, 7/20/05; emphasis added]



• "Mr. Lanier also introduced a marketing videotape that showed Merck sales representatives being trained to view doctors' concerns about Vioxx's heart risks as 'obstacles' to be avoided or dismissed. Another marketing document taught representatives to play 'Dodgeball' when doctors voiced concerns." [The New York Times, 8/21/05; emphasis added]



• "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.' ...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." [The New York Times, 7/21/05; emphasis added]

Merck worked to discredit those doctors not prescribing Vioxx

Doctors who weren't fooled by Merck's deceptive marketing of Vioxx were targeted by the company. Merck worked to discredit these doctors and even threatened Stanford University scientists who questioned the drug.

• "He [Mr. Lanier] also questioned internal Merck documents that said the Vioxx sales staff was to 'neutralize' or 'discredit' doctors who refused to back prescribing Vioxx." [The Houston Chronicle, 7/20/05]



• "Houston litigator Mark Lanier questioned Nancy Santanello, head of Merck's epidemiology department, about an internal list of 36 doctors identified as 'physicians to neutralize' in an e-mail circulated two months after the popular painkiller went on the market in 1999. 'Attached is the complete list of 36 physicians to neutralize with background information and recommended tactics. You will notice that some have already been 'neutralized,'' the e-mail said. It also said a previous e-mail had a subset of the 36 physicians 'we would like to get involved in Merck clinical research' and that the e-mail's recipient should 'be aware of our most challenging (and also most vocal) national and regional physicians.' Santanello said the term 'neutralize' was a marketing strategy to educate doctors about Vioxx." [Associated Press, 7/19/05; emphasis added]



• "Lanier also showed a January 2001 letter from Stanford Medical School professor Dr. James Fries to former Merck CEO Ray Gilmartin complaining that Merck researcher Louis Sherwood had called him to try to get him to make another professor stop saying negative things about Vioxx in lectures. Sherwood warned that if the professor didn't stop bashing Vioxx, he would 'flame out' and 'there would be consequences for myself and Stanford,' Fries wrote." [The Houston Chronicle, 7/19/05; emphasis added]



• "Lanier also presented documents showing that Vioxx sales staff members at one time earned a $ 2,000 bonus if one of the doctors they called on prescribed Vioxx more than 55 percent of the time and another $ 2,000 if that rate exceeded 61 percent." [The Houston Chronicle, 7/20/05]

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