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Latest Admission of Merck Cover-up of Vioxx Dangers Shows Need for Drug Giant to “Come Clean”
ATLA Calls on Merck to Release All Documents to Ensure Full Disclosure to Public of Vioxx Dangers

(Wednesday, May 31, 2006 -Washington DC)—Merck needs to finally “come clean’’ about the dangers presented by Vioxx, a painkiller that causes often-deadly heart problems, in light of revelations reported in The New York Times that the pharmaceutical giant misinterpreted its own data showing the drug wasn’t as hazardous as critics maintained.

The new information lends further credence to the legal claims filed against the company, asserting that Merck marketed the drug, and pocketed substantial profits, long after it knew Vioxx carried perilous side effects.

“These recent disclosures highlight the value of the nation’s civil justice system,’’ said Ken Suggs, president of the Association of Trial Lawyers of America. “Without the courthouse, America’s only remaining level playing field, Merck would still be hiding behind its phony defense that only long-term use of Vioxx is dangerous. Thousands of victims are waiting for answers. Now is the time for Merck to finally come clean with all the data on its dangerous drug.’’

Merck has proved hesitant to reveal what it knows about the dangers presented by Vioxx, pulled from the market in September 2004 amid reports it was causing serious, sometimes fatal, heart problems for some users.

After initially rejecting claims that Vioxx was deadly, Merck reluctantly admitted that heart problems could develop in patients after 18 months of use. Now the firm acknowledges the statistics collated to arrive at the 18 month determination were misinterpreted.

Documents released as the result of the lawsuits filed against the firm show Merck scientists were worried about Vioxx's potential cardiovascular risks as early as 1997, two years before the company began selling the drug. Dr. Edward M. Scolnick, at the time Merck's top scientist, said in March 2000 that the largest clinical trial conducted on Vioxx confirmed it carried heart risks.

Merck tried to hide those findings, going so far as to produce a marketing document instructing sales representatives to play ‘Dodgeball’ when doctors voiced concerns about Vioxx’s risks.

“It is well past time for Merck to publicly release every bit of scientific information it maintains on Vioxx and let the experts draw accurate conclusions free of bias,’’ Suggs said.

(Attached below are additional facts about Merck’s deadly drug Vioxx and the full New York Times story.)

The Facts About Vioxx

FACT: Merck’s own memos prove the company knew Vioxx had heart risks as early as 1997. Those risks were confirmed by a clinical trial in 2000.

• “The [internal Merck] 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. … 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]

FACT: Merck invented a game called “dodgeball” to teach drug representatives how to evade doctors’ tough questions about the safety of Vioxx.

• “[Mark Lanier, the plaintiff’s attorney] 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]

FACT: Internal Company Document Suggest Merck Allegedly Delayed Strengthening Vioxx Warning Label to Make an Extra $229 Million in Profits.

• “Lanier also showed jurors Merck internal analyses in 2001 and 2002 of the estimated amount of lost Vioxx sales if Merck put new warnings or precautions on its label, the subject of private negotiations with the FDA at the time. It figured a strict warning would reduce projected sales by at least 50 percent, according to the analysis by then-president of Merck's Human Health division, David Anstice. Another put it at $229 million in 2002.” [The Philadelphia Inquirer, 4/6/06; emphasis added]
  
  
• “[Mark Lanier] showed documents suggesting Merck shielded studies from regulatory scrutiny and was successful at delaying an FDA-suggested October 2001 labeling change. There was a push to change the label after a 2000 study showed Vioxx users suffered five times as many heart attacks as those who took an older painkiller, naproxen, which is also known under the brand name Aleve. The delay into 2002 allowed Merck, Lanier said, to sell Vioxx another four months without adding the risk information and to garner another $229 million in sales it would have lost if the label was changed.” [Chicago Tribune, 8/21/05; emphasis added]

FACT: Editor of the New England Journal of Medicine Accused Merck of Withholding Data on Vioxx.

• In an editorial published in the December 29, 2005 edition of the New England Journal of Medicine, Dr. Gregory D. Curfman, the Journal’s editor, accused Merck of misrepresenting the results of its clinical trial of Vioxx. Dr. Curfman claimed that when Merck submitted information regarding the clinical trial to the Journal, it failed to include information on three heart attacks that occurred during trial:
  
  “Until the end of November 2005, we believed that these [myocardial infarctions] were late events that were not known to the authors in time to be included in the article published in the Journal on November 23, 2000. It now appears, however, from a memorandum dated July 5, 2000, that was obtained by subpoena in the Vioxx litigation and made available to the Journal, that at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 4 1/2 months before publication of the article. Given this memorandum, it appears that there was ample time to include the data on these three additional infarctions in the article. … In addition, the memorandum of July 5, 2000, contained other data on cardiovascular adverse events that we believe would have been relevant to the article. We determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000. Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article.” [“Expression of Concern: Bombardier et al., ‘Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,’ N Engl J Med 2000; 343:1520-8.,” New England Journal of Medicine, 12/29/05; emphasis added]

FACT: Dr. David Graham, a scientist at the Food and Drug Administration, in testimony before the U.S. Congress, said that Vioxx contributed to the death of as many as 55,000 people in United States.

• “Raymond V. Gilmartin, Merck's chief executive, testified Thursday that his company followed a ‘rigorous scientific process’ as it examined the risks and benefits of Vioxx. But Dr. [David] Graham and other witnesses [testifying before the U.S. Senate Finance Committee] severely criticized Merck, saying the company should have acted years earlier to confirm the risks of Vioxx. Dr. Graham raised his estimates of those in the United States who had suffered heart attacks or stroke as result of taking Vioxx to a range of 88,000 to 139,000, up from 28,000. As many as 40 percent of these people, or about 55,000, died as a result, he said. Dr. Gurkirpal Singh, an adjunct clinical professor at Stanford University, said at the hearing that Merck scientists had tried to intimidate him after he publicly raised questions about the effects of Vioxx. Dr. Singh, a rheumatologist and science officer of the Institute of Clinical Outcomes Research and Education in Woodside, Calif., said: ‘I was warned that if I continued in this fashion there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice president and a former chief of medicine at a medical school, had extensive contacts within academia and could make life very difficult for me at Stanford and outside.’” [New York Times, 11/19/04; emphasis added]
  

The New York Times
May 31, 2006
Merck Admits a Data Error on Vioxx

By ALEX BERENSON

In an admission that could undermine one of its core defenses in Vioxx-related lawsuits, Merck said yesterday that it had erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use.

That statistical analysis test does not support Merck's 18-month theory about Vioxx, the company acknowledged yesterday.

But Dr. Peter S. Kim, Merck's chief scientist, said the company stood by the overall findings it reported in 2005 — including the conclusion that the drug's heart risks were not apparent if patients took it less than 18 months.

But outside scientists said yesterday that Merck's admission, when considered along with other clinical trials of the drug and studies tracking real-world Vioxx use, supports critics' longstanding claims that Vioxx caused heart problems quickly.

"There never was any evidence for the 18-month story," said Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University.

The 18-month issue is crucial both for the 20 million Americans who took Vioxx, an arthritis drug and painkiller, and for Merck's future. Merck faces at least 11,500 lawsuits, covering 23,000 people, from patients who say that Vioxx caused their heart attacks and strokes. Merck cited the 18-month theory when it withdrew Vioxx, a painkiller, from the market in September 2004, based on preliminary findings from a clinical trial called Approve [EXCERPT].

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As the world's largest trial bar, ATLA promotes justice and fairness for injured persons, defends the constitutional right to trial by jury, and strengthens the civil justice system through education and disclosure of information critical to public health and safety. With 60,000 members worldwide, ATLA provides lawyers with the information and professional assistance they need to serve clients successfully and protect the democratic values of the civil justice system.