Why the Data Diverge on the Dangers of Vioxx
May 31, 2006 16:07

The New York Times May 22, 2006 Why the Data Diverge on the Dangers of Vioxx By ANDREW POLLACK and REED ABELSON Eighteen months. Ever since Merck pulled its arthritis painkiller Vioxx off the market in September 2004 on evidence that it could cause... (Read this Vioxx Article)

May 2 (Bloomberg) -- Merck & Co.'s Vioxx painkiller may raise the risk of a heart attack within two weeks after patients start taking the drug, earlier than previous studies have shown, according to Canadian researchers. More than a fourth of 239 elderly... (Read this Vioxx Article)

RIO GRANDE CITY, Texas -- A Texas state jury has awarded $32 million to the family of a 71-year-old man who suffered a fatal heart attack in 2001 after taking Vioxx for less than a month. Garza, et al. v. Evans, et al., No. DC-03-84 (Texas 229th Jud. Dist. Ct., Starr Cty.). The April 21 verdict was reached moments ago by the 10-man, two-woman jury after about eight hours of deliberations over two days in the 229th Judicial District Court for Starr County. The damages awarded to the family of Leonel Garza Sr. include $7 million in compensatory damages for mental anguish and personal loss, and $25 million in punitive damages.

New research published in the March 2006 edition of the Journal of the Royal Society of Medicine indicates that the popular arthritis and painkilling drug celecoxib (CELEBREX) may double the risk for heart attacks compared to older arthritis medications.... (Read this Vioxx Article)

"A state judge on Wednesday refused a plaintiff's motion to lift a Texas cap on jury awards for punitive damages in a lawsuit over Merck & Co.'s once-popular painkiller Vioxx. State District Judge Alex Gabert ruled in the lawsuit brought by a family of a retired 71-year-old man seeking $1 billion - one of nearly 10,000 suits alleging the once-popular painkiller caused heart attacks. Texas caps punitive damages at twice the amount of economic damages awarded, and at $750,000 in addition to any non-economic damages awarded such as those for pain and suffering." Read More...

"Painkillers called COX-2 inhibitors may increase the risk of heart attacks by raising blood pressure and making the blood more likely to clot, researchers said on Thursday. They do so by the same mechanisms that they use to reduce pain and inflammation, said... (Read this Vioxx Article)

"Merck & Co., which is already facing a raft of cases over its pain reliever Vioxx, may need to hire additional attorneys to fight a recently filed lawsuit alleging the company was negligent in promoting its osteoporosis drug Fosamax. According to a lawsuit... (Read this Vioxx Article)

ATLANTIC CITY, N.J. - Merck & Co. asked a judge Friday to declare a mistrial in the case of two men who blame their heart attacks on Vioxx, saying a plaintiff's attorney tried to influence the jury by disclosing that his client had written letters to jurors thanking them for their service.

Linda A. Johnson, Associated Press, Boston Globe, 1/18/06
Vioxx Lawyers to Question Journal Editors "A current editor and former editor of the New England Journal of Medicine, which last month criticized drug maker Merck & Co. for withholding data from a published study on its withdrawn painkiller Vioxx, will be grilled next week by the company's lawyers. The depositions, ahead of the next round of product liability trials over Merck's former blockbuster arthritis pill, will be held next Tuesday and Wednesday, Paul Shaw, an attorney representing the editors, said Wednesday. The depositions are to center on a December editorial in the journal, one of the world's most respected medical publications, that said Merck concealed three heart attacks suffered by patients in a large study published in the journal in November 2000. Whitehouse Station, N.J.-based Merck has said those heart attacks happened after the study's cut-off date for side effects, but journal editors say such data is routinely added until a study's publication. The editorial also alleges the study's authors deleted some relevant data before submitting their article."

"The judge overseeing federal lawsuits over Merck & Co. Inc.'s Vioxx painkiller said he might end his effort to combine the cases for a possible settlement because of delays in getting some claims to trial. U.S. District Judge Eldon Fallon in New Orleans said he was having trouble getting jury trials scheduled after Hurricane Katrina displaced thousands of residents and shut the city's courthouses for months. Plaintiffs' attorneys are pressing ahead with similar Vioxx suits in state courts around the United States. Fallon, at a hearing on Tuesday, said he might 'shut down' the consolidation 'if all the cases are being tried in state court before we get one tried in federal court.' Bloomberg News, The Philadelphia Inquirer, 1/6/06

LA Times, 1/3/06: "For someone mired in judicial purgatory, Superior Court Judge Carol E. Higbee is remarkably upbeat. She doesn't want pity - many judges work as hard, she says. She doesn't want publicity - it makes her uncomfortable, and she grants interview requests grudgingly. She just wants justice - and she's ready to dispense it, one Vioxx case at a time, even if it takes a lifetime. And at the current rate, it could, assuming the cases are not settled or withdrawn. Higbee, 55, is the New Jersey judge assigned to thousands of cases brought in state court against Merck & Co. over its now-withdrawn painkiller Vioxx. The lawsuits - all 4,333 of them - blame the pharmaceutical company for heart attacks and strokes suffered by users."

Salt Lake Tribune: "Drug companies are making public more information about medical studies they are conducting, but some still withhold key details, a new analysis of a federal registry finds. Merck & Co., stung by allegations that it hid information on Vioxx's dangers, gets somewhat better marks in the new analysis than it did in an earlier one. However, Pfizer Inc., GlaxoSmithKline PLC and Novartis AG are lagging, according to the report in Thursday's New England Journal of Medicine. In May, the Journal's editor-in-chief accused Merck, Pfizer and Glaxo of making a mockery of efforts to increase the transparency of such experiments, called clinical trials. The new report shows some progress, said its chief author, Deborah Zarin of the National Library of Medicine, which runs the registry. 'We're getting a lot of trials being registered,' including many that U.S. drug companies are doing in foreign countries, she said."

CHRONOLOGY-Key events in the history of Merck's Vioxx

A timeline of Vioxx's history follows:

1998

*Nov. 1998 - Merck files an application with the FDA seeking U.S. approval of Vioxx.

1999

Jan. 1999 - Vioxx Gastrointestinal Outcomes Research (VIGOR) trial begins, aiming to show whether Vioxx causes fewer ulcers and other gastrointestinal problems than the standard arthritis treatment naproxen.

*Feb. 1999 - Merck begins first clinical trial of Vioxx to see whether it can treat Alzheimer's disease. A second trial begins in April 2000.

May 20, 1999 - FDA approves Vioxx for the relief of osteoarthritis symptoms, management of acute pain and primary dysmenorrhea, or painful menstruation.

2000

March 2000 - Merck unveils data from Alzheimer's trials, which it said showed no difference in heart problems between patients on Vioxx and others taking a placebo.

June 2000 - Merck submits to the FDA final data from the VIGOR study, which it said showed a decrease in gastrointestinal problems but a four-fold higher risk of heart attacks compared with naproxen.

2001

Feb. 2001 - FDA Arthritis Advisory Committee meets to discuss the gastrointestinal VIGOR study.

2002

April 11, 2002 - FDA approves changes to Vioxx label which include cardiovascular risks, gastrointestinal benefits and a new use to treat rheumatoid arthritis.

2004

Sept. 27, 2004 - Merck tells the FDA a study to see if Vioxx could prevent colon polyps showed twice the risk of heart attacks among patients taking Vioxx for 18 months as those who took placebos.

Sept. 28, 2004 - FDA officials meet with Merck, which tells the agency it will voluntarily withdraw Vioxx. Two days later Merck announces the withdrawal.

Nov. 18, 2004 - Congress holds hearing on Merck and the FDA's handling of the drug's safety issues.

2005

Aug. 19, 2005 - Merck is found negligent in the marketing and design of Vioxx and is ordered to pay $229 million in punitive damages and $24 million for mental anguish and loss of companionship to the widow of a Texas man.

The total award is expected to be cut to about $26 million because of Texas laws limiting damages.

Nov. 3, 2005 - Merck is exonerated in a New Jersey lawsuit involving a man who suffered a heart attack after taking Vioxx but survived. The case was the first tried of thousands of cases filed against Merck in the state.

Dec. 8, 2005 - The New England Journal of Medicine says Merck deleted dangers linked to Vioxx, including three heart attack deaths among users, in its analysis of the VIGOR study.

Dec. 12, 2005 - A U.S. judge declares a mistrial in the first federal lawsuit after a jury fails to reach a unanimous verdict in a case brought by the widow of a Florida man. The case is expected to be retried in 2006.

Source: FDA

According to sources, jurors told Judge Fallon midway through deliberations on Saturday that they could not reach a consensus on whether Merck failed to properly warn of cardiovascular dangers associated with Vioxx, which plaintiff Evelyn Irvin Plunkett alleged was the cause of her husband's death.

NEW YORK -- Merck & Co.'s failure to disclose information about additional heart attacks in a Vioxx clinical trial to a prominent medical journal strengthens plaintiffs' cases because it bolsters claims that the company deliberately disguised the pain reliever's risks, experts said

Mid-morning, the five men and four women on the jury sent word to U.S. District Judge Eldon Fallon that they were having trouble reaching a verdict. They've been working since Thursday afternoon to decide if Vioxx played a role in the fatal heart attack of 53-year-old Richard "Dickie" Irvin in 2001.

"As if Merck & Co. did not have enough problems with thousands of Vioxx personal injury cases pending against the company, a state court in Atlantic City, N.J., has certified a nationwide class of third-party payors alleging that the corporation misrepresented or omitted material Vioxx information, causing all class members to erroneously list and pay for the drug. Inexplicably, the court ruled that the question of whether thousands of third-party payors were misled by Merck's advertising was a "predominant" common issue that did not require an individual analysis of each purchase decision made by each member of the class. Even worse for Merck, the court held that New Jersey law applied in all 50 states, although a number of states preclude consumer class actions altogether and numerous other states require individual proof of reliance on the allegedly deceptive ads, also precluding class certification. Unless reversed on appeal, this ruling could subject Merck to refund claims by millions of Vioxx customers amounting to billions of dollars. International Union of Operating Engineers Local No. 68\Welfare Fund v. Merck & Co., No. ATL-L-3015-03 (Atlantic Co., N.J., Super. Ct. Law Div. July 29, 2005)." Hugh Latimer, National Law Journal, 12/5/05

"While president of Merck Research Laboratories, Edward Scolnick told some colleagues he was in 'minor agony' about whether the pain-reliever Vioxx led to heart attacks, according to a videotaped deposition played for jurors yesterday in the nation's first federal trial involving the drug. Jurors watched several depositions by Scolnick, who is now retired. He said he initially believed a 2000 study showing Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Although he changed his mind several months later and still attributes the disparity to naproxen's heart-friendly qualities rather than a defect in Vioxx, Scolnick said he wanted Merck to do other studies that were not done." Angela K. Brown, Associated Press, 12/6/05