Legislation

 

19 August 2005

Key events involving the safety of Vioxx, Bextra, Celebrex and other painkillers:

_December 1998: Food and Drug Administration approves Celebrex, the first cyclooxegynase-2 (COX-2) inhibitor, to treat rheumatoid arthritis and osteoarthritis. In the nonsteroidal anti-inflammatory (NSAID) drug category, it inhibits an enzyme that thins the blood to protect users against stomach bleeds and ulcers. Manufactured by Pfizer Inc.

_May 1999: FDA approves Merck & Co.'s Vioxx, another Cox-2 inhibitor, for treatment of osteoarthritis, menstrual pain and acute pain management for adults. Manufactured by Merck & Co. Inc.

_June 2000: Merck releases results of VIGOR study to FDA which shows Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than a defect in Vioxx, garnering a rebuke from the FDA for making that assertion without scientific proof.

_May 2001: Robert Ernst, a 59-year-old Wal-Mart produce manager of Keene near Fort Worth who runs marathons and teaches aerobics classes, dies in his sleep after taking Vioxx for eight months to alleviate pain in his hands. His widow, Carol, suspects Vioxx may be responsible. Dr. Maria Araneta, a pathologist for Johnson County, Texas, performs an autopsy that attributes his death to an arrhythmia, or irregular heartbeat, secondary to clogged arteries.

_September 2001: Merck receives a warning letter from the FDA about the company's post-VIGOR Vioxx promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."

_November 2001: Pfizer's Bextra, also a Cox-2 inhibitor, approved by FDA.

_April 2002: FDA changes warning label on Vioxx to reflect VIGOR study results showing increased risk of heart attacks and strokes.

_May 2002: Carol Ernst sues Merck, alleging Vioxx triggered her husband's death.

_September 2004: Merck stops long-term APPROVe study, saying it showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer. APPROVe had focused on whether Vioxx could prevent reoccurrence of colon polyps, and scientists watched for cardiovascular effects as well. Merck then voluntarily withdraws Vioxx from the market.

_February: FDA panel concludes Vioxx, Celebrex and Bextra all pose heart risks, but should be available to consumers.

_April 7, 2005: Pfizer withdraws Bextra from the market at request of the FDA, which said that in addition to risk of heart attack and stroke, it carries risk of serious, sometimes fatal skin reactions. The FDA also says not just Cox-2 inihibitors, but all other prescription NSAID drugs, should carry a black-box warning label about cardiovascular risks.

_July 13: A jury of seven men and five women is seated to hear the Ernst case in Brazoria County, a semi-rural county south of Houston.

_July 14: The Ernst case, the first of more than 4,200 state and federal lawsuits pending against Merck across the country, begins with opening statements.

_July 19: U.S. District Judge Eldon Fallon schedules the first federal Vioxx trial for Nov. 28 in New Orleans.

_Aug. 1: Araneta, whose autopsy was central to Merck's defense as proof that Robert Ernst died of an arrhythmia rather than a Vioxx-induced blood clot or heart attack, testifies for the plaintiff after Merck loses appeals to block her appearance. She attributes Ernst's arrhythmia to a blood clot that she couldn't find that led to a heart attack. Other plaintiff's experts say Vioxx induced a clot or heart attack. Merck experts say Araneta's autopsy was valid, but her opinion that a clot and heart attack were behind the arrhythmia was not.

_Aug. 17: Ernst case is handed to jurors for deliberations after hearing from 15 witnesses, including Carol Ernst, and closing arguments.

_Aug. 19: Texas jury finds Merck liable or the death of a man who took Vioxx, awarding his widow $253.4 million in damages.

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