2008 Woodie Awards
Vioxx Pulled; Hightens User Concerns
FDA under scrutiny after approving drug with dangerous side effects.
LaGina Phillips
Issue date: 10/13/04 Section: News
- Page 1 of 1
Vioxx, a drug used to treat arthritis pain, was pulled worldwide from the market Sept. 30 by pharmaceutical giant Merck & Co. after studies concluded that the drug may be responsible for more than 7,000 deaths and 27,000 heart attacks.
The latest study, conducted by a Food and Drug Administration researcher, along with other scientists and sponsored by leading health insurance company Kaiser Permanente, served as the final blow to Merck, the drug's maker, noting that from Vioxx's approval in 1999 through 2003 it has contributed to an estimated 27,785 heart attacks.
"It's a sad time, mostly for patients, many of whom had their lives transformed by Vioxx," said Edward M. Scolnick, Merck's former research president, who oversaw Vioxx development and approval in the 1990s.
Nearly two million people worldwide were taking the drug at the time it was pulled from the market.
Merck's chairman and chief executive, Raymond Gilmartin, is adamant that his firm handled the early health warnings about the drug well. According to Gilmartin, he first learned of the evidence of Vioxx's dangerous side effects two weeks ago when Merck's president of research, Peter S. Kim, confirmed that a clinical trial oversight committee had recommended halting a study of Vioxx as a treatment for colon cancer because the risk to patients was too high.
"It was totally out of the blue," Gilmartin said. "I was stunned. This was totally unexpected."
A month earlier, Merck had defended the safety of Vioxx after a separate study suggested it could harm patients.
Gilmartin agreed to pull the $2.5 billion-a-year drug off the market four days after getting confirmation of the drug's side effects from Kim. Three days later, on Sept. 30, Merck disclosed the decision, causing the market value of the company to drop 25 percent.
The potential for elevated cardiovascular risk for Vioxx was first reported in a medical journal in 1999, the same year the medication was approved by the FDA. A Merck-sponsored clinical study in 2000 also indicated a higher degree of risk for cardiovascular complications, which prompted the company to include a relatively mild caution on its label in 2002.
But the New Jersey-based company and the FDA insisted that the indications of risk were small and inconclusive. Merck continued to aggressively market its drug to consumers through television and magazine advertisements.
The first worldwide class action lawsuit was filed Oct. 5 and more are expected to follow, while similar drugs, such as Celebrex and Bextra, remain on the market. But the authors of two reports released last week by the New England Journal of Medicine said Celebrex and Bextra also may raise the risk of heart attacks and strokes.
The latest study, conducted by a Food and Drug Administration researcher, along with other scientists and sponsored by leading health insurance company Kaiser Permanente, served as the final blow to Merck, the drug's maker, noting that from Vioxx's approval in 1999 through 2003 it has contributed to an estimated 27,785 heart attacks.
"It's a sad time, mostly for patients, many of whom had their lives transformed by Vioxx," said Edward M. Scolnick, Merck's former research president, who oversaw Vioxx development and approval in the 1990s.
Nearly two million people worldwide were taking the drug at the time it was pulled from the market.
Merck's chairman and chief executive, Raymond Gilmartin, is adamant that his firm handled the early health warnings about the drug well. According to Gilmartin, he first learned of the evidence of Vioxx's dangerous side effects two weeks ago when Merck's president of research, Peter S. Kim, confirmed that a clinical trial oversight committee had recommended halting a study of Vioxx as a treatment for colon cancer because the risk to patients was too high.
"It was totally out of the blue," Gilmartin said. "I was stunned. This was totally unexpected."
A month earlier, Merck had defended the safety of Vioxx after a separate study suggested it could harm patients.
Gilmartin agreed to pull the $2.5 billion-a-year drug off the market four days after getting confirmation of the drug's side effects from Kim. Three days later, on Sept. 30, Merck disclosed the decision, causing the market value of the company to drop 25 percent.
The potential for elevated cardiovascular risk for Vioxx was first reported in a medical journal in 1999, the same year the medication was approved by the FDA. A Merck-sponsored clinical study in 2000 also indicated a higher degree of risk for cardiovascular complications, which prompted the company to include a relatively mild caution on its label in 2002.
But the New Jersey-based company and the FDA insisted that the indications of risk were small and inconclusive. Merck continued to aggressively market its drug to consumers through television and magazine advertisements.
The first worldwide class action lawsuit was filed Oct. 5 and more are expected to follow, while similar drugs, such as Celebrex and Bextra, remain on the market. But the authors of two reports released last week by the New England Journal of Medicine said Celebrex and Bextra also may raise the risk of heart attacks and strokes.
