After Vioxx Recall, FDA Renews Efforts To Ensure Safety
Lawsuits Likely To Further Damage Merck's Finances, Reputation
POSTED: 10:13 am EST November 5,
2004
UPDATED: 4:54 pm EST November 5,
2004
The Food and Drug Administration is vowing to appoint a director of drug safety and take other steps to ensure the safety of medications. The move follows congressional criticism over the recall of the pain-reliever Vioxx and comes at a time when those at risk of the flu are searching for vaccines.
Pharmaceutical company Merck withdrew Vioxx from the market on Sept. 30 because the company linked the drug to an increased risk of heart attacks.Eric Topol, cardiologist with the Cleveland Clinic, accused the FDA of minimizing the heart attack risk linked to Vioxx, alleging the agency has a climate "of suppression of ideas and concerns." An FDA official said most of the charges are not accurate. But the agency will name a director of the Office of Drug Safety, a post that's been vacant for over a year. It's also commissioning a study on whether it is effectively monitoring the drug industry. Meanwhile, a new study published in this week's issue of the British journal The Lancet also questions the FDA's actions regarding Vioxx.Swiss researchers pooled results from 29 studies of Vioxx, which totaled 20,000 patients. They found that people who took it had more than double the risk of heart attack than those given dummy pills or other painkillers.The researchers concluded that the drug "should have been withdrawn several years earlier." The researchers said there was enough evidence four years ago to justify the removal of Vioxx from the market.In a commentary accompanying the article, editor Richard Horton says licensing Vioxx and its continued use in the face of evidence of harm have been "public health catastrophes."Failure of the FDA to take decisive action against Vioxx has eroded the trust of consumers, Horton wrote. He said the episode will enhance public skepticism about "just whose interests drug makers and regulators truly represent."Merck is facing hundreds of lawsuits over the drug's side effects -- actions likely to further damage the company's finances and reputation."This controversy will not end with the drug's withdrawal," wrote Horton, who estimated Merck's litigation bill will fall between $10 billion and $15 billion."The company has seen its revenues and market capitalization slashed. It has been financially disabled and its reputation lies in ruins," he wrote. "It is not at all clear that Merck will survive this growing scandal." There's considerable concern on Wall Street about Merck's potential legal liability. Standard and Poor's warns that it may downgrade its ratings on Merck's debt because of the huge payouts the company could be forced to make.
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Fact Sheet: Merck Recalls Vioxx
Full Text: Lancet Study, Commentary Pharmaceutical company Merck withdrew Vioxx from the market on Sept. 30 because the company linked the drug to an increased risk of heart attacks.Eric Topol, cardiologist with the Cleveland Clinic, accused the FDA of minimizing the heart attack risk linked to Vioxx, alleging the agency has a climate "of suppression of ideas and concerns." An FDA official said most of the charges are not accurate. But the agency will name a director of the Office of Drug Safety, a post that's been vacant for over a year. It's also commissioning a study on whether it is effectively monitoring the drug industry. Meanwhile, a new study published in this week's issue of the British journal The Lancet also questions the FDA's actions regarding Vioxx.Swiss researchers pooled results from 29 studies of Vioxx, which totaled 20,000 patients. They found that people who took it had more than double the risk of heart attack than those given dummy pills or other painkillers.The researchers concluded that the drug "should have been withdrawn several years earlier." The researchers said there was enough evidence four years ago to justify the removal of Vioxx from the market.In a commentary accompanying the article, editor Richard Horton says licensing Vioxx and its continued use in the face of evidence of harm have been "public health catastrophes."Failure of the FDA to take decisive action against Vioxx has eroded the trust of consumers, Horton wrote. He said the episode will enhance public skepticism about "just whose interests drug makers and regulators truly represent."Merck is facing hundreds of lawsuits over the drug's side effects -- actions likely to further damage the company's finances and reputation."This controversy will not end with the drug's withdrawal," wrote Horton, who estimated Merck's litigation bill will fall between $10 billion and $15 billion."The company has seen its revenues and market capitalization slashed. It has been financially disabled and its reputation lies in ruins," he wrote. "It is not at all clear that Merck will survive this growing scandal." There's considerable concern on Wall Street about Merck's potential legal liability. Standard and Poor's warns that it may downgrade its ratings on Merck's debt because of the huge payouts the company could be forced to make.
Previous Stories:
- November 1, 2004: Report: Merck Aware Of Vioxx Risk Long Before Recall
- October 7, 2004: Vioxx May Not Be Only Drug With Heart Risk
- October 6, 2004: Report: Government Study Uncovers Vioxx Risks
- October 5, 2004: Class-Action Lawsuit Filed In Illinois Over Vioxx
- October 4, 2004: Missouri Mom Sues Vioxx Maker For Daughter's Death
- October 1, 2004: Vioxx Recall Prompts Patients To Look For Alternatives
- September 30, 2004: Arthritis Patients Scramble For Alternatives Amid Vioxx Recall
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