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Vioxx

ALSO NOTED: Celebrex cancer study on; FDA rejects Xinlay; and much more...

> Despite parallels to the Vioxx study which damaged Merck, Pfizer has given the go ahead for the M.D. Anderson Cancer Center to study Celebrex's potential value as a cancer treatment. Story

> WebMD Health Holdings (the website businesses which are being spun off from the newly renamed Emdeon) priced shares in its …

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FDA weighs decision on BMS drugs this week

This week FDA regulators will review two potential blockbuster drugs from Bristol-Myers Squibb -- the rheumatoid arthritis drug Orencia and Pargluva, a treatment for diabetes. Industry observers say how the agency handles the decisions will reveal a lot about its approach to drug-safety in the post-Vioxx era. Research has raised questions about the safety of both drugs. A study released last week showed a substantially increased risk of infection for patients taking Orencia. Where is the …

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ALSO NOTED: BCBS of Michigan launches consumer website; Presumed consent seen as answer to organ donation problem; and much mor

> Blue Cross and Blue Shield of Michigan and partner Subimo have launched a new website to serve the plan's 4.5 million customers. Release

> The FDA said it has approved Actoplus Met, a new diabetes drug developed by Japan's Takeda pharmaceuticals. …

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Editor's Corner


This week's news was dominated by last Friday's verdict in the Vioxx case that was either a decisive blow against the evils of capitalism or the end of Western civilization as we know it, depending on your point of view. The Vioxx case is perhaps a sentinel event. It could be what's needed to spur big pharma, the FDA, the medical profession and the public into a new compact. In this …

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Merck documents may worsen company's case

Meanwhile, in another potentially ominous development for Merck, the AP is reporting that it has obtained documents showing that Merck began work on a method of reducing the cardiovascular dangers of Cox-2 inhibitors in 1998, a fact that critics are likely to interpret as proof that the company was fully aware of the risks associated with the drug before it went on the market in 1999.

- see this …

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Jury awards Ernst $253.5M in Vioxx suit

News of the Vioxx verdict dominates the media this morning. While the $253.5 million in damages awarded to the widow of a user of the painkiller who died of a heart attack in 2001 will likely be sharply reduced, most observers are agreed that the impact of the decision is likely to be felt for years.

How did it happen and what does it mean? Opinion is divided. The New York Times writes that the hardball tactics pursued by the defense team misfired completely, leaving the …

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$40M award sought in Vioxx lawsuit

In his closing arguments in the first Vioxx trial yesterday, attorney W. Mark Lanier told jurors that Carol Ernst should receive $40 million in compensatory damages from drug giant Merck for the death of her husband, Robert. The Houston lawyer said "punitive damages should be many times that." Jurors begin their deliberations today. The trial is being closely watched by lawyers and analysts around the country for indications of what the future may hold for Merck. More than 4,000 people …

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Pivotal week in Vioxx trial

As arguments in the first Vioxx trial come to a close, legal observers think the outcome of the wrongful death lawsuit against Merck is likely to hinge on the instructions the judge gives to the jury. If they think Vioxx was to blame for the death of Robert Ernst, jurors will now have to decide if Vioxx alone was responsible or if it was a "contributing factor." Plaintiff attorney W. Mark Lanier argues it is enough for the drug to have been a "contributor." Merck attorneys counter that …

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Gilmartin: 'Vioxx could be back on the market'

Former Merck CEO Raymond Gilmartin told jurors that the drug company is "in discussions with the FDA as to whether or not and under what circumstances," Vioxx should be allowed back on the market, in testimony in the Ernst v. Merck case. In a videotaped deposition, Gilmartin told jurors that the company believed Vioxx was safe until researchers uncovered evidence linking the drug to cardiovascular events in 2004. That, of course, was essentially the script which the former executive, who …

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Baylor pathologist: Vioxx not to blame in Ernst death

Most media reports have suggested that Merck is not faring well in the wrongful death suit over Vioxx after two weeks of testimony generally hostile to the drug maker. But now the drug company gets its turn, as Merck lawyers introduce witnesses of their own. On Monday, the head of pathology at the Baylor College of Medicine testified that he does not think Vioxx was to blame for the death of Robert Ernst in 2001. Dr. Thomas Wheeler said he thinks hardened arteries, not Vioxx, were …

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