Vioxx World

A nation asleep: the Vioxx deception put into perspective

2006-08-18T07:10:00.000-07:00

According to estimates by the FDA's senior drug safety researcher, Dr. David Graham, the drug Vioxx caused over 140,000 heart attacks in patients, likely killing more than 60,000 Americans who took the drug.

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Is The FDA Too Cozy With Drug Makers?

2006-07-31T07:10:00.001-07:00

Dr. Graham butted heads with his FDA managers in trying to get the word out about Vioxx's risks.

"The FDA officials didn't want to allow me to present my work at a scientific conference, but at the same time they wanted to be sure that Merck had a copy of my scientific presentation," Dr. Graham said. "So it's good enough for Merck, but it's not good enough for the American people?"

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Merck Not Losing Sleep Over Vioxx Disaster

2006-07-19T07:10:00.001-07:00

"[Merck] believes that lower court cases will be overturned on appeal, and it is even considering trying to reintroduce Vioxx."

The FDA is unlikely to allow that!

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Is Pet Version of Vioxx Safe?

2006-07-14T07:13:00.002-07:00

"With pets living longer and becoming more important members of the family than ever, the demand for pet pharmacology has grown and the drugs they take are very similar to the ones we're prescribed. So, when a drug we use is pulled off the market, should you be concerned if your pet is taking its equivalent?"

Wow. Only in America, I guess.

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Merck Legal Team Makes A Killing Off Losing Vioxx Strategy

2006-07-07T07:10:00.001-07:00

[T]he company has not set aside one dime for potential damage awards in Vioxx trials through 2007. Which means the only good news to report as far as Merck's legal strategy of a case by case defense of thousands of lawsuits in the years ahead, is that the company's legal team will keep raking in dough while Merck slowly goes under.

An interesting article, although I don't know about Merck "going under," as it has quite a few high-profile drugs in the pipeline that analysts say could be huge earners.

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Witness says studies showed Vioxx users at risk of heart ailments

2006-07-07T07:10:00.000-07:00

Patients who took the painkiller Vioxx were at risk of heart attacks and stroke - something shown by studies conducted years before the product went on the market, a doctor testified Wednesday.

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Judge Signs Final Judgment in First Vioxx Trial

2006-07-03T07:10:00.002-07:00

Ten months after a jury in Angleton returned a $253.4 million verdict in the nation's first Vioxx trial, 23rd District Judge Ben Hardin signed a final judgment awarding the plaintiffs $26.1 million in damages, plus $1.25 million in pre-judgment interest.

It has been a long road to this award.

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Key Vioxx Claim Withdrawn

2006-06-30T07:10:00.002-07:00

The journal that published a key Merck study has withdrawn the conclusion that it takes 18 months for Vioxx to increase patients' risk of heart attack and stroke, potentially dealing a blow to the drug company, both in its public image and its legal battles.

This is huge news for Vioxx litigants.

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Jury Selection Begins in Vioxx Trial

2006-06-28T07:10:00.001-07:00

Jury selection began Wednesday in a lawsuit by a California man who claims he suffered a heart attack after taking the painkiller Vioxx _ one of more than 13,000 such claims brought against drug maker Merck & Co. nationwide.

The Southern California man, Stewart Grossberg, claims he took Vioxx for more than two years before he had a heart attack at 66.

At least the "18-month" issue won't play a part.

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What if the albatross around Merck's neck is an illusion?

2006-06-23T07:10:00.001-07:00

One big booster of Merck shares is Michael Krensavage, a pharmaceuticals analyst at Raymond James who has covered the industry for a decade. Krensavage is often harshly critical of companies he covers. He was among the first to point to dodgy accounting practices at AAIPharma before that company fell into bankruptcy (it has since reemerged). Before Merck pulled Vioxx, he had a "sell" recommendation on the stock. But now he says that fear of Vioxx is keeping investors away from a strong company.

"I just don't think the Street gets it," says Krensavage. "The estimates of tens of billions of dollars of liability are just wrong. I think it's one of the biggest misperceptions I've seen in pharmaceutical investing."

If Merck is in fact not in as much punitive hot water as is largely accepted, then perhaps it is a company on the verge of success, with many potentially hot drugs in the pipeline.

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Lanier Tactic Shows There's 'Desperate' -- and There's Successful

2006-06-21T07:11:00.000-07:00

"Lanier spun the case like four episodes of "Desperate Housewives," the popular prime time soap opera several jurors had indicated that they watched. Between each story, he paused for a "commercial break," playing a Vioxx advertisement for emphasis."

An interesting look at one particular Vioxx case.

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Prominent doctor who criticized Merck deposed for Vioxx trials

2006-06-19T07:10:00.001-07:00

" Dr. James F. Fries expressed his concerns about Merck's behavior, including suppressing Vioxx data, to the company's then-chief executive, Raymond Gilmartin, in a letter dated Jan. 9, 2001. He wrote that Merck has been trying to "systematically downplay some unusual side effect patterns of Vioxx" and that its employees have "systematically attacked those investigators or speakers who expressed what Merck staff felt were critical opinions in a manner which seriously impinges on academic freedoms." "

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Vioxx Timeline

2006-06-12T08:34:00.000-07:00

An interesting piece at NPR: a Vioxx Timeline, part of a larger report, Vioxx: The Downfall of a Drug.

Merck Goes for Early Knockout in Calif. Vioxx Case

2006-06-09T07:10:00.000-07:00

"With only a few weeks before the start of its first California trial involving Vioxx, Merck & Co. is seeking to have one of the cases thrown out on statute of limitations grounds."

"The two Los Angeles suits are among 1,800 cases in California filed against Merck since September 2004, when the company withdrew Vioxx from the market. Attorneys on both sides each got to select a case for trial."

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Merck admits Vioxx error

2006-06-05T07:10:00.000-07:00

"On Tuesday, Merck said that it had made a mistake in reporting that result last year. In reality, the test that the company said it had used to check the results showed that there was a 7 percent chance that Vioxx had an equally high risk of causing heart attacks both before and after the 18-month benchmark."

More evidence that the 18-month theory is a myth.

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Lawyer: Latest Vioxx plaintiff may be most sympathetic

2006-06-02T07:10:00.000-07:00

"[The] case, which starts with jury selection Friday in Atlantic City, is the seventh to come to trial out of more than 13,000 lawsuits filed so far. The trial will be the first since new Vioxx research results raised questions about how quickly the drug could cause harm, potentially undermining the credibility of Merck, which has vowed to fight every lawsuit individually. "

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The Vioxx Maelstrom

2006-05-26T07:13:00.000-07:00

"...the Vioxx mess is signaling big changes for how clinical trials will be conducted. More information about studies will likely be published before they are started, so that scientists can debate the way they are designed before they are signed up. Moreover, drug firms are increasingly pushing to eventually make more results publicly available on Web sites. But those changes are coming too late for Merck, and now the company and its critics are left in a public battle over exactly what the results of the [APPROVe] study mean."

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Merck wins Vioxx lawsuit

2006-05-19T07:10:00.000-07:00

"Merck, a U.S. drug maker, on Tuesday won dismissal of a shareholder lawsuit alleging that company officers breached their fiduciary duties in their oversight of the painkiller Vioxx.

The judge in the case, Stanley Chesler of the U.S. District Court in Newark, New Jersey, ruled that the plaintiffs had failed to show that Merck directors were negligent for allowing Vioxx to be developed and sold. He also denied shareholders' request to amend the suit."

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In The Story Of Vioxx, A Media Angle

2006-05-17T07:11:00.001-07:00

"The [Wall Street] Journal takes an exhaustive look at NEJM’s missteps as well as the broader implications of such practices among medical journals in general. One doctor told the Journal that while NEJM should be praised for eventually issuing doubts about the article, they should have corrected it far sooner: “Had it acted earlier, he says, sales of Vioxx, ‘would have been killed.’"

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Study: Vioxx Users Not at Increased Risk

2006-05-14T18:47:00.003-07:00

"Merck said data from a "preliminary safety analysis" of an additional year of patient follow-up, part of the study's original plan, did not show a statistically significant difference in the rate of heart attacks and strokes among patients who had been on Vioxx and those who had taken a dummy pill. That means the differences over that year could have been due to chance.

However, the new data shows that in the 12 months after the study's three-year treatment phase, 28 patients who had been on Vioxx had heart attacks or strokes caused by blood clots, compared with 16 of the patients who had taken placebos. The difference was mainly because seven patients who had been on Vioxx suffered a stroke compared to none in the placebo group."

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ePharmaceuticals Launches Drug Safety Newsletter

2006-05-08T07:16:00.000-07:00

"With thousands of Vioxx-related product liability lawsuits, tighter oversight by the FDA's new Office of Drug Safety, FDA-mandated risk management plans and risk communication, and intense Congressional and media scrutiny, drug safety is in the spotlight more than ever before. These factors have created an environment in which pre- and post-approval drug safety, risk management, and risk communications can make or break a drug. "

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Merck payouts could be lethal

2006-05-05T07:11:00.000-07:00

"So far, Merck has won two cases and lost two concerning Vioxx. It still faces about 9,650 cases in state and federal courts. If it loses half of them and the pattern of awards continues, it could most likely bankrupt Merck. It certainly would remove money that could be used for research to discover new medicines, almost certainly would require even higher prices for its prescription drugs and could result in some medicines many people depend upon being no longer available."

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New Vioxx Study Could Put the Hurt on Merck

2006-05-03T21:25:00.000-07:00

"Canadian researchers say older people who took the Merck pain reliever Vioxx for the first time had an elevated risk of an initial heart attack within two weeks of taking the drug.

The study's results, which contain a number of caveats, clash with Merck's assertion that Vioxx-takers had a heightened risk of cardiovascular problems after taking the drug for more than 18 months."

The 18-month issue will prove to be pivotal for future litigation.

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No Defense For This Insanity

2006-05-01T07:10:00.000-07:00

"How do the Vioxx lawsuits glorify prejudice? Well, the first case brought against Merck, the painkiller's manufacturer, concerned a man who, according to his autopsy, had died of an irregular heartbeat -- a condition that, unlike heart attacks, is not actually associated with Vioxx. Moreover, the placebo-controlled trial that linked Vioxx to heart attacks and led to Merck's voluntary withdrawal of the drug from the market found no adverse effects until after 18 months; the alleged victim had taken the medication for only eight months. These scientific niceties didn't matter to the jury. "Whenever Merck was up there, it was like wah, wah, wah," one juror told the Wall Street Journal. "We didn't know what the heck they were talking about."

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Public deserves drug trial access

2006-04-28T07:10:00.000-07:00

"EVER since pharmaceutical companies were given permission to flood the airwaves, newspapers and magazines with advertisements for prescription drugs, they have not been shy about hawking pills to treat everything from herpes to acid reflux disease to erectile dysfunction.

It follows, then, with the public appetite whetted by such direct-to-consumer advertising for drugs promising to cure what ails them, the consumer should be given access to the whole story, not just 30 seconds of marketing hype. Granting consumers access to the clinical trials used in placing these drugs in the marketplace - and responsible for stamping them "safe" - is a better way to truly inform the public. And that is the purpose of a new bill authored by veteran state Sen. Jack Scott, D-Pasadena."

Seems like common sense. The disclaimers at the end of drug commercials really are cursory at best.

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Merck's Vioxx Liability Appears 'Manageable'

2006-04-26T14:01:00.000-07:00

"Given the cap on punitive damages in Texas, the total award is likely to be reduced to $7.8 million, which in our view still is a big award against Merck," wrote analyst Roopesh Patel. "This is the second Vioxx case tried in Texas, and both verdicts have been unfavorable."

The research analyst maintained an estimated total liability of approximately $10 billion, which Patel said was "manageable" for Merck given its large cash reserves.

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Texas jury awards $US32 million in Vioxx case

2006-04-25T15:01:00.002-07:00

A Texas jury today found that the painkiller Vioxx caused the death of a 71-year-old man who had taken the drug for less than a month, and awarded his family damages of $US32 million, which will be greatly reduced by state law.

The verdict in what legal experts had said was a weak case against Vioxx maker Merck & Co. Inc. may raise pressure on the company to start settling some of the 10,000 other cases it now faces, analysts said.

Merck said it would appeal the decision.

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Welcome

2006-04-24T15:12:00.000-07:00

Welcome to Vioxx World. Vioxx was a drug marketed by Merck that was voluntarily pulled from the market in September of 2004. The reason for pulling such a popular drug (used by roughly 85 million people worldwide) was several studies that linked Vioxx to increased heart attack and stroke rates in users. The repercussions of these studies have resulted in numerous individual and class action law suits brought against Merck. Almost 2 years later, the Vioxx name still draws heated arguments.

My goal with this blog is to educate. Vioxx is in the news almost daily. I'd like this blog to serve as a filter for Vioxx related news and studies, pointing readers to the most important issues surrounding the drug.

Companies that deal directly with medicine and affect the human body need to be held to a different standard. Lawmakers who intend to serve the public interest should do their part as well, to ensure that the next Vioxx never happens.