Saturday, August 20, 2005


Vioxx Update 8-20

By Bruce Japsen Tribune staff reporter Sat Aug 20, 9:40 AM ET

Jurors on Friday held drug giant Merck & Co. liable in the heart-related death of a 59-year-old marathon runner who took its prescription painkiller
Vioxx, slapping the company with a $253.4 million judgment.

It was viewed as a staggering loss in the first of more than 4,200 lawsuits Merck faces and could have far-reaching implications for the pharmaceutical industry, which has been under fire in recent months for its aggressive marketing tactics.

Merck pulled Vioxx, taken by 20 million people, from the market in September after a study found that its use increased the risk of heart attack and stroke.

Still, the bulk of the jury's award, $229 million, was punitive.

The damages pushed far beyond even worst-case expectations and far exceeded the amounts juries are allowed to award under Texas state law.

A jury of seven men and five women took less than 11 hours to determine that Merck failed to warn doctors about Vioxx's danger, that the drug was improperly designed and that Merck's negligence caused the death of Wal-Mart produce manager Robert Ernst.

"I hope this will be a wake-up call to all drug companies," Carol Ernst, Robert Ernst's widow, told reporters outside of the Brazoria County District Court. "Consumers and physicians and doctors have a right to know about all of the risks of the drugs they are taking. I know in my heart [my husband] would be proud."

New Jersey-based Merck vowed to appeal the verdict and maintained that Ernst died of a heart arrhythmia, or irregular heart beat--a condition never linked to the use of Vioxx by any study.

The company also argued that it disclosed its safety data on Vioxx and took the drug off the market as soon as it determined that its safety was open to question.

Before the outcome of Friday's trial, analysts estimated that Merck's potential liability for all cases could reach $30 billion. Friday's ruling suggested it could go higher.

After news of the early-afternoon decision, Merck shares fell 7.7 percent to close at $28.06, wiping away almost $5.2 billion in market capitalization.

The repercussions in this case could be big, first on the bottom line for Merck--it made $2.5 billion a year on Vioxx-- and then for other pharmaceutical companies, which may need to rethink aspects of the overall process for bringing new drugs to market.

Already the Vioxx case has had a hand in changing drug company marketing practices. This month drug giants vowed to be more selective and less aggressive in the way they advertise new drugs to consumers, to avoid the charge that they are pushing new drugs on patients before the drugs' efficacy and side effects are fully understood.

The verdict resonated from this town 30 miles south of Houston to the nation's capital, where influential members of Congress say the jurors' action will fuel efforts to rein in drugmakers and push the
Food and Drug Administration to enhance its scrutiny of them. Legislation is pending to reform the FDA's post-marketing review of prescriptions.

"The Food and Drug Administration was also negligent in the Vioxx case," said Sen. Chuck Grassley, an Iowa Republican and chairman of the
Senate Finance Committee. "A too cozy relationship with a drugmaker put lives at risk."

Jurors said after the trial that they were shocked by the behavior of regulators and the drug companies, saying they believed documents dating back to 1997 showed Merck knew about Vioxx's risks to the heart and were surprised the drug stayed on the market as long as it did.

"This case certainly opened my eyes," said juror Rhonda Wade, a 41-year-old mother of four from nearby Clute, Texas. "They ignored an FDA warning letter about their marketing and they didn't give [regulators] all of the information."

"I will probably never take another pill without totally investigating it, questioning my doctor and pharmacists and reading all the information I can," Wade said.

Ten of 12 jurors ruled in favor of Ernst on every question posed to them. Under Texas law, only 10 members of the 12-member jury had to agree on the questions regarding Merck's behavior in bringing Vioxx to market and whether the drug was a "producing cause" of Ernst's death.

The two jurors who voted in favor of Merck on at least one question could not be reached for comment. Another juror said the dissenters argued that Ernst "could have died naturally," said 20-year-old juror and rice production worker Duffy Marcott of Lake Jackson, Texas, who voted with the majority.

"I personally believe Vioxx was a cause, not the cause, but a cause," Marcott said.

The dissension over whether Vioxx was a cause of an irregular heartbeat that led to death could help Merck fight future cases, legal observers say. Many people who took the drug for arthritis were elderly and suffer myriad health conditions.

Merck said it still plans to take on each and every claim brought against the company over Vioxx.

"There is no reliable scientific evidence that shows Vioxx causes cardiac arrythmias, which an autopsy showed was the cause of Mr. Ernst's death along with coronary atherosclerosis," said Jonathan Skidmore, an attorney on Merck's defense team.

Lanier argued that Ernst had a blood clot that caused an irregular heartbeat that caused his death.

Even though the award is likely to be reduced to $20 million to $30 million because of state caps, plaintiff attorney Mark Lanier said the ruling "is just a beautiful thing."

Among other tactics, Lanier showed documents suggesting that Merck shielded studies from regulatory scrutiny and was successful at delaying an FDA-suggested October 2001 labeling change.

There was a push to change the label after a 2000 study that showed Vioxx users suffered five times as many heart attacks as those who took an older painkiller, naproxen, also known under the brand name Aleve.



Vioxx History

Vioxx was recently recalled from the market due to unnecessary health risks placed upon its users. Because of the short and shaky history of Vioxx, current and former Vioxx users have been recommended to speak with Vioxx attorneys about possible Vioxx claims.

Vioxx was created by Merck and launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark Ceoxx. Worldwide sales of Vioxx in 2003 were $2.55 billion. Since Vioxx was launched in 1999, 91 million prescriptions for the drug have been written in the United States alone. Worldwide sales are unknown. In the past few years, Vioxx sales have been flat amid safety concerns worried about the increased incidence of blood clots tied to strokes and heart attacks found in clinical studies. Nothing was done until the latest clinical study administered by Merck proved the increased chance of heart attack or stroke from using Vioxx, and only then did the company recall Vioxx worldwide, on September 30th, 2004.

FDA approved Vioxx (also known as Rofecoxib) in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of nonsteroidal anti-inflammatory drug (NSAID) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. When it was approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.


Vioxx - Vioxx - Vioxx

Vioxx May Have Killed Thousands

An unreleased FDA study cited by the Wall Street Journal indicates that Vioxx may be linked to over 27,000 heart attacks and sudden cardiac deaths. Merck & Co. manufactured the drug which has been prescribed to millions of arthritis and pain sufferers worldwide since its launch in 1999. In response to a Merck study showing that patients taking Vioxx were more likely to suffer a cardiac event than those taking a placebo, the drug manufacturer abruptly pulled the popular drug from the market in late September.

The Wall Street Journal reported that the FDA study found that use of Vioxx might have caused 27,785 heart attacks that could have been avoided by using available prescription alternatives. The FDA and Merck have not issued a response to the Wall Street Journal article. A Merck spokesman has stated that the drug manufacturer could not comment on the study since the company had not yet been given the opportunity to review it. Analysts state that Merck is now confronting the possibility of numerous lawsuits and sizeable liability relating to the Vioxx recall.

WSJ also reported that Senate Finance Committee Chairman Charles Grassley has requested a copy of the study's findings, although the study has not been made public to date. Senator Grassley is heading a Senate committee investigation of the FDA's practices surrounding the agency's handling of safety concerns.

Reports of the FDA findings regarding Vioxx are occurring as growing speculation among scientists and European regulators emerges that other pain relievers may increase the risk of heart attack and stroke. The European Medicines Agency in London has recently released plans to review drugs similar to Vioxx. The New England Journal of Medicine published two reports relating to these issues on its website and plans to publish these works in the near future.

Celebrex, a Pfizer drug with similar attributes to Vioxx, has also fallen under scrutiny due to concerns that it causes similar ailments. Early studies have indicated that the problems associated with Vioxx apply to a class of drugs, a class including Celebrex. Numerous researchers have criticized the FDA for their failure to impose more strict testing requirements on drug manufacturers. FDA officials have previously stated that the heart problems reported were unique to Vioxx. Pfizer's medical director, Dr. Gail Cawkwell, insisted that Celebrex is safe, claiming that the studies on its drug exceeded the data gathered for Vioxx. Publication of a study challenging the safety of the Pfizer drug is planned for an upcoming October issue of New England Journal of Medicine.

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