Merck Vioxx News and Press Releases

Political Gateway - Feb 21 - Vioxx is more than a medical controversy, it is a political one too. Vioxx studies show huge risk to patients, stocks have fallen, research confirms risk, FDA approves Vioxx for use, British patients sue the maker of Vioxx.

Here is a complete list of the stories by date.

British Vioxx patients to sue Merck in US: report 02/19/2005
FDA panel narrowly approves Vioxx, but cites risk in drug category 02/18/2005
Research confirms health risks of Vioxx, Celebrex and Bextra 02/16/2005
Vioxx woes push down Merck profit 01/25/2005
Vioxx may have caused up to 140,000 US cases of heart disease: study 01/24/2005
US official determined to publish Vioxx risk study 01/03/2005

British Vioxx patients to sue Merck in US: report

LONDON, Feb 20 (AFP) - More than 100 British patients who suffered heart attacks or strokes while using the controversial painkiller Vioxx are pursuing its US manufacturer Merck in what could become the biggest legal action against a drugs company, a newspaper reported on Sunday. The alleged victims have joined forces with a US law firm preparing to sue Merck in the United States, The Business weekly said, citing legal sources. Locks Law Firm -- which already has 300 American patients bringing individual actions in New Jersey, Merck's home state -- was still gathering evidence but hoped to move towards the trial-setting stage in April, a partner at the comany, Marc Weingarten, told the financial newspaper. "The number of claims internationally will grow as more patients affected by Vioxx come forward," it predicted.

Any relief from a decision on Friday by the US food and drugs watchdog to allow Mercks to return its drug to the shop shelves would likely be short-lived, The Business said, warning that claims against the firm could total more than 18 billion dollars over the next decade.
Vioxx and other similar drugs widely prescribed for arthritis and severe pain have all come under fire recently for being linked to a higher incidence of cardiac problems in some patients. A study last month revealed that Vioxx may have caused as many as 140,000 cases of serious coronary heart disease in the United States before it was pulled from shelves last September.

FDA panel narrowly approves Vioxx, but cites risk in drug category

GAITHERSBURG, Maryland, Fed 18 (AFP) - A US health advisory panel Friday confirmed cardiovascular risks from certain anti-inflammatory drugs, but agreed to the return of Vioxx, withdrawn last year, and continued sale of two similar medications whose safety was questioned.
The action by the special Food and Drug Administration advisory panel, which still must go before the full FDA, is a victory for Vioxx-maker Merck, which pulled the drug from the market last year but has indicated it may reintroduce it.

The decision came from a joint meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which was reviewing the safety of certain drugs in light of reports linking them to cardiovascular risks. The FDA panel also approved Pfizer drugs Celebrex and Bextra for public use, after acknowledging heart risks from these medications. The 17-15 ruling on Vioxx paves the way for Merck to bring the controversial painkiller back to pharmacies. But some analysts said the decision was important mainly to help Merck fight a flood of litigation from Vioxx users.

The scientific panel also voted 31-1 to keep Pfizer's Celebrex -- also in the same class of drugs known as COX-2 inhibitors -- on the market. Voting was tighter on Bextra, 17-13 in favor of keeping it on the market. While the advisory panel's vote is not a final decision by the FDA, the agency generally always heeds the recommendations of its expert panels.

Vioxx, Celebrex and another Pfizer drug, Bextra, have been widely prescribed for arthritis and severe pain but have all come under fire recently for being linked to a higher incidence of cardiac problems in some patients. All three drugs, though, were determined to cause heart risk by the panel in a unanimous vote. And a majority of panelists indicated they supported warning labels for all three, but did not take a formal vote on that matter. The warning would disclose risks to patients of possible cardiovascular problems. Merck pulled Vioxx from the market in late September after a clinical study linked long-term use to an increased rate of heart attack and stroke. The company is currently facing over 600 lawsuits over Vioxx, ranging from personal injury suits to an investigation by the Department of Justice.

Addressing the FDA panel on Thursday, Merck research chief Peter Kim said: "If the advisory committee and the FDA conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers." Approval by the FDA for Vioxx to remain on the market could greatly bolster Merck's case that it was not negligent in keeping the drug on the market for as long as it did, industry experts have said. "We believe that there are likely to be multiple hurdles for Merck to overcome should they decide to relaunch in addition to the possibility of a positive committee outcome Friday," said Lehman Brothers analyst Anthony Butler in a note ahead of the decision. "We also note that if Merck were able to accomplish a renewal of Vioxx's presence in the market, if would likely have the effect of minimizing the liability in Vioxx litigation currently outstanding."

Research confirms health risks of Vioxx, Celebrex and Bextra

WASHINGTON, Feb 16 (AFP) - New research by Wellpoint Inc., the leading US private health insurance group, has confirmed a higher risk of heart attacks with the use of painkillers such as Vioxx, Bextra and Celebrex. In a letter to the Food and Drug Administration (FDA), Wellpoint director Samuel Nussbaum said the results of the research showed the risks of heart attacks were 53 percent higher than normal for Bextra, 23 percent for Vioxx and 19 percent for Celebrex.

By comparison, the study found no increase in heart attacks or other heart-related diseases with traditional anti-inflammatory drugs.
The research compared Wellpoint prescription records between January 2001 and June 2004 of some 630,000 patients, aged 40 and over, who did not take the drugs to a group of 7,200 who did take the COX-2 inhibitors. "Our findings ... without adjusting for risk factors and other confounding conditions, indicate that the COX-2 class of drugs increases the risk of myocardial infarction or stroke," Nussbaum said in his letter, a copy of which was obtained by AFP.

Vioxx was withdrawn from the market in September by pharmaceutical giant Merck after studies linked long-term use of the drug to cardiovascular risks. Celebrex and Bextra, both made by Pfizer, are the only COX-2 type drugs still on the US market. Pfizer and Merck said they had yet to analyze the Wellpoint research. Wellpoint's study, the third to examine the risks of COX-2 inhibitors, was released on Wednesday, just as the FDA began three days of public hearings to determine if Bextra and Celebrex should also be withdrawn from the market. An FDA-appointed committee of independent experts will hear from physicians, pharmaceutical companies, consumer groups and heart attack victims and their relatives before they issue recommendations that will lead to an FDA decision a few weeks later.

Vioxx woes push down Merck profit

WHITEHOUSE STATION, New Jersey, Jan 25 (AFP) - US pharmaceutical giant Merck announced Tuesday a 21 percent drop in fourth-quarter earnings compared with a year ago, to 1.1 billion dollars, mainly due to problems with the withdrawn arthritis drug Vioxx. The move to withdraw Vioxx last September after studies linked long-term use of the drug to cardiovascular risks has cost Merck between 700 million and 750 million in the fourth quarter alone. Still, the profit for the October-December period amounted to 50 cents per share, in line with Wall Street estimates. Sales for the quarter came in at 5.75 billion dollars, up slightly from 5.63 billion last year. For 2004, Merck's profit was 5.81 billion dollars, a 14.1 percent drop from 2003, while revenues grew two percent to 22.93 billion dollars. "As a company, we are moving beyond the Vioxx withdrawal," Merck chairman, president and chief executive Raymond Gilmartin said in a statement.

"We are focused on renewing growth and accelerating the process of change to position Merck to best meet the demands of the market and the challenges of the environment. We continue to streamline our business processes, allocate resources to the areas of highest potential growth and accelerate the speed at which we develop products." Merck said that it has taken a 604-million-dollar charge for the fourth quarter to bolster its legal defense fund, which now totals 675 million. The company noted that the fund is designed to cover expected legal costs from litigation over the company's recall of Vioxx over safety concerns but will not cover legal settlements.
"We have stated previously that we intend to defend these lawsuits vigorously," said Kenneth Frazier, Merck senior vice president and general counsel. "This reserve is consistent with our commitment to defend the company." Merck also reaffirmed that it expects first-quarter earnings of between 54 and 58 cents a share, with full-year 2005 earnings between 2.42 and 2.52 dollars a share.

Vioxx may have caused up to 140,000 US cases of heart disease: study

PARIS, Jan 25 (AFP) - The controversial painkiller Vioxx may have caused as many as 140,000 cases of serious coronary heart disease in the United States before it was pulled from shelves last September, according to a much-awaited study published on Tuesday.
People taking Vioxx had a 34 percent higher chance of developing this potentially fatal ailment when compared with individuals who used other medications in the same category, the study said. The research is lead-authored by David Graham, a senior official in the US Food and Drug Administration (FDA), which vets applications for new drugs. Graham has been at the heart of the storm over Vioxx and its maker, the US pharmaceutical giant Merck, over charges the drug not only boosted the risk of heart disease, but that this threat should have been spotted during clinical trials.

Last November, Graham, who is associate director of the FDA's Office of Drug Safety, said in testimony to Congress that he believed Vioxx had caused 139,000 cases of serious heart problems. And in January, he angrily accused his bosses at the FDA of trying to block publication of his research. The study -- published online by the British medical weekly The Lancet -- is based on a database of six million people in California who were enrolled with the managed health care provider Kaiser Permanente. Of the six million, 1.4 million had used a category of commonly taken painkillers, non-steroidal anti-inflammatory drugs (NSAIDs), in the period that Vioxx was marketed, from January 1999 to September 2004. The two leading NSAIDs they took were two over-the-counter drugs. One was ibuprofen, with just under a million users, and the other, naproxen, with 435,000 users. The other two NSAIDS were prescription-only drugs called cyclo-oxygenase 2 (COX2) inhibitor selective NSAIDs. These are prescribed by doctors for easing the symptoms of arthritis but without having the gastric side-effects of over-the-counter drugs.

Around 40,000 used the COX2 NSAID celecoxib, marketed as Celebrex, and about 27,000 used rofecoxib, the pharmaceutical name for Vioxx. During the period under investigation, 8,143 individuals had serious coronary heart disease, of whom 1,508 died of a sudden heart attack. Each case was compared with four "controls" -- people of the same age and sex -- to see whether there was a statistical risk between a drug and heart disease. Overall, the risk of serious coronary heart disease was 34 percent higher among Vioxx users when compared with other NSAIDS as a whole, the authors said.

The risk was even higher when Vioxx was compared to its fellow COX-2, celecoxib. On standard doses, coronary heart disease was 1.6 times likelier to develop with Vioxx than with Celebrex. Among high-dose users, says Graham's team, the risk was 3.6 times higher.
"An estimated 88,000-140,000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of rofecoxib," Graham said. "The US national estimate of the case fatality rate (in serious coronary heart disease) was 44 percent, which suggests that many of the excess cases attributable to rofecoxib use were fatal." Graham's estimate is a nationwide extrapolation for the United States, and does not cover other countries. Vioxx was marketed worldwide before its sudden withdrawal.

The study also dealt a blow to previous research which said naproxen had a protective effect against cardiac disease. In fact, according to its figures, people taken this drug had a 14-percent increased risk when compared with other NSAIDSs. "Naproxen use does not protect against serious coronary heart disease," the study says. "... Indeed, the present data show the possibility of a small increased risk."
Last year, The Lancet said Merck should have heeded warning signs from its clinical trials that should have stopped the Vioxx from ever going to market. Merck retorted it had been "vigilant in monitoring and disclosing the cardiovascular safety" of Vioxx and added that the company "absolutely disagrees with any implication to the contrary."

US official determined to publish Vioxx risk study

WASHINGTON, Jan 3 (AFP) - A US Food and Drug Administration (FDA) expert has said he is determined to publish a study linking the anti-inflammatory drug Vioxx to deaths and illness of up to 139,000 patients, media reports said Monday. Shares in Merck, the maker of the drug withdrawn around the world last September, took a new battering following reports that David Graham, associate director of the Office of Drug Safety with the FDA, has vowed to publish his study. He told the Financial Times his report would appear in the British medical journal The Lancet. Graham said last year that 28,000 people had suffered sometimes fatal heart attacks or strokes after taking Vioxx. In testimony to Congress in November, Graham revised this to 139,000. Graham told the Forbes.com news website however that publication of the paper had been delayed because of a dispute with his bosses at the FDA. "The FDA has suppressed the paper and maligned me in the media, but never responded" to study's conclusions suggesting that Vioxx is an even more dangerous drug than believed when it was pulled off the market in September, he told the Financial Times.

The study updates results of research he conducted which said some 28,000 patients had died or suffered debilitating symptoms after taking Vioxx. Before Congress, Graham called the drug "a terrible tragedy and a profound regulatory failure." Merck withdrew Vioxx from the market saying its own company-sponsored trial found patients who took the medication for more than 18 months doubled their risk of heart attack or stroke. Vioxx was approved by the FDA in 1999 and when it was withdrawn from the market, millions of people around the world were taking it. Graham testified however that there were signs of problems in company studies as early as November 2000. Merck's shares were down 2.7 per cent at 31.27 dollars in late trading Monday. The share lost about 25 percent in the weeks after the withdrawal.

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