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Merck Plans to Pull Vioxx
  Vioxx is a NSAID, nonsteroidal anti-inflammatory drug. This class of drugs and Vioxx have been used to relieve discomfort during interferon-based therapy for HCV.
Sharply Cuts Earnings GuidanceShares Drop Sharply in Early Trading
September 30, 2004 8:59 a.m.
Merck & Co. announced a voluntary world-wide withdrawal of its Vioxx arthritis and acute-pain medication amid mounting safety questions and slashed its earnings guidance for the year.
The Whitehouse Station, N.J., company said its decision, which is effective immediately, said that new data from a clinical trial showed patients had an increased risk of heart attack and other cardiovascular complications after taking Vioxx.
The data come from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.
"We are taking this action because we believe it best serves the interests of patients," said Raymond V. Gilmartin, chairman, president and chief executive, in a press release. He added: "Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."
Merck said its 2004 earnings per share guidance of $3.11 to $3.17 would be reduced by 50 cents to 60 cents a share as a result of the Vioxx withdrawal. This estimate includes lost sales, writeoffs of inventory, customer returns and costs to undertake the pullback of the product, Merck said. Included in this cost estimate is the expectation of lost fourth-quarter Vioxx sales of $700 million to $750 million, the company said.
Vioxx had U.S. sales last year of about $2 billion, compared with about $2.8 billion for Pfizer Inc.'s Celebrex, according to data from health-care information company NDCHealth, Atlanta. Merck said world-wide sales last year were $2.5 billion.
Merck's shares were quoted at around $36.35 on the INET electronic-trading service Thursday morning ahead of regular New York Stock Exchange trading. On Wednesday, the stock closed at $45.07, up 15 cents, in 4 p.m. composite trading on the Big Board.
The declines will hit the Dow Jones Industrial Average at the open, as Merck is one of the average's 30 component stocks. Each $1 change in Merck's share price equates to about seven points in the Dow average. The impact, though, could be partially offset by gains in Pfizer, also a component of the industrial average. Pfizer's shares were quoted at $31.76 in early-hours trading, up from $30.18 on the Big Board late Wednesday.
Vioxx, which came out in 1999, has been one of Merck's top products as the company has struggled recently to find new breakthrough treatments. Besides osteoarthritis and rheumatoid arthritis, it is approved to treat conditions including acute pain and migraines. It is a Cox-2 inhibitor, a type of medicine that is supposed to carry fewer gastrointestinal problems than older painkillers in the category of nonsteroidal anti-inflammatory drugs, or NSAIDS. Merck has promoted Vioxx as creating fewer gastrointestinal problems than older drugs.
Merck said Thursday it has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision. The company also is in the process of notifying health-care practitioners in the U.S. and other countries where Vioxx is marketed. The company said that patients who are currently taking Vioxx should contact their health-care providers to discuss discontinuing use of Vioxx and possible alternative treatments.
Concerns about Vioxx mounted in August after Kaiser Permanente, one of the nation's biggest health-maintenance organizations, said it was reconsidering its use the drug. The HMO cited a study, led by a Food and Drug Administration researcher, that found higher doses of Vioxx appeared to triple patients' risk of a heart attack or sudden cardiac death, when compared with the results for people who hadn't recently taken any similar drug.
Vioxx Heart-Risk Evidence Mounts
Users of Merck's Painkiller
Had More Hospitalizations
Than Those on Celebrex
May 28, 2004
Evidence continues to mount that Merck & Co.'s painkiller Vioxx carries a higher risk for heart problems than alternatives, including Celebrex from Pfizer Inc.
The latest indication comes from a study, funded by the Canadian government, that looked at elderly patients taking common arthritis pain pills called nonsteroidal anti-inflammatory drugs, or NSAIDS.
Researchers found that elderly people taking Vioxx had an 80% increase in hospital admissions for congestive heart failure within one year of starting therapy compared with patients not taking NSAIDS.
In a striking win for Pfizer, patients taking Celebrex had the same rate of hospitalization for congestive heart failure as people who weren't using any NSAIDS at all. Patients taking older NSAIDS, such as ibuprofen, had a 40% increase in such hospitalizations compared with those not taking any of the drugs.
The absolute risk for hospital admission for any patient taking Vioxx is low -- less than 1% of patients a year -- but the increase compared with other medicines is clinically significant, said Muhammad Mamdani, the lead researcher on the project. For about every 400 patients taking Vioxx, he says, "you'll see an admission for congestive heart failure" per year, said Dr. Mamdani, a clinical pharmacist at the Institute for Clinical Evaluative Sciences in Toronto. The Canadian Institutes of Health Research, a government agency, provided most of the financial support for the study. No drug company funding was used.
Dr. Mamdani's analysis, culling data from health-care records for about 1.3 million elderly residents of Ontario, appears in the current issue of the Lancet, a British medical journal. The patients studied were 66 years and older, and constitute a prime market for the drugs, which are commonly prescribed for the pain and swelling from arthritis.
He and his colleagues analyzed prescription and medical records for 15,000 patients taking Vioxx, 19,000 patients taking Celebrex, and 5,000 patients taking older nonsteroidal anti-inflammatory drugs. About 100,000 randomly selected patients not taking these pain drugs served as a comparison group.
Merck cautioned that the results from Dr. Mamdani's retrospective study have scientific drawbacks. Because the study didn't randomize patients among drug therapies ahead of time, unrecognized biases could have masked factors that could undermine the conclusions. "Because of the inherent limitations, it precludes being able to establish cause and effect," said Mary Elizabeth Blake, a spokeswoman for Merck, of Whitehouse Station, N.J. She said Merck has three prospective studies under way examining cardiovascular risk and Vioxx.
Pfizer welcomed the results, saying they support the safety profile of Celebrex. Gail Cawkwell, the leader of Pfizer's medical team for Celebrex, said the New York drug maker plans to start a randomized, prospective study this year to test whether Celebrex may, in fact, help protect patients from some forms of cardiovascular disease.
Monthly prescriptions for Celebrex and Vioxx cost about $80 or more a month.
The negative findings for Vioxx could put further pressure on Merck. While Vioxx is one of the company's top sellers, world-wide sales of the painkiller rose only 2% to $2.5 billion last year. Lingering safety concerns have crimped Vioxx's growth, analysts say. Vioxx and Celebrex are part of a subcategory of NSAIDS called Cox-2 inhibitors that are more selective in their biological effects than older drugs. The Cox-2 drugs kill pain and reduce inflammation with a lower risk of bleeding in the stomach and small intestine than for older analgesics.
Meantime, physicians and patients must decide which drugs to use while the data are incomplete. "When choosing any pain therapy, doctors need to consider how these medicines appear different in their effect on cardiovascular health," said A. Mark Fendrick, a professor of medicine at University of Michigan, Ann Arbor.
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