| Heart risk forces Vioxx off the shelf | ||
| Terence Neilan/NYT | Friday, October 1, 2004 | |
NEW YORK Merck announced Thursday that it was immediately pulling its arthritis pain medication Vioxx from the worldwide market after data from a clinical test showed that the drug produces an increased risk of heart attacks and strokes. . The company said the two million people using Vioxx should contact their doctors to discuss discontinuing the drug and shifting treatments. . "We are taking this action because we believe it best serves the interests of patients," said Merck's chief executive, Raymond Gilmartin. "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," he said in a statement, "we concluded that a voluntary withdrawal is the responsible course to take." . The recall represents a big blow for Merck, with Vioxx accounting for $2.55 billion in sales, or about 11 percent of the company's $22.5 billion in overall revenue, in 2003. Merck's shares lost more than one-quarter of their value in trading Thursday. . A Merck spokesman, Tony Plohoros, said 84 million prescriptions had been written for Vioxx since 1999. . Merck said the Vioxx cardiovascular risk came to light during a three-year trial to evaluate the drug's effect in helping patients with colon cancer. . The company found that after 18 months of treatment, patients taking Vioxx were at greater risk of heart attacks compared with those taking a placebo. . At a news conference in New York on Thursday, Merck officials said they received the data from the trial last Friday and examined it over the weekend, consulting with various medical experts. . Company officials informed Merck's board on Tuesday morning, and later met with the U.S. Food and Drug Administration to inform it of their intentions. The company then notified other regulatory agencies around the world. . There were already suggestions of cardiovascular risks linked to Vioxx going back to 1999, when the drug was introduced to the U.S. market, according to an industry analyst, Barbara Ryan of Deutsche Bank. . In 2002, the company, based in Whitehouse Station, New Jersey, changed the label on the drug to include information about higher risks of heart attacks for Vioxx patients, compared with the risk in patients taking an older painkiller, naproxen. . The recall comes at a time when Merck's overall sales have been sluggish, and just two years before the company is to lose patent protection on its biggest-selling drug, the cholesterol fighter Zocor, in 2006. . At the news conference, Gilmartin asserted that Merck remained "very strong financially" and that there would be no need to close any plants as a result of the Vioxx action. "We had anticipated expanding the sales forces," he said. "This will allow us to redeploy our sales force instead of hiring new employees." . Gilmartin said he expected earnings per share to be "negatively affected by 50 to 60 cents" a share, and as a result, the third-quarter earnings estimate would be scaled back. . Merck's shares tumbled $12.07, or 26.8 percent, to close at $33 in New York. . There is now a growing concern that Vioxx's withdrawal will be viewed as "a black eye" for the whole class of arthritis-pain drugs known as Cox-2, said Ryan, the Deutsche Bank analyst. . But she said that the longstanding concerns about Vioxx did not exist for Pfizer's Celebrex, which has been "held to the same kind of standard and study." That suggested the same concerns are not an issue for Pfizer, which could pick up some of the lost Merck earnings. Pfizer shares closed up 1.4 percent. . Vioxx has been marketed in more than 80 countries, Merck said. In some countries, the product is marketed under the trademark Ceoxx. . Gilmartin said Merck would undertake "many pro-active steps" to inform patients of the recall, including placing advertisements in newspapers. Information can be found on the Web sites merck.com and vioxx.com. . Users have been told that they can stop using Vioxx with little or no problem, and that over-the-counter drugs like ibuprofen are just as effective in fighting pain. Merck officials declined Thursday to speculate on potential litigation against the company or the impact the drug's withdrawal might have. . The Merck clinical trial confirmed the findings of a Food and Drug Administration investigator who reported similar risks with the drug in August. . The difference in heart risk was statistically significant between a recommended dose of Vioxx, 25 milligrams a day or less, and Celebrex, according to results that the investigator, Dr. David Graham, presented on Aug. 25 at a conference in France of the International Society for Pharmacoepidemiology. . The study also found that Vioxx doses in excess of 25 milligrams a day more than tripled the risk, compared with patients who had not taken painkillers within the past two months. . He said his findings did not reflect the Food and Drug Agency's official position. The acting commissioner of the agency, Dr. Lester Crawford, said Thursday that "Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market." . "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small," Crawford said in a statement, "the study that was halted suggests that, over all, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo." . At the time of Graham's investigation, Merck disagreed with the results of the study, a spokeswoman, Mary Elizabeth Blake, said. Conclusions from that type of examination do not carry as much weight as results from a study comparing two groups of patients actually taking the medicines for a set period, she said. . "While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy," Peter Kim, president of Merck Research Laboratories, said in a statement. "While we recognize that Vioxx benefited many patients, we believe this action is appropriate." The New York Times
NEW YORK Merck announced Thursday that it was immediately pulling its arthritis pain medication Vioxx from the worldwide market after data from a clinical test showed that the drug produces an increased risk of heart attacks and strokes.
The company said the two million people using Vioxx should contact their doctors to discuss discontinuing the drug and shifting treatments.
"We are taking this action because we believe it best serves the interests of patients," said Merck's chief executive, Raymond Gilmartin. "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," he said in a statement, "we concluded that a voluntary withdrawal is the responsible course to take."
The recall represents a big blow for Merck, with Vioxx accounting for $2.55 billion in sales, or about 11 percent of the company's $22.5 billion in overall revenue, in 2003. Merck's shares lost more than one-quarter of their value in trading Thursday.
A Merck spokesman, Tony Plohoros, said 84 million prescriptions had been written for Vioxx since 1999.
.Merck said the Vioxx cardiovascular risk came to light during a three-year trial to evaluate the drug's effect in helping patients with colon cancer.
The company found that after 18 months of treatment, patients taking Vioxx were at greater risk of heart attacks compared with those taking a placebo.
At a news conference in New York on Thursday, Merck officials said they received the data from the trial last Friday and examined it over the weekend, consulting with various medical experts.
Company officials informed Merck's board on Tuesday morning, and later met with the U.S. Food and Drug Administration to inform it of their intentions. The company then notified other regulatory agencies around the world.
There were already suggestions of cardiovascular risks linked to Vioxx going back to 1999, when the drug was introduced to the U.S. market, according to an industry analyst, Barbara Ryan of Deutsche Bank.
In 2002, the company, based in Whitehouse Station, New Jersey, changed the label on the drug to include information about higher risks of heart attacks for Vioxx patients, compared with the risk in patients taking an older painkiller, naproxen.
The recall comes at a time when Merck's overall sales have been sluggish, and just two years before the company is to lose patent protection on its biggest-selling drug, the cholesterol fighter Zocor, in 2006.
At the news conference, Gilmartin asserted that Merck remained "very strong financially" and that there would be no need to close any plants as a result of the Vioxx action. "We had anticipated expanding the sales forces," he said. "This will allow us to redeploy our sales force instead of hiring new employees."
Gilmartin said he expected earnings per share to be "negatively affected by 50 to 60 cents" a share, and as a result, the third-quarter earnings estimate would be scaled back.
Merck's shares tumbled $12.07, or 26.8 percent, to close at $33 in New York.
There is now a growing concern that Vioxx's withdrawal will be viewed as "a black eye" for the whole class of arthritis-pain drugs known as Cox-2, said Ryan, the Deutsche Bank analyst.
But she said that the longstanding concerns about Vioxx did not exist for Pfizer's Celebrex, which has been "held to the same kind of standard and study." That suggested the same concerns are not an issue for Pfizer, which could pick up some of the lost Merck earnings. Pfizer shares closed up 1.4 percent.
Vioxx has been marketed in more than 80 countries, Merck said. In some countries, the product is marketed under the trademark Ceoxx.
Gilmartin said Merck would undertake "many pro-active steps" to inform patients of the recall, including placing advertisements in newspapers. Information can be found on the Web sites merck.com and vioxx.com.
Users have been told that they can stop using Vioxx with little or no problem, and that over-the-counter drugs like ibuprofen are just as effective in fighting pain. Merck officials declined Thursday to speculate on potential litigation against the company or the impact the drug's withdrawal might have.
The Merck clinical trial confirmed the findings of a Food and Drug Administration investigator who reported similar risks with the drug in August.
The difference in heart risk was statistically significant between a recommended dose of Vioxx, 25 milligrams a day or less, and Celebrex, according to results that the investigator, Dr. David Graham, presented on Aug. 25 at a conference in France of the International Society for Pharmacoepidemiology.
The study also found that Vioxx doses in excess of 25 milligrams a day more than tripled the risk, compared with patients who had not taken painkillers within the past two months.
He said his findings did not reflect the Food and Drug Agency's official position. The acting commissioner of the agency, Dr. Lester Crawford, said Thursday that "Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market."
"Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small," Crawford said in a statement, "the study that was halted suggests that, over all, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."
At the time of Graham's investigation, Merck disagreed with the results of the study, a spokeswoman, Mary Elizabeth Blake, said. Conclusions from that type of examination do not carry as much weight as results from a study comparing two groups of patients actually taking the medicines for a set period, she said.
"While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy," Peter Kim, president of Merck Research Laboratories, said in a statement. "While we recognize that Vioxx benefited many patients, we believe this action is appropriate."
The New York Times
http://www.iht.com/articles/541466.html
My granny takes two of these a day.. And she took some today!
Anyone else here taking them?