Scientists plan huge painkiller risk study
The Cleveland Clinic Foundation said yesterday that it will direct a massive, $100 million clinical trial to assess risks that three popular painkillers may pose to people with heart problems.
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The study comes after the withdrawal of Vioxx and Bextra from the market, and the Food and Drug Administration's addition of warnings on other painkiller labels, left many patients fearing fatal consequences from their choice of pain relievers. The new trial will look at 20,000 arthritis patients with heart risks -- people typically excluded from clinical trials -- around the globe to determine the safety and effectiveness of Celebrex, ibuprofen, and naproxen.
''From a public health point of view, this may be the most important study that I'll ever do," said Dr. Steven E. Nissen, a Cleveland Clinic cardiologist who will lead the study. ''We've had all kinds of alarms raised. We've put black boxes on the entire class of drugs. So confusion has been enormous."
Pfizer Inc., the world's largest drug maker and manufacturer of Celebrex, will pay for the trial. But Nissen said it has been designed with safeguards to prevent the controversy raised by recent news that authors with financial ties to Merck & Co. misrepresented the heart risk of Vioxx in a pivotal New England Journal of Medicine article.
Scientists overseeing the new painkiller trial, which will be conducted in several countries, cannot accept funding from companies with similar drugs on the market or in development. Pfizer will get a courtesy copy of study results but cannot change how it is reported in scientific journals. The federal government will store a copy of the entire completed trial database, ensuring public assess.
The immediate past president of the American College of Rheumatology called the study ''very much needed." Many doctors have shied away from nonsteroidal anti-inflammatory drugs because of the new heart risk warnings in favor of narcotic painkillers, like OxyContin and morphine, that won't cause heart disease, but carry other risks.
''We're seeing a real increase in narcotics use, with all of its problems," said Dr. Elizabeth Tindall, a practicing rheumatologist in Oregon. The nonsteroidal painkillers ''all have black box warnings, so it's really created fear on the part of patients and on the part of docs. No one knows what to do."
Patient enrollment in the trial begins in mid-2006. People will be randomly assigned one of three daily drug doses to take for 24 months: 200 mg of Celebrex, 2,400 mg of ibuprofen (sold as Motrin), or 1,000 mg of naproxen (sold as Aleve).
Because of their existing heart risks, many will also take baby aspirin, which has been shown to help prevent strokes and heart attacks. And they'll receive a drug that protects against stomach bleeding associated with some painkillers, which will also help test the safety of a drug combination many patients turned to after Vioxx was withdrawn.
Celebrex is the sole drug in the troubled class of cox-2 inhibitors currently sold. Its sales from January to August this year totaled $1.05 billion, a 41 percent drop compared with the same period in 2004, according to IMS Health, a healthcare information company. Meanwhile, the arthritis drug Mobic benefited. Mobic sales for the first eight months of 2005 totaled $719 million, a 178 percent sales increase compared with the same time frame in 2004, IMS Health reported.
People in pain may have to wait up to four years to learn which of the trio of painkillers is safest.
Jason Napodano, an analyst at Zacks investment research in Chicago, applauded the study but predicted it would have little impact on Celebrex sales until results are reported. Celebrex, like Vioxx, was heavily marketed as a safer, superior alternative to naproxen in the absence of data to the contrary.
''Vioxx took 18 months to see a real statistical difference between Vioxx and naproxen, and we know that Vioxx clearly is not as safe. But Celebrex, I don't know," Napodano said. ''I think Celebrex is safer than Vioxx, but how it will compare to naproxen?"
Merck pulled Vioxx from the market in September 2004 after a company-sponsored clinical trial confirmed that it doubled the risk of heart attack and stroke. Pfizer withdrew Bextra from the market in April 2005. Merck has won one lawsuit filed in a New Jersey state court alleging that it failed to warn patients of Vioxx's heart risks, and lost one in a Texas state court. A third lawsuit ended in a mistrial in federal court on Monday.
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The study comes after the withdrawal of Vioxx and Bextra from the market, and the Food and Drug Administration's addition of warnings on other painkiller labels, left many patients fearing fatal consequences from their choice of pain relievers. The new trial will look at 20,000 arthritis patients with heart risks -- people typically excluded from clinical trials -- around the globe to determine the safety and effectiveness of Celebrex, ibuprofen, and naproxen.
''From a public health point of view, this may be the most important study that I'll ever do," said Dr. Steven E. Nissen, a Cleveland Clinic cardiologist who will lead the study. ''We've had all kinds of alarms raised. We've put black boxes on the entire class of drugs. So confusion has been enormous."
Pfizer Inc., the world's largest drug maker and manufacturer of Celebrex, will pay for the trial. But Nissen said it has been designed with safeguards to prevent the controversy raised by recent news that authors with financial ties to Merck & Co. misrepresented the heart risk of Vioxx in a pivotal New England Journal of Medicine article.
Scientists overseeing the new painkiller trial, which will be conducted in several countries, cannot accept funding from companies with similar drugs on the market or in development. Pfizer will get a courtesy copy of study results but cannot change how it is reported in scientific journals. The federal government will store a copy of the entire completed trial database, ensuring public assess.
The immediate past president of the American College of Rheumatology called the study ''very much needed." Many doctors have shied away from nonsteroidal anti-inflammatory drugs because of the new heart risk warnings in favor of narcotic painkillers, like OxyContin and morphine, that won't cause heart disease, but carry other risks.
''We're seeing a real increase in narcotics use, with all of its problems," said Dr. Elizabeth Tindall, a practicing rheumatologist in Oregon. The nonsteroidal painkillers ''all have black box warnings, so it's really created fear on the part of patients and on the part of docs. No one knows what to do."
Patient enrollment in the trial begins in mid-2006. People will be randomly assigned one of three daily drug doses to take for 24 months: 200 mg of Celebrex, 2,400 mg of ibuprofen (sold as Motrin), or 1,000 mg of naproxen (sold as Aleve).
Because of their existing heart risks, many will also take baby aspirin, which has been shown to help prevent strokes and heart attacks. And they'll receive a drug that protects against stomach bleeding associated with some painkillers, which will also help test the safety of a drug combination many patients turned to after Vioxx was withdrawn.
Celebrex is the sole drug in the troubled class of cox-2 inhibitors currently sold. Its sales from January to August this year totaled $1.05 billion, a 41 percent drop compared with the same period in 2004, according to IMS Health, a healthcare information company. Meanwhile, the arthritis drug Mobic benefited. Mobic sales for the first eight months of 2005 totaled $719 million, a 178 percent sales increase compared with the same time frame in 2004, IMS Health reported.
People in pain may have to wait up to four years to learn which of the trio of painkillers is safest.
Jason Napodano, an analyst at Zacks investment research in Chicago, applauded the study but predicted it would have little impact on Celebrex sales until results are reported. Celebrex, like Vioxx, was heavily marketed as a safer, superior alternative to naproxen in the absence of data to the contrary.
''Vioxx took 18 months to see a real statistical difference between Vioxx and naproxen, and we know that Vioxx clearly is not as safe. But Celebrex, I don't know," Napodano said. ''I think Celebrex is safer than Vioxx, but how it will compare to naproxen?"
Merck pulled Vioxx from the market in September 2004 after a company-sponsored clinical trial confirmed that it doubled the risk of heart attack and stroke. Pfizer withdrew Bextra from the market in April 2005. Merck has won one lawsuit filed in a New Jersey state court alleging that it failed to warn patients of Vioxx's heart risks, and lost one in a Texas state court. A third lawsuit ended in a mistrial in federal court on Monday.
posted by Chris Placitella at 6:39 AM
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