Vioxx. Celebrex. Now Aleve. What's a Patient to Think?
When Audrey Eisen flicked her computer on last Monday night and read the news that the painkiller Aleve had been linked to heart attacks, she winced in disbelief.
Ms. Eisen, 64, a retired professor who lives in New York, had just returned from her drugstore with a package of Aleve. Her pharmacist allowed her to return it the next morning, no questions asked.
It was the third painkiller in four months that Ms. Eisen, who has degenerative spine and disk disease, had quit abruptly because of studies linking the drugs to heart attacks. She flushed her Vioxx down the toilet in September, after it was withdrawn from the market, and switched to Celebrex. But when problems surfaced with Celebrex this month, she had to stop that, too.
"I was extremely angry," said Ms. Eisen, whose father, two uncles, and grandparents died of heart disease. "Now I just don't trust the Food and Drug Administration anymore. I told a friend of mine, who had also been on Celebrex, that I was sure there'd be some other surprise in a few days."
Many Americans who have relied for pain relief on pills believed to be safe say their faith has been eroded in the system intended to protect them. Longtime users of Celebrex and similar drugs are swearing off them, even though the details of the studies that led to the recent warnings are still under wraps, and other studies have found no added dangers.
Some doctors say they are concerned their patients may be overreacting, but psychologists who study how people evaluate risks say the widespread anxiety, raft of lawsuits and feelings of broken trust are neither surprising nor, necessarily, unwarranted.
"Based on what we know so far, it's understandable that people are worried that any risk that emerges with these drugs is probably the tip of the iceberg," said Dr. George Loewenstein, a professor of economics and psychology at Carnegie Mellon University.
"They hear that there was one study that didn't find an increase in heart attacks, but then they think, 'O.K., but how many studies have been suppressed?' " Dr. Loewenstein said. "There's a danger of a cataclysmic reduction or collapse of trust in physicians and in the government, and what we're seeing now could be a leading indicator of that."
Studies show that most people, learning of a drug's potentially deadly side effects or some other potential hazard, will accept a certain amount of danger if they feel they have unfiltered information and can properly weigh the risks. But in the last few months, the bad news trickling out of drug companies and from federal health officials has been murky and confusing, psychologists say.
"It's not like there's good information and people don't understand it," said Dr. Baruch Fischhoff, a professor of decision sciences at Carnegie Mellon. "There's lousy information and people are frustrated and acting appropriately."
Vioxx was pulled from the shelves by Merck in September when a large clinical trial linked it to heart attacks. On Thursday, responding to evidence that Celebrex and Bextra may pose the same risks, the F.D.A. recommended that physicians limit their use of the drugs. But the agency has come under criticism that it first learned Vioxx was unsafe several years ago, and the news on Thursday prompted consumer groups to say the agency was once again siding with drug companies by not acting more forcefully.
In the meantime, millions of people on Celebrex are forced to make sense of conflicting data on the drug's safety. One study has linked it to heart problems at high doses; two others, including one last week, showed no such risks. And because the studies were intended to look at the drug's effectiveness in preventing colon polyps or warding off Alzheimer's, experts say it is unclear whether the researchers controlled for underlying risks of heart disease like weight, age and smoking. The National Institutes of Health has not yet released that information.
More... http://www.nytimes.com/2004/12/28/health/policy/28pain.html?oref=login (registration required)
http://www.goupstate.com/apps/pbcs.dll/article?AID=/20041228/ZNYT04/412280366/1051/news01 (non-registration required)
Hooray.
When Audrey Eisen flicked her computer on last Monday night and read the news that the painkiller Aleve had been linked to heart attacks, she winced in disbelief.
Ms. Eisen, 64, a retired professor who lives in New York, had just returned from her drugstore with a package of Aleve. Her pharmacist allowed her to return it the next morning, no questions asked.
It was the third painkiller in four months that Ms. Eisen, who has degenerative spine and disk disease, had quit abruptly because of studies linking the drugs to heart attacks. She flushed her Vioxx down the toilet in September, after it was withdrawn from the market, and switched to Celebrex. But when problems surfaced with Celebrex this month, she had to stop that, too.
"I was extremely angry," said Ms. Eisen, whose father, two uncles, and grandparents died of heart disease. "Now I just don't trust the Food and Drug Administration anymore. I told a friend of mine, who had also been on Celebrex, that I was sure there'd be some other surprise in a few days."
Many Americans who have relied for pain relief on pills believed to be safe say their faith has been eroded in the system intended to protect them. Longtime users of Celebrex and similar drugs are swearing off them, even though the details of the studies that led to the recent warnings are still under wraps, and other studies have found no added dangers.
Some doctors say they are concerned their patients may be overreacting, but psychologists who study how people evaluate risks say the widespread anxiety, raft of lawsuits and feelings of broken trust are neither surprising nor, necessarily, unwarranted.
"Based on what we know so far, it's understandable that people are worried that any risk that emerges with these drugs is probably the tip of the iceberg," said Dr. George Loewenstein, a professor of economics and psychology at Carnegie Mellon University.
"They hear that there was one study that didn't find an increase in heart attacks, but then they think, 'O.K., but how many studies have been suppressed?' " Dr. Loewenstein said. "There's a danger of a cataclysmic reduction or collapse of trust in physicians and in the government, and what we're seeing now could be a leading indicator of that."
Studies show that most people, learning of a drug's potentially deadly side effects or some other potential hazard, will accept a certain amount of danger if they feel they have unfiltered information and can properly weigh the risks. But in the last few months, the bad news trickling out of drug companies and from federal health officials has been murky and confusing, psychologists say.
"It's not like there's good information and people don't understand it," said Dr. Baruch Fischhoff, a professor of decision sciences at Carnegie Mellon. "There's lousy information and people are frustrated and acting appropriately."
Vioxx was pulled from the shelves by Merck in September when a large clinical trial linked it to heart attacks. On Thursday, responding to evidence that Celebrex and Bextra may pose the same risks, the F.D.A. recommended that physicians limit their use of the drugs. But the agency has come under criticism that it first learned Vioxx was unsafe several years ago, and the news on Thursday prompted consumer groups to say the agency was once again siding with drug companies by not acting more forcefully.
In the meantime, millions of people on Celebrex are forced to make sense of conflicting data on the drug's safety. One study has linked it to heart problems at high doses; two others, including one last week, showed no such risks. And because the studies were intended to look at the drug's effectiveness in preventing colon polyps or warding off Alzheimer's, experts say it is unclear whether the researchers controlled for underlying risks of heart disease like weight, age and smoking. The National Institutes of Health has not yet released that information.
More... http://www.nytimes.com/2004/12/28/health/policy/28pain.html?oref=login (registration required)
http://www.goupstate.com/apps/pbcs.dll/article?AID=/20041228/ZNYT04/412280366/1051/news01 (non-registration required)
Hooray.
