December 28

What’s a Patient to Think? Prescription for Confusion – NY Times Editorial

What’s a Patient to Think? Prescription for Confusion – NY Times Editorial

Tue, 28 Dec 2004

At long last, The New York Times has validated the well-placed anger and frustration that patients feel at having their trust in medicine and the nation’s oversight agents betrayed:

“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.”

Another patients deciding which drug to risk taking concluded: “the devil she knows is better than the devil she doesn’t know.”

Today’s editorial validates the general public sentiment: "It makes one wonder whether anything out there is really safe. "

Furthermore, the Times editorial acknowledges that the current credibility crisis in medicine is a consequence of joint responsibility and irresponsible practices. The Times names three culprits: the drug companies, the FDA, and physicians who "have long been in thrall to drug companies, which bombard them with sales pitches and finance their educational programs."

We would add to that list, the academic medical institutions and journals that lent credibility to biased reports that were passed on as "evidence-based" scientific analyses when in fact the reports were financed by industy and formulated to give prescribing physicians and the public a false sense of security about drugs whose safety and benefit were (at best) in serious doubt.

We would also add to the list of culprits those who took part in the process of formulating public health policies that promoted the use of drugs and vaccines whose lethal hazards were concealed – as were their own conflicts of interest.

These include: professional medical associations, the National Institutes of Health, the Center for Disease Control and the Institute of Medicine.

The revelations of institutional and individual complicity in public deception are by no means over.

Contact: Vera Hassner Sharav

Editorial: Prescription for Confusion
December 28, 2004

It is no surprise that many people who rely on painkillers to ease their way through the day feel lost at the moment. Not only have Vioxx, Celebrex and Bextra, the only three drugs in a class thought to be especially safe, been found to cause heart attacks and strokes in some patients, but an over-the-counter painkiller, Aleve, has, too. It makes one wonder whether anything out there is really safe.

And that’s just fine. If there is any main lesson to draw from the confusing reports about these and other widely used drugs, it is that all medicines carry risks as well as benefits. Those risks may not show up in the clinical trials that are used to decide whether a drug is effective enough and safe enough to be marketed in this country. But if the drug is used by vast numbers of people for extended periods of time, adverse effects may emerge.

The COX-2 inhibitors – Vioxx, Celebrex and Bextra – were designed for people who suffer ulcers and bleeding when taking painkillers like aspirin and ibuprofen. But they were so heavily promoted that millions of arthritis sufferers at little risk of gastrointestinal problems took the pills for years in the belief that they were somehow better and safer. Now we know that those drugs were potential cardiovascular time bombs, especially when used at high doses for long periods. Any patient taking them long-term will need to decide whether the benefits of reduced pain, fewer ulcers and less bleeding are worth the small rise in the risk of heart attack.

In the finger-pointing over who is to blame for letting risky drugs stay on the market, the favorite culprits seem to be the drug companies, for resisting evidence of harm caused by their products, and the Food and Drug Administration, for failing to crack down harder. They should be joined by a third group, the doctors who prescribe drugs for long periods to patients for whom they are not appropriate.

Many doctors have long been in thrall to drug companies, which bombard them with sales pitches and finance their educational programs. Now that exquisitely calibrated judgments must be made as to which patients can truly benefit from what drugs, doctors will have to reassert their independence.

Copyright 2004 The New York Times Company

Vioxx. Celebrex. Now Aleve. What’s a Patient to Think?
December 28, 2004

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.

It also remains unclear whether Celebrex succeeded in helping prevent the recurrence of polyps in the study that was halted: the Merck study of Vioxx that led to the drug’s withdrawal found that the medication had an effect in reducing polyps.

“It is unfortunate that physicians and patients have limited data, some of it in direct conflict with existing conclusions, causing anxiety that at this time cannot be definitively confirmed nor refuted,” Dr. Elizabeth Tindall, president of the American College of Rheumatology, said in a statement last week.

Experts say that patients debating whether to continue their pain medications should meet with their doctors to determine their risk of heart disease. They can also calculate their long-term risk at a Web site set up by the health institutes,

Meanwhile, Dr. Fischhoff said, the results from the Celebrex trials will not be helpful to most people until they are combined and analyzed, indicating the drug’s overall risk. That information, he said, is particularly crucial for people who feel strongly that Celebrex works for them, but are worried about its potential cardiovascular dangers.

“If you look at one study, you’re more likely to get a statistically significant effect than if you pool the results,” he said. “If I’m somebody who’s in dire pain, and this is the only thing that works for me, I need the overall effect size. When I have that, then I might be able to say, ‘O.K., given the improvement in my quality of life, I’m willing to take that 1 in 100 chance of death.’ ”

Instead, patients are struggling to piece together information. What perhaps has most outraged people is a collective sense that facts are being concealed, making people feel that they are unwittingly playing with danger.

Dr. George Gray, the executive director of the Harvard Center for Risk Analysis, pointed to the furor that erupted two months ago when federal health officials announced a shortage of flu vaccine and urged restrictions on who should be immunized. Almost immediately, people began flooding their local health clinics – some who had never bothered to get vaccinated before – clamoring for shots.

“Everybody was going bonkers,” Dr. Gray said.

But now that there is plenty of vaccine, no one is getting immunized, he said. The demand has dwindled so much that a federal advisory committee recommended a little over a week ago that the restraints on immunizations should be eased, fearing that tens of thousands of doses of vaccine will go to waste.

“When it means that someone else is controlling whether or not I may be in danger, whether it’s not letting me have the flu shot or not telling me about the potential risks of these medications, then people will react in ways that can seem out of proportion to the actual risk,” Dr. Gray said.

People will also react more acutely if they feel they were put in danger by the very person or thing that was supposed to protect them.

So the fact that the warnings involved a drug that people took each morning thinking it would make them healthier is particularly troubling to the public, some experts say, as is the fact that health officials who were supposed to look out for them may have instead neglected to alert them about serious side effects.

“It’s like if someone is assaulted by a security guard, or if an air bag malfunctions and endangers them,” said Cass R. Sunstein, a professor at the University of Chicago Law School and the author of “Risk and Reason.”

“The degree of alarm and outrage is because something that’s supposed to make people safe is really putting them at risk,” Mr. Sunstein said.

The recent news may have prompted millions of people to throw away their pills in anger. But the past suggests that many will eventually return to them, deciding that their lives are unbearable without them or that their other options are far worse.

In 2002, for example, after a large study found that hormone replacement therapy could increase the risk of heart attacks, stroke and breast cancer, menopausal women were strongly urged to quit their hormone regimens. Millions did. But over time, experts say, many women found the hot flashes, insomnia and night sweats excruciating, and returned to hormone therapy.

“There’s usually a very big initial reaction, and then people come back,” Dr. Loewenstein said. “Once they get used to side effects, people tend to become very complacent.”

Mignon Kaplan, a ballet teacher who lives in New York, is among those who decided that returning to a cox-2 inhibitor was worth the risks. Mrs. Kaplan, who used Celebrex to treat her arthritis for four years, said she stopped taking the drug after Vioxx was pulled from the market.

In October, when her arthritis pain grew overwhelming, she went back on Celebrex, but then stopped again when it was tied to heart problems. Her doctor wrote her a prescription for Voltaren, an older arthritis drug that scared her back to Celebrex.

“It came with pages and pages of side effects,” she said. “They looked even worse than Celebrex’s. It said contact your doctor if you experience blood in your vomit, bloody or black stool, dizziness, yellowing of the skin. I thought, I don’t want these things. I’ve been taking Celebrex for a long time and it’s agreed with me, so I called my doctor and said put me back on Celebrex.”

Mrs. Kaplan’s physician, Dr. Fred Pescatore, an internist in Manhattan, said about 70 percent of his patients had stopped taking Celebrex and other cox-2 inhibitors since September. He said he pleaded with Mrs. Kaplan to do the same. She refused, agreeing only to switch to a lower dose.

“She figured that the devil she knows is better than the devil she doesn’t know,” he said.

Copyright 2004 The New York Times Company

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