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 She flushed her Vioxx down the toilet in September, after it was withdrawn from the market, and switched to Celebrex.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.

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, hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=pub.

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.

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.

True. If I was 80 or something, I probably wouldn't care about the increased risk (often times when they announce medicines have increased risks, the risk only goes up like 5 percent or something anyway). At that age, I am going to go soon anyway.

But, there are other medicines that are good for pain. I took some when I had my jaw surgery, and they worked wonders....and they weren't celebrex or vioxx etc.

I've always wondered about people who would rather suffer and complain, then do something about it, balancing risk vs. benefit.

Agreed. I also wonder if some folks fail to make the distinction between sources of everyday "aches and pains" v. the sort of pain that will destroy your body (RA, for one). When your body is manufacturing antibodies that target your own joints, it's no longer a case of "mind over matter"...it's time to reap the benefits of pharmaceutical R&D.

The media is having a grand old time hyping the evils of "Big Drug Companies". Notice how the evil people that are targeted are always "Big".

Those evil people are also working on a vaccine that is amazingly effective against cervical cancer. Someday, there will be vaccines for Alzheimer's, Parkinsons and MS.
But I am sure there will be rocket scientists who want to take their chances without them.

It is an individuals responsibility, and I include myself in this, to make choices about their health and independence not just based on how it effects them personally, but equally on how their decisions effect the people they love.

The media is having a grand old time hyping the evils of "Big Drug Companies". Notice how the evil people that are targeted are always "Big".

Heck, even that scumbag Michael Moore is getting into the act.

Nothing like biting the hand that feeds you...one day pharma manufacturing will move offshore because of an unfavorable regulatory and legal environment as well as government price controls. And then everyone will lament at how these evil drug companies could do somwthing so horrible, when all along they helped create the hostile environment that precipitated the move.

Manufacturing of drugs and vaccines is already moving off shore.

People don't seem to understand that the reason Canadians, et.al., can get drugs cheeply, is because if Pharms DIDN't sell to foreign entity's at slightly more than cost, the countries would simply ignore the patent rights of the makers and copy the drugs. Then there would be no R & D at all.

What was the last disease that a government cured?

This is how I look at it:

They did a dual test with Vioxx and Celebrex. Vioxx caused real problems compared to celebrex.

They tested Aleve against Celebrex and discovered Aleve caused problems.

They tested very high doses of Celebrex and discovered problems - in one test, and a similar, but not identical test earlier found no such problems.

My conclusions:

Celebrex is safer than Vioxx

Celebrex may be safer than Aleve (and certainly is to my tummy)

Large doses of Celebrex may be dangerous.

Doses of most NSAIDS may, at some dosage level, prove as a group, to cause heart problems.

I take Celebrex at the 100mg dose, and in the winter, especially, I need it for arthritis.

Unless they take it off the market, I am not giving it up.

There is no real evidence that it is any more dangerous than a number of other NSAIDs at normal dosages, and in fact, looks safter than a number of them.

The pain in my hands really sucks bad. Narcotics like Loritabs give me a problem with my biliary system. It takes a lot of pain to make me reach for one, knowing that I will have chest pain later if I have to take it very long.

So, I will continue with it, and know that sometimes you are trading off when you take meds for problems...

Take enteric coated aspirin. Take lots of it.

Be careful about what you advise. My mother was taking 5 milligrams of prednisone and eight coated tablets of 325 milligrams of aspirin a day. Both drugs are associated with a risk of gastro-intestinal bleeding. She became so anemic that she was transfused in a bed monitored for cardiac arrhythmia. Now she refuses to take one "baby" 81 milligram coated aspirin a day.

I am 28 and have psioratic arthritis which is hereditary and very painful, i was on Vioxx until they pulled it, i am now on Bextra but it does not help as much as the Vioxx did. While in the Navy, I was taking 2400mg a day of Motrin a day while 25mg of Vioxx took care of the pain almost completely. I am young and relatively healthy with no family history of heart disease nor of stroke, therefor have no worries of Vioxx harming me as long as I take it as recommended. tell me that it has a very slight chance of causing problems, just like anything else in this world and then back off, let ME make a decision regaurding to my life.

See my #12. I know my Mom wishes he'd take some sort of medicine. He's damned hard to get along with when he is hurting.

I gather from this post your dad currently isn't taking any medication. Has he discussed taking a DMARD with his doc? Where COX-2 inhibitors have been shown to slightly increase the risk (from miniscule to tiny) of cardiovascular events, DMARDs are a different class of arthritis drugs generally reserved for those who don't respond to NSAIDs or show side effects from their use.

Some DMARD users encounter liver problems, so if your dad takes one he'd need regular blood tests to monitor his liver enzyme levels. But it's certainly worth a try, IMHO.

also in starving i suppose, but i need my hands to work until i finish college. without vioxx or the like, i cant open my hands for an hour after i wake up and they finally stop hurting around 3 in the afternoon at which time they are too weak to pick up anything heavy and lack much dexterity, i am not looking for a "quick fix" if i was i would just take the narcotics my doc has given me for those really bad days. i just want a normal resemblance of life.

To each his own, but I agree with you. Wearing my back brace and observing good body mechanics when I'm lifting or climbing at work and taking an advil or using a tiger balm patch in the evening and a glass of wine works fine for my injured discs. I never took any hormone replacement therapy even though all my friends were trying to shove it at me as soon as I became menopausal. I found that natural herbal and soy remedies work great, and they aren't linked to anything dangerous (and they aren't made from the urine of pregnant mares, either...).

There is something about living with chronic pain that until the other has done it, they just can't understand really.

I have a stupid GI system. I make gall stones, even without a gall bladder. Hiatal hernia. IBS, too! I have a stomach that's a bit naturally hyper acidy, and it got the heck burned out of it a couple of years ago by high dosage naproxen -I developed plantar fasctitis and had arthritis in my hand, and this is what they used to treat it. I was inflamed from my esophagus through the duodenum. I solved my foot problem by switching to Danner boots. Couldn't even take Vioxx or Celebrex, and the arthritis screamed! Prevacid did make it better, and after awhile the dr. put me on Celebrex for my achies.

But then I developed more tummy problems. Had stones in my common bile duct, which kicked off pancreatitis. Before they finally operated on the stones, it was like walking around with a heart attack for almost 3 months. Narcotics make it worse - antispasmodics help (there's a little sphincter there which tends to spasm around narcotics).

Pain sucks. I still get some of the stomach symptoms. The hands hurt when cold fronts come in and I am really looking forward to winter being over already!

Pain grinds you down, causes depression, interfers with what you want to do, and takes the joy of life away.

Taking the edge off of pain makes the difference sometimes between a decent day and a day in darkness.

It's important to make the right decisions, and have something like a decent life. It's easy for people to have minimal problems to say, go take aspirin, but it's not possible for some of us.

And to have weird, junk science news stories to judge by surely doesn't make the deciding easier.

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.