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IntlSet Jan 15, 2008 1:23pm

Drug Approved. Is Disease Real? (about Fibromyalgia)
 
January 14, 2008 http://www.nytimes.com/2008/01/14/he...gewanted=print

Drug Approved. Is Disease Real?

By ALEX BERENSON
Fibromyalgia is a real disease. Or so says Pfizer in a new television advertising campaign for Lyrica, the first medicine approved to treat the pain condition, whose very existence is questioned by some doctors.

For patient advocacy groups and doctors who specialize in fibromyalgia, the Lyrica approval is a milestone. They say they hope Lyrica and two other drugs that may be approved this year will legitimize fibromyalgia, just as Prozac brought depression into the mainstream.

But other doctors — including the one who wrote the 1990 paper that defined fibromyalgia but who has since changed his mind — say that the disease does not exist and that Lyrica and the other drugs will be taken by millions of people who do not need them.

As diagnosed, fibromyalgia primarily affects middle-aged women and is characterized by chronic, widespread pain of unknown origin. Many of its sufferers are afflicted by other similarly nebulous conditions, like irritable bowel syndrome.

Because fibromyalgia patients typically do not respond to conventional painkillers like aspirin, drug makers are focusing on medicines like Lyrica that affect the brain and the perception of pain.

Advocacy groups and doctors who treat fibromyalgia estimate that 2 to 4 percent of adult Americans, as many as 10 million people, suffer from the disorder.

Those figures are sharply disputed by those doctors who do not consider fibromyalgia a medically recognizable illness and who say that diagnosing the condition actually worsens suffering by causing patients to obsess over aches that other people simply tolerate. Further, they warn that Lyrica’s side effects, which include severe weight gain, dizziness and edema, are very real, even if fibromyalgia is not.

Despite the controversy, the American College of Rheumatology, the Food and Drug Administration and insurers recognize fibromyalgia as a diagnosable disease. And drug companies are aggressively pursuing fibromyalgia treatments, seeing the potential for a major new market.

Hoping to follow Pfizer’s lead, two other big drug companies, Eli Lilly and Forest Laboratories, have asked the F.D.A. to let them market drugs for fibromyalgia. Approval for both is likely later this year, analysts say.

Worldwide sales of Lyrica, which is also used to treat diabetic nerve pain and seizures and which received F.D.A. approval in June for fibromyalgia, reached $1.8 billion in 2007, up 50 percent from 2006. Analysts predict sales will rise an additional 30 percent this year, helped by consumer advertising.

In November, Pfizer began a television ad campaign for Lyrica that features a middle-aged woman who appears to be reading from her diary. “Today I struggled with my fibromyalgia; I had pain all over,” she says, before turning to the camera and adding, “Fibromyalgia is a real, widespread pain condition.”

Doctors who specialize in treating fibromyalgia say that the disorder is undertreated and that its sufferers have been stigmatized as chronic complainers. The new drugs will encourage doctors to treat fibromyalgia patients, said Dr. Dan Clauw, a professor of medicine at the University of Michigan who has consulted with Pfizer, Lilly and Forest.

“What’s going to happen with fibromyalgia is going to be the exact thing that happened to depression with Prozac,” Dr. Clauw said. “These are legitimate problems that need treatments.”

Dr. Clauw said that brain scans of people who have fibromyalgia reveal differences in the way they process pain, although the doctors acknowledge that they cannot determine who will report having fibromyalgia by looking at a scan.

Lynne Matallana, president of the National Fibromyalgia Association, a patients’ advocacy group that receives some of its financing from drug companies, said the new drugs would help people accept the existence of fibromyalgia. “The day that the F.D.A. approved a drug and we had a public service announcement, my pain became real to people,” Ms. Matallana said.

Ms. Matallana said she had suffered from fibromyalgia since 1993. At one point, the pain kept her bedridden for two years, she said. Today she still has pain, but a mix of drug and nondrug treatments — as well as support from her family and her desire to run the National Fibromyalgia Association — has enabled her to improve her health, she said. She declined to say whether she takes Lyrica.

“I just got to a point where I felt, I have pain but I’m going to have to figure out how to live with it,” she said. “I absolutely still have fibromyalgia.”

But doctors who are skeptical of fibromyalgia say vague complaints of chronic pain do not add up to a disease. No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes.

The diagnosis of fibromyalgia itself worsens the condition by encouraging people to think of themselves as sick and catalog their pain, said Dr. Nortin Hadler, a rheumatologist and professor of medicine at the University of North Carolina who has written extensively about fibromyalgia.

“These people live under a cloud,” he said. “And the more they seem to be around the medical establishment, the sicker they get.”

Dr. Frederick Wolfe, the director of the National Databank for Rheumatic Diseases and the lead author of the 1990 paper that first defined the diagnostic guidelines for fibromyalgia, says he has become cynical and discouraged about the diagnosis. He now considers the condition a physical response to stress, depression, and economic and social anxiety.

“Some of us in those days thought that we had actually identified a disease, which this clearly is not,” Dr. Wolfe said. “To make people ill, to give them an illness, was the wrong thing.”

continued...

IntlSet Jan 15, 2008 1:23pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
In general, fibromyalgia patients complain not just of chronic pain but of many other symptoms, Dr. Wolfe said. A survey of 2,500 fibromyalgia patients published in 2007 by the National Fibromyalgia Association indicated that 63 percent reported suffering from back pain, 40 percent from chronic fatigue syndrome, and 30 percent from ringing in the ears, among other conditions. Many also reported that fibromyalgia interfered with their daily lives, with activities like walking or climbing stairs.

Most people “manage to get through life with some vicissitudes, but we adapt,” said Dr. George Ehrlich, a rheumatologist and an adjunct professor at the University of Pennsylvania. “People with fibromyalgia do not adapt.”

Both sides agree that people who are identified as having fibromyalgia do not get much relief from traditional pain medicines, whether anti-inflammatory drugs like ibuprofen — sold as Advil, among other brands — or prescription opiates like Vicodin. So drug companies have sought other ways to reduce pain.

Pfizer’s Lyrica, known generically as pregabalin, binds to receptors in the brain and spinal cord and seems to reduce activity in the central nervous system.

Exactly why and how Lyrica reduces pain is unclear. In clinical trials, patients taking the drug reported that their pain — whether from fibromyalgia, shingles or diabetic nerve damage — fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.

The F.D.A. reviewers who initially examined Pfizer’s application for Lyrica in 2004 for diabetic nerve pain found those results unimpressive, especially in comparison to Lyrica’s side effects. The reviewers recommended against approving the drug, citing its side effects.

In many patients, Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness. In 12-week trials, 9 percent of patients saw their weight rise more than 7 percent, and the weight gain appeared to continue over time. The potential for weight gain is a special concern because many fibromyalgia patients are already overweight: the average fibromyalgia patient in the 2007 survey reported weighing 180 pounds and standing 5 feet 4 inches.

But senior F.D.A. officials overruled the initial reviewers, noting that severe pain can be incapacitating. “While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,” Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.

Pfizer began selling Lyrica in the United States in 2005. The next year the company asked for F.D.A. approval to market the drug as a fibromyalgia treatment. The F.D.A. granted that request in June 2007.

Pfizer has steadily ramped up consumer advertising of Lyrica. During the first nine months of 2007, it spent $46 million on ads, compared with $33 million in 2006, according to TNS Media Intelligence.

Dr. Steve Romano, a psychiatrist and a Pfizer vice president who oversees Lyrica, says the company expects that Lyrica will be prescribed for fibromyalgia both by specialists like neurologists and by primary care doctors. As doctors see that the drug helps control pain, they will be more willing to use it, he said.

“When you help physicians to recognize the condition and you give them treatments that are well tolerated, you overcome their reluctance,” he said.

Both the Lilly and Forest drugs being proposed for fibromyalgia were originally developed as antidepressants, and both work by increasing levels of serotonin and norepinephrine, brain transmitters that affect mood. The Lilly drug, Cymbalta, is already available in the United States, while the Forest drug, milnacipran, is sold in many countries, though not the United States.

Dr. Amy Chappell, a medical fellow at Lilly, said that even though Cymbalta is an antidepressant, its effects on fibromyalgia pain are independent of its antidepressant effects. In clinical trials, she said, even fibromyalgia patients who are not depressed report relief from their pain on Cymbalta.

The overall efficacy of Cymbalta and milnacipran is similar to that of Lyrica. Analysts and the companies expect that the drugs will probably be used together.

“There’s definitely room for several drugs,” Dr. Chappell said.

But physicians who are opposed to the fibromyalgia diagnosis say the new drugs will probably do little for patients. Over time, fibromyalgia patients tend to cycle among many different painkillers, sleep medicines and antidepressants, using each for a while until its benefit fades, Dr. Wolfe said.

“The fundamental problem is that the improvement that you see, which is not really great in clinical trials, is not maintained,” Dr. Wolfe said.

Still, Dr. Wolfe expects the drugs will be widely used. The companies, he said, are “going to make a fortune.”

jellybebe Jan 15, 2008 3:03pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
Hm interesting! Thanks for the info. I know someone who has this condition and I'm still not 1000% convinced that it's not partially motivated by psychological issues. Others who suffer from it may disagree so my point is that I'd like to learn more. I think the general public needs to be better educated about it before they start hopping on the drug bandwagon.

Litigatrix Jan 15, 2008 3:03pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
I have/had a chronic pain condition, which based on my understanding of it, may be similar to fibromyalgia. However, mine was localized. It was awful, and there were no outward symptoms. It took me years before my doctor treated me, and I finally did get treatment after breaking down crying at my yearly appt because of all the pain this condition caused me. I now have some pain (after a 1 year treatment regime, which I hated BTW), but it is so much better than before. It upsets me when people act like this is one of those "all in your head" things. I can tell you from experience that chronic nerve pain is not a myth.

IntlSet Jan 15, 2008 3:16pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
By the way, just a disclaimer, I believe that chronic pain, fibro, etc., are all actually "real."

boxermom Jan 15, 2008 4:17pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
I was diagnosed with it about 10 years ago. Multiple symptoms that never showed up on any tests make it hard to treat, but those who have fibro have an awful lot of symptoms in common. Maybe after years of mysterious pain and problems that are difficult to treat lead to some psychological issues?? You go for help and doctors look at you like you're crazy--you get defensive about it.

Irishgal Jan 15, 2008 5:16pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
I may get flamed for this..but rest assured if this was a predominately male disease this question would not even be asked.

Prada Psycho Jan 16, 2008 7:34am

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
Whether it's "real" or "in your head," pain is pain and needs to be treated no differently than if it were diabetes, hypertension, heart disease or even cancer.

I've had the "luxury" of being on both sides of the chronic pain issue. I've been in the rehabilitation field 30 years, working with clients diagnosed with fibromyalgia back to work and I've been a chronic pain patient for the past 14 months. As a patient, I was blessed to find a pain management doctor that recognizes that any perceived pain is real, no matter the cause. As a rehab counselor, I've seen clients who were treated with the "secondary gain" attitude that doctors toss off onto patients that they can't help. It infuriates me. I could rattle on for days on this one, but bottom line is that it pisses me off that the medical profession always throws up their hands and blames their patients for not getting better when it is the medical professionals who are letting their patients down.

Irishgal, you're dead on the money, Gal!! :tup:

Speedy Jan 16, 2008 7:54am

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
Quote:

Originally Posted by Irishgal (Post 4933799)
I may get flamed for this..but rest assured if this was a predominately male disease this question would not even be asked.


Agreed. Look how fast they created drugs for erectile disfunction.

As someone else who has chronic nerve and muscle pain, I would never ever accuse anyone of making up something like this. I know there are whiners out there, and hypocondriacs, but the majority of people in pain are very sincere, and very, very believeable when they speak about it.

yui Jan 16, 2008 5:24pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
Quote:

Originally Posted by Speedy (Post 4940670)
Agreed. Look how fast they created drugs for erectile disfunction.

Not to mention how quickly insurance covered it.

Irishgal Jan 16, 2008 8:30pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
Quote:

Originally Posted by yui (Post 4946450)
Not to mention how quickly insurance covered it.

Yep, and the same companies that covered that did not cover birth control pills. Go figure.

boxermom Jan 16, 2008 8:50pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
^^^^Have you heard the saying, "If men got pregnant, abortion rights would be in the Constitution"? Don't mean to stir up controversy, but the difference between what is covered for men and women is a double standard.

samoXenina Jan 17, 2008 8:32pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
i think my mom may have this or something like this...we still don't know what's going on with her and she has been in pain for years. She has back pain so bad that she can hardly put on a shirt because it is soo sensitive to touch of the material...she is also sensitive to heat and cold and her left hand is also sensitive...i don't know what she has and no doc has said what it is that she has, but based on what i have read i think it may be Fibromyalgia...

Jan 17, 2008 11:00pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
I think of fibromyalgia as a condition rather than a disease simply because it is unlocalized pain - science hasn't pinpointed a cause/effect relationship yet to treat it. But that doesn't mean that the pain is not very real and should not be treated seriously, or that it should simply be brushed off as psychological (a complex issue in itself) because it's unlocalized. We as a society have so much more to learn about the brain and nervous system - despite tremendous leaps, our technology is still archaic when compared to the human body's natural circuitry.

Megs Jan 17, 2008 11:19pm

Re: Drug Approved. Is Disease Real? (about Fibromyalgia)
 
I agree with those saying there are major differences in the way men and women are treated by drug companies and insurance policies.

To say that chronic pain is psychological is really ridiculous. While it may be in many cases, in many it is not.

A male must have come up with this... just like the "have a happy period" theme. Total male comments/research/etc :rolleyes:


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