Is Fibro a Real Disease

Drug Approved. Is Disease Real?

By ALEX BERENSON
Published: January 14, 2008
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.



Related
Times Health Guide: Fibromyalgia




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.”

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.”


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http://www.nytimes.com/2008/01/14/h...rtner=rssuserland&emc=rss&pagewanted=all&_r=0

 

I do not believe that this is a real disease. It is actually TMS in disguise.

 

But doesn't it sound as though the events that Dr. Sean Mackey says precede an attack of fibro are very similar to the psychological "triggers" Dr. Sarno says can initiate TMS? An accident, a car wreck, a virus, psychological stressors etc etc etc. One thing they all have in common is that they not only affect you physically, but also stress you out psychologically:



And yet Dr. Mackey also insists that though we haven't discovered the exact drugs it will take to eradicate fibro, he's sure we will. Excuse me, but prescribing drugs to medicate a stress-caused condition seems to create more problems than it cures. Witness Prozac and Ritalin. That quixotic quest of his for a fibro gene passed on from generation to generation seems to be barking up the wrong tree too. Exactly when did fibro first emerge as a bona fide condition or disease? If it was hereditary, you'd think there would be records going back centuries describing fibro-like symptoms. Does anyone know when fibro first emerged in the medical literature? I may be wrong, but I'd guess it appeared within the last 50 years or so.

 

Bruce, I read a lame ebook entitled "Fibromyalgia is Real!" I suffered through its pages (maybe that was part of the plan to help remind one of their pain?) and finally deleted it from my Kindle. Anyhoo. The author had some vague references to fibro in early history.

I think the author's heart was in the right place - giving validation to women in chronic pain that they're not crazy. But he too missed the boat big time in his quest for a structural answer. And honestly, his "research" did nothing to comfort my heart in my pre-Sarno days. It all seemed pretty lame.

The worst part was he kept repeating "Fibro is real!" as though writing it made it so. And I hate the overuse of exclamation points too!!!

PS You've given me pause to think about the horrendous car accident that nearly took my life when I was 17. Thanks for that tidbit.

 

I think he kept saying 'fibro is real' to help ease people who were being accused of imaginary fairy dust. But if he was implying that fibro was a body problem then he's a whacknut. Too many people have healed from fibro after finding TMS. Trauma no doubt is a huge instigator.

 

"accused of maginary fairy dust"…yup. You're spot on. Oh, and BTW, yes, he was of the "structural" mindset.

I listened to enough of Dr. Mackey's lecture to hear about the triggers then I turned it off. I don't need to reinforce any of my errant thinking. That's all I need is a new symptom to tuck away into my sub-c. haha

 

"Chief, Division of Pain Management" - that says it all. As Dr Sarno is quick to point out, pain shouldn't be treated as a separate disease category, but rather, as a symptom that something else is wrong. Yup, this is an overly-specialized society.

 

As if Pfizer isn't rich enough, it jumps on the fibromyalgia bandwagon.
Bruce is right, fibro is just another symptom of TMS.
When hurting, pop a pill. Believe in pharmaceutical advertising. Then keep hurting,
until one day you decide enough is enough and you will let TMS lead the way to healing.
Whether repressed emotions or personality or whatever created anger than has built up
into repressed rage, TMS has helped a lot more people than new pills can.

I doubt anyone at Pfizer or anywhere else will ever put a pill on the market that
does what TMS knowledge does. I wouldn't even buy it because the time spent studying
and practicing TMS is well spent and the results are revelations about ourselves and others
that is priceless. It's mind-expanding, not pain numbing.

Pfizer makes me laugh.

 

This is a topic which is very close to my heart, as some of you will know I have survived the fibromyalgia diagnosis and "treatment", with TMS healing. Of all the multitude of medications I was prescribed Lyrica was by far the most damaging. It took me a year to withdraw from it, and even then I had withdrawal issues long after I stopped taking it, my hair has only just started to grow back properly after two years, I had lost about a third of it. The 20lbs I agained has also gone thankfully. I won't go into the full extent of the problems it caused me, I wouldn't want to scare anyone.

I can definitely say that fibro is indeed TMS run riot, it is not a "disease" that can be cured with medication. Sad the medical profession can't spell, it's meditation not medication where the answer lies !

Lyrica acts on the brain's GABA mechanism as do benzos, it's doesn't give the "high" that benzos do, but the withdrawals are exactly the same. With the false agent removed the balance of my brain chemistry took an age to restore.

When I first started taking it I thought it was great for pain relief, but it's an insidious drug. It takes a few months for the nasty stuff to kick in, and because you can't just stop taking it cold turkey you get worse before you get better. As Steve says in chapter 24 of his book, where he discusses drugs, the Yin certainly does chase the Yang.

Still you live and learn ! I had to do a lot of journaling and forgiveness around the whole doctor mess. I had to forgive myself for being so "stupid" in taking all that c**p in the first place, and let go of the bitterness I felt toward the medical profession.

Of course everyone's reaction to drugs is different, I know some people don't experience any problems. If anyone on the forum is struggling with medication I would be only to happy to lend a sympathetic ear.

My advice, get of EVERYTHING, INCLUDING SUPPLEMENTS - SLOWLY, eat healthy unprocessed foods, hydrated well and get as much fresh air and exercise as you can manage, neuroplasticity will take care of the rest.

Please excuse the rant !!

 

North Star, what you're noticing is what Dr. Clancy D. McKenzie has called the "two trauma process" where chronic pain, PTSD and, McKenzie maintains, schizophrenia too are the result of an earlier trauma being reactivated by subsequent traumas. For example, I met a young woman in Yosemite last summer, a U. of Hawaii graduate, who had a very bad traffic accident in her early twenties that involved broken ribs, a collar bone and a smashed jaw. Then, when she had an acrimonious divorce several years later, she developed pain all over her body that was diagnosed as fibromyalgia. In other words, the first trauma of the accident was activated by the second trauma of the divorce. This is a rather common scenario with fibro and TMS too, which leads to my gut feeling that the two are interrelated or really the same thing. It's interesting that soldiers are able to handle combat longer without developing "shell shock" if they've had happy, uneventful childhoods. Of course, the soldiers with happier childhoods will still develop combat fatigue, but will shake it off quicker without suffering long-term PTSD symptoms.

For more information, see the videos on Dr. McKenzie's site:

http://drmckenzie.com/

After a while, you begin to see McKenzie's two-trauma process happening everywhere around you all the time!

 

Rant all you want. We dont want you to be repressing any emotions now.
Great post by the way.

 

This part is worth quoting and we need to read it again.

Excellent information Herbie. Exactly what we were talking about in the other post.

 

Mermaid, EXCELLENT post. Rant on! I was on Lyrica for a few months and I DID stop it abruptly when I developed a horrendous skin infection. I'm convinced it was one of those rare side effects you see buried in the literature. And yeah, I gained weight too. Hideous stuff. The dizziness!

Bruce, yep…my "two trauma sequence" would be the car accident and then my sisters sudden illness and death several months after the accident. What gets me is the tons and tons of PT, chiro and snake oil treatments…everyone based my various pain issues on the car accident from over 30 years ago. I never really saw the absurdity of that.

I have spent some time on Dr. McKenzie's website. It is so cool how all these brilliant scientists/doctors each have bring a piece of the puzzle to light.

Matthew, I know Dr. Sarno states in "Healing Back Pain" that fibro is absolutely a severe case of TMS. Sorry I can't site a page…I listen to the audio version. But he devotes a good chunk of time to fibro.

 

I agree BruceMC, if they know its coming from our stresses then why don't they prescribe us with what they prescribe stressed out patients. Thats rest, love and knowledge. Hum, it sure sounds fishy there but he has been taught all structural right. He hasn't even considered the mind can be putting this stress on the body so the mind needs to be soothed... makes ya wonder but the structural teaching really settles it cause most Drs. have never thought about the connection, right. Even though there saying it left and right they aren't putting 2 and 2 together ya know.

 

"A symptom that something else is wrong". That is exactly what Tms is, Awesome. If they would just do more test right, but the test have been done.
Big Pharma is a powerful force -- money and what it can do, greed.

The important thing is we all know how to heal and the truth, we heard it from the horses mouth, so its something to be thankful for, for sure. The important thing too is that we spread the word and keep teaching, one day our kids and grand kids will all know the truth. We are all part of something bigger than ourselves. This is good times to be alive cause at least we are hearing the truth now. It's in a distance crying out, Our voices are heard everyday. I'm going to tell the truth the rest of my life, If we believe -- we can.
Bless You

 

Mermaid, I can really relate to this and fully agree with everything. I was on Lyrica for about 2,5 years and the withdrawal was one of the worst things I ever experienced. I did not even expect to experience any withdrawal symptoms because my doctor said it will cause no problems. In fact I experienced pain I never had before, I got anxious and depressed and my whole body starts to hurt 24/7. I once began to take lyrica because of my pain and when I stopped it I had the worst pain I could ever imagine. It lasted about 1,5 years to get back to "normal" again. I am now where I was before I took Lyrica and the bad symptoms of the withdrawal completely disappeared. This must not happen to everyone; I know several people who came off Lyrica without any problems. As mermaid said it probably has something to do with the GABA-system in the brain (it's the inhibitory system for pain and anxiety) and Lyrica acts on similar receptors as Benzos. It's a fact that a Benzo-withdrawals can cause symptoms for a long time, even if the Benzo is not in the body any longer. Ok, I really do not want to frighten anybody, but I find it very dangerous to advertise Lyrica for a fibro-healing as it really undermines the real psychological causes of fibro and, in addition, can cause really severe problems in some people when they try to stop Lyrica. Lyrica may be a blessing in some causes of realy nerve damage after an injury or maybe for epilepsy, but that's all.

I once watched the advertising-movie by Pfizer and got really angry about it.

 

Thank You Richsimms22. You told me where it was when you mentioned the story. Find more like that when you can -- the truth is awesome I love knowing I have a choice to know now ya know. WE do have a choice to know so its an awesome day to be living. I love Mondays.

 

For some people Lyrica is a dangerous poison. This is the first time I've been in contact with anyone who has shared this experience. I was made to feel like a crazy person by my doctor, who insisted that this medication was safe and could not be the cause of the strange side effects I had, even though they were listed on the information sheet which comes in the box !

Some of them were very embarrasing, the memory lapses drove me crazy. The emotional blunting and suicidal depression in withdrawal were no fun either, but I always had a little voice deep inside telling me that it was false and I would eventually be OK, which of course I am.

I was polydrugged to within an inch of my life, never, ever again !!

 

Mermaid, I think you're wonderful. That doctor ought to lose his license to practice.
Thank God you know about TMS and had the courage to recover from the Lyrica.

Birdie, I hope you're better and don't need anything anymore.

I cringe when I see a tv commercial about medications. Most have disclaimers that
the medication could cause side affects worse than the reason for taking them,
including suicide or death.