Drug Approved. Is Disease Real?

Here is an interesting article from the New York Times. I wish that the doctor who doesn't believe in the disease would have fibro for a few days, just to see what it feels like.

Sheesh...

(Jan. 14) - 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.”

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.”

Strange Day

Well,I sit here and am completely overwhelmed by fatigue. Even though I managed to get 7 hours of sleep last night, I am so completely exhausted.

I am at the point where I am going to fall asleep at my desk. As I sit here studying, I am having partial visual and auditory hallucinations. I "snap out of it" right before I answer the person. It's strange, it seems like a melding of two worlds; the present one (at work) and a different one.

I've never (to my recollection) experienced anything like this. It's so strange. I just want to lay down...


I wonder what my co-worker thinks


To make matters worse, I called my doctor's office to confirm my appointment for next week and they told me that she is no longer seeing patients and that I will be referred to a pain management center here in town.

Well, I guess that's it for now.

Well, I just decided that since I haven;t posted in a while that I should. Today, I feel exhausted. There's no other way to put it. I could put my head down at my desk and sleep for hours.

It's cold outside; around 32 degrees, and although I love the cold weather, today I am in a great deal of pain, especially with my legs and upper back/shoulder area.

On days like this, I pray that I can get to work early enough to get one of the availabl disabled parking spots as the lot fills up pretty fast.

I guess that's it for now.

Do you ever have one of those days when we sort of feel better than yesterday, buit still feel like junk?

Yesterday, I made a comitment to post regularly on this blog for several reasons; one, to track and make some sense of my condition and two, to hopefully help others.

This morning, I am in pain and discomfort. It is bad, but more discomfort and exhaustion than pain... I think.

My shoulders, back and legs really ache this morning. My left knee burns so bad.

It's bad when you can't get comfortable at work. I often wish that I had a couch to lie down on because our work chairs are VERY old (~10 years) it seems and offer little comfort and NO back support as they can't lock in an upright position.

It's been another long time since I've psoted, but felt like I need to write today.

Today is a really rough day for me. It started off as early. I had to be at work at 5:00AM just in case there were any preproduction problems at work.

It is now only 6:45 and I am overwhelmed with pain and fatigue. My enite body hurts... burning pain in my shoulders, back and thighs... stabbing pain in just about everywhere else. I just came back from the restroom where I soaked my hands in hot water to help with the pain.

I really don't understand what coud've set this off. I didn't have a stressfull weekend.

I just want to curl up in a corner and sleep. I pray that today goes well and for strength from the Lord to make it through today.

I also wanted to mention that for personal reasons, I am assigning a "pain number" to how I am feeling to help me track what's going on.

This is a good thing as I've always wanted to, but never did for some reason. Anyway, today is an 8. It's really bad. I expect that if it gets more than an 8, that I will be in no position to post anything.

It's time

Well, it's been a long time since I've posted, so I wanted to journal what I'm going through right now.

Yesterday , June 3, 2007, I went to church with the kids and about a 1/2 hou from the end of the sermon, I started feeling exhausted for no reason. My legs, arms and hands got really achy and sore.

I came home and Diana got me some medicine and I took a hot bath to loosen my muscles up abd then took a brief nap.

Later, last night, we went to a Smal Group meeting. I was hurting the entire way through. When I got home, Diana again gave me medicine and I webt to bed.

This morning, I feel better; not a lot better, but better. I still have ached and pains, but can;t do much dince I'm at work. I feel tired and sore.

Today is Fibeomyalgia Awareness Day

This is cross-posted from my other blog.

Today, May 12, 2007 is National Fibromyalgia Awareness Day. Fibro-ma-what?!?! Fibromyalgia is a condition that affects a large number of people, including myself, but is not widely known or understood, even among the medical professionals.

Fibromyalgia or FMS is a chronic pain illness characterized by widespread musculoskeletal aches, pain, and stiffness, soft tissue tenderness, general fatigue, and sleep disturbances. The most common sites of pain include the neck, back, shoulders, pelvic girdle, and hands, but any body part can be affected. Fibromyalgia patients experience a range of symptoms of varying intensities that wax and wane over time.

The symptoms of Fibromyalgia include:

Pain:
The pain of FM is profound, widespread and chronic. It knows no boundaries, migrating to all parts of the body and varying in intensity. FM pain has been described as deep muscular aching, throbbing, twitching, stabbing and shooting pain. Neurological complaints such as numbness, tingling and burning are often present and add to the discomfort of the patient. The severity of the pain and stiffness is often worse in the morning. Aggravating factors that affect pain include cold/humid weather, non-restorative sleep, physical and mental fatigue, excessive physical activity, physical inactivity, anxiety and stress.

Fatigue:
In today's world many people complain of fatigue; however, the fatigue of FM is much more than being tired. It is an all-encompassing exhaustion that interferes with even the simplest daily activities. It feels like every drop of energy has been drained from the body, which at times can leave the patient with a limited ability to function both mentally and physically.

Sleep Problems:
Many fibromyalgia patients have an associated sleep disorder that prevents them from getting deep, restful, restorative sleep. Medical researchers have documented specific and distinctive abnormalities in the stage 4 deep sleep of FM patients. During sleep, individuals with FM are constantly interrupted by bursts of awake-like brain activity, limiting the amount of time they spend in deep sleep.

Other Symptoms:
Additional symptoms may include: irritable bowel and bladder, headaches and migraines, restless legs syndrome (periodic limb movement disorder), impaired memory and concentration, skin sensitivities and rashes, dry eyes and mouth, anxiety, depression, ringing in the ears, dizziness, vision problems, Raynaud's Syndrome, neurological symptoms, and impaired coordination.

I once read an incredible analogy of what having Fibro means; it's called the Spoon Theory. Although it's written by a lady with Lupus, but the theory still appies to all fibro sufferers. It is worth a look at it.

Posted by George Romano at 9:28 PM