Fibromyalgia Awareness - New York Times not HELPFUL!

[Guest guest]

The following New York Times article was NOT helpful to us at all!

I'm certain most of you have read this, but if not, here is the

copy. It took a long time for people to believe the diabetes and

depression were diseases. This is why people like OPRAH will never

support our pain syndromes! Sad! Yes! Very Sad! And, if a Movie

Star has it - believe me, they are not going to endorse it because

it is so not believed by doctors and society. Only WE can get the

message out there!

And, now....everything else under the sun is considered a disease:

smoking, alcohol, and illegal drug addictions are all considered

diseases????? If there were no cigarettes, alcohol or manufactured

drugs such as meth etc... it makes no sense. We also are labeling

reflux as a disease, metabolic syndrome as a disease (yes I have an

overeating problem - but I don't consider it a disease!)GRRRR!

Anyway, here is the article dated January 14, 2008.

January 14, 2008

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. "

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. 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. "