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Fibromyalgia - upcoming new treatments

Posted By: good read (see article inside) on 2005-08-28
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Copyright 2005 Los Angeles Times
All Rights Reserved

Los Angeles Times

August 22, 2005 Monday
Home Edition

HEALTH; Features Desk; Part F; Pg. 1

2286 words
On pain's trail;
fibromyalgia's mysteries, researchers look to the central nervous system,
gaining deeper insight into why we suffer.

Shari Roan, Times Staff Writer

FOR years, pain, stiffness and fatigue clung to Lauren Armistead like an
invisible shroud. It was tough enough to live with fibromyalgia -- but
the skepticism she encountered when she discussed her condition was intolerable.

"Throw out a word like fibromyalgia and you'll get this blank
stare," the 28-year-old said recently, sitting in her Santa Monica apartment.
"For so long, it was my own private battle."

Today, however, Armistead is slowly, tentatively opening up about a
disease that is simultaneously emerging from its own mysterious black box.

A groundswell of research has begun to expose the underpinnings of the
baffling disorder that affects an estimated 6 million to 10 million Americans,
most of them women. Not only do the findings have the potential to ease the
condition's stigma, they also may provide clues to other illnesses for which
there is no clear clause.

Fibromyalgia, experts now believe, is a pain-processing disorder
-- arising in the brain and spinal cord -- that disrupts the ways the body
perceives and communicates pain.

"There was a time when it was thought to be psychosomatic," said Dr.
Robert Bennett, a fibromyalgia expert at href=http://www.mtstars.com/medical_transcription/Oregon/>Oregon Health
& Science University in Portland. "We now understand the pain in
fibromyalgia is an abnormality in the central nervous system in which
pain sensations are amplified."

Now doctors are more likely to acknowledge fibromyalgia as a real
illness. Because patients are being diagnosed and referred to specialists more
quickly, they're finding relief, and acceptance, easier to come by.

Pharmaceutical companies have jumped on the new theory of the disorder
too. The first prescription drug approved specifically for fibromyalgia
will likely be approved late next year or early in 2007, and at least half a
dozen pharmaceutical companies are developing other treatments. Meanwhile, the
federal government is funding 10 studies of the disease.

"It's very rewarding," said Dr. Stuart Silverman, medical director of
Cedars-Sinai Medical Center's Fibromyalgia Rehab Program. "I was seeing
patients before because no one else wanted to see them. Patients would tell me,
'Everyone has told me there is nothing I can do.' "


The difficulty of diagnosis

Fibromyalgia typically is defined as unremitting pain in multiple
areas of the body -- at least 11 of 18 specific tender points -- accompanied by
fatigue, difficulties with concentration and other vague physical discomforts.
The illness is called a syndrome because the cluster of symptoms lacks the clear
markers of disease, such as changes in the blood or organ function.

Because patients often look healthy, doctors have sometimes diagnosed
fibromyalgia as a muscle problem or an autoimmune disorder. It can also
be a "wastebasket" diagnosis, attached to people with inexplicable pain
problems. Some have even dismissed it as the complaints of emotionally troubled

Many fibromyalgia patients stumble around for years seeking help
for their symptoms -- even after receiving a diagnosis. Always athletic,
Armistead first experienced back pain when she was a child, but
she assumed the discomfort was a part of playing sports.

By the time she had joined the UCLA volleyball team in the mid-'90s,
however, Armistead knew something was seriously wrong. After games, she would be
racked with pain. She sometimes took as many as 15 over-the-counter pain pills a

Coaches and trainers, alarmed at her use of painkillers, insisted she
undergo medical tests. Over a year, Armistead saw numerous doctors but got no

"Eventually everyone started doubting whether or not I was really in
pain," she said. "My coach couldn't understand how I could play one day and be
bedridden the next."

Debilitated by pain and fatigue, Armistead quit the team and began to cut
back on classes. She lost 35 pounds in eight months. It was a time in her life
"so painful, I've tuned a lot of it out."

In 1996, however, a doctor diagnosed her problem as ankylosing
spondylitis, a type of arthritis affecting the spine, and

Today Armistead takes an arthritis medication, two sleep
medications, vitamins and herbs. She undergoes acupuncture, exercises moderately
and works only a few hours each day doing freelance marketing.

"With each passing year I've accepted the cards I've been dealt," she
said. "I'm not giving up. I keep trying new treatments."


The evolution of treatment

Armistead, like many fibromyalgia patients, is a long way from
being pain-free. But the new research on fibromyalgia's causes offers a
blueprint for more effective treatments.

For years doctors had been looking for a cause of fibromyalgia at
the site of the pain: the head, back, hands, neck, gut or elsewhere. And their
treatments focused on soothing pain in these locations. As their understanding
has grown, however, these treatments have begun to change and new ones are in

Fibromyalgia is now thought to arise from miscommunication among
nerve impulses in the central nervous system, in other words the brain and
spinal cord. This "central sensitization" theory is described in detail this
month in a supplement of the Journal of Rheumatology. The neurons, which
send messages to the brain, become excitable, exaggerating the pain sensation,
researchers have found.

As a result, fibromyalgia patients feel intense pain when they
should feel only mild fatigue or discomfort -- such as after hauling bags of
groceries. They sometimes feel pain even when there is no cause.

"The pain of fibromyalgia is not occurring because of some injury
or inflammation of the muscles or joints," said Dr. Daniel Clauw, a
fibromyalgia researcher and director of the Center for the Advancement of
Clinical Research at the University of Michigan. "There is something wrong with
the way the central nervous system is processing pain from the peripheral
tissues. It's over-amplifying the pain."

Recent studies show multiple triggers for the amped-up response to pain.
Fibromyalgia patients have, for instance, elevated levels of substance P,
a neurotransmitter found in the spinal cord that is involved in communicating
pain signals.

They also appear to have lower levels of substances that diminish the
pain sensation, such as the brain chemicals serotonin, norepinephrine and
dopamine. Growth hormone, which helps promote bone and muscle repair, is also
found in lower levels in fibromyalgia patients.

New therapies are aimed at these abnormalities. The experimental drug
pregabalin, for example, can reduce the release of brain chemicals involved in
the pain response. Other medications might encourage the deep, restorative sleep
during which the body secretes growth hormone to nourish tissues.

Although antidepressants that increase just serotonin have been a
disappointment in treating fibromyalgia, a new class of drugs may provide
better pain relief by boosting both serotonin and norepinephrine. The pain and
depression of fibromyalgia are caused by abnormal levels of these
neurotransmitters, doctors now believe, not simply by the inability to live life

"What we have realized is there is a very strong relationship between
depression and pain physiologically," Bennett said.

Medications approved specifically for fibromyalgia will
dramatically change treatment, Silverman predicts.

"Fibromyalgia will get a lot more respect," he said. "People will
think there must be a disease if there is a medicine for it. It must be


A multifaceted model

The "central sensitization" model of fibromyalgia may even be used
to help explain and treat other chronic pain conditions that have stumped
doctors, such as irritable bowel syndrome, chronic low back pain,
interstitial cystitis and vulvodynia, Clauw said. All may be variations of
central sensitization and the resulting imbalance of chemicals and hormones.

Although fibromyalgia is thought to affect mostly women, he
believes many men are afflicted but are instead diagnosed with chronic low
back pain.

"These enigmatic chronic conditions are all probably central pain
syndromes," he said. "People were taught that there is one kind of pain, a pain
that occurs in the area of the body where people are experiencing pain. But this
notion of central pain, that's where we really need to move."

Others aren't so sure, however. Many questions about central pain
disorders remain, including why some people are afflicted and not others; why
symptoms can vary so widely among patients; and whether the emerging chemical
markers -- high levels of substance P and low levels of serotonin and
norepinephrine -- cause the exaggerated pain or are its result.

The central sensitization theory hasn't convinced everyone that
fibromyalgia is a real illness, said Dr. Nortin M. Hadler, a professor of
medicine, microbiology and immunology at the University of North Carolina.

It's possible that fibromyalgia patients simply have a different
mind-set, he said. They tend to catastrophize small burdens, exaggerate minor
discomforts and quickly lose hope. This psychic despair, he said, can alter
neurotransmitters and influence other central nervous system functions.

"Is central sensitization something we want to label as a pathological
process or is this something we are all capable of doing if we prepare ourselves
intellectually?" he said.

Hadler is the author of the 2004 book "The Last Well Person," in which he
said that too many normal human characteristics and conditions are "medicalized"
into problems that require treatment.

Once fibromyalgia patients are treated as if they have a disease,
he said, "they never return to wellness."


A hard disorder to treat

This perception of fibromyalgia, while falling out of favor among
many doctors, nevertheless strikes a nerve in patients and among doctors
specializing in its treatment.

Fibromyalgia patients are difficult to treat, Bennett said,
requiring much time and attention. Some patients never get better, although
about 80% improve with a dedicated treatment plan and lifestyle modifications,
he said.

"There is no recipe for treating fibromyalgia patients. The
treatments have to be fully individualized, and that takes a lot of time,"
Bennett said. "Most patients aren't getting the treatment they need."

Armistead, however, has reached a turning point. Now she sits down with
loved ones and friends and explains to them, one on one, what her illness is
like, how she must be flexible when making plans, that she may not feel well
even though she looks fine.

"The name 'fibromyalgia' is recognized now," she said. "I think
someday people will be shocked that anyone thought it was all in your head."

On a recent day, as the clock approached 6 p.m., Armistead pushed herself
through a 90-minute yoga class at a sunny Westside studio. She slowly picked up
her mat, towel and water and left the studio looking tired and moving gingerly.
Her back throbbed. Her neck hurt. A headache was coming on.

But she did it. She made herself do the stretching exercises her doctor
said are necessary. She enjoys the small satisfaction of knowing that she did
her best.

"Living with any chronic illness is not easy," she said. "It's a constant
battle. My saving grace is I know there will be a day when I'll wake up


New options for treatment

As understanding of fibromyalgia has grown, so too have options
for treating the condition. These medications are under study:

* Pregabalin (brand name Lyrica): This antiepileptic drug, also approved
for diabetic nerve pain, appears to be effective in reducing pain and disturbed
sleep in fibromyalgia patients. If late-stage trials prove successful,
Pfizer plans to ask the FDA to approve the drug for fibromyalgia.

* Milnacipran: Marketed outside the United States as an antidepressant,
this drug increases the brain chemicals norepinephrine and serotonin. Early
studies showed it to be successful in reducing fibromyalgia pain, and
data from the first phase-three trial is due out this fall. Cypress Bioscience
and Forest Laboratories hope to seek FDA approval late next year.

* Duloxetine (brand name Cymbalta): This antidepressant, already on the
market, increases the activity of serotonin and norepinephrine. It was
successful in reducing fibromyalgia pain in early-phase studies, and
plans for a phase-three study are underway. If successful, Lilly may seek FDA
approval of the medication for fibromyalgia.

* Xyrem: Approved for narcolepsy with the complication of weak or
paralyzed muscles, the drug might be able to increase deep sleep in people with
fibromyalgia. The results of an initial study on fibromyalgia are
due later this year. It's made by Jazz Pharmaceuticals.

* Provigil: Approved for daytime sleepiness associated with narcolepsy
and shift-work disorders, or sleep problems in those who work nights or on
changing schedules, the medication might help treat fatigue related to
fibromyalgia. The manufacturer, Cephalon Inc., has no plans to seek
approval for the drug for this purpose, but it can be used off-label.

* Mirapex: Approved for Parkinson's disease, this drug works by
increasing the neurotransmitter dopamine. The manufacturer, Boehringer
Ingelheim, has no plans to study the drug for use in fibromyalgia, but it
can be used off-label. An independent study showed it was promising for reducing
fibromyalgia pain.


Fibromyalgia's link to other disorders

The recent fibromyalgia research might also lead to a greater
understanding of several other disorders. The suspected cause of the condition
-- central sensitization, in which nerve impulses in the central nervous system
malfunction -- may also play a role in:

* Irritable bowel syndrome

* Chronic fatigue syndrome

* Gulf War syndrome

* Interstitial cystitis

* Vulvodynia

* Chronic low back pain

* Chronic headaches

* Endometriosis

PHOTO: REGIMEN: Yoga is part of 28-year-old Lauren Armistead's treatment plan
for fibromyalgia. Before she was diagnosed with the condition, she
sometimes took up to 15 or more over-the-counter pain pills a day. PHOTOGRAPHER:
Perry C. Riddle Los Angeles Times

August 22, 2005

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