LKW shares these thoughts:
My brief comments on the article below:
I've been told many times I have FM because I consistently have 18 of 18
Tender Points at any given time. Problem is, I also have many other types of
pain, plus I display the very specific 'symptom cluster' that makes up ME,
G93.3. (Not 'CFS', Fukuda, et al, R53.82). Once again, the details are
important. So is being as specific as possible, and not just lumping things
together casually and indiscriminately....
Additionally, if a person has widespread pain they may also have a Vit D
deficiency, which is treatable by getting one's levels back up where they
should be. But don't try this at home - you need to have your blood tested
both before and during this process.
Also know that taking too many pain meds can cause a sort of 'rebound'
effect, making the situation worse, not better.
The 'conflict of interest' by some listed below is very troublesome. I
personally would never trust a Dr who's being paid by a pharmaceutical
company. (Here in MN, they are publishing these Drs names and their
reimbursement amounts in the newspapers, and also clamping down firmly on
this questionable practice.)
Lastly, isn't it amazing how quickly dangerous drugs can be concocted--or
already existing ones renamed and marketed to meet a newly identified
'need'--but no one wants to bother doing any actual scientific research on
well-defined patient groups???
Prescribing drugs, many originally derived for a different purpose and so
many with a multitude of serious adverse effects. Talk about an easy way to
control the masses....while not curing anyone or anything (because remember:
most drugs are designed to 'mask symptoms' only). Yikes.
Increase the consumers' intake, and raise the profit margins for the drug
companies. (A lot. They wouldn't bother, otherwise....)
And of course, this practice is also contributing hugely to the dramatically
rising health care costs overall - one of the things that is destroying our
country's economy.
LKW
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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 firstmedicine 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 absolutelystill 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 andby 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."
http://www.nytimes.com/2008/01/14/health/14pain.html?th=&emc=th&adxnnlx=1200326614-zwYnh2Bicy5hMsmDNR5zA&pagewanted=print
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