A ‘Murky Business’ – Yes it is REAL

AP Associated Press IMPACT:

Drug makers’ push boosts ‘murky’ ailment

Collated by Jeanne Hambleton FMS Global News Desk ©2009        

 

A ‘Murky Business’ – Yes it is REAL

AP Associated Press IMPACT:

Drug makers’ push boosts ‘murky’ ailment

Collated by Jeanne Hambleton FMS Global News Desk ©2009        

 

Business Writer Matthew Perrone for AP: Associated Press has  “set the cat among the pigeons” with his reference to fibromyalgia and ‘murky ailments’. Posted in Washington on February 8 2009, this article has the promise of the same reaction given to the infamous IS DISEASE REAL article on fibromyalgia that appeared in the New York Times.

 

The  above story by NY Times reporter Alex Berenson published January 14, 2008 can be read at  <http://www.nytimes.com/2008/01/14/health/14pain.htmlem&ex=1200459600&en=bac45d5aff5a17d7&ei=5087> 

 

The members of the fibromyalgia community who are somewhat sensitive about questions suggesting FMS is an imaginary illness, has risen to the bait and letters are flocking in from around the USA where the article was published and in the UK, where it has been given coverage by FMS Global News.

 

Matthew Perrone, a business writer, suggests huge sums of money were provided by two drug companies last year in an endeavor to raise awareness of a “murky illness” as well as boost the sales of their medication recently approved by the Food & Drugs Association (FDA.). The writer claims the drug companies have been “drowning out unresolved questions” …. “whether it is a real disease at all”. 

 

Oooophs. That went down like a lead balloon.

 

Matthew Perrone discovered that the two drug companies, Pfizer and Eli Lilly, have in the first nine months of 2008 donated upward of $6 million towards educational events and to supporting non-profit making medical conferences. He claims this sum is greater than funds given to Alzheimer’s and diabetes. Top priority for funding by Pfizer was for cancer, AIDS and the fibromyalgia. Similarly Eli Lilly favoured cancer, depression and fibromyalgia.

 

While reminding readers that the cause for fibromyalgia still not known, with no specific test to confirm diagnosis, patients often showed overlapping symptoms with other neurological diseases. He claimed the specialists are in no doubt about the pain these patients suffer but they cannot agree how it should be treated and what illness it actually is.

 

It is believed by many patients and doctors, says Matthew Perrone, that the actions of the drug manufacturers are helping to solved the mysteries of fibromyalgia within the medical profession. He does acknowledge that patients with fibromyalgia say doctors often disbelieved them claiming the pains are imaginary or “all in your head.”

 

The article adds “critics say the companies are hyping fibromyalgia along with their treatments, and that the grant making is a textbook example of how drug makers unduly influence doctors and patients.”

 

Dr Frederick Wolfe, a member of the panel who helped to definite the criteria for fibromyalgia and adopt the name in 1990, suggests the drug companies are guilty of  “a little disease-mongering” to encourage patients to buy their medication. The business writer reports that the companies have been successful in the actions showing huge increases in sales and profits between 2007 and 2008 for Lyrica and Cymbalta –both approved for the treatment of fibromyalgia by the FDA. 

 

Responding to questions from the author the drug companies say their actions are “just the evolution of greater awareness” of a condition that has been poorly managed and neglected. 

 

The article includes the story of a patient taking both Cymbalta and Lyrica and three other medications. Describing her medicated condition as fibro fog she is quoted as saying she is so medicated she feels as though she is not here. Struggling to find money for her medication she claimed she is receiving free samples of Lyrica from the drug company representative to help her get through the month.

 

The article reports both drug companies spent of $125 million on advertising in the first nine months of 2008.

 

Grants from the drug companies are available for education for doctors, non-profit making groups and advocacy. Some of this money is used for research and patients outreach.

 

President of the USA National Fibromyalgia Association Lynne Matallana is quoted as saying lack funding would impact on patients’ care due to lack of money for medical education. Matthew Perrone claims that 40% of the funding for the $1.5 million a year Association’s operations is provided by corporate funds, like those given by Eli Lilly and Pfizer. Lynne Matallana who has fibromyalgia claimed she visited 37 doctors before being diagnosed.

 

In a Pfizer television commercial the drug company acknowledged fibromyalgia is real, but Matthew Perrone says the researchers report it is not that easy. The condition usually known as a syndrome, has been described as a disease, a collection of symptoms and even a behaviour disorder.

 

This description suggesting a behaviour disorder has caused some concern among the fibromyalgia community who insist it is not a mental disorder.

 

It is thought that up to 12million people in the USA may have fibromyalgia in the USA with a large percentage of them women.

 

Market research on behalf of the pharmaceutical industry indicated that possibly 50% of this number are not diagnosed said Dr. Daniel Clauw (University of Michigan).

 

Dr. Don Goldenberg (Tufts University) who has spent 30 years working with fibromyalgia claims it remains a “murky area”.  He said patients preferred to have a name for what ailed them.  It was suggested that while Dr. Goldenberg is a diagnosing patients he said a number of doctors no longer diagnosed FMS patients suggesting it is a “catchall covering a range of symptoms”.

 

A professor at the University of North Carolina Dr. Nortin Hadler believes identifying fibromyalgia can “doom” patients to endure suffering for the rest of their lifetime and just confirms to them that this is a condition with no cure.  Dr. Hadler said the likelihood for patients diagnosed with fibromyalgia improving was “pretty dismal”

 

His view was that fibromyalgia was not a medical disease but a psychological condition (‘having to do with the mind’). He believed therapy should be available instead of drugs and medication, to help patients “unlearn” their problem.

 

Dr. Clauw whose research has revealed patient’ brains reveal  “unusual activity” when suffering pain, confirms fibromyalgia is a legitimate disease and he had no time for experts who analyse definitions instead of helping patients.  He also agreed that the new drugs approved by the FDA do not work for all  patients.

 

This article is a summary of  a story published by AP Associated Press distributed by Google.  © 2009 The Associated Press. All rights reserved.

http://www.google.com/hostednews/ap/article/ALeqM5jZDQjkt1twJK_3GpRKJUbXZ_-oMwD967HPG81

 

Fibromyalgia is not ‘murky’ to millions of people who live with it

Letter to the Editor of CantonRep.com  Posted Feb 13, 2009 

 

I read with interest “Drug makers push boosts a ‘murky’ ailment” (Feb. 9). I am both a patient with fibromyalgia and a physician who specializes in this condition, so I find it incredible when the article refers to so-called experts who are skeptical that the diagnosis even exists and that drug makers are somehow responsible for perpetuating this condition. 



Fibromyalgia is not “murky” to the many millions of patients worldwide who have it, and to the thousands of doctors who diagnose and treat it. It is a real condition with its own insurance code, specific diagnostic criteria and proven helpful treatments. It is recognized by major medical and legal organizations, including the Food and Drug Administration. 



We have not found a cure yet, but ongoing research is necessary to help improve the quality of lives of those who suffer from this chronic disease. To date, the FDA has approved three medicines for treatment of fibromyalgia pain.

These so-called experts mentioned in the article do not believe fibromyalgia exists, thus they never diagnose or treat it. To me, no experience with this condition means no expertise. Fortunately for patients, there are many primary-care doctors and specialists  (in the USA) who understand, research and treat fibromyalgia: the true experts. 



Unlike the critics, these professionals have actual experience and skills in trying to improve lives affected by chronic pain and will prescribe approved medications, not blame drug makers or patients for the pain. The true experts may not be as vocal as the so-called experts, but their efforts to help those with fibromyalgia have spoken the loudest. 


MARK J. PELLEGRINO, M.D., 

JACKSON TOWNSHIP

Reproduced courtesy of CantonRep.com Connecting Stark County

(http://www.cantonrep.com/opinion/letters/x817675485/Fibromyalgia-isnt-murky-to-millions-of-people-who-live-with-it)

 

National Fibromyalgia Association’s Response to

AP Article on Drug Companies & Fibromyalgia

Fibromyalgia & CFS Blog Friday February 13, 2009

By Adrienne Dellwo, About.com Guide to Fibromyalgia & CFS

 

The inaccuracies of the recent AP report, Drug makers push boosts ‘murky’ illness, go even beyond what I pointed out in a recent blog. Here is the response from Lynne Matallana, president of the National Fibromyalgia Association:

“To the editors:

“The recent Associated Press story on fibromyalgia hardly qualifies as news; it merely regurgitates the same arguments that have been published in the past and offers the opinions of the same two men who have built careers out of drawing attention away from the hundreds of scientists who continue to make amazing scientific strides toward understanding the underlying cause(s) and pathophysiology of what fibromyalgia patients experience.

 

“By perpetuating this message, the article implies that it is more acceptable to debate names or labels for this “set of symptoms” and to point fingers at the usual “villains” (i.e.: pharma and the non-profits who accept money from them), than to focus on the millions of desperate patients who deserve to have a voice in the discussion.

 

“The fact is that credible medical institutions and organizations recognize fibromyalgia as a life-altering disease; the fact is that patients who suffer with FM depend on the medical system (including pharmaceutical companies) to help them inform the public that this is a very real illness and that they need treatments, including pharmaceutical agents, to help them get through each day and to look forward to some sort of quality of life in the future.

 

“This article misinforms readers in a way that undermines and victimizes innocent people. By telling only selective parts of the story the author is perpetuating misperceptions and making it difficult, if not impossible, for readers to grasp what is truly important: that we need to stop debating and pointing fingers and start asking why it is perceived as acceptable to stigmatize a patient population just because medical research has not yet provided us with all the information needed to understand that particular illness. Every illness seems to go through a stage of having to prove its legitimacy, but why should the patients be suspect during that phase of research?

 

“Why would AP print information that is simply not true – people with fibromyalgia are “more likely to have a history of mental illness and are economically disadvantaged?” That is totally false, as is the writer’s statement that the National Fibromyalgia Research Association received pharma money to fund Dr. Clauw’s functional MRI study. The money for all of the NFRA’s funded research came from the founder (the husband of a fibromyalgia patient), general donations, and revenue generated from a non-profit bingo game. (Yes, the FM community has had to rely on bingo games to fund our research!)

 

“How can we allow the system to fail millions of people whose only ‘fault’ is to have developed a devastating illness? Along with the rest of the fibromyalgia patient community, I look forward to the day when society (including the medical community, the media, and our government agencies) accepts the responsibility of treating fibromyalgia patients like any other group of chronically ill patients; when it is a given that fibromyalgia will be further studied, that treatments will be developed and made accessible to patients, that the media presents the facts rather than perpetuating threadbare controversies.

“Now that would be news worth printing.

“Sincerely,

“Lynne Matallana

President, National Fibromyalgia Association”

Courtesy About.com

http://chronicfatigue.about.com/b/2009/02/13/national-fibromyalgia-associations-response-to-ap-article-on-drug-companies-fibromyalgia.htm

 

A ‘Murky Business’. Yes it is REAL

http://fmsglobalnews.wordpress.com

 A FIBROMITE’S RESPONSE

 

To the Editor and Business Writer Matthew Perrone Associated Press (info@ap.org).

Dear Sirs,

It is with great distress that I have read the article that denies the existence of this truly horrible illness. I would like to stress firstly that I am not a previous sufferer of mental illness, although I am now being treated for depression, and I am from an economically secure background.

 

Just answer me one question, if this illness is all in my head, how come so many millions of us suffer from such similar symptoms. Are we transmitting then to each other telepathically? We do not suffer identical intensity of each symptom, some us have irritable bowel syndrome worse than others for instance, but we all suffer from unexplained severe pain, terrible tiredness and loss of the quality of our lives.

 

I, sir, am a qualified psychologist who for a long time thought I was going mad, especially as every test I had came back negative. To actually realise that the awful symptoms I was suffering were not a result of “being in my head” came as a great relief and if drug companies are making profits that can be used to find out what causes this and find a cure I say hallelujah!!!

 

Articles like this do nothing to help and indeed set us back and damage us immeasurably in our quest to be taken seriously and find a cure.

 

Yours in despair

Carolyn from Felpham, West Sussex. UK

 

 THE FIBROMYALGIA COMMUNITY RESPONDS

 TO ASSOCIATED PRESS ARTICLE

 

1. The Associated Press article by Matthew Perrone (February 8, 2009, “Drug makers’ push boosts ‘murky’ aliment) has drawn several comments.

Click here to read the article.

Click here to read the NFA’s response, as well as some comments by other readers.

To send a letter to AP business editor Kevin Noble or writer Matthew Perrone, email info@ap.org  (no attachments).

2. The NFA is in the process of contacting media outlets across the nation that published Mr. Perrone’s article. In addition to sharing the disappointment of the fibromyalgia community, our response provides accurate information about fibromyalgia, including the science behind fibromyalgia and the lack of research funding.

3. For a list of 10 ways to respond to negative and false Information about fibromyalgia, click here.

4. Several points made in the AP article were addressed by fibromyalgia experts on February 11, 2009 during a medical talk show produced by Patient Power. Guests included leading FM researcher Daniel Clauw, MD, professor of medicine in the Division of Rheumatology, University of Michigan Health System; Martha Beck, Ph.D., who has been diagnosed with fibromyalgia; and Lynne Matallana, president and founder of the National Fibromyalgia Association. Click here to listen.

5. The NFA has created two information sheets—the Fibromyalgia Fact Sheet and Recognition, Research and Science—for your reference and use in helping dispel misunderstandings about fibromyalgia.

Click here to view the Fibromyalgia Fact Sheet.

Click here to view an overview on Recognition, Research and Science.

6. In addition to a variety of articles about managing FM symptoms, overlapping conditions, and healthy lifestyle choices, the NFA’s 10-year anniversary issue (September-November 2007) includes a special section on the History of Fibromyalgia. Topics include:

The state of FM and how it has changed in the last 10 years

How changing perspectives on FM have impacted the specialties that focus on it  

How patients have succeeded in changing public perception of FM

The latest studies on medications commonly prescribed to treat FM. Click here 

 

Undermining the Validity of FM


Sharon Waldrop – Director, Fibromyalgia Association of Michigan USA

 

My name is Sharon Waldrop. I am the Founder and Director of the Fibromyalgia Association of Michigan, a volunteer nonprofit organization. I am a patient living with fibromyalgia (FM) and I am deeply disappointed in the article that ran yesterday in the Free Press copied off the AP. I am writing to you to ask if you would do a story on fibromyalgia to provide a balanced report on fibromyalgia? 

I am very sad that the millions of people who are suffering and struggling every minute of every day with fibromyalgia never get a chance to give their viewpoint in the media. Instead articles are written to please editors who have a formula that dictates what type of story “gets attention” and therefore gets printed …never taking into consideration or caring about the ramifications that their message will have on millions of innocent people.


The ramifications are that more marriages crumble, friendships (i.e. support systems) end, people lose jobs, people are denied access to care because the opinions of a select few are given mass attention. Credible medical institutions like Johns Hopkins University, the University of Michigan, the National Institutes of Health, (just to name a few), recognize fibromyalgia as a life-altering disease. It is time to treat FM patients with respect. Millions of people suffer from FM.  Millions more are suffering too as they watch their loved one struggle. These people do not need to read stories that FM is not real. They need to read stories about the exciting medical advances in fibromyalgia like the brain imaging study done at the University of Michigan that concretely prove people’s brains with FM act differently than people without FM. 

They need to be given hope and given the treatment they deserve as a human being.

My group has over 800 members in the Metro Detroit area.  We provide support and education to people affected by fibromyalgia.  People come to me in tears because they don’t know where to go for help. I am pleased that for 11 years I have given people a place to go – even if it is just for one night a month. No human being should have to fight an illness and also fight with spouses, friends, employers and yes, even doctors that they are in disabling physical pain. The question is not why do we continue to undermine the validity of FM but why are people afraid to provide support to people suffering from the chronic pain of fibromyalgia?
 In this time of uncertainty in the world, people more than ever need hope and help. Please will you write a story to help your readers understand FM? On behalf of my group we would greatly appreciate it.

 

Is Fibromyalgia Real?
 Andrew Schorr -
Founder Patient Power

We could have predicted it. Naysayers who say that now there are three approved prescriptions medicines for fibromyalgia, a chronic pain syndrome, marketing is fueling hype hype about a condition some people say is all in a patient’s head.

Here we go again. The drug companies are always an easy target. When a drug is a success it can bring in more than a billion dollars a year. Treatments are costly and many people, including millions with no insurance or who are under insured, struggle to pay for them. So the pharmaceutical industry continues to have a public relations problem.

But none of that has anything to do with whether people, primarily women, are suffering with debilitating pain, pain that is effectively treated often by the approved medicines.

Critics including some doctors say that because there is no definitive test for fibromyalgia it is a disservice to rush to treatment with the new drugs when maybe some patients need psychotherapy instead. It is in the patient’s head.

I am not qualified to evaluate who needs the medicines and who does not. But I do know this: the FDA advisory panels and the FDA itself would not have approved the medicines, nor would the drug companies have invested hundreds of millions of dollars on clinic trials, if they had no effectiveness.

After approval the drug companies have hit the airwaves with television commercials and with websites trying to raises awareness for the condition and that there are approved treatments. They also have been funding education programs to connect rheumatologists, who know all about fibromyalgia, with many primary care doctors who don’t. And they are funding patient education in partnership with groups like the National Fibromyalgia Association, founded by a patient and an organization that has cried out for awareness and effective treatments for years.

Is this public and medical education effort a bad thing?

Some media reports suggest it is: getting doctors and the public in a tizzy about a phony or overused diagnosis fueled by greedy drug companies who want to make billions. Oh please! While one could argue such important issues should be debated, I think we should focus on how to help give suffering patients relief from their pain and celebrate that private industry has made huge investments to meet the need.

Do we need to sort out exactly who needs these treatments and who could benefit in other ways? Sure. But to cast the same old aspersions on the drug companies is unfair and if we keep skewering them one day we can kiss drug development goodbye. The next time you swallow a pill that helps, you ask yourself what the world would be like if no one invented or marketed products like that.

 

FIBROMYALGIA Painfully Real 

Frederic Porcase Physician,

Jacksonville USA

 

Monday’s article demeans all of us with fibromyalgia.

The horrible part was the “Mind over Matter?” stating, “Patients diagnosed with fibromyalgia are more likely to have a history of mental illness, be overweight and economically disadvantaged. Some doctors say their suffering may stem from difficult circumstances rather than disease.”

I run a support group for people with fibromyalgia, and that is not the case. We are all type “A” personalities who have been forced to change our lives due to this horrible disease/syndrome.

All of us would give up our “great” disability funds for the more profitable lives we were living before the chronic pain and fatigue. We may be overweight now, due to not being able to exercise, but this was not the case before the chronic pain and fatigue started not after the diagnosis.

We all had the symptoms years before we actually got a diagnosis. No, we are not hypochondriacs. Fibromyalgia is an invisible disease. Thank goodness we don not look as bad as we feel. Walk in our shoes just one day and then say we have a mental disorder.

Courtesy Opinion.jacksonville/com

http://jacksonville.com/opinion/letters_from_readers/2009-02-11/story/letters_from_readers

 

Utterly real

Letters Published: Tue, Feb. 10, 2009 

Taryn Oesch – Raleigh USA

 

I was diagnosed with fibromyalgia when I was 13 by a Duke rheumatologist. It was a struggle to get back to feeling healthy, but it was a relief to know that I wasn’t imagining my achiness and debilitating fatigue. I have always considered myself fortunate to live in a time when fibromyalgia is considered a real syndrome.

The Feb. 9 Associated Press article “Help or hype? Drug makers fibromyalgia grants raise questions,” however, made me realize we still have a way to go.

Apparently, there are still those who would question the diagnosis, despite the fact that it has helped many people. It disturbed me especially that the article seemed to sympathize with the skeptics. Having a complaint of “I’m very tired” is hard enough to try to explain to professors or employers. 

The only press those of us with fibromyalgia need is press that makes everyone more aware that yes, fibromyalgia is real and yes, its diagnosis is backed by medical research.

 

 

Courtesy The News&Observer

http://www.newsobserver.com/opinion/letters/story/1401086.html

READERS: If you are writing to the Editor of Associated Press or the Business Writer Matthew Perrone, please send a copy of the email to me. I am interested and would like to publish your comments. Thanks. Please write to fmsglobalnews@me.com.Jeanne 

 

 

 

PIERRE FABRE MEDICAMENT AND FOREST LABORATORIES TO COLLABORATE ON DEVELOPMENT AND COMMERCIALIZATION

From the Desk of Jeanne Hambleton – courtesy PR-Canada.Net. 

 (http://pr-canada.net/index.php?option=com_content&task=view&id=71522&Itemid=61)

Saturday, 27 December 2008

Forest Laboratories, Inc. and Pierre Fabre Medicament today announced that they have entered into a definitive collaboration agreement to develop and commercialize F2695 in the United States and Canada. F2695 is a proprietary selective norepinephrine and serotonin reuptake inhibitor that is being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.    Under the terms of the agreement, Forest will make an upfront payment to Pierre Fabre of $75 million and will pay future, undisclosed milestone payments. In addition, Pierre Fabre will receive royalty payments based on F2695 sales. Forest will assume responsibility for the clinical development and commercialization of F2695 in the United States and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide. “We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004,” commented Howard Solomon, Chairman and Chief Executive Officer of Forest. “We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market.” “Pierre Fabre is looking forward to working with Forest on this exciting product opportunity,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre Medicament. “Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695.” In a recently completed European placebo-controlled, double-blind Phase II study of F2695 in over 550 patients with major depressive disorder, the compound demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (“MADRS”). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale (“HAMD-17″) and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment initiation. About F2695 F2695 is an isomer of milnacipran and is protected by a method of use patent that extends through June 2023. F2695 exerts its effects by selectively inhibiting the reuptake of both norepinephrine and serotonin, two neurotransmitters known to play an essential role in regulating mood. Forest, in partnership with Cypress Bioscience, Inc. and Pierre Fabre, is currently developing milnacipran; a selective serotonin and norepinephrine dual reuptake inhibitor, for the management of fibromyalgia. The New Drug Application is under FDA review and we continue to plan for a first quarter 2009 product launch meeting About Pierre Fabre Medicament The Pierre Fabre Group, the second largest independent laboratory in France, employs some 10,000 people, and achieved a turnover of 1.7 billion euros in 2007. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands: Avene, Ducray, A-Derma, Galenic, Klorane and Rene Furterer and dermo-cosmetics. Pierre Fabre Medicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1,400 employees dedicated to R&D, Pierre Fabre Medicament has invested 30% of its annual sales to R&D during 2008, in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament, with 50% of all R&D expenses), psychiatry, urology, cardio-vascular, rheumatology. To learn more about Pierre Fabre, visit http://www.pierre-fabre.com. About Forest Laboratories Forest Laboratories is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com. Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

 

NEW DATA ON THERAPIES FOR PAIN AND INFLAMMATION FROM PFIZER

By Jeanne Hambleton © Fibromite NFA Leader Against Pain

While I am a great believer in positive thinking, I have to accept that medication can be the only way that allows some people to live with pain and this impossible invisible condition called fibromyalgia. From this point of view I must say I am pleased that the drug companies are continuing to find ways of easing our pain and hopefully one day will find a cure.
This morning I received a press release from Pfizer who are working to help those of us with fibromyalgia and arthritic problems. I wanted to share this with you and the full report is listed below.

Having read this one of my greatest hopes is that the UK medical authorities will, in the near future, give its blessing to Lyrica, Cymbalata and now Esreboxetine.

Let us hope if these new drugs are approved in the UK that there will be no ‘post code lottery’ by the NHS for the prescription of these medications. Currently British fibromites are victims of the lack of approval of any specific fibromyalgia drugs. While American patients are able to gain relief from the new drugs, it seems the UK fibromites must suffer in silence.

In recent years I have read and signed numerous epetitions appealing to the Prime Minister Gordon Brown to bring some relief to those of us with fibromyalgia. The epetitions have asked for research, better education of doctors and specialists, fibromyalgia clinics and much more – but all have met with lame excuses. This has nothing to do with the current financial crisis. We have been writing to Prime Ministers – Tony Blair and Gordon Brown -for years. What do we have to do to get attention – camp out in our wheelchairs outside the Houses of Parliament? We might get more press coverage that way!

I am not surprised that Guy Fawkes chose to blow up the Houses of Parliament on November 5 if this was the only way he could get the attention of those working inside that building. Maybe we need a fictional Gun Powder Plot to enlighten the Government and spur the MPs into allocating funds for research to find a cure for fibromyalgia. But it does appear that nothing seems to stir those in the ‘corridors of power’.

A little correction here – according to Hansard and TheyWorkforYou on October 14 Dr John Pugh MP (Shadow Minister, Treasury; Southport, Liberal Democrat) is reported to have said, “…I was recently approached by someone in my constituency who suffered from a disease called Fibromyalgia, which had to be explained to me. That person found that there was wholesale ignorance of the disease in all parts of the NHS and many parts had been accessed about the condition.”

Hooray for John Pugh. Shall we all write to our MPs and talk about the ‘F’ word? You do know I mean F for fibromyalgia, I hope! I am not into writing about politics but for goodness sake if someone wants to win the next election they should become our champion – do something about the plight and despair of the fibromites. That should get them at least 2 million votes plus their families and friends. I wonder why are we treated as second class citizens? Just because we have an invisible disability it does not mean we have no feelings and do not deserve some respect. What do you say?

As a matter of interest something like 10 years ago the public were ignorant about ME. Today everyone has heard of it? We must spread the ‘F’ word – fibromyalgia. I have banned the other ‘F’ word in my house. Now we all say ‘fibromyalgia’ when we lose our temper and burst into fits of laughter.

Results from Clinical Trials Show Promise for Innovative Therapies in Rheumatoid Arthritis and Osteoarthritis Pain and Fibromyalgia

SAN FRANCISCO–(BUSINESS WIRE)–Pfizer will present data on three investigational compounds that represent potential new mechanisms for targeting pain and inflammation. These data will highlight tanezumab, a molecule designed to target nerve growth factor, a key pain mediator; CP-690,550, a JAK-inhibitor that suppresses immune-related inflammatory response; and esreboxetine, a highly-selective norepinephrine reuptake inhibitor which plays a role in controlling the activity of this important neurotransmitter. These data will be presented at the 2008 American College of Rheumatology Scientific Meeting in San Francisco, California.

“Pfizer has an established track record of bringing innovative therapies to patients suffering with pain and inflammation,” said Martin Mackay, Ph.D., president, Pfizer Global Research and Development. “Data to be presented at ACR confirm our clinical approaches in developing these three compounds – CP-690,550, esreboxetine and tanezumab – as potential new medicines to provide relief from these serious medical conditions.”

Fibromyalgia

Pfizer is a pioneer in the study of fibromyalgia, investing many years of research into treatment options for this complex pain condition. In June 2007, Lyrica (pregabalin) CV became the first FDA-approved treatment for the management of fibromyalgia. Data supporting that approval showed Lyrica patients experienced significant reduction in pain as early as week one in some patients.
While widespread pain is the cornerstone of fibromyalgia, the condition is also characterized by other hallmark symptoms such as fatigue and difficulty concentrating.

Data presented at ACR will highlight the results of a phase 2 proof of concept study with esreboxetine, a highly selective norepinephrine reuptake inhibitor in a fibromyalgia population.
Data from this study showed that esreboxetine may be effective in relieving in key fibromyalgia symptoms, including pain, function and fatigue and was generally well tolerated. In the study, 43 percent of patients receiving esreboxetine reported their condition was much improved or very much improved as compared to 23 percent of placebo-treated patients.

The most common side effects compared to placebo were constipation, insomnia, dry mouth, headache and nausea. The proportion of patients who discontinued as a result of adverse events was 8.2 percent in the esreboxetine group and 2.3 percent in the placebo treatment group.
Fibromyalgia has been recognized by the professional community for over 30 years as a common, chronic widespread pain condition and is now thought to affect up to six million Americans. Recent evidence suggests a neurological basis to fibromyalgia, as demonstrated by brain scans and altered levels of certain neurotransmitters.

Rheumatoid Arthritis

Data is being presented from several clinical trials studying CP-690,550, an oral medication that inhibits the Janus Kinase enzyme (JAK). This enzyme plays a major role in controlling the activation and proliferation of white blood cells, key elements of the immune system, which play a major role in rheumatoid arthritis (RA). CP-690,550 has shown encouraging results for the treatment of rheumatoid arthritis at doses that don’t appear to be associated with excessive immune suppression.

Investigators will present interim results from a late-breaking Phase 2B study evaluating the activity of CP-690,550 in combination with methotrexate, the most commonly-used RA treatment. Approximately 60 percent of patients on doses at or above 3 mg of CP-690,550 responded to treatment as compared to 37.7 percent on placebo. These data confirm and extend the promising data seen in an earlier phase 2A study to this longer, 12 week study, and to patients who are already taking methotrexate to treat their rheumatoid arthritis.

Also being presented is a pharmacokinetic drug interaction study which showed that CP-690,550 and methotrexate can be co-administered without dose adjustment. In addition, preliminary results from an open label extension study will be presented.

In these studies, the most commonly reported adverse events were nausea, headache, dizziness, disorientation, hot flushes, urinary tract infections, diarrhea and liver function tests. Larger and longer phase 3 studies are expected to start in 2009 to help further define the benefits and risks of CP-690,550 as a potential treatment for rheumatoid arthritis.

According to the Arthritis Foundation, 1.3 million Americans live with rheumatoid arthritis, a type of arthritis that can be severe, debilitating, deforming and even shorten life.

Osteoarthritis Pain

Pfizer continues to research new ways of treating osteoarthritis pain. Two studies to be presented highlight a new compound in development and new data for Celebrex (celecoxib) in the treatment of osteoarthritis pain.

Results from a Phase 2 study exploring the safety and efficacy of tanezumab, a novel biologic designed to block nerve growth factor, show that treatment once every eight weeks may significantly decrease pain in patients suffering from moderate to severe osteoarthritis pain in the knee. In the trial, approximately 75 percent of patients in both the tanezumab 100 and 200 μg/kg treatment groups experienced a 50 percent reduction in knee pain as compared to 26 percent of patients in the placebo group. In the study, the most common adverse events associated with tanezumab include headache, upper respiratory tract infection, paresthesia (abnormal sensations), hypoesthesia (decreased sensations) and arthralgia (joint aches).

Another late-breaking study evaluated continuous use of daily Celebrex treatment over a 22-week period compared to intermittent use of the medicine in preventing spontaneous OA flares. The study showed that continuous use resulted in 42 percent fewer OA flare episodes than the intermittent use. The results from the study also demonstrated that there were no significant differences in overall adverse events between the intermittent and continuous use groups.

According to the Arthritis Foundation, osteoarthritis affects 27 million Americans. Recent data show that one in two Americans are at risk for knee osteoarthritis over their lifetime. Loss of joint function as a result of osteoarthritis is a major cause of work disability.

About Celebrex

CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis in adults and ankylosing spondylitis, and for the management of acute pain in adults.

Cardiovascular Risk
All prescription NSAIDS, including CELEBREX, may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.

All prescription NSAIDs, including CELEBREX, are contraindicated for the treatment of perioperative pain in coronary artery bypass graft surgery.

Gastrointestinal Risk

All prescription NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

About Lyrica

LYRICA is indicated for the management of Fibromyalgia, neuropathic pain associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and as adjunctive therapy for adults with Partial Onset Seizures. There have been post-marketing reports of angioedema and hypersensitivity. Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse events include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally.

About Pfizer’s Investor Briefing at ACR (American College of Rheumatology)
On Tuesday, October 28 at 6:00 p.m. PCT, Pfizer will host a briefing for analysts and investors to review data presented at the meeting on candidates in Pfizer’s pain and inflammation portfolio

EUROPEAN FIBROMITES ARE DENIED CYMBALTA/DULOXETINE

By Jeanne Hambleton © 2008

News that the drug Cymbalta/Xeristar, a medicine containing the active substance duloxetine, will not be approved in Europe as the first official drug to treat fibromyalgia has been announced, causing grave concern to those who suffer with pain 24/7. This has led to fears that the decision may lead to more delays in a UK approval of new drugs to bring relief to fibromyalgia patients. There are currently no approved drugs for the treatment of Fibromyalgia available to UK patients.

This follows news that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency have adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules for treatment of Fibromyalgia.

Cymbalta is the first medication for Fibromyalgia treatment that has been filed in Europe by Eli Lilly for the treatment of this invisible disability. The medicine was approved by the US Food and Drug Administration (FDA) for Fibromyalgia in June 2008.

The European Network for Fibromyalgia Associations suspect that the misperception, even among some medical professionals in Europe, that fibromyalgia is not a real medical condition may have contributed to the decision. Despite the fact that the World Health Organisation (WHO) has recognized Fibromyalgia as a disease in 1992, and several well respected medical organizations including the European League Against Rheumatism (EULAR), the American College of Rheumatology and the American Pain Society (APS) have developed criteria and guidelines for the classification and treatment of fibromyalgia, some medical professionals and some governments in Europe have been slow to recognise Fibromyalgia as a disease.

Cymbalta/Xeristar is a medicine containing the active substance duloxetine. It is available as gastroresistant capsules. Cymbalta/Xeristar was authorised for this purpose in December 2004. It is also used for adults with major depression; pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes); and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

In the European Medicines Agency press release from Canary Wharf, London, it states the major concerns that led the committee to recommend the refusal of the change to the marketing authorisation, came from concern that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently. The results of five studies involving a total of 1,718 adults with fibromyalgia were submitted to the CHMP. Four of these were short term and one long term involving 307 patients.

In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients. There was no clear demonstration of improvement in symptoms and the modest effects of Cymbalta/Xeristar could be due to the medicine’s effect of improving the patients’ mood. The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.

The CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks and recommended that the change to the marketing authorisation be refused.

Mr. Robert Boelhouwer, President of the European Network for Fibromyalgia Associations (ENFA), expressed his concern following months of work in Brussels with the European Parliament to raise awareness, establishing a declaration for acceptance by the ENFA countries and promoting a petition for the recognition of Fibromyalgia.

He said, “The ENFA encourages the regulatory agency and its professional committee members to recognise the sufferings that the patients have been enduring and approve other effective and safe treatment options as soon as possible. This negative recommendation has put the 14 million Fibromyalgia patients in Europe in despair. They have been hoping to have access to the first innovative medicine to treat their disease. I cannot believe that Fibromyalgia patients in Europe cannot have an access to the medicine that has been helping the patients in the US and other countries in the world.”

The latest ENFA press release suggests that the misperception even among some medical professionals in Europe that fibromyalgia is not a ‘real’ medical condition may have contributed to the decision. Despite the fact that the World Health Organisation (WHO) has recognised Fibromyalgia as a disease in 1992, and several well respected medical organisations including the European League Against Rheumatism (EULAR), the American College of Rheumatology and the American Pain Society (APS) have developed criteria and guidelines for the classification and treatment of fibromyalgia, some medical professionals and some governments in Europe have been slow to recognise Fibromyalgia as a disease.

The ENFA claim it is estimated that about 12-14 million people in Europe suffer from fibromyalgia and the epidemic is more prevalent with women (87% of total prevalence). Due to the complex pathology of the disease, a comprehensive diagnosis requires multi-disciplinary approach. A recent global survey showed that healthcare professionals lack confidence in diagnosing and managing Fibromyalgia. Educating healthcare professionals, patients and the public to promote better understanding and management of Fibromyalgia will benefit patients, healthcare providers and the society. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

Currently, two medicines have been approved in the US to treat Fibromyalgia. The US Food and Drug Administration, the equivalent of the EMEA in Europe, has approved the first medicine Lyrica (pregabalin) in June 2007 for specifically treating fibromyalgia and Cymbalta (duloxetine hydrochloride) in June 2008. Both Lyrica and Cymbalta are proven to reduce pain and to improve function in people with Fibromyalgia.
Fibromyalgia imposes large economic burdens on the society as well as on affected individuals. A study shows that an average patient in Europe consults up to seven physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments. In fact, a Dutch study in 2005 estimates that the average annual cost of fibromyalgia is €980 million in the Netherlands. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations

The ENFA describes Fibromyalgia as a complex disease with chronic widespread pain as the defining symptom and various additional symptoms including fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, depression, anxiety and cognitive dysfunction often referred to as “fibro fog.” All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life.

As with all new medication the patient’s information leaflet and details of potential side effects should be read before taking any medication.

A LETTER TO ‘NORMALS’

by Jeanne Hambleton © 2008
NFA Leader Against Pain-Advocate

How many times do you feel guilty when you watch your family do jobs which you used to do without thinking about it? What is your reaction to that barbed comment, “No, you sit still. You said you don’t feel well!”

Yes me too – I want so much to do what I have always done but these days I am forced to look at the jobs and think maybe tomorrow I will feel better. In fact (tomorrow) Mother Mañana has become my middle name

I read an article about one fibromites who made the front page of her local newspaper because she told them she was dying to do her own washing up? Certainly a good angle for a story and it raised quite a bit of awareness, but that nevertheless does not stop you feeling isolated with your invisible disability.

Come to think of it, this could be a wonderful story for the local paper for International Fibromyalgia Awareness Day on May 12. Just imagine if all the local newspapers carried the story and talked about raising awareness, it is such a silly story we would even make television.

But I do try to look on the bright side of any situation and must admit I have met such pointed remarks with the comment, “Well, you know I had to drop out of the London Marathon and was very disappointed I could not do the skydive.” This usually brings a smile and clears the air. It helps if no offence was intended.

But recently someone sent me a copy of a letter written by Ronald J. Waller on behalf of his wife, for the website, www.fibrohugs.com, where it has been viewed almost 29,000 times.

It is a poignant letter that supports the need for understanding for fibromites and leaves the reader in no doubt that the writer is certainly suffering and under pressure.

The composer of this letter is Ronald J. Waller, who is a published writer and has his own website http://rjswritingloft.com.

He told me, “After watching my best friend, my wife, suffer from fibromyalgia I felt compelled to write, inform and continue to learn more about this demon that not only invades Carolyn’s life but also has affected all who are close to her.”

My thanks to Ronald for sharing this with us and thanks to Fibrohugs for allowing us to publish this.

LETTER TO NORMALS

Hello Family, friends and anyone wishing to know me,

Allow me to begin by thanking you for taking the time out of your day to spend time with me and to get to know me better. A person’s time is their most valuable asset and yours is appreciated.

I want to talk to you about Fibromyalgia Syndrome (FMS) and Chronic Myofascial Pain Syndrome (MPS). Many have never heard of these conditions and for those who have, many are mis-informed. Because of this judgements are made that may be incorrect…….So I ask you to keep an open mind as I try to explain who I am and how FMS/MPS has assaulted not only my life but those whom I love as well.

You see, I suffer from a disease that you cannot see – a disease that there is no cure for and that keeps the medical community baffled at how to treat and battle this demon, whose attacks are relentless. My pain works silently, stealing my joy and replacing it with tears. On the outside we look alike you and I. You will not see my scars as you would a person who had suffered a car crash. You will not see my pain in the way you would a person undergoing chemo for cancer. However, my pain is just as real and just as debilitating. In many ways my pain may be more destructive because people cannot see it and do not understand……..Please do not get angry at my seemingly lack of interest in doing things. I punish myself enough I assure you. My tears are shed many times when no-one is around. My embarrassment is covered by a joke or laughter, but inside I want to die……..

Most of my ‘friends’ are gone, even members of my own family do not understand. I have been accused of ‘playing games’ for sympathy. I have been called unreliable because I am forced to cancel plans I made at the last minute. This is because the burning and pain in my legs or arms or both is so intense I cannot put my clothes on. I am left in my tears as I miss out on yet another activity I used to love and once participated in with enthusiasm.

I feel like a child at times……just the other day I put the sour cream I had bought in the pantry instead of in the fridge. By the time I noticed it, it had spoiled. When I talk to people, many times I lose my train of thought in mid sentence or forget the simplest word needed to explain or describe something. Please try to understand how it feels to have another go behind me in my home to make sure the stove is off after I cook an occasional meal. Please try to understand how it feels to ‘lose’ the laundry, only to find it in the stove instead of the dryer. As I try to maintain my dignity the demon assaults me at every turn.. Please try to understand…………

Sleep, when I do get some, is restless. I wake often because the pain of the sheets on my legs is unbearable or because I twitch uncontrollably. I walk through many of my days in a daze with the fibro-fog laughing at me as I stumble and grasp for clarity.

Just because I can do a thing one day, that does not mean I will be able to do the same thing the next day or next week. I may be able to take that walk after dinner on a warm July evening. The next day or even in the next hour I may not be able to walk to the fridge to get a cold drink because my muscles have begun to cramp and lock up or spasm uncontrollably. There are those who say ’but you did that yesterday!’ ’What is your problem today?’ The hurt I experience at those words scars me so deeply that I have let my family down again, and still they do not understand……………..

On the brighter side I want you to know that I still have my sense of humour. If you take the time to spend with me you will see that. I love to tell that joke to make another’s face light up and smile at my wit. I love my kids and grandkids and shine when they give me a hug or ask me to fix their favourite toy. I am fun to be with if you will spend time with me in my own playing field. Is this too much to ask? I love you and want nothing more than to be a part of your life. I have found that I can be a strong friend in many ways. Do you have a dream? I am your friend, your supporter and many times I will be the one to do research for your latest project. Many times I will be your biggest fan and the world will know how proud I am at your accomplishments and how honoured I am to have you in my life.

So you see, you and I are not that much different. I too have hopes, dreams, goals…..and this demon….Do you have an unseen demon that assaults you and no one else can see? Have you had to fight a fight that crushes you and brings you to your knees? I will be by your side, win or lose, I promise you that. I will be there in ways that I can. I will give all I can as I can. Please understand that I am in such a fight myself and I know that I have little hope of a cure or effective treatment, at least right now anyway…….Please understand……..

Thank you for spending your time with me today. I hope we can work through this thing, you and I…..I just need you to just try to understand that I am just like you……………………

For a small insight into the constant pain of a fibromyalgic lift your arm and squeeze the muscle just below your neck on the top of your shoulder, hard enough until it is uncomfortable. Then squeeze a little more and hold it for a few minutes if you can stand it. That is the pain we feel from the roots of our hair to the tips of our toes……………………..

Thank you for taking the time to read this, sorry if the pain experiment hurt’s, it does!! xxxxxxxx

Copyright of Ronald J. Waller and www.fibrohugs.com

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HELP WITH RESEARCH

by Jeanne Hambleton © 2008
NFA Leader Against Pain-Advocate

If you have fibromyalgia, has your doctor has prescribed nefopam also known as
Acupan, as a strong painkiller for you? Have you suffered any side effects? Does it suit you and kill off your pain?

Professor Patrick Wood, M D, well known for his fibromyalgia and brain imagining research in Canada, would like to know the answer to these questions to help him with some research.

Although not available in the United States, it is prescribed here in the UK as a non-opioid medicine. I understand nefopam is described as a useful alternative to other painkillers that work on the brain as it produces less side effects that opioid medicines and is said to be more effective than non-steroidal anti-inflammatories.

Professor Wood is anxious to hear from anyone who has taken nefopan to help with the pains of fibromyalgia. Please tell him how effective you found it, how long you took the painkiller, the dosage, and whether it was in tablet or injection form. Side effects are said to include dry mouth, blurred vision and drowsiness. Did you have any?

Please write direct Professor Patrick Wood at

nefopam.survey@gmail.com

with as much detail as you can about the medication. Thank you for your help.

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Stress, depression high among Canadian peacekeepers

By Communications Staff

Thursday, December 13, 2007 Canada’s peacekeepers suffer similar rates of Post-Traumatic Stress Disorders (PTSD) as combat, war-zone soldiers, according to a London, Ont. research team.
Psychiatrist J. Donald Richardson and his co-investigators also found that PTSD rates and severity were associated with younger age, single marital status and deployment frequency.

Richardson is a consultant psychiatrist with the Operational Stress Injury Clinic at Parkwood Hospital, part of St. Joseph’s Health Care, London and a professor with the Schulich School of Medicine & Dentistry at The University of Western Ontario.

His team conducted a random, national survey of more than 1,000 Canadian peacekeeping veterans with service-related disabilities. The participants were below the age of 65 and had served with the Canadian Forces from 1990 to 1999.

The research, published in the Canadian Journal of Psychiatry, found a third of veterans deployed more than once suffered probable clinical depression, and 30 per cent of those deployed one time were affected.

The rates of probable PTSD were 11 per cent for those deployed once and 15 per cent for those deployed more than once. The authors also found peacekeepers were more likely to have PTSD and more severe symptoms if they were young, single, or had multiple deployments.

“This study has important clinical implications because understanding such risk factors can help predict potential psychiatric problems in veterans who have been deployed,” says Richardson.

“The high rates of depression observed in deployed veterans can have a significant impact when they seek treatment for PTSD because depression must be aggressively treated to help patients respond more effectively to psychotherapy.”

“Many veterans are also living and working in the community as civilians, therefore it is important that primary care physicians and psychiatrists become more knowledgeable about the emotional impact of military deployment and screen for possible PTSD,” says Richardson.

The Operational Stress Injury Clinic is funded by Veterans Affairs Canada and provides specialized services to help veterans and members of the Canadian Forces deal with PTSD, anxiety, depression or addiction resulting from military service.

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Anti-polymer antibody in Italian fibromyalgic patients.

Bazzichi L, Giacomelli C, De Feo F, Giuliano T, Rossi A, Doveri M, Tani C, Wilson RB, Bombardieri S.

ABSTRACT: The objectives of our study were to evaluate the presence of antipolymer antibody (APA) seropositivity in 285 Italian patients affected by primary fibromyalgia (FM) and to verify if APA levels correlate with the disease severity and cytokine levels. APA levels were determined on serum samples by an indirect ELISA kit that detect IgG APA. Cytokines (IL-1, IL-6, IL-8, IL-10 and TNF-alpha) were measured by ELISA in plasma. The impact of fibromyalgia on the quality of life was estimated using the “Fibromyalgia Impact Questionnaire” (FIQ), while pain severity was evaluated using a Visual Analogic Scale (VAS). Patients were also characterized by the presence of tiredness, stiffness, non restorative sleep, anxiety, depression, tension headache, irritable bowel syndrome, temporomandibular dysfunction, Raynaud phenomena. Using a cut-off value of 30 U, APA positive values were detected in 60 FM patients (21.05%) and in 15 healthy controls (15.00%) without significant differences among their levels or percentage of seropositivity. FM patients with moderate and severe symptoms had slightly higher APA levels with respect to patients with mild symptoms. APA seropositive patients exhibited significant correlations between APA levels and FIQ (P=0.042), tiredness (P=0.003) and IL-1 levels (P=0.0072). In conclusion, APA cannot be considered a marker of disease in Italian FM patients. However, its presence might permit the identification of a subset of FM patients with more severe symptoms and who may respond differently to different therapeutic strategies.

PMID: 17822528 [PubMed - as supplied by publisher]

1: Arthritis Res Ther. 2007 Sep 6;9(5):R86 [Epub ahead of print]

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