Living with Fibromyalgia

ENFA (the European Network of Fibromyalgia Associations) and the European Federation of IASP Chapters have joined together to produce a petition calling for a European Union in which the rights of the 14 million people affected by Fibromyalgia Syndrome are recognized.

ENFA is hoping to reach their goal of 10,000 signatures by Friday 14th November 2008. If they reach this goal, the petition will be able to be used as leverage to get the remaining signatures needed on the European Parliament Written Declaration about Fibromyalgia Syndrome.

If you haven’t yet put your name to the petition, please do so on the ENFA website here.

FibroAction Press release 27 October 2008

Severe blow for millions of Fibromyalgia Syndrome sufferers

as European Medicines Agency rejects first drug approval

The millions of Fibromyalgia Syndrome sufferers across Europe have this week received a severe knock-back with the announcement that that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) has rejected the application of the first medicine, Duloxetine hydrochloride, trying to get approval as a treatment for Fibromyalgia Syndrome (Fibro) in the EU.

Earlier this year Duloxetine was the second medicine to get approval by the Food and Drug Administration (FDA) in the USA for the treatment of Fibro. Pfizer’s Lyrica (Pregabalin) was the first drug to get FDA approval in the USA for the treatment of Fibro in 2007.

Duloxetine has been authorised by the EMEA since December 2004 and is used for the treatment of adults with episodes of major depression, pain due to diabetic peripheral neuropathy, generalised anxiety disorder and stress urinary incontinence.

Pharmaceutical companies Eli Lilly and Boehringer Ingelheim (who would market the drug as Cymbalta and Xeristar respectively) applied for a change to the marketing authorisation so that Duloxetine could be officially indicated as a treatment for Fibromyalgia Syndrome and marketed for this purpose.

The CHMP refused this change, citing as reasons that they were concerned that the effectiveness of Cymbalta/Xeristar (Duloxetine) in treating Fibro had not been shown sufficiently, and that at that point in time, they were of the opinion that the benefits of Cymbalta/Xeristar (Duloxetine) in the treatment of Fibro did not outweigh its risks. The CHMP stated that their concern about the lack of effectiveness of the drug was because the “modest effects” could be due to the medicine’s effect of improving the patients’ mood. However a number of trials of Duloxetine as a treatment for Fibro have concluded that the drug’s effect on Fibro symptoms is independent of its effect on depression (Russell et al, 2008; Arnold et al, 2005; etc). The conclusion of multiple trials was that the drug was safe and efficacious in reducing symptoms of Fibro.

The European Network of Fibromyalgia Associations issued a press release yesterday saying that “it is suspected that the misperception, even among some medical professionals, in Europe that [Fibro] is not a real medical condition must have contributed to the decision”.

Despite an increasing body of evidence that Fibro is a real, physical condition that is not psychosomatic in nature, but is related to Central Nervous System (CNS) dysfunction, there are still medical professionals who refuse to admit the evidence and say that Fibro is a not a real condition.

Fibro is a debilitating, chronic condition whose main symptoms are widespread chronic pain, hypersensitivity to pain and chronic fatigue. Despite the high numbers of sufferers (between 1.2 and 2.7 million people in the UK alone), awareness of the condition, and the knowledge and treatments available for it, is very low, even amongst medical professionals, and many patients are left to suffer alone.

The EU marketing approval for Duloxetine and future drugs to apply is needed because, without it, pharmaceutical companies are unable to promote their products as treatments for Fibro. This product promotion has been seen in the USA to significantly raise awareness of the condition, and of the fact that there are treatments available for it, something that is desperately needed.

“FibroAction are disappointed to learn of the refusal by the CHMP to allow the clinical indications of Duloxetine to be extended to include Fibromyalgia Syndrome” said Lindsey Middlemiss, founder and chair of FibroAction. “We hope that outdated views of Fibromyalgia Syndrome were not a factor in this decision and that the evidence was considered without an unfair bias. The millions of people with Fibromyalgia Syndrome across Europe desperately need the help that a properly approved drug would bring and we hope that the CHMP will shortly be indicating a positive opinion about other treatments for the condition.”

The negative response from the CHMP is likely to perpetuate the myth that because no drugs have marketing approval in the EU for Fibromyalgia Syndrome, there are no treatments available for the condition. Because Duloxetine already has EMEA authorisation, it is available on prescription if a doctor considers that it is an appropriate treatment. This is also true of many other treatments for Fibro, some of which are already widely used.

For more information see www.fibroaction.org

ENDS

A press release from Eli Lilly and Company – a full response from FibroAction will be coming soon.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on a Cymbalta® (duloxetine hydrochloride) application for the treatment of fibromyalgia.

“Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP’s opinion,” said James Russell, M.D., global medical director for duloxetine, Eli Lilly and Company. “We remain confident in the duloxetine data.”

No medication has been approved in Europe for the treatment of fibromyalgia, a disease characterized by chronic widespread pain.

The CHMP received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies and 350 patients in one open-label safety study, a total of 1,761 patients in five clinical trials.(1,2,3,4,5)

The cause of fibromyalgia remains unknown;(6) however, scientists believe it may be related to some combination of genetic disposition(7) and subsequent changes in pain processing in the brain.(6) The disorder, which has a worldwide prevalence ranging from 0.5 percent to 5.0 percent of the population,(8) has a high impact on quality of life. In addition to chronic widespread musculoskeletal pain, many fibromyalgia patients experience other symptoms such as tenderness, fatigue, sleep disturbance, anxiety and depression.(1,9)

In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), major depressive episodes, generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). Duloxetine was approved in the United States for the management of fibromyalgia in June 2008 by the U.S. Food and Drug Administration (FDA).

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs. For more information please visit www.lilly.co.uk.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit www.boehringer-ingelheim.com.

Duloxetine for major depressive episodes, diabetic peripheral neuropathic pain and generalised anxiety disorder is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Germany, Greece, Italy and Spain. In Germany, Lilly and Boehringer Ingelheim market duloxetine for major depressive episodes under the brand name Cymbalta, and market the product for diabetic peripheral neuropathic pain as Ariclaim®. In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar®. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve®.

1. Russell, IJ, et al. Efficacy and Safety of Duloxetine for Treatment of Fibromyalgia in Patients With or Without Major Depressive Disorder: Results From A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Trial, Pain. 2008.
2. Arnold, L, et al. A Randomized, Double-Blind, Placebo Controlled Trial of Duloxetine in the Treatment of Women with Fibromyalgia With or Without Major Depressive Disorder. Pain. 2005; 119 (1-3): 5-15
3. Arnold, L, et al. A Double-Blind, Multicenter Trial Comparing Duloxetine with Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder. Arthritis Rheum 2004; 50(9):2974-84.
4. Chappell, AS, et al. Duloxetine 60-120 mg Versus Placebo in the Treatment of Fibromyalgia Syndrome. Poster presented at the American College of Rheumatology Annual Meeting; Nov 2007, Boston, MA.
5. Chappell, AS, et al. A 1-Year Safety and Efficacy Study of Duloxetine in Patients with Fibromyalgia. Poster presented at European League Against Rheumatism Annual Meeting; Jun 2008, Paris, France.
6. Leventhal, LJ. Management of Fibromyalgia. Annals of Internal Medicine. 1999; 131: 850-858.
7. Arnold, L, et al. Family Study of Fibromyalgia. Arthritis & Rheumatism. 2004; 50(3): 944-952.
8. White, et al. Classification, Epidemiology, and Natural History of Fibromyalgia. Current Pain and Headache Reports 2001; 5:3320-329
9. Epstein, SA, et al. Psychiatric Disorders in Patients with Fibromyalgia. Psychosomatics. 1999; 40(1):59
10. Rao, SG, et al. Understanding the Fibromyalgia Syndrome. Psychopharmacology Bulletin. 2007: 4:24-67
11. Carville, SF, et al. EULAR Evidence-based Recommendations for the Management of Fibromyalgia Syndrome. Ann Rheum Dis. Republished 2008: 67: 536-541.

Source: Eli Lilly and Company

Having said in August that I would start blogging more about the day-to-day stuff related to running a Fibro charity, the workload took over and me blogging, along with article writing, has suffered.

FibroAction is doing pretty well. It’s a registered charity now (#1125957), registered with the Charity Commission for England and Wales, which oversees charities here. Getting the registration was remarkably fast, but the preparation for submitting the final registration forms was remarkably slow! Myself and my fellow trustees had to get up to speed very quickly on Charity Commission paperwork and the legal aspects and we’re aware that we’re still learning. Charity law is extremely complicated sometimes, especially when you have to bring in aspects of company and even gambling laws! We’re doing our best to ensure that FibroAction has the optimum legal structure to move forward, but it all takes time and sometimes no one has the answers.

Having suffered for months because we couldn’t finalise the opening of our bank accounts, we now have these set up. Many thanks to people who set us cheques in the interim – some have now been cashed, but others will have to be returned because of the time lapse. We’re still waiting to sort out Justgiving, but we do now have an online donation facility through the Charity Aid Foundation, which is available here.

Our first event – US expert Andrew Holman MD’s lecture on December 22 - is finally public knowledge and we’re really excited about it. Andrew Holman is an American doctor who has been doing a lot of exciting research into better understanding of Fibro and new treatment modalities for the condition. It was Dr Holman who carried out the first trial of Pramipexole for Fibro and he has recently been looking at a specific kind of spinal cord compression as a possible cause of Fibro in a small subset. All exciting stuff! We are applying to get CPD (Continuing Professional Development) accrreditation for the event, which will mean that healthcare professionals can get some of the points they need for training by attending the lecture. I hope that we will see a significant number of healthcare professionals at the lecture, but patients are welcome too (we can discuss anything we don’t understand well afterwards!). The lecture is titled ‘Fibromyalgia in 2009: What It Is. What It Isn’t. And What To Do About It’ and is being held on the evening of December 22. Ideally it would have been held earlier in December, but Dr Holman is kindly giving the lecture whilst on holiday in the UK and he only flies in on the 21st! It does however, offer the opportunity for people to make a Christmas trip to London, see the lights and do some last-minute (or not so last minute if you’re anything like my husband!) shopping as well as attend the lecture. The lecture is being held at St. Thomas’ Hospital, which is across the river from the Houses of Parliament, so it is ideally located in central London.

I was recently asked why I set up FibroAction and at first my mind went blank, but the answer is quite simple: I knew from personal experience that there was a problem, found that that, contrary to what many people think, something could be done about that problem and I set out to try and help do that. Awareness of Fibro is very low in the UK, and awareness of how much is known about the condition and how much can be done for it is appalling low amongst medical professionals. Doctors tell patients, and believe themselves, that nothing is known about the condition and nothing can be done about it. This could hardly be farther from the truth. A lot is known about Fibro and much can be done about it – US expert Daniel Clauw calls Fibro “eminently treatable”. Trying to help address that imbalance is why I set up FibroAction – I didn’t see it being done so I decided to try doing it myself. We still have a very small team behind FibroAction and for all of us, this is a labour of love. None of us get paid for what we do – we’re lucky if we get expenses covered! – and we’re all doing it because we don’t want other people with Fibro to suffer unneccessarily.

I think we’re already making a difference – NHS DIrect updating their information and Andrew Holman agreeing to do a lecture have been great achievements for a charity that has been running for 6 months – but I hope that FibroAction can grow and make more and more of a difference. Like it says on the front page of our website, out vision is that “the needs of people with Fibro are universally recognised and met, with fast and accurate diagnoses and easy access to optimal treatment programs available to all people with Fibro”. We’ll get there, even if it is a slow road. Things are starting to change and the changes should snowball.

I hope to try and blog more, especially in the run up to the Christmas lecture, but please do check out the FibroAction website as well and sign up for the e-newsletter. If you are able to support us by making a donation or by buying FibroAction merchandise from Spreadshirt, your help will be gratefully received and will help us to help all the people in the UK affected by Fibro. If you would like to help in a more practical way, email me via info- AT-fibroaction.org.

US rheumatologist and Fibromyalgia Syndrome expert Andrew J. Holman MD will be giving a lecture on Fibromyalgia Syndrome on Monday 22nd December, as part of a short visit to the UK. The lecture will be hosted by Prof John E. Davies, who leads the Fibromyalgia Syndrome clinic at Guy’s Hospital.

This Christmas lecture presents a rare opportunity to hear and ask questions of an expert who is leading the way into new avenues of knowledge and treatment regarding Fibromyalgia Syndrome. As FibroAction’s first major event, and an accredited educational event for healthcare professionals about Fibro, this is extremely exciting.

For more information, see the announcement about the lecture on the FibroAction website here or get the details and the registration form here.

Over at FibroAction, we’ve done an article aimed at healthcare professionals that summarises the research from 2007 and 2008 that supports the view that fibromyalgia may be associated with Central Nervous System (CNS) dysfunction.

The article is properly referenced and summarises 6 research articles published in peer-reviewed medical literature.

Click here for the full article.

The symptoms of Fibromyalgia Syndrome (Fibro) may be explained by the dysfunction of an area of the brain called the Hippocampus, according to three research articles published this year. See the FibroAction article for more details.

An article has suggested that the use of specialised nurses in the diagnostic process of Fibromyalgia Syndrome (Fibro) is a trustworthy, successful and cost-effective approach that saves waiting time and provides greater patient satisfaction.

Specialist nurses are used for a number of conditions, including neurological conditions such as Multiple Sclerosis. In general, they are found to decrease costs and increase patient satisfaction. The West Berkshire Neurological Alliance (WBNA), which I am now on the executive committee of, has been involved in the provision of specialist nurses in our area, the latest project having been a specialist nurse for rare neurological conditions. The WBNA and interested member bodies funded a two-year trial of the post, which was deemed so successful that awards were given locally and nominated for nationally. It would be great to see specialist nurses for Fibro.

For more information on the research into specialist nurses for Fibro, see the FibroAction article here.

The September Pain Blog Carnival is up at How To Cope With Pain with a theme of New Beginnings.

Grand Rounds 5.1 is up at Emergiblog, wher Dr Val and the Voice of Reason is guesting whilst waiting for a new site. A massive bunch of posts, appropriate for Grand Rounds fifth birthday! Dr Val choose to present the submissions in their authors’ own words – the purest form of expression – selecting a favorite quote from each blog post, and organising them topically with an introductory cartoon. The order in which they appear reflects the order in which they were submitted.