Addition of Lyrica Significantly Improved Generalized Anxiety Disorder Symptoms in Patients Who Responded Only Partially to Previous GAD Treatments

From the FMS Global News Desk of Jeanne Hambleton (UK)

First Large, Placebo-Controlled Study to Demonstrate Efficacy of Lyrica as Add-on Therapy Strategy in Difficult-to-Treat GAD Patients

May 19, 2009 03:00 PM Eastern Daylight Time

SAN FRANCISCO–(BUSINESS WIRE)–The addition of Pfizer’s Lyrica® (pregabalin) capsules CV to other generalized anxiety disorder (GAD) treatments significantly improved the symptoms of the condition in patients who responded only partially to previous treatments, according to a study presented today at the American Psychiatric Association annual meeting in San Francisco, Ca. In this study, patients treated with Lyrica showed significant improvements in both their psychological and physical symptoms of anxiety.

Generalized anxiety disorder is a chronic, debilitating anxiety disorder affecting nearly seven million Americans and is characterized by persistent, excessive, uncontrollable worry about everyday things. Patients also frequently experience physical symptoms such as muscle tension, fatigue, sleep disturbance, and other aches and pains.

The condition is complex and often difficult to treat, with 40 percent to 60 percent of patients failing to achieve remission after six months of treatment in clinical studies with serontonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) – two common classes of FDA-approved GAD treatments.

“These data are very encouraging for the high percentage of GAD patients who still struggle with debilitating symptoms despite treatment,” said Dr. Rakesh Jain, one of the study’s investigators and director, adult and child psycho-pharmacology research, R/D Clinical Research, Inc. “It is clear we need additional effective, well-tolerated options to address this difficult to treat condition.”

This is the first large, placebo-controlled trial to demonstrate the efficacy of an add-on therapy strategy in patients who had failed to respond to two different courses of GAD monotherapy with a SSRI, SNRI or benzodiazepine.

The study found that patients treated with Lyrica in addition to their baseline SSRI/SNRI therapy had a significantly greater improvement in overall anxiety symptoms as well as individual psychological and physical symptoms compared to baseline therapy alone as measured by the Hamilton Anxiety Scale (HAM-A), an interview scale that measures the severity of a patient’s anxiety. Over the eight week treatment period, patients receiving add-on Lyrica therapy had, on average, an anxiety score that was 1.2 points lower on the HAM-A compared to baseline therapy alone (P=0.012).

Significantly more patients receiving add-on Lyrica treatment (50 percent) showed at least a 50 percent reduction in their anxiety symptoms compared to SSRI/SNRI treatment alone (37 percent) (P=0.023). Lyrica was also shown to be well tolerated as an add-on therapy in this study.

About the Study

This study was a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive Lyrica in 353 patients with a primary diagnosis of GAD. To be included in the study, patients had to have a HAM-A score greater or equal to 22, and to have not responded, or only minimally responded, to treatment with a SSRI, SNRI or benzodiazepine prior to the study.

These patients were then treated with a different SSRI/SNRI for eight weeks. At the end of the eight week open-label treatment period, patients who had shown only a partial response to treatment (as defined by a HAM-A score of greater than or equal to 16, less than 50 percent decrease in HAM-A score, and a Clinical Global Impression Improvement score of less than 3) were then randomized to an additional eight weeks of double-blind treatment with either Lyrica (150 to 600 mg/day) or placebo while continuing treatment with the existing background SSRI or SNRI therapy.

The primary endpoint was the mean change score on the Hamilton Anxiety Rating Scale. The SSRIs and SNRIs used in this study included escitalopram, paroxetine and venlafaxine XR.

The most common side effects in the study compared to other GAD treatments plus placebo were dizziness (11.7 percent vs. 5.7 percent), headache (9.4 percent vs. 4 percent), and somnolence (8.3 percent vs. 3.4 percent).

This study was sponsored by Pfizer, Inc.

About Lyrica

In the United States, Lyrica is approved for the management of fibromyalgia, painful diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and for the adjunctive treatment of partial onset seizures (a type of epilepsy) in adults. Lyrica is not approved for GAD in the U.S.

Outside of the United States, Lyrica is indicated in adults for the management of peripheral and central neuropathic pain, treatment of generalized anxiety disorder, and adjunctive therapy for partial seizures with or without secondary generalization.

Important Safety Information

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse reactions include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally. There have been post-marketing reports of angioedema and hypersensitivity. Like other anti-epileptic drugs, Lyrica may cause suicidal thoughts or actions in a very small number of people.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

DISCLOSURE NOTICE: The information contained in this release is as of May 19, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the use of Lyrica for GAD, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the Food and Drug Administration (FDA) regarding whether and when to approve any supplemental drug application that may be filed for a GAD indication for Lyrica as well as the FDA’s decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.

(Contacts: Pfizer Inc Media: Sally Beatty, 212-733-6566
Permalink: http://www.businesswire.com/news/home/20090519006509/en)

FOR MORE FIBROMYALGIA STORIES SEE http://jeannehambleton77.wordpress.com

Cheltenham woman in mission to raise awareness of fibromyalgia

From the FMS Global News Desk of Jeanne Hambleton (UK)
Courtesy thisisgloucestershire.co.uk/news/

Monday, May 04, 2009

ALICE Reeve says more needs to be done to help sufferers of fibromyalgia.

The 34-year-old was diagnosed with the condition, which causes wide- spread musculo-skeletal pain and fatigue, 10 years ago. The illness has become so acute she has been forced to seek private treatment to complement the pain management she gets on the NHS.

Alice, who lives in Evesham Road, Cheltenham, is now trying to raise awareness of the condition and get more treatments available for free.

She says she has to travel to a private hospital in London to get injections of vitamins, minerals, magnesium and pain relief, which cost £150.

Awareness of fibromyalgia and treatments for the condition are due to be debated in the House of Commons tomorrow, and Alice is planning to attend.

EDITOR’S NOTE:To view of the May 5 historic fibromyalgia debate log on to
http://www.fibromyalgia-associationuk.org/content/view/385/1/

To read it try: http://fmsglobalnews.wordpress.com/2009/05/09/mps-call-for-fibromyalgia-education-for-doctors-in-first-ever-fms-debate-in-uk-parliament/

She said: “I feel I should be able to have treatment close to home. Another part of fibromyalgia is that you are very, very tired all the time so the travelling does not help.”

Alice has not been able to work in recent years because of the condition, but previously taught English abroad and completed a degree and a masters. She wants to address the stigma attached to fibromyalgia and change people’s opinions.

“Because people cannot see the illness they cannot understand it. Many people have said to me ‘get a life and go and get a job’.

“There is a lot of stigma attached to it. People see it as yuppy flu,” she added.

Alice’s mum Patricia Reeve, who lives with her daughter, is concerned that other families of sufferers do not understand the condition.

She said: “People who suffer need more emotional support from their families. Some families try to bury their head in the sand over it.”

A spokesman for NHS Gloucestershire said: “We are sorry to hear of the patient’s illness.

“NHS Gloucestershire is always concerned with achieving the best possible health outcomes for its patients within the resources available.

“There are some treatment options available through the NHS to help ease the symptoms of fibromyalgia but some patients may prefer to use complementary options.

“It is important to stress that while we do not routinely fund complementary treatment for this condition at this time, we will always consider a request from a patient’s doctor if they believe there to be exceptional clinical circumstances.

“NHS Gloucestershire’s Review Panel takes into account information provided by the patient, GP and hospital consultant and any previous treatment and its outcome. It also takes into account guidance from NICE on any particular treatment, where relevant.”

COMMENTS (26)

I have suffered with Fibromyalgia for many years but was only given a positive diagnoses this February. I tis the most awful disease and the pain and sleeplessness, tiredness and all the other symptoms that come along with it are so debilitating. No-one seems to understand at all. I recently applied for DLA and was turned down becasue my GP report siad I wasnt disabled, which is so unfair as I cannot walk on some days and cannot work at all at the moment as I feel so ill all the time and am in so much pain. My consultant also said in his report that I can walk up to half a mile and I’d love to know where he got that idea from! He saw me once and has no idea of how I live my life day to day!

I feel like no-one wants to help and that my GP just doesnt want to understand this illness. It is time the Govt took notice of this horrible disease and did more to help sufferers. I have no income other than Employment and support allowance and I will soon not be entitled to even that as I live with my boyfriend and he is expected to pay all my bills when this money runs out which is so unfair. I cannot get any help with prescriptions and it just seems that I pay out endless amounts of money on medication and get very little relief.

If one of these Govt ministers had to live with this condition for just one day and suffer the excrutiating pain and tiredness they would soon be trying to sort out ways to help sufferers.

This link lists the 50 most common symptoms of Fibromyalgia http://fmsupport.org.uk/2008/04/50-signs-of-fibromyalgia it might just make people stop and think for a moment if they try to imagine living with all of these every day of your life!

The worst thing is that some days you think you are never going to make it to the end of a day and that you are truely going mad because of this stupid brain fog thing that makes everything so jumbled up in your head and prevents you from thinking properly, it is so frustrating!

I have tried to find a support group in my area but to no avail and travelling is out of the question as I am so tired all the time.

My GP has provided me with no information and anything I have managed to find out for myself via the internet he will not take heed of as he says that a lot of the information we find on the web can be misleading which is just a cop out!

This is the first article I have ever seen connected to any newspaper,so congratulations for bringing this to the publics attention finally. But why has it taken so long for the media to finally realise that there is something newsworthy in reporting the unfairness of how people with this disease are treated by the system.

Maybe if all the UK sufferers got together and presented ourselves at the House of Commons people might sit up and take notice!!
Tracy Hicks, Godmanchester, Cambs
commented on 18-May-2009 11:46

I was extremely intereted to read Alice’s views and congratulate her on her struggle to bring awareness for this condition. I am not a sufferer myself but know well someone who is and the devistating effect it has had on their quality of life. It is shocking that someone should have to travel from Cheltenham to London for basic treatment.which should certainly be provided by the National Health Service. Let’s hope that someone takes notice.
Stella, London
commented on 17-May-2009 22:34

TONY HOWES FEELS NHS A SOCIAILIST IDEA L IN 50S SHOULD SUPPORT ANY ILLNESS AS THEIR IS NO PRICE ON LIFE BUT MONEY IS BECOMING TO IMPORTANT .. IMAY BE LITTLE IDEALISTIC JOHN LENNON FAN BUT PLEASE LETS NOT PUT A PRICE ON LIFE ESPECIALLY IN ALICES CASE AS WE ALL LOVE HER
Tony Howes, London
commented on 16-May-2009 10:09

Unless someone famous get FMS , Media and others don’t care. We need to push , we deserve a cure and soild treatment, Fighting with insurace companys to get medications to make my life livable are only fair I am a human being and I suffer. Why won’t Oprah set up and do a show on FMS ?
Robin Smith, California
commented on 15-May-2009 06:35

It took me around 22 years to get a diagnosis, I saw Dr after Dr as a child and most said it was all in my head, one sent me to Physio with a covering letter saying to humor me.

It was 2007 when I had knee surgery again and I was left unable to bend or straighten the knee afterwards my Dr sent me to see a Pain Specialist thinking that I had Regional Pain Disorder.

When I got to the Clinic I was asked to fill out a questionnaire so I did and waited, while I was waiting to see the Dr he was sitting in his office reading my notes all of them, and reading my answers to the questionnaire, after 20 mins or so he called me in, he asked me key questions then told me that in no uncertain terms that I have Fibromyalgia, I did not know weather to kiss hug or cry, after so long of not 1 single person in the medical profession since I was 12 years old believed me or seemed to care to find out why my body hurt so much there was this one Dr who now I felt was my new best friend, finally to have something to say to people when they ask what have you done to yourself when I walk with crutches, and funny looks when people see me using a scooter when I am shopping and parking in disabled bays people thinking to themselves she doesn’t look like she deserves that bay. I had a response I could finally say what I had, I don’t want sympathy although some would be nice sometimes, I want understanding not odd looks and comments about parking and using the scooter.

FMAUK have helped me so much I go to group meetings and talk to fellow sufferers which is a great help especially as they are the only people who really understand what it is like to be us. I am lucky with my Husband and Children who do understand and my Family who have always stood by me and knew I was hurting and were as frustrated as me not knowing why.

TREAT THE PATIENT NOT THE INJURY OR REASON YOU WERE SENT.

That is why I finally got diagnosed, My pain Dr treated me not just my knee which was why I was sent to him, if all medical personal think this way we would all be so much better off.

FIBROMYALGIA needs to be more commonly known in the medical profession to stop someone else having to wait 22 years to get diagnosed.
Jaki, Wirral
commented on 14-May-2009 12:32

i have had f.m. for now going on 11 years,the struggle to find out what was wrong ith me took many years and seeing many drs…I now still live with the pain , the not sleeping all nite,and the parts of my body that does not always work right, to some points i just don’t go to far from home ,i miss out on family dues at times because i just don’t have the energy to attend.Some days i have feeling of not even wanting to talk to anyone ,I do have a very stronge support team of family and friends but still some days i feel like if i say again i dont feel well i feel like i am weak .It will always be a up hill battle.Even foods can cause problems for me so again i have to watch what i eat.And if i have to run across a dr that still in this day and age that says there is no such thing ,i think to myself then walk in my shoes for a day .Again in Canada it is a fight to get any kind of disablity for f.m.they tell you if you are not in a wheel chair you are not looked at but my question to that is who will hire someone that some days can barly get out of bed or that your feel sick or am so tired from not sleeping the nite before that there is no way you can hold down a job.Let alone some days of even getting dressed as again cloths can feel very tight on a person let alone the energy to get dressed.yes i know there is meds out there that work but again not for everyone,as some meds make a person even feel sicker. if i had one wish that would be that some day they will find a cure for everyone because again everyone comes by this f.m in more then one way ,any were from a car accident to something bad happened in thier life ,also to much stress again a big part of a very big no no for anyone with f.m. yet we live in a very stressfull world.It is not only very hard on the people that live with f.m. but also our loved ones watching us go throw this .So for anyone living with f.m. i wish you a pain free day .and i tell anyone i talk to read up on anything you can find about f.m.and if you have a dr that does know about f.m. talk to him about all your feeling and about any info you run across.and don’t give up on finding a dr that knows about f.m it is real it is not in your head .thank you for listening to what i have had to say and i hope i have been of some help.
louise chandler, canada
commented on 14-May-2009 04:21

I was diagnosed with fibromyalgia in 2005. I have progressively gotten worse since then. I suffer daily with this debilitating disease, and it is a full-time job just to manage the pain, and all the symptoms that goes with this illness. I hardly ever sleep…and I suffer terribly with concentration(fibro fog). Thank you Alice, for getting the word out. This is a real illness people suffer from, I know…because I am one of them. Fibromyalgia needs to be taken seriously, treated just like every other debilitating disease out there. May 12, 2009 was “National Fibromyagia Awareness Day”. I hope many were educated, and will continue to be educated on this invisible illness.
Janet, North America
commented on 13-May-2009 23:00

I was diagnosed with Fibromyalgia a year and a half ago. I have had symtoms for years. I can barely walk on somedays. The pain in my back and legs makes me cry everyday. My doc has faxed a note to Michigan Works that I can do everything and I have no restrictions. I’m clearly misunderstood. I don’t know why my doc would do this to me. Just because you can’t see it doesn’t mean that it’s not there. We need more docs to understand this diease. The pain is real and it never goes away! I’m so sad and very depressed.
Sandra Busch, Michigan
commented on 13-May-2009 13:45

I have fibromyalgia and have had it for a few years now but was just diagnosed a year and a half ago. My doc just faxed a note to Michigan Works that I have no restrictions and can do anything. The pain I feel everyday sometimes makes me not able to walk. I cry alot and am very depressed. I know that the pain is real. Why did my doc not understand? Why would he put me through this? I’m very sad and misunderstood.
Sandy Busch, Michigan
commented on 13-May-2009 13:40

It is always good when people are aware of illnesses such as this that are often misinterpreted. Sufferers should get more sympathy and therefore more help
angela edwards, Carmarthenshire
commented on 13-May-2009 10:56

It took me 3 years to get a diagnosis of FM and I had to ask fro a referral to a rheumatologist myself. If I hadn’t I’d still be none the wiser. I say a neurologist a few times but he couldn’t find anything wrong so threw me back out into an uncaring system instead of suggesting I see someone else. I was told not to ask to see him again as there wasn’t anything wrong.

A bit more education and understanding in the NHS would go a long way to helping people. We are made to believe it’s all in our heads or down to depression… well you’d be depressed if you were in pain 24/7!

Doctor’s packs with information for your GP can be obtained from FMA UK a registered charity trying to get the word out to as many people as possible.
Gill, S Wales
commented on 13-May-2009 00:46

I have had FMS for about 16 years but was only diagnosed 10 years ago. I had never heard of it, and neither had any one else I knew. 10 years later nothing seams to have changed much. I haven’t worked for 9 years and struggle to get through the day. i rely on my parents for many things and between sleeping / resting and attempting life’s esstentials i don’t have much time or energy for much else. I take amitrypline and fluxotine and would love to be well enough to work again and not rely on benefits. My doctor say that we don’t know what causes it so how can we treat it? More research please, and more publicity – i haven’t seen anything on TV today about Fibromyalgia Awareness Day.
Karen, Worcester
commented on 12-May-2009 19:26

I am 18 years old and have been diagnosed with Fibromyalgia for a while now. Having this illness means i have to use crutches on bad days, I can never go out with friends becauuse i’m too tired, my college work suffers too, and yet we are still not getting recognised as we should be. I’m all for what FibroAction is doing, i think everyone should be aware how debilitating this condition is.
Emma, Lincolnshire
commented on 12-May-2009 18:08

I emailed our local news programme, but didnt even get a mention or indeed a reply. My husband emailed the World Community Grid and the reply from them was “as its not a fatal illness they cannot research it” ok so we all know we wont die from it, but our whole life chages dramatically because of it. Its like being thrown on the scrapheap of life
Anne Walker, Glasgow
commented on 12-May-2009 17:36

At nearly 49, but young for my age, I have a long memory and remember the struggle that sufferers of MS and ME had to get the severity and extent of the conditions to be recognised by the powers that be as being genuine and not figments of the imagination. When reading about fibromyalgia. I read the same kind of stories of discrimination, misunderstanding and to some extent ignorance from the very bodies set up to care for sufferers namely the NHS and H. M. Gov as those writen in the 1970¿s about MS and later about ME. It seems that nothing realy changes, in that the NHS and H. M. Gov have to be dragged kicking and screaming into accepting newly identified and dibilitating conditions that are recognised in other countries. And, possibly the only way to make the NHS and H. M. Gov to see reason is to follow the example of past campains and raise the publics awareness of the condition and keep it there untill that little light in the minds of a ministers turns on and they start singing ¿I¿ve seen the light¿, but until then don¿t hold your breath but keep up the good work.
Keith Sharpe, Basildon
commented on 12-May-2009 15:00

I had heard of this illnes, but until i read your article, like many other people,i was unaware of the severity of this horrendous condition .
Thank you for opening my eyes to the amount of suffering and loss of normal life that these people have to endure.
Gillian Parkes, Moreton in Marsh, Glos.
commented on 12-May-2009 12:05

Fibro is a horrendous life changing illness. i am 22 i cannot work i recently married. no one seems to know what top offer in terms of pain relief. i have to use a stick to walk. what my future holds i have no idea but it doesnt look that bright at the moment. we need all the help we can get to raise awareness of this terrible life changing disease
laura, yorkshire
commented on 12-May-2009 08:43

Many thanks to this newspaper for highlighting this illness. This is an illness of the 21st Century, which most of the population do not know about. Perhaps we could have more tolerance and compassion.
Annie, Cheltenham
commented on 11-May-2009 21:48

I was dignosed in 2007 as having fibro, after about 6 years of lots and lots of tests that all came back normal. I felt like a hypochondriac and was treated like one at times, simply because this is an invisible illness and does not show up in routine tests. My last GP was an idiot who obviously was a non-believer and who refused to prescribed the only mild medication I was taking. I am in pain 24 hours a day, every day of the year, some days I can barely move. Yet the struggle thousands of us have to get any kind of DLA benefit and which is usually refused! This IS a REAL disability, if we had M.S. (no offence to MS sufferer’s) we would be able to access more benefits, more tretments and more understanding so much easier. Life is a struggle as it is, yet we are made to struggle by our own government and health system to access a diagnosis and suitable treatment, as well as the benefits.

I have also tried to raise the awareness for Fibro Day (12th May) by emailing local TV and radio, local newspapers, GMTV, but nobody has returned an email, which just goes to show how ignorant and unsympatheitc and plain disinterested a lot of this country really is. We need this to be recognised by ALL medical professions, ALL government and health departments, and as many people locally and nationally as possible.

Rant over, I’m now going back to bed before I have to pick my children up from school, as if I don’t, I will be ILL for some time and unable to even cook for them, Thank god I have a lovely partner who does understand!
Linda, Merseyside
commented on 11-May-2009 13:13

As the Operations Director of an International Medical Assistance Company, as well a Travel Insurer for people suffering from medical conditions I would just like to express my support for this campaign. All the more so given that my wife has recently been diagnosed with Fibromyalgia.

MIA Online already insures numerous Fibromy’ patients and we are aware of how debilitaing it can be.
Sir Jan Dalrymple, Rayleigh
commented on 11-May-2009 10:01

I was diagnosed with FM in 1992. I have very limited use of left side now and am constantly in pain. I actually use a wheelchair for distances and also have orthotic shoes and crutches. I do not allow this to be my life but can completely understand the frustration when people say ‘you’re just being lazy’ or ‘we all get tired’.
Go to the UK Forum for FM, it is a great release and a chance to chat to fellow sufferes who will never say those things.

It’s hard to have self belief when you want to detract from your physical disabilities and, of course, it alters your everyday routine but we should all support research into it, if only for the future sufferers.
I work part time which is a struggle but I won’t give it up. I am also a single parent of an 11 year old but he is a fantastic support for me, considering it changed his life as well.
Elaine, Tewkesbury
commented on 10-May-2009 15:23

I am 43 and have recently been diagnosed with fibro but have had symptoms for years. I am taking duloxetine and gabapentin for pain relief but find this still leaves me with plenty of pain.

Fatigue is the main problem. I’ve had to give up employment, Open University study, voluntary work and most of my social life. I now struggle to cook and cannot cope with the housework.

The future looks very bleak. There is no hope of returning to full time work but I do not want to spend the rest of my life living off benefits. The pay is lousey and there are no days off from pain and fatigue.
Hazel, Evesham
commented on 08-May-2009 07:45

I had post-viral fatigue after a bout of tonsilitis a year ago January. I have now been diagnosed with Fibromyalgia (Chronic Fatigue Syndrome) – my biggest concern is the fuzzy brain (or brain fog) – I have just been referred to the CFS clinic that operates out of Bristol at more local clinics and am awaiting an appointment – just some advice on managing the condition would be really helpful. The pain, especially in my feet and legs is really uncomfortable – I do work, and am taking part in the Sue Ryder Midnight Walk this coming Saturday – am determined this condition will not take over my life completely. My friends will stay with me until I do the walk. They are being very supportive. I feel for anyone who has the same condition, and look forward to seeing some progress in its more formal recognition.
Tracy, Cheltenham
commented on 06-May-2009 18:47

I was diagnosed in December last year with Fibro as my partner calls it, untill then i had never heard of it but have since made contact with another sufferer.As i am on strong painkillers for my back my Dr. has since put me on anatriptoline which i have found helps with it. But i can get it for three or four days a week then have two or three days without it . It seems a cycle that i have told myself to accept it,but as i’m on other meds and painkillers i find wheni got the pain i just found the best position on the sofa and sleep alot.I can wake up in the morning and feel fine then an hour or so later feel ILL.Before i was diagnosed with Fibro my Dr. sent me to the hospital to be tested for Rhumatoid Arthritis the hospital Dr dagnosed the fibro,as i sai put me on Anatriptoline and gave me a booklet about fibro and sent me home with another appointment to see him in 6mths time
bob, Hertfordshire
commented on 04-May-2009 14:25

I too have suffered from this condition for years. Being in constant pain 24 hours a day is exhausting and depressing. Sleep is in short supply as it is impossible to get comfy. If one more person tells me I “look well” I may well scream!! Do magnesium injections help? Many thanks to Alice for taking up the cause. I wish her everything I wish myself.
victoria, cheltenham
commented on 04-May-2009 13:17

The use of local anaesthetic injected intramuscularly as pain relief and the use of injected vitamins and minerals to counteract deficiencies in someone with reduced absorption capabilities is not a complementary therapy.

Using drugs to treat pain is the remit of traditional medicine. Treating vitamin and mineral deficiencies is also part of traditional medicine.
Lindsey Middlemiss, Berkshire
commented on 04-May-2009 12:39

(Copyright Harmsworth Newspaper Printing

http://www.thisisgloucestershire.co.uk/news/Cheltenham-woman-mission-raise-awareness-fibromyalgia/article-958681-detail/article.html?cacheBust=7vk40nSNjqBF&success=true#community)

My thanks to Sue SB for bringing this story to my attention. It is good to share. I wonder how many more fibromyalgia patients have been refused support by the GP when applying for benefits. It is a pity they cannot try having this invisible disability for a week to see how it really feels and that IT IS REAL!

FOR MORE FIBROMYALGIA STORIES SEE: http://jeannehambleton77.wordpress.com

FDA Requires Additional Labelling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy FDA US Food and Drugs Administration – For Immediate Release

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labelling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research.

“However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labelling do not address all of the labelling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of April 28 2009.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

Source: FDA
OTC Pain Relievers – Acetaminophen: Tylenol & other Brands
NSAIDS – Aspirin: Bayer & other brands, Ibuprofen: Advil, Motrin & other brands. Naproxen: Aleve & other brands.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go to

http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf

To read the FR Notice announcing the FDA Advisory Committee meeting, see link below:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf

Consumer Inquiries: 888-INFO-FDA

(http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html)

FDA MedWatch – Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B): Boxed Warning required

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of FDA/Center for Drug Evaluation and Research

FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication.

UPDATE
Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)

This information reflects FDA’s current analysis of available data concerning these drugs.

As the result of an ongoing safety review, FDA has notified the manufacturers of licensed botulinum toxin products of the need to strengthen warnings in product labeling, and add a boxed warning, regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA also has notified the manufacturers that development and implementation of a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the product outweigh the risks. The REMS would include a Communication Plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.

In addition, FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

Botulinum toxin products have been approved by FDA for one or more of the following uses: temporary improvement in the appearance of glabellar lines (frown lines between the eyebrows), treatment of strabismus (crossed eyes), blepharospasm (abnormal tics and twitches of the eyelids), cervical dystonia (involuntary sustained or repetitive contraction of the neck muscles), and primary axillary hyperhidrosis (severe underarm sweating). For these uses, botulinum toxin is injected into the skin or into muscle tissue.

Postmarketing Review

The following information summarizes FDA’s review of postmarketing safety data obtained from the manufacturers of botulinum toxin products, and all existing data within the Agency regarding these adverse events:

In pediatric postmarketing adverse event case reports, botulinum toxin products were mostly used to treat muscle spasticity in cerebral palsy, a use that has not been approved by the FDA. The reported cases of spread of botulinum toxin effect beyond the site of injection were described as botulism, or involved symptoms including difficulty breathing, difficulty swallowing, muscular weakness, drooping eyelids, constipation, aspiration pneumonia, speech disorder, facial drooping, double vision, or respiratory depression. Serious case reports described hospitalizations involving ventilatory support and reports of death.

The majority of the adult postmarketing case reports of distant spread of toxin effects occurred following use of botulinum toxin for the treatment of spasticity (an unapproved use) or cervical dystonia. Some cases resulted in hospitalization, including several cases that required placement of a gastric tube or mechanical ventilation. Although there were several deaths in adults, it is not possible to attribute them to the botulinum toxin because the patients also suffered from complications of their pre-existing conditions. In addition, there have been reports where some symptoms could be consistent with distant spread of toxin effect following dermatologic use. However, no definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of Botox at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been identified.

Recommendations

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication; that healthcare professionals who use botulinum toxin products should:

Understand that dosage strength (potency) expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.

Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.

Advise patients to seek immediate medical attention if they develop any of these symptoms.

FDA urges both healthcare professionals and patients to report side effects from the use of Botox and Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B), and Dysport (abobotulinumtoxinA) to the FDA’s MedWatch Adverse Event Reporting program through:

Online at http://www.fda.gov/medwatch/report.htm
By returning the postage-paid FDA form 3500 available in PDF format at http://www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
Faxing the form to 1-800-FDA-0178
By phone at 1-800-332-1088

EDITOR’S NOTE: In January 2008 the Public Citizen Health Research Group presented a citizens petition led by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Shiloh Stark, B.A. Sidney Wolfe, M.D. that requested the Food and Drug Administration (FDA or Agency) immediately to require the Biologics License Application (BLA) holders of all formulations of botulinum toxin to issue a ‘Dear Health Care Professional’ (DHCP) letter to “alert physicians to serious problems, including hospitalizations and deaths, resulting from the spread ofthe toxin from the site of injection to other parts ofthe body” (Petition at 1).

The Petition also requested that FDA require BLA holders of botulinum toxin products to provide “additional warnings in the form of a black box” to product labeling regarding the risk of distant spread of the toxin effects from the site of injection and provide an FDA-approved Medication Guide for patients, to be dispensed by physicians at the time of injection. The request was based on rates of dysphagia and muscle weakness in preapproval clinical trials and postmarketing adverse event reports of dysphagia, aspiration, and/or pneumonia.

In April 2009 the Department of Health and Human Services Food and Drug Administration in Rockville MD 20857, replied. To read the full text log on to:

http://www.fda.gov/cder/drug/early_comm/botulinum_CP_response.pdf

The FDA reply includes the following information:

Spread of Botulinum Toxin Effects

Botulism is a serious bacterial toxin-mediated neuroparalytic illness whose onset is typically marked by cranial nerve dysfunction (resulting in double vision (diplopia), inability to control or coordinate the muscles used in speaking (dysarthria), and/or difficulty swallowing (dysphagia)), followed by progressive descending muscle weakness or paralysis that can lead to respiratory failure and death.6 Thebotulism syndromes may result from absorption of botulinum toxin through a mucosal membrane (intestine or lungs) or from a wound.7 The clinical use of licensed botulinum toxin products presents the potential for iatrogenic botulism, which may be described as the appearance of one or more clinical manifestations of botulism that has the potential to be clinically serious.8

Local extension of effect of the botulinum toxin to anatomical structures (nerves and muscles) adjacent (contiguous) to the site of injection may occur and is described in product labeling.9 For example, dysphagia (difficulty swallowing) is described in product labeling as a “commonly reported adverse event following treatment with all botulinum toxins in cervical dystonia patients.”l0 However, dysphagia may also be a sign of distant spread of botulinum toxin effects when the botulinum toxin is administered at a site other than the neck.

Details of references can be found on the website link.
(http://www.fda.gov/cder/drug/early_comm/botulinium_toxins200904.htm)

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Fibromyalgia and Epilepsy Drug Lyrica Helps Restless Leg Sufferers, Researchers Say

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of attorneyatlaw.com Legal Briefs

Lyrica, the Pfizer drug for treatment of the chronic pain disorder fibromyalgia and preventing epileptic seizures, also appears to benefit people who cannot get to sleep because of restless legs syndrome, new findings suggest.

A recently completed clinical trial found that pregabalin, the active ingredient in Lyrica, is “a promising alternative to current treatments” in terms of helping people with restless legs syndrome get more quality sleep, according to research unveiled this week at a meeting of the American Academy of Neurology.

Lyrica for Fibromyalgia Pain

In 2007, Lyrica became the first FDA-approved treatment for fibromyalgia, a debilitating condition which affects as many as six million Americans, mostly adult women. Fibromyalgia victims tend to experience chronic or long-lasting pain as well as muscle stiffness and tenderness, the FDA said.

Restless legs syndrome is a neurological disorder which causes burning or tugging sensation in the legs, sometimes called parethesias or dysethesias, particularly when the person is lying down at rest. The sensations can range from uncomfortable to extremely painful.

Study of Restless Legs Sufferers

Researchers from the Sleep Research Institute in Madrid, Spain studied 58 patients who suffered from restless legs syndrome. The patients were given placebo pills for two weeks then half were given 150 to 600 milligrams daily doses of Lyrica, while half continued to receive placebos for another 12 weeks.

The researchers monitored the severity of restless legs syndrome and sleeping habits of both groups and found that those taking Lyrica experienced less severe symptoms of the syndrome.

Less Symptoms, More Sleep

Using the International Restless Legs Syndrome Rating Scale, people on Lyrica saw their scores on the disease severity index decline from 19.8 to 6.8, while scores for participants on placebo treatments declined from 21.5 to 11.2, the researchers said.

Also, people in the study who were taking Lyrica spent significantly more time sound asleep in what is called deep slow wave Stage 3 sleep and less time in light sleep, called state 1 or 2 sleep, compared to people not taking the drug, the researchers said.

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/04/fibromyalgia-and-epilepsy-drug-lyrica-helps-restless-leg-sufferers-researchers-say/)

From the FMS Global News Desk of Jeanne Hambleton (UK)

Low Doses of Drug for Alcoholics Helps Reduce Fibromyalgia Pain, New Research Finds

Courtesy of attorneyatlaw.com Legal Briefs

Taking low doses of a drug commonly given to alcoholics and drug addicts reduces pain and fatigue in some people battling the chronic-pain condition fibromyalgia, Stanford University researchers say.

In preliminary research, the drug, naltrexone, reduced the pain and fatigue in fibromyalgia patients by an average of 30 percent, researchers said. The findings are an encouraging development for millions of Americans who suffer from fibromyalgia, a somewhat mysterious disorder for which there is no reliable cure or treatment.

However, larger and more detailed studies are needed before naltrexone can be recommended for treating fibromyalgia, researchers said.

Study Finds Benefits for Fibromyalgia Sufferers

The Stanford University study focused on 10 fibromyalgia patients. Some of the patients received low doses of the drug at bedtime while some were given placebos. Those taking naltrexone reported significant drops in daily pain, highest pain, stress, fatigue, and improved pain thresholds, according to the study.

On average, patients given naltrexone had their fibromyalgia symptoms reduced by 32.5 percent, compared to improvement of 2.3 percent in patients given placebo treatments.

Few Side Effects, Relatively Inexpensive

Naltrexone treatments resulted in few side effects, although some participants reported experiencing vivid dreams after taking the drug. Researchers are excited about the prospects of naltrexone as a fibromyalgia treatment because there currently are few treatment options for such patients and the drug is relatively inexpensive, costing about $40 a month.

A second, longer-term study of the effects of naltrexone on fibromyalgia symptoms and including 30 patients tested over a period of four months is set to begin soon, Stanford researchers said.

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/04/low-doses-of-drug-for-alcoholics-helps-reduce-fibromyalgia-pain-new-research-finds/)

From the FMS Global News Desk of Jeanne Hambleton (UK)

Fibromyalgia: Millions Are Spent To Educate the Public About a Mysterious Condition

Courtesy of attorneyatlaw.com Legal Briefs

Two of the world’s biggest drug companies have paid millions of dollars to promote a chronic pain syndrome about which little is known, prompting some critics to accuse the companies of hyping a mysterious condition hoping to sell more drugs.

In the first nine months of 2008, drug makers Pfizer and Eli Lilly gave more than $6 million in grants to nonprofit groups to sponsor medical conferences and educational campaigns focused on fibromyalgia.

That sum tops the amount spent by the companies to raise awareness of more established diseases, such as diabetes and Alzheimer’s, and trails only AIDS, cancer, and depression in terms of educational spending from drug companies, officials said.

The problem, critics say, is that no one is exactly sure what fibromyalgia is. There is no known cause of the disease, critics note, and there are no tests for confirming its presence. Fibromyalgia patients most often may also be diagnosed with more widely understood conditions, including chronic fatigue syndrome.

Therefore, drug companies may simply be trying to drum up more patients for a disease that is treated by Lyrica, Cymbalta, and other popular drug brands, critics allege.

WHY THE FOCUS ON FIBROMYALGIA?

Why are drug companies paying millions of dollars to educate the public about a condition that even medical experts tend to agree may or may not even exist?

Are the drug companies engaging in the common practice of trying to influence the medical community into accepting and promoting a disease whose treatment might include the companies’ drugs, as critics allege?

Or, as the drug companies contend, are they simply exposing a newly developing disease which affects millions of Americans, just like depression, which went widely misunderstood and untreated for decades?

By convincing doctors to diagnose patients with fibromyalgia, Pfizer, Lilly and other drug companies figure to pocket billions in sales of drugs designed to treat the disorder. In fact, sales of Cymbalta, an antidepressant approved in June 2008 as a fibromyalgia treatment, and Lyrica, an anti-epileptic seizure drug also approved for fibromyalgia, have spiked amid the public-awareness campaigns.

In 2007 and 2008, sales of Pfizer’s Lyrica increased from $395 million to $702 million, while sales of Cymbalta, made by Lilly, were boosted from $442 million to $721 million, officials said. The drugs can help reduce pain in fibromyalgia patients, although researchers are not exactly sure how they work.

At the same time, the drug companies also poured millions of dollars into advertising the fibromyalgia drugs. Lilly spent about $128.4 million in the first half of 2008 to promote Cymbalta, while Pfizer shelled out more than $125 million on advertising for Lyrica, according to some estimates.

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

According to the American College of Rheumatology, between six million and 12 million people in the U.S. currently have fibromyalgia. Women are more likely to have the condition, accounting for more than 80 percent of all cases.

Symptoms of fibromyalgia include widespread muscle pain, fatigue, headache and depression. However, despite more than 30 years of studying the condition, researchers say the understanding of fibromyalgia remains “murky.”

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

The policy of drug companies issuing grants to nonprofit groups to conduct educational campaigns about diseases and conditions is fraught with potential abuses. It is not hard to see why companies like Pfizer and Lilly want to get the word out about fibromyalgia, since the companies make two of the drugs most commonly prescribed to treat the disorder.

By convincing physicians to diagnose cases of fibromyalgia and prompting patients to ask their doctors if fibromyalgia might be the reason for their unexplained pain, the companies have already earned millions of dollars in sales of the drugs.

The FDA must keep closer tabs on this practice to ensure that drug companies are not acting improperly in funding work to promote diseases or conditions. In the end, such practices may prove harmful to patients and drug users who are grasping at straws and desperate to find answers to their nagging pain.

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/02/fibromyalgia-millions-are-spent-to-educate-the-public-about-a-mysterious-condition/)

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Lyrica Significantly Reduced Pain and Improved Other Symptoms of Post-Traumatic Peripheral Nerve Pain, New Data Show

From the FMS Global News Desk of Jeanne Hambleton (UK)

SEATTLE–(BUSINESS WIRE)

Patients suffering from post-traumatic peripheral nerve pain treated with Lyrica® (pregabalin) capsules CV experienced significantly reduced pain compared to those taking placebo, according to new data presented today at the American Academy of Neurology annual meeting. The data also showed that patients treated with Lyrica reported less pain interference with sleep and were significantly more likely to report feeling better overall at the end of the study compared with placebo.

Post-traumatic peripheral nerve pain is a difficult to treat condition that occurs after nerve damage due to trauma from accidental injury or surgery. It can be a chronic condition, affecting the injured area with pain persisting long after the initial injury has healed. Traumatic injury causing long-lasting changes to the peripheral nervous system – the communications network that transmits information to and from the central nervous system (the brain and spinal cord) and every other part of the body – is believed to be the cause of this persistent pain.

Post-traumatic peripheral nerve pain can have a wide array of symptoms, including numbness, tingling and prickling sensations, sensitivity to touch or more extreme symptoms including burning pain.

“The findings of the study are good news for the many patients who suffer from this painful and debilitating condition,” said Robert van Seventer, MD, Chair of the Department of Anesthesiology and Director of Amphia Pain Clinic and Research Centre, Amphia Hospital, the Netherlands.

“Post-traumatic peripheral neuropathic pain has historically been a challenging condition to treat so this data demonstrating the ability of pregabalin to provide relief for patients is encouraging.”

The study found patients treated with Lyrica experienced significantly reduced pain compared to those taking placebo. At the end of the study, patients receiving Lyrica had, on average, a pain score that was 0.62 points lower on an 11-point scale compared to placebo.

Patients receiving Lyrica reported less pain interference with sleep compared to placebo. At the end of the study, patients receiving Lyrica had an average self-reported weekly pain-related sleep interference score of 2.73 (from a baseline of 4.1) on an 11-point scale measuring how much pain had interfered with sleep during the past 24 hours, compared to 4.13 for placebo (from a baseline of 4.8). Additionally, at the end of the study, significantly more patients receiving Lyrica (64 percent) reported feeling “improved” compared to placebo (41 percent).

About the Study

The multi-center, double-blind, placebo controlled study of Lyrica in 254 adult patients with post-traumatic peripheral neuropathic pain randomized patients to receive flexible dose Lyrica 150 mg to 600 mg daily for four weeks of dose optimization, followed by fixed dosing for four weeks.

The study was conducted at 60 sites across Canada and Europe. The average Lyrica dose was 326 mg daily. Patients had to experience persisting, neuropathic pain for at least three months following a traumatic event such as an accident, surgery, amputation or a nerve injury and have a pain score greater than or equal to 4 on an 11-point scale. Patients remained on existing treatments during the study.

Patients were asked to measure their pain on a scale of zero to 10; the average baseline scores for study participants were 6.0 in the pregabalin group and 6.3 in the placebo group on this 11-point scale. A score of 4.0 to 7.0 is considered moderate pain and a score of greater than 7.0 is considered severe pain.

The primary endpoint was the difference in average self-reported pain score at the study’s conclusion between patients treated with Lyrica and placebo. Secondary endpoints included the effects of Lyrica compared to placebo on co-morbid symptoms of post-traumatic peripheral neuropathic pain including anxiety, patients’ self-reported pain-related sleep and patients’ self-reported overall improvements.

The most common side effects in the study versus placebo were dizziness (43.3 percent vs. 9.4%) and somnolence (15.7 percent vs. 6.3%), followed by headache (11.8 percent vs. 11.0%), fatigue (11.8 percent vs. 7.9%) and dry mouth (11.0 percent vs. 4.7%). The study was funded by Pfizer Inc.

About Lyrica

In the United States, Lyrica is approved for the management of fibromyalgia. Lyrica is also indicated for the management of painful diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and for the adjunctive treatment of partial onset seizures (a type of epilepsy) in adults.

Outside of the United States, Lyrica is indicated in adults for the management of peripheral and central neuropathic pain (NeP), treatment of generalized anxiety disorder, and adjunctive therapy for partial seizures with or without secondary generalization.

Important Safety Information

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse reactions include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally. There have been post-marketing reports of angioedema and hypersensitivity.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Contacts Pfizer Inc
Media:
Sally Beatty, 212-733-6566

Investor:
Jennifer Davis, 212-733-0717
Permalink: http://www.businesswire.com/news/home/20090429006303/en

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Still no treatment in Europe for the 14 million FMS patients trapped in pain!

From the FMS Global News Desk of Jeanne Hambleton (UK)

Press Release from ENFA – 29.04.2009

Brussels, (29.04.2009)

Last week was high on activities for the Fibromyalgia community, on one hand the European Network of Fibromyalgia Associations (ENFA) met with the European Health Commissioner Ms Androulla Vassiliou1. And on the other hand the European Medicines Agency (EMEA) gave another negative decision for a treatment for fibromyalgia in Europe2.

Ms. Pam Stewart, Vice-President of European Network of Fibromyalgia Associations (ENFA) and chairman of the trustees of Fibromyalgia Association UK, said one of the biggest challenges that the patients have been facing is the lack of officially recognised medical treatment options in the European Union.

By comparison there are three drugs in the United States of America approved by the Food and Drug Administration: Cymbalta from Eli Lilly, Lyrica from Pfizer and recently authorised Savella from Forest and Cypress (Pierre Fabre).

Last October, Cymbalta received a negative decision from the EMEA and last week was the turn of Lyrica said Ms Stewart. One dossier is still remaining to be evaluated by the EMEA: Savella. Each of these drugs has a limited success and judged alone leads to their failure to get approval.

However with a full range of treatment options, more people with fibromyalgia could have reduced levels of pain. This could enable them to embark on a management programme to significantly improve their quality of life said the Vice President.

“We are constantly hearing from people diagnosed with fibromyalgia that their doctor tells them there is no treatment because no approved guidelines or medications are available. Medical professionals that do not have time to research treatment options should have clearly signposted guidelines for effective treatment options. No one should be sentenced to a life of pain, she said.

“Patients across Europe are currently using these medicines off label. However, the European Medicines Agency told European Network of Fibromyalgia Associations that this is a common situation already faced in other disease areas such as cancer, and the situation with off label use cannot be taken into consideration in the assessment of medicines for which a marketing authorisation is sought.

“The difference with Fibromyalgia is that patients in the UK, for example, are unlikely to be prescribed any of these effective drugs because they have not been officially approved for Fibromyalgia. Patients are left with inadequate treatment options and although these drugs can be purchased over the Internet, this means their use is not monitored and people could be at the mercy of unscrupulous suppliers, which could put their lives at risk,” said Ms. Stewart.

Another example, coming from Germany, concerns the social status of patients since they are labeled as “depressive patient” for their life insurance or health insurance in order to have their drugs fully reimbursed by the National Health Insurance. In order to get any effective medicines, doctors should not diagnose fibromyalgia at all because the medicines are not indicated for fibromyalgia.

At the same time, an ENFA delegation was meeting with the European Health Commissioner Ms. Vassiliou. The meeting was only a natural step, concluding ENFA’s activities on the ‘European Institutions Fibromyalgia Awareness Campaign’ launched in 2008 on World Fibromyalgia Day.

Since the commencement of the campaign last May, with the support from 418 Members of the European Parliament, the Written Declaration on Fibromyalgia was adopted by the European Parliament in December 2008. The written declaration was necessary to raise awareness to all the European politicians from the 27 member states. It also helps create a mapping of the disease status disparity across Europe and increase awareness of better diagnosis and treatment.

“However, we realised that without any officially approved treatment options available, it was almost impossible to properly raise awareness of Fibromyalgia. The patient petition with over 27,000 signatures from all over Europe that MEP Adamou voluntarily hand delivered to the Health Commissioner, clearly demonstrates the frustration from the fibromyalgia community and strong and urgent needs to have treatment options to be officially available. The Fibromyalgia community is left with one hope to see maybe Savella drug approved before the summer. But unfortunately, the hope for a multiple choice of treatment in Europe seems to be lost.

“The European Network of Fibromyalgia Associations and all its associations have for years raised awareness on Fibromyalgia among national and European politicians, health professionals and the general public, and will keep on being active as long as it is necessary,” the Vice President.

About ENFA

ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see Fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right.

About Fibromyalgia

Fibromyalgia is 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. Fibromyalgia imposes a large economic burden on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 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 estimated that the average annual cost of fibromyalgia was €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.

For more information on the European Network of Fibromyalgia Associations (ENFA) contact Ms. Pam Stewart Vice-President of ENFA Brussels@enfa-europe.eu; http://www.enfa-europe.eu.
1 On Wednesday 22 April in Strasbourg, for more information visit http://www.enfa-europe.eu; 2 On Thursday 23 April in London, for more information visit http://www.emea.europa.eu

One in seven GPs may be told to retrain under revalidation plans

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of PulseToday.com

On July 2008 the PulseToday.com on line magazine for GPs carried a story concerning compulsory annual assessment for GPs.

Chief Medical Officer Sir Liam Donaldson then formally laid out controversial plans for the revalidation of doctors.

Under the plans, revealed in the report, Medical Revalidation: Principle and Next Steps, GPs will face compulsory annual assessments, and could have their licenses removed if they are judged to be performing poorly.

The process, which has been in the pipeline for over a decade, will require GPs to renew their licenses every five years, with senior doctors asked to assess colleagues who are practicing in their area to ensure they are not putting patients at risk.

Patient feedback will also be used in the assessment process, pilots of which will start next year.

The proposals have been produced by the GMC with the help of the medical colleges, including the RCGP. But critics have warned that the extra scrutiny could lead to the spread of defensive medicine.

GPs will have to clear two hurdles to gain revalidation; recertification – to confirm that they meet standards appropriate for the specialty of their medicine, and re-licensure – to confirm that they practise in accordance with the GMC’s generic standards.

Mandatory annual reviews will look at prescribing habits, assessment of a patient’s condition and any personal issues such drug or alcohol abuse.

Pulse revealed earlier this year that GPs will be assessed using so-called 360-degree colleague surveys, with up to a dozen practice staff and colleagues asked to rate their performance.

The process is expected to be rolled out gradually to all specialities, including general practice, with pilots beginning in 2009.

UP DATE

Last week on 16 April 2009 Gareth Iacobucci wrote an up to datge story for PulseToday.com.

Exclusive: As many as one GP in seven will face having to retrain under the RCGP’s (Royal College of General Practitioners) plans for revalidation, Pulse can reveal.

LMCs (Local Medical Committees) have been told to expect between 5% and 14% of all GPs will fail at least one element of the programme, with some having to do up to 18 months of ‘corrective training’.

The figures, which the college said were in line with its own predictions, could mean up to a third of three-partner practices, and almost half of four-partner practices, having at least one GP who does not pass first time.

Dr Maurice Conlon, national director of the NHS Revalidation Support Team and a GP in Birmingham, told Pulse practices might need to consider rewriting partnership agreements to outline who was financially liable if a partner had to take time out of work to retrain. He said he expected a ‘surge’ of GPs to need some sort of intervention in the first year or two of revalidation, but insisted this would then ‘settle down and tail off’.

He added: ‘A very small number of doctors might find they are in the wrong job, some will have a significant need for remediation and some will need some form of retraining.’

The RCGP expects GPs to begin compiling portfolios from this month for the first five-year revalidation cycle, with the first GPs scheduled to move through the system in 2010/11.

Professor Steve Field, chair of the college, said the 5-14% estimate was ‘about right’, but that most struggling GPs should be identified via PCT appraisals long before the end of the five-year cycle:

‘Learning needs should be identified each year and additional support given. But nothing will work unless we have effective appraisal.’

Dr Conlon said many GPs requiring retraining would still be fit to practise, depending on how much work was needed, with revalidation targeting areas such as communication problems, absence of an established practice team and lack of engagement with CPD

(Editor’s Note: Doctors have a responsibility to keep up to date. The GMC publishes Guidance on Continuing Professional Development, which sets out the principles on which continuous professional development should be based, and the roles of the relevant organisations involved in its delivery.)

But Dr Conlon warned that GPs might have to fund some retraining themselves if it extended beyond study leave written into their contracts. “Partners could choose to write into agreements that if you run into difficulty, you limit their ability to share profits. I would be very disappointed to see that,” he said.

Kent LMC has begun warning its members of the ‘significant’ effort and cost likely to be involved, after being presented with the failure-rate figures at a meeting between GP educationalists and local PCT managers.

Dr Gary Calver, secretary of Kent LMC, said: “There are big question marks over how it is going to work and be funded.”

Gloucestershire LMC warned: “Partnerships should consider very carefully and put into partnership agreements what is to occur should a partner fail. For instance, would the partnership continue to pay the GP a share of profits while retraining?”

The GPC has stressed the need to ensure all aspects of revalidation, appraisal and remediation are adequately supported, but the Department of Health has given no guarantees.

PULSE READERS’ COMMENTS:

Umesh Prabhu | 18 Apr 09

If the plan is to retrain ‘poorly performing’ GPs then there is no need to worry. The question is how we are going to identify these GPs? Who makes the decision that the GP needs re-training? Who is going to fund it? How do we make sure that there are no ‘hidden’ or personal agendas at local PCT?

Of course, it is important to protect patient safety and their well-being but it is equally important that all doctors are treated fairly and correctly and action taken is proportionate. Big question is who is going to fund the re-training?

THE REVALIDATION PROCESS

Areas where GPs could fail
GPs may demonstrate deficiencies in areas such as communication, poor premises or CPD.

What type of retraining?
GPs could receive educational support from the RCGP, deaneries or other specialised academics for those that need ‘more intensive support’. With significant concerns, and if remediation is required, National Clinical Assessment Services procedures could be used, which can last up to 18 months.

The process
GPs to collect information for revalidation portfolios over five-year period. PCT responsible officers will give a recommendation to the GMC over whether or not to revalidate

Practice staff to rate GPs as part of tougher appraisal

GPs will be scored by colleagues and staff every few years as part of a new process to prove they are qualified to continue practising, said Gareth Iacobucci in Pulse Today.

Verdicts from colleagues form a key part of controversial plans for recertification and will take place either once or twice every five years.

GPs will be assessed using so-called 360-degree surveys, with up to a dozen practice staff and colleagues asked to rate their performance.

Annual appraisal will also be toughened up under the plans, released to Pulse, by the Royal College of General Practitioners’. The current informal appraisal will be replaced by summative assessment and performance management.

The more rigorous appraisals and 360-degree surveys – both of which are bound to be contentious – will feed into the five-yearly recertification process.

Recertification will require GPs to demonstrate the skills and knowledge expected of their profession, and will occur in parallel to the GMC’s relicensure procedures to investigate fitness to practise. GPs will need to clear both hurdles in order to gain revalidation.

The RCGP told Pulse toughening up appraisals was essential to meet the regulatory requirements expected of the profession and ensure it could continue to self-regulate.

The college’s chair, Professor Steve Field, insisted most GPs had nothing to fear: “This is about professional development in the vast majority and, in cases where performance is below standard, identifying those in need of help.”

The college will publish a draft of ‘criteria standards and evidence’ to guide appraisers in judging GP performance. GPs will be judged on the quantity and quality of their portfolio, and expected to detail difficult incidents and lessons learned.

Professor Mike Pringle, professor of primary care at the University of Nottingham, who led the RCGP group examining the criteria to be applied in appraisals, said GPs should feel reassured that they would be judged by peers, not external bodies, during recertification.

“People will sit at a computer, and anonymously rate the GP on a five-point scale on a set of attributes. GPs get an aggregated score so they can see how colleagues view them,” he said .

But some GPs were alarmed by the plans. Dr Cornel Fleming, a GP in Islington in north London, said the system would breed discontent among GPs.

“It is getting ridiculous,” he said. “Appraisals were supposed to be helpful, not disciplinary. It is becoming like a police state.”

The RCGP said detailed proposals would be completed later this year, piloted in 2009 and rolled out in 2010. Appraisals will remain annual, but it is yet to be decided how often surveys will take place over five years.

In the surveys GPs would be ranked by colleagues of their choice, which could include fellow GPs within or outside the practice, practice nurses and practice managers.

Pulse, CMP Medica. All rights reserved.
(http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4122447&c=2)
(http://www.pulsetoday.co.uk/story.asp?storycode=4118102)

DEBATE

Are recertification plans good for general practice?

The RCGP’s Professor Mike Pringle insists the system will be fair and transparent. But GMC member Dr Krishna Korlipara believes assessment by staff is an inappropriate way of judging clinical competence.

Yes

Are recertification and revalidation really necessary?

Well, my view is that it is no longer sufficient to qualify as a doctor and to pass the MRCGP before, say, the age of 30, and then to practise through to 65 or older with no further question about your competency.

We could rely, as we have in the past, on dodgy doctors ‘coming to light’ through complaints or PCT investigations, but that is not sufficient reassurance to us as colleagues or to the public.

So if periodically demonstrating that we are keeping up to date and still fit to practise is necessary, we need to be sure that the system imposed on us is appropriate.

By this I mean that it achieves its aims of ensuring our fitness, and being fair, transparent and feasible.

The first step is to agree what we mean by an acceptable GP, and this is the purpose of the RCGP’s Good Medical Practice for General Practitioners.

The college is asking for your views on the new draft of this at present. The second step is to say what tests will be applied, to what level, and how doctors will demonstrate their compliance.

This is the purpose of a document called Criteria, Standards and Evidence that is being worked up. When it is published, every GP and member of the public will see clearly what is expected.

What follows in this article is a personal view based on the early thinking for Criteria, Standards and Evidence. Whatever the college proposes will be put out for consultation and tested in pilots.

The plans will have to be approved by the GMC, which will want to be sure the college’s plans are fit for purpose and equivalent to those for other types of doctors.

Much of the evidence will be already available to most GPs. It will come through their appraisals, their audits – including significant events – their patient surveys and clinical governance.

Standard process

A new method of measuring continuing professional development is likely to form part of the package. One new element is likely to be multi-source feedback – asking your colleagues to rate you. It is a fairly standard process and such surveys are already part of regular appraisal at the GMC.

“We can design a process that is fair, fit for purpose and transparent”

At each annual appraisal GPs will be asked to share the evidence they are gathering. The appraiser will check both its quantity (is it enough for this phase in the five-year cycle?) and its quality (does it show good enough care?).

If it is insufficient, the appraiser will advise on how to improve it. At each appraisal GPs will plan what to put in the folder for the next year.

At the end of the five-year cycle, GPs will submit the folder of evidence containing enough for relicensure (continuing to be a doctor) and recertification (continuing to be a GP). There will be local sign-off from the PCT and appraiser.

If the folder meets the standards in Criteria, Standards and Evidence, the college will recommend you to the GMC.

As a five-year exercise, this sounds doable, but that will be tested through pilots – as will its effectiveness in sorting the vast majority who are good GPs from the few who are not. If the college cannot recommend a GP for recertification, there is no immediate effect.

The GMC would need to review the evidence and, if necessary, start fitness-to-practise processes. So for the few, the case that they are unacceptable GPs must be proven.

I believe we can design and implement a recertification process that is fair, fit for purpose, transparent and which is not too bureaucratic. I hope all GPs will look out for and comment on the college’s proposals.

The eventual system should be what you decide will be best for GPs and patients.

Professor Pringle is a council member of the RCGP, a member of the RCGP stakeholder group on recertification and a GMC council member

No

Under the current proposals for revalidation, all GPs need to be recertified every five years by the RCGP, in addition to annual appraisals by their local colleagues.

In order to be acceptable to the GMC for purposes of relicensure and revalidation, appraisals are to be based on seven Good Medical Practice criteria – good clinical care, maintaining good medical knowledge, teaching and training, surveys from patient questionnaires, peer questionnaires, probity, and health.

Based on satisfactory outcomes, doctors can expect to be given relicensure.

But the RCGP’s proposals for recertification go further. They rely on feedback from not just one’s peers, but also from nurses, managers and presumably other members of the healthcare team such as medical secretaries, health visitors and social workers.

“The views of staff are subjective and carry the risk of personal bias”

These proposals are seriously flawed in many respects.

Recertification, to be fair and fit for purpose, should be based not on third-party opinions but on an assessment of a GP’s knowledge and skills.

Such assessment should be measured by evidence of their participation in educational activities, the lessons learned from such activities, and an audit of disease management in different clinical areas – such as diabetes, coronary artery disease and COPD (chronic obstructive pulmonary disease ).

The remit of the RCGP is to come up with the criteria, standards and evidence needed to make a good doctor, to guide the appraisers, but not to take over the functions of the GMC, which has the sole responsibility for relicensing and revalidating doctors.

Patient and peer questionnaires can be a valuable tool for revalidation, and should be administered every five years as part of the revalidation process, which is a function of the GMC, not of the Royal College.

Information gathered from surveys of patient questionnaires selected at random can give valuable insight into the listening and communication skills of the doctor and can inform the revalidation process.

Peer questionnaires could also be used for revalidation, specifically to gather a cross-section of opinion from medical colleagues on a doctor’s qualities as a team member, referral patterns and adverse incidents.

But such questionnaires are not appropriate for recertification, which is all about assessment of knowledge and skills, rather than an assessment of a doctor’s continuing fitness to practise.

Wary of bias

We should also be wary of the dangers of seeking feedback from nurses and other members of the primary healthcare team, who may find themselves in an invidious position of either saying all the right things about a doctor with whom they have to work, for fear of offending, or saying things which are not strictly true based on mutual dislike.

Either way these views are unreliable and should not be used even for appraisals. They are too subjective to be of any real value and carry the risk of personal bias.

Doctors have hitherto been led to believe that appraisals will be formative rather than summative, and supportive rather than punitive, so that an appraisee can confidently and confidentially cooperate with the appraiser, knowing that the whole exercise is meant to help the candidate to learn from identified gaps in knowledge.

To retain the confidence of all doctors, appraisals should remain formative and supportive, with the sole exception of cases where a doctor’s performance is found to be so deficient that their continued practice could be a danger to patients.

In such cases – but only in such cases – an appraiser should be bound to share their concerns with the employer. But any more onerous system of appraisal could become a threat to thousands of doctors.

Dr Korlipara is an elected member of the GMC and former chair of the GP consultative group on revalidation

Pulse, CMP Medica. All rights reserved
(http://www.pulsetoday.co.uk/story.asp?storycode=4118904)

FOR MORE HEALTH STORIES SEE http://jeannehambleton77.wordpress.com

Minister calls for pain indicators in QOF (Quality

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of PulseToday.com

By Nigel Praities -21 Apr 09

A Government minister has invited applications for new pain management indicators for the QOF in a parliamentary debate held yesterday.

Health minster Ann Keen said the inclusion of pain in the QOF was a ‘key issue’ and that she hoped organisations would submit proposed indicators for the next review.

The debate was proposed by Anne Begg MP, the chair of the recently formed All-Party Parliamentary Group on Chronic Pain, who said pain should be considered as a ‘vital sign’ for PCTs and incentivised through the QOF.

‘The inclusion of pain assessment in the QOF would strongly encourage health professionals to be proactive and to ask a patient about their pain, treat it promptly and reassess it to ensure that the treatment given is effective, rather than expecting the patient to raise it first,’ she said.

Ms Begg also criticised the complete withdrawal of co-proxamol by the MHRA, and quoted figures revealed in Pulse earlier this year that showed an increase in morphine and tramadol prescriptions as a result of the withdrawal.

In response, Ann Keen said Ms Begg had made a ‘persuasive and eloquent case’ for pain indicators in the QOF and she hoped pressure groups, such as the Chronic Pain Policy Coalition – would press for its inclusion.

‘I understand that the next opportunity to submit suggestions for new indicators to NICE will be this summer. I hope that the chronic pain policy coalition will take the opportunity to suggest specific indicators at that stage,’ she said.

A spokesperson from the Chronic Pain Policy Coalition confirmed it would submit a proposal for new QOF indicators for the routine management and assessment of pain to NICE later this year.

‘Given the important role GPs have to play in the early identification, diagnosis and management of patients with pain, we strongly believe that this is an area in which greater incentivisation through inclusion within the QOF indicators would have a considerable positive impact,’ he said.

(http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4122478&c=2&cid=pain042209#)

IN THE HOUSE OF COMMONS 20 April 09 (Hansard source/TheyWorkForYou.com)

In the House of Commons on April 20 MP Anne Begg spoke about the Pain Management Services (England) as reported by Hansard and TheyWorkForYou.com

She said, “In the United Kingdom, 7.8 million people live with pain, day in and day out; that is the equivalent of about one in seven people in every single parliamentary constituency. I have asked for this debate in order to draw attention both to their problems and, more importantly, to some solutions that would not only improve the quality of life of so many of our constituents, but also reduce public expenditure on health, social care and incapacity benefits.

“If anyone is wondering why I, as a Scottish MP, am raising the issue of pain management services in England when health is a devolved issue, it is because I am the chairman of the recently set up all-party group on chronic pain. I suppose I should also declare an interest: I am one of the 7.8 million people in the UK who live with chronic pain.

“There could not be a better opportunity to consider the problem and suggest solutions. People in pain and the health professionals helping them have been pushing at a closed door for many years now. They have argued for early recognition of the needs of people in pain, early access to expert advice and treatment, and referral to a specialist pain clinic when necessary. That door was closed until recently; suddenly, it looks as though it is opening, and I am grateful to the chief medical officer for beginning that process.

MAJOR INITIATIVE

“His latest annual report, only just published, includes a chapter called “Pain: breaking through the barrier”. Sir Liam Donaldson looks at the issue of people living with pain in a sensitive and comprehensive way, and concludes with this statement:’A major initiative to widen access to high-quality pain services would improve the lives of millions of people.’ “

Ms Begg also said, “The evidence suggests that although pain services do exist in most secondary care NHS trusts, they are patchy, and variable in their resources and in the services that they provide. Crucially, the CMO’s report makes this point: each year, more than 5 million people in the United Kingdom develop chronic pain, but only two thirds will recover. Clearly, much more needs to be done to improve outcomes for patients. He reminds us that pain affects 7.8 million people, and that more than a third of households have someone in pain at any given time. Those figures are rising. Indeed, recent surveys suggest that chronic pain is more common now than it was 40 years ago.
Pain is becoming more common, but the effect that it has on individual lives is immense.

“The CMO highlights the fact that pain has a major impact on people’s lives, causing sleeplessness and depression, and interfering with normal physical and social functioning. That often leads to unemployment. He points out how it affects all age groups. Perhaps most worryingly, he states that 8 per cent. of children experience severe pain, that back pain alone costs the economy £12.3 billion per year and that early intervention may prevent pain from becoming persistent. In fact, it has been shown that the cost of chronic pain is greater than that of heart disease or diabetes.

“Looking at the limited number of specialist pain clinics, the CMO points out that systems and infrastructure do not meet need or demand, and that better co-ordination of services, and services designed around patients’ needs, are essential. Pain needs to be considered in its own right, because it is often the pain that dominates the patient’s life, not the illness or condition that causes the pain.

As one patient has said: ‘At first I presumed the pain would eventually go away and I would get better. I didn’t expect to develop chronic pain, or that it would stop me working and lead me to consider suicide. I just want my life back.’

Another said: ‘I am in constant and debilitating pain, often unable to do even the most simple activity such as making myself a cup of tea. I have daily bad headaches, and have no quality of life. It is making me very depressed and life is hell.’

Clearly, we have a duty to ensure that the individual has access to the right treatment as early as possible. That treatment has to come from a properly trained professional, and a multidisciplinary team if needed.

“I was surprised by the amount of interest that this debate has generated. I have been contacted by a number of organisations wishing me to raise their concerns. Age Concern and Help the Aged have particular issues relating to the elderly.

AGEING PROCESS

“They say that pain is not a normal part of the ageing process, and we should not accept it as such. We should challenge discrimination and ageist attitudes with regard to pain in older people. They say that constant pain can lead to a loss of dignity. Some 90 per cent. of calls to Arthritis Care’s helpline concern pain, most of them from people in severe pain. In the UK, pain crises account for 60 to 80 per cent. of emergency presentations in hospital admissions for sickle cell disorder.

CO-PROXAMOL WITHDRAWAL AND NAMED PATIENTS

“This is not the first time I have had an Adjournment debate on the issue of pain. Ever since the Government first indicated that they intended to withdraw the analgesic co-proxamol, I have been trying to persuade Ministers that it should not be completely withdrawn as a small group of people still has not been able to find an alternative and certainly not anything so effective. These are all people who suffer chronic pain, who are saying that only co-proxamol works not because they want to be awkward but because it allows them to carry on with their life.

“One person in that position has said: ‘With co-proxamol I had pain but it was bearable, now I can walk only a few steps before being forced to rest; before I managed to tend my flower garden, now I can only sit and feel depressed with pain and frustration’.

“I have several constituents who depended on co-proxamol but cannot now get access to it. While the Government say that co-proxamol is available on a named patient basis, that is of cold comfort to those whose GPs are refusing to prescribe the drug at all. GPs are not comfortable prescribing off licence as they do not always feel that they have the specialist knowledge. But consultants at pain clinics do.

“The main reason the Government gave for withdrawing co-proxamol was the suicide statistics. As it is now extremely difficult for even those who need the drug to access it, the incidence of suicide attributed to co-proxamol is now tiny. However, the use of stronger pain relief and particularly opiates has grown. A recent Pulse article says that there has been a 44 per cent. rise in prescriptions for morphine and a 61 per cent. rise in tramadol prescriptions. That cannot be good pain management, so I ask the Minister to look at this issue again.

“I have not, however, sought this debate to lay blame at the Government’s door on this matter: rather, I hope to encourage the Minister to consider the recommendations laid out in the chief medical officer’s report and to give due regard to their feasibility. I do not have time to discuss them all, but I do want to take this opportunity to bring some to the Minister’s attention.

PAIN TRAINING SHOULD BE EXTENDED

“First, training on chronic pain should be included in the curriculum for all health professionals who deal with patients. However, it is vital that this core training is extended to all health professionals, and in particular to GPs who, at the very least, should have pain training as part of their standard undergraduate education.

“Secondly, consideration should be given to the inclusion of the assessment of pain and its associated disability in the quality and outcomes framework—QOF—in primary care. That is an extremely important point, because the inclusion of pain assessment in the QOF would strongly encourage health professionals to be proactive and to ask a patient about their pain, treat it promptly and reassess it to ensure that the treatment given is effective, rather than expecting the patient to raise it first.

“A recent report on osteoarthritis found that 50 per cent. of people said that they would need to be in frequently unbearable pain before considering seeing their GP—clearly this is a significant barrier.

FIFTH VITAL SIGN – PAIN SCORE

“Another recommendation was that a pain score should become part of the vital signs monitored routinely in hospital. Indeed, the Chronic Pain Policy Coalition has been campaigning for some time now for pain to be adopted as the fifth vital sign. If implemented, this recommendation would ensure that health professionals become proactive in asking their patients about pain. People would recover faster and reduce the burden of care on others.

MODEL PAIN SERVICE OF PATHWAYS OF CARE

“The final recommendation I want to highlight relates to the development by experts of a model pain service of pathways of care with clear standards. The work could build on the excellent 18-week cross specialty chronic pain pathway developed by patients and clinicians that has been supported by the Department of Health.

“It is an important step forward and should be extended to ensure that all patients are offered comprehensive treatment options. That would improve rapid access and reduce the current variability in treatment that patients receive. Patients need to be confident that they can be offered effective options wherever they live.

“Commitments have already been made both in Scotland with the ‘Getting to GRIPS with Chronic Pain’ report and in Wales under the ‘Designed for Life’ programme to assess and improve the services available for patients with chronic pain. I hope I have shown the Minister that there are patients, third sector organisations such as Arthritis Care and health professionals in England anxious to get hold of these recommendations and take them forward. They will need encouragement and flexibility in the way in which integrated services are funded and in how outcomes are measured.

PAIN CHAMPION DEMANDED

“Above all, people in pain need a champion. Tsars such as Mike Richards for cancer and Roger Boyle for cardiology have shown how such champions can make a difference. Pain affects cancer patients and heart patients as well as millions of others with back pain, arthritis, pelvic pain and a multiplicity of conditions. Surely the numbers involved and the importance of early intervention demand a pain champion.

“I know that the concerns I have raised in this debate are shared by a number of my hon. Friends and indeed by many of their constituents. I thank the Minister for hearing me out, and I hope that she can give consideration to the points I have raised.

REPLY

Replying Ann Keen (Parliamentary Under-Secretary (Health Services), Department of Health; (Hansard source) congratulated Miss Begg on securing this Adjournment debate on a “most important topic, which Professor Sir Liam Donaldson chose to highlight recently in the 150th report of the chief medical officer.”

She said, “The report of the chief medical officer is an independent report to Government on aspects of the nation’s health and, as such, draws attention to a number of different major health challenges. In his annual report for 2008, the chief medical officer called for a major initiative to widen access to high-quality pain services to improve the lives of millions.

NATIONAL PAIN DATABASE

“I am delighted to inform my hon. Friend and the House that I received a letter from Professor Black, the chair of the advisory group, just before the Easter recess, and it recommended that the national pain database, run jointly by the Royal College of Anaesthetists and the British Pain Society, should be funded as part of the national clinical audit programme.”

EDITOR’S NOTE: On behalf of the fibromyalgia community living with chronic pain, numbering around two million, mainly women, me included, and those of us who survived thanks to co-proxamol, I would like to thank Anne Begg MP publicly for speaking out on our behalf.

Had I known Miss Begg was to initiate this debate I would, of course, have asked her to include fibromyalgia in her chronic pain list. Hopefully she will read this somewhere, sometime, and might think kindly of us when next raising chronic pain and co-proxamol.

For many of us co-proxamol, when it was £2.79 for 100 tablets, was an inexpensive painkiller. Had we known this it would have been cheaper than the prescription charge if we had been able to buy it. This was before the Government got involved. It was a life saver for those with fibromyalgia, and many others. In those days we had some relief…now it is pain 24/7 thanks those who meddled against the wishes of many doctors, consultants, a number of MPs and the patients. They did not give a jot about us at the ‘coal face’ living with pain for the rest of the life. Yes I have tried the alternatives and they disagreed with me and my IBS and gastric problems. They should have tightened the rules allowing those who really need it to be able to get it, prescribed without litigation problems.

Today albeit your GP knows you are in pain and you should be a named patient, after years of safely taking co-proxamol without a hint of any problems, he will not prescribe it due to the risk of litigation involved with prescribing an unlicensed drug. Mr. B. sitting comfy in his armchair (free of pain) with all found, at No.10, your Government has a lot to answer for…….. the loss of co-proxamol is most certainly one of them.

Letters to Anne Begg at begga@parliament.uk would I am sure be much appreciated by her especially if you make reference to her debate in the House of Common on 20 April 200 and give her more ammunition about your problems with co-proxamol and fibromyalgia. Maybe you will send a copy to me please -fmsglobalnews@me.com. Thanks.

For the background to the Co-proxamol debate and MP Anne Begg.
SEE: http://fmsglobalnews.wordpress.com/2009/03/13/co-proxamol-a-controlled-drug/

http://fmsglobalnews.wordpress.com/2009/03/24/prescriptions-for-opioids-jump-following-co-proxamol-ban/

http://jeannehambleton77.wordpress.com/2008/01/03/no-u-turn-on-co-proxamol-withdrawal/

http://jeannehambleton77.wordpress.com/2007/12/05/co-proxamol-bungled-withdrawal-is-a-farce/

http://jeannehambleton77.wordpress.com/2007/11/26/co-proxamol-withdrawal-debate/

SEE: http://jeannehambleton77.wordpress.com for more health stories

Inexpensive drug appears to relieve fibromyalgia pain in Stanford pilot study

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy Stanford University Medical Center and Eurekalert.org

Margarita Gallardo -17-Apr-2009

STANFORD, Calif. — For Tara Campbell, the onset of her fibromyalgia began slowly with repeated sore throats, fevers and fatigue. By the time she was diagnosed, a year later, she had become so debilitated by flulike symptoms and exhaustion that she often could not get off the couch all day.

“Fall, a year ago, I hit my very, very worst,” said Campbell, 39, of Walnut Creek, Calif. “I felt overall pain to the point that even when my children or husband just touched me it hurt.”

Campbell’s symptoms still linger, but since taking part in a Stanford University School of Medicine clinical trial in the spring of 2008, she has improved enough that she has gone back to working again as an interior decorator and even headed up the fundraising auction at her daughters’ school.

“I am really, really good,” Campbell said. “Having said that, I am still not 100 percent. I am still not that person I was before.”

Campbell was one of 10 women with fibromyalgia to take part in a small pilot study at Stanford over a 14-week period to test the new use of a low dose of a drug called naltrexone for the treatment of chronic pain. The drug, which has been used clinically for more than 30 years to treat opioid addiction, was found to reduce symptoms of pain and fatigue an average of 30 percent over placebo, according to the results of the study to be published April 17 online in the journal Pain Medicine.

“Patients’ reactions were really quite profound,” said senior author Sean Mackey, MD, PhD, associate professor of anesthesia and chief of the pain management division at Stanford University Medical Center. “Some people decided to come off other medications. Some people went back to work really improving their quality of life.”

Still, Mackey and his colleagues remain cautious about recommending the drug this early on in the research process. “People need to understand that while we are excited about preliminary results, they are still preliminary, and we need to do longer studies with more patients. There is still a significant amount of work to be done.”

The researchers are moving ahead with a second, longer-term trial of 30 patients who will be tested during a 16-week period.

The drug is particularly promising, the study states, because of the few treatment options available for fibromyalgia patients, its low cost of about $40 a month and its limited side effects. Vivid dreams were reported by a few participants.

Still considered a controversial diagnosis, fibromyalgia is a disorder classified by chronic widespread pain, debilitating fatigue, sleep disturbance and joint disorder. Advocates and doctors who treat the disorder, estimate it affects as much as 4 percent of the population.

“The symptoms of fibromyalgia are commonly seen in a number of other diseases, and there is no well-established and objective blood test to confirm the diagnosis,” said Jarred Younger, PhD, the study’s lead author and an instructor in anesthesia and pain management at Stanford.

“In the meantime, new treatments that work particularly well for fibromyalgia go a long way toward validating the usefulness of the diagnosis.”

The idea to explore the use of a low-dose of naltrexone as a treatment for fibromyalgia began about two years ago when Younger began searching for relief for patients with the disorder. “I was asking patients, ‘Does anything work for you?’” he recalled. “A lot of people in support groups were saying, ‘Yeah, I tried naltrexone and it works for me.’ It just kept coming up.”

The use of naltrexone to treat pain at first seems counterintuitive, Younger said, because at normal doses the drug actually blocks the body’s pain relief systems. However, naltrexone appears to have the opposite effect when given at a lower dose. Naltrexone, at these lower doses, is thought to work by modulating glial cells in the nervous system, Mackey said. Glial cells provide support and protection for neurons and act as a link between the neuronal and inflammatory systems.

“We are learning more and more that maybe by modulating these glial cells we can impact the abnormal processing of pain in these patients,” Mackey said.

During the study, the women used a handheld electronic device to capture their symptoms on a daily basis. They took a placebo for two weeks and then the drug for eight weeks, but they were not told when they were taking the drug or the placebo.

Some of the women, including Campbell, have continued to take the drug after the end of the study because the results were so positive, Younger said.

“Even after the study, it just got better and better and better,” Campbell said. “I think my improvement was about 40 percent during the study. When you are not capable of doing much of anything, that is a lot. I still have localized pain, but I do not have the overall body pain. I can live with that if I do not have the fatigue and flulike symptoms. I am much more back to normal.”

(http://www.eurekalert.org/pub_releases/2009-04/sumc-ida041309.php)
(http://paincenter.stanford.edu/.)(mjgallardo@stanford.edu)

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