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

Economy Down, Vasectomy Up

From the FMS Global and UK News Desk of Jeanne Hambleton

More Men Choosing Permanent Sterilization in Trying Economic Times
Courtesy of WebMD.com
By Daniel J. DeNoon – Reviewed by Louise Chang, MD – WebMD Health News

March 26, 2009 — In these tough economic times, more men are making a tough decision: vasectomy.

Urologists across the country are reporting that nearly twice as many men have been seeking permanent sterilization via vasectomy since the economic crisis began.

There is no official count but it is clearly a trend, says Lawrence Ross, MD, professor of urology at the University of Illinois at Chicago and a past president of the American Urological Association.

“We are definitely, in our experience in Chicago, seeing increasing numbers of patients requesting vasectomy. A rough estimate is perhaps twice the number per week we saw a year ago,” Ross tells WebMD.

“Since mid-November we have gone from 40 or 45 to about 70 or 75 a month,” J. Stephen Jones, MD, chairman of the Cleveland Clinic’s department of regional urology, tells WebMD.

“I am seeing a lot more men coming in for vasectomy, and they are saying the reason they are doing it now is they are losing their insurance,” David Shin, MD, chief of the Center for Sexual Health and Fertility at Hackensack University Medical Center, N.J., tells WebMD.

One of those men is Peter Collum of Upper Saddle River, N.J. Three months ago, Collum was laid off from his job as an investment banker. His severance package runs out next month.

“It is not like being out of work was the only driver for getting a vasectomy,” Collum tells WebMD. “But it is a lot easier having this done while I am unemployed.”

Collum’s third child was born four months ago. He and his wife had planned on two to four kids; when the third was born they knew their family was big enough.

Like other urologists, Shin always counsels men before performing the sterilization procedure. In previous years, he says, men simply told him they did not want another child.

“But now economics plays a role,” Shin says. “We live in a time where people are saying, ‘Times are tough, and there is not going to be the disposable income to pay for food and diapers and to save up for college tuition.’”

One of Jones’ patients did not have far to travel after losing his job.

“One very demonstrative patient was a gentleman who had a great job for three or four years, working on a federally funded road project just out the door from our clinic,” Jones says. “When the job went away, he came into my office and said, ‘In this environment, I do not feel I could have any more children.’ And I think there are a thousand more stories like that.”

Many of the men now coming into urologists’ offices had already decided on vasectomy, but were motivated to act by fear of losing their health insurance. Others had even more pragmatic concerns.

“Couples are finding ways of trying to save money, so they do not go out to a fancy dinner or an extravagant show,” Shin says. “And if they are staying home, what is the most common free activity? And what does it lead to? If sexual activity is on the rise, vasectomy is a sure way of preventing a mistake.”

Ross warns that the decision to have a vasectomy should not be made lightly. While the procedure is safe, inexpensive, and relatively minor — recovery is rapid and takes only a day — it should be considered permanent.

“Doing a vasectomy is simple and relatively inexpensive. Undoing it is very expensive and is not covered by any insurance,” Ross says. “”We have to make sure every patient we talk to knows this is permanent, and they have to be absolutely certain they do not want to father any more children.”

©2005-2009 WebMD, LLC. All rights reserved.(http://www.webmd.com/sex/news/20090326/economy_down_vasectomy_up?ecd=wnl_men_040709)

Vasectomy
A vasectomy is considered a permanent method of birth control. A vasectomy prevents the release of sperm when a man ejaculates.

During a vasectomy, the vas deferens from each testicle is clamped, cut, or otherwise sealed. This prevents sperm from mixing with the semen that is ejaculated from the penis. An egg cannot be fertilized when there are no sperm in the semen. The testicles continue to produce sperm, but the sperm are reabsorbed by the body. (This also happens to sperm that are not ejaculated after a while, regardless of whether you have had a vasectomy.) Because the tubes are blocked before the seminal vesicles and prostate, you still ejaculate about the same amount of fluid.

It usually takes several months after a vasectomy for all remaining sperm to be ejaculated or reabsorbed. You must use another method of birth control until you have a semen sample tested and it shows a zero sperm count. Otherwise, you can still get your partner pregnant.

During a vasectomy:

Your testicles and scrotum are cleaned with an antiseptic and possibly shaved.
You may be given an oral or intravenous (IV) medicine to reduce anxiety and make you sleepy. If you do take this medicine, you may not remember much about the procedure.

Each vas deferens is located by touch.

A local anesthetic is injected into the area.

Your doctor makes one or two small openings in your scrotum. Through an opening, the two vas deferens tubes are cut. The two ends of the vas deferens are tied, stitched, or sealed. Electrocautery may be used to seal the ends with heat. Scar tissue from the surgery helps block the tubes.

The vas deferens is then replaced inside the scrotum and the skin is closed with stitches that dissolve and do not have to be removed.

The procedure takes about 20 to 30 minutes and can be done in an office or clinic. It may be done by a family medicine doctor, a urologist, or a general surgeon.

No-scalpel vasectomy is a technique that uses a small clamp with pointed ends. Instead of using a scalpel to cut the skin, the clamp is poked through the skin of the scrotum and then opened. The benefits of this procedure include less bleeding, a smaller hole in the skin, and fewer complications. No-scalpel vasectomy is as effective as traditional vasectomy. 1

In the Vasclip implant procedure, the vas deferens is locked closed with a device called a Vasclip. The vas deferens is not cut, sutured, or cauterized (sealed by burning), which possibly reduces the potential for pain and complications. Some studies show that clipping is not as effective as other methods of sealing off the vas deferens. 2

What To Expect After Surgery

Your scrotum will be numb for 1 to 2 hours after a vasectomy. Apply cold packs to the area and lie on your back as much as possible for the rest of the day. Wearing snug underwear or a jockstrap will help ease discomfort and protect the area.

You may have some swelling and minor pain in your scrotum for several days after the surgery. Unless your work is strenuous, you will be able to return to work in 1 or 2 days. Avoid heavy lifting for a week.

You can resume sexual intercourse as soon as you are comfortable, usually in about a week. However, you can still get your partner pregnant until your sperm count is zero. You must use another method of birth control until you have a follow-up sperm count test 2 months after the vasectomy (or after 10 to 20 ejaculations over a shorter period of time). Once your sperm count is zero, no other birth control method is necessary.

A vasectomy will not interfere with your sex drive, ability to have erections, sensation of orgasm, or ability to ejaculate. You may have occasional mild aching in your testicles during sexual arousal for a few months after the surgery.

Why It Is Done

A vasectomy is a permanent method of birth control. Only consider this method when you are sure that you do not want to have a child in the future.

How Well It Works

Vasectomy is a very effective (99.85%) birth control method. Only 1 to 2 women out of 1,000 will have an unplanned pregnancy in the first year after their partners have had a vasectomy. 3

Risk of failure

Pregnancy may occur after vasectomy because of:

Failure to use another birth control method until the sperm count is confirmed to be zero. It usually takes 10 to 20 ejaculations to completely clear sperm from the semen.

Spontaneous reconnection of a vas deferens or an opening in one end that allows sperm to mix with the semen again. This is very rare.

Risks

The risk of complications after a vasectomy is very low. Complications may include:

Bleeding under the skin, which may cause swelling or bruising.

Infection at the site of the incision. In rare instances, an infection develops inside the scrotum.

Sperm leaking from a vas deferens into the tissue around it and forming a small lump (sperm granuloma). This condition is usually not painful, and it can be treated with rest and pain medication. Occasionally, surgery may be needed to remove the granuloma.

Inflammation of the tubes that move sperm from the testicles (congestive epididymitis).
In rare cases, the vas deferens grows back together (recanalization), and the man becomes fertile again.

What To Think About

Advantages

Vasectomy is a permanent method of birth control. Once your semen does not contain sperm, you do not need to worry about using other birth control methods.

Vasectomy is a safer, cheaper procedure that causes fewer complications than tubal ligation in women. 1

Although vasectomy can be expensive, it is a one-time cost and is often covered by medical insurance. The cost of other methods, such as birth control pills or condoms and spermicide, is likely to be greater over time.

Disadvantages

A vasectomy does not protect against sexually transmitted diseases (STDs), including infection with the human immunodeficiency virus (HIV). Condoms are the most effective method for preventing STDs. To protect yourself and your partner from STDs, use a condom every time you have sex.

Other considerations

If you are considering a vasectomy, be absolutely certain that you will never want to father a child. Think through whether this might change after any of the following life events:

One of your living children dies (if you are a father).

You divorce and lose custody of your children.

You have a new partner who wants children.

Your financial situation improves and you can afford another child.

Your children grow up and leave home.

A vasectomy is not usually recommended for men who are considering banking sperm in case they decide later to have children. Discuss other options with your partner and your health professional.

Surgery to reconnect the vas deferens (vasectomy reversal) is available. However, the reversal procedure is difficult. Sometimes a doctor can remove sperm from the testicle in men who have had a vasectomy or a reversal that did not work. The sperm can then be used for in vitro fertilization. Both vasectomy reversal and sperm retrieval can be expensive, may not be covered by insurance, and may not always work.

Some older studies showed a risk of prostate cancer in men who have had vasectomies. However, many years of research have found no clear evidence that vasectomy is linked to prostate cancer. 1

Some doctors or health insurance plans may require a waiting period from the time you request a vasectomy and the time the procedure is done. This time allows you to be certain about your decision.

Researchers are studying other male birth control methods, such as reversible vasectomy or hormonal methods. Reversible vasectomy involves plugging the vas deferens and then removing the plug when birth control is no longer wanted. Hormonal methods include pills or injections that the man would use to prevent sperm production. So far, no new method has been shown to be effective enough, with low side effects, to be marketed for men.

Citations
Pollack AE, et al. (2004). Female and male sterilization. In RA Hatcher et al., eds., Contraceptive Technology, 18th ed., pp. 531–573. New York: Ardent Media.
Labrecque M, et al. (2002). Effectiveness and complications associated with 2 vasectomy occlusion techniques. Journal of Urology, 168(6): 2495–2498.
Trussell J (2004). The essentials of contraception: Efficacy, safety, and personal considerations. In RA Hatcher et al., eds., Contraceptive Technology, 18th ed., pp. 221–252. New York: Ardent Media.

Author Bets Davis, MFA; Editor Maria G. Essig, MS, ELS; Associate Editor Michele Cronen;
Associate Editor Denele Ivins; Associate Editor Pat Truman, MATC; Primary Medical Reviewer Joy Melnikow, MD, MPH – Family Medicine; Specialist Medical Reviewer Kirtly Jones, MD – Obstetrics and Gynecology. Last Updated May 22, 2008.

©2005-2009 WebMD, LLC. All rights reserved.(http://www.webmd.com/sex/birth-control/vasectomy-14387)

FIBROMYALGIA AND PFIZER

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

Pfizer, the manufacturers of Lyrica, the first fibromyalgia drug to be approved by the American Food & Drugs Associations (FDA), have decided to end human testing on a late-stage experimental drug, esreboxetine, which may have improved the cognitive function of patients with fibromyalgia. A second drug also to be withdrawn from the testing programme is associated with general anxiety problems. Both of these conditions are among the many symptoms of fibromyalgia.

The company announced it would stop further testing on these experimental primary care medications, now in the late stages of development, as they were other drugs available to treat these conditions.

The decision follows a move to ‘shift funding’ to alternative experimental drugs that have a greater profile.

The Wall Street Journal website, (http://blogs.wsj.com/health/2009/02/24/pfizer-drops-two-drugs-from-late-stage-pipeline/trackback/) overnight, on February 24, 2009, announced Pfizer Drops Two Drugs from Late-Stage Pipeline.

Sarah Rubenstein wrote two drugs in Pfizer’s late-stage pipeline are biting the dust.

The company said today it is ending development of esreboxetine, for fibromyalgia, and a drug known as PD 332,334, for generalized anxiety disorder.

In announcing the decision, Pfizer made a between-the-lines reference to the increasing pressure from insurers and regulators on the drug industry to pour research resources into products that make a real difference for people’s health rather than just add on to crowded categories. The economic-stimulus bill, for instance, offers up $1.1 billion for research comparing drugs and other treatments to each other.

Based on the data on the two drugs, “along with current market dynamics,” Pfizer said, “it was considered unlikely that either compound would provide meaningful benefit to patients beyond the current standard of care.” It added that safety was not the issue.

That said, there are not a lot of drugs on the market for fibromyalgia: Pfizer’s Lyrica was the first to win approval for fibromyalgia, and Lilly’s Cymbalta got the nod too. But fibromyalgia, a condition characterized by long-standing pain, has been the subject of controversy over its legitimacy, despite being recognized as a disease by the FDA and insurers.

Pfizer said today it is still seeking approval for Lyrica for generalized anxiety disorder, despite the demise of PD 332,334. In this case, though, there is a lot out there. The Mayo Clinic lists a bunch of drugs used for the disorder, including Cymbalta and Forest Labs’ Lexapro and generic versions of Lilly’s Prozac and GlaxoSmithKline’s Paxil.

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FIBROMYALGIA: FIRST STEP FORWARD IS EU RECOGNITION SAY MEPS

FROM THE DESK of Jeanne Hambleton – October 27 2008

Just imagine what would happen if the word ‘fibromyalgia’ was casually dropped into conversation. Chances are there would be a lot of blank faces staring back. So just think what its like for the 14 million people in the EU, whose condition, fibromyalgia, is at the moment not even recognised as a disease.

It is hoped by sufferers that this is all set to change, as Members of the European Parliament sign up to a petition for recognition of fibromyalgia across the European Union. Even though the World Health Organisation has formally recognised the condition – whose symptoms includes chronic musculoskeletal aches, pain and stiffness in addition to soft tissue tenderness, general fatigue and sleep disturbances – since 1992, fibromyalgia is not yet recognised at an EU level.

Euro-MP for the North East Fiona Hall warns that this lack of recognition not only hinders a formal diagnosis and treatment of the condition, but also limits research into the causes of the disease and new treatment methods.

Says Fiona,

“Recognising fibromyalgia as a disease is the first step towards making life that little bit easier for those suffering from the condition. A formal recognition would also provide comfort to those sufferers, who have for many years, been met with blank stares when trying to discuss the condition.

“Hand in hand with this, there is still little understanding of the disease in terms of both cure and effective treatment available at the moment. More research facilities are needed to try to determine the cause and effect of fibromyalgia and I am confident that putting a name to the disease would allow this to happen.

“A formal recognition of fibromyalgia could also make it easier for patients to apply for Disability Living Allowance. Holding a regular job is hard for people suffering from the condition. Fibromyalgia is a real disease and should be treated as such.”

UK sufferers such as Gemma Rouston, who was diagnosed in 2007, support the MEP’s actions and calls for more widespread understanding of the disease.

Gemma, who is membership secretary of the Liberal Democrat Disability Association (LDDA) said,

“It was such a relief to be told that I was not imagining things. However, I was not given any real idea of how to cope with the condition apart from taking painkillers and exercise.

“It is very difficult to cope with fibromyalgia; it varies everyday and every hour. I am in my early forties, and have to use a walking stick. I have two disabled children, who I am supposed to care for, but they look after me.

“Even if you get a formal diagnosis, the Department of Work and Pensions are reluctant to help out financially. Fibromyalgia makes it difficult to do any work on a regular basis. No employer will be willing to be as flexible as I need them to be, especially the way that things are at the moment.”

“Having fibromyalgia means that my family are restricted in what we do and where we go. I cannot really plan what I will do each day, even if it is just myself.”

Ends

Lucy Towers

Press Officer to Fiona Hall MEP
Regional Media Co-ordinator for the Liberal Democrats in the North East

55a Old Elvet
Durham
DH1 3HN
0191 383 2269 / 07776 256333
lucy@fionahallmep.co.uk

http://www.fionahall.org.uk

States taking action to insure nation’s 13.3M uninsured young adults

New report finds young adults in low-income families most likely to lack coverage; raising SCHIP/Medicaid eligibility age an important solution

August 8, 2007, New York, NY—Since 2003, 16 states have enacted legislation requiring insurance companies to provide health insurance coverage to dependent young adults on their parents’ health plans beyond age 18 or 19, according to a new report from The Commonwealth Fund. While Utah has had such a law since 1994, recent legislative activity reflects states’ rising concern about the steady loss of coverage among young adults under the age of 30.

Because a majority of uninsured young adults have low incomes, extending eligibility for Medicaid and the State Children’s Health Insurance Program (SCHIP) beyond age 18 would be an important policy solution to cover this group, the authors say. The SCHIP reauthorization bill recently passed in the House of Representatives would allow states to extend coverage up to age 25. Currently, Medicaid and SCHIP coverage for children typically ends at age 19.

The report, Rite of Passage” Why Young Adults Become Uninsured and How New Policies Can Help, finds that 13.3 million young adults ages 19 to 29 were uninsured in 2005, up from 12.9 million in 2004. Young adults also continue to represent the largest age group without health insurance. Despite comprising only 17 percent of the under-65 population they account for 30 percent of the uninsured in that group. Two-fifths (41%) of uninsured young adults ages 19-29 are in families below the poverty level, and 72 percent have incomes below twice the poverty level). The analysis is based on the latest updated Census Bureau data, and is an update of a May 2006 Commonwealth Fund report.

“There are misconceptions that young adults don’t have health insurance by choice,” said Sara Collins, lead author and Assistant Vice President for the Future of Health Insurance at The Commonwealth Fund. “However, affordability and access to coverage are real barriers for many young people who lack access to employer coverage. Even the cost of basic coverage on the individual insurance market can amount to a large share of a low or moderate income. ”

States with laws requiring health plans to cover young adults on their parents’ insurance until age 25 include Colorado, Idaho, Maine, Maryland, Massachusetts, Minnesota, New Mexico, Rhode Island, Texas, Washington, and West Virginia. Delaware, Indiana, and South Dakota require coverage until age 24, New Hampshire and Utah until age 26; and New Jersey until age 30. Most of the state laws apply to all young adults but laws in Idaho, Rhode Island, and South Dakota only apply to students. Most of the laws were passed between 2005 and 2007; the Utah legislation was passed in 1994, and the Texas law in 2003.

States aren’t alone in seeking to expand coverage to young adults. Several federal level proposals, including the SCHIP reauthorization bill that recently passed in the House include provisions that would allow states to increase access to Medicaid and SCHIP up to age 25.

“State-level efforts to cover young adults—one of the largest and fastest-growing segments of the uninsured population—are very important, and it is exciting to see the momentum in this area,” said Commonwealth Fund President Karen Davis. “However, most uninsured young adults do not have access to private coverage through their parents’ plans. For these young adults, extending Medicaid and SCHIP coverage beyond age 18 can make a real difference.”

In addition to increasing Medicaid and SCHIP eligibility, the authors recommend continued efforts to expand eligibility for dependents under private coverage beyond age 18 or 19 and that states take steps to ensure that colleges and universities require and offer health insurance coverage to students.

###
The Commonwealth Fund is a private foundation working toward a high performance health system.

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FMS Global News

Fibromyalgia Support

Source

Characteristics and healthcare costs of patients with fibromyalgia syndrome.

Berger A, Dukes E, Martin S, Edelsberg J, Oster G.
Policy Analysis, Inc. (PAI), Brookline, MA, USA.

Purpose: To examine the characteristics and healthcare costs of fibromyalgia syndrome (FMS) patients in clinical practice. Materials and methods: Using a US health-insurance database, we identified all patients, aged >/= 18 years, with any healthcare encounters for FMS (ICD-9-CM diagnosis code 729.1) in each year of the 3-year period, 1 July 2002 to 30 June 2005. A comparison group was then constituted, consisting of randomly selected patients without any healthcare encounters for FMS during this 3-year period. Comparison group patients were matched to FMS patients based on age and sex. Characteristics and healthcare costs of FMS patients and comparison group patients were then examined over the 1-year period, 1 July 2004 to 30 June 2005 (the most recent year for which data were available at the time of the study). Results: The study sample consisted of 33,176 FMS patients and an identical number in the comparison group. Mean age was 46 years, and 75% were women. FMS patients were more likely to have various comorbidities, including painful neuropathies (23% vs. 3% for comparison group), anxiety (5% vs. 1%), and depression (12% vs. 3%) (all p < 0.001); they also were more likely to have used pain-related pharmacotherapy (65% vs. 34% for comparison group; p < 0.001). Mean (SD) total healthcare costs over 12 months were about three times higher among FMS patients [$9573 ($20,135) vs. $3291 ($13,643); p < 0.001]; median costs were fivefold higher ($4247 vs. $822; p < 0.001). Conclusions: Patients with FMS have comparatively high levels of comorbidities and high levels of healthcare utilization and cost.

PMID: 17655684 [PubMed - as supplied by publisher]

FMS Global News

Source

Feeling bad in more ways than one: comorbidity patterns of medically unexplained and psychiatric conditions.

1: J Gen Intern Med. 2007 Jun;22(6):818-21

Schur EA, Afari N, Furberg H, Olarte M, Goldberg J, Sullivan PF, Buchwald D.
Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA. ellschur@u.washington.edu

BACKGROUND: Considerable overlap in symptoms and disease comorbidity has been noted among medically unexplained and psychiatric conditions seen in the primary care setting, such as chronic fatigue syndrome, low back pain, irritable bowel syndrome, chronic tension headache, fibromyalgia, temporomandibular joint disorder, major depression, panic attacks, and posttraumatic stress disorder.

OBJECTIVE: To examine interrelationships among these 9 conditions.

DESIGN: Using data from a cross-sectional survey, we described associations and used latent class analysis to investigate complex interrelationships.

PARTICIPANTS: 3,982 twins from the University of Washington Twin Registry.

MEASUREMENTS: Twins self-reported a doctor’s diagnosis of the conditions.

RESULTS: Comorbidity among these 9 conditions far exceeded chance expectations; 31 of 36 associations were significant. Latent class analysis yielded a 4-class solution. Class I (2% prevalence) had high frequencies of each of the 9 conditions. Class II (8% prevalence) had high proportions of multiple psychiatric diagnoses. Class III (17% prevalence) participants reported high proportions of depression, low back pain, and headache. Participants in class IV (73% prevalence) were generally healthy. Class I participants had the poorest markers of health status.

CONCLUSIONS: These results support theories suggesting that medically unexplained conditions share a common etiology. Understanding patterns of comorbidity can help clinicians care for challenging patients.

PMID: 17503107 [PubMed - indexed for MEDLINE]

FMS Global News

Tenderpoints

The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial.

1: PLoS Clin Trials. 2007 May 18;2(5):e19.

The GK, Bleijenberg G, van der Meer JW.

Department of General Internal Medicine, Nijmegen Expert Centre Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.

OBJECTIVES: It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio).

DESIGN: A randomized, placebo-controlled, double-blind clinical trial. SETTING: Radboud University Nijmegen Medical Centre, The Netherlands. PARTICIPANTS: Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals.

INTERVENTION: Acclydine or placebo for 14 wk.

OUTCOME MEASURES: Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis.

RESULTS: There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI -4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI -201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio -0.5 (95% CI -2.8 to +1.7, p = 0.63).

CONCLUSION: We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS.

PMID: 17525791 [PubMed - in process]

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JRRD releases single-topic issue on pain and pain management

Effects of depression and pain severity on satisfaction in medical outpatients: Analysis of the Medical Outcomes Study, pg. 143

Patient satisfaction is a critical measure of healthcare quality. We performed this study to see how depression and pain severity affected patient satisfaction in medical outpatients. We analyzed data from the Medical Outcomes Study and found that pain was very common and patients with depression and pain were much more likely to be dissatisfied with their healthcare. These findings may also have care-delivery implications, should dissatisfaction indicate poorer quality of care. Further study is needed to determine the reasons for dissatisfaction with care in patients with depression and pain.

Veterans seeking treatment for posttraumatic stress disorder: “What about comorbid chronic pain” pg. 153

In veterans who were being treated for posttraumatic stress disorder (PTSD), many (66%) were also diagnosed with chronic pain problems by their doctors. This is the first study to show that people with PTSD have pain-related conditions according to their doctors. The veterans who told their primary care doctor that they had pain before PTSD treatment said that their pain was less during and after the PTSD treatment. However, this finding was based on a review of charts, so other reasons could also explain the improvement in pain symptoms. More research about treatment for veterans with pain and PTSD is needed.

Prevalence and correlates of posttraumatic stress disorder and chronic severe pain in psychiatric outpatients, pg. 167

This study contributes to the growing literature on the co-occurrence of posttraumatic stress disorder (PTSD) and chronic severe pain. We found moderate rates of PTSD (46%) and chronic severe pain (40%) in a sample of psychiatric outpatients. In addition, 24% of the sample had both disorders. We found that persons with both disorders were significantly different from those with neither disorder on all variables and that they had greater physical and psychosocial stressors. In addition, persons with either PTSD or chronic severe pain alone were more likely to have a chronic medical condition, higher ratings of psychiatric distress, and more stressful life events than those with neither disorder. Mental health treatment providers should routinely assess and develop management strategies for these two disorders in psychiatric outpatients.

Pain and combat injuries in soldiers returning from Operations Enduring Freedom and Iraqi Freedom: Implications for research and practice, pg. 179

Operations Enduring Freedom and Iraqi Freedom have resulted in a growing number of seriously injured soldiers evacuated to the United States for medical care. Trauma-related pain is almost always present among these war-injured soldiers. Several military and Department of Veterans Affairs programs have been implemented to improve pain care. We describe several of these new approaches. We also present data on the soldiers treated, the services provided, and the effects of treatment. Finally, we identify some of the challenges emerging from work with this population and recommend future research and practice priorities.

Efficacy of selected complementary and alternative medicine interventions for chronic pain, pg. 195

We review published research on commonly used complementary and alternative medicine (CAM) approaches to treating chronic pain. Our findings show that CAM therapies, as a group, have a mixed track record of efficacy. The modalities that have the best track records for pain management include biofeedback, hypnosis, and massage (mostly for low back pain and shoulder pain). In selecting a CAM modality, practitioners must weigh the pros and cons and tailor the interventions to the needs of patients with chronic pain. Other issues relevant to practitioners include additional time and energy investments, need for specialized training to administer the modality, side effects or potential toxic effects, safety in combining CAM and other modalities, likely acceptance by clients and the public, and ease of incorporation into traditional pain management practices.

Preliminary evaluation of reliability and criterion validity of Actiwatch-Score, pg. 223

Restoration of normal physical activity is a primary objective of most chronic pain rehabilitative interventions, yet few clinically practical objective measures of activation exist. We evaluated the measurement properties of the Actiwatch-Score (AW-S). We conducted separate trials to examine concordance between units when worn concurrently at the same and different body sites and to compare the AW-S with a validated optical three-dimensional motion-tracking system. The data indicate that the AW-S has excellent interunit reliability and good criterion validity, but its intersite reliability varies with activity type. These results suggest that this device, and those like it, warrants further investigation and is likely to yield valuable data regarding the optimal application of this technology.

A closer look at pain and hepatitis C: Preliminary data from a veteran population, pg. 231

Many veterans who have hepatitis C also experience pain. Researchers are learning how to care for patients who experience hepatitis C and pain. They are also learning how hepatitis C and pain can affect patients’ lives. We review research on the relationship between hepatitis C and pain. We also present findings from a survey given to patients at two Department of Veterans Affairs hospitals. Finally, we suggest how physicians and mental health providers can best care for patients with hepatitis C and pain.

Overview of the relationship between pain and obesity: “What do we know. Where do we go next” pg. 245

Many veterans who struggle with being overweight also experience pain. Researchers are beginning to learn more about how being overweight or obese can affect several health conditions, including pain. We reviewed recent research examining the relationship between pain and overweight/obesity to promote understanding of when, why, and how these conditions occur together. Additionally, we suggest ways researchers can better study the problem of weight and pain to help veterans who experience both.

Medical residents’ beliefs and concerns about using opioids to treat chronic cancer and noncancer pain: A pilot study, pg. 263

Chronic pain from conditions such as arthritis or nerve injuries may be disabling and poorly controlled with aspirin, acetaminophen (Tylenol), or ibuprofen (Advil). In selected cases, opioid analgesics (e.g., morphine), combined with other treatments, can safely and more effectively relieve pain and improve function. We surveyed less experienced doctors and found that they had many fears, concerns, and negative beliefs toward using opioids to treat noncancer pain such as low back pain. If other doctors share these feelings, finding ways to increase their comfort by identifying and treating patients who might safely benefit from opioids to reduce their suffering and disability is important.

Persistent benefits of rehabilitation on pain and life quality for nonambulatory patients with spinal epidural metastasis, pg. 271

We evaluated the long-term effects of a 2-week course of rehabilitation on people with paraplegia caused by cancer compressing the spinal cord. Twelve patients received rehabilitation that focused on transfers, skin care, bladder and bowel management, nutrition, and incentive spirometry. We compared these study patients with a historical control group of 30 patients who had paraplegia from cancer but did not receive rehabilitation. Subjects were followed until death. The study patients had less pain and depression and more satisfaction with life; these benefits persisted for the remainder of their lives. In contrast, the control patients had worsening pain levels, declining satisfaction with life, and higher pain medication use for the remainder of their lives. While our study suggests that rehabilitation benefits people with cancer-related spinal cord injury, it needs to be supported by a randomized study.

Pain and palliative medicine, pg. 279

Pain control is an important part of medical care for patients with advanced illnesses. We summarize available information on pain in different patient groups near the end of life and on developments using behavioral and physical therapy methods to treat pain. Clinical trials to treat pain in patients within healthcare systems are the next topic, followed by ideas on how information technology and clinical databases can be used to guide future patient care. Finally, we present perspectives on how pain control can be studied and further improved within healthcare systems.

Moving to new settings: Pilot study of families’ perceptions of professional caregivers’ pain management in persons with dementia, pg. 295

Pain in persons with severe dementia is often not recognized or treated because these persons cannot communicate their needs. Family caregivers are in the best position to provide information to hospital care personnel about the patients’ needs, including pain. Little research has evaluated the role of the family caregiver when patients move between care facilities. This study describes family caregivers’ experiences when their family members with dementia were admitted to unfamiliar care sites and provides the caregivers’ recommended changes to healthcare settings. This article is relevant to family members and healthcare professionals who care for persons with severe dementia.

Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents, pg. 305

More than 80% of nursing home residents have chronic pain, and of these, many are not getting adequate treatment. Good pain treatment begins with knowing how severe the pain is. Several different pain-intensity tools are available: one uses a number (0–10) scale, another uses words, and a third shows pictures of people in pain. We asked nursing home residents to rate their pain using all three scales. We wanted to know how the pain reported on one scale translated onto another scale. The 42,000 veterans who live in nursing homes and their families will benefit from this study.

Cognitive impairment and pain management: Review of issues and challenges, pg. 315

Research shows that pain is often not recognized in persons with communication problems related to brain disease. Older persons with dementia experience memory loss, and seriously ill and dying patients experience confusion. Treating pain will increase the comfort of all these persons. In this article, we review the types of problems that affect the brain and interfere with pain management, how pain is measured, what pain management approaches help, and future research needs. Those who care for adults with brain-related disease will find this article relevant.

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Now Available Online and in Print–http://www.rehab.research.va.gov

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University of Leicester academics publish results of one of the largest studies of physical activity among inner city school children

Contact: Kamlesh Khunti
kk22@le.ac.uk
University of Leicester

Inactive kids storing up illness for the future

A new University of Leicester study funded by the British Heart Foundation reveals that the level of physical inactivity among children today has reached epidemic levels. Researchers from Leicester -Professor Kamlesh Khunti, Professor Melanie Davies and Dr Margaret Stone- have just published one of the largest studies of physical activity levels of inner city school children.

They surveyed over 3500 pupils from five inner city secondary schools in Leicester. They identified low levels of physical activity in both South Asian and white children. For example only half the children walked to school although south Asian children were less likely to walk to school compared to white children. Furthermore, half the pupils spent 4 hours or more a day watching television or videos or playing computer games. Family history of diabetes or heart disease in parents is a risk factor for development of diabetes or heart disease in their children. However, the researchers found that children of parents with a family history of diabetes or heart disease were just as likely to have sedentary behaviours as those without a family history.

Professor Khunti said: “People of South Asian origin comprise significant-sized minority ethnic populations in many countries worldwide. A consistent finding in South Asian migrant populations, wherever they are located, is a higher incidence and prevalence of premature coronary heart disease compared with the local population.

“Metabolic abnormalities precede the development of diabetes by some years and risk factors for cardiovascular in children often persist into adulthood. There is also evidence of increased risk of cardiovascular disease risk factors in children of South Asian origin compared to white children. The need to implement prevention strategies for childhood obesity is therefore a major target for the government and health care professionals.

“Inactive behaviour, such as watching television, may predict subsequent adult overweight and obesity in children and adolescent. However, there is a lack of data on physical activity levels of South Asian children despite them having a higher cardiovascular risk profile.

‘This study shows that overall the physical activity levels in inner city school children are very low and parents, schools and community health providers need to address the results of these findings to reduce their future risks of developing diabetes and heart disease in children ”.

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NOTE TO NEWSDESK

For more information, please contact:

Professor Kamlesh Khunti, Division of General Practice and Primary Health Care, Department of Health Sciences, University of Leicester. kk22@le.ac.uk

Or contact Ather Mirza, University of Leicester press office, 0116 252 3335; mobile 07711 927821

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