Category Archives: Medical

UK Fibromyalgia Conference & Unique Pamper Weekend

From the FMS Global News Desk of Jeanne Hambleton

With just weeks to go to the final booking date, fibromites from all around the UK are rushing for places at a weekend filled with laughter, fun, relaxation and learning.

Believed to be the first Fibromyalgia Conference in the south east of England working under the FMA UK umbrella, influenced by a yoga teacher working with fibromites, Sarah Owen, the event is offering pampering as a unique part of the programme along with leading speakers in the field of fibromyalgia.

Between 20 and 30 pamper therapists are expected to give free tasters allowing fibromites to try complementary therapies they have not previously experienced prior to booking one to one therapies at reduced cost at conference.

While many visitors are coming for the pamper experience, lots of fibromites have admitted they want to meet like-minded people from other groups with the view to twinning with other UK groups. Living in a world that does not understand fibromyalgia, those suffering with FMS enjoy the company of others suffering with the same condition. The idea of twinning has prompted one small Tee group with just 12 members to be the first group to enlist in a twinning programme with a partner group.

Others are anxious to listen to the speakers, attend workshops and try new treatments in the exhibition for those with disability and needing pain relief. The event will include scooters, adjustable beds, tilt and rise chairs, walk in baths, walkers, wheelchairs, fancy walking sticks and much more.

Dr. Ernest Choy, a consultant rheumatologist from Kings College Hospital, London, who specialises in fibromyalgia, who will travel from the annual meeting of the British Society of Rheumatology to join the conference. The Doctor will talk about new advances in the understanding of fibromyalgia. Other speakers will discuss sleep, pain management, digestive problems, chronic fatigue syndrome, food and mood, nutrition, benefits, and the controversial lightning process used by Esther Rantzen’s daughter for her ME/CFS.

Social highlights of the weekend will be the Fibro Factor, a chance for fibromites to have their moment in the spotlight. Following a gala dinner there will be the Folly Pogs Ball with posh frocks and dickie bow ties or fancy dress options. On Sunday the audience will join a charity auction of donated gifts to raise funds for fibromyalgia research.

Among the visitors will be Pam Stewart, chairman of the board of trustees for FMA UK, who is also the Vice President of the European Network of Fibromyalgia Association. Pam is looking forward to meeting newly diagnosed fibromites, members and group leaders.

“We have every intention on over dosing on laughter, which is the best medicine and has no side effects,” said who is one of the main organisers.

For more information email jeannehambleton@mac.com.

Fibromyalgia, Diet, and Nutrition – Breaking the Relationship between Them

From the FMS Global News Desk of Jeanne Hambleton

Courtesy of Fibromyalgia Consultant

By Matt Dew

The currant debated issue has been the relation between fibromyalgia, diet, and nutrition. There is no study could exactly explain whether or not fibromyalgia is influenced by diet and nutrition. Hence, this article may give you a bit of enlightenment of the uncertainty of the link between fibromyalgia, diet, and nutrition.

Even though the sufferers of fibromyalgia seem to be growing all over, actually this is not a new condition. There is no way to know just how long people have affected by fibromyalgia, but until lately there was no term to add to the condition.

Nowadays, we recognize that it is a valid concern and that the effects of fibromyalgia are, in fact, very severe for some people. Fibromyalgia can often engage nearly constant pain and fatigue. Some sufferers are unable to involve in their normal activities due to these and other symptoms as well. Some often builds up a deep depression because they are unable to take part in life like they used to.

So far, there have not been many studies into the link between fibromyalgia, diet, and nutrition. It has long been known that diet and nutrition are factors in nearly every kind of condition, but since fibromyalgia research is still in the early stages, the study of fibromyalgia, diet, and nutrition has yet to be conducted in a thorough manner by formal researchers.

Amateur Research Trials

That is not to say that amateur researchers have not been conducting their own studies of fibromyalgia, diet, and nutrition, though. Many people with fibromyalgia have been examining the effects that different foods can have on their symptoms, and they have seen surprising results.

It seems that the relationship between fibromyalgia, diet, and nutrition are quite close. It has been proven since the foods that affect fibromyalgia symptoms are mostly the same ones that can cause other kinds of chronic conditions like migraine headaches. Chocolate, alcohol, caffeine, and processed foods have all been said as possible culprits in the link between fibromyalgia, diet, and nutrition.

These offending foods may exacerbate the symptoms that a sufferer would feel on a normal day, but they are not though to be the cause of fibromyalgia. There may be even more foods that have not yet been linked to the symptoms of fibromyalgia.

Though direct relation between fibromyalgia, diet, and nutrition has not proven yet, eating a balanced diet is one of the best things that you can do to ease your fibromyalgia symptoms. A good balanced diet can do speculates for improving your overall healthiness and allow your body to get on with its normal processes, including healing any diseases or injuries.


Detox Diet to Cure Fibromyalgia – Knowing It’s Efficacy

People often wonder is there any detox diet to cure fibromyalgia since there is believe that nutrition influences the health condition. In most of the cases, healthy diet is proven to help in keeping the body fit but how about detox diet to cure fibromyalgia. Does it really work? Let’s take a look on it!

Up till now, the cure for fibromyalgia has not been known, and lots of the treatment choices cannot effectively take the relief that many patients wish for. That is why many people have turned to alternative methods for treating this chronic condition, and some of these choices have met with success.

One such treatment is a detox diet to cure fibromyalgia, which is worth a serious look since many have sworn by the success of this way of achievement. But what is it, and how to use a detox diet to cure fibromyalgia?

The Basics of a Detox Diet

For those who believe in employing a detox diet to cure fibromyalgia, the idea is that our bodies are crammed with toxins from the polluted air that we breathe and the unhealthy food. These pollutants need to be effectively removed from our bodies for optimal health, but they are not equipped to completely get rid of the many toxins that we absorb now.

By adhering to a detox diet to cure fibromyalgia and a host of other chronic conditions, we are assisting our bodies in the elimination process by allowing our own systems to work at their best. At the same time, we avoid putting any additional chemicals into our bodies by consuming only organic substances that are created to work with our own internal systems for maximum efficiency.

Consuming caffeine-free detox teas said to be one way of detox diet to cure fibromyalgia. This diet contains a combination of herbs for cleansing the system. Other herbs that work well in a detox diet include Echinacea, fenugreek and ginger. To gain energy and aid in the cleansing process of the digestive system, you can intake raw foods, like fresh, organic fruits and vegetables.

Drinking abundance of water is also key to a thriving detox diet program. Some people will feel side effects with a detox diet to cure fibromyalgia at first like nausea, headaches and diarrhea. Nonetheless, if you begin to find a relief from your fibromyalgia symptoms, a bit of discomfort in the beginning is well worth the long term advantages.

Composing a detox diet to cure fibromyalgia should be suited with each person who suffers the disease.

Remember to consult your doctor before beginning any type of diet.

If your doctor says okay, a detox diet to cure fibromyalgia may be just what you have been seeking to finally discover relief from your excruciating symptoms.


Are Fibromyalgia and Weight Gain Closely Related?

Fibromyalgia and weight gain have a strong connection. Majority people who are suffering from fibromyalgia may gain their weight. However, you can take measures to avert weight gain difficulties when you get an idea concerning the connection between fibromyalgia and weight gain.

This article let us discover the triggering factors of weight gain throughout fibromyalgia and then discuss the healthy diet you can follow throughout fibromyalgia. So, it is possible to go through weight management.

Slower Metabolic Process

Fibromyalgia causes weight gain in people is due to a wide variety of aspects which are either directly or indirectly linked to the occurrence of the illness itself. Since fibromyalgia results in hormonal imbalances, it can influence levels of insulin, cortisol, thyroid, and serotonin. Also, it profoundly influences the production of growth hormones. Since there is a clear hormonal imbalance, it affects the metabolism process and makes it slower than normal, which causes weight gain.

Fatigue and Sleep Apnea

Apart from hormonal imbalance, since fatigue is one of the most vital symptoms of fibromyalgia, it also leads to weight gain problems. It has been revealed that there is a strong connection between fatigues of fibromyalgia and weight gain.

People with fibromyalgia may also suffer from sleep disturbances, leading to a poor quality sleep, that makes individuals even more tired and these people simply lack the ability to stay active, which means fewer calories are actually burnt. This also causes problems with weight gain.

Excessively Low Blood Sugar

Insulin sensitivity is increasing in fibromyalgia patients. This leads to an excessive amount of glucose to be transferred from the blood and forced in to the muscles. However, the transferred glucose virtually has no places to go because muscles have a restricted capacity to store glucose.

This leads the body to powerfully construct a fat-depositing system, in which excess glucose become fatty tissue. Opposing to the popular conviction that fatty food contributes to increased weight, it is actually caused by a high-carbohydrate diet.

Helpful Diet

The diet needs to be designed for fibromyalgia patients in such a manner that these factors can be effectively taken under consideration. This is because fibromyalgia deeply influences the maladaptive nature of metabolism and the dysfunctional characteristics of carbohydrate response. A higher carbohydrate diet cannot benefit patients with fibromyalgia, rather it could worsen the condition to a greater level. Since the metabolic rate is much slower, eating less is usually difficult for these people.

The strong connection between fibromyalgia and weight gain is a fact of the truth. Selecting the proper ‘quality’ of foods can provide benefit to patients with fibromyalgia and weight gain. In addition, you must eat your food very slowly and must chew your food well since your metabolism decreases.

The Difference between Fibromyalgia and Polymyalgia – A Confusing Matter

Owing to the similarity between the terms and symptoms, most people are bemused if there is a difference between fibromyalgia and polymyalgia. Once person is diagnosed with fibromyalgia or polymyalgia, he or she may become puzzled thinking whether these two are similar. Are you burned up of the difference between fibromyalgia and polymyalgia? Check this out!

Since the term ‘myalgia’ means ‘pain taking place in the muscles’, both of these conditions are featured by an intense sensation of muscle pain. Yet, there is still a difference between fibromyalgia and polymyalgia. However, let us find out if there are any noteworthy differences between fibromyalgia and polymyalgia.

Causes Are Different

When we try to seek the causes of each disease, there is a significant difference between fibromyalgia and polymyalgia. Even though the precise reason behind the progress of polymyalgia is still unidentified, many scientists convince that polymyalgia is another type of autoimmune disease, during which connective tissues develop into adversely exaggerated by the immune system itself.

Conversely, fibromyalgia develops as a result of maladaptive sensory processing emerging in the central nervous system (CNS). This is why people with fibromyalgia may become tremendously sensitive to the horrible stimuli present in the environment. These people are also very sensitive to ache.

Not All Symptoms Are the Same

The main symptoms of polymyalgia include severe form of stiffness and muscle pain in the neck, shoulders, and hips. People with polymyalgia may feel flu-like conditions as well. On the other hand, people suffering from fibromyalgia experience widespread pain all over the body. There are a large number of tender points in the body. Fatigue, headache, lack of concentration, poor quality of sleep and irregular bowel syndrome are the common symptoms of fibromyalgia.

Prevalence of the Complications

Both fibromyalgia and polymyalgia may occur more in women more than men, so there is no gender specific difference between fibromyalgia and polymyalgia. However, there is a difference in the age factor, since fibromyalgia can occur at any age, whereas, polymyalgia usually occurs in people over 50 years of age.

Treatment Methodologies

The principal mode of treatment for polymyalgia occupies relief from inflammation. Polymyalgia patients may be recommended to undertake Non-steroid anti-inflammatory drugs (NSAIDs), if they are suffering mild degree of polymyalgia. Prolonged usage of this drug may bring bad side effects like intestinal bleeding, stomach bleeding, high blood pressure, etc. Corticosteroids are administered as the severe type of polymyalgia.

In treating people with fibromyalgia, the administration of non-steroid anti-inflammatory drugs may put them out of action. However, narcotics including oxycodone, propoxyphene and codeine are found to be effective in reducing pain. Light exercise and healthy diet is a must in both the cases. There is no difference between fibromyalgia and polymyalgia in such conditions. For more information, please check out links on this Fibromyalgia Consultant site.

(http://fibromyalgiaconsultant.com/fibromyalgia/fibromyalgia-diet-and-nutrition-breaking-the-relationship-between-them/ -
http://fibromyalgiaconsultant.com/fibromyalgia/fibromyalgia-diet-and-nutrition-breaking-the-relationship-between-them/

http://fibromyalgiaconsultant.com/difference-between-fibromyalgia-and-polymyalgia/the-difference-between-fibromyalgia-and-polymyalgia-a-confusing-matter/)

Disclaimer: Any views or opinions expressed in this article are those solely of the author/writer and do not necessarily infer endorsement by the News Desk.  Any advice or recommendation of a medical or legal  nature must always be discussed with a qualified professional.  FMS Global News cannot be held responsible for omissions and/or errors. 

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

International Fibromyalgia Awareness Day 12th May 2009

From FMS Global News Desk of Jeanne Hambleton (UK)

In the wake of the historic first ever debate about fibromyalgia in Parliament (Westminster Hall) last week on May 5, the Fibromyalgia Association UK, (FMA UK) praised for its work in helping sufferers, has issued a press release.

The Chairman of the Trustees of FMA UK Ms Pam Stewart said, “A year has passed and what has changed?”


EUROPEAN NETWORKS OF FIBROMYALGIA ASSOCIATIONS & NICE REJECTION

In Brussels, the Written Declaration on Fibromyalgia won a majority of votes. This asked all member states to recognise fibromyalgia and ensure diagnosis and treatment is available. It also stated that research funding should be awarded for fibromyalgia.

“It is likely to be some time before we see the results of this as it is a slow process,” said the Chairman.

“In the UK, the recommendation for guidelines for the treatment of fibromyalgia were not considered to be a priority by the National Institute of Clinical Excellence (NICE). This rejection by NICE which is independent from the government is a blow for UK fibromyalgia sufferers,” said Pam Stewart.

CHIEF MEDICAL OFFICER’S ANNUAL REPORT

The annual report from the Government’s Chief Medical Officer Sir Liam Donaldson, which included a whole section on pain and especially chronic pain, gave hope that at least this area of fibromyalgia might be given some attention but it is only part of the range of symptoms and cannot be treated in isolation.

FIBROMYALGIA DEBATE IN THE HOUSE

“We were delighted to have a debate with Ann Keen, Parliamentary Under Secretary of State in the Department of Health, so that questions about the future of fibromyalgia diagnosis and treatment could be assured. This debate was secured by Rob Wilson MP for Reading East and Chair of the All Party Parliamentary Group on Fibromyalgia (APPG).

“Sadly it seemed that complacency with the initiatives already in place means we still have a fight on our hands. Since the Musculoskeletal Service Framework was put in place in 2006, we have not heard that treatment options have improved and we still hear of people being told to go away and live with it.

“We have been told that in one hospital, a mention of fibromyalgia will bar the patient access to further treatment from pain specialists, physiotherapy or other recommended treatment options!

” When asked about training for medical professionals, which Sir Liam Donaldson had mentioned in his report, we were informed that we would have to take this up with the professional bodies involved in accrediting training even though deficiencies in knowledge have been acknowledged,” she said.


DO DOCTORS USE THIS NHS SITE?

However, the new website http://www.NHSevidence.uk was mentioned by the Under Secretary. When fibromyalgia is searched for, this has the European League Against Rheumatism (EULAR) guidelines that were sent to NICE as a beginning for official UK clinical guidance. This is encouraging if medical professionals use this service. This advocates a multidisciplinary approach for the treatment of fibromyalgia. There are some centres around the country that use this but those with fibromyalgia need all PCTs to have the ability to refer patients with fibromyalgia to a multi-disciplinary team of medical professionals for appropriate treatment.

“It is unacceptable that these specialist clinics are not available on the NHS Choose and Book system thereby denying easy access to sufferers. We hope this debate will have raised the profile of fibromyalgia but it has highlighted that there is still much more to do. People in constant pain should have the right to effective treatment. How can between 1.7 and 2.8 million people living with such a poor quality of life be treated so badly?

..end..

EDITOR’S NOTE: As someone with fibromyalgia I was very pleased to hear Rob Wilson MP had secured this debate. May I also publicly thank the handful of MPs who were in the Chamber to support this plea for support for the neglected people with fibromyalgia. I guess like many of the 2.7 million people diagnosed with fibromyalgia in the UK, I felt the response from the Minister, Department of Health, was a ‘white wash’. As a health professional herself I did believe she wanted to help but it appeared her ‘hands were tied’ by red tape and maybe civil servants’ constraints. She appeared unable to make a commitment sadly.. regardless of pressure from Norman Lamb MP. If there is a will, there must be a way.

Yes I accept there are many conditions causing chronic pain and quite a number who have been given funding for research to find a cure, but we fibromites – the Fibromyalgia Cinderellas, have no funding for research and apparently must endure our pain, a poor quality of life and the huge financial burden that fibromyalgia imposes, not to mention the hoops the Benefits people ask you to jump through.

What makes me mad is the time it takes (at least 2 years) to get a diagnosis and the enormous costs in those 24 months (at least). We spend hours seeing doctors, specialists, having blood tests, x-rays, scans, all in a process of elimination. If over two years we see three or four specialists, doctors and others and it costs, for example, say £5,000 for one person to get diagnosed (I am guessing), just multiply that by 2.7 million people. (Sorry no good at maths.) What a staggering cost that must be when much less could be spent on research in an attempt to save NHS money. Does the Department of Health care about this major drain on resources?

WRITE TO YOUR MP FOR HIS SUPPORT

Send your MP chapter and verse about your aches, pains, symptoms and quality of life or lack of it, the financial burden you face. Urge him to help you by supporting all these cross-party points raised at the debate. It is the MPs who are pulling the purse strings in the ‘corridors of power’.

Ask your MP to support these points and raise them again in Parliament – they are all valid and raised during the fibromyalgia debate on May 5. See the previous story for the full text of that debate.

* Providing better education for doctors enhancing their knowledge about fibromyalgia,

* The importance of fast diagnosis and the provision of treatment,

* For an improvement and wider access to pain management,

* Highlight the lack of focus on the illness in the Department of Health,

* For the Department for Work and Pensions to address the condition and take it more seriously,

* Consideration a nationwide awareness campaign to highlight fibromyalgia syndrome,

As Pam Stewart has said there is much work still to be done.and we have a fight on our hands. You can help from your own home by contacting your MP. Tell him to read the full debate on this website. Be sure to tell him where you live and that you are one of his constituents. He will want you to vote for him at the next election so hopefully he will help you.

How do you contact your MP? Log on to http://www.theyworkforyou.com/ add your post code and click send a message to you MP. Best type it out first and then cut and paste into the little box.

I am considering writing an e petition on the No.10 Downing Street website raising these points. Will you support that and sign it? If so watch this space!

What are you doing on Tuesday,May 12 – our day. Are you celebrating the International Fibromyalgia Awareness Day with some fund raising? Do you have the Fibro What? CD to raise your spirits. If you do nothing else get a copy to help raise funds for research – see http://www.domcollins.co.uk and look at MY SPACE top right hand side. Fibro What? is serious but the three backing tracks will make the family laugh. It is a hoot!

It would be good to hear you have written to your MP. Email me with news from MPs or about Fibro What? on jeannehambleton(@)mac.com. Take care and keep well. Jeanne

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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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)

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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

Stanford develops imaging technique to catch arthritis early in onset

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

Courtesy of Stanford School of Medicine USA

BY BRUCE GOLDMAN

STANFORD, Calif. — You come into a doctor’s office with severe knee pain. The physician orders an MRI, which reveals substantial loss of cartilage — osteoarthritis, that is—in your knee joint.

At this point, not much can be done beyond gulping down palliatives and trying to keep your weight off the joint. But the damage may have started building as much as 20 years earlier, possibly due to a traumatic injury to the affected joint.

Just ask Garry Gold, MD, an associate professor of radiology at the Stanford University School of Medicine. Now 45, Gold sustained a knee injury 20 years ago while playing in a pickup basketball game. These days, he is starting to wish his house, currently being remodeled, did not have any stairs.

Gold, who has been diagnosed with osteoarthritis, is working with an imaging technology called sodium MRI to diagnose osteoarthritis as long as decades before the onset of physical symptoms. That may spawn new therapies that could possibly have blocked his disease before it put an end to his basketball days.

Gold is collecting young athletes who have suffered damage to the anterior cruciate ligament, or ACL, in their knee—an injury afflicting several hundred thousand people annually in the United States alone. This knee insult is especially common among female athletes.

“A good fraction of the Stanford women’s basketball and soccer teams either have torn their ACL sometime in the past or will tear it while they are still at Stanford,” Gold said. Even when the initial ligament lesion is repaired surgically, victims remain at almost doubled risk for symptomatic osteoarthritis in the injured knee a decade or two down the road, compared with uninjured people.

MRI now in routine use works by pulsing the area to be observed with electromagnetic energy, at a frequency that preferentially excites the protons in water molecules. As the protons settle back to a relaxed state, they send out an electromagnetic burst of their own, which can be picked up by sensors in the apparatus. Because cartilage has lots of water compared with nearby bone, it shows up on a computer-generated image of the region.

But while standard MRI gives a reasonable display of overall cartilage structure, it does not tell a diagnostician much about the quality of that cartilage.

“If you look into a big house and you see that it is standing up,” Gold said, “you may assume it is going to be safe in the event of an earthquake. But without closer inspection, you do not know much about the integrity of the structure.”

If standard MRI is akin to a view of standing timber in the house, the version Gold is using, called sodium MRI, enables the visualization of dry rot infecting and weakening the wood.

A key structural material in cartilage, called glycosaminoglycan, occurs in a complex with sodium, an elemental metal that has its own set of excitation and relaxation frequencies and is more restricted to cartilage than water is.

Sodium MRI has been around for years, but until recently it could not be used in clinical settings. For one thing, the magnets employed to excite sodium atoms were too puny, making crisp resolution possible only with tiny creatures such as mice.

Gold and his colleague Brian Hargreaves, PhD, assistant professor of radiology, have designed improved magnets and software to scale up the technology for human application.

They are on the right track, said Ari Borthakur, a University of Pennsylvania scientist who is not involved in Gold’s research but has done pioneering work with sodium MRI since writing his PhD thesis on it some years ago.

“Everything his lab has developed is going to be applicable in the clinics,” said Borthakur. “As America ages, we are expecting to see a huge increase in osteoarthritis, and any technique that could be used for its early diagnosis, or that could help developing therapies for curing it, or even slowing the progression of cartilage loss, would be tremendous.”

Gold and Hargreaves’ project is being conducted with funding from the National Institutes of Health and GlaxoSmithKline, an international pharmaceutical company. Neither researcher owns stock in, or receives consulting fees from, the company.

Working with Hargreaves, Gold has imaged the knees of about a dozen volunteers who have suffered a recent ACL injury. In every case so far, significant losses of glycosaminoglycan can be glimpsed under sodium MRI scanning, despite the absence of any sign of damage to cartilage observed with standard MRI. Almost invariably, sodium MRI scans of the injured knee—but not of the other, uninjured one—reveal glycosaminoglycan deficits within three years of the injury, potentially enabling a vastly accelerated diagnosis.

This ought to speed the development of new therapies, and radically lower the cost of doing so, Gold said. The idea is to be able to use glycosaminoglycan loss as a “surrogate marker” of impending osteoarthritis, much as high LDL levels are used to flag people at risk of heart disease—perhaps years before actual symptoms of heart disease manifest. While not everybody with elevated LDL develops cardiovascular disease, this marker has been sufficiently predictive of that condition that regulatory authorities routinely approve drugs based on their ability to lower LDL.

Catching osteoarthritis during its stealth phase may spur clinical trials that would be prohibitively time-consuming and costly if standard MRI were employed, because of the huge lag from the time of an ACL injury until the time cartilage deterioration can be detected by that old method.

With sodium MRI, cohorts of treated vs. untreated at-risk patients could be imaged over time to see if, within a few years of the injury, a drug or a lifestyle change is reducing or arresting the loss of glycosaminoglycan from the ligament. Once promising drugs or lifestyle changes are identified, they could then be administered to at-risk patients long before symptoms surface, Gold said.

As for Gold himself, he has yet to see what his own damaged knee looks like under sodium MRI. The 6-foot-6 once-avid amateur basketball center’s knee is too big for even his improved new experimental apparatus to fit. It’s probably too late for any kind of imaging to do Gold much good now, anyway. He already knows he’s got arthritis. “I don’t even want to look,” he said.

The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

(http://med.stanford.edu/news_releases/2009/january/sodium.html)

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

Diet Plans for Men

From the FMS Global and UK News Desk of Jeanne Hambleton

Atkins vs. Ornish, South Beach Diet vs. the Zone: Does any weight loss plan really work?

Courtesy of WebMD.com

By Peter Jaret – Reviewed by Matthew Hoffman, MD – WebMD Feature

After four years of following one diet plan after another and watching his weight yo-yo up and down, Marv Leicher finally discovered the secret formula for losing weight and keeping it off successfully.

And he is not sharing it with anyone.

“I wasted enough of my own time following somebody else’s idea of the perfect diet plan,” says Leicher, 42, an insurance claims adjuster in Iowa. “I do not want some poor fool following my advice and then wondering why it is not working for him. The real secret is that there is no one perfect diet. What works for one person would not necessarily work for someone else.”

From one diet plan to the next

Leicher began by following a low-fat diet. For a few months, the pounds dropped away. He bought a new set of pants with a slimmer waist. And before long, the numbers on the bathroom scale started climbing again. Frustrated, Leicher took a friend’s advice and started following the Atkins high-protein/low-carb diet. He started losing weight within the first week. After four months, he was back to wearing his new lean and mean wardrobe.

“I really thought, OK, this is it. I am home free.”

Then came the holidays — office parties, family dinners — and when they were over, Leicher had regained 10 pounds and was on his way back to being overweight.

“That is when I said to myself, ‘Wait a minute. I am a capable guy. This is not rocket science. I should be able to figure this out.’”

So Leicher sat down and made a list of the parts of diets that seemed to work for him. He went through all the rest of the advice that he had heard — eat breakfast, do not eat breakfast; choose healthy snacks, avoid snacks — and added the tips that seemed to help.

“I ended up with six rules. Frankly, I would be embarrassed to show them to anyone else. But they were changes I knew I could make without feeling like I was doing penance for some past sins.”

Within three months, he was back down to his college weight. This time, though, he stayed there. “It has been almost a year, and I do not even really think of myself as being on a diet. This is just the way I eat.”

How popular diet plans score

What works? What does not? With some 38,000 diet books in print — and 2,500 new ones hitting the shelves every year — not to mention magazines trumpeting the ultimate new fad diet in every monthly issue, there is plenty to choose from. Lately, even researchers have got into the act. The National Institutes of Health and university medical centers around the nation have spent many years and millions of dollars to test the Atkins diet versus the South Beach, the American Heart Association diet versus the Zone.

Along the way, there have been genuine surprises. The low-fat diet, widely endorsed by many official groups, has not turned out to be as safe or effective as most experts thought. Some people do manage to lose weight on low-fat diets, but usually weight loss is fairly slow — only a pound or two a month. And while levels of bad cholesterol (LDL) fall, studies show that levels of good cholesterol also drop. Many people on low fat diets also see a rise in triglycerides — an independent risk factor for heart disease.

To almost everyone’s surprise, low-carb/high-protein diets — Atkin’s is the model — have proved much safer and more effective than expected. Here was a diet that featured eggs and bacon and warned people away from bread. Yet study after study has shown that for people who are overweight or obese, high-protein/low-carb diets have real advantages.

“These diets push most of the numbers in the right direction,” says Ronald Krauss, MD, a senior researcher at Children’s Hospital Oakland Research Institute and a spokesperson for the American Heart Association.

“Body weight and body fat go down, triglycerides and LDL cholesterol drop, while at the same time good cholesterol levels remain up. Low-carb diets also improve insulin sensitivity even without weight loss, so they offer better protection against diabetes.”

The best news for dieters is that high-protein/low-carb dieters also shed pounds faster, on average, than low-fat dieters. In the latest of a string of studies that have pitted one popular diet against another, researchers at Stanford put the Atkins, Zone, Ornish, and LEARN diet to the test. After 12 months, volunteers on the Atkins diet had lost more weight — twice as much — as people on any of the other diets.

But if you are looking to dramatically change your shape, the numbers were not all that encouraging. The average weight loss was a scant 10.3 pounds.

In a slew of recent head-to-head studies of popular diets, in fact, the Atkins diet has pulled ahead in the first few months, resulting in more and faster weight loss. Many experts have come around to accept the notion that protein-rich foods may be more satiating than carb-rich foods.

Unfortunately, the Atkins lead typically evaporates by the end of a year. In a 2006 British study that compared four popular weight loss plans, for example, volunteers lost weight faster on the high-protein/low-carb plan. But after a year, all four diets had resulted in about the same weight loss, about 13 pounds. What is more, several studies comparing diets have seen very high drop-out rates. Even with scientists looking over their shoulders, it turns out people have trouble sticking with most diets.

The best diet plan

Disheartening? Sure. But lurking behind the generally glum news about fad diets and popular weight loss programs are individual success stories — and important information for anyone looking to lose weight.

“If you look at all these studies, you find that on almost any diet, some people do very well and others do not lose any weight at all,” says Janet King, PhD, professor of nutrition at the University of California, Berkeley,who chaired the 2005 Dietary Guidelines Advisory Committee for the U.S. High-protein diets may have an initial advantage in jump-starting weight loss.

But all weight loss plans have one thing in common: They restrict certain kinds of foods and thus limit calories. “Most diets work in the short-term, and the reason is that they simplify decisions about what you’re going to eat,” says King. “They take variety out of the diet. Some restrict carbohydrates. Some restrict fat. But the end result is that they offer a way to eat fewer calories.”

The reason some people succeed is also simple: motivation. “What really matters is compliance, which is another way of saying someone is motivated enough to stick with a diet,” says King.

The best diet plan, in other words, is the one that you are most likely to be able to follow for the long haul. And that is likely to be different for different people. Men who are basically vegetarians are going to have a tough time following the Atkins diet. Steak-and-eggs men are not going to stick with a low-fat, mostly veggie diet plan for long.

Kathleen M. Vohs, a psychologist at the University of Minnesota, believes choosing a regimen that most closely matches the way you like to eat is crucial. She offers a provocative reason.

“Studies show that self-control is a limited resource,” says Vohs. “People may have an easy time giving something up the first time. But when people are repeatedly asked to exhibit self-control, that ability begins to erode.”

It is easier to eat a healthy meal for breakfast, in other words, than to stick with a diet plan once dinner rolls around, especially if it means saying no to foods you love. And by extension, it is easier to stick with a diet that does not eliminate most of the foods you love.

One man’s diet plan

That is a lesson Marv Leicher took to heart when he decided to abandon popular diets and fashion his own weight loss regimen. “Basically, I picked and chose from the strategies that seemed easiest for me to follow,” he says. “It was no big deal to give up soft drinks and fruit drinks, so I did that religiously. No liquid calories. I’m not the kind of guy who can eat just half of what’s in front of him, so I gave up trying to divide portions. Instead, I decided, no desserts. At lunch, I used to go out with people from the office. Now I bring a cup of yogurt and some trail mix, and if the weather is good I take a half hour walk and eat a quick lunch. Little stuff like that.”

Little stuff. But for Leicher, it adds up to big results. Over the past year, he’s lost 30 pounds. Best of all, he’s keeping them off.

©2005-2009 WebMD, LLC. All rights reserved.
(http://men.webmd.com/guide/diet-plans-men?ecd=wnl_men_040709)

Vitamin and Mineral Supplements for Men
Why multivitamins and other dietary supplements can be hazardous to your health

Courtesy WebMD.com

By Arthur Allen -Reviewed by James E. Gerace, MD – WebMD Feature

More than half the adults in America regularly use multivitamins and other supplements to boost their immune systems and enhance nutrition, supporting an industry worth more than $20 billion annually. Grocers stock every conceivable vitamin, mineral, and herbal “boost,” and every neighborhood seems to have its own supplement store.

So are vitamins and mineral supplements for men really necessary?

Based on the current evidence, the answer is a definitive “no.” “For me,” says Christian Gluud, MD, a vitamin researcher at Copenhagen University Hospital in Denmark, “the simple answer is do not use them.”

“Except for certain defined population groups,” says Irwin H. Rosenberg, MD, director of the nutrition and NeuroCognition Laboratory at Tufts University, “there is no evidence that supplemental vitamins and minerals are beneficial for your health.”

He goes on to tell WebMD, “There is no indication that a poor diet is going to be made into a good diet by taking multivitamins.”

Vitamin and mineral supplements can lead to early death

It is not just that vitamin and mineral supplements provide little benefit for the healthy middle-aged man. Large doses of the pills can actually make you sick and reduce your lifespan. A review of 68 randomized trials of high-dose antioxidant supplements such as vitamins C and E found a 5% higherrisk of death in those who took them.

The study, published in February in the Journal of the American Medical Association (Gluud is the lead author), found an even greater risk of death for vitamin users in a subset of 47 carefully conducted trials.

At first glance, this seems contradictory. Over the past three decades, many studies have found that eating fresh fruits and vegetables, which contain high amounts of antioxidants and other vitamins and minerals, can add years to a healthy life. But there are obviously components of a healthy lifestyle that can not be bottled.

“Multivitamins are not a shortcut,” Gluud says. “You are better off eating a varied diet instead of risking the increased mortality of taking these supplements.”

Multivitamins and the middle-aged man

To be sure, vitamin supplements can be beneficial for certain groups of people. After the age of 55 or so, your body starts to lose the capacity to make vitamin D from sunshine, and adding a vitamin D pill may be a good idea.

The elderly also lose the ability to absorb vitamin B12 from their diet, and some of this deficiency can be met by taking a B12 supplement. Cancer patients, or people eating fewer than 1,000 calories a day, may have vitamin deficiencies. Vegans may need some B vitamins and iron unless they are meticulous about getting these nutrients from their diet.

“There really is no strong evidence to support the need of the average 35- to 55-year-old man to take a multivitamin,” says Cheryl Rock, MD, professor of nutrition in the Department of Family and Preventive Medicine at the University of California, San Diego, School of Medicine.

“If you’re concerned about your nutritional levels, a doctor can order tests. It is quite easy to find out, for example, if you are deficient in B12 or vitamin D. And usually one visit with a dietician will be covered by health insurance.”

So far, the evidence of benefit, and harm, from supplements comes from careful studies of large doses of particular vitamins and minerals. There is almost no evidence of health effects from multivitamins. Taking a once-a-day vitamin pill is probably as harmless as it is pointless, except for the manufacturer that can produce a bottle of pills for a few cents and market it for $9.99, nutrition experts say.

Do multivitamins work if you think they do?

There can be, of course, a placebo benefit from a multivitamin or other supplement — the benefit of feeling in control of your health and hopeful of the results. “Even in the face of evidence that multivitamins lack efficacy, people are still going to take them,” says Marion Nestle, PhD, professor of nutrition at New York University and author of What to Eat.

“You’re dealing here with something that goes beyond science and has to do with belief systems.”

Nestle notes that when the recent JAMA study came out, many scientists interviewed about its findings said they would still keep taking vitamins. (Nestle, for one, does not regularly take supplements: “Sometimes when I need a placebo, I’ll pop one.”)

An unhealthy dose of heavy metal

But buyers beware. Some pills contain less or more of a vitamin than promised, and it is not unusual to find heavy metals like lead in the pills, according to chemical analyses by the commercial laboratory ConsumerLab.com, which tests vitamins for sports teams and others.

To be sure, the existence of a vast industry selling products that are potentially dangerous and probably of marginal value strikes some as troubling. We have Congress to thank for the virtually unregulated state of the supplement industry.

The 1994 Dietary Supplement Health and Education Act effectively handcuffed regulation of dietary supplements by the Food and Drug Administration. The term “supplements” includes everything from vitamins and minerals to herbal supplements such as ephedra, saw palmetto, ginkgo biloba, and other substances, some of which have powerful pharmacological effects. Purveyors of these substances are not required to prove their efficacy, and the FDA must show they are dangerous before removing them from the market. The supplement maker has no obligation to test the safety of the product.

Since passage of the bill, the market in vitamin and mineral supplements has ballooned from an estimated $3.3 billion in 1990 to well over $20 billion.

How did vitamin and mineral supplements get such a good rep?

A body of research conducted in the 1980s and 1990s seemed to show benefit from vitamin and mineral supplements in preventing chronic diseases like cancer and osteoporosis and heart disease. But reviews of these studies showed that much of the benefit attributed to supplements was actually attributable to the overall better health practices of those who took them. In other words, people who took vitamin supplements also tended to eat better, smoke less, and get more exercise, says Rosenberg.

Many people have started taking supplements containing antioxidants because of research gathered over the past three decades showing these compounds help slow cell damage. But a well-fed population is already ingesting enough to overcome oxidative stress, and adding more antioxidants probably would not lower the risk of chronic diseases, says Rock.

Foods rich in antioxidizing compounds range from walnuts, blackberries, artichokes, and pecans to brewed coffee and chocolate cupcakes. Yet these products are not equally good for you, and you obviously would not want to build a diet exclusively around antioxidants.

SOURCES: Bjelakovic, G. et al., Journal of the American Medical Association, Feb. 28, 2007; vol 297(8): pp 842–57. Huang et al., American Journal of Clinical Nutrition, 2007; vol 85 (suppl): pp S265–S268. Gad, S.C. and S.E., International Journal of Toxicology, 2003; vol 22: pp 381–385. Fletcher, F., JAMA, June 19, 2002; vol 287(23): 3116–3126. Halvorsen, B. et al., American Journal of Clinical Nutrition, 2006; vol 84: pp 95–135. Morris, M.C. et al., Archives of Neurology, April 2005; vol 12: pp 641–645. Christian Gluud, MD, Copenhagen University Hospital. Irwin H. Rosenberg, MD, director, Nutrition and NeuroCognition Laboratory, Tufts University. Cheryl Rock, MD, professor of nutrition, Department of Family and Preventive Medicine, University of California, San Diego, School of Medicine. Marion Nestle, PhD, professor of nutrition, New York University; author of What to Eat (North Point Press, 2007). Paul M Coates: testimony before the Committee on Government Reform, US HR, March 9, 2006. ConsumerLab.

©2005-2009 WebMD, LLC. All rights reserved.
(http://men.webmd.com/guide/vitamin-mineral-supplements-men)

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