FDA APPROVAL OF HIP RESURFACING SYSTEMS IN AMERICA

The first hip resurfacing system that was approved by the United States Food and Drug Administration (FDA) was the Birmingham Hip Resurfacing System (BHR) that is made by Smith & Nephew Inc. of Memphis, TN. The system was approved in May 2006.

A year later, in July 2007, FDA approved Corin Group’s Cormet hip resurfacing implant for sale in the United States.

In November 2009, Wright Medical Group Inc.’s Conserve Plus system for bone-saving hip-resurfacing surgery also received the approval of the Food and Drug Administration.

So today, there are 3 companies that have the FDA’s approval to sell hip resurfacing systems in the US.

The hip resurfacing system relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Those degenerative joint diseases include osteoarthritis and rheumatoid arthritis.

In the hip resurfacing system, the cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly polished metal.

The hip resurfacing system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

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Salmonelle: les produits bio ne sont pas épargnés

Dossier Alimentation

Pascal Lapointe

(Agence Science-Presse) – L’alerte à la salmonellose qui a frappé les États-Unis depuis janvier a attiré les projecteurs sur un aspect méconnu: une bonne partie des aliments désormais étiquetés «bio» font partie de la même chaîne alimentaire.

Des tonnes de produits à base d’arachides, ou à saveur d’arachides ont dû être rappelées en janvier et février. Les rapports officiels font état de plus de 680 personnes qui auraient été malades, et d’au moins neuf morts… Aucun cas n’a été signalé au Canada, où des produits ont également été retirés des tablettes par l’Agence canadienne d’inspection des aliments.

Mais là où il y en a qui l’ont trouvé encore plus dure à avaler, c’est que l’usine d’où provenaient les arachides contaminées avait sa certification «bio».

À la base, selon l’Associated Press, il y aurait un inspecteur du ministère de l’Agriculture qui aurait négligé de vérifier si l’usine de la compagnie Peanuts Corporation of America (PCA) se conformait bel et bien aux normes «bio», en présumant que la certification était chose acquise.

Naïveté bio

Mais ceci n’a rien à voir avec la contamination à la salmonelle. Car derrière cette tuile qui tombe sur le mouvement bio, il y avait une grande naïveté. Parce que la nourriture bio offre «des bénéfices accrus pour la santé, les gens assument que c’est libre de pathogènes», résume Urvashi Rangan, scientifique à l’emploi de l’Union de défense du consommateur (qui publie le magazine Consumer Reports). «Je ne présumerais pas nécessairement que c’est plus sécuritaire.» Peut-être que ça l’est, mais peut-être pas.

Comme le souligne le New York Times dans un article intitulé It’s Organic, but does it means it’s safer?, la certification des aliments bio et la sécurité des aliments sont deux processus complètement distincts.

Autrement dit, certification biologique ne veut pas nécessairement dire petit fermier qui fait pousser des arachides dans son potager. La certification biologique est le résultat de réglementations imposées aux fermiers par un gouvernement (non-usage de pesticides, restrictions sur l’alimentation des animaux, etc.). Cela s’avère important pour qui achète ses fruits et légumes au marché. Mais cela ne dit rien sur la façon dont un pot de beurre d’arachides a été traité, une fois à l’usine — cette partie-là incombe à l’agence d’inspection des aliments (la FDA aux États-Unis, l’ACIA au Canada).

La négligence a manifestement été à plus d’un niveau. Le Times rapporte que l’Association pour l’amélioration des produits biologique — une compagnie privée chargée d’émettre les certifications bio — a envoyé en juillet 2008 une note à la compagnie PCA, disant que son usine de Géorgie ne se conformait plus aux normes bio. En l’absence de réponse, ce n’est que sept mois plus tard — alors que la crise était commencée — que la firme a demandé au ministère américain de l’Agriculture que la certification bio soit retirée à l’usine

Certifié biologique: une étiquette vendeuse

«Pour le meilleur et pour le pire», résume un dossier du magazine en ligne Science Progress, le «bio» d’aujourd’hui fait partie intégrante du système d’alimentation traditionnel, dépendant des mêmes usines de transformation, des mêmes distributeurs et du même marketing qu’à peu près tout le reste de ce que nous mangeons. Et ainsi, lorsque le système d’alimentation traditionnel éternue, les bios attrapent le rhume. »

Plus sévère que d’autres, Emily Brown, de la firme de Pennsylvanie Certified Organics déclare: « le ministère de l’Agriculture insiste beaucoup sur le fait que la nourriture bio n’est pas une garantie de sécurité ou de qualité — c’est une norme de marketing. » Et c’est un marketing payant, souligne Science Progress: 20 milliards$ de ventes en 2008, pour un marché qui n’existait pratiquement pas il y a 20 ans.

Rappel du rappel

Le rappel d’aliments, qui a commencé en janvier et s’étirait encore, début-mars, serait le plus gros de l’histoire des États-Unis: la liste des produits à base d’arachides qui ont fait l’objet d’un rappel, produits bios et non bios confondus, fait… 46 pages de long! Ça va des barres d’énergie jusqu’aux biscuits pour chien en passant par plusieurs marques de beurre d’arachides. Si la liste est si longue, c’est parce qu’en général, ce n’est pas toute une marque qui est en cause, mais un type d’aliment, produit à tel endroit et entre telle date et telle date.

La compagnie PCA a annoncé le 20 février qu’elle se mettait sous la protection de la Loi sur les faillites. L’enquête se poursuit.

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

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

May 19, 2009 03:00 PM Eastern Daylight Time

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

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

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

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

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

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

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

About the Study

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

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

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

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

This study was sponsored by Pfizer, Inc.

About Lyrica

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

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

Important Safety Information

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

Pfizer Inc: Working together for a healthier world™

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

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

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

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

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

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

Courtesy FDA US Food and Drugs Administration – For Immediate Release

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

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

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

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

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

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

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

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

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

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

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

Consumer Inquiries: 888-INFO-FDA

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

Lyrica for Fibromyalgia Pain

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

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

Study of Restless Legs Sufferers

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

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

Less Symptoms, More Sleep

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

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

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

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

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

Study Finds Benefits for Fibromyalgia Sufferers

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

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

Few Side Effects, Relatively Inexpensive

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

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

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

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

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

Courtesy of attorneyatlaw.com Legal Briefs

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

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

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

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

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

WHY THE FOCUS ON FIBROMYALGIA?

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

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

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

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

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

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

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

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

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

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

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

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

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

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

AttorneyatLaw.com has a network of attorneys that are available for a free legal consultation

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

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

Courtesy WebMD.com. Health and Cooking /em>

EDITOR’S NOTE: Mines a beer please!

SOURCES:
Gary Hemphill, Beverage Marketing Corp.
International Bottled Water Association web site: “Frequently Asked Questions.”
FDA: “Bottled Water Regulations and the FDA,” September 2002.
National Association for PET Container Resources Q&A.
Rolf Halden, PhD, PE, associate professor of civil and environmental engineering, Arizona State University; adjunct associate professor of environmental health and science, Johns Hopkins Bloomberg School of Public Health.
Joseph Doss, president, International Bottled Water Association.
Sarah Janssen, MD, PhD, MPH, scientist, Natural Resources Defense Council.
IWG Bottled Water Investigation, Oct. 15, 2008.
CDC Fact Sheet on Questions About Bottled Water and Fluoride.
WebMD Medical News: “Many Tap Filters Work Well.”
Associated Press: “Drugs Found in Drinking Water,” Sept. 12, 2008.
National Resources Defense Council: “Summary Findings of 1999 Bottled Water Report.”

© 2008 WebMD, LLC. All rights reserved.(http://www.webmd.com/food-recipes/news/20081107/bottled-water-faq-on-safety-and-purity?ecd=wnl_day_041309)

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

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)

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.

FDA Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability
Courtesy FDA (http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html)
Contact: Daniel Movens: (313) 871-8400 – Thomas Versosky: (313) 556-4150

FOR IMMEDIATE RELEASE — DETROIT, March 31, 2009

Caraco Pharmaceutical Laboratories, Ltd. (NYSE AMEX: CPD), a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase.

Product Identification

Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with “437”

Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:

Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count)

Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-count)
57664-441-18 (1000-count)

Patients using Caraco’s Digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at (800) 818-4555, Monday through Friday, 8:00 a.m. – 5:00 p.m. EST, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions experienced with the use of all affected product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

EDITOR’S NOTE: In the UK, should you experience any serious problems with Digoxin, you should contact your doctor, NHS Direct, or call an ambulance.

From the FMS Global & UK News Desk of Jeanne Hambleton

Courtesy of WebMD – Feature from “Marie Claire” Magazine

By Anndee Hochman

Bottled water — already a more than $10 billion industry — is the fastest-growing beverage category in the U.S. But is it good for you? Here’s the pure truth.

Myth #1: BOTTLED WATER IS BETTER THAN TAP

Not necessarily. While labels gush about bottled water that “begins as snowflakes” or flows from “deep inside lush green volcanoes,” between 25 and 40 percent of bottled water comes from a less exotic source: U.S. municipal water supplies. (Bottling companies buy the water and filter it, and some add minerals.) That’s not really a bad thing: The Environmental Protection Agency oversees municipal water quality, while the Food and Drug Administration monitors bottled water; in some cases, EPA codes are more stringent.

Myth #2: PURIFIED WATER TASTES BETTER

The “purest” water — distilled water with all minerals and salts removed — tastes flat; it’s the sodium, calcium, magnesium, and chlorides that give water its flavor. The “off” taste of tap water is the chlorine; if you refrigerate it in a container with a loose-fitting lid, the chlorine taste will be gone overnight.

Myth #3: BOTTLED WATER WITH VITAMINS, MINERALS, OR PROTEIN IS MORE HEALTHY THAN REGULAR WATER

“Vitamins, color, herbs, protein, and all the other additions to water — those are a marketing ploy,” says Marion Nestle, Ph.D., professor of nutrition studies at New York University. Plus, the additives are usually a scant serving of the vitamins you really need in a day, adds Amy Subar, Ph.D., a nutritionist with the National Cancer Institute. Enhanced waters usually contain sugars and artificial flavorings to sweeten the deal and can pack more calories than diet soda. When it comes to providing fluoride, tap water usually wins, though that element is increasingly being added to bottled waters.

Myth #4: YOU NEED EIGHT 8-OUNCE GLASSES OF WATER EACH DAY

The Institute of Medicine recommends about 91 ounces (a little more than 11 8-ounce glasses) of fluid daily for women. But here is the thing: It expects 80 percent of that to come from water, juice, coffee, tea, or other beverages and the remaining 20 percent from food. That means if you drink a 12-ounce cup of coffee and a 12-ounce can of diet soda, you only need 48 more ounces (three 16-ounce glasses, or four soda cans’ worth) for the day.

Myth #5: AFTER AN INTENSE WORKOUT, BOTTLED WATER IS BEST

There is a reason volunteers hand out Gatorade during marathons. If your workout lasts longer than an hour, you need to replace the water and electrolytes, such as sodium and potassium, that you have lost (that is what sports drinks generally do). For less intense workouts, regular water is fine.

Myth #6: WATER BOTTLES ARE EASY ON THE ENVIRONMENT BECAUSE THEY CAN BE RECYCLED

Wouldn’t it be nice? And it is not just the bottles. Eco-costs include manufacturing, trucking, shelving, and marketing. And meeting the annual U.S. demand for plastic bottles requires enough oil to keep 100,000 cars on the road for a year, says Janet Larsen of the Earth Policy Institute. Sure, the 70 million empty water bottles the U.S. produces per day can be recycled, but the sad truth is, about 86 percent of them end up in the trash. Hardly worth it, for what flows out of the tap and into a reusable glass for free.

(http://www.webmd.com/food-recipes/features/top-6-myths-about-bottled-water?ecd=wnl_day_033109)

EDITOR’S NOTE: Often known as Adam’s Ale, as presumably he had nothing else to drink, did you know that water covers 70% of the earth’s surface and that water makes up between 60% to 70% of the human body. (http://encyclopedia.farlex.com/Adam’s+ale)

If you are really interested in learning more about Adam’s Ale, water, and wells, read Chapter 14 of Maybole, Carrick’s Capital Facts, Fiction & Folks by James T. Gray, Alloway Publishing, Ayr, first published 1972, reprinted on the following link below:
(http://www.maybole.org/history/Books/carrickscapital/adamsale.htm)

From the FMS Global News Desk of Jeanne Hambleton

Courtesy of Fibromyalgia Network – February 2009

While patients are rightfully concerned about not receiving adequate pain relief, physicians harbor fears about drug abuse, safety issues, and government oversight. New clinical guidelines for the use of chronic opioid therapy in chronic non-cancer pain patients, developed by consensus of the American Pain Society and the American Academy of Pain Medicine, may ease both patient and physician concerns.

The guidelines, published in the February issue of the Journal of Pain, offer a roadmap for physicians on how to safely prescribe opioids to patients with moderate to severe pain.* The authors specifically state that their report applies to patients with “chronic non-cancer pain conditions, including common conditions such as back pain, osteoarthritis, fibromyalgia, and headache.”

Throughout the guidelines, physicians are urged to evaluate their patients’ pain and function on a regular basis. And, if doctors are worried that a patient is abusing or misusing the prescribed opioid, they may need to reduce the time between scheduled office visits. In addition, physicians are encouraged to look at all of the available options for treating patients’ chronic pain, including the use of opioids, and it is emphasized that this class of medications will seldom provide sufficient pain control. This means that patients placed on opioids will likely need to be prescribed medications from other drug classes as well as non-drug therapies. And, physicians who do not have the skill-set to prescribe opioids need to coordinate their patients’ care with another doctor who is experienced in providing this therapy.

The American Pain Society emphasized the following three points to all its members this month:

The guidelines are comprehensive and evidenced-based to assist physicians in managing chronic opioid therapy, according to the American Pain Society President Charles Inturrisi, Ph.D

“Regular monitoring of chronic opioid therapy patients is warranted because the therapeutic benefits of these medications are not static and can be affected by changes in the underlying pain condition, coexisting disease, or in psychological or social circumstances,” said Gilbert J. Fanciullo, M.D., director of the division of pain and palliative care at Dartmouth Hitchcock Medical Center.

Cochair Perry Fine, M.D., professor of anesthesiology at the University of Utah Medical Center, added that doctors do not have to solely rely upon patient self reports. Pill counts, urine drug screening, family member or caregiver interviews, and prescription monitoring data may all be used to check for possible abuse or other opioid-related problems.

The message is clear that under most circumstances, there are reasonable ways for physicians to prescribe chronic opioid therapy for their patients in pain while emphasizing safety issues and minimizing side effects or the potential for drug misuse. The guidelines offer physicians 25 recommendations with detailed explanations on how to follow them—all to help doctors prescribe opioids to their chronic pain patients in a responsible fashion. In addition to the key points already made, here are other highlights from the published guidelines:

Clinicians may consider a trial of chronic opioid therapy (COT) for moderate to severe pain that is having an adverse impact on a patient’s function or quality of life as long as the therapeutic benefits outweigh the risks (abuse, misuse and addiction). Three different patient screening tools (questionnaires that are easy to administer) are included with the guidelines to help doctors assess potential risks associated with COT for a given patient (the SOAPP, the ORT, and the DIRE).

Before initiating a trial of COT, physicians should provide their patients with informed consent, which alerts patients to all of the potential risks associated with taking opioids. After informed consent, doctors should discuss with their patients a COT management plan that outlines the goals of therapy, expectations, monitoring requirements, etc. A sample consent form and management plan are included in the guideline.

Initial treatment with an opioid should be regarded as a therapeutic trial to determine if COT is effective. If the first opioid does not work or produces adverse side effects, other types of opioids may be tried, but patients need to keep in mind that opioids are prescribed on a trial basis.

Physicians should anticipate, identify, and track common opioid-associated side effects. Constipation is the most frequent problem, and unfortunately it does not go away or get better with continued use of the medication. With this in mind, doctors should recommend stool softeners or increased fiber intake when issuing patients an opioid prescription. Nausea or vomiting may occur but tends to diminish over a few days. If it lasts longer, doctors can prescribe a medication to treat this side effect. Sedation and clouded thinking usually goes away with continued opioid use, while reduction in sex hormones may appear down the road with COT. If a patient begins to experience a decrease in libido, sex hormones can be checked and supplemented if necessary. Other side effects may also occur, so patients and physicians need to be on the lookout for them.

Chronic pain is often a complex condition and physicians who prescribe COT should routinely promote other therapies, such as psychotherapy (pain can be awful to cope with), physical and occupational therapies for restoring function, and other non-drug approaches in addition to prescribing other non-opioid medications. The purpose of this recommendation is to treat the whole person and improve the odds that a patient with chronic pain will achieve a more fulfilling life.

Doctors need to counsel patients prior to starting COT and continue until a stable dose is reached or if the dose is later increased as the patients’ cognitive skills may be impaired for a short period of time. If clouded thought processes do occur, driving should temporarily be avoided … so patients might want to start an opioid on a weekend when they do not have to drive. After a stable dose is reached, there is no evidence to suggest that patients on COT should be restricted from driving or engaging in most work activities.

The opioid guidelines give your doctor the “how to” advice for prescribing opioids, including sample copies of patient screening questionnaires, a consent form, management plan, and full details on how to responsibly prescribe opioids. However, they also assume that the prescribing physician is already knowledgeable about issues concerning this class of medications (i.e., the guidelines cannot possibly convert a novice into an expert on COT). Neither the patient nor physician should feel awkward about the consent and management forms, or random urine tests. Doctors who follow these guidelines should be better equipped to implement opioid therapies for their chronic pain patients (such as fibromyalgia) in a safe manner.

* Chou R, Fanciullo GJ, Fine PG, et al. J Pain 10(2):113-130, 2009.

Calling the Kettle Black
… editorial comment

By Kristin Thorson, Editor, Fibromyalgia Network

Posted: February 27, 2009

If your newspaper ran the February 8th Associated Press article “Drugmakers’ push boosts ‘murky’ ailment,” implying that the drug industry has fabricated fibromyalgia in an effort to churn a profit, you have every right to be furious!1 Controversy sells, and that was what the reporter, Matthew Perrone banked on. Perrone sought out Fred Wolfe, M.D., of Wichita, KS, because he knew from the January 14, 2008 front-page article in the New York Times that Wolfe had a track record for trashing patients with fibromyalgia and big, bad pharma as well. It is ironic, however, that Wolfe would make derogatory statements about the drug industry when he is heavily funded by six drug companies himself.

Wolfe is the director (and paid employee) of the National Data Bank for Rheumatic Diseases, a nonprofit registered as The Arthritis Research Center Foundation, Inc. Its mission is “conducting ongoing research to improve conditions for people with arthritis, fibromyalgia, lupus and other conditions.” He openly declares in his research papers, in which he is testing the effectiveness and safety of drugs for rheumatoid arthritis, that he is funded by Centocor, Aventis, Pfizer, Bristol-Myers Squibb, Amgen, and Abbott. So perhaps Wolfe’s dislike is not so much for the drug industry as it seems for fibromyalgia.

Prompted by mixed reports on increased cancer rates in people with rheumatoid arthritis (RA), Wolfe conducted an observational study on the incidence of cancer in RA patients who took the tumor necrosis factor (TNF) blocking agents Enbrel (etanercept) or Remicade (infliximab).2 His findings were derived from information in the National Data Bank (NDB) and per the NDB’s agreement with Centocor, the maker of Remicade, the drug company was allowed to review Wolfe’s manuscript prior to publication. But Wolfe does not just cater to Centocor. His NDB organization has similar contractual agreements with Bristol-Myers Squibb and Sanofi-Aventis.

Wolfe’s study contradicted earlier reports of increased cancer risks for RA patients taking Enbrel or Remicade. It also confirmed that TNF blocking drugs are linked to skin cancers, including potentially deadly melanomas. Instead of using his findings to alert the medical community that these drugs may pose a health hazard, Wolfe went on record with WebMD as stating: “The drugs, at this moment, do not seem to add any risk except for skin cancer and melanoma. This is a small overall risk and I do not think people should be concerned.” He also added that the risks did not outweigh the benefit for patients who truly need the new drugs.3

While there is no argument that people with RA deserve effective therapies, do you not think it is odd that Wolfe is the one pushing drugs on RA patients while in the recent AP article he bashes the drug industry for fabricating fibromyalgia to boost their sales? Yet he is quoted in the AP article as saying, “I think the purpose of most pharmaceutical company efforts is to do a little disease-mongering and to have people use their drugs.” Further in the article he says, “The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials.” Wolfe’s negative sentiments about fibromyalgia appear clear in a February 2009 report in which he writes, “Recently, regulatory authorities have approved treatments for fibromyalgia, offering some de facto support, although no proof, for fibromyalgia as a distinct disorder.”4 However, there was a time when RA had no “proof,” but that does not mean that the patients who suffered with it years ago did not have a real disease.

It is true that Wolfe was the lead author for the 1990 American College of Rheumatology criteria for fibromyalgia, but that was 18 years ago and much has changed.5 In 1990, the number of rheumatologists who were skeptical about the realness of fibromyalgia far outnumbered the believers. I should know, because I hosted an information booth on fibromyalgia at the annual rheumatology meetings throughout the 1990s, and in the early years I can attest to the ugly controversies surrounding this disease.

In 1994, Wolfe orchestrated a consensus conference (paid by the insurance industry) whose primary goal was to trivialize fibromyalgia and restrict patient care.6 Why he wanted to turn his back on fibromyalgia is still unknown, but his efforts failed. During the past eight years, the rheumatologists have rallied to increase the legitimacy of fibromyalgia by developing guidelines for improving the quality of research and for testing therapies to treat this patient population. Today, Wolfe and many of his colleagues do not see eye to eye when it comes to issues concerning fibromyalgia. At age 74, he appears to get his jollies by trash-talking fibromyalgia to headline-mongering reporters.

For all of you who were subjected to the AP story, I hope my comments help you understand the nonsensical nature of the article and that you can ignore any future reports that happen to quote Wolfe. I also want to make three additional points about the AP article:

Although Wolfe’s own nonprofit takes money from the drug companies, this does not mean that all nonprofits and organizations that help patients must do the same to stay afloat. Fibromyalgia Network and its sister organization, the American Fibromyalgia Syndrome Association (AFSA), have never received money from the pharmaceutical industry or other companies that could bias the way these two organizations operate.

Daniel Clauw, M.D., of the University of Michigan, did receive a small grant award from the National Fibromyalgia Research Association (NFRA) in Salem, OR, but the NFRA should not be confused with the National Fibromyalgia Association (NFA). NFRA does not receive money from the drugmakers.

The article implies that Clauw’s brain imaging research, which has documented many brain processing abnormalities over the past ten years, was tainted by drug money. That simply is not true because the funding for these studies came from government grants based on the merits of his proposals. “Most of us conducting research in the field of fibromyalgia were here ten years before the drug industry even took notice of this disease,” Clauw points out.

Perrone M. Associated Press © hosted by Google, Feb 8, 2009; (AP article).
Wolfe F, Michaud K. Arthritis Rheum 56(9):2886-2895, 2007.
DeNoon DJ. WebMD Health News Aug. 29, 2007; (WebMD article).
Wolfe F, Michaud K. J Rheumatol First Release Feb. 15, 2009; doi:10.3899/jrheum.080897.
Wolfe F, et al. Arthritis Rheum 33(2):160-72, 1990.
Wolfe F. J Rheumatol 23(3):534-9, 1996.

Kaufmann I, et al. Rheumatol Int [epub ahead of print] December 4, 2008.
Kaufmann I, et al. Clin Immunol 125:103-111, 2007.

(http://www.fmnetnews.com/basics-news.php#opioid)
All information on this site is copyrighted by
Fibromyalgia Network, P.O. Box 31750, Tucson, AZ 85751 (800) 853-2929.
This site is provided for informational purposes only. To remain unbiased, we do not accept endorsements, advertisements, or pharmaceutical industry grants. Patients should always consult their physician for medical advice and treatment.

From the FMS News Desk of Jeanne Hambleton
Without prejudice
Courtesy of NewsInferno.com
Date Published: Wednesday, March 18th, 2009

Eli Lilly recently spent millions promoting Cymbalta as a treatment for the controversial disease, fibromyalgia. Now, the Epoch Times places the figure donated by the company to nonprofits to “educate” doctors about the disease at nearly $4 million. Fibromyalgia, a chronic, widespread pain condition of unknown origin, is a controversial diagnosis with no biological diagnostic tests, nor links to any environmental or biological causes.

Some criticized Lilly for seeming to ignore established diseases such as diabetes and Alzheimer’s in order to fund research on fibromyalgia, said the Epoch Times, noting that Cymbalta—generically known as duloxetine—is Lilly’s second highest selling drug.

Cymbalta has long been linked with suicidal problems, yet is being researched for a wide and growing array of ailments. Approvals are expected for its use in the treatment of chronic knee and low-back pain and, said the Epoch Time. According to the report, it is also being studied as a treatment for binge eating, social phobia, chronic fatigue, restless legs disorder, seasonal affective disorder, migraines, attention deficit disorder and childhood depression. Research is also looking into Cymbalta as a possible remedy for PMS, menopause, alcoholism, panic disorder, obsessive compulsive disorder, kleptomania, and tennis elbow.

The drug, which is linked to serious pediatric risks, continues to be looked at for treatment of childhood depression, the Epoch Times said.

The Epoch Times detailed some troubling situations involving Cymbalta (some were outlined in the February 2008 Journal of Clinical Psychopharmacology by four physicians from the Department of Psychiatry and Behavioral Sciences at the University of Kansas Medical Center), including:

* The hanging death of a 19-year-old test subject in a Cymbalta Clinical Trial at the Lilly Clinic in 2004 who had no prior history of mental illness.

* The carbon monoxide suicide attempt by a man in his late 30s after taking Cymbalta for back pain for a couple of months

* Suicidal ideation in a 63-year-old man with no prior history of such ideation and who was prescribed Cymbalta for fatigue, insomnia, and sadness.

* A Texas man prescribed Cymbalta for peripheral neuropathy suddenly killed himself.

* A 19-year-old college student recently prescribed Cymbalta hanged himself after completing some routine job search tasks.

* A 21-year-old college student recently prescribed Cymbalta, took his own life three minutes after speaking to his family while driving home and sounding fine.

Soon after the first suicide, an unflinching U.S. Food and Drug Administration (FDA) approved Cymbalta as an antidepressant and for diabetic nerve pain in 2004, said the Epoch Times. It 2007 it was being prescribed for general anxiety disorder and maintenance treatment of depression; and, in 2008, it was being prescribed for fibromyalgia.

WA Today reported that in Australia, Lilly was making a “concerted effort” to promote Cymbalta off-label at up to “twice the approved dose” for depression-related physical pain. In that country, WA said that Lilly was fined $100,000 and had to remove all promotional material. Lilly appealed, claiming its material was “educational”; the appeal was dismissed. Lilly mailed an apology to all Australian doctors for “any unintentional confusion” over the marketing of Cymbalta, admitting the material might have been misleading, and might have suggested using a higher than appropriate dose of the drug, reported WA Today.

Eli Lilly has faced scandals over drug promotions before. It recently agreed to pay $1.42 billion in the U.S. to settle claims it illegally marketed Zyprexa.

© 2005 NEWSINFERNO.COM

http://www.newsinferno.com/archives/5137

From the FMS News Desk of Jeanne Hambleton

NEW YORK (CBS) ― HEALTH
Courtesy © MMIX, CBS Broadcasting Inc. All Rights Reserved

Millions of Americans suffer from Fibromyalgia, an illness that often leaves patients unable to function because of intense pain. Despite the severity of the condition, there are limited treatments available. But a new drug recently approved by the FDA is offering patients new hope.

Karen Morse remembers when making lunch for her two sons was nearly impossible. “It was a lot of pain. I’d wake up in the morning, can’t get out of bed; I couldn’t function,” Morse described. “I couldn’t take care of my kids.”

The 41-year-old mother suffers from Fibromyalgia, an illness that causes chronic, debilitating pain. Patients are more sensitive to pain, and feel it longer. The condition even forced Karen to quit her job.

Karen recently took part in a trial for the newly FDA-approved drug Savella. With the help of the medication, Karen is getting her life back.

“I feel so much better. I’m more alive. I am almost myself again, my old self again,” Karen said happily.

Nearly six-million Americans suffer from Fibromyalgia. Sufferers are often misdiagnosed because there is no obvious cause for the pain. There is no cure, though doctors say patients can manage the illness with medicine, in addition to sleeping right and exercising.

But the intense pain often triggers a vicious cycle. “If you have pain, it’s harder to sleep, and if you don’t have sleep, you wake up even more fatigued and more muscles still the next day,” explained Dr. Alan Manevitz, a Clinical Psychiatrist at New York’s Presbyterian Hospital and Weill Cornell Medical Center.

Doctors say the new drug could help patients take the steps they need to feel better. “Savella is a medication that impacts on the chemistry of the brain and helps with the chemicals that make the pain felt,” Dr. Manevitz clarified. The drug’s maker says Savella should be available, with a prescription, later in 2009.

After just a few weeks on the drug, Karen has begun working full-time. She went on a cruise with her husband and even attended a high school reunion at a roller rink. Now, she hopes her story will lead others to seek out the help they need to manage the pain and enjoy their lives.

(http://cbs4.com/)

From the FMS News Desk of Jeanne Hambleton

COURTESY usnews.com Health Day – Monday March 16

Capsaicin works on nerves to ease joint discomfort, scientists say

(HealthDay News) – University of Buffalo scientists say they have found how capsaicin, the compound that gives chili peppers their fiery flavor, also works to relieve joint and muscle pain.

In a study appearing Tuesday in the journal PLoS Biology, researchers found that capsaicin flips on nerve-ending receptors that sense both pain and heat.

“The receptor acts like a gate to the neurons. When stimulated it opens, letting outside calcium enter the cells until the receptor shuts down, a process called desensitization,” study leader Feng Qin, an associate professor at the university’s School of Medicine and Biomedical Sciences, said in a news release issued by the institution.
The flood of calcium changes the levels at which the receptors detect pain signal. “In other words, the receptor had not desensitized per se, but its responsiveness range was shifted,” Qin said.

While capsaicin has been used in folk medicines for generations, knowing how it works in relation to PIP2 may lead to developing other analgesics that ease pain without first causing irritation on their own, the team said.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about capsaicin .
(http://health.usnews.com/articles/health/healthday/2009/02/25/chili-pepper-compound-can-bring-pain-relief.html)

Finding Effective Treatment for Your Chronic Pain

Studies are underway to look into the effectiveness of alternative ways of delivering pain medications

By January W. Payne

Chronic pain is a problem that—when healthcare, lost income, and lost productivity are taken into account—is estimated to cost about $100 billion in the United States each year. More than a quarter of Americans age 20 or older, or about 76.5 million people, say they’ve experienced pain that lasted longer than 24 hours, according to the American Pain Foundation—and 42 percent have endured pain lasting longer than a year. Nobody keeps good long-term national stats, but if North Carolina’s experience is any guide, the numbers are on the rise.

A just-published study in the Archives of Internal Medicine found that the prevalence of chronic low-back pain in the state more than doubled, to 10.2 percent, between 1992 and 2006. Paul J. Christo, assistant professor and director of the Multidisciplinary Pain Fellowship at the Johns Hopkins University School of Medicine, calls undiagnosed, untreated, or undertreated pain a “significant public-health problem.”

Chronic pain encompasses a multitude of ills, from back pain, headaches, neck pain, and conditions like arthritis and fibromyalgia to pain that develops as a result of cancer treatment and lingers for months or even years. Low-back pain, migraines, and joint pain (particularly in the knees) are among the most common complaints, according to the National Center for Health Statistics. knee pains,

Still, while it may have different origins, chronic pain “can be viewed as an illness in its own right because of its effect on function,” says Russell Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center in New York City.

Studies have shown that some people with chronic pain have brain abnormalities, though the connection between that and pain is not well understood. One recent study, for instance, showed that women with fibromyalgia had blood flow abnormalities in a region of the brain known to discriminate the intensity of pain that were not observed on CT scans done in healthy women.

Another study showed that chronic pain may harm the wiring of the brain, as demonstrated on functional MRIs. Chronic pain may also be caused by a problem with the “fight or flight” response, Christo says. “We believe that in certain pain conditions . . . the stress response can worsen pain because that stress response releases a chemical called noroepinephrine. . . . And noroepinephrine binds to certain receptors in the body that trigger pain.”

“Pain is essentially an alarm system that is designed to grab your attention, and when it works properly, it signals harm or healing,” says Scott Fishman, professor and chief of the division of pain medicine at the University of California-Davis School of Medicine. When the body heals, the pain should dissipate, but “the nervous system can become injured,” Fishman says. “That’s when the symptom of pain becomes the disease of chronic pain.”

Finding relief can take quite an effort, since the causes are often not immediately clear and there is not a sure-fire treatment. The battle can require a team of experts, so the multidisciplinary pain clinics or pain management programs that have sprouted up at hospitals, rehab centers, and in free-standing facilities over the past decade or so may be of particular help.

The clinics provide an all-in-one setting for care that, in addition to pain management specialists who may be trained as neurologists, psychiatrists, physiatrists, or anesthesiologists, may include physical therapists, family and vocational counselors, and massage therapists, for example. (The American Chronic Pain Association offers advice on selecting a pain clinic.)

After a full assessment, tailored treatment may include medications from anti-inflammatory drugs to antidepressants to opioids. Since commonly prescribed opioid medications such as oxycodone, fentanyl, and morphine can cause addiction, the American Pain Society and the American Academy of Pain Medicine have just released the first comprehensive clinical practice guidelines to help physicians make treatment decisions.

The guidelines, published in the Journal of Pain, suggest that physicians regularly assess people taking long-term opioids and do periodic drug screenings of patients who are considered to be at risk for abuse or addiction. Meanwhile, the Food and Drug Administration announced plans this month to require the brand-name and generic makers of morphine, oxycodone, fentanyl, and methadone to assist with a plan to reduce the risks associated with the drugs.

Other treatment options include injections of steroids or other medications, nerve blocks that interrupt pain signals, physical therapy, alternative therapies, and psychological interventions such as cognitive behavioral therapy, biofeedback, and guided imagery and other relaxation techniques. Acupuncture, which some people with pain find helpful, is thought to ease pain by raising the level of endorphins in the body, Christo says. “Endorphins are sort of like opioids. . . . They are natural pain relievers,” he says.

“They are released when the body experiences pain—when you sprain your ankle, cut your finger, in response to injury.” Still, research offers conflicting conclusions about the pain-relieving effects of acupuncture. A review of 13 studies published last month in British Medical Journal found that acupuncture offered only a small level of pain relief for people with low-back pain, migraines, knee osteoarthritis, and postoperative pain.

Jennifer Phillips, 41, of Providence Forge, Va., saw 54 doctors before the fibromyalgia that caused her pain was diagnosed in 1996. Finally, after seeing an internist whose nurse had fibromyalgia, she found a routine that works for her: a combination of proper sleep (achieved, in part, using the tricylic antidepressant amitriptyline), daily supplements of vitamins, magnesium, and potassium, plenty of water, and a low-carb diet.

The search is on for greater relief. Studies are underway to look into the safety and effectiveness of alternative ways of delivering pain medications, such as an inhaled form of fentanyl that would get the drug into the patient’s system more quickly. For older people who have fractures of the spine, vertebroplasty and kyphotlasty—two minimally invasive techniques in which bone cement is injected into the collapsed bone in the spine—can result in “significant pain reduction,”

Christo says. In the ongoing debate over how best to handle back pain, a study just published in the Journal of the American Academy of Orthopaedic Surgeons finds that the most effective way to treat most degenerative disc disease cases is to combine physical therapy and anti-inflammatory medications, rather than having surgery.
While it may seem counterintuitive, people with chronic pain should try to get exercise. Experts say it is important to keep moving, both for the usual cardiovascular reasons and in order to avoid muscle atrophy. A supervised, individually designed exercise program, incorporating stretching or strengthening, may improve pain and functioning in people with chronic low-back pain, according to a 2005 study published in Annals of Internal Medicine.

A physical therapist or personal trainer can offer the necessary advice. In fact, staying in bed for more than a day or two can make back pain worse, according to the National Library of Medicine’s MedlinePlus.

Jeff Nance of Indianapolis, whose chronic pain is caused by degenerative disc disease and spinal stenosis of his lower back, recalls that he barely wanted to leave his home three years ago. Then he discovered the Meridian Health Group pain clinic in Indianapolis. Now he is working full time again, and he recently participated in an annual bike ride across the state of Indiana. Nance goes back to the clinic every few months for a check of his medications, and he sees a psychologist a couple of times a month.

“What we try to do is really recognize that people can have pain for all kinds of reasons, [and we] find as many of those causes as possible and treat them in the most specific fashion as possible,” says Michael Clark, associate professor and director of the Chronic Pain Treatment Program in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins Hospital. “Ultimately, you’d like to get somebody well.”

(http://health.usnews.com/articles/health/pain/2009/02/10//finding-effective-treatment-for-your-chronic-pain.html?loomia_ow=t0:a41:g2:r2:c0.160667:b22273524&s_cid=loomia:chili-pepper-compound)

Copyright © 2009 U.S.News & World Report LP All rights reserved.

On Friday, the FDA posted the first of its quarterly reports on drrugs it is investigating for safety reasons based on post marketing adverse events reports it has received from patients and doctors, in line with new legislation introduced last year (Title IX, Section 921 of the Food and Drug Administration Amendments Act of 2007).

The first report listed 20 drugs identified based on a review of reports in FDA’s Adverse Event Reporting System (AERS).

According to the FDA, “Drugs that appear on the agency’s new AERS-based table, titled “Potential Signals of Serious Risks/New Safety Information,” are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk”.

The FDA will name the drug and the nature of the “adverse events” but will not describe their seriousness or the number of complaints received. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

If patients have questions or concerns because their drug appears on the list they should talk to their doctor, as director of FDA’s Center for Drug Evaluation and Research, Dr Janet Woodcock explained:

“My message to patients is this: Don’t stop taking your medicine.”

The list will be new every quarter; it will not show any drugs that appeared on previous lists that are still under investigation.