F.D.A. TO PLACE NEW LIMITS ON PRESCRIPTIONS OF NARCOTICS

From the News Desk of Jeanne Hambleton

By GARDINER HARRIS -Published: February 9, 2009

WASHINGTON — Many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce the deaths and injuries that result from these medicines’ inappropriate use, federal drug officials announced Monday.

A new control program will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like OxyContin, fentanyl patches, methadone tablets and some morphine tablets.

These products are classified as Schedule II narcotics and already are restricted according to rules jointly administered by the Food and Drug Administration and the Drug Enforcement Agency. But the current restrictions have failed to “fully meet the goals we want to achieve,” said Dr. John K. Jenkins, director of the F.D.A.’s new drug center.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” Dr. Jenkins said in a news conference on Monday. “This is going to be a massive program.”

Hundreds of patients die and thousands are injured every year in the United States because they were inappropriately prescribed drugs like OxyContin or Duragesic or they took the medicines when they should not have or in ways that made the drugs dangerous. The agency has issued increasingly urgent warnings about the risks, but the toll has only worsened in recent years.

The blame for this is shared among doctors who prescribe poorly, patients who pay little attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally.

The F.D.A. this year will hold meetings with manufacturers, patient and consumer advocates, and the public to ask for advice on how to carry out the new control program, officials announced. The first meeting will be on March 3, and no immediate changes in access to the drugs is planned.

The 24 medicines under review had 21 million prescriptions written for them in 2007, to 3.7 million patients, Dr. Jenkins said. They are extremely effective in reducing pain, which many medical studies suggest is widely undertreated in patients suffering serious illness. (A complete list of the drugs is at www.fda.gov/cder.)

But many doctors prescribe the drugs far too cavalierly, Dr. Jenkins said. The F.D.A. has received reports of patients’ being prescribed such medicines to treat something as simple as a sprained ankle, he said. In such patients, the medicines can be dangerous.

Part of the problem is marketing. Several reports, for instance, have suggested that Purdue Pharma, the maker of OxyContin, helped fuel widespread abuse of the drug by aggressively promoting it to general practitioners not skilled in either pain treatment or in recognizing drug abuse.

The company has denied such a connection, but a holding company connected with Purdue and three top Purdue executives pleaded guilty last year to criminal charges that the company had misled doctors and patients by claiming for five years that OxyContin was less prone to abuse because it was a long-acting narcotic.

Doctors are also to blame. A common reason for disciplinary actions at state medical boards is the use of narcotics in patients who show clear signs of addiction or for whom the drugs are obviously inappropriate.

The F.D.A. generally avoids interfering with the practice of medicine because doctor behavior is governed by state medical boards. Instead, the agency usually tries to provide doctors with the best and most current information, and then allows them to decide how to use it.

Most of the drugs withdrawn over the last 20 years, however, were taken off the market because doctors continued to use the medicines in ways that the F.D.A. warned against.

For decades, the agency’s armory in these battles held only a popgun and a cannon — the popgun being the issuance of widely ignored warnings; the cannon being its ability to force a medicine’s withdrawal. But a law passed in 2007 gave the agency a new, intermediate weapon — Risk Evaluation and Mitigation Strategies. Known as REMS, these programs allow the agency to place strong restrictions on the distribution of certain drugs.

 

Courtesy New York Times (Money & Policy – Health Alert) Copyright  & All Rights Reserved 

(http://www.nytimes.com/2009/02/10/health/policy/10fda.html?_r=1&emc=tnt&tntemail1=y)

 

 

PIERRE FABRE MEDICAMENT AND FOREST LABORATORIES TO COLLABORATE ON DEVELOPMENT AND COMMERCIALIZATION

From the Desk of Jeanne Hambleton – courtesy PR-Canada.Net. 

 (http://pr-canada.net/index.php?option=com_content&task=view&id=71522&Itemid=61)

Saturday, 27 December 2008

Forest Laboratories, Inc. and Pierre Fabre Medicament today announced that they have entered into a definitive collaboration agreement to develop and commercialize F2695 in the United States and Canada. F2695 is a proprietary selective norepinephrine and serotonin reuptake inhibitor that is being developed by Pierre Fabre for the treatment of depression and other central nervous system disorders.    Under the terms of the agreement, Forest will make an upfront payment to Pierre Fabre of $75 million and will pay future, undisclosed milestone payments. In addition, Pierre Fabre will receive royalty payments based on F2695 sales. Forest will assume responsibility for the clinical development and commercialization of F2695 in the United States and Canada, while Pierre Fabre will fund all preclinical development and drug substance manufacturing activities worldwide. “We are pleased to expand our relationship with Pierre Fabre to include this collaboration on the development of F2695 for the treatment of depression. Pierre Fabre has been an outstanding partner for Forest since we commenced our alliance in 2004,” commented Howard Solomon, Chairman and Chief Executive Officer of Forest. “We are highly encouraged by the strong clinical antidepressant activity and good tolerability exhibited by F2695 in the recently completed placebo-controlled, double-blind Phase II study. We look forward to initiating Phase III studies with F2695 next year. F2695 is the second late-stage product candidate we have licensed this quarter, underscoring our commitment to further building our pipeline and bringing novel therapeutics to the market.” “Pierre Fabre is looking forward to working with Forest on this exciting product opportunity,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre Medicament. “Forest has an excellent record of developing and commercializing products for the treatment of depression and we are happy to extend our existing partnership to include F2695.” In a recently completed European placebo-controlled, double-blind Phase II study of F2695 in over 550 patients with major depressive disorder, the compound demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (“MADRS”). Statistically significant improvement for F2695 compared to placebo was also demonstrated using the change from baseline in the Hamilton Depression Rating Scale (“HAMD-17″) and in response and remission rates using both the MADRS and HAMD-17. In addition, F2695 demonstrated improvement compared to placebo within two weeks after treatment initiation. About F2695 F2695 is an isomer of milnacipran and is protected by a method of use patent that extends through June 2023. F2695 exerts its effects by selectively inhibiting the reuptake of both norepinephrine and serotonin, two neurotransmitters known to play an essential role in regulating mood. Forest, in partnership with Cypress Bioscience, Inc. and Pierre Fabre, is currently developing milnacipran; a selective serotonin and norepinephrine dual reuptake inhibitor, for the management of fibromyalgia. The New Drug Application is under FDA review and we continue to plan for a first quarter 2009 product launch meeting About Pierre Fabre Medicament The Pierre Fabre Group, the second largest independent laboratory in France, employs some 10,000 people, and achieved a turnover of 1.7 billion euros in 2007. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands: Avene, Ducray, A-Derma, Galenic, Klorane and Rene Furterer and dermo-cosmetics. Pierre Fabre Medicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1,400 employees dedicated to R&D, Pierre Fabre Medicament has invested 30% of its annual sales to R&D during 2008, in five major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament, with 50% of all R&D expenses), psychiatry, urology, cardio-vascular, rheumatology. To learn more about Pierre Fabre, visit http://www.pierre-fabre.com. About Forest Laboratories Forest Laboratories is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com. Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

 

NEW DATA ON THERAPIES FOR PAIN AND INFLAMMATION FROM PFIZER

By Jeanne Hambleton © Fibromite NFA Leader Against Pain

While I am a great believer in positive thinking, I have to accept that medication can be the only way that allows some people to live with pain and this impossible invisible condition called fibromyalgia. From this point of view I must say I am pleased that the drug companies are continuing to find ways of easing our pain and hopefully one day will find a cure.
This morning I received a press release from Pfizer who are working to help those of us with fibromyalgia and arthritic problems. I wanted to share this with you and the full report is listed below.

Having read this one of my greatest hopes is that the UK medical authorities will, in the near future, give its blessing to Lyrica, Cymbalata and now Esreboxetine.

Let us hope if these new drugs are approved in the UK that there will be no ‘post code lottery’ by the NHS for the prescription of these medications. Currently British fibromites are victims of the lack of approval of any specific fibromyalgia drugs. While American patients are able to gain relief from the new drugs, it seems the UK fibromites must suffer in silence.

In recent years I have read and signed numerous epetitions appealing to the Prime Minister Gordon Brown to bring some relief to those of us with fibromyalgia. The epetitions have asked for research, better education of doctors and specialists, fibromyalgia clinics and much more – but all have met with lame excuses. This has nothing to do with the current financial crisis. We have been writing to Prime Ministers – Tony Blair and Gordon Brown -for years. What do we have to do to get attention – camp out in our wheelchairs outside the Houses of Parliament? We might get more press coverage that way!

I am not surprised that Guy Fawkes chose to blow up the Houses of Parliament on November 5 if this was the only way he could get the attention of those working inside that building. Maybe we need a fictional Gun Powder Plot to enlighten the Government and spur the MPs into allocating funds for research to find a cure for fibromyalgia. But it does appear that nothing seems to stir those in the ‘corridors of power’.

A little correction here – according to Hansard and TheyWorkforYou on October 14 Dr John Pugh MP (Shadow Minister, Treasury; Southport, Liberal Democrat) is reported to have said, “…I was recently approached by someone in my constituency who suffered from a disease called Fibromyalgia, which had to be explained to me. That person found that there was wholesale ignorance of the disease in all parts of the NHS and many parts had been accessed about the condition.”

Hooray for John Pugh. Shall we all write to our MPs and talk about the ‘F’ word? You do know I mean F for fibromyalgia, I hope! I am not into writing about politics but for goodness sake if someone wants to win the next election they should become our champion – do something about the plight and despair of the fibromites. That should get them at least 2 million votes plus their families and friends. I wonder why are we treated as second class citizens? Just because we have an invisible disability it does not mean we have no feelings and do not deserve some respect. What do you say?

As a matter of interest something like 10 years ago the public were ignorant about ME. Today everyone has heard of it? We must spread the ‘F’ word – fibromyalgia. I have banned the other ‘F’ word in my house. Now we all say ‘fibromyalgia’ when we lose our temper and burst into fits of laughter.

Results from Clinical Trials Show Promise for Innovative Therapies in Rheumatoid Arthritis and Osteoarthritis Pain and Fibromyalgia

SAN FRANCISCO–(BUSINESS WIRE)–Pfizer will present data on three investigational compounds that represent potential new mechanisms for targeting pain and inflammation. These data will highlight tanezumab, a molecule designed to target nerve growth factor, a key pain mediator; CP-690,550, a JAK-inhibitor that suppresses immune-related inflammatory response; and esreboxetine, a highly-selective norepinephrine reuptake inhibitor which plays a role in controlling the activity of this important neurotransmitter. These data will be presented at the 2008 American College of Rheumatology Scientific Meeting in San Francisco, California.

“Pfizer has an established track record of bringing innovative therapies to patients suffering with pain and inflammation,” said Martin Mackay, Ph.D., president, Pfizer Global Research and Development. “Data to be presented at ACR confirm our clinical approaches in developing these three compounds – CP-690,550, esreboxetine and tanezumab – as potential new medicines to provide relief from these serious medical conditions.”

Fibromyalgia

Pfizer is a pioneer in the study of fibromyalgia, investing many years of research into treatment options for this complex pain condition. In June 2007, Lyrica (pregabalin) CV became the first FDA-approved treatment for the management of fibromyalgia. Data supporting that approval showed Lyrica patients experienced significant reduction in pain as early as week one in some patients.
While widespread pain is the cornerstone of fibromyalgia, the condition is also characterized by other hallmark symptoms such as fatigue and difficulty concentrating.

Data presented at ACR will highlight the results of a phase 2 proof of concept study with esreboxetine, a highly selective norepinephrine reuptake inhibitor in a fibromyalgia population.
Data from this study showed that esreboxetine may be effective in relieving in key fibromyalgia symptoms, including pain, function and fatigue and was generally well tolerated. In the study, 43 percent of patients receiving esreboxetine reported their condition was much improved or very much improved as compared to 23 percent of placebo-treated patients.

The most common side effects compared to placebo were constipation, insomnia, dry mouth, headache and nausea. The proportion of patients who discontinued as a result of adverse events was 8.2 percent in the esreboxetine group and 2.3 percent in the placebo treatment group.
Fibromyalgia has been recognized by the professional community for over 30 years as a common, chronic widespread pain condition and is now thought to affect up to six million Americans. Recent evidence suggests a neurological basis to fibromyalgia, as demonstrated by brain scans and altered levels of certain neurotransmitters.

Rheumatoid Arthritis

Data is being presented from several clinical trials studying CP-690,550, an oral medication that inhibits the Janus Kinase enzyme (JAK). This enzyme plays a major role in controlling the activation and proliferation of white blood cells, key elements of the immune system, which play a major role in rheumatoid arthritis (RA). CP-690,550 has shown encouraging results for the treatment of rheumatoid arthritis at doses that don’t appear to be associated with excessive immune suppression.

Investigators will present interim results from a late-breaking Phase 2B study evaluating the activity of CP-690,550 in combination with methotrexate, the most commonly-used RA treatment. Approximately 60 percent of patients on doses at or above 3 mg of CP-690,550 responded to treatment as compared to 37.7 percent on placebo. These data confirm and extend the promising data seen in an earlier phase 2A study to this longer, 12 week study, and to patients who are already taking methotrexate to treat their rheumatoid arthritis.

Also being presented is a pharmacokinetic drug interaction study which showed that CP-690,550 and methotrexate can be co-administered without dose adjustment. In addition, preliminary results from an open label extension study will be presented.

In these studies, the most commonly reported adverse events were nausea, headache, dizziness, disorientation, hot flushes, urinary tract infections, diarrhea and liver function tests. Larger and longer phase 3 studies are expected to start in 2009 to help further define the benefits and risks of CP-690,550 as a potential treatment for rheumatoid arthritis.

According to the Arthritis Foundation, 1.3 million Americans live with rheumatoid arthritis, a type of arthritis that can be severe, debilitating, deforming and even shorten life.

Osteoarthritis Pain

Pfizer continues to research new ways of treating osteoarthritis pain. Two studies to be presented highlight a new compound in development and new data for Celebrex (celecoxib) in the treatment of osteoarthritis pain.

Results from a Phase 2 study exploring the safety and efficacy of tanezumab, a novel biologic designed to block nerve growth factor, show that treatment once every eight weeks may significantly decrease pain in patients suffering from moderate to severe osteoarthritis pain in the knee. In the trial, approximately 75 percent of patients in both the tanezumab 100 and 200 μg/kg treatment groups experienced a 50 percent reduction in knee pain as compared to 26 percent of patients in the placebo group. In the study, the most common adverse events associated with tanezumab include headache, upper respiratory tract infection, paresthesia (abnormal sensations), hypoesthesia (decreased sensations) and arthralgia (joint aches).

Another late-breaking study evaluated continuous use of daily Celebrex treatment over a 22-week period compared to intermittent use of the medicine in preventing spontaneous OA flares. The study showed that continuous use resulted in 42 percent fewer OA flare episodes than the intermittent use. The results from the study also demonstrated that there were no significant differences in overall adverse events between the intermittent and continuous use groups.

According to the Arthritis Foundation, osteoarthritis affects 27 million Americans. Recent data show that one in two Americans are at risk for knee osteoarthritis over their lifetime. Loss of joint function as a result of osteoarthritis is a major cause of work disability.

About Celebrex

CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis in adults and ankylosing spondylitis, and for the management of acute pain in adults.

Cardiovascular Risk
All prescription NSAIDS, including CELEBREX, may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.

All prescription NSAIDs, including CELEBREX, are contraindicated for the treatment of perioperative pain in coronary artery bypass graft surgery.

Gastrointestinal Risk

All prescription NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

About Lyrica

LYRICA is indicated for the management of Fibromyalgia, neuropathic pain associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and as adjunctive therapy for adults with Partial Onset Seizures. There have been post-marketing reports of angioedema and hypersensitivity. Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse events include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally.

About Pfizer’s Investor Briefing at ACR (American College of Rheumatology)
On Tuesday, October 28 at 6:00 p.m. PCT, Pfizer will host a briefing for analysts and investors to review data presented at the meeting on candidates in Pfizer’s pain and inflammation portfolio

Scripps research team sheds light on long-sought cold sensation gene

Contact: Marisela Chevez
mchevez@scripps.edu
858-784-2171
Scripps Research Institute

Discovery could lead to new treatments to ease pain

The discovery, reported in the May 3 issue of the journal Neuron, might one day lead to the development of drugs that induce cold sensation as an analgesic, or block it to prevent certain forms of chronic pain associated with cold sensation.

“This study represents the first demonstration that a single gene is responsible for most cool temperature sensation,” says team leader Ardem Patapoutian, who has joint appointments with the Department of Cell Biology at Scripps Research and the Genomics Institute of the Novartis Research Foundation. “Many previous candidates have been postulated to play a role in our ability to sense cool temperatures, but none have withstood the test of genetics,” he says.

TRPM8 was first discovered by Patapoutian’s group and proposed as a key gene controlling cold sensation. To test the hypothesis, the group observed the behavior of mice genetically altered to lack the gene in response to cold stimuli.

When placed in compartments with a temperature gradient, or in an enclosure where they could choose between two temperatures, mice without TRPM8 showed essentially no preference in the temperature range of 18 to 31°C, suggesting their ability to sense this range was completely disabled without the gene. Normal mice, on the other hand, found cold temperature unpleasant, reliably avoiding cold temperatures in favor of warmer areas.

“It’s pretty amazing that one gene could impact thermal sensation this much,” says Ajay Dhaka, a Scripps Research postdoctoral fellow in the Patapoutian lab and lead author on the Neuron paper. “It really highlights the importance of the peripheral nervous system and how temperature affects our behavior,” he says.

The altered mice also showed little response to the application of acetone to their hindpaw, which causes an unpleasant cold sensation, while the acetone caused normal mice to flick their paw and lick them.

TRPM8 codes for an ion channel found at the tips of sensory neurons, which innervate the skin. When opened, ions flowing through TRPM8 lead to the activation of the sensory neuron, which in turn sends a signal to the brain. The Patapoutian team’s results support the idea that activation of TRPM8 by temperature triggers cold sensation. “TRPM8 acts as a gate,” says Dhaka, “At warm temperature it remains closed, but opens when exposed to cool temperature.”

The TRPM8-deficient mice did not lose their ability to feel pain in response to extreme cold, as evidenced by responses similar to wild type mice when exposed to -1° C cold plates. This suggests that other genes are responsible for this facet of cold sensation.

Though cold can be unpleasant or painful under certain circumstances, it can also deaden pain, as illustrated by icing an injury to relieve pain. To test this side of cold sensation, the researchers injected the mice with small amounts of a pain-causing chemical, formalin, and then exposed the affected paw area to a cold plate.

Cold temperature clearly reduced the acute pain felt by control mice as shown by a reduction in the response to formalin injection when compared to the amount of time control mice spent flicking and licking their paws when placed on a room temperature plate. In contrast, TRPM8-deficient mice did not receive any acute pain relief from the cold plate suggesting that cold activation of TRPM8 can mediate some of the analgesic effects of cold.

Just how the same sensation can be interpreted as unpleasant under certain circumstances and pleasant in others is still not clear, but is a question the group plans to investigate. “It would be really interesting to find out how the brain takes essentially the same signal and, depending on context, interprets it differently,” says Dhaka.

###
Other authors on the paper, entitled “TRPM8 Is Required for Cold Sensation in Mice,” were Amber Murray and Taryn Earley, from Scripps Research, and Jayanti Mathur and Matt Petrus, from the Novartis Research Foundation.

About The Scripps Research Institute

The Scripps Research Institute is one of the world’s largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.

FMS Global News

Tenderpoints

Scientists find new agent to fight genetic disorders — Zorro-Locked Nucleic Acid

Contact: Cody Mooneyhan
cmooneyhan@faseb.org
301-634-7104
Federation of American Societies for Experimental Biology

A study to appear in the June 2007 issue of The FASEB Journal describes a new agent, called “Zorro-LNA,” which has the potential to stop genetic disorders in their tracks. In the study, researchers from the Karolinska Institute in Stockholm, Sweden, describe how they developed Zorro-LNA to bind with both strands of a gene’s DNA simultaneously, effectively disabling that gene. This development has clinical implications for virtually every human condition caused by or worsened by dominant defective genes. Examples include: Huntington’s disease, familial high cholesterol, polycystic kidney disease, some instances of glaucoma and colorectal cancer, and neurofibromatosis, among others.

“Zorro-LNA is a new substance that targets DNA and turns off genes,” said co-author Edvard Smith of the Karolinska Institute in Sweden. “It has the potential of becoming a new drug for the treatment of human genetic disease.”

The findings described in this article significantly raise the possibility that new therapies could arise where defective DNA is deactivated more completely and more thoroughly than ever before. For instance, Zorro-LNA could be used in combination with “RNA interference” (RNAi). Like Zorro-LNA, RNAi has the ability to deactivate genes, but does so by degrading the gene’s RNA. In addition, Zorro-LNA could be used to deactivate certain genes in stem cells, which could eventually lead to the development of new cells, tissues, or organs. The discovery of RNAi was recognized by a Nobel Prize award in 2006 to two American scientists.

“This is a major development in the treatment not only of genetic diseases, but also of acquired diseases when microbes or toxins cause genes to go awry” said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal. “One might say these researchers have found a gene-hunter’s Holy Grail for which scientists have been hunting for many years. Zorro-LNA should give us a new, safe way of blocking the effects of errors in our genetic repertoire.”

###
The Editor-in-Chief of The FASEB Journal will be available for interviews about this or other articles at a press reception at this year’s Experimental Biology meeting in Washington, D.C., on Tuesday, May 1, 2007, between 1:30–3:00 PM in the Experimental Biology press lounge. (Refreshments will be provided.) For more information about the meeting, visit http://www.eb2007.org.

A fact sheet on this article is available at The FASEB Journal’s press room. Visit http://www.fasebj.org and click “Press Room” in the left column.

The FASEB Journal is published by the Federation of American Societies for Experimental Biology (FASEB) and is consistently ranked among the top three biology journals worldwide by the Institute for Scientific Information.

FASEB comprises 21 nonprofit societies with more than 80,000 members, making it the largest coalition of biomedical research associations in the United States. FASEB advances biological science through collaborative advocacy for research policies that promote scientific progress and education and lead to improvements in human health.

FMS Global News

Tenderpoints

Neck and back pain: musculoskeletal disorders.

1: Neurol Clin. 2007 May;25(2):419-38.

Meleger AL, Krivickas LS.

Department of Physical Medicine and Rehabilitation, Harvard Medical School and Spaulding Rehabilitation Hospital, 125 Nashua Street, Boston, Massachusetts 02114, USA.

In this article, non-neurologic causes of neck and back pain are reviewed. Musculoskeletal pain generators include muscle, tendon, ligament, intervertebral disc, articular cartilage, and bone. Disorders that can produce neck and back pain include muscle strain, ligament sprain, myofascial pain, fibromyalgia, facet joint pain, internal disc disruption, somatic dysfunction, spinal fracture, vertebral osteomyelitis, and polymyalgia rheumatica. Atlantoaxial instability and atlanto-occipital joint pain are additional causes of neck pain. Back pain resulting from vertebral compression fracture, Scheuermann’s disease, spondylolysis and spondylolisthesis, pregnancy, Baastrup’s disease, sacroiliac joint dysfunction, and sacral stress fracture is discussed.

PMID: 17445737 [PubMed - in process]

FMS Global News

Tenderpoints

The relationship between psychological factors and health care-seeking behavior in fibromyalgia patients

1: Turk Psikiyatri Derg. 2007 Spring;18(1):22-30.
Gulec H, Sayar K, Yazici Gulec M.
Uzm., SB, Erenkoy RSHH., Istanbul, Turkey. huseyingulec@yahoo.com

OBJECTIVE: The aim of this study was to examine whether cognitive factors, such as attributions, expectations, and anger management style, contribute to the decision to seek medical care for fibromyalgia syndrome (FMS).

METHOD: We recruited 3 groups of subjects; patients from a FMS tertiary care setting, community residents with FMS who had not sought medical care for their FMS symptoms (nonpatients), and healthy controls. In all, 38 FMS nonpatients were compared to 37 FMS patients and 41 healthy controls on measures of anxiety, depression, anger, locus of control (LOC), attributions, pain intensity, and disability, as well as demographic characteristics.

RESULTS: The prevalence of FMS non-patients was 2%. There was a significant difference between the 3 groups on the measures of anxiety, depression, LOC, and somatic and normalizing subscale scores of the symptom interpretation questionnaire (SIQ). FMS nonpatients, relative to FMS patients and healthy controls, were characterized by a significantly higher measure of both LOC and normalizing subscale score on the SIQ. There were no differences between the 2 FMS groups in demographical percentage and other psychometric measures. A hierarchical logistic regression model showed that the number of tender points, normalizing attribution style, and depression were independent predictors of help-seeking behavior.

CONCLUSION: The rate of psychiatric and medical history is not related to the FMS syndrome. Expectations and a normalizing attribution style may contribute to help-seeking behavior for FMS.

PMID: 17364265 [PubMed - in process]

FMS Global News

Tenderpoints

US Senate introduces bill to train more preventive medicine doctors

Contact: Paul Bonta
pbonta@acpm.org
202-466-2044 x110
American College of Preventive Medicine

Preventive medicine physicians are on the frontlines of America’s emerging health threats

Washington, D.C., April 16, 2007 – U.S. Senators Tom Harkin (D-IA), Johnny Isakson (R-GA), Jeff Bingaman (D-NM), and Joe Lieberman (I-CT) joined together today to take a major step toward stemming the tide of America’s eroding preventive medicine and public health workforce. Their landmark bill, the Preventive Medicine and Public Health Training Act, introduced in Congress today, will ensure the nation has a continuous supply of highly trained preventive medicine and public health physicians to lead the efforts to promote health and protect all Americans from today’s ever growing public health threats.

This is an especially critical measure as baby boomers approach retirement in greater numbers than ever before, obesity plagues young and old alike, emerging and re-emerging infections become harder to treat, and Americans face imminent threats to their health and well-being from around the globe.

The bill will provide the Centers for Disease Control and Prevention (CDC) the necessary funds to train highly specialized public health physicians in the skills necessary to lead pandemic flu planning, bio-terrorism surveillance, chronic disease prevention, quality improvement and safety in the health care system, and health promotion at both the patient and population levels.

“Preventive medicine physicians – the only U.S. physicians trained in both clinical medicine and public health – are uniquely equipped to address the health needs of individuals and populations alike,” said Dr. Michael Parkinson, president of the American College of Preventive Medicine. “We applaud this bi-partisan group of health care leaders for their foresight in protecting the nation’s health.”

A TROUBLESOME TREND

Preventive medicine’s mission is to protect, promote, and maintain health and well-being while preventing disease, disability, and premature death. This is becoming increasingly more difficult as the number of preventive medicine physicians decreases.

“Preventive medicine physicians represent an underutilized and increasingly threatened resource to meet the nation’s health and health care needs,” said Dr. Parkinson.

In 1998, there were 90 preventive medicine training programs in the U.S. training 420 physicians. Today, there are only 76 programs training an all time low of 364 physicians. At the same time as this decrease, the Health Resources and Services Administration estimates that between the years 2000 and 2010 the demand for public health professionals will grow at twice the rate of all other occupations in the U.S.

“This decrease in the number of preventive medicine physicians represents a perfect storm of an aging public health workforce, decreased funds for training, fewer training programs, and fewer medical residents choosing to specialize in preventive medicine,” said Dr. Parkinson.

“Inadequate funding means that many who choose this specialty must dig into their own pockets to receive the specialty training the federal government assures at no cost to all other medical residents,” he said. “The current system has built-in disincentives to dedicating one’s career to public health. This bill will change that.”
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ABOUT THE AMERICAN COLLEGE OF PREVENTIVE MEDICINE

The American College of Preventive Medicine (ACPM) is the national medical specialty society representing physicians committed to health promotion and disease prevention. Founded in 1954, ACPM provides leadership in research, professional education, development of public policy, and enhancement of standards of preventive medicine. ACPM members include physicians board-certified in preventive medicine and in other medical specialties who have a strong interest in health promotion and disease prevention. For more information about ACPM, visit www.acpm.org.

FMS Global News

Tenderpoints

Concepts in pain management.

Gulur P, Soldinger SM, Acquadro MA.

Harvard Medical School, Massachusetts General Hospital Pain Center, 15 Parkman Street, WACC 333, Boston, MA 02114, USA.

Pain has become an increasingly recognized symptom that plays a major role in the treatment of many podiatric patients. Management of this now accepted fifth vital sign can be accomplished through many avenues. Nonsteroidal anti-inflammatory medications and short- and long-acting opioids are typically used by many podiatric physicians; however, the benefits and potential hazards of other pharmaceutic approaches using antidepressants, anticonvulsants, topical medications, and other centrally acting medications must also be recognized. In addition, the role of the psychiatrist or therapist should not be neglected because many types of cognitive therapies are available to aid in treating these patients.

PMID: 17430773 [PubMed - in process]

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Abnormal brain processing of affective and sensory pain descriptors in chronic pain patients.

Sitges C, Garcia-Herrera M, Pericas M, Collado D, Truyols M, Montoya P.

Department of Psychology, University of Balearic Islands, Spain; Research Institute on Health Sciences (IUNICS), Palma, Spain.

OBJECTIVE: Previous research has suggested that chronic pain patients might be particularly vulnerable to the effects of negative mood during information processing. However, there is little evidence for abnormal brain processing of affective and sensory pain-related information in chronic pain. Behavioral and brain responses, to pain descriptors and pleasant words, were examined in chronic pain patients and healthy controls during a self-endorsement task. METHODS: Eighteen patients with fibromyalgia (FM), 18 patients with chronic musculoskeletal pain due to identifiable physical injury (MSK), and 16 healthy controls were asked to decide whether word targets described their current or past experience of pain. The number of self-endorsed words, elapsed time to endorse the words, and event-related potentials (ERPs) elicited by words, were recorded. RESULTS: Data revealed that chronic pain patients used more affective and sensory pain descriptors, and were slower in responding to self-endorsed pain descriptors than to pleasant words. In addition, it was found that affective pain descriptors elicited significantly more enhanced positive ERP amplitudes than pleasant words in MSK pain patients; whereas sensory pain descriptors elicited greater positive ERP amplitudes than affective pain words in healthy controls. CONCLUSIONS: These data support the notion of abnormal information processing in chronic pain patients, which might be characterized by a lack of dissociation between sensory and affective components of pain-related information, and by an exaggerated rumination over word meaning during the encoding of self-referent information about pain.

PMID: 17434596 [PubMed - as supplied by publisher]

FMS Global News

Tenderpoints