Friday, June 29, 2007

Living with Fibromyalgia, First Drug Approved (FDA site)

Living with Fibromyalgia, First Drug Approved

\Drug name: Lyrica (pregabalin)

Manufactured by: Pfizer Inc.

Approval date: June 21, 2007

Approved for: Lyrica is approved for treating fibromyalgia in adults who are 18 years and older. Pfizer has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.

How it works: Lyrica reduces pain and improves function in patients with fibromyalgia. The mechanism of action is unknown, but there is some data suggesting that it has effects on the release of neurotransmitters in the brain. Neurotransmitters are chemicals in the brain that transmit signals from one neuron to another. People with fibromyalgia experience pain differently than people who don't have the condition. Treatment with Lyrica reduces the level of pain in some patients.

Effectiveness: The effectiveness of Lyrica in treating fibromyalgia was established in two randomized, placebo-controlled trials of approximately 1800 people. These trials showed that treatment with Lyrica in doses of 300-450 mg per day reduced pain and improved function in patients with fibromyalgia. They also demonstrated that symptoms of fibromyalgia worsened when Lyrica was withdrawn.

Safety: The most common side effects of Lyrica include dizziness and sleepiness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions can also occur. These are rare, but potentially serious. FDA advises patients to talk with their doctors about whether using Lyrica will impair their ability to drive.

About Fibromyalgia

LYRICA is now FDA-approved for the management of fibromyalgia.
What is fibromyalgia?

Fibromyalgia is one of the most common chronic widespread types of pain in the U.S. In fact, it affects over 6 million people. And its causes are still not fully known. But recent data suggest that changes in the central nervous system may contribute to the chronic pain of this condition.

Thursday, June 28, 2007

Study Shows Surgery Is More Effective Than Other Treatments for Common Back Problem

When it comes to low back pain, physicians generally advise exhausting nonsurgical options before resorting to surgery. But a new study shows that for degenerative spondylolisthesis with spinal stenosis, surgery provides significantly better results than nonsurgical alternatives. The study, published in the May 31 issue of the New England Journal of Medicine, is the second in a series reporting findings of the Spine Patients Outcomes Research Trial (SPORT), a five-year, multicenter study supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the National Institutes of Health.

Degenerative spondylolisthesis is a condition in which breakdown of the cartilage between the vertebrae of the spine causes one vertebra to slip over the one below. This can result in narrowing of the spinal column (spinal stenosis), which can put pressure on the nerves, resulting in pain in the buttocks or legs with walking or standing. The condition generally occurs after age 50 and it affects six times as many women as men.

The management of degenerative spondylolisthesis with spinal stenosis is controversial, says James N. Weinstein, D.O., M.Sc., lead author and chairman of the Departments of Orthopaedics at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School. Surgery is widely used, but its effectiveness in comparison with nonsurgical treatment had not been demonstrated in controlled clinical trials. The purpose of this arm of the SPORT trial was to make that comparison.

SPORT followed 601 patients diagnosed with degenerative spondylolisthesis and symptomatic spinal stenosis. Of those, 372 received a surgery called decompressive laminectomy, which involved removing bone and soft tissue to relieve pressure on the nerves. The remaining 235 pursued nonoperative treatments such as physical therapy, steroid injections and analgesic medications. Two years after enrollment in the trial, patients in the nonoperative groups reported modest improvement in their condition; however, patients who had the surgery reported significantly reduced pain and improved function. Furthermore, for the surgery group, relief from symptoms came quickly; some reported significant improvement as early as six weeks after the procedure.

"The SPORT study was undertaken with one purpose in mind: to give physicians and patients solid information that would allow them to make informed choices when faced with a decision of how to treat their back condition," says Dr. Weinstein. "As a surgeon, it's very important to me that I have evidence that I can share with my patients as they are trying to decide how to proceed with treatment. Up until now, we suspected surgery produced better results, but we had little objective data to support that. With the results of this study, we can now discuss much more fully the surgical and nonsurgical options available to our patients so that they can make an informed choice."

The study initially intended to randomize patients into either a surgical or nonsurgical group and then observe and compare the results of the two groups. Unfortunately, a comparison of the two groups wasn't as easy as hoped. The researchers found that 40 percent of patients crossed over from the group into which they were randomized. That is, members of the nonoperative group chose to have surgery and members of the surgical group decided to forgo surgery for nonsurgical treatments. For that reason, the researchers compared groups based on the treatment they actually received instead of the treatment group to which they were assigned. Because the scientists were also studying similar patients who wanted to select which treatment they would receive (instead of being randomly assigned to a surgical or nonsurgical option), they were able to pool results from both studies, essentially creating a more powerful osbservational study at the expense of information gained from the statistically rigorous study design originally planned.

Thursday, June 21, 2007

Smart painkillers target damaged tissue - health - 31 May 2007 - New Scientist

Imagine a painkiller that only switches on in injured tissue, leaving
the rest of the body unaffected. That is the idea behind a new class of
pH-dependent drugs that interfere with nerve signals to the brain and
spinal cord - but only where the tissue is slightly acidic due to injury.

Normal tissue has a pH of around 7.4, but this drops to around 7.0 in
injured tissue, largely because the blood supply is disrupted, resulting
in the accumulation of waste products such as carbon dioxide and a
switch to anaerobic respiration, which produces lactic acid.

The new drugs act by blocking NMDA receptors, which are found on cells
throughout the brain and central nervous system and are implicated in a
variety of nerve functions, including pain sensitisation. Earlier
generations of drugs, such as ketamine, also targeted NMDA receptors,
but these often have unwanted side effects such as impaired movement or hallucinations, because they act on undamaged nerve tissue as well.

How a chill pains us - Nature

How a chill pains us

Researchers identify protein that signals cold-induced pain.

Heidi Ledford

Whether the pain comes from holding an ice cube for too long or staying out on a frigid winter day, the source is clear: it's the cold that hurts. Now researchers have found a protein responsible for provoking pain in response to extreme cold in mice.

The protein, called Nav1.8, was already known to play a role in detecting tissue damage, and was previously associated with inflammation and pain in response to damaged nerves. Now it looks like the same protein gets involved when the temperature plummets.

Physiologist Katharina Zimmermann at the University of Erlangen-Nuremberg, Germany, and her colleagues found that mice lacking the protein became impervious to pain from cold. Normal mice placed on a plate chilled to 0°C will hop about and lift their feet, but mice engineered to lack Nav1.8 do not, they found. The results are published this week in Nature.1

The protein works by helping sodium ions to pass through the cell membrane of neurons, a process that is crucial to transmitting signals — including pain signals — along nerve fibres. It works unusually well in the cold; unlike other similar proteins, its activity doesn't decline as the temperature drops. "That goes against what cells are supposed to do in the cold," says Ardem Patapoutian, a cell biologist at Scripps Research Institute in La Jolla, California, who was not affiliated with the study.

Wednesday, June 20, 2007 | Relief for 'bad pain' is possible, researchers say

People who suffer from chronic pain may be able to gain some relief thanks to a discovery that may block pain signals leading to the brain.

University of Calgary scientists have found a way to block 'bad pain' while leaving 'good pain' alone, by manipulating a key protein.

The research, which was conducted on rats, has found a way to intervene in the usual way pain is perceived.

Usually, when an injury is suffered, a nerve is activated and a signal travels up the pain pathway in the spinal cord. When it connects with another nerve leading to the brain, the feeling of pain is communicated. One of the key mechanisms involved in this process is called a calcium channel.

"If you block the activity of these calcium channels, you block the transmission of the pain signals from the first nerve to the second nerve and therefore blocking pain," said Dr. Gerald Zamponi, University of Calgary professor and the Canadian Research Chair of the Cellular and Molecular Neurobiology Research Group.

"The problem that you have is that these calcium channels are also found all over your brain where they do many, many important things. So we have to find a way of selectively eliminating the ones in the pain pathway, but leaving the ones that are in your brain alone. And the work that we've done has identified a way to do that," he told CTV's Canada AM.

The scientific research by the researchers at the University of Calgary has found a way to intervene in this process and to target the proteins that are responsible for what is termed as 'good pain'  and 'bad pain.'

The ability to feel pain is vital as it is a warning and defence mechanism that alerts of injuries or illness.

However, 'bad pain' can be termed as the kind of pain people suffering from diabetes, cancer or nerve damage endure.

"There's very little out there in terms of treatments for people to block this kind of pain," Zamponi said.

"So that's what we're trying to block while maintaining the normal pain sensation that you actually need to survive in this world."

To help address the treatment of bad pain, researchers are teaming with pharmaceutical companies to develop drugs that will target the elimination of 'bad pain.'

Additional research by scientists found that a protein called ROCK -- Rho-associated kinase -- can control neurons in the central nervous system.

With this knowledge, brain activities that occur during epileptic seizures could potentially be reduced.

The results of the studies conducted by the scientists at the University of Calgary were published in the Journal of Neuroscience and Nature Neuroscience.

Sunday, June 17, 2007

When Is a Pain Doctor a Drug Pusher? - New York Times

Ronald McIver is a prisoner in a medium-security federal compound in Butner, N.C. He is 63 years old, of medium height and overweight, with a white Santa Claus beard, white hair and a calm, direct and intelligent manner. He is serving 30 years for drug trafficking, and so will likely live there the rest of his life. McIver (pronounced mi-KEE-ver) has not been convicted of drug trafficking in the classic sense. He is a doctor who for years treated patients suffering from chronic pain. At the Pain Therapy Center, his small storefront office not far from Main Street in Greenwood, S.C., he cracked backs, gave trigger-point injections and put patients through physical therapy. He administered ultrasound and gravity-inversion therapy and devised exercise regimens. And he wrote prescriptions for high doses of opioid drugs like OxyContin.

McIver was a particularly aggressive pain doctor. Pain can be measured only by how patients say they feel: on a scale from 0 to 10, a report of 0 signifies the absence of pain; 10 is unbearable pain. Many pain doctors will try to reduce a patient's pain to the level of 5. McIver tried for a 2. He prescribed more, and sooner, than most doctors.

Some of his patients sold their pills. Some abused them. One man, Larry Shealy, died with high doses of opioids that McIver had prescribed him in his bloodstream. In April 2005, McIver was convicted in federal court of one count of conspiracy to distribute controlled substances and eight counts of distribution. (He was also acquitted of six counts of distribution.) The jury also found that Shealy was killed by the drugs McIver prescribed. McIver is serving concurrent sentences of 20 years for distribution and 30 years for dispensing drugs that resulted in Shealy's death. His appeals to the U.S. Court of Appeals for the Fourth Circuit and the Supreme Court were rejected.

McIver's case is not simply the story of a narcotics conviction. It has enormous relevance to the lives of the one in five adult Americans who, according to a 2005 survey by Stanford University Medical Center, ABC News and USA Today, reported they suffered from chronic pain — pain lasting for several months or longer. According to a 2003 study in The Journal of the American Medical Association, pain costs American workers more than $61 billion a year in lost productive time — and that doesn't include medical bills.

Contrary to the old saw, pain kills. A body in pain produces high levels of hormones that cause stress to the heart and lungs. Pain can cause blood pressure to spike, leading to heart attacks and strokes. Pain can also consume so much of the body's energy that the immune system degrades. Severe chronic pain sometimes leads to suicide. There are, of course, many ways to treat pain: some pain sufferers respond well to surgery, physical therapy, ultrasound, acupuncture, trigger-point injections, meditation or over-the-counter painkillers like Advil (ibuprofen) or Tylenol (acetaminophen). But for many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.

Thursday, June 14, 2007

Anticonvulsant medication gabapentin effective for fibromyalgia pain

New research supported by the National Institutes of Health's National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) shows that the anticonvulsant medication gabapentin, which is used for certain types of seizures, can be an effective treatment for the pain and other symptoms associated with the common, often hard-to-treat chronic pain disorder, fibromyalgia.

In the NIAMS-sponsored, randomized, double-blind clinical trial of 150 women (90 percent) and men with the condition, Lesley M. Arnold, M.D., director of the Women's Health Research Program at the University of Cincinnati College of Medicine, and her colleagues found that those taking gabapentin at dosages of 1,200 to 2,400 mg daily for 12 weeks displayed significantly less pain than those taking placebo. Patients taking gabapentin also reported significantly better sleep and less fatigue. For the majority of participants, the drug was well tolerated. The most common side effects included dizziness and sedation, which were mild to moderate in severity in most cases.

NIAMS Director Stephen I. Katz. M.D., Ph.D., remarked that While gabapentin does not have Food and Drug Administration approval for fibromyalgia, I believe this study offers additional insight to physicians considering the drug for their fibromyalgia patients. Fibromyalgia is a debilitating condition for which current treatments are only modestly effective, so a study such as this is potentially good news for people with this common, painful condition."

Fibromyalgia is a chronic disorder characterized by chronic, widespread muscle pain and tenderness, and is frequently accompanied by fatigue, insomnia, depression, and anxiety. It affects three million to six million Americans, mostly women, and can be disabling.

The precise cause of fibromyalgia in not known, but research suggests it is related to a problem with the central nervous system's processing of pain. As with some other chronic pain conditions, people with fibromyalgia often develop a heightened response to stimuli, experiencing pain that would not cause problems in other people. Yet, unlike many other pain syndromes, there is no physical evidence of inflammation or central nervous system damage.

Although gabapentin has little, if any, effect on acute pain, it has shown a robust effect on pain caused by a heightened response to stimuli related to inflammation or nerve injury in animal models of chronic pain syndromes. Researchers have suspected that it might have the same effect in people with fibromyalgia. The new research, published in the April 2007 edition of Arthritis & Rheumatism, indicates the suspicions were correct.

Although the researchers cannot say with certainty how gabapentin helps reduce pain, Dr. Arnold says one possible explanation involves the binding of gabapentin to a specific subunit of voltage-gated calcium channels on neurons. "This binding reduces calcium flow into the nerve cell, which reduces the release of some signaling molecules involved in pain processing," she says.

How gabapentin improves sleep and other symptoms is less clear, and there are probably different mechanisms involved in fibromyalgia symptoms. "Gabapentin improved sleep, which is an added benefit to patients with fibromyalgia who often report unrefreshing or disrupted sleep," Dr. Arnold says.

What is important is that people with fibromyalgia now have a potential new treatment option for a condition with few effective treatments. "Studies like this give clinicians evidence-based information to guide their treatment of patients," says Dr. Arnold.

Tuesday, June 12, 2007

MK-0974 Significantly Improved Migraine Pain on Several Efficacy Measures in a Phase II Study

Clinical results from a Phase II study presented for the first time at the American Headache Society (AHS) annual meeting showed that MK-0974, an investigational oral calcitonin gene-related peptide (CGRP) receptor antagonist, significantly improved migraine pain relief two hours after dosing compared to placebo, and the relief was sustained through 24 hours. MK-0974 was generally well tolerated in the study. Responses specific to other measures, such as migraine-associated symptoms, functional disability and use of additional rescue medications also were reported. MK-0974 is Merck's investigational medicine in Phase III clinical development for the acute treatment of migraine in adults and, if approved, may be the first in a new class of migraine treatments since the approval of the first triptan drug in 1991.

Algie Vasculaire de la Face - A French language blog on cluster headache

A large list of headache-related blogs

Headache, Migraine & Chronic Illness Blogs (from The Daily Headache blog)

A ClusterHead's Life

A ClusterHead's Life

The chronicles of my life with chronic cluster headaches

The Daily Headache

  • Migraines and chronic headaches are miserable. Every day I try to keep them from ruling (or ruining) my life. Some days it works. This blog is to share what I learn as I stumble along. From info about meds and triggers to getting out of bed and not blaming yourself -- and everything else headache sufferers should know but are in too much pain to ask. There's still hope!
  • (And I'm a patient too, so nothing here counts as official medical advice.)

Somebody Heal Me: Migraines


I have had migraines for 25+ years, and I also deal with depression. I'm engaged in seeking out news and information about migraine disease and related health issues, and I enjoy being able to pass what I learn and read about along to other people. I also have a lot of thoughts about my life with these conditions, so I hope my musings will connect with someone out there. ~ Diana

Pain - CareCure Forums

Pain Forum: Experiences and treatments of pain

Tuesday, June 05, 2007

Pain mechanisms poster - Stephen McMahon and David Bennett, Nature Reviews Neuroscience

Pain is an unpleasant sensation resulting from the intricate interplay between sensory and cognitive mechanisms. Chronic pain, resulting from disease or injury, affects nearly every fifth person in the Western world, constituting an enormous burden for the individual and society.

Sensitization of pain signalling systems is a key feature of chronic pain and results in normally non-painful stimuli eliciting pain. Such sensory changes can occur not just at the sites of injury, but insurrounding normal tissues. This and other observations suggest that sensitization occurs within the CNS as well as within nociceptors terminals.

Here we consider the consequences of noxious stimulus applied to our unfortunate builder's hand, from sensory transduction to pain perception. We describe the structural and functional elements present at different levels of the nociceptive system, as well as some of the changes occurring in chronic pain states. Although our poster highlights a flow of information from the periphery to the CNS, it should be noted that higher brain centres exert both inhibitory and facilitatory controls on lower ones. The challenge for the next decade will be to effectively translate this knowledge into the development of novel analgesic agents for better pain relief.

Chronic Pain linked to old memories



Scientists have found that a key source of chronic pain appears to be an old memory trace stuck in the prefrontal cortex.

With new understanding of the pain source, Vania Apkarian, professor of physiology, and of anesthesiology, at Northwestern University's Feinberg School of Medicine (USA), has identified a drug that controls persistent nerve pain by targeting the part of the brain that experiences the emotional suffering of pain. The drug is D-Cycloserine, which has been used to treat phobic behaviour over the past decade.

In animal studies, D-Cycloserine appeared to significantly diminish the emotional suffering from pain as well as reduce the sensitivity of the formerly injured site. It also controlled nerve pain resulting from chemotherapy, noted Apkarian, who is a member of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University.

The drug has long-term benefits. Animals appeared to be pain free 30 days after the last dose of a 30-day regime of D-Cycloserine.

"In some ways, you can think of chronic pain as the inability to turn off the memory of the pain," Apkarian said. "What's exciting is that we now may be relieving what has clinically been the most difficult to treat - the suffering or the emotional component of pain."

Scientists have always tried to understand pain from the viewpoint of sensation, Apkarian said. "To control it, they tried to stop the sensory input to the brain. "We are saying there's a cognitive memory and emotional component in the brain that seems abnormal. Easing that may have a bigger effect on suffering."

Chronic pain is not caused by a single mechanism, Apkarian noted. Sensory abnormalities in people with chronic pain probably drive this memory abnormality.

One of Apkarian's studies with rats tried to separately measure their emotional suffering and their physical pain after being treated with the drug (The rats had chronic pain from a healed limb injury). The results indicated the animals' emotional suffering decreased much more than their physical pain. While the physical pain appeared to be reduced 30 per cent – their emotional suffering completely disappeared.

Based on the animal results, the next step will be to test the drug in clinical trials, Apkarian said.

"When we do this in a clinical trial, we expect people to say I still have the pain, but it's not bothering me anymore," Apkarian said. "We think they will have a physical awareness of the pain, but its emotional consequences will have decreased." He said the drug potentially may lower the amount of standard analgesics people have to use.

In Apkarian's previous study, published in late 2006, he revealed that chronic back pain appears in a different part of the brain than the discomfort of burning your finger, for example. With a functional MRI, he found that chronic back pain shows up in the prefrontal cortex. By contrast, the acute sensory pain of the burned finger appears in the sensory part of the thalamus.

Apkarian also found that the longer a person has been suffering from chronic pain, the more activity in the prefrontal cortex. He was able to predict the years of their suffering from the MRI.

"It's cumulative memory," he explained. "I can predict with 90 per cent accuracy how many years they have been living in that pain without even asking them the question."

The study will be published online in Pain: The Journal of the International Association for the Study of Pain .

Sunday, June 03, 2007

Wired Science - Wired Blogs

First Steps Toward a New Pain Medication

Scientists have developed a strategy for fighting pain with significantly fewer side effects. Unfortunately, the new chemical can't be taken orally, so the companies that developed it, Abbott Labs and Icagen,  won't commercialize it. But it proves that the new strategy for stopping pain is viable.

It's the first time a small chemical that blocks specific sodium channels, which carry pain signals from nerves, rather then all of them at once.

The team, led by Doug Krafte and Michael Jarvis, described their new strategy in the current issue of the Proceedings of the National Academy of Sciences. A group of researchers from Merck wrote a separate article that explains the importance of the work done by Krafte, Jarvis, and their team. The researchers at Merck claim that chemicals like the one discovered at Icagen will usher in a new era of pain research.

Minimal Care May Be Best for Whiplash - CME Teaching Brief® - MedPage Today

Whiplash patients may benefit from benign neglect, according to researchers here.

In a cohort of patients in the Canadian province of Saskatchewan, aggressive treatment of whiplash was associated with a slower time to recovery, according to Pierre Côté, D.C., Ph.D., of Toronto's University Health Network.

The finding replicated a previous observation by the same authors, but in an independent population and with a different medical insurance scheme, Dr. Côté and colleagues reported in the June issue of Arthritis Care & Research.

The best choice for patients was two or fewer visits to a generalist, while the worst was more than six visits to the doctor, combined with chiropractic care, the researchers found. Articles on pain is dedicated to science, physics and technology

New Research Into Pain Treatment - Newsweek Health -

The Changing Science of Pain
Millions of aging boomers and the latest generation of wounded soldiers hope the secrets of our most enduring medical foe can finally be unlocked.