Spanning five years, costing almost $22 million and spread across 13 separate research trials nationwide, several federal agencies are tackling head-on the mounting problem of how to treat chronic pain in the U.S. military without exacerbating the country's opioid abuse problem.
The new research program, spearheaded by the National Institutes of Health's National Center for Complementary and Alternative Medicine (NCCAM), the National Institute on Drug Abuse (NIDA) and the U.S. Department of Veterans Affairs (VA) Health Services Research and Development Division, will look at non-drug approaches for treating chronic pain and some of the conditions that go hand-in-hand with it, such as post-traumatic stress disorder (PTSD), drug abuse and sleep problems. Modalities to be studied will include, but are not limited to psychotherapy, bright light therapy and self-hypnosis.
The multicenter research effort, involving VA medical centers and academic institutions, will not only focus on active military and U.S. veterans but will look at the effects on their families as well.
According to NCCAM director Josephine Briggs, MD, more Americans turn to complementary and alternative therapies for pain relief than for any other condition. That fact, and the need to stem the increasing problem of prescription painkiller abuse among military personnel, has led to the large-scale research effort, she said.
"The need for non-drug treatment options is a significant and urgent public health imperative," Dr. Briggs said in a statement. "We believe this research will provide much-needed information that will help our military and their family members, and ultimately anyone suffering from chronic pain and related conditions."
A recent large-scale study (N=2,597) showed that chronic pain among U.S. military following deployment was reported by 44% of study subjects, compared with 26% in the general population, and opioid use was seen in 15% versus 4%, respectively. Of individuals reporting chronic pain in the study, 65.6% described it as constant, and 51.2% stated that their pain was moderate or severe. Estimated costs related to chronic pain and its treatment in military personnel are close to $5 trillion (JAMA Intern Med 2014;174:1402-1403).
"Prescription opioids are important tools for managing pain, but their greater availability and increased prescribing may contribute to their growing misuse," said Nora D. Volkow, MD, director of NIDA, in a statement. "This body of research will add to the growing arsenal of pain management options to give relief while minimizing the potential for abuse, especially for those bravely serving our nation in the armed forces."
http://www.painmedicinenews.com/ViewArticle.aspx?d=Web%2BExclusives&d_id=244&i=October+2014&i_id=1108&a_id=28331
After New Federal Rules, Popular Painkillers Will Be Harder to Get | Valley News
It's going to be more difficult to refill prescriptions for the most popular painkillers starting today, when new federal rules move products with hydrocodone into a stricter drug class reserved for the most dangerous and addictive substances.
In approving the change, the Drug Enforcement Administration cited the 7 million Americans who abuse prescription drugs and the 100,000 overdose deaths from painkillers in the last decade. Hydrocodone combinations, including Vicodin, Lortab and Norco, now account for more prescriptions than any other drug, with more than 130 million filled each year.
Proponents of the new rules believe many prescriptions go to younger people for recreational use because they are less likely to suffer from arthritis or other chronic pain conditions.
But many doctors, pharmacists and patients say the rule change effectively punishes people suffering from pain conditions because a small minority of the population abuses the drugs. The changes will be most burdensome for patients with cancer, disabilities and those who live in rural areas or in nursing homes, advocates say.
"For some patients who are legitimately using hydrocodone products for pain, this will be more challenging for them," said Amy Tiemeier, associate professor at St. Louis College of Pharmacy. "For physicians, the hassle will make them think twice about whether it's really necessary to prescribe this drug or maybe they should prescribe something else that has less addiction potential."
More ..,
http://www.vnews.com/news/nation/world/13836289-95/after-new-federal-rules-popular-painkillers-will-be-harder-to-getPathways to Prevention Workshop on The Role of Opioids in the Treatment of Chronic Pain - NIH
Chronic pain is a major public health problem, which is estimated to affect more than 100 million people in the United States and about 20–30% of the population worldwide. The prevalence of persistent pain is expected to rise in the near future as the incidence of associated diseases (including diabetes, obesity, cardiovascular disorders, arthritis, and cancer) increases in the aging U.S. population.
Opioids are powerful analgesics that are commonly used and found to be effective for many types of pain. However, opioids can produce significant side effects, including constipation, nausea, mental clouding, and respiratory depression, which can sometimes lead to death.
In addition, long-term opioid use can also result in physical dependence, making it difficult to discontinue use even when the original cause of pain is no longer present. Furthermore, there is mounting evidence that long-term opioid use for pain can actually produce a chronic pain state, whereby patients find themselves in a vicious cycle in which opioids are used to treat pain caused by previous opioid use.
Data from the Centers for Disease Control and Prevention indicate that the prescribing of opioids by clinicians has increased threefold in the last 20 years, contributing to the problem of prescription opioid abuse.1 Today, the number of people who die from prescription opioids exceeds the number of those who die from heroin and cocaine, combined.
Health care providers are in a difficult position when treating moderate to severe chronic pain; opioid treatments may lessen the pain, but may also cause harm to patients. In addition, there has not been adequate testing of opioids in terms of what types of pain they best treat, in what populations of people, and in what manner of administration. With insufficient data, and often inadequate training, many clinicians prescribe too much opioid treatment when lesser amounts of opioids or non-opioids would be effective. Alternatively, some health care providers avoid prescribing opioids altogether for fear of side effects and potential addiction, causing some patients to suffer needlessly.
The 2014 National Institutes of Health (NIH) Pathways to Prevention Workshop on The Role of Opioids in the Treatment of Chronic Pain will seek to clarify:
Long-term effectiveness of opioids for treating chronic pain
Potential risks of opioid treatment in various patient populations
Effects of different opioid management strategies on outcomes related to addiction, abuse, misuse, pain, and quality of life
Effectiveness of risk mitigation strategies for opioid treatment
Future research needs and priorities to improve the treatment of pain with opioids.
The workshop is co-sponsored by the NIH Office of Disease Prevention (ODP), the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.
Initial planning for each Pathways to Prevention Workshop is coordinated by a Working Group that nominates panelists and speakers, and develops and finalizes questions that frame the workshop. After finalizing the questions, an evidence report is prepared by an Evidence-based Practice Center through a contract with the Agency for Healthcare Research and Quality. During the 11⁄2-day workshop, invited experts discuss the body of evidence, and attendees have opportunities to provide comments during open discussion periods. After weighing evidence from the evidence report, expert presentations, and public comments, an unbiased, independent panel will prepare a draft report that identifies research gaps and future research priorities. The draft report is posted on the ODP website, and public comments are accepted for two weeks. The final report is then released approximately two weeks later.
Dying Without Morphine - NYTimes.com
Imagine watching a loved one moaning in pain, curled into a fetal ball, pleading for relief. Then imagine that his or her pain could be relieved by an inexpensive drug, but the drug was unavailable.
Each day, about six million terminal cancer patients around the world suffer that fate because they do not have access to morphine, the gold standard of cancer pain control. The World Health Organization has stated that access to pain treatment, including morphine, is an essential human right.
Most suffering because of a lack of morphine is felt in the poorer regions of the globe. About 90 percent of the world's morphine consumption is in countries in North America and Europe, whereas all the globe's low- and middle-income countries combined use a mere 6 percent. In sub-Saharan Africa, which has the world's lowest consumption of morphine and other opioids, 32 of 53 countries have little, if any, access to morphine.
However, this grossly lopsided use of morphine is not about the unequal distribution of wealth. Morphine is easy to produce and costs pennies per dose. But its per-dose profits are also low, which decreases a drug company's incentive to enter low-income markets in the developing world.
If it were just about the money, the solution — subsidized access — would be obvious. However, the issue is complicated by a dizzying array of bureaucratic hurdles, cultural biases and the chilling effect of the international war on drugs, which can be traced back to the 1961 United Nations Single Convention on Narcotic Drugs that standardized international regulation of narcotics. Driven by its lopsided concern over the illicit use of opioids, a class of drugs that includes heroin, the Single Convention drove countless, onerous country-level restrictions on morphine use, for fear that it would be abused.
India offers a glaring example of how such restrictions can have devastating effects on human lives. In a powerful documentary, "The Pain Project," India's leading palliative care specialist, Dr. M. R. Rajagopal, explains that India's narcotic regulatory agencies are so irrationally stringent that in 27 of the country's 28 states doctors simply avoid prescribing morphine for cancer pain, for fear of running afoul of the law.
In the documentary, you see an aged Indian woman with terminal breast cancer lying on a cot and wailing in pain. It's agonizing to watch, but it illustrates the unrelenting soul-searing effects of untreated cancer pain.
Under mounting pressure, India recently eased some restrictions on the medical use of morphine and consolidated the licensing process from four or five agencies into a single authority. While a step forward, the new amendment doesn't address many harsh regulations that dissuade doctors from freely prescribing morphine. Adding to the regulatory roadblocks, India's health care delivery system is woefully fragmented and understaffed. And India is just one, albeit very large, country — the same story can be found across the developing world.
Continue reading the main storyContinue reading the main storyContinue reading the main story
Several organizations, such as Global Access to Pain Relief Initiative, Hospice Without Borders and Human Rights Watch, are devoted to easing the global crisis of untreated cancer pain, but it is a Sisyphean undertaking for a handful of cash-strapped nongovernmental organizations. Still, by partnering with international organizations and developing innovative delivery systems, certain resource-challenged areas in the developing world have made progress.
The sparsely populated, war-ravaged country of Uganda has made strides in providing morphine to its cancer patients, thanks to the determination of public health advocates like Dr. Jack Jagwe, a former adviser to the Ugandan Health Ministry. In the 1990s, Dr. Jagwe and others partnered with foreign doctors and members of the international community to write into the health code that every Ugandan citizen had the right to palliative care, which was a first in Africa.
Thanks in part to this initiative, Uganda amended its rigid narcotics laws, allowing nurses to prescribe morphine to cancer patients without having a doctor present, which proves essential in delivering morphine to patients in rural areas who are unable to trek long distances to city clinics.
That regulatory easing has opened the door for a nongovernmental entity, Hospice Africa Uganda, to produce its own morphine. This process not only frees Hospice Africa Uganda from dealing with international suppliers; it makes the market more efficient by allowing it to manufacture morphine on demand — indeed, per-patient pain-control costs are now estimated to be about $1 per week. That experience, though still a work in progress, should be a model for other resource-challenged countries.
As with all successful human rights movements, we need to put a face on the injustice of untreated cancer pain. Witnessing a clinic full of poor children with advanced cancer, crying in agony, should convince anyone that access to morphine is a human right.
http://www.nytimes.com/2014/10/01/opinion/dying-without-morphine.html
Each day, about six million terminal cancer patients around the world suffer that fate because they do not have access to morphine, the gold standard of cancer pain control. The World Health Organization has stated that access to pain treatment, including morphine, is an essential human right.
Most suffering because of a lack of morphine is felt in the poorer regions of the globe. About 90 percent of the world's morphine consumption is in countries in North America and Europe, whereas all the globe's low- and middle-income countries combined use a mere 6 percent. In sub-Saharan Africa, which has the world's lowest consumption of morphine and other opioids, 32 of 53 countries have little, if any, access to morphine.
However, this grossly lopsided use of morphine is not about the unequal distribution of wealth. Morphine is easy to produce and costs pennies per dose. But its per-dose profits are also low, which decreases a drug company's incentive to enter low-income markets in the developing world.
If it were just about the money, the solution — subsidized access — would be obvious. However, the issue is complicated by a dizzying array of bureaucratic hurdles, cultural biases and the chilling effect of the international war on drugs, which can be traced back to the 1961 United Nations Single Convention on Narcotic Drugs that standardized international regulation of narcotics. Driven by its lopsided concern over the illicit use of opioids, a class of drugs that includes heroin, the Single Convention drove countless, onerous country-level restrictions on morphine use, for fear that it would be abused.
India offers a glaring example of how such restrictions can have devastating effects on human lives. In a powerful documentary, "The Pain Project," India's leading palliative care specialist, Dr. M. R. Rajagopal, explains that India's narcotic regulatory agencies are so irrationally stringent that in 27 of the country's 28 states doctors simply avoid prescribing morphine for cancer pain, for fear of running afoul of the law.
In the documentary, you see an aged Indian woman with terminal breast cancer lying on a cot and wailing in pain. It's agonizing to watch, but it illustrates the unrelenting soul-searing effects of untreated cancer pain.
Under mounting pressure, India recently eased some restrictions on the medical use of morphine and consolidated the licensing process from four or five agencies into a single authority. While a step forward, the new amendment doesn't address many harsh regulations that dissuade doctors from freely prescribing morphine. Adding to the regulatory roadblocks, India's health care delivery system is woefully fragmented and understaffed. And India is just one, albeit very large, country — the same story can be found across the developing world.
Continue reading the main storyContinue reading the main storyContinue reading the main story
Several organizations, such as Global Access to Pain Relief Initiative, Hospice Without Borders and Human Rights Watch, are devoted to easing the global crisis of untreated cancer pain, but it is a Sisyphean undertaking for a handful of cash-strapped nongovernmental organizations. Still, by partnering with international organizations and developing innovative delivery systems, certain resource-challenged areas in the developing world have made progress.
The sparsely populated, war-ravaged country of Uganda has made strides in providing morphine to its cancer patients, thanks to the determination of public health advocates like Dr. Jack Jagwe, a former adviser to the Ugandan Health Ministry. In the 1990s, Dr. Jagwe and others partnered with foreign doctors and members of the international community to write into the health code that every Ugandan citizen had the right to palliative care, which was a first in Africa.
Thanks in part to this initiative, Uganda amended its rigid narcotics laws, allowing nurses to prescribe morphine to cancer patients without having a doctor present, which proves essential in delivering morphine to patients in rural areas who are unable to trek long distances to city clinics.
That regulatory easing has opened the door for a nongovernmental entity, Hospice Africa Uganda, to produce its own morphine. This process not only frees Hospice Africa Uganda from dealing with international suppliers; it makes the market more efficient by allowing it to manufacture morphine on demand — indeed, per-patient pain-control costs are now estimated to be about $1 per week. That experience, though still a work in progress, should be a model for other resource-challenged countries.
As with all successful human rights movements, we need to put a face on the injustice of untreated cancer pain. Witnessing a clinic full of poor children with advanced cancer, crying in agony, should convince anyone that access to morphine is a human right.
http://www.nytimes.com/2014/10/01/opinion/dying-without-morphine.html
Health Researchers Will Get $10.1 Million to Counter Gender Bias in Studies - NYTimes.com
In an effort to begin addressing persistent gender bias in laboratory research, the National Institutes of Health announced Tuesday that it will distribute $10.1 million in grants to more than 80 scientists studying a diverse array of subjects, including drug addiction, fetal development, migraines and stroke.
The researchers will use the additional funds to include more human participants — generally women — in clinical trials and to ensure that their laboratory animals, even cell lines, are representative of both genders. The money also will be used to analyze gender differences in the resulting data, officials said.
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NIH Pain Consortium
The NIH Pain Consortium was established to enhance pain research and promote collaboration among researchers across the many NIH Institutes and Centers that have programs and activities addressing pain. To this end, the following goals have been identified for the Pain Consortium:
To develop a comprehensive and forward-thinking pain research agenda for the NIH - one that builds on what we have learned from our past efforts.
To identify key opportunities in pain research, particularly those that provide for multidisciplinary and trans-NIH participation.
To increase visibility for pain research - both within the NIH intramural and extramural communities, as well as outside the NIH. The latter audiences include our various pain advocacy and patient groups who have expressed their interests through scientific and legislative channels.
To pursue the pain research agenda through Public-Private partnerships, wherever applicable. This underscores a key dynamic that has been reinforced and encouraged through the Roadmap process.
September is Pain Awareness Month
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