FDA Committee Nixes Sensible Opioid-REMS Plan

Late last week a special U.S. FDA Advisory Committee considered the agency’s proposed Risk Evaluation and Mitigation Strategy (REMS) intended to stem the tide of problems associated with extended-release opioid pain relievers. By a large majority, the committee turned down the FDA’s sensible plans, saying a broader approach and more rigorous restrictions are needed; however, the wisdom of the Committee’s decision at this time might be questioned.

After 2-days of hearings on July 23-24, 2010, the FDA’s Advisory Committee voted 25 to 10 in favor of rejecting the agency's proposed plan to help prevent inappropriate prescribing, misuse, and abuse of extended-release (ER) opioid analgesics, saying the plan is not rigorous enough to stem the "public health crisis" of opioid addiction, overdose, and death. We have previously discussed the opioid-REMS initiatives [here] and, prior to the meeting, the FDA released a new and sensible REMS that would require drug companies that make ER opioids to develop educational programs guiding physicians in patient selection, dosing, and monitoring. Prescribers also would be trained in counseling their patients on how to safely store and dispose of opioids, and manufacturers would provide FDA-approved information sheets for physicians to use in their interactions with patients, along with "medication guides" highlighting safe use of opioids to be dispensed with the drugs. [See the FDA’s REMS proposal document available here.]

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Vitamin D: Latest Research Updates & Perspectives

Vitamin D is no longer considered a vitamin, but rather a hormone that may have remarkably beneficial functions well beyond those of regulating calcium absorption and bone health, including the relief of pain for many patients. This long blogpost provides an UPDATE on recently published research as well as some contrary perspectives and rather perplexing new guidelines on vitamin D.

We have previously written extensively on the role of vitamin D in pain conditions of various sorts [reports here / blogpost series here open in new window]. Additionally, the association with and possible causal effect of insufficient vitamin D in many chronic diseases is becoming more widely appreciated. Recent observational studies have reported inverse associations between levels of serum 25-hydroxyvitamin-D, or 25[OH]D, the metabolite that best reflects overall vitamin D status, and the risk of cancer, vascular disease, infectious conditions, autoimmune diseases, osteoporosis, type 2 diabetes mellitus, and obesity [Pearce and Cheetham 2010]. Still, what constitutes an optimal blood concentration of 25(OH)D for humans remains unknown and the subject of debate. Following, are some recently reported items of interest.

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Treat RA Early, Aggressively, Researchers Say

According to a recent clinical trial, disease-modifying antirheumatic drugs (DMARDs) should be used early and aggressively at the first signs of rheumatoid arthritis (RA). Results of an 11-year study, published in the open-access journal Arthritis Research & Therapy, show that active treatment with multiple DMARDS from the outset is effective both short- and long-term.

A team of researchers in Finland randomized 199 patients with early active RA to receive either treatment with a combination of methotrexate, sulfasalazine, and hydroxychloroquine with prednisolone (COMBO), or treatment with a single DMARD (initially, sulfasalazine) with or without prednisolone (SINGLE) [Rantalaiho et al. 2010]. After 2 years, the drug-treatment strategy became unrestricted, but still targeted to achieving remission. Radiographs (x-rays) of hands and feet were analyzed by using the Larsen score at baseline, 2, 5, and 11 years, and the radiographs of large joints (eg, knee) were assessed at 11 years. The Larsen scoring method [more info here] incorporates both erosions and joint space narrowing in each joint determined from radiographs as a single score on a scale of 0 to 5.

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Does the Weather Really Affect Pain?

Traditional wisdom says that aches and pains flare up on cold, damp, dreary days. Now, research has confirmed this is the case and there are seasonal variations as well, whether for ‘any pain’ or chronic widespread pain.

Between January 2005 and December 2006, 2,491 persons in Northwest England completed questionnaires that enquired about pain — either ‘any pain,’ assumed to be more temporary and/or localized, or chronic widespread pain (CWP) — as well as about potential mediating factors such as sleep quality, exercise, and mood. Researchers were able to determine information on sunshine, precipitation, air temperature, and pressure at the time each questionnaire was completed.

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CAM Popular for Back Pain Relief, Survey

A newly reported survey notes that 6 out of 10 persons treated with Complementary and Alternative Medicine (CAM) therapies for back pain claim beneficial effects. Chiropractic care was rated first, followed by massage, yoga/tai chi/qi gong, acupuncture, herbal remedies, and relaxation techniques.

Overall, the report authors note that back pain affects 15% to 30% of the United States population and 6% of all Americans (5.4 million adults) use CAM to treat the condition. The study examined 17 CAM therapies, ranging from hypnosis to homeopathic remedies to special diets and more. Among the 1,647 back pain sufferers who used CAM in the previous 12 months, chiropractic care was the most frequently used choice at 74%, followed by massage therapy at 22%, and at less than 10% each were acupuncture, yoga/tai chi/qi gong (considered together), herbal remedies, and relaxation techniques. About 30% used more than one of those 6 most-popular CAM therapies, while any other approaches were only rarely used.

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Glucosamine of No Help for Chronic Low Back Pain?

A newly reported clinical trial found that glucosamine was no better than a sugar pill for patients with chronic low back pain (LBP) and degenerative lumbar osteoarthritis (OA). During 6 months of therapy, glucosamine was comparable to placebo on measures of pain-related disability, low back and leg pain, and health-related quality of life, according to the report in the July 7, 2010 issue of the Journal of the American Medical Association (JAMA). However, both DID provide some benefits.

Glucosamine — a natural precursor of bone cartilage and made commercially from the exoskeletons of sea creatures — is widely used as a treatment for OA, despite controversial and conflicting evidence in the past for its benefits, and it is also increasingly taken by patients with LBP. Researchers in Norway investigated the effectiveness of 6-months of therapy with oral glucosamine sulfate (1,500 mg/day) compared with placebo in reducing pain-related disability in 250 patients >25 years of age with chronic LBP (for longer than 6 months) and degenerative lumbar OA. This was a well-designed randomized, controlled trial with adequate power (n=125/group) to detect any significant benefits of glucosamine.

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Dietary Supplements for Arthritis Pain Examined

Researchers examined all available clinical trial reports exploring the efficacy of various antioxidant and anti-inflammatory dietary supplements promoted to help manage painful osteoarthritis (OA) and rheumatoid arthritis (RA). Credible research evidence was found only for cats claw in aiding OA and omega-3 fatty acids for RA.

An extensive literature search spanning 1996 through January 2009 was conducted to discover efficacy trials of the following agents purported to have antioxidant and/or anti-inflammatory properties: cat's claw, ginger, fish oil, omega-3, turmeric, vitamin E, vitamin C, Baikal skullcap, barberry, Chinese gold thread, green tea, Indian holy basil, hu zhang, oregano, and rosemary [Rosenbaum et al. 2010]. Glucosamine, chondroitin, and methyl sulfonyl methane were excluded from the search since their mechanisms of action are not antioxidant or anti-inflammatory.

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Action Needed to Prevent GI Problems with NSAIDs

While nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used agents for pain relief, 6 out of 10 high-risk patients may not be receiving appropriate prescribing of these medications, according to new research. There is a strong need to consider gastrointestinal (GI) risk factors associated with NSAIDs and implement preventive strategies for minimizing them.

Writing in Alimentary Pharmacology and Therapeutics, researchers in the Netherlands examined a primary care population comprised of 50,126 NSAID users ≥50 years of age during an 11-year period (1996-2006) [Valkhoff et al. 2010]. Their objective was to determine trends in the use of preventive strategies to reduce GI complications of NSAIDs.

Adverse upper-GI events with NSAIDs can range from simple indigestion to more serious bleeding, ulceration, perforation, or obstruction, which can lead to hospitalization or, in some cases, death. Recommended preventive strategies typically include either prescribing a COX-2-selective inhibitor (coxib) or combining traditional nonselective NSAIDs (including aspirin) with a gastroprotective agent (eg, proton pump inhibitor [PPI], histamine blocker, or misoprostol).

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Studies Confirm Vitamin D Impact on Rheumatism

Several studies recently presented at EULAR 2010, June 16-19, in Rome, Italy — the Annual Congress of the European League Against Rheumatism — confirmed that vitamin D deficiency is a common feature in patients with a range of painful rheumatic and related autoimmune disorders. What is less clear, however, is the amount of vitamin D supplementation that would benefit these patients.

Here are highlights from the three studies:

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European Specialists Get Tough on Chronic Pain

Reacting to the latest data showing that chronic pain is highly prevalent but undertreated across Europe, pain specialists have banded together in a new initiative to attack the problems. Could this become a model for other parts of the world?

We have recently noted [here] that chronic pain prevalence worldwide is at least 20% and much higher in select populations. A comprehensive literature review found that in Europe the average time between onset of chronic pain and referral to a specialist pain center is 12 years, and that pain relief at this stage is achieved by only 1 in 5 patients [Varrassi et al. 2010]. Among other problems, evidence-based guidelines are frequently ignored and pharmacologic therapies are based mainly on tradition or personal experience.

In response, pain specialists from across Europe have joined together in launching a major education program to improve the management of chronic pain. "Chronic pain should not be regarded as an indicator of an underlying disease or damaging process, but as a disease in its own right," said Professor Giustino Varrassi, president of the European Federation of the International Association for the Study of Pain, quoted in Medical News Today [Mayor 2010]. He was speaking at a meeting of the CHANGE PAIN initiative in June 2010. The group’s education program — which is noncommercial but supported by Grünenthal GmbH — includes interactive e-learning modules designed to update healthcare professionals on the basics of: assessing pain, improving doctor-patient communication, multimodal management of chronic pain, and mechanism-orientated pharmacological pain therapy. The CHANGE PAIN website can be accessed at: http://www.change-pain.com/.

SOURCES:
> Mayor S. Pain Specialists Across Europe Launch Education Programme To Improve Chronic Pain Management. Medical News Today. 2010(June 28) [article here].
> Varrassi G, Muller-Schwefe G, Pergolizzi J, et al. Pharmacological treatment of chronic pain – the need for CHANGE. Curr Med Res Opin. 2010;26(5):1231-1245 [abstract here].