UK Research Could Lead to Blood Test for Fibromyalgia

By Pat Anson, Editor

British researchers have launched a genetic study of fibromyalgia patients that they hope could lead to a new blood test to diagnose the disease.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression and insomnia. It is notoriously difficult to diagnose and treat, and some doctors refuse to recognize it as a disease.

Scientists at King’s College London will study tissue samples and measurements taken from volunteers enrolled in Twins UK, a comprehensive study on the effects of genes, aging, disease and the environment on over 12,000 identical and non-identical twins.

Four hundreds twins are enrolled in the fibromyalgia study. In each set of twins, one twin suffers from chronic widespread pain, while the other does not. Tissue samples from both twins will be compared to try to identify biomarkers in their DNA associated with chronic pain.

"Our research will help patients in two ways. First it'll contribute to our understanding of how fibromyalgia – and other chronic pain syndromes such as irritable bowel syndrome – develop, and point to pain pathways which we may not have suspected,” said lead researcher Dr. Frances Williams.

"Secondly, we hope it'll lead to identification of a biomarker which we could work into a blood test."

Fibromyalgia is believed to have genetic influences, but researchers say there are many complicated steps between the genes that may contribute to fibromyalgia and the condition itself.

The study will focus on identifying markers in DNA that are associated with the “switching” on or off certain genes. DNA switching is important to health, as it prevents inappropriate processes from occurring in the body when they should not. Identifying those markers could then lead to a blood test.

“As well as enabling the condition to be diagnosed more effectively, it could help to ‘stratify’ patients into groups depending on disease severity, which will help in clinical trials of potential new treatments. It might even help us predict how the condition will progress,” said Williams.

A bioresearch company based in Santa Monica, California is already marketing a blood test that it claims is 99% accurate in diagnosing fibromyalgia.

EpicGenetics introduced the blood test in 2013, calling it the first definitive test for fibromyalgia.

The FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to the company, and have weaker immune systems than normal patients.

The blood test costs several hundred dollars and results are available in about a week. Critics have said the test is unreliable and the same molecules can be found in people with other disorders, such as rheumatoid arthritis.

Better Sleep Means Less Pain

By Pat Anson, Editor

Getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day, according to a large new study by researchers in Norway.

The study included more than 10,400 adults from an ongoing Norwegian health study. Each participant underwent a standard test of pain sensitivity -- the cold pressor test -- in which they were asked to keep their hand submerged in a cold water bath for 106 seconds.

Only 32% of participants were able to keep their hand in cold water throughout the experiment. Those who suffered from insomnia were more likely to take their hand out early: 42% did so, compared with 31% of those without insomnia.

Pain sensitivity also increased depending on the frequency of insomnia. Those who had trouble sleeping at least once a week had a 52% lower pain tolerance, while those who reported insomnia once a month had a 24% lower tolerance for pain.

"While there is clearly a strong relationship between pain and sleep, such that insomnia increases both the likelihood and severity of clinical pain. It is not clear exactly why this is the case," wrote lead author Børge Sivertsen, PhD, of the Norwegian Institute of Public Health.

The study, which is published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample. The results suggest that psychological factors may contribute to the relationship between sleep problems and pain, but they do not fully explain it.

“We conclude that impaired sleep significantly increases the risk for reduced pain tolerance. As comorbid sleep problems and pain have been linked to elevated disability, the need to improve sleep among chronic pain patients, and vice versa, should be an important agenda for future research,” the study said.

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Another study, recently published in PLoS One, found that insomnia – not surprisingly – made chronic pain patients less likely to exercise. Researchers followed 119 chronic pain patients, most of whom suffered low back pain, and found that quality of sleep was the best predictor of physical activity the next day – not mood or pain intensity.

Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

“Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Survey: Two-Thirds of Patients Unable to Get Hydrocodone

By Pat Anson, Editor

About two-thirds of pain patients say they were no longer able to obtain hydrocodone after the opioid painkiller was reclassified by the U.S. government from a Schedule III medication to a more restrictive Schedule II drug, according to the results of a new survey.

Many patients who had been taking hydrocodone at the same dose for years said their doctor would no longer prescribe the painkiller. Over a quarter (27%) said they had suicidal thoughts after being denied a prescription for hydrocodone.

The survey of over 3,000 patients was conducted online by the National Fibromyalgia & Chronic Pain Association (NFMCPA) and the findings presented this week at the annual meeting of the American Academy of Pain Medicine. An abstract of “Hydrocodone Rescheduling: The First 100 Days” can be found here.

Hydrocodone was rescheduled by the Drug Enforcement Administration in October of last year to combat an “epidemic” of prescription drug abuse. The rescheduling limits patients to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

The reclassification quickly made a drug that was once the most widely prescribed pain medication in the country – at nearly 130 million prescriptions each year – to one of the hardest to get.

Other key findings of the survey:

• 88% of respondents believe the change to Schedule II denies pain patients the right to adequate pain care.
• 75% believe the change will not prevent prescription drug abuse.
• 72% believe the change is harmful to pain patients.
• 18% said it led to a "worsened relationship" with their doctor.
• 30% reported "issues" with their pharmacy filling prescriptions.

Patients also reported higher expenses due to increased doctor’s visits, higher co-pays, greater transportation costs to visit the doctor and multiple pharmacies, and lost income due to inability to work because of pain.

The survey is believed to be the first to report on the experiences of pain patients treated with hydrocodone since the rescheduling took effect. The respondents were overwhelmingly female, which reflects the demographics of fibromyalgia and many other chronic pain conditions.

Hydrocodone isn’t the first pain medication to be in short supply. A report released last month by the Government Accountability Office (GAO) faults the DEA for poor management and “weak internal controls” of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was difficult to obtain for eight and a half years.

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

Lyrica Fails in Study of Juveniles with Fibromyalgia

By Pat Anson, Editor

Lyrica, a blockbuster drug widely prescribed to treat chronic pain in adults, works no better than a placebo in treating juveniles with fibromyalgia, according to the results of a new study released by Pfizer (PFE). Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

The double-blind Phase IV trial was conducted to fulfill a post-marketing study required by the Food and Drug Administration after Lyrica was approved for the management of fibromyalgia in adults in 2007. The generic name of Lyrica is pregabalin, which was originally developed as an anti-epileptic drug.

“The primary endpoint of the study was not achieved as there was not a statistically significant difference between pregabalin and placebo in mean pain score,” Pfizer said in a statement.

A total of 107 adolescents (ages 12-17 years) were enrolled in the 15-week study at multiple centers across the U.S., Europe and Asia. It was the first large study on the efficacy and safety of Lyrica in juveniles with fibromyalgia.

The National Institutes of Health estimates that about 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia.

In the study, Lyrica was administered twice daily, starting at 75 mg/day and then increasing to up to 450 mg/day, depending on the tolerability and response of the patient. The most common side effects in the study were dizziness, nausea, headache, increased weight and fatigue. Many other patients who take Lyrica complain of similar symptoms.

"Pfizer is committed to better understanding the full clinical profile of our approved medicines in pediatric and adolescent patients. This study advances the understanding of this patient population," said Steve Romano, MD, senior vice president of Global Medicines Development for Pfizer. "These results do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults."

In addition to fibromyalgia, Lyrica is approved by the FDA to treat chronic pain associated with epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.