U.S. Hydrocodone Prescriptions Dropping

By Pat Anson, Editor

The number of prescriptions filled in the U.S. for hydrocodone declined in 2014, the first concrete evidence that restrictions on the widely used opioid painkiller are starting to have an impact.   

According to the IMS Institute, 119.2 million prescriptions for hydrocodone pain medications were dispensed by pharmacies last year -- down from 129.5 million the year before – a decline of 8 percent. Hydrocodone is typically combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone products.

The IMS report also found that levothyroxine – a synthetic hormone used to treat thyroid deficiency -- has replaced hydrocodone as the #1 most widely filled prescription in the U.S.

The decline in hydrocodone prescriptions is striking because it was only in the last three months of 2014 that the painkiller was reclassified by the U.S. Drug Enforcement Administration from a Schedule III drug to a more restrictive Schedule II medication.

The DEA and Food and Drug Administration have been under pressure to restrict access to opioids because of the so-called epidemic of prescription drug abuse. Over 16,000 Americans die annually from painkiller overdoses, although most of those deaths involve other drugs or alcohol.

“The rise in opioid prescribing, which led to an opioid becoming America’s most prescribed medication, resulted in a public health catastrophe,” said Andrew Kolodny, MD, director of Physicians for Responsible Opioid Prescribing (PROP), which played an instrumental role in getting hydrocodone rescheduled.

“The trend is clearly moving in the right direction. I’d predict that up-scheduling will accelerate the decline in prescriptions. This will go a long way toward bringing the opioid crisis under control because with more cautious prescribing we are likely to see less new cases of opioid addiction.”

The rescheduling of hydrocodone limits pain patients to an initial 90-day supply of hydrocodone — and also 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.

Since the rescheduling, many patients have complained that their doctors were no longer willing to prescribe hydrocodone and that pharmacists were unwilling to fill valid prescriptions. A recent survey found that many pain patients had suicidal thoughts after being denied a prescription. Others said that rescheduling hard been harmful to their relationship with their doctor.

Hydrocodone prescriptions were dropping even before the rescheduling took effect. They peaked in 2011 with nearly 137 million prescriptions filled by pharmacies.

The IMS report found that prescriptions of tramadol, a weaker Schedule IV opioid, rose by over 5% in 2014 – a possible sign that tramadol is being used as a substitute for hydrocodone. The number of tramadol prescriptions being dispensed has nearly doubled since 2010 from 28 million to over 44.2 million in 2014.

“I predicted tramadol prescriptions would increase,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“I think the overall amount of opioids has declined a little.  Physicians are prescribing less because of publicity, and fear of regulatory interventions. Payers are also limiting what patients can receive. Seems inappropriate that payers have so much control.”

Total spending on all prescription medications in the U.S. rose over 10% to $373.9 billion in 2014, according to IMS, with a record volume of 4.3 billion prescriptions filled.

Researchers Say Acetaminophen Dulls Emotions

By Pat Anson, Editor

Health experts have been warning for years about the risk of liver damage caused by taking too much acetaminophen.  Now a new study is out that found a previously unknown side effect of the drug: It also dulls emotions.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications.

Researchers at Ohio State University conducted two studies involving over 80 college students, half of whom took a large dose of 1000 milligrams of acetaminophen and half who took a placebo. They waited 60 minutes for the drug to take effect.

The students then viewed 40 photographs from a database used by researchers to elicit emotional responses. The photographs ranged from the extremely unpleasant (crying, malnourished children) to the neutral (a cow in a field) to the very pleasant (young children playing with cats).

After viewing each photo, participants were asked to rate how positive or negative the photo was on a scale of -5 (extremely negative) to +5 (extremely positive). Then they viewed the same photos again and were asked to rate how emotional they felt, ranging from 0 (little or no emotion) to 10 (extreme amount of emotion).

Results in both studies showed that participants who took acetaminophen rated all photos less extremely than did those who took the placebo. Positive photos were not seen as positively under the influence of acetaminophen and negative photos were not seen as negatively. The same was true of their emotional reactions.

“People who took acetaminophen didn’t feel the same highs or lows as did the people who took placebos,” said Baldwin Way, an assistant professor of psychology at the Ohio State Wexner Medical Center’s Institute for Behavioral Medicine Research.

For example, people who took the placebo rated their emotional response relatively high (average score of 6.76) when they saw jarring photos of the malnourished child or the children with kittens. But people taking acetaminophen didn’t feel as much in either direction, reporting an average emotion level of 5.85 when they saw the same photos.

Neutral photos were rated similarly by all participants, regardless of whether they took the drug or not.

“This means that using Tylenol or similar products might have broader consequences than previously thought,” said Geoffrey Durso, lead author of the study and a doctoral student in social psychology at The Ohio State University.

“Rather than just being a pain reliever, acetaminophen can be seen as an all-purpose emotion reliever.”

Previous research has shown that acetaminophen reduces not only on physical pain, but also psychological pain.

“Most people probably aren’t aware of how their emotions may be impacted when they take acetaminophen,” said Way.

The study is published online in the journal Psychological Science.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Urine Drug Test Often Gives False Results

By Pat Anson, Editor

A urine drug test widely used by pain management and addiction treatment doctors to screen patients for illicit drug use is wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The “point-of-care” or POC tests come with immunoassay testing strips that use antibodies to detect signs of recent drug use. Physicians like the urine tests because they can be performed in their offices, are inexpensive, and give immediate results. But experts say the tests are wrong so often that no doctor should base a treatment decision solely on the results of one test. 

“Immunoassay testing has an extraordinarily high rate of false positives and false negatives as compared to laboratory testing,” said Steve Passik, PhD, Vice President of Research and Advocacy for Millennium Health, which analyzed urine samples from nearly 4,300 POC tests obtained at addiction treatment clinics.The Millennium study was published in The Journal of Opioid Management.

A false positive reading means a drug was detected that isn’t actually there, while a false negative means the POC test missed finding a drug that was present in a urine sample.

The Millennium study found plenty of both.

False positive readings for marijuana, for example, were given over 21% of the time, while false negative results for marijuana also appeared about 21% of the time.

The POC tests had an even worse track record for oxycodone, a widely prescribed opioid pain reliever. False positive results were detected over 41% of the time and false negatives over 31% of the time for oxycodone.

“We always knew it wasn’t as sensitive and we always knew that it didn’t look for specific drugs within a class. But this was revealing in regard to how much it misses, with false negative and false positives rates in 40 to 50 percent in some instances,” said Passik.

“If we were in another area of medicine, let’s say oncology, and you had a tumor marker or a test that you were going to base important treatment decisions on, and it was as inaccurate as immunoassay is, the oncologists would never stand for it.”

Passik says “the word is starting to get out” how inaccurate the immunoassay tests are. But few patients are aware of it and some doctors are still dropping patients from pain management programs after POC tests found illicit or unprescribed drugs in their urine. 

Passik told Pain News Network that patients should insist on a second test if they feel the first one is wrong.

“If they think it’s a false positive, they need to ask the doctor to be re-tested. And particularly they should ask what method was used. And if they find out they were tested with immunoassay, they should say they want the same specimen either re-tested at the lab or they want to provide another specimen tested at the lab,” Passik said.

A laboratory test that uses chromatography-mass-spectrometry to break down and identify individual molecules is far more accurate than an immunoassay POC test, but it could cost thousands of dollars -- something many insurers and patients are unwilling to pay for.

And critics say Millennium – one of the largest drug screening companies in the nation – has produced a self-serving study designed to drum up more business for itself.

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test,” said a source with broad experience in the drug testing industry. “Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company.”

The source told Pain News Network the data in Millennium’s study was “skewed toward exaggeration” and questioned the need for further testing.

“In addiction centers, there is not really a large demand for confirmation testing. I understand Millennium wants to increase that business because that’s what they do.  However, medical necessity does play into all laboratory testing.  The great majority of the time, when a patient in a treatment center is confronted with the results of a POC test that shows a drug in their system that shouldn’t be there, they will confess to taking the drug.  So, what would be the medical necessity of confirming that test?

“I believe many of the urine drug testing labs are promoting confirmation testing when it is not medically necessary.”

Millennium took offense that the validity of its study was being questioned.

“Millennium Health strongly disagrees with the characterization in the story that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.”

"Liquid Gold"

A growing number of doctors who treat addicts and chronic pain patients require them to submit to random drug screens. And some companies and government agencies also require employees and job applicants to submit to POC tests as a condition of employment.

The competition between drug screening companies for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019.

But addiction experts say more reliable and expensive testing is needed, simply to be fair to patients.

“Heavy reliance on immunoassays in addiction treatment can be detrimental to the patient due to their higher risk for false positives and false negatives in comparison with more reliable technology, such as chromatography-mass-spectrometry,” said Michael Barnes, executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a non-profit that gets some of its funding from Millennium.

“A false positive can be detrimental to a patient by subjecting her to unjust suspicion or accusations, unnecessary adjustments to the treatment plan, or the deterioration of the practitioner-patient relationship. A false negative may result in delayed diagnosis or misdiagnosis, false confidence that a patient has not relapsed, and failure to catch behavior that could eventual result in a preventable overdose death. Therefore, chromatography-mass-spectrometry is often more appropriate.”

Millennium’s Passik says most doctors recognize that both tests may be needed.

“These two different methods yield very different kinds of results,” Passik said. “If I was still practicing, I wouldn’t feel that immunoassay is accurate enough to be the only test that you use.”

Ironically, a federal court last year found Millennium guilty of giving illegal kickbacks to doctors by providing them with free POC test cups – the very tests the company says have an “extraordinarily high rate” of false results.

Physical Therapy Lowers Healthcare Cost of Back Pain

By Pat Anson, Editor

Early physical therapy for low back pain significantly lowers healthcare costs by reducing the use of expensive treatments such as spinal surgery, injections, imaging and painkillers, according to a large new study published in the journal BMC Health Services Research.

About a quarter of Americans report an incidence of low back pain (LBP) within the previous three months and it is one of the most common reasons to visit a physician. Most LBP episodes resolve within 2 to 4 weeks, but about 25% of patients will experience recurring back pain for a year or more. 

Researchers analyzed health care records for over 122,000 patients in the U.S. Military Health System who went to a primary care physician for an initial episode of low back pain and received physical therapy within 90 days. 

Over 17,000 patients in the study received early physical therapy within 14 days – and it was this group that made significantly less use of advanced imaging, spinal injections, spine surgery and opioids than patients who started physical therapy later. 

Health care costs on average were 60% lower (about $1,200) over a two year period for patients who had early physical therapy compared to those who delayed therapy.

"Physical therapy as the starting point of care in your low back pain episode can have significant positive implications," said physical therapy researcher John Childs, PhD. "Receiving physical therapy treatment that adheres to practice guidelines even furthers than benefit."

Medical guidelines recommended for low back pain are to avoid opioids and advanced imaging as a first-line of treatment. However, recent research shows those guidelines are often ignored.

A large new study by pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"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.

Another study of older adults with low back pain found that spending thousands of dollars on advanced imaging such as CT scans or MRI’s within six weeks of visiting a primary care doctor was often a waste of money.  

“Early imaging was not associated with better one-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain,” said Jeffrey G. Jarvik, MD, a professor of radiology in the University of Washington School of Public Health, who studies the cost effectiveness of treatments for patients with low back pain.

Combined direct and indirect costs for low back pain in the U.S. are estimated to be between $85 billion and $238 billion a year.

"Given the enormous burden of excessive and unnecessary treatment for patients with low back pain, cost savings from physical therapy at the beginning of care has important implications for single-payer health care systems," said Paul Rockar, President of the American Physical Therapy Association.

A Pained Life: Hey Handicap!

By Carol Levy, Columnist

You may have seen a story in the news a few weeks ago about an Ohio woman with a prosthetic leg who left a note on the windshield of a car parked in a handicapped spot. The car had no handicapped ID, placard or license plate, so it appeared it was parked illegally, taking a place someone with a handicap (and proper ID) might have needed.

The owner of the car responded to the note in a very, very nasty way – leaving a note of her own:

“Hey handicap! First, never place your hands on my car again! Second, honey you ain’t the only one with ‘struggles.’ You want pity go to a one leg support group!” the note said.

There was no excuse for what she wrote. When a picture of the note was posted on Facebook, it went viral.

I abhor it when I see someone without proper ID parking in a handicapped spot. I have a handicapped license plate which allows me to park in the designated spots. Why should or would someone who does not need it take a space reserved for the handicapped, absent being lazy and self-centered? Does it not occur to them they are possibly making life much harder for someone truly in need?

There is nothing about me that looks disabled (at least not until I take off my sunglasses because of a facial paralysis). As a result, I get "the look" sometimes when someone watches as I exit my car.

Only once did someone actually accost me. She came flying towards me, nostrils flaring, her voice shaking with rage.

"How dare you park there? There's nothing wrong with you!" she said.

I was ready to respond in kind. I could feel the blood rushing to my face. My body tensed, ready to engage.

I should not have to defend myself, especially to a stranger. My pain is none of her business.

And then a calm came over me.

This can be a perfect teaching moment.

“You know, not everyone has a visible disability,” I told her. “I don't need to be on crutches, use a cane or be in a wheelchair to be disabled. I could have lung disease, heart disease, cancer, any number of things that makes me physically fragile and yet look fine to the outside world."

I watched as her face registered a variety of reactions. She went from indignation, to surprise, to maybe even a scintilla of understanding. As upset as I had been by her remarks, a sense of relief replaced my anger. Maybe one more person now “gets it.”

What bothers me about the story of the disabled person leaving the note on the windshield was that she did not consider the possibility that maybe the person who parked there was invisibly disabled.

It is possible that she forgot to put her handicapped placard on the mirror or dashboard. It is possible she was parked legally and legitimately needed the spot.

I see that in myself at times. How dare she park there? Look how healthy she looks!

And then I catch myself. My disability is invisible. How dare I not give others the same consideration without having to prove it.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Two Drug Combo Relieves Neuropathy Pain

By Pat Anson, Editor

British researchers say a combination of two widely used drugs – an antidepressant and an opioid – can significantly relieve pain and other symptoms caused by neuropathy.

In a study published in the journal PAIN, researchers at Queens University say combining the painkiller morphine with the antidepressant nortriptyline relieved chronic neuropathic pain in nearly 90 percent of patients – significantly better than when either drug is used alone.

"Morphine and nortriptyline are excellent candidates for pain management because of the extensive research conducted on them, their low cost, and widespread availability all over the world," said Ian Gilron, MD, a professor in Queen's School of Medicine and anesthesiologist at Kingston General Hospital.

"Current neuropathic pain treatments are ineffective or intolerable for many sufferers so this new evidence supporting the morphine-nortriptyline combination is important news for patients."

Nortriptyline, an antidepressant sold under the brand names Aventyl and Pamelor, is already being used to treat pain in the arms and legs caused by multiple sclerosis. Morphine has long been used to treat both acute and chronic pain.

Neuropathic pain is characterized by tingling or burning sensations that develop as result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects.

In the double-blind, randomized study, 52 neuropathy patients were given a choice of trying every one of three treatments: morphine alone, nortriptyline alone, and a combination of the two drugs over six-week treatment periods. Patients were asked to record their pain levels and side effects during each treatment.

The average daily pain before treatment was 5.6, measured using a rating scale from 0-10. Average daily pain dropped to 2.6 when patients received the two drug combination. Patients taking nortriptyline and morphine alone rated their pain at 3.1 and 3.4, respectively.

Researchers said that common side effects for both drugs, which include constipation and dry mouth, did not worsen with the combined treatment.

"It's important to remember that we don't want to completely eliminate patients' ability to sense pain as it's a warning system for us, but we do want to find the right balance of pain relief and drug side effects," said Gilron

Nortriptyline and morphine are currently not available in a combined formulation. According to the Mayo Clinic, using the two drugs together is usually not recommended because they both cause sedation.

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.

Physical Therapy vs. Surgery for Spinal Stenosis

By Pat Anson, Editor

Physical therapy works just as well as surgery in relieving pain and other symptoms of lumbar spinal stenosis in older patients, according to researchers at the University of Pittsburgh.

Their two year-year study, published in the Annals of Internal Medicine, is believed to be the first that compares outcomes between surgery and physical therapy (PT) for spinal stenosis, a condition caused by narrowing of the spinal canal that causes pain, numbness and weakness in the lower back.  Decompression surgery to relieve pressure on spinal nerves has become a fast-growing intervention in today's older population.

"Probably the biggest point to put across to physicians, patients and practitioners is: Patients don't exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of their non-surgical options," said principal investigator Anthony Delitto, PhD, chair of the Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Sciences.

Delitto, a physical therapist, was puzzled why some patients responded well to physical therapy  and others to surgery.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

After both groups were re-examined at intervals of six months, one year and two years, the patient outcomes appeared to be about equal. There were no detectable differences between the groups in how their pain abated and the degree to which function was restored in their backs, buttocks and legs.

"The idea we had was to really test the two approaches head to head," said Delitto. "Both groups improved, and they improved to the same degree. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in PT, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same."

The research project also revealed issues surrounding physical therapy and the cost of co-pay – which apparently discourage some patients from continuing their treatment.

"One of the big things that we know held patients back from PT were co-payments," Dr. Delitto added. "Patients were on Medicare, and a lot of them were on fixed incomes. Some of those co-payments had to come out of pocket at $25, $30, $35 per visit. That adds up, and some of the patients just couldn't afford it."

Most patients didn't finish the PT regimen allowed under Medicare and one-third of the patients failed to complete even half of the regimen. About one in six didn't show for a single treatment, though they had agreed to consider physical therapy.

Florida's State of Pain

By Pat Anson, Editor

If you suffer from chronic pain or care for someone who does, a recent half hour special report by WESH-TV in Orlando is “Must See TV” – whether you live in Florida or not.

In many ways Florida was ground-zero in the “War on Drugs,” with a sordid history of pill mills and unscrupulous doctors who dished out prescriptions for painkillers like they were candy.

In 2010, according to the Centers for Disease Control and Prevention, 98 of the top 100 oxycodone dispensing doctors in the country were in Florida and eight Floridians were dying every day from drug overdoses.

The state started cracking down. Law enforcement agencies raided doctors’ offices, shutdown over 100 pill mills, and heavily penalized pharmacies that were dispensing too many opioids.

The crackdown worked and overdoses soon declined, but somewhere along the way – in the view of many chronic pain patients -- the War on Drugs became a War on Patients. 

Florida doctors started dropping pain patients from their practices and pharmacies began turning away longtime customers who had never abused painkillers, forcing many to go on a “pharmacy crawl” in search of someone to fill their prescriptions. Faced with daily unrelenting pain, some patients resorted to suicide.

Much of what happened in Florida is now occurring on a national level, with pain patients being marginalized and viewed as drug addicts by a health care system that has grown fearful and paranoid.

WESH-TV investigative reporter Matt Grant and his producers do a commendable job covering all of this, explaining how legitimate pain patients have become unintended casualties in Florida’s War on Drugs.

You can watch his report below in three installments:

From Russia with Pain

By Pat Anson, Editor

If you’re a pain sufferer who has difficulty getting prescriptions written and filled for opioid pain medication – be glad you don’t live in Russia.

In Russia, even terminally ill cancer patients have trouble getting opioids. And some have committed suicide rather than spend their remaining days in pain.

In February, 11 cancer patients committed suicide in Moscow alone, according to a special report published in Meduza, a web-based Russian media outlet that operates out of Latvia.

“There’s no end to the pain. It won’t stop next morning, or tomorrow, or the day after. It won’t disappear if a tooth is pulled out or if drops of medicine are squeezed into your ear. If you don’t relieve the pain somehow, it eats you up right to the end. It’s absolutely unbearable,” one cancer patient was quoted as saying.

Getting painkillers in Russia is difficult for everyone, whether they have cancer or not. It can take up to three days for adults, according to Meduza, and for children up to 12 days.

Here’s what cancer patients have to do:

First they visit a general practitioner at a clinic, who will assess their pain levels and send them to an oncologist. The oncologist will then write up an assessment and send the patient back to the general practitioner, who will write up a prescription. The head of the clinic must then stamp the prescription, which is only valid for five days.

Clinics typically forward prescriptions to pharmacies at 4 pm – so if a patient doesn’t have a prescription approved by then, they have to wait until the next day.

All of these steps leading to long lines at the clinic, the oncologist and the pharmacy. The final indignity for patients is that they have to return the used containers and packaging from their previous medication to get a new one.

Adding to the stigma is that narcotic painkillers have long been deemed unnecessary in Russia – dating back to Soviet times. Patients who use the drugs are often treated like addicts and doctors who prescribe narcotics are sometimes punished as criminals.

This has led to a thriving black market for painkillers and soaring prices for pain medication that are sold legally. The government is reported to be conducting checks of pharmacies in major cities to protect against price gouging.

Meduza’s story about the suicides sparked a backlash and a heavy-handed attempt by the government to prevent other websites from reporting on poor access to pain medication. The pretext given for the censorship was a 2012 Russian law that prohibits online content advocating suicide and drug use. Any website violating the law can be blocked by the government.

One site was told to delete copy that simply said: "The wife of the deceased explained that her husband suffered from constant pain because of cancer and often said he was tired of being sick."

Moscow's deputy mayor disputed the notion that the suicides were in any way connected to lack of access to painkillers -- claiming that at least seven of the 11 people who killed themselves were unaware they had cancer.

The deputy head of the Russian Federation Council's constitutional law committee disputed the notion that forcing websites to delete information would prevent more suicides.

"The information about the reasons for suicides by cancer sufferers is socially significant in this case,” Senator Konstantin Dobrynin told the state news agency RIA Novosti. “Covering up such information could lead to even more victims."

The World Health Organization ranks Russia 38th out of 43 European countries in access to painkillers, but the problem isn’t unique to Russia.

According to one recent study, pain medications such as morphine and codeine were not widely available or virtually non-existent in a dozen eastern European countries stretching from Poland to Turkey.

'National Pain Strategy' Report Released

By Pat Anson, Editor

The National Institutes of Health has quietly released a draft copy of its National Pain Strategy, a long awaited report designed to advance pain research, healthcare and education in the U.S.

The report calls chronic pain a “complex disease and a threat to public health” and identifies several areas where physicians and the healthcare system are failing pain sufferers.

“Access to high-quality integrated care based on clinical evidence is hindered by many challenges, including a payment system that does not support optimal care. Pain management often is limited to pharmacological treatment offered by a single primary care practitioner or to procedure-oriented and incentivized specialty care that is not coordinated and not aligned with the best available evidence or expected outcomes,” the report says.

“Even when interdisciplinary care is provided, creating and executing a care plan is often fragmented, with poor communication among clinicians and without consideration of patient preferences. The clinician or team’s choice of therapy may be based on practice experience or on insurance coverage, rather than one informed by a comprehensive pain assessment, clinical evidence or best practices.”

The report only briefly addresses the controversy over the abuse and diversion of opioid painkillers, and how some pain sufferers are being denied pain medication by their doctors and pharmacists.

“The reluctance of many clinicians to prescribe these medications, and patients’ concerns over stigmatization associated with opioids may jeopardize quality pain control in the population. Only a small percentage of practitioners and patients account for the majority of opioid-related risk through abuse of prescribing privileges and inappropriate management of prescriptions,” the report said.

Other key findings of the report:

• People with pain are too often stigmatized in the health care system and in society, which can lead to delayed diagnosis, misdiagnosis, and bias in treatment.
• Significant barriers to pain care exist, especially for populations disproportionately affected by pain.
• Although pain is widespread in the population, research is lacking on the prevalence, impact, and outcomes of most common chronic pain conditions.
• Significant improvements are needed in pain management practices.
• Primary care doctors are not sufficiently trained in pain assessment and treatment.  
• Greater collaboration is needed between primary care doctors and pain specialists.

“I agree that collaboration between primary and pain specialists is helpful in some cases, though I do not believe it is mandatory,” said Celeste Cooper, a retired nurse and patient advocate who reviewed the report.

“To think that a primary physician cannot complete continuing education courses for management of mild to moderate chronic pain is ridiculous. Primary physicians are on the front lines. They will be held accountable for prevention strategies, but they aren’t able to make assessments for treating pain? This seems like tying their hands behind their backs.’

The National Pain Strategy is an outgrowth of the 2011 Institute of Medicine report, “Relieving Pain in America,” which found that 100 million Americans suffer from chronic pain.

One critic of the new report says it lacks vision and will not make pain care better.

 “I think the report reflects that it has been developed by (and for) special interest groups who are not very skilled at planning or project management. This report is ungainly and lacks a real focus -- and so I think people in pain will be wondering what exactly they can expect to be different and better for them,” said patient advocate David Becker in an email to Pain News Network.

“I think it is unethical for special interest groups to assume that any and every individual in pain cannot be cured and should not receive stem cell therapy or other curative/regenerative care. In this regard, it reinforces the received view -- and a self- serving view -- that people in pain should be treated indefinitely by medical care."

While not perfect, Cooper said she was encouraged by the report's recommendations.

"Looking at chronic pain as a public health issue is the right approach in my opinion. It will avail resources that wouldn’t otherwise be accessible. The report is comprehensive, there will be roadblocks in implementing all the suggestions, but hopefully generations to come will benefit. As an educator, I was impressed on seeing short-term to long-term goals. This strategy provides a mechanism for reassessment and revision," Cooper said in an email.

The Interagency Pain Research Coordinating Committee is accepting public comments on the National Pain Strategy until May 20, 2015.

Comments can be emailed to NPSPublicComments@NIH.gov.

When Your Body Betrays You

By Jennifer Martin, Columnist

I remember very vividly the day I first began thinking about how much my body has betrayed me. It wasn’t too long after I got home from spending nearly six weeks in the hospital.  I was recovering from my first j-pouch surgery. 

I was sitting on the couch at my mother and stepfather’s house, feeling depressed, weak and hopeless.  I couldn’t see the light at the end of the tunnel.  These were emotions I had not experienced to this extent before; even after the years of ups and downs I had had living with rheumatoid arthritis and ulcerative colitis.

I remember my mom telling me, “You need to work through these feelings of depression.  We need to get you out of the house.  Staying inside all day isn’t going to help.  Let’s go to the harbor so you can at least sit outside and be around people.”

My husband told me, “You need to fight.  I can’t fight for you if you are going to give up.”

My stepdad said to me, “You are strong.  I know you can get through this.  We are all here for you.”

While I appreciated all of these sentiments, all I wanted to do was scream at them, “You have no idea what I need!  I am not strong!  I don’t want to do this anymore!” 

And I wanted to scream at my body, “How could you do this to me? Why are you doing this to me?” 

I had never felt so lost and confused.  And I had never felt so betrayed by my own body, which at the time struck me as odd, seeing as I had been living with chronic illness and pain my whole life.

What I eventually learned from that horrible day was that my family was right.  The only way you can begin to resolve these feelings of body betrayal is to do something about it;  to learn to cope with your chronic pain or chronic illness, even if you don’t want to. 

Trust me, the last thing I wanted to do that day was to go out in public looking as sick as I did and feeling like I was about to collapse.  I had no idea how I was even supposed to make it from the car to the nearest bench to sit down.  But I did, and while I’m not going to claim that it fixed everything, it did help my mood somewhat. 

At that time I was angry at my husband because I felt like he was putting a lot of pressure on me.  I felt like in order to fight I had to put on a happy face all of the time and that I was not allowed to experience my pain or sorrow in front of him.  

After giving what he said some thought however, I realized what he meant.  He didn’t mean that I was never allowed to feel sorry for myself and he didn’t mean that I was never allowed to complain or cry. 

What he meant was that I was the only one who had control over how I dealt with my situation and the upcoming struggles I was still to have.  I could either  give in and give up or I could find a way to work through what I was going through.  He couldn’t do that for me.

I remember wanting to tell my stepdad that I felt the complete opposite of strong.  I also remember feeling guilty for the support my family was giving me.  I felt like a burden and I didn’t want them to give up so much just for me.  It didn’t feel fair and it didn’t feel right that just because I was going through something so terrible they had to go through it with me. 

Looking back on my experience, I realize how lucky I was and still am to have that kind of support.  It is so important for those experiencing chronic pain or chronic illness to have a support system, whether it is one friend, a support group or a whole clan of people.

I have learned that all you can do in those moments when you feel your body has betrayed you is do what you can.  We don’t have control over the chronicity of our conditions.  However, as much as it doesn’t seem like it at times, we do have control over how we choose to approach our condition. 

We can learn to cope by:

• participating in enjoyable activities when we feel well
• advocating for our health
• taking our medications
• getting help when we feel depressed or anxious
• exercising when we have the energy and aren’t in too much pain
• making sure we aren’t isolating ourselves from friends and family
• resting when we do not feel well
• focusing on the positive things in our lives
• learning to manage the guilt we may feel

We can give in to all of the negative thoughts, or we can learn how to combat negative thinking.

We can let our pain or illness define us or we can learn how not to let that happen.

We can give in and give up, or we can fight. 

Jennifer Martin, PsyD, is a licensed psychologist in Newport Beach, California who suffers from rheumatoid arthritis and ulcerative colitis. In her blog “Your Color Looks Good” Jennifer writes about the psychological aspects of dealing with chronic pain and illness. 

Jennifer is a professional member of the Crohn’s and Colitis Foundation of America and has a Facebook page dedicated to providing support and information to people with Crohn’s, Colitis and Digestive Diseases, as well as other types of chronic pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Issues Guidance on Abuse Deterrent Opioids

By Pat Anson, Editor

The U.S. Food and Drug Administration has released its long-awaited guidance on abuse-deterrent opioids, beating a Congressional deadline and a potential loss of $20 million in funding.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about abuse-deterrent properties and recommends to drug makers how clinical studies should be conducted to evaluate their effectiveness.

Abuse deterrent formulas are intended to make it harder for drug abusers to crush or liquefy a narcotic painkiller for snorting or injecting. But the evidence is mixed that they actually work.

“It should be noted that these technologies have not yet proven successful at deterring the most common form of abuse — swallowing a number of intact capsules or tablets to achieve a feeling of euphoria. Moreover, the fact that a product has abuse -deterrent properties does not mean that there is no risk of abuse.  It means, rather, that the risk of abuse is lower than it would be without such properties. Because opioid products must in the end be able to deliver the opioid to the patient, there may always be some abuse of these products,” the FDA said in its report.

The agency has been under pressure from Congress to move faster in developing guidelines for abuse deterrence. An appropriations bill passed late last year would have moved $20 million in funding from the FDA’s Commissioner’s office if the guidance wasn’t released by June 30.

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret Hamburg, MD. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

So far only four opioids have been approved with abuse-deterrent formulas, OxyContin, Embeda, Targiniq and Hysingla. The latter was recently introduced by Purdue Pharma as the only “pure” hydrocodone extended release product with abuse-deterrence.

Purdue’s reformulated version of OxyContin was the first opioid to have abuse deterrence. It was introduced in 2010, at a time when the painkiller was widely being abused.

A recent study by researchers at Washington University’s School of Medicine in St. Louis found that over a quarter of drug abusers entering treatment facilities admitted they still abused OxyContin. About a third of the abusers said they had found a way to inhale or inject it. The rest took the painkiller orally.

One unintended consequence of reformulating OxyContin is that 70% of the drug abusers who stopped using it and who switched to other narcotics started using heroin.

"The newer formulations are less attractive to abusers, but the reality is -- and our data demonstrate this quite clearly -- it's naïve to think that by making an abuse-deterrent pill we can eliminate drug abuse. There are people who will continue to use, no matter what the drug makers do, and until we focus more on why people use these drugs, we won't be able to solve this problem,” said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

Some patients believe the reformulated version of OxyContin is less effective as a pain reliever and causes gastrointestinal problems because it is harder to digest.

The FDA said it would take “a flexible, adaptive approach” to the future evaluation and labeling of abuse-deterrent products.

“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

“While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”

Over 16,500 deaths in the U.S. were linked to opioids in 2010. According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Acetaminophen Ineffective for Back Pain

By Pat Anson, Editor

The world’s most widely used over-the-counter pain reliever is ineffective in treating low back pain and provides little benefit to people with osteoarthritis, according to a new study published in the British Medical Journal.

In a systematic review of a dozen research reports (a study of studies), Australian researchers also questioned many of the conventional treatments for back pain and other musculoskeletal conditions.

Acetaminophen -- also known as paracetamol – is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. It is often recommended by doctors worldwide for back pain and osteoarthritis.

"Clinicians should carefully weigh benefits and harms when making treatment decisions. Paracetamol is not efficacious and potentially harmful. In this context we cannot justify its continued use for these prevalent diseases,” said Professor David Hunter of the University of Sydney.

The researchers found “high quality” evidence showing that patients taking acetaminophen are at greater risk of liver toxicity and nearly four times more likely to have abnormal results from liver function tests.

"World-wide, paracetamol is the most widely used over-the counter medicine for musculoskeletal conditions so it is important to reconsider treatment recommendations given this new evidence," said lead author, Gustavo Machado of The George Institute and the University of Sydney.

Low back pain is the leading cause of disability worldwide, and osteoarthritis of the hip or knee is the 11th highest contributor to global disability.

"This latest research, the most comprehensive systematic review of its kind, reaffirms this with an even larger, global patient base, and has for the first time also established that the effects of paracetamol for knee and hip osteoarthritis are too small to be of clinical importance." said senior author Manuela Ferreira of the George Institute for Global Health and the University of Sydney.

"We urgently need to take stock of the evidence for common musculoskeletal conditions, a largely under-recognized health priority, and make sure people are receiving appropriate care."

Treatments known to be effective for low back pain include counseling, physical therapy, exercise and psychological therapies such as cognitive behavioral therapy.

Aerobic exercise, strengthening exercise, weight management and anti-inflammatory medicines have been shown to provide benefit for patients with lower limb osteoarthritis.

A recent study published in The Lancet found that acetaminophen had no effect on pain, disability, function, sleep quality, or quality of life for people with low back pain.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Study Claims 10% of Pain Patients Addicted to Opioids

By Pat Anson, Editor

Estimating rates of opioid abuse and addiction has never been easy. Dozens of different studies have come to startling different conclusions, and there is even disagreement over the definition of abuse and addiction.

Now a professor at the University of New Mexico is weighing in on the subject -- and his conclusions are likely to stir even more debate.

In a systematic review of 38 research reports (a study of studies) published in the journal PAIN, lead author Kevin Vowles and his colleagues estimate that up to 30 percent of the opioids prescribed for pain are misused and that about 10 percent of pain patients are addicted to them.

They also question whether opioids should be prescribed at all for chronic pain.

“It is not clear whether the risks of opioid use outweigh the potential for benefit. The efficacy of opioids and their suitability for the long-term management of chronic pain still remain very much in question and while this uncertainty in effectiveness is well established, it stands in somewhat stark contrast to the clinical reality of chronic pain treatment, where rates of prescriptions have skyrocketed such that opioids are now among the most frequently prescribed medications,” wrote Vowles.

“We are not certain whether the benefits derived from opioids, which are rather unclear based on the extant literature, compensate for this additional burden to patients and health care systems.”

The researchers noted there was extremely wide variation in the rates of opioid misuse and addiction in the studies they analyzed. Rates of “problematic use” ranged from less than 1% all the way up to 81%.

One study -- a review of 25 research reports – left the barn door wide open by broadly estimating the “prevalence of problematic opioid use behavior” at 0% to 50% of pain patients.

“The vagueness inherent in these definitions, areas of overlap among them, and their sometimes interchangeable use have made it difficult to determine exact rates and types of problematic opioid use,” conceded Vowles.

Exactly what constitutes opioid misuse is also debatable.

Vowles defined misuse as “opioid use contrary to the directed or prescribed pattern of use, regardless of the presence or absence of harm or adverse effects.” Such a definition means a patient who has stopped using a prescribed opioid – even if they no longer have pain – is misusing the medication.

(Several years ago this writer was sent home from the hospital after surgery with a two week supply of Vicodin. Fortunately, the surgery was successful and the pain subsided after a few days. A half empty bottle of Vicodin sat unused in my medicine cabinet for years before I had sense enough to throw it out. Under Vowles’ definition, I had “misused” the Vicodin.)

Studies by some of the nation’s largest drug screening companies consistently show that many Americans don’t take the drugs that are prescribed for them. A large study by Quest Diagnostics found that 60% of Americans failed to take a medication as prescribed by their physicians and that 42% had no drugs in their system. Should they be included in estimates of misuse?

Rates of addiction in the studies analyzed by Vowles also varied greatly – from 0.7% of pain patients up to 34.1%.

An adjusted analysis by Vowles estimated the average rate of addiction at 8% to 12% -- a figure nearly double the estimate of the National Institutes of Health (NIH). According to the NIH, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

“Misuse, abuse and addiction mean different things to different researchers,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“We must keep in mind that behaviors determine the diagnoses of misuse, abuse and addiction and these behaviors are subjective interpretations. Subjective interpretations are influenced by one's biases and perspective.  Misuse to one researcher can be addiction to another. Unfortunately there has not been a standard interpretation of behaviors and I doubt there ever will be due to personal beliefs about opioids and addiction.”  

While Webster doesn’t take issue with the design of the study – he does dispute the overall conclusion that the risks of opioid abuse outweigh the benefits.  

“It is undoubtedly true that some people should not be prescribed opioids.  But even using their reported averages for abuse and addiction, a majority of people do not abuse or become addicted and therefore shouldn't necessarily be denied treatment particularly if there is no other option,” Webster wrote in an email to Pain News Network. 

Ironically, only one study analyzed by Vowles even looked at the recreational abuse of opioids – perhaps the biggest contributor to the so-called “epidemic” of prescription drug abuse in the U.S.  That study estimated the rate of abuse by pain patients at just 8% -- far below their estimated rates of misuse.

Vowles admits there are several limitations to his study.

“The most obvious is the degree of variability within this literature. In spite of our attempts to minimize the impact of this variability, the range of misuse and addiction was incredibly broad,” he wrote.

“These sources of variability will likely continue to cloud our ability to make precise estimates. There is clearly room here for a series of carefully controlled studies where sources of variability are held constant, or as constant as possible, to more clearly illuminate prevalence rates of problematic opioid use in individuals with chronic pain.”