How Chronic Pain Changes Mood and Motivation

By Pat Anson, Editor

Researchers in California have found the first biological evidence that chronic pain alters regions in the brain that regulate mood and motivation -- raising the risk of depression, anxiety and substance abuse.

In animal studies at UCLA and UC Irvine, researchers found that brain inflammation in rodents that was caused by chronic nerve pain led to accelerated growth and activation of immune cells called microglia. Those cells trigger chemical signals within the brain that restrict the release of dopamine, a neurotransmitter that helps control the brain's reward and pleasure centers.

"For over 20 years, scientists have been trying to unlock the mechanisms at work that connect opioid use, pain relief, depression and addiction," said Catherine Cahill, associate professor of anesthesiology & perioperative care at UCI, Christopher Evans of UCLA's Brain Research Institute. "Our findings represent a paradigm shift which has broad implications that are not restricted to the problem of pain and may translate to other disorders."

The study also revealed why opioid drugs such as morphine and cocaine may lose their effectiveness as animals transition from acute pain to chronic pain. Cahill and her colleagues learned that opioids fail to stimulate a dopamine response in mice and rats, resulting in impaired reward-motivated behavior.

Treating the rodents with a long-acting antibiotic called minocycline inhibited microglial activation, and restored dopamine release and reward-motivated behavior. That finding suggests that a similar approach could be used in treating chronic pain in humans.

"Our findings demonstrate that a peripheral nerve injury causes activated microglia within reward circuitry that result in disruption of dopaminergic signaling and reward behavior. These results have broad implications that are not restricted to the problem of pain, but are also relevant to affective disorders associated with disruption of reward circuitry," the study found.

The results of the five-year study appear online in the Journal of Neuroscience.

Cahill and her research team are now trying to establish that pain-derived changes in human brain circuitry can account for mood disorders.

"We have a drug compound that has the potential to normalize reward-like behavior," she said, "and subsequent clinical research could then employ imaging studies to identify how the same disruption in reward circuitry found in rodents occurs in chronic pain patients."

Five Ways TIME Gets Pain Pills So Wrong

By Crystal Lindell, Columnist

Access to pain pills is not a cause I chose. I didn’t wake up one day and think, “Gee, more people need opioids.”

No, access to pain pills is a cause that chose me. Because I really did wake up one day two and half years ago, and say, “What is wrong with me? Why do I suddenly have insane pain in my ribs?”

It’s a pain that never went away. And for months, the doctors didn’t take me seriously. They gave me prescription-strength Advil, Lidoderm patches, and told me to wear looser bras.

None of that worked.

So, for weeks on end, the pain got worse and worse, while I tried multiple doctors, trying to find someone who could help.

I was in so much pain that I would often lay down on the ground mid-sentence because I didn’t have it in me to keep standing. The pain was just that overwhelming.

And at night, after trying to survive the day, I would lay in bed and plan ways to commit suicide. I wish I was exaggerating.

Finally, I found a pain specialist who put me on hydrocodone. At the time I had no idea that opioids were controversial. I was just happy to finally have found something that gave me relief.

The problem with hydrocodone though is that it comes with these crazy spikes. So you take a pill, it relieves the pain and then it completely wears off within a couple hours — and you to wait six hours for your next dose. It’s a horrible way to live.

I’m also on a time-released morphine that lasts about 8 hours. I take it three times a day — so I am always on an opioid, 24 hours a day. And then, on top of that, I also take hydrocodone as needed.

I pretty much always need it.

The pain still gets bad. But now, because of the pain pills, I have times when I am nearly pain free. Times when I can catch my breath and remember that life is worth living.

Opioids have literally saved my life.

Which is why I’m so upset about TIME magazine’s cover story about the “worst addiction crisis America has ever seen.” 

I realized when I read the article that I am spoiled by my Facebook news feed. I tend to follow chronic pain groups, so most of the information I see is about how chronic pain patients need access to these drugs. As a result, I’ve been lulled into thinking that the chronic pain community is actually making progress on this issue.

Apparently, we aren’t.

And it is articles like this that make it that much harder for pain patients like me to get the relief they need.

Let’s break down what it gets so wrong, with some quotes from the report:

1.    It implies time-released morphine is basically heroin.

“The longer patients stay on the drugs, which are chemically related to heroin and trigger a similar biological response, including euphoria, the higher the chances users will become addicted.”

Aside from the excessive number of commas, there are so many infuriating things about this sentence. 

While the drugs can give you a “high” feeling when you first start taking them, I can promise you — after being on morphine all day, every day for over a year — that the “high” is only a short-term side effect.

Also, comparing the drugs I take to heroin is like saying that both TIME and US Weekly are similar because they both require reading. Yes, that’s true. But that’s about all they have in common.

2. The article focuses on how much the drug companies are supposedly making on these meds.

“The total annual sales for opioids in the U.S. has grown over 20 years to more than $8 billion.”

While there have been some new meds on the market, like Zohydro, the pills that I take and the pills most of the people I know take, are generic. Morphine isn’t exactly a brand name.

Giving people relief from horrific, daily pain is not part of some drug company conspiracy. It’s called compassion.

3. It devalues how horrible pain can be.

“The standard-setting Joint Commission on Accreditation of Health Care Organizations in 1999 required doctors to measure pain as part of their basic assessment of a patient’s health, which had the effect of elevating pain the same level of importance as objective measurements like temperature and heart rate.”

The author writes that like it’s a bad thing. I’m here to tell you, it’s not. Pain is such a huge part of your health. And managing it is just as important as managing your blood pressure or your insulin level.

Having too much pain will ruin your life and your body just like any other health issue.

Living with chronic pain is like living every day of your life with the same amount of pain you would wake up with after an extensive surgery, or a horrific car accident, or a stabbing.

Anyone in those situations would be given adequate pain relief. And, just because people with chronic pain have that same pain every day, all day, doesn’t mean they don’t deserve the same relief.

4. It implies that anyone on long-term pain medications is an “addict.”

“With America awash in opioids for the foreseeable future, health care providers and public officials are searching for ways to help addicts get clean.”

I don’t need to “get clean.” I need a cure, but there isn’t one for what I have. The next best thing is daily pain relief. Going off all my meds would be catastrophic for me, not because I’m addicted, but because I would end up stuck on the couch for the rest of my life in too much pain to shower.

Also, we need to take a second to talk about the word “addicted.” It is very different from what’s actually happening for most people, which is “dependence.”

Dependence is what happens when you take lots of different types of drugs long-term. Your body becomes dependent, so going off them cold turkey would be hell. However, if you taper off it, you’re good. Just like anti-depressants. And nobody ever says people are “addicted to anti-depressants.”

Addiction is when you start to crave that high feeling you get the first few times you take the drug, so you start taking higher and higher doses seeking it out. Sort of like how all of us are dependent on food, while a select few are addicted.

5. The authors don’t mention any alternatives.

For those enduring chronic pain, the real-life alternative to not having adequate pain pills is suicide.

Articles like this just make it that much harder for people with chronic pain to get the medications they need. If you want to see the suicide rate jump, just take away the medications that so many people rely on to do even simple things, like make dinner or do a load of laundry.

Look, I’m not saying everyone with a cold should get a prescription for morphine. I’m just saying that there are millions of people out there who need these drugs. And more regulation just gets in the way of decisions that doctors and patients should make together to help those who are suffering cope with their pain. The government should never be in anyone’s doctor’s appointment.

At the end of the day, I guess I just wish that TIME had talked to even one chronic pain patient for the article. There are millions of us out here, responsibly using opioids long-term, and we would have loved to chat with TIME.

If only they had asked.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Many Doctors Not Confident Prescribing Opioids

By Pat Anson, Editor

Nearly two-thirds of physicians who prescribe opioids say they are not confident or only somewhat confident about managing patients on opioid painkillers, according to the results of a new survey that found widespread gaps in education about opioid safety.

"This indicates a critical need for provider education addressing this issue. It is important our medical community is given the training it needs to confidently manage chronic pain while significantly reducing prescription opioid misuse, overdose and diversion," said Daniel Alford, MD, of Boston University School of Medicine.

Boston University and Haymarket Medical Education conducted an online survey of nearly 800 physicians who are registered with the Drug Enforcement Administration to prescribe Schedule II and III controlled substances.

Over a quarter (28%) said they had not completed certified medical education (CME) in safe opioid prescribing. Many also said they lacked the time or staff to implement an opioid monitoring system for patients, such as drug testing and pill counts.

"It's troubling that so many physicians say implementing safe opioid prescribing systems is not a priority, even though this is an acute issue. We've created a situation where some physicians are comfortable not doing anything about it,” said Alford.

Only a quarter of the doctors surveyed said they were very confident about their ability to safely manage chronic pain with opioid pain medication. Four out of ten said they don’t even prescribe opioids.

 “Lack of knowledge regarding some narcotics. Concerns of dealing with patients who appear to be drug seeking. Lack of time to follow some of these patients closely,” said one doctor who was not confident about prescribing opioids.

“Lack of training. Fear of providing access to patients who might abuse opioids,” said another.

Pain education for doctors – or the lack of it – is such a concern that the recently released National Pain Strategy considers it a top priority.

“Many health professionals, especially physicians, are not adequately prepared and require greater knowledge and skills to contribute to the cultural transformation in the perception and treatment of people with pain,” a draft version of the report states. “Core competencies in pain care are not fully developed and generally do not inform undergraduate curricula in health professions schools or graduate training programs, even those in pain medicine.”

A 2012 study published in the Journal of Pain  called pain education in the U.S. and Canada “lackluster” and warned that unless steps were taken to improve the training of pain physicians, “the crisis in pain care and resultant deaths from opioid abuse will only spiral upwards.”

The study of 117 U.S. and Canadian medical schools found that less than 4% required a course in pain education and only one in six schools offered a pain elective. A large number of U.S. medical schools do not have any pain courses and many of those that do have less than five hours of classes.

Study Links Painkillers to Homicides

By Pat Anson, Editor

You can add the term “homicidal” to the list of stigmas faced by chronic pain patients.

A new study in the journal World Psychiatry has found that certain drugs that affect the central nervous system – particularly opioid painkillers – significantly increase the risk of committing murder.

The Swedish and Finnish researchers behind the study wanted to know if there was any scientific basis for the claim that anti-depressants and other psychotropic drugs can cause violent behavior. It’s an issue that was debated after massacres committed by young people in schools and other public places in Finland and around the world.

"It has been repeatedly claimed that it was the anti-depressants used by the persons who committed these massacres that triggered their violent behavior. It is possible that the massive publicity around the subject has already affected drug prescription practices," said lead author Jari Tiihonen of the Karolinska Institute in Sweden.

In one of the first studies of its kind, researchers analyzed a database of 959 people convicted of homicide in Finland between 2003 and 2011 to see what medications they were taking before their crimes.  

They found that anti-psychotic medication was not associated with a significantly increased risk of homicide, and there was only a slightly elevated risk for most people taking anti-depressants and benzodiazepines – drugs used to treat anxiety and insomnia.

But the study did find, rather surprisingly, that there was a significantly higher risk of committing a homicide associated with opioid pain medications like oxycodone and tramadol (93% higher) and anti-inflammatory pain relievers such as acetaminophen (206% higher).

The risk was even more elevated for young people. For someone under the age of 26, there was a 223% greater chance of them killing someone if they were taking opioids. Young people taking benzodiazepines had a 95% greater risk.

"Benzodiazepines can weaken impulse control, and earlier research has found that painkillers affect emotional processing. Caution in prescribing benzodiazepines and strong painkillers to people with a history of substance abuse is advisable," Tiihonen concluded.

Although alcohol and other intoxicants were also involved in a majority of the homicides, the researchers said their use did not explain the differences between the drug groups.

In 2007, an 18-year old Finnish high school student named Pekka-Eric Auvinen fatally shot eight people at his school before taking his own life. He had been taking anti-depressants for a year prior to the massacre.

The Citizens Commission on Human Rights UK has a list of several other massacres around the world linked to the use of anti-depressants. Opioids are not mentioned in any of the examples.

New Software Helps Doctors See Kids' Pain Levels

By Pat Anson, Editor

Accurately assessing pain levels in a patient is difficult because pain is so subjective. No one really knows how much pain a patient is in – except the patient.

It gets even harder when the patient is a young child who can’t verbally express their feelings the same way an adult can. For decades doctors have relied on low-tech diagnostic tools like the Wong Baker Pain Scale – a series of sad and smiling faces the child chooses from to help the doctor understand how much pain they are in.

Thankfully, that era may be coming to an end with the development of a high-tech approach at the University of California, San Diego School of Medicine.

Researchers there have demonstrated the validity of new software that measures pediatric pain by recognizing facial patterns in each patient. Their study is published online in the journal Pediatrics.

“The current methods by which we analyze pain in kids are suboptimal,” said senior author Jeannie Huang, MD, a professor in the UC San Diego School of Medicine Department of Pediatrics and a gastroenterologist at Rady Children's Hospital-San Diego.

COURTESY UC SAN DIEGO SCHOOL OF MEDICINE

“In this study, we developed and tested a new instrument, which allowed us to automatically assess pain in children in a clinical setting. We believe this technology, which enables continuous pain monitoring, can lead to better and more timely pain management.”

The researchers used the software to analyze pain-related facial expressions from video taken of 50 youths, ages five to 18 years old, who had laparoscopic appendectomies.

Researchers filmed the patients during three different post-surgery visits: within 24 hours of their appendectomy; one calendar day after the first visit and at a follow-up visit two to four weeks after surgery. Facial video recordings and self-reported pain ratings by each patient, along with pain ratings by parents and nurses were collected.

“The software demonstrated good-to-excellent accuracy in assessing pain conditions,” said Huang. “Overall, this technology performed equivalent to parents and better than nurses. It also showed strong correlations with patient self-reported pain ratings.”

Huang says the software also did not demonstrate bias in pain assessment by ethnicity, race, gender, or age – an important consideration given how subjective current pain scales can be.

Because the software operates in real-time, doctors can be alerted to pain when it occurs instead of during scheduled assessments. The technology could also advocate for children when their parents are not around to notify medical staff about their child's pain level.

Huang said the software needs further study with more children and other types of pain in a clinical setting.

“It still needs to be determined whether such a tool can be easily integrated into clinical workflow and thus add benefit to current clinical pain assessment methods and ultimately treatment paradigms,” she said.

Huang says controlling pain is important, not only for the child's comfort, but also for their recovery since studies have shown that under-treatment of pain is associated with poor surgical outcomes.

Tramadol ER Visits Soar as Prescriptions Rise

By Pat Anson, Editor

Emergency room visits in the U.S. involving tramadol have nearly tripled in the last decade, coinciding with a sharp increase in the number of prescriptions for the opioid pain reliever.

According to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA), emergency room visits involving adverse reactions to tramadol rose from 10,901 visits in 2005 to 27,421 visits in 2011. A second SAMHSA report  found a similar increase in the number of ER visits related to the abuse or misuse of tramadol. The vast majority of patients were treated and released.

Ironically, tramadol is considered less risky than other opioid painkillers and doctors have been increasingly prescribing it. The IMS Institute recently reported the number of tramadol prescriptions in the U.S. nearly doubled from 28 million in 2010 to over 44.2 million in 2014.

Tramadol is the active ingredient in brand name pain relievers such as Ultram, Ultracet, Ryzolt and Rybix.

“Tramadol is not abused as much as most pain medication, but it is often overtaken in an effort to obtain additional pain relief.  Like with all pain medication, excessive amounts can cause serious harm,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

Webster predicted that tramadol would be prescribed even more often when hydrocodone was reclassified in 2014 by the Drug Enforcement Administration from a Schedule III drug to a more restrictive Schedule II medication. Tramadol is a Schedule IV drug, meaning it has less potential for abuse than other narcotic pain relievers.

“In the past several years there has been tremendous pressure to reduce prescribing strong opioids. Tramadol has been used in place of other opioids. But it is not without risks as well,” said Webster in an email to Pain News Network.

“The rise in problems associated with tramadol underscores the larger problem of an unmet need to effectively treat pain. Most people, including policymakers, don't realize how many people are desperate to have their pain treated.”

About two-thirds of the ER visits related to misuse or abuse involved tramadol that was taken with other opioid pain relievers or anti-anxiety drugs (benzodiazepines). When tramadol is combined with other drugs that depress the central nervous system its sedative effects can be enhanced, causing seizures and a potentially fatal drug reaction known as serotonin syndrome.

Women were far more likely to have a tramadol-related trip to the ER than men, according to SAMHSA.

The greatest increase in tramadol-related misuse or abuse occurred in patients aged 55 and older. A SAMHSA spokesman said the higher number of older adults was not surprising because seniors are more likely to combine tramadol with other medication.

"Tramadol and other pain relievers can help to alleviate pain, but they must be used carefully and in close consultation with a physician," said SAMHSA Chief Medical Officer Elinore McCance-Katz, MD. "Like all medications tramadol can cause adverse reactions, which can be even more severe if the drug is misused. We must all work to lower the risks of taking prescription drugs.”

'Robust Response' to National Pain Strategy

By Pat Anson, Editor

Public reaction to the National Pain Strategy has been “very robust” according to the co-chair of the government committee that released a draft version of the report in early April.

Today marks the deadline for public comments on the 72-page report, a long awaited study that calls chronic pain a threat to public health, and identifies several areas where physicians and the healthcare system are failing pain sufferers.

“I think it’s safe to say that there was a very robust response,” said Linda Porter, PhD, co-chair of the National Institutes of Health’s Interagency Pain Research Coordinating Committee (IPRCC).

“I feel  like we really got the word out widely and the comments are coming in from a very broad range of the community, ranging from the professional societies, individual patients, coalitions of patients that have come together, and patient advocacy. So yes, I’m comfortable with it. We’ve gotten a good range of comments from a really broad set of folks.”

Some pain patients and advocates have complained that the IPRCC was dominated by academic researchers, physicians and government bureaucrats – and not enough input was sought from pain sufferers during the drafting of the National Pain Strategy (NPS).

“The NPS is essentially an underpowered, unrealistic, and undemocratic occupational strategy of some pain experts and professionalized lay experts, who were chosen because of their ideology and rank in certain organizations and government,” wrote patient advocate David Becker in his public comment on the NPS.

“There is no evidence that a survey or needs assessment of what Americans want from pain care was done or considered by the NPS and the NPS fails to make a case for their ‘evidence based, high quality, interdisciplinary, integrated multimodal biopsychosocial model’ as being what people in pain actually want out of pain care -- and especially those Americans in pain who will be forced to live with a plan they had no say in developing.”

Porter said she could not release the number of comments that have come in during the public comment period, but she was satisfied patients had a voice in drafting the National Pain Strategy.

“We felt very strongly that their voice had to be heard,” Porter told Pain News Network. “We had patients and patient advocates on every single one of the work groups, on the oversight panel, and on the IPRCC. There was actually a large group of patient advocates and we made sure that each of the working groups had at least a voice on it and some of them had several.”

A list of members on the IPRCC’s oversight committee can be found here. Two of the panel’s 14 members are pain sufferers and/or patient advocates. The rest are longtime experts in the field of pain management, including several who helped write the 2011 Institute of Medicine report, “Relieving Pain in America,” which estimated that 100 million Americans suffer from chronic pain.

Implementing the Plan

One member of the oversight committee said he found it “really exciting in terms of changing the culture of pain,” but admitted there were “minor things” about the NPS that bothered him.

“There is nothing in it about pediatric pain. There’s not as much emphasis on research as we would always like, particularly basic science is left out of it,” said Greg Terman, MD, an anesthesiologist and professor at the University of Washington who is president of the American Pain Society.

“The general problem that I had as a member of the oversight committee is how are we going to implement any of the recommendations? And the answer is I don’t think anyone knows yet, it’s not even final. But I am optimistic.”

The NPS calls for significant improvement in pain management practices, including better education in pain care for physicians, more collaboration between primary care physicians and pain specialists, broader insurance coverage of pain treatments, and more research. But nowhere in the report is the cost for any of the recommendations even discussed.

“That was not our responsibility nor did we have the ability to estimate what these would cost,” says Linda Porter. “It was really out of our scope and we were not asked to do that. It will certainly come up in the planning stage.”

Porter said cost estimates will be handled by the federal Department of Health and Human Services, which is still in the “discussion and planning stage” of deciding which recommendations to implement first. She expects a plan to be announced in late summer or early fall of this year.

“Things move slowly in government I hear,” says Terman. “It’s there, at least in writing, what needs to be done from our expert opinion. Having it gathered all in one area has never been done before and maybe if we can’t make it happen in the next year, maybe in a few more years. If it’s still sitting there waiting to be implemented, sadly there will still be patients waiting to be helped.”

Why Doctors Are Slow to Embrace Medical Marijuana

By Pat Anson, Editor

Public attitudes toward marijuana have changed considerably in recent years. Voters and legislators in 23 states and the District of Columbia have legalized medical marijuana, and nationwide polls show that most Americans now support legalization.

But the nation’s medical organizations – while intrigued about the potential for marijuana to treat conditions like chronic pain – have been slow to embrace cannabis. And most doctors still refuse to prescribe it, even in states where marijuana is legal.

Those conflicting attitudes were on display last week at the annual meeting of the American Pain Society (APS) in Palm Springs, California – a conference focused on pain research. Although the APS has no stated policy on marijuana, the organization chose as its keynote speaker one of the most prominent medical marijuana researchers in the world, Dr. Mark Ware.

“I’ve done presentations and sessions, and it always surprises people how much interest there is,” said Ware, who is a family physician and associate professor in Family Medicine and Anesthesia at McGill University in Montreal.

“Cannabis gives people a window to come and learn, and while they’re learning about medical cannabis they can be learning about pain management and other things. It’s a very useful magnet to get people interested in a topic that’s obviously of enormous public importance.”

DR. MARK WARE SPEAKING AT THE APS CONFERENCE

Ware’s two presentations at the APS conference were well-attended, but it was mostly researchers – not practicing physicians – who were listening.

“A lot of doctors are afraid to authorize it (marijuana) because they’re afraid of losing their licenses and their practices. So there’s a lot of fear and a lot of stigma,” Ware told Pain News Network.

“I think the researchers themselves are seeing opportunities, with changing state laws and increasing evidence of efficacy, that suddenly this is becoming a drug that can be taken a bit more seriously. And I think that’s giving rise to the opportunity that maybe there’s some work we can be doing here.”

Federal laws making marijuana illegal – which are still in effect – have stymied serious research into its medical benefits. Most of the evidence so far is anecdotal or the result of small academic studies – not the in-depth and expensive clinical research that pharmaceutical companies have to conduct to get FDA approval for their drugs.

“There’s still work to be done on the safety and efficacy of these cannabinoid compounds,” says Gregory Terman, MD, an anesthesiologist who is president of the APS.  “They’re very interesting molecules. But they’re not approved for people and we don’t want to pretend they’re anywhere near ready for prime time.”

The APS currently has a committee working on a policy statement about medical marijuana.

“I think people are opening their eyes to the possibility,” said Terman. “Marijuana’s already out there, and that’s why we felt like it was important to work on a policy statement.”

The American Academy of Pain Management (AAPM) also doesn’t have a formal position on marijuana – although some members are urging the organization to take one.

“I think there’s no doubt there are substances in there that can be beneficial to some people with pain. It’s just a question of figuring out what they are and how do you get them extracted in a way so that we know what we’re giving people,” said Bob Twillman, PhD, executive director of the AAPM. “We haven’t settled on a policy because there are so many different variables and so much is up in the air that coming up with a good policy is hard to do.”

Twillman says he is being lobbied by some AAPM members to advocate for the rescheduling of marijuana from an illegal Schedule I controlled substance – the same classification the DEA has for heroin and LSD – to a Schedule II medication that can be prescribed to patients.

“I don’t think you can do that with a product like this because every batch is different. How do you standardize the dose that a patient is given? I think in a regulatory scheme of things it’s more like an herbal supplement than it is a drug,” Twillman told Pain News Network.

The American Medical Association, the nation’s largest medical group, has moderated its position on marijuana – from one of strict opposition to a grudging call for more research.

“Our AMA calls for further adequate and well-controlled studies of marijuana and related cannabinoids in patients who have serious conditions for which preclinical, anecdotal, or controlled evidence suggests possible efficacy,” the AMA says in a policy statement.

“This should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.”

Until that research is done and federal laws change – which could take years – many practicing physicians are unlikely to endorse or prescribe a drug that is still technically illegal.

“I think there’s still this stigma and the lack of data and concerns about safety that will always plague that discussion as long as we don’t have it,” says Mark Ware.  “So I think there will be clinicians who will be early adopters who take this a bit more seriously and there will be others who will be almost religiously opposed to the idea. And I hope that starts to breakdown.”

Using Marijuana and Opioids Doesn't Raise Risk of Abuse

By Pat Anson, Editor

As more and more states legalize medical marijuana, many chronic pain patients are turning to cannabis for pain relief. Some are also continuing to use opioid pain medication – raising concern that the combination could increase their risk of substance abuse.

But a new study at the University of Michigan found that patients who use marijuana and opioids are not at higher risk for alcohol and drug abuse. Researchers studied 273 patients at a marijuana clinic in Michigan and found that more than 60% were also using prescription opioids.

"We expected that persons receiving both cannabis and prescription opioids would have greater levels of involvement with alcohol and other drugs," said Brian Perron, PhD, of the School of Social Work at the University of Michigan.

"However, that wasn't the case -- although persons who were receiving both medical cannabis and prescription opioids reported higher levels of pain, they showed very few differences in their use of alcohol and other drugs compared to those receiving medical cannabis only."

Participants in the study, which is being published in the Journal of Studies on Alcohol and Drugs, did report higher rates of drug use than the general population. But their use of other drugs -- including alcohol, cocaine, sedatives, heroin, and amphetamines – was similar whether they used opioids or not.

“I am thrilled this research is now happening so others will also gain the confidence in trying medical marijuana,” said Ellen Lenox Smith, a medical marijuana advocate and columnist for Pain News Network.

“People who have addictive personalities will have issues weather it is alcohol, marijuana, smoking, or opioids. Those of us without that tendency do not have to be concerned. We have patients that have been using both medications successfully, but most of them have eventually chosen to wean away from the opioids due to the annoying side effects. But while using both, they have seemed to cope fine and metabolize both.”

A noted medical marijuana researcher says cannabis may actually make opioids more effective – enabling some patients to take lower doses.

“We’ve seen it in patients who started using cannabis successfully and they were able to reduce their other medications,” said Mark Ware, MD, an associate professor in Family Medicine and Anesthesia at McGill University in Montreal.

“In some cases they find that the dose of opioids that they were taking, they can lower it and get a similar effect at much lower doses. In others, they don’t need the opioids any longer and they’re able to taper off and stop it completely.”

Ware and other researchers believe medical marijuana may be a safer alternative to opioids, which have a higher risk of addiction and overdose. But they stress that communication between doctors and patients is important – since some doctors may have no idea if a patient is using marijuana.

"Physicians do not actually 'prescribe' medical cannabis -- they only certify whether the patient has a qualifying condition, which allows the patient to gain access to medical cannabis,” said Perron.

“The system of dispensing medical cannabis is completely separate from prescription medications, so physicians may not know whether a given patient is using medical cannabis, how much, and in what form."

FDA Approves Migraine Drug for Children

By Pat Anson, Editor 

Millions of children who suffer from migraine headaches have a new treatment option -- an old drug that's already available to adults. 

The Food and Drug Administration approved Treximet for pediatric patients 12 years of age and older for the treatment of migraine with or without aura. Treximet is the first approved combination prescription drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

About 20 percent of all pediatric patients 11 years and older suffer from migraine, but treatment options have been limited, compared to adults. 

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and a consultant to Pernix Therapeutics (NASDAQ: PTX), which developed Treximet. Pernix expects Treximet to be available for pediatric patients in the third quarter of 2015.  

“As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school,” said Diamond. 

FDA approval came after a Phase III safety and efficacy study that found Treximet was significantly more effective than placebo in treating migraine in pediatric patients and has a safety profile similar to that of Treximet for adults. It comes with a black box warning of cardiovascular and gastrointestinal risks. 

The FDA approved Treximet for adults in 2008. The FDA set a priority review of Treximet for pediatric patients, in part, on the need for more treatment options for younger migraine sufferers.  

Amgen Migraine Drug 

Meanwhile, Amgen (NASDAQ: AMGN) announced the first results from a Phase II study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine.

The  company said the study met its primary goal of reducing monthly mean migraine days compared with placebo.  The data were presented at the International Headache Society in Valencia, Spain.

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting a peptide receptor that is believed to transmit signals that can cause incapacitating pain.  

In the trial, 483 patients who averaged 8.7 migraine days per month prior to the study had their number of migraine days nearly cut in half by taking AMG 334.

"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said Sean Harper, MD, executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

CDC Social Media Campaign Backfires

By Pat Anson, Editor

A social media campaign by the Centers for Disease Control aimed at raising awareness about the  "epidemic" of painkiller abuse had the unintended effect of launching another campaign about the "pandemic" of untreated chronic pain -- and how the agency was failing to address it.

Last month the CDC encouraged people to "help us tell stories of the many people whose lives have been affected by prescription painkiller addiction or the death of a loved one."

The agency, which estimates that over 16,000 Americans die annually from painkiller overdoses, asked for stories to be posted on Facebook, Instagram and Twitter with the hashtag #RxProblem.

“Prescription drug overdose devastates individuals, families and communities,” said Erin Connelly, associate director for Communication at the CDC. “We’d like to get everyone talking and thinking about the risks involved with opioid painkillers.”

While painkiller addiction and overdoses are undoubtedly a public health issue, the #RxProblem campaign rubbed some activists in the pain community the wrong way.

"There are really two problems with prescription drugs. One is the problem of abuse. But the other problem is patients who have pain and have a legitimate medical need for these drugs and can't access them," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

"I think they (the CDC) know what the problems are, but for some reason they don't want to deal with the chronic pain problem. I've criticized them for calling the problem of prescription drug overdoses and prescription drug abuse an 'epidemic' and taking a much, much bigger problem like chronic pain and not saying anything about it.  Because to me, if 16,000 people a year dying from overdoses is an epidemic, then 100  million people with chronic pain must be a pandemic."

It was Twillman's idea to launch a rival social media campaign to draw more attention to the chronic pain problem.

"What we came up with was the idea of the hashtag #AnotherRxProblem, and have people who have trouble getting their medications write in about that experience and the impact that's had on them," Twillman told Pain News Network.

Write in they did, with hundreds of people complaining about the one-sided approach the CDC was taking to prescription pain medication.

"We need to live a quality life. Don't punish us. Find better pain control," posted Teri Daniel on Twitter.

"When will we take untreated pain seriously?" asked Melissa VanHouten.

"We have 2 public health crises: RxDrugAbuse & UnrelievedPain. Stop blaming. Work together," wrote Barby Ingle.

"We got a tremendous response. If you look at the Twitter feed for #RxProblem, about half of the posts are #AnotherRxProblem posts. We started another campaign on Facebook and the Facebook response absolutely blew up," said Twillman.

Dozens of pain patients also shared their stories on Dr. Jeffrey Fudin's blog.

"I’m going to get right to the point. PAIN AND OPIOIDS. They do help us. Yes, they’re in every group abusers and non-abusers. Those that it helps for medical necessity should not have to be punished, denied, etc. for those who choose to disregard the contract they signed," wrote Gina. "CDC there are alternatives, to wean out drug abusers. Utilize the resources you have vs. taking the easy way and punishing all."

The CDC's #RxProblem campaign officially ended May 15th. Did they get the message from #AnotherRxProblem get through?

"I'm not optimistic that it's going to make a change in what they're doing. But if it raises someone's awareness, then it was worth it," said Twillman. 

Hillary Clinton: Please Be Responsible for Opioids

By Lynn R. Webster, MD

While Presidential candidate Hillary Clinton only recently announced her bid for office in 2016, she has already declared a few important issues on her presidential agenda, including the ever-important opioid crisis in the United States.

Many are chiming in to offer their best solutions to curbing the opioid abuse epidemic; sadly, many of the proposed solutions fail to promote and fund safer alternative therapies for people suffering from chronic pain who rely on opioids to live a semblance of a normal life.

I applaud Clinton’s desire to work toward a safer, opioid-free world. It’s a goal we should all aspire to. In order to realize it, however, we must not forget those people who rely on opioids to get through the day in the absence of alternative treatments.

Here is what Hillary Clinton must consider as she seeks to curb opioid abuse:

Redefine the prescription opioid problem as the chronic pain problem

Prescription opioids have garnered a great deal of attention for the possible health risks involved in taking the drug. While it is easy to get caught up in the whirlwind of bad press, it is still important to remember why opioids are such a prominent treatment form in the first place.

More than 100 million people in the United States suffer from chronic pain, meaning a third of the entire country may rely on some form of medication to make their lives better. Pain ranges in severity, with many suffering from severe pain that makes it difficult to live a normal life.

While no medical professional advocates that opioids should be the first line of defense, in some cases, they happen to be the only thing that works for a patient. Trying to end opioid abuse without addressing the needs of those who rely on the drug may make the problem of chronic pain worse.

Understand why prescription opioids have risen in popularity

In 2007, Americans spent $34 billion in out of pocket expenses to cover the cost of alternative forms chronic pain treatment.  To be clear, opioids are not the only means of treating chronic pain. Alternative therapies exist, but are woefully underfunded by payers. As a result, many patients with severe chronic pain, those who struggle to get out of bed, who sometimes lose their jobs, must rely only on what their insurance covers – in most cases, that form of treatment is opioids.

The chronic pain community needs access to safer alternative therapies. We need to invest in research to bring even more alternative therapies to the market, and crucially, insurance companies must then cover those alternative forms of care.

In 2012 the National Institutes of Health (NIH) spent only about 400 million dollars on chronic pain conditions but more than 2.5 billion dollars was spent on drug and other substance research.  We certainly need to find safer and more effective therapies for addiction but some of the current cost associated with substance abuse it due to the limited options to treat the number one public health problem in America: pain.

Stop stigmatizing patients who currently rely on opioids

Alternative forms of medication that could potentially help chronic pain patients and decrease the demand for opioids remain underfunded and under-researched. Despite being one of the largest health researchers and sponsored by the U.S. Department of Health and Human Services (HHS), the NIH continues to operate on a shoestring budget.

Despite the lack of options for alternative therapies for chronic pain, the topic of opioid abuse has become a popular topic in the media, and sadly, caused an increase in stigmatization of patients who use opioids for pain management. Patients have reported reluctant doctors and pharmacists unwilling to prescribe necessary medications.

The DEA has rescheduled hydrocodone as a Schedule II drug, leading to a series of unintended consequences with which patients today are left to suffer. Many patients report feeling like drug addicts for simply trying to fill their legally obtained prescriptions.

Require all opioids to be abuse-deterrent

Abuse deterrent formulations (ADF) have been shown to curb some forms of opioid abuse, while maintaining the benefits for patients that need the drug.  Unfortunately payers have priced these safer formulations so that there is little incentive for market adoption.  HHS should lead the way and negotiate deals with manufactures to make ADFs no more expensive than generic alternatives to patients.

Remove methadone as a “preferred” drug

While the use of methadone as an analgesic for chronic pain has expanded in recent years, it shows up in mortality reports with a higher frequency than other opioids. Despite the evident risk associated with this drug, many states have listed it as a “preferred” analgesic in treating severe chronic pain, largely due to its low cost and savings for publicly funded health plans.

The American Academy of Pain Medicine holds that methadone should not be a preferred drug unless special education is provided, and that it should never be the first choice in treating chronic pain.

The opioid crisis is not a black and white issue. Until we stop treating it as such, we will not be able to tackle the problem at its root. Eliminating opioids does not alleviate the problem, end patient suffering or acknowledge what the true issue is. Millions of Americans suffer from chronic pain, but very few have access to multiple options to manage their pain.

Through an increase in funding and research of alternative therapies, implementation of ADF’s and greater coverage by payers, we can finally begin to treat the opioid epidemic in a safe and responsible way – a way that does not hurt the millions of Americans who rely on opioids to get out of bed, to play with their children, to get through the day.

Lynn R. Webster, MD, is Past President of the American Academy of Pain Medicine, and vice president of scientific affairs at PRA Health Sciences. He is a Pain Medicine News editorial board member and author of a forthcoming book, “The Painful Truth.” He lives in Salt Lake City. Follow him on Twitter @LynnRWebsterMD, Facebook and LinkedIn.

This column is republished with permission from Dr. Webster’s blog.

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.

Study: Painkiller Abuse Costs Employers $25 Billion

By Pat Anson, Editor

Painkiller abuse is costing U.S. employers over $25 billion a year in lost productivity and missed work days, according to a new analysis by a healthcare consulting firm that also found that the vast majority of patients who are prescribed opioids do not have an abuse problem.

The “white paper” was produced by Healthentic, a Seattle-based company that helps employers identify health savings to reduce the cost of employee healthcare. You can download a copy of the report, called “Painkiller Abuse Is Costing Your Company” by clicking here.

"Opioid misuse costs employers in multiple ways including more medical costs and productivity loss," said Jeff O'Mara, CEO of Healthentic. "Employers have a unique opportunity to help people get more productivity for less money by identifying and engaging the people at risk."

Healthentic reviewed four years of health insurance claims data from 2011 to 2014 and found that only a small percentage of pain patients were misusing or abusing opioids.

"It was remarkably consistent that most people with an opioid prescription do not have a chronic or abuse problem. In fact, 87% of those prescribed an opioid in those four years didn’t show a cause for concern in the claims data,” the report states.

And what about the other 13 percent?

Healthentic identified three red flags in those patients that raised potential cause for concern:

1. Ten or more opioid prescriptions
2. A prescribed opioid supply for 120 days or more
3. A week or more of overlapping prescriptions for opioids and benzodiazepine, a sedative used to treat anxiety, depression and insomnia

“These people – just 13% -- are responsible for 92% of employer’s costs. And if you break it down even further, the 7% of the population with an opioid prescription that have two or more issues account for over 80% of the cost,” the report states.

Healthentic said opioid abusers used significantly more healthcare resources than non-opioid users, and cited a study that estimated the cost of their healthcare at $10,627 annually. In addition, opioid abusers cost employers $1,244 more in lost work days compared to non-abusers.

The company advised employers that opioids “should not be the first line of treatment” for back pain and other common workplace injuries, and said over-the-counter pain relievers like Tylenol and ibuprofen are “a more affordable and safer option.”

Healthentic recommended four actions to employers to address opioid abuse:

1. Understand and insist upon conservative prescribing guidelines for pain treatment for all participating providers.
2. Evaluate and know which employees are at risk by reviewing their insurance claims.
3. Educate employees about the risks of opioid drug use.
4. Increase and ensure access to treatment programs for employees with an abuse problem.

"Our hope is this analysis provides further insight into the societal and financial issue of prescription painkillers, and helps employers take strides in alleviating the problem to ensure the well-being of their people," said O'Mara.

Healthentic provides healthcare data and analytic services to nearly 11,000 corporate clients in 19 states.

Researchers Develop New Painkiller from Lidocaine

By Pat Anson, Editor

A fast acting pain reliever widely used to treat everything from itching to dental pain could be developed into a new medication that offers longer lasting pain relief.

"Because of its versatility and effectiveness at quickly numbing pain in targeted areas, lidocaine has been the gold standard in local anesthetics for more than 50 years," said George Kracke, PhD, an associate professor of anesthesiology and perioperative medicine at the University of Missouri (MU) School of Medicine.

"While lidocaine is effective as a short-term painkiller, its effects wear off quickly. We developed a new compound that can quickly provide longer lasting relief. This type of painkiller could be beneficial in treating sports injuries or in joint replacement procedures."

Lidocaine is used as an injectable pain reliever for minor surgical or dental procedures, and as an over-the-counter ointment or spray to relieve itching, burning and pain from shingles, sunburns, and insect bites.

The new compound -- called boronicaine -- could potentially serve many of those same functions as an injectable or topical painkiller.  

MU researchers synthesized boronicaine as a derivative of lidocaine by changing its chemical structure. They found that boronicaine provided pain relief that lasted five times longer than lidocaine. In pre-clinical, early stage studies, boronicaine provided about 25 minutes of relief, compared to about five minutes of pain relief with lidocaine.

"Although some conditions may warrant the use of a short-lasting painkiller, in many cases a longer lasting anesthetic is a better option," said Kracke, who is lead author of a study published in the chemistry journal ChemMedChem . "Having a longer lasting anesthetic reduces the dosage or number of doses needed, limiting the potential for adverse side effects."

Other types of short term analgesics provide longer pain relief than lidocaine, but they also have side effects they can cause heart toxicity and gastrointestinal problems. Preliminary findings show no toxicity in single-dose studies of boronicaine, though more studies are needed.

"Boronicaine could have distinct advantages over existing painkilling medications," said M. Frederick Hawthorne, PhD, director of MU's International Institute of Nano and Molecular Medicine and a pioneer in the field of boron chemistry. "We're conducting more research into the side effects of the compound, but in time it could very well become a useful material to use as an anesthetic."

Survey: Most Pain Patients Don't Abuse Painkillers

By Pat Anson, Editor

Only a small percentage of chronic pain patients misuse or abuse their opioid painkillers, according to a wide ranging survey by the Partnership for Drug-Free Kids that also found a “disconnect” between patients and their doctors about opioid prescribing.

About one in ten pain patients (7% of chronic pain patients and 13% of acute pain patients) admitted misusing their opioid medications. Nearly half took longer to finish their prescriptions than directed – which was usually an effort to save the pain medication for another time.

More than one in ten (13% of chronic pain patients and 15% of acute pain patients) admitted using someone else's opiate prescription.

The online survey of 705 pain patients and 360 prescribing physicians was conducted by the research firm Whitman Insight Strategies (WINS) earlier this year.

About two-thirds of the opioid prescribers said they “always” warned their patients about the risk of addiction and dependency.

But when patients were asked who, if anyone, explained to them the potential for becoming dependent or addicted to painkillers, 19% of chronic pain patients and 40% of acute pain patients said "no one."

The survey also found that most patients pay little attention to the proper storage and disposal of pain medication. Only 11% of chronic pain patients and 13% of acute pain patients said they were concerned that someone else in their household might use their medications.

Less than half of chronic pain patients (42%) who have children said they store their medication somewhere their kids can’t reach. Most patients said their doctors never discussed the proper storage and disposal of painkillers.

"This research highlights key opportunities for prescribers of Rx opiates and their patients to have better communication around proper use and disposal of prescribed painkillers," said Marcia Lee Taylor, Interim President and CEO of the Partnership for Drug-Free Kids.

"The Centers for Disease Control has deemed abuse of prescription painkillers an 'epidemic,' and we can all do our part to help turn the tide on this critical health issue. Prescribers and patients can become more aware of the repercussions surrounding the improper storage and disposal of Rx pain medications and talk more at length in order to improve doctor-patient communication and help curb abuse."

The survey also found that many physicians are concerned about patients misusing their pain medication – by either taking too little or taking too much.

The majority of prescribers (77% of primary care physicians and 75% of pain management specialists) believe their patients do not always use their prescribed opiates in accordance with instructions. Twenty percent of the primary care physicians said they don’t feel comfortable prescribing opiates at all.

"This research suggests to us that prescribers need to feel more confident in assessing the potential risk of misuse or abuse of the Rx medicines, but unfortunately many of them feel they have not received proper training to assess those risks. There is a lot more we can do to help prescribers feel they have the proper tools they need to feel comfortable prescribing these medicines and taking action if a patient is abusing them," Taylor said.

The survey also found that most pain patients would prefer alternatives to opioids. About 9 in 10 chronic pain patients have tried an alternative treatment such as physical therapy and massage. Many were hindered in their use of alternative therapies by restrictions on insurance coverage.