Smoking Linked to Longer Opioid Use

By Pat Anson, Editor

About one in five patients who are prescribed an opioid pain medication for the first time are still taking painkillers 90 days later, according to a small new study published in the Mayo Clinic Proceedings. Smokers and former smokers who were found to have the highest risk of using painkillers long-term.

Researchers at the Mayor Clinic studied a health database of residents in Olmsted County, Minnesota and identified 293 patients who were prescribed opioids in 2009. Nearly two-thirds were women who received their first opioid prescription after surgery, or some type of musculoskeletal pain or injury.

Most of the patients only needed one or two prescriptions and stopped taking pain medication. But 61 of them (21%) progressed to an “episodic” prescribing pattern in which they were still using opioids 90 days later. Nineteen patients (6%) were classified as “long term” users – which was defined as someone who had ten or more opioid prescriptions or at least 120 days of supply.

Women, Caucasians, people with a high school education or less, and patients with a history of depression or substance abuse had higher risks of long-term use.

But it was current or past smokers who stood out – nearly 74% of long-term opioid users had a history with tobacco. Nicotine is known to activate a group of nerve receptors in the brain, in a way very similar to how opioids and chronic pain activate them.

Researchers say the identification of potential risk factors like tobacco is an important tool for physicians, who should be careful about prescribing painkillers to patients with such histories.

“Before initiating a new opioid prescription, patients should be screened for past or current tobacco use and past or current substance abuse. This would allow the clinician to assess the risk of longer-term prescribing and would provide the opportunity to counsel the patient about these potential risk factors before actually receiving the initial prescription,” said lead author W. Michael Hooten, MD, a Mayo Clinic anesthesiologist.

"From a patient perspective, it is important to recognize the potential risks associated with these medications. I encourage use of alternative methods to manage pain, including non-opioid analgesics or other non-medication approaches. That reduces or even eliminates the risk of these medications transitioning to another problem that was never intended."

Not only does smoking raise the risk of longer opioid use, previous studies have shown it also increases your chances of having chronic pain.

A study of over 6,000 Kentucky women found that those who smoked had a greater chance of having fibromyalgia, sciatica, chronic neck pain, chronic back pain and joint pain than non-smokers. Women in the study who smoked daily more than doubled their odds of having chronic pain, while occasional smokers showed a 68% percent higher risk, and former smokers showed a 20% greater risk.

A large study in Norway found that smokers and former smokers were more sensitive to pain than non-smokers. Smokers had the lowest tolerance to pain, while men and women who had never smoked had the highest pain tolerance.

Is Your Doctor Getting Money from a Drug Company?

By Pat Anson, Editor

Have you ever wondered why your doctor recommended a particular drug or treatment, when cheaper and better alternatives were available?

A treasure trove of data released by the Centers for Medicare & Medicaid Services (CMS) may help you get some answers. It shows that pharmaceutical and medical device companies paid nearly $6.5 billion to doctors and research hospitals in 2014, the first full year the companies were required to disclose the payments under the Affordable Care Act (ACA).

You can see what your doctor was paid, if anything, by clicking here to search the CMS "Open Payments" database.

“Consumer access to information is a key component of delivery system reform and making the healthcare system perform better,” said acting CMS Administrator Andy Slavitt. “This is part of our larger effort to open up the health care system to consumers by providing more information to help in their decision making.”

About half of the $6.5 billion was for research, such as clinical trials to find new treatments for cancer, diabetes, Alzheimer’s and other debilitating diseases.

Over $400 million went to doctors to reimburse them for meals, beverages, lodging and travels costs.

The Wall Street Journal dug into the data further and found some questionable items, including a trip to a Cayman Islands resort, tickets to Alcatraz, and a $65 airport massage.

But it’s the sheer scale of the payouts – over 11 million payments to over 600,000 physicians – that has critics wondering if prescribing practices and treatment decisions are being unduly influenced by money and gifts. The average physician received about $3,644 last year.

“No pharma companies spend this kind of money in a disinterested way,” Jason Dana, a professor at Yale School of Management told Bloomberg Business. “We have to know where the money is going to really understand the problem, to develop policy.”

Dana says doctors can be influenced by free meals and perks, even if they’re not consciously aware of it.

“If we have a financial incentive to believe something or conclude something, we kind of trick ourselves into thinking it’s true. And we’re not always aware we’re doing it,” he said.

Purdue Pharma, the maker of OxyContin and several other painkillers, reported $5.8 million in research payments and $6.1 million in general payments to doctors -- modest amounts compared to what others companies paid.

Pfizer, the maker of Lyrica, reported at least $234 million in research payments and $53.3 million in general payments.

Eli Lilly, the maker of Cymbalta, paid over $137 million for research and $8.7 million in general payments.

The American Medical Association disputes a lot of this data, saying the “vast majority” was never vetted by physicians.

"The complicated and cumbersome process for physicians to register to review their data and seek correction of any inaccuracies continues to hinder their participation in the validation process," the AMA said in a statement.

Curious about your doctor? I was about our longtime family physician and searched his name in the CMS database.

I found nothing scandalous or suspicious, but there was a surprising amount of detail. I learned he received $707.59 in “food and beverage” and “informational meal” payments last year from AstraZeneca, Forest Pharmaceuticals, Eli Lilly, Pfizer and several other companies. What was on the menu is anyone’s guess, but what they talked about is duly noted.

For example, the arthritis drug Celebrex was discussed at a $12.60 meal that Pfizer paid for. And Eli Lilly bought a $11.74 meal for my doctor so he could learn more about the erectile dysfunction drug Cialis.

The most expensive item was a meal for $127.80 paid for by Shionogi, a Japanese drug company. The topic was Osphena, a post-menopausal drug for women to help them have pain free sex -- a discussion apparently reserved for only the finest of restaurants.

Which Marijuana Strain Works Best for Pain?

By Ellen Lenox Smith, Columnist

Unfortunately, “one size does not fit all” when it comes to using medical marijuana for pain relief. You and I could have exactly the same medical condition and use the same strain, but we will not necessarily react in similar fashion.

Because of that, it may take time to find your effective strain. This process will require patience and holding onto hope that you will eventually succeed. I was lucky. The first time I tried some Indica oil, I literally slept the entire night. However, we have had patients who sampled numerous strains before they found what works for them.

a leaf of cannabis sativa

There are two strains of marijuana plants, both of which provide pain relief: Indica has a calming and soothing effect that can help you sleep, while Sativa helps stimulate the brain and body so you can have a more productive day.

The other thing you have to pay attention to is the THC (Tetrahydrocannabinol) and CBD (Cannabidiol) content of the strain you are selecting. THC is known to provide the “high” sensation that people refer to when marijuana is used recreationally.

Those of us who use marijuana for pain generally do not have that experience, unless we take too high of a dose or just react wrong to a strain. 

CBDs are believed to be responsible for the therapeutic and medical benefits of cannabis.  They don’t make people feel “stoned” and can actually counteract the psychoactive effects of THC.  The fact that CBD-rich cannabis doesn’t get you high makes it an appealing treatment option for patients seeking anti-inflammatory, anti-pain, anti-anxiety, anti-psychotic, and/or anti-spasm effects, without the troubling side effects of lethargy or depression.

However, we don’t all experience pain relief without a higher content of THC. In fact, we have seen some patients be more successful in reducing seizures with more of the THC included. So do not become discouraged if you don’t have success at first.

Please know that THC and CBD levels don’t mean that every plant ever produced of a specific strain will always have the same percentages and ratios. Due to different growing methods, those levels can vary. So, always make sure what you are buying has been tested by a reputable testing facility if cannabinoid levels are important to you.

One successful thing I would like to pass on to you is a trick we discovered making our sleep inducing pain relief oil and day tinctures. 

We now mix all of our five types of Indica strains or Sativa strains together to create the oil or tincture. We make it from the small clippings around the bud, instead of the whole bud. Patients seem to prefer it made this way. You are exposed to the benefits of each plant, along with it being very gentle and less expensive.

female flowers of cannabis indica

In conclusion, remember that you may have to test several strains of medical marijuana to find the right match for your personal needs. It is worth the time and effort, because the pain relief is gentle, non-invasive, and allows you to return to a more productive life without worrying about organ damage from pharmaceuticals.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis.

Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition. For more information about medical marijuana, visit their website. 

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.

Medical marijuana is legal in 23 U.S. states and the District of Columbia, but is still technically illegal under federal law. Even in states where it is legal, doctors may frown upon marijuana and drop patients from their practice for using it.

Opioid Implant Raises Safety Questions

(Editor’s Note: Our story about an opioid implant that could someday be used to treat chronic pain struck a nerve with a lot of readers. One of them was Mary Maston, a pain sufferer and  patient advocate, who wrote in expressing concern about the safety and risks associated with implants and other medical devices.)

By Mary Maston, Guest Columnist

Why is everything going to implants? Implants seem to have an initial success rate and I can't argue with the fact that they do work for some, but it seems that class action lawsuits for side effects and internal injuries invariably come about down the line.

Transvaginal mesh was touted as the "next big thing." I had a doctor try to convince me that it would solve all of my female problems. Luckily, I didn't bite. We all know how that ended up.

Bladder slings come to mind too. Some IUD’s have caused issues. People have had major problems with hip and knee replacements. Spinal cord stimulators are being pushed on patients in record numbers, and the bomb is eventually going to drop on those too.

While there are success stories, there are some pretty horrific stories floating around online about implanted devices in general. Some will argue collateral damage: "Just think of the ones they've helped. The many outweigh the few.”

But I can promise you that the ones that have been harmed by these implants see things much differently.

Here's the thing: anything implanted in the body is going to be seen as a foreign object. What does the body tend to do when there's a foreign object inside it? It attacks it, trying to force it out. That's why your eyes water when you get something in them, that's why you vomit when you ingest something that's harmful, and that's why you go to the bathroom -- so the body can rid itself of waste.

When it can’t force the implants out, the body rebels with side effects, infections and pain. The surgeries required to implant these things damage nerves and create scar tissue, which also contribute to pain.

courtesy titan pharmaceuticals

If they're planning on this new implant being simply injected into the arm instead of being surgically implanted, that's going to have to be one heck of a big needle! The size of a match stick? Ouch!!

Then there is the issue of tolerance. Pain medication is not a "one size fits all" fix like the makers of this implant are implying. It comes with a preloaded dose of buprenorphine. How can they guarantee that the dosage they put in it is going to work for the majority of the people it's implanted in? 

What if it stops working in a month or two, or doesn't work at all? Do they have that one taken out and another one put in, or is the old one left in and a new one with a stronger dose implanted?

Will the patient be able to go back to taking oral pain medication? What if it causes side effects in the patient after a few days or weeks that they can't handle, or they end up being allergic to the medicine? How long would they have to live with those issues before it is removed?

Some people metabolize medications faster than others, so saying that it's going to work for a full six months for the implant or an entire month for the injection in everyone isn't practical. What about breakthrough pain? If someone had the implant, but showed up in the ER in pain because of their condition, would they be treated respectfully and in a timely manner, or dismissed because they had the implant and "that should take care of all of your pain."

There needs to be a very specific and compassionate treatment protocol set up for patients before this scenario happens, and all doctors need to be required to follow it.

I can understand and appreciate some of the pros listed in the article. Not having to make trips to the pharmacy, not having to remember to take pills and waiting for them to kick in to feel better. Possibly and hopefully not having to go to the doctor every month and being subjected to random drug screens and pill counts.

Doctors would certainly benefit because they wouldn't be prescribing pain medications nearly as much or maybe not at all. That would definitely get them off the hook with the DEA and I can see how that would make them want to push it onto all of their patients.

I understand that addiction and chronic pain go hand in hand for some people. Not all, but some. But as a chronic pain patient, I don't want to be lumped into the same category as addicts, because I am not an addict, never have been and never will be.

This raises serious questions that I think should be considered before we shout to the heavens how wonderful this new implant is going to be for addicts and legitimate chronic pain patients alike.

I understand there is still a lot of work to be done, and that it's going to take time and testing to answer a lot of these questions. Oral medications certainly have their own set of problems and aren't without risks either. However, history tells us that jumping on a bandwagon isn't necessarily a good thing down the road in a lot of cases.

I'm not saying that the thought of being pain free for an extended amount of time isn't appealing. Honestly, I would probably be more apt to try this than a spinal cord stimulator. But I hope that the manufacturers and the FDA will address the questions I've posed. I guarantee you I'm not the only one that will ask them.

Mary Maston suffers from a rare congenital kidney disease called Medullary Sponge Kidney (MSK), along with Renal Tubular Acidosis (RTA) and chronic cystitis. She is an advocate for MSK and other chronic pain patients, and helps administer a Facebook support group for MSK patients.

Mary has contributed articles to various online media, including Kidney Stoners, and is an affiliate member of PROMPT (Professionals for Rational Opioid Monitoring & Pharmaco-Therapy).

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.

Implant Could Be ‘Game Changer’ in Pain Treatment

By Pat Anson, Editor

Imagine going to your doctor’s office and getting an implant put in your arm that delivers a steady flow of pain medication for six months.

No more pills. No more trips to the pharmacy. No more worries about your pain medication getting lost or stolen.

That’s the scenario a New Jersey drug maker envisions for its Probuphine implant – tiny rods about the size of a matchstick designed to be inserted subcutaneously under the skin of the upper arm.

Probuphine was developed by Braeburn Pharmaceuticals under a license agreement with Titan Pharmaceuticals (OTC: TTNP), which holds the rights to the implant technology. Both companies have applied to the Food and Drug Administration to have Probuphine approved to treat opioid addiction, but Braeburn’s long term goal is to also have the implant approved for chronic pain.

COURTESY TITAN PHARMACEUTICALS

“We are definitely interested in talking to the FDA about the use of Probuphine in pain,” said Behshad Sheldon, President and CEO of Braeburn.

The active ingredient in Probuphine is buprenorphine, a weaker opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone. Buprenorphine is also used to treat chronic pain and comes in various forms – pills, patches and film strips – but none as long-acting as an implant.

The advantages of an implant are many. The dosage is controlled and there’s hardly any risk of abuse, diversion, or accidental overdose. You also never have to remember to take a pill.

“We believe a buprenorphine implant could be a really great clinical tool to treat pain,” Sheldon told Pain News Network. “There’s just a peace of mind aspect for the patients. The medicine’s on board and they don’t have to worry about it.”

“I personally would want a Lipitor implant, because I can’t manage to take it three days in a row,” she joked.

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study of Probuphine’s effectiveness in treating opioid addiction.

Braeburn recently reported the results of a six month, double-blind clinical trial of Probuphine on 177 patients, which found that the implant was more effective than buprenorphine tablets in treating addiction. The company said the implant insertion and removal were "generally well tolerated," although nearly one in four patients had a "mild" adverse event at the implant site.

“The data from this trial are encouraging and underscore the benefit of longer term medical treatments for patients with opioid addiction. I am confident that the implant, if approved by FDA, will be at least as effective as a sublingual formulation and have the added benefits of reducing problems related to compliance, misuse and abuse,"  said Richard Rosenthal, MD, Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai.

Braeburn and Titan plan to resubmit a New Drug Application (NDA) for Probuphine to the FDA in the second half of this year.

Long Term Injection for Pain

Braeburn has formed another partnership with Camurus, a Swedish drug company, to develop an injectable buprenorphine drug to treat addiction and chronic pain -- a single injection that lasts as long as a month. Camurus has already completed successful Phase I and II studies on the drug and both companies hope to start a Phase III trial later this year -- with the goal of seeking regulatory approval in 2016.

“There have been many conversations with expert clinicians and they’ve told us that they think buprenorphine in general, in a non or less abuse-able form of buprenorphine, in either an implant or an injection could really be game changing,” said Sheldon. “It is part of our plan to move into pain because pain and opioid addiction are so interconnected and we think there are ways, by treating patients with a less abuse-able formulation, you could actually help alleviate the addiction problem.”

Sheldon admits a lot more work needs to be done before a buprenorphine implant or injection is available to treat chronic pain.

“We haven’t studied it yet in pain and we haven’t had any conversations yet with the FDA. So there’s a lot more to do to get to that point,” she said.

Another formulation of buprenorphine to treat pain may be coming to the market relatively soon. Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI) have submitted a new drug application for a buprenorphine film patch to the FDA. The companies are hoping for FDA approval by October of this year.

Although the patch contains much smaller doses than buprenorphine tablets or patches already on the market, the companies say the film is very effective in treating pain because the drug is absorbed through the inside lining of the cheek and enters the blood stream faster.

Cymbalta and Lyrica in Legal Battles

By Pat Anson, Editor

The makers of Cymbalta and Lyrica – two blockbuster drugs widely used to treat fibromyalgia and other chronic pain conditions – face legal battles this summer that could potentially cost the companies billions of dollars.

In London, a court case begins next week on Pfizer’s efforts to keep doctors in the U.K. from prescribing pregabalin – a cheaper generic version of Lyrica.

And in Los Angeles, a federal judge this week ordered Eli Lilly to face claims in lawsuits alleging that the company misled consumers about the side effects of withdrawal from Cymbalta.

Over 5,000 patients have filed suit against Lilly claiming that Cymbalta caused “brain zaps” – electric shocking sensations – as well as nausea, vomiting and insomnia when they stopped taking the drug.  The first two cases will be heard in August.

“The withdrawal symptoms from Cymbalta were hell,” wrote Crystal Lindell, a Pain News Network columnist in a recent article.

“Less than a week after my last pill, I was getting so dizzy that I seriously thought I had a new disease. Then, there was this thing called the brain zaps that I didn’t understand until they happened to me. In short, it literally felt like my brain was being, well, zapped by electricity. There was also nausea and vertigo and just an overall feeling of falling off a skyscraper.” 

Several readers shared their own experiences with Cymbalta.

“My neurologist put me on Cymbalta, I took 2 pills, I thought my head was going to explode,” wrote Judy Dunn.

“I suffered from 6 weeks of vertigo, nausea, dizziness, and MASSIVE headaches,” said Andy, who was prescribed Cymbalta to treat depression. “I will never take Cymbalta again. EVER.”

“While on the drug I did get a better mood and it helped a lot, but it raised my blood pressure and I was shaky and jittery. I also went through the brain ZAPS!!” wrote Candra Clark.

“We believe in our defenses to these claims and we will continue to defend Lilly vigorously,” Scott MacGregor, a Lilly spokesman told Bloomberg Business.

Cymbalta generated annual sales of $5 billion for Lilly until its patent expired in 2013 and cheaper generic versions of Doluxetine became available.

Lyrica Legal Battle

Like Cymbalta, Lyrica wasn’t originally developed to treat pain. It was used as a treatment for anxiety and epilepsy until drug maker Pfizer realized it could also be effective for fibromyalgia and neuropathic pain.

Pfizer’s patent on Lyrica for epilepsy and anxiety expired last year, but its secondary patent for pain is good until July of 2017 – and that is the essence of its legal fight in the U.K.

Rival drug makers started making pregabalin – the generic version of Lyrica – when its original patent expired. But it didn’t take long for doctors to also start prescribing pregabalin for pain.

According to Pharmalot, about 80% of all U.K. patients on pregabalin are using it to treat pain and Pfizer has launched an aggressive campaign to stop that. Last year the company wrote an unusual letter to physician groups in the U.K. warning them that prescribing pregabalin for pain was a violation of its patent.

“Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the U.K. would infringe Pfizer’s patent rights,” the company said in the letter.

The Royal College of Physicians, which represents 29,000 U.K. doctors, responded with a statement of its own.

“Pregabalin is a useful drug for many patients and, given the current financial pressures the NHS (Britain’s National Health Service) is under, it is disappointing that a pharmaceutical company has made a move that will, potentially, prevent some patients from getting access to it,” a spokesman said.

The NHS has since issued guidance to doctors telling them to use the brand name Lyrica when prescribing pregabalin for pain “so far as reasonably possible.” Pfizer is seeking a stronger statement from the British High Court.

Ironically, Pfizer paid $2.3 billion dollars in 2009 to settle criminal and civil charges in the U.S. for the “off-label” marketing of Lyrica and other medications – the very sort of off-label use it is trying to stop in the U.K.

Lyrica remains one of Pfizer’s top selling drugs, generating $5.1 billion in revenue in 2014.  

Opioid Abuse Takes Back Seat to Cost at Medicare

By Pat Anson, Editor

The U.S. Food and Drug Administration calls the development of abuse deterrent opioids a “priority” in combatting the so-called epidemic of prescription painkiller overdoses.

But when it comes to Medicare coverage of opioids, new research shows that lowering the cost of painkillers is a bigger priority for the federal government than discouraging abuse.

The study by Avalere, a health analytics research firm, found that Medicare Part D coverage of abuse deterrent OxyContin is falling rapidly. From 2012 to 2015, OxyContin coverage fell from 61% to 33% of Medicare Part D plans. In addition, one quarter of Part D plans now require prior authorization for OxyContin. 

In contrast, a generic version of OxyContin (oxycodone hydrochloride) that has no abuse-deterrent properties is covered by all Medicare Part D plans – and prior approval for it is only needed in 0.3% of Part D plans.

“While prescription opioid abuse continues to be a priority for public health experts and lawmakers, coverage for these products by Part D plans is limited and plans are increasingly favoring lower-cost generic products on their formularies,” said Caroline Pearson, senior vice president at Avalere.

“Policymakers seeking to limit opioid abuse will have to balance the desire for greater access to abuse-deterrent opioids with the increased costs of such medications to public programs and private payers.”

OxyConin was reformulated by Purdue Pharma in 2010 to make it harder for addicts to crush or liquefy for snorting and injecting. In 2014, the FDA approved three other opioids with abuse deterrent properties and in April of this year issued guidance to drug makers strongly encouraging them to develop more.  

“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.”

But combating opioid abuse apparently takes a back seat to price, not only for Medicare but private insurers and the drug makers that developed abuse deterrent formulations.

According to the Healthcare Bluebook, a website that estimates the market price of medications, the “fair price” for a 60-day supply of OxyContin 20mg is $316.

A 60-day generic version of oxycodone -- without abuse deterrence -- retails for just $78.

“It will be important for policymakers to monitor and consider the implications of these trends,” the Avalere study says, warning that abuse-deterrence formulations may be pricing themselves out of the market.

“The potential increase in costs due to new innovations may be a barrier to policies that increase the coverage of abuse-deterrent opioids, especially in public programs, despite potential long-term public health savings associated with lower levels of opioid abuse. While the greater number and quality of abuse-deterrent options—both brand and generic—can support competition, reduce cost, and increase plan coverage, the potential of abuse-deterrent technologies may not be fully realized as long as non–abuse deterrent alternatives have less restrictive insurance coverage.”

Funding for the Avalere study came from Pfizer. Avalere says it maintained “full editorial control” over its content.

Over 16,500 deaths in the U.S. were linked to opioid overdoses in 2010, according to the CDC. The government estimates that over 400,000 seniors are  “misusing” pain medication.

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.

Doctors Prescribing Opioids for Migraine Despite Risks

By Pat Anson, Editor

Physicians are still prescribing opioid painkillers or barbiturates to treat migraine, even though frequent use of the drugs can make headaches worse and raise the risk of addiction.

Over half the patients who visited a headache center in New York City said they had been prescribed opioids and/or barbiturates, according to a new study presented at the annual scientific meeting of the American Headache Society. About 20 percent of the 218 patients surveyed, most of whom had a migraine diagnosis, said they were still taking the drugs.

"Headache specialists are often in a difficult position when patients request opioids or increasing quantities of barbiturates," said lead author Mia Minen, MD, Director of Headache Services at NYU's Langone Medical Center. "Although many patients find these effective, they are known to contribute to headaches related to medication overuse."

Minen and her research team identified which physicians were prescribing the drugs and found the most frequent first prescribers of opioids were emergency room physicians, while general neurologists were the most frequent first prescribers of barbiturates. Primary care physicians were also identified as first prescribers.

"Taken as a whole, these data provide a useful snapshot of the wide variety of physician specialties that might benefit from additional education on the appropriate use of opioids and barbiturate-containing medications in patients with headaches," said Minen.

Opioids and barbiturates should only be used as a last resort to treat migraine, according to the American Board of Internal Medicine's "Choosing Wisely" campaign. The campaign recommends the first medications for migraine should be either over-the-counter pain relievers or a class of prescription drugs called triptans that are made specifically for migraine.

"This study underscores the fact that prescribers may not be aware of best practices in migraine care,” said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“Problems arise when ‘crisis solutions’ are applied as the de facto treatment for daily management of pain. Patients may believe that opioids are beneficial but they lead to worse migraine and headache pain, and are not considered appropriate first-line treatment for these conditions. If possible, patients should seek a specialized evaluation with a board certified specialist to ensure they receive medications that will help them in the long run.”

Darnall called opioids and benzodiazepines “a dangerous combination of medications,” and said they should be avoided or combined only under close medical supervision.

The problem extends far beyond the borders of the United States. According to the recently released Global Burden of Disease Study, the number of headaches caused by medication overuse has risen by 120% since 1990. Medication overuse headache is the 18th leading cause of disability worldwide.

New “Landmark” Class of Migraine Drugs Being Developed

Meanwhile, clinicians and researchers at the American Headache Society’s annual meeting are reportedly excited about a new class of drugs called Calcitonin Gene-Related Peptide (CGRP) monoclonal antibodies, which are showing promise in treating high-frequency episodic migraine and chronic migraine. Research studies on CGRP are being presented at the meeting, which draws more than 1,000 migraine specialists from around the world.

"This development is a transformative moment in migraine treatment," said Peter Goadsby, MD, who is chief of the UC San Francisco Headache Center and one of the world's leading headache treatment experts. "Up till now, migraine patients have had limited choices for preventive treatment. Now four pharmaceutical companies are showing positive results in human trials targeting CGRP mechanisms."

The new drugs appear to reduce elevated levels of the peptide known as calcitonin gene-related peptide, which is a key driver of migraine pain. Versions of anti-CGRP therapies are being tested by Alder Pharmaceuticals, Amgen, Eli Lilly and Teva Pharmaceuticals.

Teva reported that in a Phase II clinical study its CGRP therapy achieved a significant reduction in the number of headache hours after one week, with more than half of patients experiencing a 50% or greater reduction in headache frequency.

Amgen’s research showed showed that its anti-CGRP product also reduced the number of migraine days by 50% in about half the treated patients after 12 weeks.

"The potential of these new compounds is enormous and gives us real hope that effective specific treatments for migraine may be on the near horizon," said Goadsby. "The development of CGRP antibodies offers the simple, yet elegant and long awaited option for migraine patients to finally be treated with migraine preventives; it's a truly landmark development."

There has not been a new class of anti-migraine drugs since the development of triptans in the early 1990s.

Migraine is thought to affect a billion people and about 36 million adults in the United States, according to the American Migraine Foundation. 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.

The month of June is Migraine Awareness Month.

Nasal Spray Approved for Migraine in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a nasal spray for the treatment of migraine in pediatric patients, the second migraine drug the agency has approved in the last month for patients 12 years of age and older.

About one in five teens suffer from migraine, but treatment options for them have been very limited compared to adults.

Zomig nasal spray was first approved by the FDA in 2003 for the treatment of migraine in adults. It provides pain relief in as little as 15 minutes, with most patients obtaining some relief in about two hours.

The FDA’s approval came after the agency reviewed safety and efficacy data from clinical trials demonstrating that Zomig was significantly more effective than placebo in relieving headache pain and other migraine symptoms in pediatric patients. It also had a safety profile similar to that in adults.

Zonig is the first prescription nasal spray approved for migraine in children. The most common adverse reaction to Zomig in pediatric patients during clinical trials was an unusual taste.

"Treatment options have been limited for pediatric patients and we are pleased with FDA's decision and look forward to bringing migraine relief to pediatric patients by making Zomig Nasal Spray available to this 'school age' patient population," said Fred Wilkinson, President and CEO of Impax Laboratories, which obtained the U.S. commercial rights to Zomig products from AstraZeneca in 2012. Impax has since lost exclusive rights to Zonig tablets and is focused on the nasal spray.

The recommended starting dose for Zomig in pediatric patients is 2.5 mg. The dosage can be adjusted on an individual basis, but should not exceed 5 mg in a single dose or a maximum daily dose of 10 mg in any 24 hour period.

Last month the FDA approved the migraine drug Treximet for pediatric patients 12 years of age and older.. Treximet is the first approved combination 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. 

Like Zomig, Treximet had already been on the market for several years to treat migraine in adults.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. 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.

The month of June is Migraine Awareness Month.

Aleve & Other Pain Relievers Reduce Fertility in Women

By Pat Anson, Editor

Health experts have warned for years about the side effects of over-the-counter pain relievers – everything from liver failure to heart disease to hearing loss.

Now researchers are saying that Aleve and some other non-steroidal anti-inflammatory drugs (NSAIDs) reduce the fertility of women so significantly they could potentially be used as an emergency form of contraception.

The results of a small study presented at the European League Against Rheumatism Annual Congress show that three NSAIDs --  naproxen, diclofenac, and etoricoxib -- inhibited ovulation in women after just a few days of treatment.

Naproxen, diclofenac, and etoricoxib are the active ingredients in several brand name drugs sold around the world, including Aleve, Voltaren, and Arcoxia, respectively. Etoricoxib is not approved for use in the United States.

Thirty nine Iraqi women of childbearing age who suffered from back pain took part in the study; receiving diclofenac (100mg once daily), naproxen (500mg twice daily), etoricoxib (90mg once daily), or a placebo.

Treatment was given for 10 days from day 10 of the onset of their menstrual cycle, with their progesterone levels and follicle diameter analyzed via blood sample and sonography.

“After just ten days of treatment we saw a significant decrease in progesterone, a hormone essential for ovulation, across all treatment groups, as well as functional cysts in one third of patients,” said study investigator Professor Sami Salman, Department of Rheumatology, University of Baghdad.

“These findings show that even short-term use of these popular, over-the-counter drugs could have a significant impact on a woman's ability to have children. This needs to be better communicated to patients with rheumatic diseases, who may take these drugs on a regular basis with little awareness of the impact.”

Of the women receiving NSAIDs, only 6.3% taking diclofenac, 25% taking naproxen, and 27.3% taking etoricoxib ovulated, compared with 100% of the control group that was not taking a pain reliever.

The dominant follicle remained unruptured in 75% of the women taking diclofenac, 25% taking naproxen and 33% of the patients receiving etoricoxib. Rupturing of the dominant follicle and the subsequent release of an oocyte (unfertilized egg), is essential for ovulation to occur.

“These findings highlight the harmful effects NSAIDs may have on fertility, and could open the door for research into a new emergency contraception with a more favorable safety profile than those currently in use,” said Salman.

NSAIDs are among the most common pain relief medicines in the world. Every day more than 30 million Americans use them to relieve pain, lower fever and reduce inflammation.

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.