New Rule Expands Access to Buprenorphine

By Pat Anson, Editor

This week marks the start of a major expansion in access to buprenorphine – a medication that is both widely praised for treating opioid addiction and also blamed for fanning the flames of abuse and diversion.

The Department of Health and Human Services (HHS) updated a federal rule, nearly tripling the number patients that can be treated with buprenorphine by an eligible physician.

Raising the limit from 100 to 275 patients is intended to give addicts greater access to buprenorphine, especially in rural areas where few doctors are certified to prescribe the drug. According to HHS, over two million people who are dependent on heroin and other opioids could benefit from buprenorphine treatment.

“For too long, addiction specialists like me have had to turn patients in need away from treatment that might save their lives, not because we don’t have the expertise or capacity to treat them, but because of an arbitrary federal limit,” said Dr. Jeffrey Goldsmith, President of the American Society of Addiction Medicine .

But critics of the rule change say there will be a price to pay.

“Buprenorphine is one of the most abused pharmaceuticals in the world,” warns Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“Sales of buprenorphine formulations have exceeded $2 billion a year, but we have not had any lessening of heroin addiction. Increased access to buprenorphine and increased availability of potent heroin and heroin laced drugs like fentanyl will only exacerbate the problem.”

The problem with buprenorphine is that it’s an opioid that can be used to treat pain or addiction. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse. For many years the drug was sold exclusively under the brand name Suboxone, but it is now produced by several different drug makers and is sold in tablets, sublingual films and even an implant.

Addicts long ago discovered that buprenorphine can also be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

“Too many physicians erroneously believe that naloxone in the formulation makes the drug safe,” Menzies said in an email to Pain News Network. “Increasing the limit is definitely going to increase diversion. The majority of the physicians prescribing buprenorphine do not provide any comprehensive relapse prevention counseling, random drug testing, etc. In the absence of standards for treating addictive disorders, anything goes and will be no different than treating chronic pain.

“We saw the problem with prescription opioids when opioids were promoted as safe and non-abusable in the treatment of chronic pain. Very quickly the numbers grew into the tens of millions and the addiction exploded. The unintended victims were the patients in genuine chronic pain.”

Menzies uses buprenorphine as an initial treatment for opioid addiction in his clinics, but prefers another medication -- naltrexone -- for long-term maintenance therapy. He says doctors who rely on buprenorphine exclusively will, in effect, be sentencing their patients to lifetime use of the drug.     

"Financial Opportunity" for Doctors

HHS acknowledges there could be “unintended negative consequences” to increased prescribing of buprenorphine. One is diversion. Another is an increase in patient volume, physician profits and buprenorphine “pill mills” – which are already popping up in states like Florida. Patients typically pay cash for buprenorphine at those clinics and receive little or no addiction counseling or services.  

“This proposed rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine,” HHS said in an extensive analysis of the rule change. “We believe that this may translate to a financial opportunity for these physicians.”

HHS estimates the cost of treating new buprenorphine patients at up to $313 million in the first year alone. Many of the patients are low-income and the bills for treating them – about $4,300 annually for each patient – will often be covered by Medicaid. The additional cost of treating these patients, according to HHS, will be offset by the health benefits achieved by getting addicts into treatment, which the agency generously estimates at $1.7 billion.

The Obama administration asked Congress for nearly $1 billion in additional funding to help pay for addiction treatment, but didn’t get it in when Congress passed the Comprehensive Addiction and Recovery Act (CARA Act). The President reluctantly signed the bill into law anyway.

A little noticed provision of the CARA Act is that it expands access to buprenorphine even further. Currently only a trained and certified physician can prescribe buprenorphine, but CARA requires HHS to update its rules within 18 months to allow nurse practitioners and physician assistants to prescribe buprenorphine, provided they undergo training first.

How can buprenorphine diversion be prevented when access to it is rapidly increasing?

One solution proposed by Menzies is to change the classification of buprenorphine from a Schedule III controlled substance to a Schedule II drug – the same classification change that hydrocodone went through in 2014. Such a move would limit buprenorphine prescriptions to an initial 90-day supply and require patients to see a doctor for a new prescription each time they need a refill.

“We are caught between a rock and a hard place. We need to increase access to buprenorphine and it will lead to increased diversion and abuse, and therefore I am recommending changing the schedule,” Menzies said in his email to PNN.

“This is the psychotic state of affairs! No chronic condition/disease/disorder has ever been successfully treated with an addicting drug and we think we can do it for opioid addiction!”

DEA: U.S. Facing ‘Fentanyl Crisis’

By Pat Anson, Editor

The United States is facing an unprecedented “fentanyl crisis” that is likely to grow worse as drug dealers ramp up production of counterfeit pain medication made with illicit fentanyl, according to a new report from the Drug Enforcement Administration.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is legally prescribed in patches and lozenges to treat severe chronic pain, but illicit fentanyl has recently emerged as a fast-growing scourge on the black market, where it is increasingly being used in the manufacture of counterfeit drugs.

“The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyls is only detected upon laboratory analysis,” the DEA warns in the unclassified report.

“Fentanyls will continue to appear in counterfeit opioid medications and will likely appear in a variety of non-opiate drugs as traffickers seek to expand the market in search of higher profits. Overdoses and deaths from counterfeit drugs containing fentanyls will increase as users continue to inaccurately dose themselves with imitation medications.”

Dozens of Americans have died this year after ingesting counterfeit versions of oxycodone, Norco and Xanax, which are virtually indistinguishable from the real medications. Even a few milligrams of fentanyl can be fatal.

Tennessee bureau of investigation

The DEA said “hundreds of thousands of counterfeit prescription drugs” laced with fentanyl were on the market and predicted more would be produced because of heavy demand and the “enormous profit potential” of fake medication.

“The seizures of fentanyl-laced pills and clandestine pill press operations all across North America indicate that this is becoming a trend, not a series of isolated incidents,” the DEA said.

The report highlighted the fact that U.S. forensic laboratories tested over 13,000 seized drugs containing fentanyl in 2015, up sharply from less than a thousand cases two years earlier.

The DEA said counterfeit pills are being smuggled into the U.S. from Mexico and Canada. Traffickers usually purchase powdered fentanyl and pill presses from China, and pill press operations have recently been found in Los Angeles and New York.

The counterfeit drugs problem is so serious the DEA believes it is undermining efforts to limit opioid prescribing.

“The arrival of large amounts of counterfeit prescription drugs containing fentanyls on the market threatens to devalue such initiatives and replaces opioid medications taken off of the street,” the DEA said. “Although not all controlled prescription drug users eventually switch to heroin, fentanyl-laced pills give DTOs (drug trafficking organizations) broader access to the large controlled prescription drug user population, which is reliant upon diversion of legitimate pills. This could undermine positive results from the state Prescription Drug Monitoring Programs, as well as from legislative and law enforcement programs.”

As Pain News Network has reported, Massachusetts and Rhode Island recently said fentanyl was to blame for nearly 60 percent of their opioid overdose deaths.

Senators Urge DEA to Reduce Supply of Opioids

A group of U.S. Senators is urging the DEA to "aggressively combat the opioid epidemic," not by going after fentanyl traffickers, but by making legal opioids even harder to get.

In a letter to acting DEA administrator Chuck Rosenberg, Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV) urged the agency to tighten its annual quotas for manufacturers to produce controlled substances.

"In effect, DEA serves as a gatekeeper for how many opioids are allowed to be legally sold every year in the United States. Yet, for the past two decades, DEA has approved significant increases in the aggregate volume of opioids allowed to be produced for sale," the letter states.

The Senators urged the agency to rollback a 25 percent increase in production quotas for Schedule II opioids that was implemented in 2013. Schedule II opioids include hydrocodone, a widely prescribed painkiller that was reclassified from a Schedule III to a Schedule II drug in 2014.

The Senators also said the DEA should make a mid-year adjustment in the quota to immediately reduce the supply of prescription opioids. The letter did not address the fentanyl crisis or the rapid growth in counterfeit medication.

Lower Back Pain Linked to More Drug Use

By Pat Anson, Editor

People with chronic lower back pain are more likely to have used illicit drugs -- including marijuana, cocaine, heroin and methamphetamine -- compared to those without back pain, according to new research published in the journal Spine.

The study also found that people with lower back pain who had used illicit drugs were somewhat more likely to have an active prescription for opioid pain medication (22.5% vs. 15%).

Lower back pain is the world’s leading cause of disability and most people will suffer from it at least once in their lives. Although nearly a quarter of the opioid prescriptions written in the U.S. are for low back pain, medical guidelines often recommend against it.

Researchers analyzed data from over 5,000 U.S. adults who participated in a nationally representative health study and found that nearly half (49%) of those who reported lower back pain admitted having a history of illicit drug use, compared to 43% of those without back pain.

Current use of illicit drugs (within the past 30 days) was much lower in both groups; 14% versus nine percent.

The study did not differentiate between recreational and medical marijuana use, nor did it draw a distinction between marijuana use in states where it is legal and where it is not. All marijuana use was considered "illicit."

All four illicit drugs in the survey were more commonly used by people with low back pain compared to those without back pain. Rates of lifetime use were 46.5% versus 42% for marijuana; 22% vs. 14% for cocaine; 9% vs. 5% for methamphetamine; and 5% vs. 2% for heroin.

Researchers said there was no evidence that illicit drug use causes lower back pain, only that there was an association between the two that bears watching when opioids are prescribed.

“The association between a history of illicit drug use and prescription opioid use in the cLBP (chronic lower back pain) population is consistent with previous studies, but may be confounded by other clinical conditions,” said lead author Anna Shmagel, MD, Division of Rheumatic and Autoimmune Diseases at the University of Minnesota.

“Mental health disorders, for example, have been associated with both illicit substance use and prescription opioid use in the chronic low back pain population. In the context of management, however, illicit drug abuse is predictive of aberrant prescription opioid behaviors. As we face a prescription opioid addiction epidemic, careful assessment of illicit drug use history may aid prescribing decisions.”

In a recent analysis of prescriptions filled for 12 million of its members, pharmacy benefit manager Prime Therapeutics found that nearly a quarter of the opioid prescriptions were written to treat low back pain.

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

In a 2014 position paper, the American Academy of Neurology said opioids provide “significant short term pain relief” for low back pain, but there was “no substantial evidence” that long term use outweighs the risk of addiction and overdose.

Doctor: Pain Has Never Killed Anyone

By John Hsu, MD, Guest Columnist

The opioid problem with medicine began when The Joint Commission promoted the concept that pain is the fifth vital sign, and that patients should be asked about their pain and the quality of their treatment.

Ten years ago, when my hospital was undergoing an inspection, I clearly remember the examiner chastising me about my multimodal pain therapy and her concern that it would leave patients in pain. Clearly, doctors were put on alert that they could be sued for leaving a patient in pain.

Pain as a fifth vital sign is really contraindicated. Pain has never killed anyone, but opioids killed over 29,000 Americans last year. They don’t have any vital signs.

Doctors are now at a crossroads. The Centers for Medicare and Medicaid (CMS) has attached patient satisfaction scores to reimbursement. A patient comes to the office and demands pain meds. If the doctor prescribes pain meds, the doctor can not only lose their license, but go to jail for murder, as Dr. Lisa Tseng from Rowland Heights, CA has. Or they can risk poor patient satisfaction scores and, if they are a part of an accountable care organization (ACO), risk losing their employment.

Why are doctors burned out? Because other people have come between the doctor-patient relationship. I had a nurse tell me that she would put her 21 years in ICU up to my skills as a physician, to which I retorted that she still had to take orders from me.

This loss of respect amid the loss of autonomy is frightening.  It is one of the major complaints doctors describe when they are asked about burnout and why they are leaving medicine. The healthcare team is no longer run by the doctor. It is run by nurses from the quality review department, enforcing best practices on physicians so protocols and guidelines set up by the government are followed.

I call that evidence-less based medicine. Guidelines have destroyed the doctor-patient relationship. Does the government really have patient interests at heart or is the government really just a big micromanager? 

Perhaps the answer to the opioid problem lies with outside-the-box thinking. What if we correctly promote that pain must be present for us to live and that some pain is good?  Unlike Patrick Henry, who said “Give me liberty or give me death,” I personally would prefer to say, "Give me pain and give me liberty, but don't give me death."

Patients have a responsibility to take care of their own health. All prescriptions written by doctors and filled by pharmacists were written correctly. Yet some patients are not compliant and take too many pills. We all know we should not overeat, but 70% of the American public is obese. Humans are their own worst enemies.  Unpopular as this stance may seem, it must be mentioned that while the population of the U.S. is 324 million, 259 million opioid prescription were written in in 2012. 

The Joint Commission's edict that no patient should be in pain changed patients' expectations. Everyone expected and demanded to be pain free. But focusing on the short term discomfort experienced by those in pain ignores the long term goal of improving a patient's health.

The government (FDA, DEA, CDC and policymakers) has decided to restrict opioid prescriptions. This is logical, but does not address human nature. The end result has been that addicts and patients who cannot get prescription opioids have turned to cheaper and easily attainable $5 bags of heroin. Heroin deaths have quadrupled in the last decade. In 2015, over 10,000 people died from heroin overdoses. The situation is rapidly worsening, as illicit drug makers are mixing heroin with fentanyl, which is 70 times stronger than morphine. 

The opioid conundrum has become readily apparent. Opioids may be the best treatment for pain, but they raise the risk of addiction, respiratory suppression, and death.

Cultural Shift Needed in Patient Education

The solutions needed for this dilemma include a cultural shift in the education physicians and nurses give to patients and the perception that pain is bad. We have to forsake the short term treatment of pain with opioids and look to the long term goal of preserving human life.

Let’s look at patient satisfaction scores and medical education. Studies show that when patient satisfaction scores are considered in prescribing care to patients, their care is not only more expensive, but often worse -- resulting in higher morbidity and mortality. Despite this evidence, CMS has connected patient satisfaction scores to hospital reimbursement. 

The Joint Commission has promoted an atmosphere where patients believe that they should never have to suffer pain and have the right to be “pain free.” More opioids were prescribed, but often patients demanded and even threatened doctors if they did obtain pain relief.  Doctors were accused of elder abuse and medical negligence if they did not prescribe pain medication, despite the lack of medical indications or consideration of narcotic alternatives. 

Fast forward a decade and suddenly the government realized that more addicts existed and more people were overdosing. Nearly 19,000 people died in 2014 from opioid prescription overdoses legally obtained from physicians and correctly filled by pharmacists.  The government ironically declared that doctors were to blame. 

The government could not blame patients for the problem, even though the general consensus is that patients were non-compliant with their prescribed opioid doses and shared their narcotics with family and friends.  Patients were not blamed for their actions because they vote and they reelect government officials. 

The government’s solution to the current opioid overdose epidemic was a policy change.  The FDA and CDC forced physicians to limit opioid prescriptions, and increased the difficulty of prescribing opioids by changing the scheduling of hydrocodone from Schedule III to Schedule II.  The government also began criminally prosecuting physicians for murder, even though the patient was noncompliant and overdosed on opioids. 

Why did the The Joint Commission, representing the federal government, have to get involved in medicine?  Why should a federal entity interfere with the doctor-patient relationship? It is not our fault that policies make us do certain things we believe are not in the best interest of the patient.

The Hippocratic Oath directs physicians to not allow outside influences effect their patient care decisions. I would like to see medicine practiced so that the government can no longer come between patients and their doctors. Let us amend the constitution so that there is a separation of medicine and state, just like the separation of church and state.  

JOHN HSU, MD

John Hsu, MD, has been practicing anesthesia at 600-bed hospital inCalifornia for the past 23 years.

Dr. Hsu recently founded MedRev Pharma, a pharmaceutical development company which is developing a safer opioid that minimizes the risk of abuse, addiction and respiratory depression.  Dr. Hsu is also the Director of SBS Medical Management, a consultation service that addresses issues relating to healthcare reform policies, physician practice management, and medical devices.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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.

DEA: ‘Hundreds of Thousands’ of Fake Pills in U.S.

By Pat Anson, Editor

A new report from the U.S. Drug Enforcement Association about the national threat posed by heroin may tell us more about another illegal opioid – fentanyl -- than it does about heroin.

The recently unclassified report, which you can read by clicking here, documents a stunning 248% increase in overdose deaths involving heroin from 2010 to 2014. Over 10,500 Americans died from heroin overdoses in 2014 alone.

But it turns out many of those deaths may have actually been caused by fentanyl, a synthetic opioid 50 to 100 times more potent than morphine. We’re not talking about pharmaceutical grade fentanyl legally prescribed in transdermal patches or lozenges to treat chronic pain, but bootleg white powder fentanyl manufactured in China and smuggled into the U.S.

The DEA says there were 5,544 deaths caused by fentanyl and other synthetic opioids in 2014, but admits “the true number is most likely higher.” The actual number is not known because many coroners and state crime laboratories do not test for fentanyl.

What medical examiners do often test for in suspected drug overdoses is heroin – and that is why the statistics on heroin should be taken with a grain of salt. Because the real culprit is often fentanyl.

“Most of the areas affected by the fentanyl overdoses are in the eastern United States, where white powder heroin is used,” the DEA report states. “Fentanyl is most commonly mixed with white powder heroin or is sold disguised as white powder heroin.”

Massachusetts and Rhode Island – two eastern states with big heroin problems – recently came out with reports showing that fentanyl, not heroin, was to blame for nearly 60 percent of their opioid overdose deaths. The states used toxicology tests that are far more accurate than the death certificate codes used by the DEA and the Centers for Disease Control and Prevention.  

The DEA and CDC overdose statistics are muddied even further by the fact that heroin deaths are “often undercounted” and blamed on morphine, a prescription painkiller.

“Many medical examiners are reluctant to characterize a death as heroin related,” the DEA admits. “Thus many heroin deaths are reported as morphine-related deaths. Further, there is no standardized system for reporting drug related deaths in the United States. The manner of collecting and reporting death data varies with each medical examiner and coroner.”

Why does any of this matter to chronic pain patients? Because deaths caused by fentanyl and heroin are being lumped together with overdoses caused by prescription painkillers. The CDC has been doing it for years to build a case against opioid pain medication and to justify its release of guidelines that discourage doctors from prescribing opioids for chronic pain.

Prescribing of opioid pain medication has been in decline for several years and hydrocodone prescriptions have fallen by 30 percent since 2011. Yet the CDC claims there was a sudden spike in opioid analgesic deaths in 2014 and that nearly 19,000 Americans died.

Some pain patients – no longer able to get opioids legally – are turning to the streets for pain relief. And the DEA report acknowledges that patients are now being targeted by drug dealers selling counterfeit medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA report says. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.

“The equipment and materials necessary to produce these counterfeit drugs are widely available online for a small initial investment, greatly reducing the barrier of entry into production for small-scale drug trafficking groups and individuals. In addition, fentanyl pill press operations have been identified in the United States, Canada, and Mexico, indicating a vast expansion of the traditional illicit fentanyl market.”  

The DEA says counterfeit medication caused at least 19 deaths this year in California and Florida. But, like the statistics for fentanyl and heroin, the actual number may never be known.   

When asked to comment on the DEA report, a spokesperson for the CDC told us that "the large distribution of pills seems to be a new threat that we are still assessing."

Should Pain Patients Be Prescribed Naloxone?

By Pat Anson, Editor

A medication that rapidly reverses the effects of an opioid overdose should be prescribed to patients taking opioid analgesics for chronic pain, according to a study published in the Annals of Internal Medicine.

But the study fails to address the soaring cost of naloxone and whether pain patients can afford it.

In a pilot program at primary care clinics in San Francisco, doctors gave naloxone “rescue kits” to nearly 2,000 pain patients on long-term opioid therapy, and found that they had 63 percent fewer opioid-related emergency rooms visits in one year than patients not prescribed naloxone. Naloxone is usually administered by injection to reverse the effects of an overdose and has been credited with saving thousands of lives.

Naloxone has rapidly gone mainstream in recent years as public health officials have reacted to the so-called opioid epidemic. The rescue kits are increasingly being carried by police and paramedics, and given to heroin and opioid addicts to keep at home. But they are not usually prescribed to people taking opioids for pain relief.

Researchers say being given a rescue kit and being trained how to use one may have made pain patients in the study more careful with their opioids, without the kits ever actually being used.

“The educational component of the intervention may have reduced ED (emergency department) visits by altering risky behaviors, thus preventing overdoses in the first place,” said lead author Alexander Walley, MD, in an editorial also published in the Annals of Internal Medicine. "Receiving a naloxone rescue kit may have served as tangible reinforcement of overdose prevention messages, though this warrants further study.”

university of washington

The Centers for Disease Control and Prevention recently released opioid prescribing guidelines that encourage physicians to prescribe naloxone to high-risk patients.

“Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present,” the guidelines state.

The Food and Drug Administration is also encouraging the widespread distribution of naloxone. Last November, the agency approved Narcan -- a naloxone nasal spray – as an emergency life-saving medication. The approval came less than four months after the FDA received a new drug application from Adept Pharma. The process usually take the agency years to complete. 

“Anyone who uses prescription opioids for the long term management of chronic pain, or those who take heroin, are potentially at risk of experiencing a life-threatening or fatal opioid overdose where breathing and heart beat slow or stop,” Adept Pharma said in a statement.

The company said Narcan would be available at a “public interest price” of $75 for a package of two nasal sprays when ordered by public health  organizations.  For consumers, however, Narcan costs nearly twice as much. Healthcare Bluebook lists the retail “fair price” of Narcan at $134.

Prices for naloxone have soared in recent years as demand for the medication has increased. Some hospital emergency departments have run out of naloxone, according to Politico, and some drug makers are being accused of price gouging.

"You have increased demand and a few people who control the pricing, so they can charge whatever they want," said Eliza Wheeler, who runs an overdose prevention project in Northern California, in Politico.

Generic versions of naloxone cost only pennies in other countries, but in the U.S. an auto inject version sold by Kaleo Pharma soared from $575 for a two-dose package to $3,750, according to Truven Health Analytics.

“Opioid abuse is an epidemic across our country, yet drug companies continue to rip off the American people by charging the highest prices in the world because they have no shame,” Democratic presidential candidate Sen. Bernie Sanders said in a statement. “The greed of the pharmaceutical industry is killing Americans.” 

Many drug makers offer discounts on naloxone rescue kits to hospitals, schools, non-profits and public agencies, but patients often wind up paying full price.

Wearable Devices Could Monitor Opioid Use

By Pat Anson, Editor

We’ve written before about wearable medical devices, a fast growing $2.8 billion industry aimed at helping us lead healthier lives. Some devices relieve pain, while others monitor your blood pressure, pulse, body temperature, sleep, or even the number of calories you’re burning.

One device can even be used as a sort of “Big Brother” to monitor your use of opioid pain medication.

A small study published in the Journal of Medical Toxicology followed 30 emergency room patients who were given opioids for severe acute pain. For four months the patients wore a Q sensor, a wristband device made by Affectiva,  a Massachusetts company that specializes in technology that tracks and measures human emotions.

The wristband only monitors skin temperature and locomotion (movement) of the user, but researchers found the data can be used to track and predict opioid use with a fair degree of accuracy.

Researchers say people who take opioids daily for pain or addiction treatment (methadone and buprenorphine) are more likely to fidget or show restless activity when they feel cravings for medication. A sudden decrease in movement and an increase in skin temperature can be signs that they had taken a dose of medication.   

affectiva photo

"The patterns may be useful to detect episodes of opioid use in real time," says lead author Stephanie Carreiro, MD, a professor of Emergency Medicine at the University of Massachusetts Medical School. "The ability to identify instances of opioid use and opioid tolerance in real time could for instance be helpful to manage pain or during substance abuse treatment."

Carreiro and her colleagues say wearable devices could help identify pain patients at risk for substance abuse or addiction. They could also be used to remotely monitor patients enrolled in addiction treatment programs to detect whether they are relapsing.

“Wearable biosensors show a consistent physiologic pattern after opioid administration in an ED (emergency department) population,” they said. “This biometric response shows some distinguishing features between heavy and non-heavy opioid users in a controlled ED setting. This pattern may be useful to detect episodes of opioid use in real time. Further study is needed to evaluate the potential diagnostic and interventional applications of these devices in drug abuse treatment and pain management."

The Q sensor was initially developed to monitor children with epilepsy or autism, but they’ve since grown into a tool used in consumer focus groups to measure responses to advertising. They’re also being tested in middle schools as an “engagement pedometer” to measure if students are interested in a particular subject.

Critics say the technology is creepy and the data it generates can easily be misinterpreted.

"In high school biology I didn't learn a thing all year, but boy was I stimulated. The girl who sat next to me was gorgeous. Just gorgeous," Arthur Goldstein, an English teacher and critic of the technology told Reuters.

Affectiva recently raised $14 million in funding to develop facial recognition software for video games.  

U.S. ‘Inundated’ with Fake Fentanyl Pills

By Pat Anson, Editor

With much of the U.S. focused on the so-called epidemic of prescription opioid abuse, another deadly problem is quietly taking root around the country: illicit fentanyl being sold as counterfeit pain medication.

“It’s unreal. They’re inundated with fentanyl in the Midwest and in the northeast,” says DEA spokesman Rusty Payne. “A lot of these fentanyl pills are being marketed as knockoff oxy (oxycodone).”

We first began reporting on the fake fentanyl pain pills in April, when 14 deaths in California and 9 in Florida were blamed on counterfeit medication.  Since then, the problem has spread to virtually every state.

In Massachusetts, Boston police are warning about counterfeit fentanyl pills that are nearly indistinguishable from prescription oxycodone.

“This dangerous drug is being sold to buyers who presume the pills, which are accurately formed and marked with the designation A/215, are Oxycodone 30 mg tablets. Anyone who ingests these Fentanyl pills may put themselves in serious danger of overdosing which can result in death,” police said.

In Layton, Utah, at least one recent overdose death is blamed on counterfeit roxicodone with the same markings.

LAYTON POLICE DEPT. PHOTO

“If you locate prescription pills with roxicodone markings "A" and "215" and you aren't sure where they originated from - use caution in handling them as you can absorb fentanyl through your skin,” the Layton police department warned in recent a Facebook post. “Counterfeit prescription pills are being made by street drug dealers and sold on the street, as they are cheaper and easier to obtain.”

In West Virginia, officials are investigating three non-fatal overdoses possibly caused by fentanyl disguised as Xanax, an anti-anxiety medication.

“You can tell it’s not really Xanax — if you look at the two they look the same, but not quite,” Dr. Elizabeth Scharman, director of the West Virginia Poison Center, told the Charleston Gazette-Mail. “The brand-name 2-milligram Xanax tablets are not that popular, so many people haven’t seen them before, and to them they look the same.”

And in Alabama, a routine traffic stop this week led to the arrest of a man with a vial of marijuana and a bag full of 78 white tablets. The pills looked similar to Xanax, but when tested were found to contain fentanyl.

Buyers Playing Russian Roulette

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. It is available legally by prescription in patches and lozenges to treat more severe types of acute and chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge across the U.S. and Canada.

“It’s just Russian roulette,” says the DEA’s Payne. “Pharmaceutical grade fentanyl that you have in hospitals and such, that’s really not what we’re talking about here. We’re talking about black market, underground labs in China that are manufacturing this stuff.”

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, have no idea the drug they’re getting from a dealer or friend could be lethal.  The dealers may be killing their own customers, but they’re driven by profit.

“We found that the profit margin in fentanyl is so much larger than heroin. And so have the Mexican cartels and the drug organizations,” said Payne. “A kilo of fentanyl versus a kilo of heroin on the street, when you cut it up and adulterate it enough to get it ready for street level distribution, they’re making a million to two million dollars from a kilo of fentanyl versus $80,000 for a kilo of heroin. So finances and profit are really playing a part in this. And you’ve got people here who are so addicted to opioids that there’s a market for it unfortunately.

In the past year, the DEA has issued two public safety alerts about fentanyl, but the Centers for Disease Control and Prevention (CDC) has remained relatively quiet about the problem – focusing instead on guidelines to reduce the prescribing of legal opioid medications.  So have many politicians, who have railed against opioid prescribing while supporting more federal funding for addiction treatment.

But the fentanyl problem is becoming too big to ignore.

States like Massachusetts, Rhode Island, Ohio and Delaware have reported an “alarming surge” in fentanyl related deaths in recent months. In some states, the number of deaths from fentanyl now exceeds those from prescription opioids.

“We think fentanyl and fentanyl overdoses have been underreported over the years in a lot of places. But we think people are now starting to pay more attention to it,” says Payne.

What no one seems willing to admit is that – while fentanyl dealers may be killing their customers – restricting access to legal opioids may only be creating new ones. In Canada’s western province of British Columbia, where fentanyl is involved in over half the drug overdoses, regulators have adopted opioid prescribing guidelines that are even more stringent than the CDC’s.

“The guidelines will make it much harder for pain sufferers, but will do absolutely nothing to discourage abuse and addiction. That population just goes on to something else as we all know from history,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.

The guidelines are forcing pain sufferers like Hugh Lamkin to buy fentanyl off the street because doctors won't give him an opioid prescription for arthritis and chronic back pain.

"I don't want to be buying street drugs," Lampkin told CBC News. “I think that I have a legitimate medical condition where I should be getting medication from my doctor."

Heroin Use Reaches 20-year High in U.S.

Limits on opioid prescribing may also be fueling a surge in heroin use in the United States, according to the chief researcher for a United Nations report on worldwide drug use.

"There is really a huge epidemic (of) heroin in the U.S.," Angela Me told Reuters.

According to the U.N. World Drug Report 2016, the number of heroin users in the U.S. reached one million in 2014, the highest in 20 years. Heroin use has increased sharply over the last two years in both North America and Europe.

The increase has coincided with a drop in heroin prices, but Me believes it could also be connected to the development of abuse deterrent formulas for OxyContin and other opioid pain medications, which have made the pills harder to crush and snort.

"This has caused a partial shift from the misuse of these prescription opioids to heroin," Me said.

Pain Care Shouldn’t Be Political Theater

By Richard Oberg, MD, Guest Columnist

The current hysteria over opioid pain medication is, without a doubt, the most unbelievable and difficult situation for patients I've ever seen in my 30 years of practice. With an increasing number of deaths due to overdose, the message has become that opioid medication is the problem. 

Healthy people, including healthy physicians, don't seem to believe chronic pain really exists to the degree that it does. Add in media hysteria with gross misrepresentation of the facts, often-cited CDC propaganda, and you have a recipe for disaster: addiction models applied to chronic pain patients.

Everyone's favorite defense mechanism – projection -- is overused constantly and many healthy people really think if they had chronic pain they'd somehow handle it differently or “beat it” which is nonsense.

Empathy is not a learned skill, nor is it widely prevalent in the population, including the majority of physicians. You feel it every time you see that look of disbelief from anyone, including physicians, regarding your chronic painful illness. Skepticism overrides compassion.  This attitude in the current climate has led to a crisis for patients.

At age 39, before I was diagnosed with psoriatic arthritis and eventually late stage complications of spondylitis and neuropathy, I was a multi-mile runner and very active member of our large hospital staff. Then suddenly every step was like walking on broken glass, aching everywhere with flu-like symptoms, and getting maybe two hours of sleep per night.

I saw multiple colleagues who'd give me a pat on the back and tell me to “hang in there” as I was heading for a meltdown.  Instead of a rheumatologist, I was sent to a psychiatrist.  Even after I got a definitive diagnosis, everyone still just chose to ignore it.

Sound familiar?

RICHARD OBERG, MD

I finally found an “old school” internist, one of the few in our area willing to treat chronic pain, who convinced me to try opioid medication cautiously, despite my reservations.  Like many people, I thought they'd make me fuzzy headed (bad for a diagnostic pathologist spending 8 hours under a microscope), but the opposite happened. Suddenly I was back at a tolerable pain level and able to sleep at night again. I’ll never forget how compassionate he was.

Biologic drugs such as Enbrel, which were new then, helped a lot for maybe 12 years. Over time they can become less effective for many patients. I became severely allergic to Remicade (anaphylactic reaction) and all other biologic/systemic medications also ceased to do anything, including Rituxan, which is for rheumatoid arthritis and B-cell lymphoma. I was desperate to continue working and was only able to with opioid medication.

Opioid Propaganda

So here's our dilemma as pain patients: we have a major federal agency (CDC) peddling “addictionologist” propaganda on a massive scale and investigative journalism no longer exists. The news media is no longer the fourth branch of government, but merely a vehicle for their propaganda.

Our physicians, despite being the highest paid in the world in the most expensive healthcare system in the world, have signed onto this -- not wanting any scrutiny whatsoever from state or federal regulators. They won't script in these “militarized” situations, and are either risk averse or co-dependent (the latter is why they want to drop the pain scale). Most are going along with the CDC because they don't want the extra trouble and have abandoned patient responsibility entirely, going for the low hanging fruit of more routine healthcare issues instead.

We have a supply and demand situation working against us with too few providers, an abundance of chronic pain patients, and pills that aren't as profitable as procedures. This varies from state to state and even within states, but is rapidly spreading. Physicians obviously caused part of the problem by over-prescribing, but they have the money and power, and are now just walking away from it all. There is a deafening silence from physicians, even when they know their patients are being abused.

In many states, like Tennessee where I live, physicians run everything. State officials passed tort reform, so lawyers won't take medical cases anymore (we tried and know firsthand).  Physicians own our state malpractice insurer, State Volunteer Mutual, which brags every year about malpractice premium refunds due to a decreased numbers of lawsuits. It's not because our state has a phenomenal group of physicians, it's just that the bar for a lawsuit is so high (like death of someone young) there are very few of them.

Within relatively few years (partly due to addictionologists like Dr. Andrew Kolodny having an outsized voice at the CDC) the conversation went from the “epidemic” of overdose deaths (which it never really was) to “opioids don't work for chronic pain” -- despite the fact that there are no good studies to support that because they really haven't been done.

They just say it and the news media repeats it, much like Dr. Sanjay Gupta, who stated on CNN’s “Prescription Addiction: Made in the USA” that overdoses were the #1 cause of preventable deaths in the Unites States. 

Sorry Sanjay, not even close. The CDC’s own statistics state that smoking and alcohol are the leading causes, with about 480,000 people dying every year – 25 times higher than the alleged 19,000 dying from prescription opioid medications.

How does this blatant propaganda get on CNN and what makes Sanjay Gupta an expert?

The ridiculous Consumer Reports cover story, The Dangers of Painkillers, also misused information supplied by the CDC. I've had a running email conversation with someone there for over a year asking why the bogus misuse of data - and got no answers of course.

Perhaps one of the most abominable statistical misuses by the CDC is confirmation bias, where they cherry pick data to “confirm” what they want to peddle, while ignoring other data, like the vast majority of pain patients doing well with opioid medication and most not having addiction issues.

Their argument simply doesn't work. In the 1990’s, the first decade of “massive” opioid prescribing that media outlets love to cite, there was no similar increase in complications caused by the number of “highly addictive” pills being prescribed. Then we had the 2008 financial meltdown, society changed, drug addiction became a prominent issue, and suddenly people were dying from too many pills.

Finally, the artificial breakdown of “cancer” pain vs. “non-cancer” pain is complete nonsense and always has been. The final common denominator of pain is pain, and cancer is merely one of many etiologies that can cause it.

Incidentally, the word “cancer” is pretty meaningless, especially to a pathologist like me. Large numbers of physicians and virtually all lay people have little understanding of the pathophysiologic processes pathologists are trained to understand.  Most things called “cancer” aren’t chronically painful and many autoimmune diseases can be much more painful than cancer.

Ironically, as cancer treatments have become better (such as those for breast cancer) and with longer survival times, many cancer patients are developing chronic pain conditions that have nothing to do with their cancer.

Do they get special treatment even if they have a good long-term prognosis?

Richard Oberg, MD, is disabled by psoriatic arthritis and no longer practices medicine. Dr. Oberg receives no funding from pharmaceutical manufacturers. 

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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.

Canadian Province Adopts CDC Guidelines

By Pat Anson, Editor

Less than three months after their adoption in the United States, the CDC’s opioid prescribing guidelines are now being implemented in Canada.

The College of Physicians and Surgeons of British Columbia has released new professional standards and guidelines that are closely modeled after the CDC’s guidelines.

One key difference is that while the CDC’s guidelines are “voluntary” and intended only for primary care physicians, British Columbia’s standards of care are legally enforceable for all opioid prescribers because they set a “minimum standard of professional behaviour and ethical conduct.”

“The public health crisis of prescription drug misuse has developed in part due to the prescribing of physicians. The profession has a collective ethical responsibility to mitigate its contribution to the problem of prescription drug misuse, particularly the over-prescribing of opioids, sedatives and stimulants,” the college said.

"Every physician is professionally responsible for the prescription that they provide to a patient."

Like the CDC guidelines, the college discourages the prescribing of opioids for chronic pain, but goes even further by saying they should not be used to treat three specific health conditions: headaches, fibromyalgia and low back pain.

Opioids for acute pain should be limited to three to seven days’ supply, and when prescribed for chronic pain should be limited to only a month’s supply at a time. British Columbia physicians are also warned not to prescribe opioids concurrently with benzodiazepines and other anxiety medication.

Doctors are also cautioned to carefully document their reasons for increasing doses over 50 morphine milligram equivalents (MME) per day and to avoid increasing the dose to over 90 MME per day.

The British Columbia standards are more strict than Canada’s national guidelines, which have not been revised since 2010, “leaving them out of date with current research associated with taking painkillers,” according to The Globe and Mail.

“While Canada’s guidelines for opioid-prescription are expected to be updated in January, the death toll is mounting too quickly to wait,” said the Toronto Star in an editorial urging Ontario’s College of Physicians and Surgeons to adopt guidelines similar to British Columbia’s.

“B.C. has shown the way for other provincial regulatory bodies. Colleges across the country, including Ontario’s, should follow its example and set informed rules now. Injudicious prescriptions have already destroyed the lives of too many Canadians.”

Like the United States, Canada is one of the top opioid prescribing countries in the world and is struggling with an “epidemic” of addiction and overdoses. A growing number of deaths, however, can be attributed to illegal opioids such as fentanyl and heroin, and it remains in doubt whether restricting access to prescription opioids will lessen the problem or only make it worse by forcing legitimate patients to turn to the streets for pain relief.

As Pain News Network has reported, Canadian drug dealers are now selling counterfeit painkillers laced with fentanyl, an opioid that is more potent and dangerous than most pain medications.

The Star sees the problem differently, blaming doctors for Canada's opioid problem.

“It’s hard to believe that a large part of the blame for Canada’s latest drug-addiction crisis lies not with dealers, but with doctors. That is the conclusion of a growing number of health experts across the country who say our ballooning opioid problem can’t be solved until physicians stem the flow of prescriptions for the highly addictive painkillers,” the newspaper said in its editorial.

Fentanyl Blamed in Prince Overdose

By Pat Anson, Editor

A medical examiner has confirmed widespread speculation that opioids were involved in the accidental death of pop star Prince. The surprise was the type of opioid that was found in the singer's system.

“The decedent self-administered fentanyl,” Dr. A. Quinn Strobl, chief medical examiner for the Midwest Medical Examiner’s Office, wrote in his widely awaited report, which you can see by clicking here.

The report was released six weeks after Prince's death and only covered the manner and cause of death. All other information is considered private under Minnesota law.

The medical examiner’s report is likely to focus new attention on the so-called opioid abuse epidemic, which is routinely blamed on prescription opioids. Fentanyl is a potent opioid more powerful than morphine, and when prescribed the drug is generally only given to people in severe pain.

However, the report does not state whether the fentanyl that killed Prince was from a prescription or if it was illicit fentanyl obtained through other means.

Illicit fentanyl is an odorless white powder that is typically combined with heroin or cocaine to boost their potency. In recent months it has increasingly been found in counterfeit pain medication sold on the streets.  

Thousands of people have died from fentanyl overdoses in the U.S. and Canada, but because of the nature of the drug it’s impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and sold as a street drug.

“Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl. Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl,” said a recent report from the Centers for Disease Control and Prevention, which nevertheless still classifies all fentanyl overdoses as prescription drug deaths.

Massachusetts and Rhode Island recently reported a “significant increase” in fentanyl-related overdoses, with nearly 60% of the fatal overdoses in those states now attributed to fentanyl. Rhode Island health officials say the shift to fentanyl worsened when “more focused efforts were undertaken nationally to reduce the supply of prescription drugs.”  

Prince’s body was found in an elevator at his Paisley Park estate near Minneapolis on April 21. There was immediate speculation the singer was addicted to pain medication that he took for hip pain, but the only opioid ever mentioned was Percocet.  In the days before his death, Prince reportedly sought help from an addiction specialist in California.

The singer’s use of painkillers and how he obtained them are now the focus of a criminal investigation. No charges have been filed and a judge has sealed all records in the case.

According to search warrant that was accidentally released and obtained by the Los Angeles Times, Dr. Michael Todd Schulenberg, a family medicine practitioner, treated Prince on April 7 and 20, the day before his death.

Senators Propose Tax on Opioid Pain Meds

By Pat Anson, Editor

A group of U.S. Senators has introduced legislation that would establish a federal tax on all opioid pain medication. If approved, it would be the first federal tax on a prescription drug levied directly on consumers.

The bill, called the Budgeting for Opioid Addiction Treatment Act, would create a one cent fee on each milligram of an active opioid ingredient in pain medication. Money from this “permanent funding stream” would be used to provide and expand access to addiction treatment.  

“A major barrier that those suffering from opioid addiction face is insufficient access to substance abuse treatment,” said Sen. Joe Manchin (D) of West Virginia. “This legislation will bridge that gap and make sure that we can provide treatment to everyone who makes the decision to get help. I look forward to working with my colleagues to get this bill passed so we can take another step forward in the fight against opioid abuse.”

Sens. Amy Klobuchar (D-MN), Jeanne Shaheen (D-NH), Angus King (I-ME), Heidi Heitkamp (D-ND), Tammy Baldwin (D-WI) and Bill Nelson (D-FL) are co-sponsoring the bill, which has been dubbed the “LifeBOAT” Act.

“By establishing a reliable stream of funding, this bill will bolster treatment facilities across the country, increase the amount of services available, and support people as they fight back against addiction – all while doing so in a cost-effective way,” said Sen. King.

The opioid tax would raise an estimated $1.5 billion to $2 billion per year. In an interview with the Portland Press Herald, King said the fee would range between 75 cents and $3 for a 30-day prescription, depending on the dose. He claimed many patients wouldn’t have to pay the additional cost because their insurance would cover it.

King said treatment programs need funding, and tacking the cost onto the price of the drug is a fair way to do it, much like automakers are required to install seat belts and air bags in vehicles.

“The obvious way to fund this is to build it into the price of the drug,” said King. “The cost of the drug should reflect the danger of the drug.”

Although most of the press releases and public statements from the senators avoid using the word “tax” and refer to it as a fee, the bill itself doesn’t hide behind semantics. The legislation would apply to the sale of “any taxable active opioid” and would amend the Internal Revenue (IRS) Code to make it possible.

The federal government and the vast majority of states do not levy a sales tax on prescription drugs. Only two states, Illinois and Georgia, currently have a sales tax on prescription medication.

"I don't understand how, in a world where we are getting upset about the 'tampon tax' we find it perfectly socially acceptable to tax chronic pain patients to pay for addiction treatment," said Amanda Siebe, who suffers from Chronic Regional Pain Syndrome (CRPS) and is a founder of the advocacy group #PatientsNotAddicts.

"With less than 5% of chronic pain patients becoming addicted to opiates, this leave the other 95%, who are often some of the poorest in America and have nothing to do with addiction or addiction treatment, to pick up the tab for addiction treatment. I find myself truly disappointed and ashamed of our government. This tax is discriminatory and we are going to fight it."

The LifeBOAT Act would exempt buprenorphine, an opioid used to treat addiction, from taxation, as well as all over-the-counter pain relievers such as acetaminophen. Cancer and hospice patients would be exempted from the opioid tax, although they would have to apply for a rebate to get their money back.

“The discount or rebate mechanism shall be determined by the Secretary of Health and Human Services with input from relevant stakeholders, including patient advocacy groups. The discount or rebate shall be designed to ensure that the patient or family does not face an economic burden from the tax,” a fact sheet on the bill states.

Sen. Manchin told to his colleagues that there would be little or no opposition to the bill.

“There’s not one person who will lose a vote over this. Not one person. You won’t be accused of voting for a tax,” Sen. Manchin said during a news conference announcing the bill.  He noted that no Republican senators have signed on as co-sponsors.   

“This is something that’s much needed, overdue and they all recognize it, but they’re scared to death. They’ve taken the (no tax) pledge. They’re scared to death somebody will use it against them. I’ll be standing beside my Republican colleagues if any Democrat tried to attack them and said they tried to vote for a tax,” Manchin said.

To read the full text of the bill, click here.

To watch a video of the press conference, click here.

Canada Fights Wave of Fake Pain Pills

By Pat Anson, Editor

Canada’s Healthy Ministry today added a dangerous synthetic opioid – known as W-18 -- to a list of illegal controlled substances after the drug was found in counterfeit pain medication sold on the street.

W-18 has been used recreationally in Europe and Canada over the past two years. Recently, Canadian law enforcement have found W-18 disguised to look like legitimate prescription pain medication, such as oxycodone. W-18 is believed to be manufactured in China. It is blamed for one overdose death in Calgary.

"Substances like W-18 are dangerous and have a significant negative impact on some of the most vulnerable people in our society,” said Jane Philpott, Canada’s Minister of Health.

Classifying W-18 as a Schedule I controlled substance – the same class as heroin and cocaine -- makes its production, possession, importation and trafficking illegal in Canada. W-18 was originally developed in the 1980’s as a pain reliever at the University of Alberta, but was never marketed commercially. It is 100 times stronger than fentanyl, another synthetic opioid that is also increasingly being disguised as pain medication and sold on the street.

A Health Canada analysis of counterfeit oxycodone and Percocet pills confirmed the presence of W-18 last month, according to The Globe and Mail.

“Of particular concern is a green coloured oxycodone tablet marked CDN80,” said Corporal Eric Boechler of the Royal Canadian Mounted Police. "It was discontinued as a prescription tablet in 2012, so virtually any encountered on the street today are counterfeit and will contain fentanyl and/or other potent synthetic opioids such as W-18.”

Last week police in North Bay, Ontario seized hundreds of fake fentanyl pills that were disguised to look like 30 mg oxycodone prescription pills. The pills are blue and imprinted with “A 215.”

Counterfeit fentanyl pills have previously been found in western Canada, where they are blamed for dozens of overdose deaths. This was the first time they were found in North Bay, according to BayToday.

“I don’t think these illicit pills coming in from China are aimed at pain patients," said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.

NORTH BAY POLICE PHOTO

"They appear to be aimed at those who are willing to try ‘new’ things and the usual addiction population. I don’t know what possesses the younger groups to try this stuff from the street as they know full well what could happen.”

As Pain News Network has reported, fake fentanyl pills have also been appearing in the United States, where they are blamed for at least 14 deaths in California and 9 in Florida.  Some pills were purchased off the street by pain patients who were unable to get prescription medication through a doctor.

Massachusetts and Rhode Island have both reported an “alarming” rise in fentanyl overdoses. Over half the opioid overdose deaths in those states are now blamed on illicit fentanyl, not prescription pain medication.

Most Patients Don’t Think Opioids Are Risky

By Pat Anson, Editor

A small survey of chronic pain sufferers may give physicians a better understanding  of why many patients are reluctant to reduce or discontinue their use of opioids. Most patients simply don’t see themselves at risk of abuse and addiction, and think they can manage their opioid use safely.

Researchers at the University of Colorado School of Medicine and the VA Eastern Colorado Health Care System conducted in-depth interviews with 24 patients who were on long-term opioid therapy for chronic non-cancer pain. Six of the patients were still taking their regular opioid dose, 12 were tapering, and 6 had discontinued the use of opioids.

“When asked about specific concerns related to opioid medications, patients were generally aware of opioid overdose as a potential complication but did not perceive themselves to be at risk,” said lead author Joseph Frank, MD, assistant professor of medicine and a primary care physician at the VA Medical Center in Denver.

“The majority of patients described a long history of opioid medication use without prior overdose and cited this as evidence of their ability to safely take opioid medications. Patients attributed overdoses to others using opioids in risky ways or overdosing intentionally rather than accidentally.”

The survey findings, published in the journal Pain Medicine, include comments from some of the patients.

“Overdose? No. I’m very mature, very conscious, very intelligent as far as adhering,” said a 52-year old man who was still taking his regular opioid dose.

“The concern is that if they increase my opioid dosage, I could stop breathing. It’s ridiculous,” said another patient who was also taking his normal dose.

Even patients who were tapering or had discontinued opioids said that overdose risk was not their primary motive for cutting back. Others said they were so focused on pain relief they were willing to overlook the side effects of opioids.

“I like to research everything, but the pain was so severe I didn’t care about anything else... I don’t think that people actually consider the side effects and what not when it comes to something like that. I think that they just want the pain to go away,” said a 46-year old woman who was tapering.

“I don’t think people in chronic pain think about long term. We are basically, how do I get through today? I just gotta get through today,” said another woman who was still taking her regular dose.

Many patients said they had extensive experience with non-opioid therapies and found they weren’t effective. That led to pessimism about their ability to manage pain without opioids.

“I needed help desperately by the time [hydrocodone] was prescribed for me... I had taken ibuprofen, Aleve, everything over the counter, and it did nothing to help me at all. So I knew I needed more help, stronger help,” said a 73-year old woman who was tapering.

"Throughout my life, the doctors have done everything, trying to get me to exercise, to stretch, things that shocked my muscles,” said a 58-year old man. “In the ‘70s, they put some kind of body cast on me that I wore for months... Gosh, I’ve had everything. I’ve went through all the minor ones like Tylenols and aspirins and stuff, you know... I’ve went through a few years on Morphine. I’ve went to a time on Oxycodone and OxyContin, Vicodin, Tramadol. Now I’m on Fentanyl patches.”

Several patients said they eventually decided to taper when they realized that opioids weren’t helping as much or reduced their quality of life.

“The pills turned out horribly for me... I wasn’t caring for myself. I wasn’t bathing. I was sleeping all the time... Everything in my life was such a mess, and my husband was, you know, really worried about me... My husband [told me] that this is bad. This is really bad. You’re not doing well,” said a woman who was tapering.

“I didn’t stop under doctor’s orders or discussion or anything. I just got up one day and I’m done,” said a 60-year old male patient. “Instead of taking four, I took three and I did that for a couple of weeks and then I took two and then I took one. I never felt any discomfort or anxiety or anything so... it worked for me.”

Patients who tapered successfully emphasized the support they received from family, friends and healthcare providers in helping them make the transition.

“My doctor is very conscientious, and I respect her very much... It wasn’t her idea to take me off OxyContin,” said a 73-year old woman. “I just quit cold turkey, which was difficult... She was overjoyed. She thought it was just great that I didn’t need it anymore."

“It’s not much worse without the medication as it is with it. After you’ve taken it for a while, it doesn’t do any good. That’s what I’ve found,” said a 61-year old woman. “But that’s hard to convince people of it. They look at me like I’m nuts, but it’s true... I mean my pain is not any more severe than it was when I was taking all that stuff.”

“I am more alert since I stopped taking [OxyContin], and I need less sleep, which is a blessing. So I’m able to do more things with my life,” said a 72-year-old female patient.

The researchers admit their study was small and may not be representative of the pain community. But they think there are important lessons to learn from it, because tapering “may become an increasingly common patient experience.”

"To achieve goals of improving quality of life and preventing opioid-related harms, we need better evidence and more resources to support patients both during and after this challenging transition," Frank said.  “It will be important to ensure that patients' voices are heard in the national conversation about these medications."

FDA Approves New Drug Implant

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved the use of a new drug implant for the treatment of opioid addiction.  Probuphine is the first implant of its kind approved by the agency and could potentially be a game changer for other medical conditions such as chronic pain that require steady doses of medication around-the-clock.

Probuphine is designed to be inserted into the arm beneath the skin, where it delivers a low dose of burprenorphine directly into the bloodstream for up to six months.  

Buprenorphine is an opioid itself, but when combined with naloxone, the medication reduces cravings for opioids. Until now the drug has only been available as a pill or film strips placed under the tongue.

For many years buprenorphine was sold exclusively under the brand name Suboxone, but several pharmaceutical companies have entered the lucrative addiction treatment market and now make versions of their own. As many as 2.3 million people who are dependent on opioid pain medication or heroin could benefit from buprenorphine treatment,

FDA approval was a major win Braeburn Pharmaceuticals and its partner, Titan Pharmaceuticals (OTC: TTNP), which holds the rights to the implant technology. Titan and Braeburn were stunned in 2013 when the FDA denied approval of the implant and asked for new clinical studies proving Probuphine’s effectiveness.  

Results from a recent Phase III study showed that over 85% of the patients who had the implant abstained from using illicit opioids for six months, compared to about 72% of patients who used buprenorphine film strips that were taken daily.

"Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Robert Califf, MD. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Expanding the availability of addiction treatment is a major goal of the Obama administration. The White House has asked Congress for an additional $1.1 billion to fight opioid abuse, with much of the money earmarked for addiction treatment. The administration has also proposed doubling the number of patients that doctors can treat with buprenorphine from 100 to 200.

Buprenorphine can be abused and is a popular street drug that is used to get high or to ease withdrawal pains from illegal opioids such as heroin. An implant will be much more difficult to abuse, since it can’t be crushed or liquefied for snorting or injecting. It’s also less likely to be diverted.

Probuphine is expected to cost about $1,000 a month. It consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm. Administering Probuphine will require special training because it must be surgically inserted and removed.

The most common side effects are pain at the implant site, as well as itching, redness, headache, depression, constipation, nausea, vomiting, back pain, toothache and oral pain. The FDA is requiring post-marketing studies to establish the safety and effectiveness of the implants.

Probuphine was developed using a patented implant technology called ProNeura, which is designed to provide continuous levels of medication in the blood. Titan is also developing implants to treat Parkinson’s disease and hypothyroidism, and its CEO told Pain News Network that ProNeura could also potentially be used to deliver pain medication.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” said Titan CEO and President Sunil Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting.”

“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,” Behshad Sheldon, President and CEO of Braeburn, told PNN in an earlier interview.