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.

The Coming ‘Economic Bonanza’ in Addiction Treatment

By Pat Anson, Editor

The addiction treatment industry is lobbying hard for a proposed rule change to expand the number of patients that doctors can treat for opioid addiction. At stake is hundreds of millions of dollars in potential new business, much of it paid for by taxpayers.

The Obama administration has proposed doubling the maximum number of patients that a doctor can prescribe with buprenorphine from 100 to 200. Buprenorphine is an opioid that can be used to treat both pain and 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 generates nearly $2 billion in sales annually.

Because buprenorphine is an opioid that can also be abused, prescribers have to register with the Drug Enforcement Administration and undergo special training. Over 33,000 doctors have done so, but most are limited to just 30 patients.

About 10,000 physicians are currently allowed to prescribe buprenorphine to the maximum number of 100 patients.

Many addiction experts say the patient limits have restricted access to a valuable treatment tool, especially in rural areas where fewer doctors are certified to prescribe buprenorphine. According to the Health and Human Services Department (HHS), about 2.3 million people who are dependent on opioid pain medication or heroin could benefit from buprenorphine treatment, but many lack access to the drug because of limits on prescribers.

In a joint letter to HHS Secretary Sylvia Burwell, the American Psychiatric Association, American Academy of Addiction Psychiatry, and the American Osteopathic Academy of Addiction Medicine stated that as “the number of people addicted to these opioids increases, there continues to be a shortage of physicians who are appropriately trained to treat them. The shortage severely complicates and impairs our ability to effectively address the epidemic, particularly in many rural and underserved areas of the nation.”  

While the goal of treating opioid addiction is laudable, little attention has been paid to the diversion of buprenorphine or the financial incentives that doctors have to prescribe it.

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

HHS broadly estimates the added cost of treating new patients at between $43.5 million and $313 million in the first year alone. Many of the patents are low-income and the bills for treating them – about $4,300 annually for each patient – will often be paid by Medicaid. The Obama administration has asked Congress for an additional $1.1 billion to fight opioid abuse, with much of the money earmarked for addiction treatment.

The additional cost to taxpayers for expanding buprenorphine treatment, according to HHS, will be more than offset by the health benefits achieved by getting opioid addicts into treatment, which the agency generously estimates at $1.7 billion in the first year.

But some addiction experts have sounded a note of caution, warning that buprenorphine prescribing has already become a lucrative cash cow for some unscrupulous doctors.

“In northeast Tennessee, I am not aware of any buprenorphine provider that accepts insurance. Here buprenorphine clinics charge $100 cash at the time of service and require weekly visits for refills. This amounts to a cost to patients of over $5,000 yearly for medical services. This is a significant economic barrier for patients who typically have little or no income,” wrote Jack Woodside, MD, a professor at East Tennessee State University College of Medicine, in a public comment on the proposed rule change.

“From the provider's perspective, collecting $5,000 yearly from 100 patients amounts to an annual gross income of $500,000, with low overhead and no costs associated with billing insurance. This economic bonanza is causing many physicians to abandon traditional medical practices. A primary care physician remarked that he earns as much in one day in the buprenorphine clinic as he does the rest of the week in primary care.”

Buprenorphine Abuse

HHS acknowledges there could be “unintended negative consequences” to increased prescribing of buprenorphine – one of them being diversion.  Buprenorphine is a popular street drug, with addicts using it to either get high or to ease their withdrawal pains from illegal opioids like heroin. In 2014, the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. 

Some experts say the drug naltrexone is a better treatment option than buprenorphine. Naltrexone also reduces cravings, but it is not an opioid and is non-addicting.

“As I have been saying for longest time, buprenorphine is a double-edged sword. I contend greatly expanding the access of opioids contributes to the spread of addiction and a major factor in relapse,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“We are seeing more and more patients getting exposed to heroin and it is going to get worse. Sadly, the heroin addiction is being sustained by buprenorphine preparations.”

A 2013 study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for the "non-medical" use of buprenorphine – meaning many users took the drug to get high.

“It is important to note that studies have found that the motivation to divert buprenorphine is often associated with lack of access to treatment or using the medication to manage withdrawal—as opposed to diversion for the medication's psychoactive effect.  Thus, the overall effect of this rulemaking on diversion is not clear,” HHS says in its analysis.

Clear or not, many of the same government regulators and anti-opioid activists who want to restrict access to opioid pain medication are some of the biggest supporters of expanding access to buprenorphine.

They include Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), a program funded by Phoenix House, which operates a chain of addiction treatment centers in 10 states and the District of Columbia. 

Kolodny, who is Phoenix House’s chief medical officer, has long advocated the use of buprenorphine, calling it “one of the most effective medications for opioid addiction” on C-SPAN last year. During the same interview, Kolodny likened other opioid pain medications to “heroin pills.”

Kolodny declined to comment to Pain News Network for this story.

Patient Limits “Indefensible”

Under the proposed rule change, only doctors who are certified in addiction medicine or addiction psychiatry will be eligible for the expanded limit on buprenorphine prescribing. The rule changes also favor physicians in larger “qualified practices” – excluding many primary care physicians and other doctors who don’t offer additional therapies such as addiction counseling.

HHS is accepting public comment on the rule change until the end of this month. The vast majority of the nearly 300 comments received so far are from doctors, including many who are angry that the restrictions on buprenorphine aren’t being loosened further:

“The current limit is indefensible. There are not enough doctors now who are willing to deal with addicted patients, there is no need to further limit which doctors can treat more patients. The goal should be to get as many doctors as possible treating as many patients as they can comfortably handle,” wrote Jon Robertson, MD.

“We should have an immediate increase in the number of opiate addicts/heroin addicts we can treat with buprenorphine. We should have an unlimited number of patients we can treat,” said Peter Rogers, MD. 

“Why is it that I can give 10,000 patients OxyContin, yet I cannot meet the need in my community to treat addiction? No other specialty of medicine, no other physician, has any limit on any prescribing, especially during an epidemic,” wrote Anne Pylkas, MD.  “I am not a thief, I am not a charlatan or a quack. I am not a pill mill. I take insurance. I do not make millions on the backs of the helpless.”

 “It makes no sense to limit physicians to an arbitrary number of patients that can be treated to get the patients out of opiate addiction,” wrote Raymond Moy, MD. “Instead of making it hard to treat opiate addicts, why don't you make it harder to create opiate addicts? Make all these regulations apply to doctors prescribing opiates.”

“I practice in a rural area with a shortage of physicians to treat opioid addiction. My staff is capable of treating many more than 100 patients, so our contributions to the community's health are hampered by the current limits,” said Nels Kloster, MD, who runs a treatment center in Vermont. “There are many more persons seeking this treatment, but we have to turn them away due to this artificial restriction to our services.”

Only a few commenters warned that buprenorphine is already widely available on the black market and some doctors are likely to abuse the system.

“While it seems logical that increasing the patient limit would increase the ability to get people into the system, it does have some very serious downsides,” wrote Karl Hafner. “Several of these providers (at least in our area) are what most would consider pill mills. This only puts more medication on the street for abuse.

"By increasing the limit you will move physicians from doing this as part of a practice to just doing Suboxone and they will become pill mills. Do not increase the cap unless it is tied to treatment programs. There are plenty of providers.”

In a recent column in the Journal of Psychiatric Practice, one expert also warned of unintended consequences if the cap on buprenorphine prescribing is raised.

“Buprenorphine is an effective treatment for opioid use disorder; however, with increased access and availability, its abuse and diversion may be inevitable,” warned Daryl Shorter, MD, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine.

“This real-world, almost paradoxical, phenomenon demonstrates the complexity inherent in the treatment of addictive disorders -- a medication intended to treat substance use disorder that has its own abuse potential, upon gaining popularity and increased availability, will inevitably be explored by drug abusers for reward and reinforcement purposes.”

CNN Gets It Wrong About Pain Patients

By Sarah Daniels, Guest Columnist

You may have seen last night’s CNN town hall meeting on “Prescription Addiction: Made in the USA.”

I couldn’t believe it when Dr. Drew Pinsky said that real compliant pain patients are “a very tiny minority” of prescription opioid users.

I’m so sick of being grouped in with addicts! Because of all the new CDC regulations, I had to go weeks without my medication after being on high doses of opiates for a long time.

No one would give me my medication. Every pharmacy I went to said they were out. One pharmacy had the medication and was getting ready to fill it when the head pharmacist came over and told me unfortunately they wouldn't be able to give me the script. When I asked why she said they didn’t have it. I explained I was told they did and it was being filled. She said it wasn’t enough.

I asked if my doctor could write a different script for a temporary amount, would they be able to fill it and she just handed it back to me saying, "Like I said, I’m sorry, I can’t help you."

Then I went to a hospital pharmacy that did have the medication and they actually told me they needed to save it for patients who had short-term pain like surgeries for broken ankles. When I asked how someone's broken ankle pain was more important than my chronic pain from my genetic illness they asked me to quiet down and leave. If I didn't they would have to call security.

I was being polite and respectful, because I know as a pain patient you have to be the best advocate you can be, especially with all the stigma attached to opiates. I was also being quiet because I am never loud when discussing my pain meds, as you never know who is listening.

I never fight or argue or really raise my voice with anyone. I am a happy person despite my illness. I am grateful and thankful for each day I wake up and am able to spend with the people I love.

I did not appreciate someone making me out to be a completely different person than I am. It was like they actually felt threatened by me. Give me a break. I was in a wheelchair.

Now I’m not able to find the medication. My doctor wrote me a script for the medication because we have both decided it is the only thing and best thing for me to be on. It gets me out of bed and still, I can’t get it.

Now I am forced to go to a new pain clinic with new meds, where they're making me stop medical marijuana, which is the only thing keeping me from a feeding tube. They are making me come in for a visit once a week and each week I have to get drug tested and get labs drawn which costs $16. The visit itself costs $35.

SARAH DANIELS

They also want me to see a pain psychologist twice a week (who I already saw with my previous pain specialist and was cleared by). God only knows what that costs.

I’m on disability. It barely covers my insurance and yet I have to do all of these things to be compliant. I have to come up with the money for all of these appointments and procedures, find someone who will be able to drive me, as I am disabled and cannot do so on my own, and also be  well enough to even leave my house to make these appointments, just so that I am considered compliant. So that I can take a medication that I’m not sure will even work.

I am just disgusted by what is going on. As pain patients we are left in the dust. Nobody stands up for us. We try to stand up for ourselves, we are pretty strong, but we need bigger louder forces on our side.

Sarah Daniels lives in the Detroit, Michigan area. She suffers from Ehlers Danlos syndrome and gastroparesis. Sarah is a proud supporter of the Ehlers Danlos National Foundation and the Gastroparesis Patient Association for Cures and Treatments (G-Pact).

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Fentanyl Blamed for Half of Massachusetts Overdoses

By Pat Anson, Editor

New studies in Massachusetts and Rhode Island show that the nation’s fentanyl problem may be much worse than previously thought, while the abuse of opioid pain medication may not be as bad as it is often portrayed.

The Massachusetts Department of Public Health released new data showing that over half of the opioid overdose deaths in the state in 2015 were related to fentanyl, a powerful synthetic opioid that is more potent and dangerous that heroin.

It was the first time toxicology tests were used to detect the presence of fentanyl, a method that is far more accurate than the death certificate codes that the Centers for Disease Control and Prevention uses to classify opioid-related deaths. 

“The first-time inclusion of data on fentanyl allows us to have a more honest and transparent analysis of the rising trend of opioid-related deaths that have inundated the Commonwealth in recent years,” said Secretary of Health and Human Services Marylou Sudders.

Of the 1,319 opioid overdose deaths in Massachusetts for which a blood test was available, over 57 percent had a positive result for fentanyl.

The state’s findings do not distinguish between prescription fentanyl that is used to treat more severe forms of chronic pain and illicit fentanyl sold by drug dealers. But it seems likely the vast majority of deaths involve the latter.

illicit fentanyl powder

Massachusetts also released new data from its prescription drug monitoring program for the first quarter of 2016, showing that relativity few pain patients prescribed a Schedule II opioid medication had signs of abusing the drugs. Schedule II opioids include hydrocodone products such as Vicodin and Lortab.

Of the nearly 350,000 patients who had an opioid prescription, the state identified only 484 people (or 0.0014%) as “individuals with activity of concern.” The method used to identify possible abuse was someone receiving Schedule II opioid prescriptions from 4 or more providers and having them filled at 4 or more pharmacies during a three month period.   

Rhode Island Overdoses

Rhode Island this week also released a report showing a "significant increase" in fentanyl-related overdoses. Blood tests detected fentanyl in about 60 percent of the state's overdose deaths in the last two and a half months. There have been 28 fentanyl-related overdoses in Rhode Island so far this year.

“People are injecting, swallowing, and snorting this drug without realizing that they are often breathing their last breaths. Unfortunately, fentanyl kills, and it kills quickly,” said Nicole Alexander-Scott, MD, Director of the Rhode Island Department of Health.

Deaths linked to prescription opioids have been in decline in Rhode island for several years. The prescribing of Schedule II and Schedule III drugs in the state has fallen by over a third since 2011.

"The shifts in prescription and illicit drug overdose deaths also began roughly when more focused efforts were undertaken nationally to reduce the supply of prescription drugs," the health department said in a statement.

source: rhode island department of health

‘Alarming’ Rise in Fentanyl Overdoses

In recent years Rhode Island, Massachusetts and other eastern states have seen a surge in the illicit fentanyl drug trade. The white powdered drug is usually mixed with heroin or cocaine to boost their potency, but in recent months counterfeit pain medication made with fentanyl has appeared on both coasts. The “death pills” are blamed for at least 14 deaths in California and 9 in Florida.

COUNTERFEIT NORCO PILLS

“The counterfeit pills are a newer thing that is going on and that is popping up in different places. It’s certainly something we’re keeping an eye on,” said Erin Artigiani, deputy director of the Center for Substance Abuse Research (CESAR) at the University of Maryland.

CESAR tracks emerging trends in illegal drug use through a nationwide network of more than 1,500 researchers and volunteers.

“It’s very alarming. It’s something we’re very concerned about. And it’s something that local researchers and other members of the network are worried about as well,” Artigiani said.

The appearance of fake pain medication  came just as the CDC finalized guidelines that discourage primary care physicians from prescribing opioids for chronic pain. Artigiani stopped short of saying there’s a connection, but admits some pain patients may be seeking opioids on the streets.

“There are people that are looking for other sources or maybe got cutoff by their doctor or maybe their doctor had second thoughts about prescribing pain medications for one reason or another,” said Artigiani. “The people making and selling these illegal drugs are meeting market demand. So if there’s an increase in people looking for pills, then they’re going to make something to sell to those people.”

‘Biased’ CDC Reports

Pain News Network asked to interview someone at CDC about the Massachusetts fentanyl deaths and was told no one would be available.

“We aren’t able to provide comment on non-CDC research,” a spokesperson said in an email. “At CDC we don’t publish state drug overdose death rates for Rx opioids (or for any specific drug type) due to variability in states reporting drugs involved with deaths.”

While CDC may not consider the state data all that reliable, it has not hesitated to use reports from local medical examiners and death certificates in its reports on opioid overdose deaths.

The agency’s most recent report on 2014 overdoses said the U.S. was experiencing an “epidemic of drug overdose” that it blamed largely on prescription opioids.

“Natural and semisynthetic opioids, which include the most commonly prescribed opioid pain relievers, oxycodone and hydrocodone, continue to be involved in more overdose deaths than any other opioid type,” the report states.

Only briefly does the report acknowledge the “emerging and troubling” number of deaths related to illicit fentanyl. Like Massachusetts, CDC cannot distinguish between illicit fentanyl and prescription fentanyl, an important point because all fentanyl related overdoses are classified by the agency as prescription opioid deaths.

The CDC also admits some opioid-related deaths may be counted twice in its reports and some heroin-related deaths may have been misclassified as prescription opioid overdoses.

“We already know that the CDC's info is biased. Not because they are bad people, but because of the way that data is reported to them. Garbage in, garbage out,” says Terri Lewis, PhD, a rehabilitation specialist, medical researcher and patient advocate.

“There is so much variability in the collection of data at the state level, along with the fact that data collection and reporting is voluntary, not mandatory, that one simply cannot rely on the data set. Of course they won't tell you that.” 

The CDC uses data on death certificates known as International Classification of Disease (ICD) codes, which do not determine the cause of death, only the conditions that exist at the time of death. Someone could die from lung cancer, for example, but because they were on opioids to relieve cancer pain, an ICD code box for opioids may be checked by a doctor or coroner. Autopsies and toxicology tests are not usually conducted to verify ICD coding.

“The largest part of the problem of reported death certificates is that of variability – local jurisdictions have wide variation in the preparation of individuals who complete these reports, and few are actually physicians or medical examiners. Often local coroners are appointed or elected,” said Lewis. “Until every state is doing exactly the same thing, we have muddy statistics. 

“Massachusetts has enacted one of the most sweeping changes to their reporting systems in the country – for that they are to be commended.  Distinguishing drugs by the manner of their death is important information for policy managers.” 

Until other states and CDC follow Massachusetts’ lead, we may never know the extent of the fentanyl problem. The CDC’s reliance on ICD codes not only distorts the true nature of the nation’s drug problem, but can lead to the misallocation of resources aimed at combating it.. 

The Obama administration recently asked Congress for an additional $1.1 billion to fight opioid abuse. Most of the money is earmarked for addiction treatment for prescription opioids, not for getting fentanyl off the streets.    

Seeing Both Sides of the Opioid Debate

By Crystal Lindell, Columnist

I have suddenly found myself on both sides of the opioid issue.

I’m a chronic pain patient who is among the lucky few to have gotten better, or at least mostly better. And now, I’m so “lucky” that I get to take myself off opioids. It’s been hell.

I had this idea in my head that it would be like in the movies — 72 hours of feeling like death and then I would go on with my life. But it turns out even after your physical body adjusts to life without the drugs, your brain aches for them and begs you to take them.

I have it on good authority — a psychiatrist at a university hospital who specializes in this sort of thing — that I was never classically addicted to the morphine and hydrocodone that I took on a daily basis for my intercostal neuralgia. I never took more than the prescribed dose. I never took them to get that “high” that can come from the drugs. I never bought any off the streets.

I took them for pain. As prescribed. And I passed every stupid urine test they ever gave me. If they gave out grades for taking opioids correctly, I’m not saying I would definitely have an A+, I’m just saying I probably would. 

But when you’re on morphine 24 hours a day/ seven days a week for three years straight, your brain doesn’t much care why or how you took them, it just wants to know why the heck you stopped.

And so even after the initial diarrhea and the sweating and the body aches subsided, my brain was left in shambles. And I was hit with horrific, lingering crippling anxiety and insomnia.

It turns out there’s this thing called post-acute withdrawal syndrome, or PAWS. And first it should be noted that they really didn’t take things typically associated with puppies and use them to name ugly, terrible withdrawal-related issues. But whatever.

Anyway, as you go off certain drugs, like opioids, “Post-acute withdrawal occurs because your brain chemistry is gradually returning to normal. As your brain improves the levels of your brain chemicals fluctuate as they approach the new equilibrium causing post-acute withdrawal symptoms,” according to an article on Addictions and Recovery.org.

“Most people experience some post-acute withdrawal symptoms. Whereas in the acute stage of withdrawal every person is different, in post-acute withdrawal most people have the same symptoms.”

And the symptoms can last for two years.

Here’s is a list of symptoms from that article:

• Mood swings
• Anxiety
• Irritability
• Tiredness
• Variable energy
• Low enthusiasm
• Variable concentration
• Disturbed sleep

I have all of them, if you were wondering.

The anxiety and insomnia are a special kind of hell, because they don’t even let you escape with sleep for a few hours a day. You’re just awake, all the time, wondering if the world is actually going to end right then.

And you know in your mind that the anxiety isn’t logical. You know that just because the guy you’re seeing has read your text message but he hasn’t immediately responded to it doesn’t mean he’s met someone else and gotten married to her in the last seven minutes.

But anxiety doesn’t give an eff about logic. So your heart rate ramps up and you feel sick to your stomach and you convince that if he would just TEXT YOU BACK it would all be fine. And then he does, but it’s still not fine. Because it’s never fine.

Possibly most depressingly of all, I’m struggling to write. The anxiety convinces me that I have nothing important to say and nobody would want to read it anyway, and that anything I type has probably already been said better by someone else. It paralyzes me, and takes away the one thing in life I have always been able to count on. And getting this very column out has been an exercise in sheer will.

So yeah, it’s been awful. And most of the doctors I’ve been working with truly believe that since the drugs are technically out of my system and I wasn’t an “addict,” that I should be super awesome and totally good to go. Except I’m the completely opposite of that, and I’m really struggling with all this.

The worst part might be that dealing with withdrawal has so many ties to morality in our culture, so every time I have an anxiety attack and I reach for half a hydrocodone to calm me down, I feel like I failed at life. I feel like I went from A+ to F-.

The thing is, even with all this hell, I still don’t regret going on morphine three years ago. Back then I was in so much pain that I was genuinely planning ways to kill myself and the opioids were the only thing that helped me. They not only saved my life, they helped me keep my job and stay somewhat social.

But now, as I try to get my brain back to normal, I’m struggling. Like I mentioned, I’m working with a psychiatrist and psychologist and I have also recently made the decision to go on anxiety medication and try sleeping pills.

I still wake up in a state of panic more days than not though. I feel like something horrible is going to happen at any moment, and feel lucky if I get five hours of sleep in one night. So it’s not like I’ve found a magic cure.

The bottom line is it’s time we all admit how incredibly complicated opioids really are.

On one side, people in pain deserve access to them. Quality of life is important and nobody should have to suffer because of mass hysteria about hydrocodone. 

But we can’t ignore the fact that no matter how responsibly we take these drugs, our brains get addicted to them over time. And stopping them isn’t as easy as a 72-hour withdrawal weekend.

Doctors need to know these things, and then they need to relay them to their patients. And only when we have an honest conversation about the benefits AND the risks associated with these drugs can we begin to move forward in a productive way.

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.

Untreated Pain Raises Risk of Drug & Alcohol Abuse

By Pat Anson, Editor

Nearly nine out of ten people who abuse drugs or alcohol have chronic pain and most are using the substances for pain relief, according to the findings of a new study at Boston University School of Medicine.

The study seems likely to stir further debate about the nation’s opioid abuse problem and whether taking patients off pain medication or lowering their doses will only lead to more substance abuse.

Researchers surveyed nearly 600 primary care patients who screened positive for illegal drug use, misuse of prescription drugs or heavy alcohol use and found that 87 percent of them had chronic pain. About half rated their pain as severe.

Over half (51%) of the patients who admitted using marijuana, cocaine, heroin or other illegal drugs said they did it to treat pain.

And about eight out of ten who abused prescription pain medication (81%) or alcohol (79%) said they did it to manage pain.

"While the association between chronic pain and drug addiction has been observed in prior studies, this study goes one step further to quantify how many of these patients are using these substances specifically to treat chronic pain,” said lead author Daniel Alford, MD, an associate professor of medicine at Boston University School of Medicine.

“In this study, it was common for patients to attribute their substance use to treating symptoms of pain. Over half of the cohort using illicit drugs, two thirds misusing prescription drugs without a prescription, and one-third using their prescription in greater amounts than prescribed, reported doing so to treat pain. Among those with any recent heavy alcohol use, over one-third drank to treat their pain, compared to over three-quarters of those who met the criteria for current high-risk alcohol use.”

Alford said it was important for primary care doctors and addiction counselors to recognize the link between pain and substance abuse, because counseling efforts are likely to fail if a patient’s pain is not addressed.

“If drugs are being used to self-medicate pain, patients may be reluctant to decrease, stop or remain abstinent if their pain symptoms are not adequately managed,” Alford wrote.

“Addressing pain symptoms is complicated for the most experienced physician and is outside the skill set of most allied health staff performing brief intervention counseling. Brief interventions focusing solely on the harmful effects of an illicit or misused drug may be ignored or disregarded if the patient perceives the drug as necessary to treat a symptom.”

The study is published in the Journal of General Internal Medicine.