Lessons About the Opioid Crisis from ‘Unbroken Brain’

By Roger Chriss, Columnist

The book “Unbroken Brain: A Revolutionary New Way of Understanding Addiction” by Maia Szalavitz offers invaluable insights about addiction. Her key point is that addiction should be seen as a learning disorder -- not a moral failing or brain disease.

Szalavitz says addiction treatment and drug policy should meet addicts where they are and deal with their reality, instead of using the moralistic or legalistic framework commonly seen in the opioid crisis.

Throughout the book, Szalavitz shares her own experiences with drug use in a way that does not mythologize addiction or recovery. Instead, her personal history highlights that there is no such thing as a typical addict and that addiction is not simply a moral failing or choice.

Szalavitz explains that addiction results from a complex combination of a person’s genetic makeup, early life experiences, and socio-cultural situation. Specifically, she states that: "There are three critical elements to it; the behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

She likens addiction to dysfunctional self-medication, an effort to self-soothe and regulate internal states that have gone horribly wrong. This means that addiction is not about a substance, but about a person.

“Drugs alone do not ‘hijack the brain.’ Instead, what matters is what people learn -- both before and after trying them,” Szalavitz writes. “Addiction is, first and foremost, a relationship between a person and a substance, not an inevitable pharmacological reaction.”

Further, she states that “by itself, nothing is addictive; drugs can only be addictive in the context of set, setting, dose, dosing pattern, and numerous other personal, biological, and cultural variables.”

And there are several major risk factors for addiction, including severe early childhood trauma or abuse, existing mental illness, and serious life challenges. Particular emphasis is given to a history of abuse.

“In fact, one third to one half of heroin injectors have experienced sexual abuse, with the usual abuse rates for women who inject roughly double those for men. And in 50% of these sexual abuse cases, the offense was not just a single incident but an ongoing series of attacks, typically conducted by a relative or family friend who should have been a source of support, not stress,” wrote Szalavitz.

She also states that addiction is not just about euphoria: “Research now suggests that there are at least two distinct varieties of pleasure, which are chemically and psychologically quite different in terms of those effects on motivation. These types were originally characterized by psychiatrist Donald Klein as the ‘pleasure of the hunt’ and the ‘pleasure of the feast’.”

This means that addiction is about far more than just dopamine levels: “If dopamine is what creates the sense of pleasure, animals shouldn’t be able to enjoy food without it. Yet they do.”

Lower Risk of Addiction to Opioid Medication

On the subject of opioid medication, Szalavitz notes that about one in seven people do not tolerate opioids well enough to take them repeatedly and therefore have essentially no risk of opioid use disorder. Because of this and the importance of “set and setting” to addiction, she explains, “medical use of drugs carries a far lower risk of addiction than recreational use does.”

Because addiction involves a person in a particular sociocultural situation, she writes that “People with decent jobs, strong relationships, and good mental health rarely give that all up for intoxicating drugs; instead, drugs are powerful primarily when the rest of your life is broken.”

Approaches to addiction treatment that don't recognize the above are unlikely to succeed. Detox regimens, short-term medication therapy, and abstinence-only programs like Alcoholics Anonymous are generally inadequate. For instance, Szalavitz found a 2006 Cochrane Review that summarized the data plainly: “No experimental studies unequivocally demonstrated the effectiveness of AA.”

Instead, Szalavitz emphasizes the value of harm reduction, a process whose aim is to "meet the addicts where they are" and support them unconditionally, even if this means clean needle exchanges and safe injection sites.

“Don’t focus on whether getting high is morally or socially acceptable; recognize that people always have and probably always will take drugs and this doesn’t make them irrational or subhuman,” she wrote.

But American policy toward illegal drugs and attitudes toward medications with psychotropic effects are grounded in a moralistic view. “More generally, in the West, unearned pleasure has been labeled as sinful—the opposite of valued,” Szalavitz writes, explaining why any medication that helps a person feel good, or just not feel as bad, is viewed negatively. This has led to all manner of misguided policy in the War on Drugs.

“One of the sad ironies of our current drug policy is that the same treatment providers who have been cheerleaders for the war on drugs and who advocate the ongoing criminalization of drug use also claim to want to destigmatize ‘the disease of addiction’,” she wrote.

“This approach is doomed to failure because “punishment cannot solve a problem defined by its resistance to punishment.” Moreover, it is cruelly counterproductive because “the uniquely moral nature of the way we treat addicts as both sick and criminal also reinforces stigma.” By contrast, understanding addiction as a learning disorder leads to harm reduction as the core of a more effective approach to treatment.

“Unbroken Brain” is not pedantic or moralistic. Indeed, Szalavitz says that part of the reason U.S. policy toward drug addiction has failed is that it is pedantic and moralistic. But she also says that people who now say that addiction is a "brain disease" are missing the point too. "Drug exposure alone doesn't cause addiction," she says in the conclusion of the book.

A person's situation and circumstances matter a lot in drug use and addiction. And treatment requires recognizing that even the most addicted person can still learn and make positive changes in their life when given the chance.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Fed Prosecutors to Target Doctors and Pharmacists

By Pat Anson, Editor

Attorney General Jeff Sessions has announced the formation of a special prosecution unit in the U.S. Justice Department to target opioid fraud and abuse.

The 12-member unit will not focus on the flourishing underground trade in heroin and illicit fentanyl, but will instead use healthcare data to identify doctors and pharmacies that prescribe or dispense large amounts of opioid pain medication, and prosecute those suspected of fraud or diversion.

“I have created this unit to focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to this opioid epidemic,” Sessions said in a speech at the Columbus Police Academy in Ohio.

“This sort of data analytics team can tell us important information about prescription opioids -- like which physicians are writing opioid prescriptions at a rate that far exceeds their peers; how many of a doctor's patients died within 60 days of an opioid prescription; the average age of the patients receiving these prescriptions; pharmacies that are dispensing disproportionately large amounts of opioids; and regional hot spots for opioid issues.”

For the next three years, Sessions said 12 experienced prosecutors will focus solely on investigating and prosecuting health care fraud related to prescription opioids, including pill mills and pharmacies that divert or dispense prescription opioids for illegitimate purposes.

The Opioid Fraud and Abuse Detection Unit will concentrate on 12 federal court districts around the country:

  1. Middle District of Florida
  2. Eastern District of Michigan
  3. Northern District of Alabama
  4. Eastern District of Tennessee
  5. District of Nevada
  6. Eastern District of Kentucky
  7. District of Maryland
  8. Western District of Pennsylvania
  9. Southern District of Ohio
  10. Eastern District of California
  11. Middle District of North Carolina
  12. Southern District of West Virginia

The Attorney General said preliminary data shows that nearly 60,000 Americans lost their lives to drug overdoses last year, but only in passing did he note that many of those deaths were caused by heroin and illicit fentanyl. In some states, such as Ohio, Pennsylvania and Massachusetts, more overdoses are linked to illicit fentanyl than any other drug. The CDC estimated that about one in four overdose deaths in 2015 involved prescription opioids.

Sessions said in recent years some government officials – who he did not identify -- have sent “mixed messages” about the harmful effects of drugs.

“We must not capitulate intellectually or morally to drug use. We must create a culture that is hostile to drug abuse. We know this can work. It has worked in the past for drugs, but also for cigarettes and seat belts. A campaign was mounted, it took time, and it was effective. We need to send such a clear message now,” Sessions said. “I issue a plea to all physicians, dentists, pharmacists: slow down. First do no harm.”

Last month the Justice Department announced the largest health care fraud takedown in history, resulting in the arrests of over 400 people around the country. Over 50 of the defendants were doctors charged with opioid-related crimes.

The department also announced the seizure and take down of AlphaBay – a large “dark net” website that hosted over 200,000 listings for synthetic opioids and other illegal drugs.

Sessions has long been a critic of marijuana legalization, but did not mention it in his Columbus speech. In May, he wrote a letter to congressional leaders asking them not to renew a federal law that prevents the Justice Department from interfering with state medical marijuana laws.

Pfizer Agrees to Support CDC Opioid Guideline

By Pat Anson, Editor

Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s "voluntary" recommendations as policies or even law.

As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them. We have tried to keep you informed and aware of these facts.

Now one of the world’s largest drug makers has agreed to not make any statements that conflict with the CDC guideline and to withdraw support for any organizations that challenge it. Pain News Network is among them.

In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”

That voluntary guideline discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.

Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a $10,000 charitable grant awarded to PNN. Pfizer had sponsored PNN’s newsletter for the past year.  

"Kindly note Pfizer recently entered into an agreement with Santa Clara County, California that places limits on Pfizer’s ability to provide opioids-related funding to outside organizations.  After careful consideration, we regret to inform you that we are unable to support your request and must rescind the previous approval notification," the email said.

“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”

Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and exaggerated their benefits.

“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”

Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release and little known pain medication called Embeda.

As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no studies supporting the use of opioids long-term for pain relief. Pfizer signed a nearly identical agreement with the city of Chicago last year to avoid litigation.

Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.

In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses.

Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

Feds Bust Operators of Bogus Medical Clinics

By Pat Anson, Editor

Hardly a day goes by without the U.S. Drug Enforcement Administration announcing a new drug bust or the sentencing of someone for drug trafficking. The announcements have become so routine they’re often ignored by the news media.

But a drug bust in Los Angeles this week is worth sharing, if only because it shows that the underground market for prescription painkillers is booming and criminals are eager to take advantage of it.

The DEA announced the indictment of 14 defendants and released details of a brazen scheme that involved a string of sham medical clinics, fake prescriptions and kickbacks to doctors who were paid “for sitting at home.”

The feds estimate that at least two million prescription pills – most of them painkillers – were diverted and sold to customers looking for pain relief or to get high.

Indictments by a federal grand jury allege the suspects established seven bogus medical clinics in the Los Angeles area. The clinics would periodically open and then close, after illegally obtaining large quantities of oxycodone, hydrocodone, alprazolam (Xanax) and other prescription drugs from pharmacies using fake prescriptions. The drugs were then sold to street level drug dealers.

Prosecutors say the ringleader of the scheme -- Minas Matosyan, aka “Maserati Mike” -- hired corrupt doctors to write fraudulent prescriptions under their names in exchange for kickbacks.

“This investigation targeted a financially motivated racket that diverted deadly and addictive prescription painkillers to the black market,” said David Downing, DEA Special Agent in Charge of the Los Angeles Division.

“The two indictments charge 14 defendants who allegedly participated in an elaborate scheme they mistakenly hoped would conceal a high-volume drug trafficking operation,” said Acting U.S. Attorney Sandra R. Brown.

The indictments describe how Matosyan would “rent out recruited doctors to sham clinics.”  In one example described in court documents, Matosyan provided a corrupt doctor to a clinic owner in exchange for $120,000. When the clinic owner failed to pay the money and suggested that Matosyan “take back” the corrupt doctor, Matosyan demanded his money and said, “Doctors are like underwear to me. I don’t take back used things.”

In a recorded conversation, Matosyan also discussed how one doctor was paid “for sitting at home,” while thousands of narcotic pills were prescribed in that doctor’s name and Medicare was fraudulently billed more than $500,000 for the drugs.

Prosecutors say the identities of doctors who refused to participate in the scheme were sometimes stolen. In an intercepted telephone conversation, Matosyan offered one doctor a deal to “sit home making $20,000 a month doing nothing.” When the doctor refused the offer, the defendants allegedly created prescription pads in the doctor’s name and began selling fraudulent prescriptions for oxycodone without the doctor’s knowledge or consent. 

The conspirators also issued fake prescriptions and submitted fraudulent billings in the name of a doctor who was deceased.

The indictment alleges that criminal defense attorney Fred Minassian tried to deter the investigation. After a load of Vicodin was seized from one customer, Matosyan and Minassian allegedly conspired to create fake medical records to throw investigators off track.

Matosyan, Minassian and 10 other defendants were arrested and arraigned in federal court. Authorities are still looking for the two remaining fugitives.

While the DEA continues to bust drug dealers and unscrupulous doctors, the diversion of opioid medication by patients is actually quite rare. A DEA report last year found that less than one percent of legally prescribed painkillers are diverted. The agency also said the prescribing and abuse of opioid medication is also dropping, along with the number of admissions to treatment centers for painkiller addiction.

Kaiser Permanente Prescribing Fewer, Cheaper Opioids

By Pat Anson, Editor

One of the largest medical organizations in California has significantly reduced high dose opioid prescribing for its patients and shifted many of them to generic opioids, according to the results of a new study by Kaiser Permanente of Southern California.

“You can treat pain differently without putting people on high doses of opioids,” said co-author Michael Kanter, MD, an executive with the Southern California Permanente Medical Group. “There is no proven benefit of long term opioid therapy.”

Researchers looked at prescription data for over 3 million Kaiser Permanente patients in southern California from 2010 to 2015, and found a 30 percent reduction in high dose opioid prescribing, along with a major decline in the prescribing of brand name opioids.

The medical group instituted system wide policies in 2010 that promoted safer prescribing and encouraged its 6,600 physicians to prescribe lower doses using cheaper, generic opioids.

The change in policy resulted in far fewer prescriptions being written for OxyContin, Opana, and brand name hydrocodone, oxycodone and codeine products. OxyContin was the first painkiller to have abuse deterrent properties, while Opana is being taken off the market because of concerns it is being abused.  Both are more expensive than generic opioids.

“This study adds promising results that a comprehensive system-level strategy has the ability to positively affect opioid prescribing,” Kanter and his colleagues wrote in the Journal of Evaluation in Clinical Practice.

Like other studies of its kind, however, the report did not assess whether there was any improvement in patient pain, function and quality of life, nor did it assess the impact of alternative pain therapies and treatments that were prescribed in lieu of opioids. Also unknown is whether the medical group’s policies resulted in fewer overdoses or cases of opioid misuse and addiction.

“But we did note that, generally speaking, patients were satisfied with the process that they went through,” said Kanter, adding that a subsequent research paper will be published on patient satisfaction.

Kanter told PNN that many pain patients take opioids long-term because of “therapeutic inertia” on the part of prescribers.

“We do know that some patients are just started on opioids for chronic pain, (their) doses may be increased over time, and they may be actually doing quite well pain-wise, but nobody takes the time to titrate their dose down and deescalate, and so a lot of the patients we think were just on too high of a dose for no real good reason,” Kanter explained. “Some of the patients, if not many, we think did just as well on lower doses.”

Several other medical groups and insurance companies have taken steps to reduce opioid prescribing, but the results so far have been mixed in terms of preventing overdoses.

As PNN has reported, opioid prescribing fell by 15 percent for members of Blue Cross Blue Shield of Massachusetts after the state's largest insurer adopted policies in 2012 that discourage the dispensing of opioid medication. The new policies failed to slow the growing number of opioid overdose deaths in Massachusetts, which more than doubled. Many of those deaths were not due to painkillers, but linked to heroin and illicit fentanyl.

Blue Shield of California says its Narcotic Safety Initiative has resulted in an 11% reduction in members using high dose opioids and prevented 25% of all new opioid users from using the drugs for more than 90 days.  

Like the Kaiser Permanente study, the Blue Cross Blue Shield initiatives in California and Massachusetts did not assess the impact on patient pain, function and quality of life after opioid prescribing was lowered.

The opioid overdose death rate in California is 4.9 deaths per 100,000 people, less than half the national average. From 2014 to 2015, the opioid overdose rate in California declined by 2 percent, while the national average rose by 16 percent. Click here to see trends in your state.

Poorly Treated Pain Main Reason for Opioid Misuse

By Pat Anson, Editor

Over a third of the U.S. adult population -- nearly 92 million Americans – used prescription opioids in 2015, according to a large new survey that found the primary reason people misuse opioid medication was to relieve pain.

The findings of the annual survey by the Substances Abuse and Mental Health Services Administration (SAMHSA), published in the Annals of Internal Medicine, seem likely to fuel another round of anti-opioid media coverage about the overdose crisis. 

The study estimated that 11.5 million Americans misused opioids in 2015, and nearly two million thought they were addicted and had an opioid use disorder. 

But a closer reading of the reasons behind the misuse indicates that pain is poorly treated by the healthcare system, especially for Americans who are economically disadvantaged or lack insurance.

“Misuse” in the survey was defined as using an opioid medication without a prescription, for reasons other than directed, or in greater amounts or more often than prescribed.

Asked what was the main reason behind their misuse, two-thirds (66%) of those who self-reported misuse said it was to relieve physical pain. Nearly 11 percent said it was to “get high or feel good” and less than one percent (0.6%) said they were “hooked” or addicted to opioids.

Our results are consistent with findings that pain is a poorly addressed clinical and public health problem in the United States and that it may be a key part of the pathway to misuse or addiction. Because pain is a symptom of many pathologic processes, better prevention and treatment of the underlying disorders are necessary to decrease pain and the morbidity and mortality associated with opioid misuse,” wrote lead author Beth Han, MD, PhD, a SAMHSA researcher.

“Simply restricting access to opioids without offering alternative pain treatments may have limited efficacy in reducing prescription opioid misuse and could lead people to seek prescription opioids outside the health system or to use nonprescription opioids, such as heroin or illicitly made fentanyl, which could increase health, misuse, and overdose risks.”

That appears to be what is happening. The CDC recently acknowledged that opioid prescribing has been in decline since 2010, yet opioid overdoses are soaring around the country, reaching 33,000 deaths in 2015, many of them caused by illicit opioids.  The DEA reported last week that over half the overdoses in Pennsylvania in 2016 were linked to illicit fentanyl. Prescription painkillers were involved in only about 25% of the overdoses, behind fentanyl, heroin, benzodiazepines (anti-anxiety medication), and cocaine.

In the SAMHSA survey, only a third of those who misused opioids said they obtained them legally from a doctor. The rest said they were obtained for free from a friend or relative, or were bought or stolen.

In addition to physical pain, the survey found that economic despair was a leading factor associated with opioid misuse. Uninsured, unemployed and low-income adults had a higher risk of opioid misuse and use disorder. People who were depressed, had suicidal thoughts, or were in poor health also were at higher risk.

“In more than 20 years practicing primary care in safety-net health settings, I have come to think of the patients at highest risk as my patients -- those with lower levels of education and income and higher rates of unemployment and uninsurance, our society's most vulnerable members,” wrote Karen Lasser, MD, Boston Medical Center and Boston University School of Medicine, in an editorial published in the Annals of Internal Medicine.

The fact that uninsured persons were twice as likely as those with insurance to report prescription opioid misuse and also had higher rates of use disorders augments the urgency of expanding insurance coverage. With insurance, persons suffering from pain could seek medical care rather than relying on opioids prescribed for others or purchased illegally.”

Over 72,000 American adults participated in the SAMHSA survey. Each interview lasted about an hour and participants received $30 in cash afterwards.

Trump Opioid Commission Calls for National Emergency

By Pat Anson, Editor

A White House commission on combating drug addiction and the opioid crisis has recommended that President Trump declare a national emergency to speed up federal efforts to combat the overdose epidemic, which killed over 47,000 Americans in 2015.

“If this scourge has not found you or your family yet, without bold action by everyone, it soon will. You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately,” the commission wrote in an interim report to the president.

The 10-page report was delayed by over a month, which New Jersey Gov. Chris Christie attributed to over 8,000 public comments the commission received after its first meeting in June. Christie, who chairs the commission, said the panel wanted to carefully review each comment.

In addition to declaring a national emergency, the commission recommended a variety of ways to increase access to addiction treatment, mandate prescriber education about the risks and benefits of opioids, and prioritize ways to detect and stop the flow of illicit fentanyl into the country.

There were no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October.

“We urge the NIH (National Institutes of Health) to begin to work immediately with the pharmaceutical industry in two areas: development of additional MAT (medication assisted treatment)... and the development of new, non-opioid pain relievers, based on research to clarify the biology of pain,” Christie said. “The nation needs more options that are not addictive.  And we need more treatment for those who are addicted.”

“I think we also have to be cognizant that the advent of new psychoactive substances such as fentanyl analogs and heroin is certainly replacing the death rate due to prescription opioids. That is going to continue until we have a handle on the supply side of the issue,” said commission member Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School.

“If we do not stop the pipeline into substance use, into addiction, into problematic use, into the entire scenario of poly-substance use, we are really not going to get a good handle on this.”     

Other measures recommended by the commission:

  • Grant waivers to states to eliminate barriers to mental health and addiction treatment
  • Increase availability of naloxone as an emergency treatment for opioid overdoses
  • Amend the Controlled Substance Act to require additional training in pain management for all prescribers
  • Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
  • Stop the flow of synthetic opioids through U.S. Postal Service
  • Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

Gov. Christie also spoke about eliminating pain levels as a “satisfaction criteria” for healthcare providers being evaluated and reimbursed for federal programs like Medicare.

“We believe that this very well may have proven to be a driver for the incredible amount of prescribing of opioids in this country. In 2015, we prescribed enough opioids to keep every adult in America fully medicated for three weeks. It’s an outrage. And we want to see if this need for pain satisfaction levels, which is part of the criteria for reimbursement, is part of the driver for this problem,” Christie said.  

Last year, the Centers for Medicare and Medicaid Services (CMS) caved into pressure from politicians and anti-opioid activists by dropping all questions related to pain in patient satisfaction surveys in hospitals.  CMS agreed to make the change even though there was no evidence that the surveys contributed to excess opioid prescribing

Indiana Doctor Killed in Dispute Over Pain Meds

By Pat Anson, Editor

A gunman who fatally shot an Indiana doctor this week was upset because the physician refused to prescribe opioid pain medication to his wife, according to police.

Dr. Todd Graham was confronted Wednesday afternoon in the parking lot outside a South Bend medical center by 48-year Michael Jarvis. After a brief argument, Jarvis shot Graham twice in the head. Jarvis then drove to a friend’s house and killed himself, according to the South Bend Tribune.

An investigation later determined that Jarvis’ wife had an appointment with Graham Wednesday morning and the doctor declined to prescribe an opioid medication for her chronic pain.

“It was Dr. Graham’s opinion that chronic pain did not require prescription drugs,” St. Joseph County Prosecutor Ken Cotter said at a news conference Thursday. "He did what we ask our doctors to do. Don't over-prescribe opioids.”

DR. TODD GRAHAM

Michael Jarvis was present during his wife's appointment and argued with Graham. Jarvis eventually left, but returned in the afternoon with a gun and confronted the doctor outside the medical center.

"Make no mistake, this was a person who made a choice to kill Dr. Graham. This is not a fallout from any opioid epidemic or any opioid problems. That probably leads us into an examination of what is happening with the opioid problem in our community, and frankly, in our whole nation," said Cotter.

Cotter said Jarvis had a “confrontation” with Graham before Wednesday, but did not go into details.

"This was a very targeted attack," said Commander Tim Corbett of Saint Joseph County Metro Homicide. "I am a firm believer -- and I think Ken feels the same way -- that if Jarvis would have got inside that building, although there wouldn't have been any specific target, it's like trapping an animal in a corner: they're going to come out fighting. I truly believe this could have escalated into a mass shooting. I do believe that."

Mrs. Jarvis was apparently unaware of her husband’s plans.

"It was clear that she didn't know what he was doing. She's suffering as well," Cotter said.

The 56-year old Graham was married and had three children. His obituary can be seen here. Graham's wife learned of her husband’s death through social media, according to the South Bend Tribune.

Several of Graham’s patients left messages about him on the Tribune’s website.

“He was a very caring person. I am lost of words my heart is breaking for his wife and family,” wrote one patient.

“Dr. Graham has been my Dr. for 3 years. After 3 accidents, and surgeries he has helped me tremendously. My condolences to his wife. He will be missed,” wrote another.

The Indiana shooting was the third in recent months involving a pain patient and a doctor.

In June, a gunman shot and wounded two people at a Las Vegas pain clinic before taking his own life.  The shooter, who suffered from chronic back pain, had been denied pain medication during an unscheduled appointment.

In April, a disgruntled pain patient in Great Falls, Montana burned down a doctor's home, held the doctor's wife at gunpoint and killed himself during a standoff with police.

Pennsylvania Overdoses Soar, But Not from Painkillers

By Pat Anson, Editor

A new study by the U.S. Drug Enforcement Agency underscores the changing nature of the nation’s overdose crisis and the diminishing role played by opioid painkillers.

In an analysis of 4,642 drug related overdose deaths in Pennsylvania last year, the DEA found that over half of those deaths (52%) involved fentanyl or fentanyl related substances. In many cases, toxicology reports found multiple drugs in the bodies of those who died.

Heroin was the second most frequently identified drug (45%), followed by benzodiazepines (33%), a class of anti-anxiety medication, and cocaine (27%).  

Prescription opioid medication was the fifth most common type of drug found. Painkillers were involved in 25 percent of the Pennsylvania overdoses, while ethanol (alcohol) was ranked 6th at nearly 20 percent.

Overall, the number of overdoses in the state was 37 percent higher than in 2015, according to the DEA report. Pennsylvania's overdose rate was 36.5 deaths per 100,000 people, twice the national average.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine, and is available legally by prescription to treat severe chronic pain. In recent years however, illicit fentanyl has become a deadly scourge across the U.S. and Canada, where it is often mixed with heroin or used in counterfeit painkillers. Illicit fentanyl is believed to be involved in the vast majority of the fentanyl-related deaths in Pennsylvania.    

DRUGS INVOLVED IN PENNSYLVANIA OVERDOSES (2016)

SOURCE: DEA

The DEA report was prepared in conjunction with the University of Pittsburgh’s School of Pharmacy Program Evaluation Research Unit (PERU). Unlike other reports on overdose deaths, the PERU analysis excluded suicides and included toxicology reports, a methodology that is considered more reliable than the ICD codes traditionally used by the CDC and other federal agencies to determine the drugs involved in overdoses.

“The expertise of PERU in the analysis and interpretation of public health data, which is outside of the traditional scope of law enforcement intelligence analysis, resulted in the creation of this comprehensive report that can be used to implement effective strategies to address the overdose crisis,” said Gary Tuggle, Special Agent-in-Charge of DEA’s Philadelphia Field Division.

Perhaps the most striking aspect of the report was the presence of anti-anxiety drugs in so many of the overdoses, and the smaller role played by prescription opioids. Toxicology reports found opioid medication in 1,181 of the overdose deaths, with oxycodone involved in most of them.

Still, more Pennsylvanians died with Xanax (alprazolam) in their system than oxycodone (846 vs. 679). And the anti-anxiety drugs clonazepam (Klonopin), diazepam (Valium), oxazepam and lorazepam (Ativan) were also involved in hundreds of overdoses.

The existence of valid prescriptions was not analyzed in the DEA report, which did not assess whether medications were diverted or obtained fraudulently.

In 2016, approximately 13 people died of a drug-related overdose in Pennsylvania each day. 

Although painkillers were not involved in most of those deaths, efforts at fighting the overdose crisis are still largely focused on reducing access to legally prescribed opioid medication.

Last month, Independence Blue Cross, the largest health insurer in the Philadelphia area, said it would limit the prescribing of opioids in its network to just five days for acute pain. Independence already limits the quantity of opioids that physicians can prescribe. The company claims that policy has reduced "inappropriate" opioid use by its members by nearly 30 percent.

Deaths from prescription opioids in Philadelphia started declining in 2013, a year before Independence started limiting access to painkillers.

The Myth of the Opioid Addicted Chronic Pain Patient

By Roger Chriss, Columnist

Prescription opioid use for chronic pain does not usually lead to addiction or to the use of illicit opioids such as heroin. But media reports often say otherwise.

“Opioids can be so addictive that many people develop a desperate need for them even after the pain has subsided, or disappeared. So when they’re turned away by doctors and pharmacies, they look for a fix on the streets,” Fox News recently reported.

Public officials also confuse the issue.

“Most of our constituents with substance-use disorders began their path to addiction after forming dependencies to opioids prescribed as a result of an injury or other medical issue,’ Anne Arundel County Executive Steve Schuh wrote in a letter to Maryland doctors. ‘Their opioid dependence may have led to obtaining illegal street opioids like heroin, sometimes laced with fentanyl, after valid prescriptions ran out.’”

But this is not what usually happens.

“What the media has sometimes missed is that of those people who started with prescription opioids and then went on to use heroin, 75% never had a legal prescription for opioids. They were already stealing or buying the drugs illegally,” Judith Paice, PhD, RN, director of the Cancer Pain Program at Northwestern University told Medscape.

In other words, the reality of opioid therapy for chronic painful conditions is quite different from what media coverage and public officials claim.

In fact, the majority of chronic pain patients never even receive opioid medications. Recent estimates state that between 8 and 11 million chronic pain patients receive an opioid prescription at some point in a given year, with only some of them taking opioids for pain control on a daily basis.

Although that is a large number, it is dwarfed by the National Institutes of Health’s estimate that 25.3 million Americans live with daily chronic pain and nearly 40 million have severe pain. That  includes people in hospice and other end-of-life care, as well as people enduring cancer pain.

Moreover, many of the chronic pain patients who receive daily opioid therapy get there only after having failed many other treatment options, including non-opioid drugs and physical therapy. Opioids are rarely the first choice for treating persistent pain conditions, especially in the wake of opioid prescribing guidelines from the CDC, Department of Veterans Affairs, and some states.

Chronic pain patients are carefully screened, scrutinized, and monitored. They are subjected to risk assessment using the Opioid Risk Tool, required to take urine and saliva drug tests, told to show their prescription bottles and have their pills counted, and given pain contracts to sign. Their prescriptions are verified at pharmacies and tracked through prescription drug monitoring programs. Opioid misuse in any form is readily detected and is far from common.

Therefore, it is a myth that opioid addiction or other forms of opioid use disorder starts with a prescription. Instead, it almost always begins at a young age with the misuse of other drugs, such as tobacco, alcohol and marijuana. About 90% of drug addiction starts during adolescence.

And although most people who are addicted to heroin have previously used prescription opioids, the opposite is not true. Most people on opioid therapy do not become addicted to prescription opioids, and most of the people who do become addicted do not transition to heroin.

But the myth confuses and conflates chronic pain and opioid addiction. And this is having real-world consequences, both for people on opioid therapy for chronic pain and for people with opioid use disorder.

For people on opioid therapy, the problems include forced medication tapers or even termination of therapy. Pain management is an essential part of a variety of diseases and disorders, from the neuropathy of arachnoiditis and multiple sclerosis, to the visceral pain of interstitial cystitis and porphyria, to the musculoskeletal pain of Ehlers-Danlos syndrome. The choice and dose of medication should be a clinical decision made between patient and physician, not a blanket determination made by a guideline, regulation or committee.

Further, chronic pain is fast becoming undertreated or even untreated, which can have major health consequences. Forcing people to live without good pain management only creates more medical problems. 

For people suffering from opioid use disorder, the addiction myth embodies the idea that it is just accidental chemistry. But as Maia Szalavitz explains in her book Unbroken Brain, addiction has three key components: “The behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

The perpetuation of this myth has resulted in people not getting effective care, because the focus is on the substance instead of the sufferer.

“If we don’t invest in people and we focus on drugs, we end up creating another polarizing conversation about substances and people will continue to fall through the cracks,” Dr. Joseph Lee of the Hazelden-Betty Ford Foundation told the Minnesota Post.

The myth of the opioid-addicted chronic pain patient needs to be banished before it causes more people to fall through the cracks.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

6 Reasons Opioids Get More Attention Than Alcohol

By Janice Reynolds, Guest Columnist

Every day we hear how the “opioid crisis” is spiraling out of control.  Some even claim it is the worst health crisis to ever hit our country.  The response has largely been to restrict access to opioid pain medications and to sue the pharmaceutical companies that produce them.

But what is the real crisis? The elephant in the room that everyone conveniently ignores?

I believe opioids are being used to cover-up and distract from the real addiction crisis, which is alcohol abuse. 

Alcoholic beverages have been with us for thousands of years and are an important part of everyday life. Alcohol consumption has been increasing in the U.S. since the late 1990's and today about 57 percent of Americans drink alcohol at least once monthly, far more than consume opioids. Drinking to excess is usually frowned upon, but has long been treated as socially acceptable, even by the Puritans:

Drink is in itself a good creature of God, and to be received with thankfulness, but the abuse of drink is from Satan, the wine is from God, but the Drunkard is from the Devil.                                                                                                                                                        --  Increase Mather, Puritan clergyman in “Wo to Drunkards” (1673)

Alcohol is the fourth leading cause of preventable death in the in the United States. In 2015, over 30,000 Americans died directly from alcohol induced cases, such as alcohol poisoning and cirrhosis of the liver. 

There are another 88,000 deaths annually from alcohol related causes, including motor vehicle accidents, homicide, suicide, and incidents of poor judgement – such as going out in subzero weather and freezing to death, and infants dying after being left in hot cars by drunk fathers.

Many harms also occur that usually do not result in death, such as alcohol-related sexual assault or date rape, fetal alcohol syndrome, and fetal alcohol spectrum disorders. The World Health Organization reports that alcohol contributes to more than 200 diseases and injury-related health conditions, including alcohol dependence, cirrhosis, cancers, and injuries.

So why is alcohol ignored and the so-called opioid epidemic is hyped? Here are six reasons:

1) Many people drink alcohol. They may only drink “socially” and need a glass of wine or beer to relax, enjoy a sporting event or socialize at a party. Alcoholic beverages are an integral part of mealtime for many people.   

We also have functional alcoholics who are secret addicts.  As a nurse for over 20 years, it was not uncommon for me to have a patient begin to go through withdrawal after 48 hours in the hospital. Usually they deny drinking alcohol or admit to one drink a night. There is also denial by the medical profession about the dangers posed by alcohol, such as addiction specialists who differentiate between heavy drinkers and alcoholics.

Research frequently ignores alcohol entirely. A recent study looked at health conditions linked to Alzheimer’s disease and mentioned obesity, high blood pressure, diabetes and depression. Alcohol was not even considered, even though it has been shown in valid studies to damage brain cells.

2) Alcohol is BIG business.  Profits are immense and generate tax revenue.  Profits for breweries, distilleries and related businesses far outstrip what pharmaceutical companies make from opioids.  We see these monies going not only to shareholders, but government, lobbyists and advertising.

No one complains about a full-page newspaper ad for a brand of vodka, but a commercial during the Super Bowl for medication to treat opioid induced constipation sparks outrage. And no one bats an eye when a story about Maine liquor stores dropping the price of hard liquor is on the same front page with another article on the opioid crisis.

When have you ever seen a stadium named after an opioid or even a pharmaceutical company? Yet we have Coors Field in Denver, Busch Stadium in Saint Louis, and Miller Park in Milwaukee.

3) Problems need scapegoats. In this case we have two scapegoats: people in pain and opioids.  

Prejudices against people in pain have long existed: “It’s all in your head” or “the pain can’t be that bad” are all too familiar. It could also be simple bigotry towards someone different or a lack of compassion. We used to call pain management “an art and a science,” now it is optional and politically driven medicine.

Opiophobia has a long history as well; fear of addiction, fear of respiratory depression, belief that opioids don’t work, and that people in pain are drug seekers. The “opioid epidemic” has opened the gateway for uncontrollable and irrational bigots.

Nearly all the interventions to curb drug overdoses have been directed at people in pain, who are not responsible for the illegal use of opioids. If all prescription opioids disappeared tomorrow, it would have nil effect on the opioid crisis. Addicts would just turn to heroin and illegal fentanyl (if they haven’t already). There are a boatload of ways to get high.

4) McCarthyism: In the 1950’s, Senator Joseph McCarthy went hunting for communists and many lives were ruined. Today, the term “McCarthyism” defines a campaign or practice that uses unfair and reckless allegations, as well as guilt by association. 

Politicians, the media and many doctors are afraid to say anything not endorsing the “opioid epidemic” or supporting people in pain, because it will be held against them.

5) Fear-mongering:  The spread of frightening and exaggerated rumors of an impending danger that purposely and needlessly arouses public fear.

We can see this in the psychological manipulation that uses scare tactics, exaggeration and repetition to influence public attitudes about opioids. This is exactly what Andrew Kolodny and Physicians for Responsible Opioid Prescribing (PROP) are doing, along with formally reputable organizations such as the Food and Drug Administration and professional medical associations.

6) The alphabet soup: The CDC, DEA, and the bureau of Alcohol, Tobacco and Firearms (ATF) have all played a part in distracting us from alcohol abuse.  Although it is a drug, alcohol is not usually covered by the DEA, but is handled by the ATF, which mainly concerns itself with alcohol licensing and collecting alcohol taxes.

The DEA has been totally helpless to stop the influx of illegal opioids like heroin and illicit fentanyl, as well as thediversion of prescription medications. Their survival mechanism is to go after the legitimate use of opioids for pain.  They have become a terrorist organization that is driving providers out of pain management.

In order to cover-up the heavy cost of alcohol abuse, we have seen hysteria driven by politicians and the media. This has resulted in difficulty getting opioids prescribed for pain, skewered facts to support the “opioid epidemic,” the CDC’s opioid guidelines, and what I call the passive genocide of people in pain.

There are many different means by which genocide can be achieved and not all have to be active (murder or deportation). For our usage, genocide means “the promotion and execution of policies by a state or its agents which result in the deaths (real and figuratively) of a substantial portion of a group.” 

Our genocide is passive because it relies on the harmful effects of pain, suicide, withdrawal of treatment, excessive use of over-the-counter pain relievers, malpractice, and the total dismissal of the human rights of people with pain; as well as lies and falsehoods being held as truths to promote this genocide.

This is not to say that alcohol should be made illegal. Prohibition did not work because most people wanted alcohol and it lead to a huge criminal enterprise. It is to say prescription opioids should not be treated differently than other medications or alcohol.  And people in pain should not be used to further an agenda based on fallacious, unethical and immoral sensationalism. 

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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

Pain Patients Need to Stop Demonizing Addicts

By Crystal Lindell, Columnist

Ok. Wait. Before you read the headline and send me hate mail, I just want to remind you guys that I am a pain patient. Just like you. So take a breath and let me explain.

So yes, the pain patient community needs to stop demonizing “addicts.” I know. I know. They make a great enemy. I mean, if it wasn’t for all those opioid addicts out there, we’d all be able to get the medications we need. Am I right?

But just as pain is complicated, so is addiction and so are opioids.

I recently wrote a column about my first time getting a lidocaine infusion, and it included a throwaway line about how I was hoping the treatment will help me get off opioids because, “I don’t actually love being high all the time.”

Dang. People were not happy I said that.

Apparently, there is this idea out there that if you are taking opioids like hydrocodone for legitimate physical pain, then you don’t get high from the medications. And if you are getting a high from them, then you’re an addict. The end.

Unfortunately, that’s not exactly how opioids work. There is no magic pill (yet) that we can take that relieves physical pain without also impacting our brains.  

Part of the problem that people seem to have a very specific idea about what the word “high” means. There’s a common trop in pop culture that shows addicts in tattered clothes, lying in an alley with their eyes rolled back in their heads. But that is far from the full picture.

When I take a hydrocodone, even a very small dose of 2.5 mg, I get more relaxed, a little tired, and my reactions are delayed. That’s also a version of getting high. And pretty much everyone else on even a low dose of opioids is likely having the same reaction.

Personally, I have found that when the drugs don’t have that impact on you, it usually means your body is getting used to them, and it will be that much harder to quit taking them.

Look, I get it. The current mood of the country is that opioids are evil and must be stopped. And for people suffering from horrific chronic pain, losing what is often the only treatment that actually works is horrifying. It’s easy to just point to the people causing all the opioid hysteria (the addicts) and blame them. But it’s more complicated than that.

Because when a Ohio sheriff refuses to carry the opioid overdose medication Narcan, it doesn’t just hurt addicts. It hurts pain patients who may accidentally overdose too.

And when addicts start out taking these drugs because of physical pain, what right do we have to attack them? We started taking them for the exact same reason.

I know that many pain patients find great comfort in separating the idea of addiction and physical dependence, but I have to tell you something that I learned when I took myself off morphine — the two aren’t actually all that different.

When you are on 60 mg of opioids a day for years at a time like I was and then stop taking them, your body doesn’t care why you started in the first place. And even if you can get through the first week of hellish withdrawal with horrible flu symptoms, panic attacks, insomnia and diarrhea, your brain could still crave the drug for as long as two years. It got used to having opioids, and has to rewire itself to function without it.

Pain patients often take opioids hoping it will alleviate their symptoms and make them feel normal again. But guess what? Addicts take them for the same reason. At a certain point, they need the drugs just to feel normal because their brain doesn’t work right without them anymore.

And, while pain patients start taking opioids for physical pain, many addicts usually started taking them to relieve pain as well — it’s just that their pain is emotional. But anyone who has ever suffered through a truly tragic loss or heartbreak can tell you that emotional pain can be just as awful as any physical pain. We all just want to feel better.

What Can We Do?

I truly believe that the government should not be involved in our health care decisions and I’m against many of the new regulations that try to limit what doctors can prescribe. Whether or not you should take opioids is a decision that should be made solely between you and your doctor. And I know that the reason many people take opioids is because there are no other effective treatment options available.

However, pretending that pain patients somehow have a different response to these medications than anyone else is naïve. And the sooner we recognize how intense the drugs are, the sooner we can actually start looking at realistic ways to help pain patients as well as addicts.

So how can we move forward? Well, legalizing marijuana everywhere would be a good first step, but even that won’t help everyone. We also need more research into pain treatments that actually work as realistic alternatives to opioids. We also must approach addiction with the same compassion we usually reserve for physical health problems. Addiction is a mental health issue, and the key word there is health.

We need to take a hard look at how we treat addiction, and move into longer-term models that help people for years and include professional psychiatric help. Pretending someone can get over opioid withdrawal by solely going to Narcotic Anonymous meetings is like pretending someone can get over cancer by solely going to weekly support group meetings.

We also need to treat underlying mental health issues like the serious health problems they are, because when people get their clinical anxiety and depression treated correctly, they are less likely to try to self-medicate with drugs like opioids.

Perhaps the best thing pain patients can do is join the same team as the addicts we love to hate. Because if fewer people were abusing opioids, then maybe the government would stop trying to take them away from pain patients.

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.

PROP Founder Calls for Forced Opioid Tapering

By Pat Anson, Editor

Have you or a loved one been harmed by being tapered off high doses of opioid pain medication?

The founder of an anti-opioid activist group wants to know – or at least he posed the question during a debate about opioid tapering with colleagues on Twitter this week.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses.  Where exactly is this done in a risky way?” wrote Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP). 

“I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

It’s not an idle question. About 10 million Americans take opioid medication daily for chronic pain, and many are being weaned or tapered to lower doses -- some willingly, some not -- because of fears that high doses can lead to addiction and overdose.

Kolodny’s Twitter posts were triggered by recent research published in the Annals of Internal Medicine that evaluated 67 studies on the safety and effectiveness of opioid tapering. Most of those studies were considered very poor quality.

“Although confidence is limited by the very low quality of evidence overall, findings from this systematic review suggest that pain, function, and quality of life may improve during and after opioid dose reduction,” wrote co-author Erin Krebs, MD, of the Minneapolis Veterans Affairs Health Care System. 

Krebs was an original member of the “Core Expert Group” – an advisory panel that secretly helped draft the CDC opioid prescribing guidelines with a good deal of input from PROP. She also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Curiously, while Krebs and her colleagues were willing to accept poor quality evidence about the benefits of tapering, they were not as eager to accept poor evidence of the risks associated with tapering. 

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

But the risk of suicide is not be taken lightly, as we learned in the case of Bryan Spece, a 54-year old chronic pain sufferer who shot himself to death a few weeks after his high oxycodone dose was abruptly reduced by 70 percent.  Hundreds of other pain sufferers at the Montana clinic where Spece was a patient have also seen their doses cut or stopped entirely.

Spece’s suicide was not an isolated incident, as we are often reminded by PNN readers.

“A 38 year old young lady here took a gun and put a bullet in her head after being abruptly cut off of her pain medication,” Helen wrote to us. “Her whole life ahead of her. This is happening every day, it just isn't being reported.”

“I too recently lost a friend who took his own life due to the fact that he was in constant pain and the clinic he was going to cut him off completely,” said Tony.

“I have been made to detox on my own as doctors who were not comfortable giving out these meds would take me off, not wean me,” wrote Brian. “Was a nightmare. Thought I was gonna die. No, I wanted to die.”

“In the end when you realize that you’re not going to get help and that you have nothing left, suicide is all you have,” wrote Justin, who is disabled by pain and no longer able to work or pay his bills after being taken off opioids. “I don't want to hurt my family. I don't want to die. However it is the only way out now. I just hope my family and the good Lord can forgive me.”

Patient advocates like Terri Lewis, PhD, say it is reckless to abruptly taper anyone off high doses of opioids or to aim for artificial goals such as a particular dose. She says every patient is different.

“There is plenty of evidence that persons treated with opiates have variable responses - some achieve no benefit at all.  Some require very little, others require larger doses to achieve the same benefit,” Lewis wrote in an email to PNN.

“It is an over-generalization to claim that opiates are lousy drugs for chronic pain. Chronic pain is generated from more than 200 medical conditions, each of which generate differing patterns of illness and pain generation. For some, it may be reflective of its own unique disease process. We have to retain the ability to treat the person, not the label, not to the dose.”

Patient ‘Buy-in’ Important for Successful Tapering

And what about Kolodny’s contention that high opioid doses should be reduced even if a patient refuses? Not a good idea, according to a top CDC official, who says patient “buy-in” and collaboration is important if tapering is to be successful.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial in the Annals of Internal Medicine.  “Clinicians have a responsibility to carefully manage opioid therapy and not abandon patients in chronic pain. Obtaining patient buy-in before tapering is a critical and not insurmountable task.”

The CDC guideline also stresses that tapering should be done slowly and with patient input.

“For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline states. “Experts noted that patients tapering opioids after taking them for years might require very slow opioid tapers as well as pauses in the taper to allow gradual accommodation to lower opioid dosages.”

The CDC recommends a "go slow" approach and individualized treatment when patients are tapered.  A "reasonable starting point" would be 10% of the original dose per week, according to the CDC, and patients who have been on opioids for a long time should have even slower tapers of 10% a month.

The Department of Veterans Affairs takes a more aggressive approach to tapering, recommending tapers of 5% to 20% every four weeks, although in some high dose cases the VA says an initial rapid taper of 20% to 50% a day is needed. If a veteran resists tapering, VA doctors are advised to request mental health support and consider the possibility that the patient has an opioid use disorder.

Have you been tapered at a level faster than what the CDC and VA recommend? Let us know by leaving a comment below.

If you think you were tapered in a risky way, you can let Dr. Kolodny know at his Twitter address: @andrewkolodny.

Safeway Fined $3 Million for Painkiller Thefts

By Pat Anson, Editor

Safeway has agreed to pay a $3 million fine to settle allegations that it failed to timely report the theft of tens of thousands of hydrocodone tablets from pharmacies in Alaska and Washington state. The company also agreed to a compliance agreement with the Drug Enforcement Administration to ensure such lapses do not happen again.

The DEA learned of the hydrocodone thefts at Safeway pharmacies in North Bend, Washington and Wasilla, Alaska in April 2014, months after Safeway discovered the pills were stolen by employees. Under federal law, pharmacies are required to notify the DEA of the theft or significant loss of any controlled substance within one business day of the discovery of the theft or loss.

A DEA investigation of the case was later widened to review practices at all Safeway pharmacies nationwide between 2009 and 2014.  The investigation revealed a “widespread practice” of Safeway pharmacies failing to timely report missing or stolen controlled substances. 

“At this crucial juncture in our efforts to combat abuses of prescription drugs, it is imperative that pharmacies notify DEA immediately when drugs are stolen or missing.  A quick response to such reports is one of the best tools DEA has in stopping prescription drug diversion,” said DEA Special Agent in Charge Keith Weis.

As part of the settlement, Safeway will close a pharmacy in Belmont, CA and will suspend filling prescriptions for controlled substances for four months at a pharmacy in North Bend, WA.

“Safeway cooperated fully with government investigators throughout the investigation and remains an active partner with the DEA, local law enforcement and the communities it serves in the fight against prescription drug abuse, including the abuse of opioids,” the company said in a statement.  “Since early 2015, the Company has significantly enhanced its controlled substance monitoring program and implemented a variety of improved policies and procedures to enforce compliance with the Controlled Substances Act.”

Safeway is the latest in a string of pharmacy operators that have been fined for failing to comply with the Controlled Substances Act.

Last week CVS Health Corp agreed pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone. In January, Costco paid nearly $12 million to settle allegations that its pharmacies filled invalid prescriptions and failed to maintain accurate records at two central fill locations in Sacramento, California and Everett, Washington.

“We call on all participants in drug distribution to carefully monitor their practices to stem the flow of narcotics to those who should not have them,” said U.S. Attorney Annette L. Hayes.  “Pharmacies have a key role to play in making sure only those with legitimate prescriptions receive these powerful and potentially addictive drugs, including by timely reporting losses of those drugs.  Failure to do so hamstrings DEA’s investigative abilities and frustrates some of our best methods at curbing abuse.” 

New Opioid Painkiller Has Less Abuse Potential

By Pat Anson, Editor

A new opioid medication being developed by Nektar Therapeutics for the treatment of moderate to severe chronic pain has significantly less abuse potential than oxycodone -- even at high doses – according to the results of a new clinical study.

The investigational oral drug – known as NKTR-181 -- is the first analgesic opioid designed to reduce side effects such as euphoria, which can lead to abuse and addiction.

In a small study involving 54 recreational drug users, NKTR-181 had significantly less “drug liking” than oxycodone in the first hours of use. The dosage given to the study participants ranged from a maximum therapeutic dose of 400mg of NKTR-181 to a “supratherapeutic” dose that was 3 to 12 times higher than common doses of oxycodone.

"It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.  Further, and critically important in the context of this public health emergency, NKTR-181's less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation,” said Ivan Gergel, MD, Senior Vice President and Chief Medical Officer of Nektar. 

“Many patients do not receive adequate pain relief because they fear taking conventional opioids, including abuse-deterrent formulations, because of their potential for abuse and addiction.  We believe NKTR-181 is a transformational pain medicine that should significantly advance the treatment of chronic pain and could be a fundamental building block in the fight against prescription opioid abuse.”

nektar therapeutics

In March, NKTR-181 received “fast track” designation from the Food and Drug Administration -- a status that allows for an expedited review of the drug – after Nektar reported positive results from a Phase 3 study of over 600 patients with chronic back pain.  Pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain – thus reducing the “high” or euphoric effect. Many pain sufferers say they do not get high or experience euphoria from opioid medication, but drug makers and regulators are working to develop painkillers with less risk of abuse and addiction.  

"Getting very high, very fast, is a mark of conventional high-risk, abused opioids," said Jack Henningfield, PhD, vice president at Pinney Associates and adjunct professor at The Johns Hopkins University School of Medicine. "NKTR-181 represents a meaningful advance in the treatment of pain as the first opioid analgesic with inherent brain-entry kinetics that avoids this addictive quality of traditional opioids. This prevents the rapid 'rush' that abusers seek during the critical period immediately after dosing. Importantly, these properties of NKTR-181 are inherent to its molecular structure and are not changed through tampering or route of administration." 

Because NKTR-181 produces less euphoria, Nektar believes it should be scheduled as a Class III or Class IV controlled substance, a less restrictive schedule than Class II medications, a category that includes oxycodone, hydrocodone and many other opioids.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.