CDC: Still Not Enough Naloxone   

By Pat Anson, PNN Editor

The Trump Administration is stepping up efforts to increase prescribing of naloxone, an overdose recovery drug credited with saving thousands of lives.

Although naloxone prescriptions have increased dramatically, a new CDC Vital Signs report estimates that nearly 9 million additional prescriptions could have been dispensed last year if every patient with a high-dose opioid prescription was offered naloxone.  Patients are considered “high risk” if they take an opioid dose of 50 morphine milligram equivalent (MME) or more per day.

Naloxone has been used for years by first responders and emergency medical providers to revive overdose victims. Current efforts are focused on expanding access to the drug by prescribing it directly to patients considered at risk of an overdose.

In 2018, CDC researchers say only one naloxone prescription was dispensed for every 70 high-dose opioid prescriptions nationwide. Naloxone “under-prescribing” was even more acute in rural counties, which are nearly three times more likely to be ranked low in naloxone dispensing than metropolitan counties.

Naloxone2.jpg

“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths. The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention,” CDC Director Robert Redfield, MD, said in a statement.

Ironically, federal policies contribute to the under-prescribing. In 2018, most (71%) Medicare prescriptions for naloxone required a copay, compared to 42% for commercial insurance.

In January, the Food and Drug Administration encouraged drug makers to make naloxone available over-the-counter without a prescription. The FDA even developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135. Seven months later, the FDA could not confirm to PNN that any company had submitted an application for an OTC version of naloxone.

Last year the Department of Health and Human Services released guidance urging doctors to “strongly consider” prescribing naloxone to patients on any dose of opioids when they also have respiratory conditions or obstructive sleep apnea, are co-prescribed benzodiazepines, have a mental health or substance abuse disorder, or a history of illegal drug use or prescription opioid misuse.

Many states are also taking steps to increase naloxone prescribing. California now requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an overdose. State law does not make the prescriptions mandatory, yet some patients say they were “blackmailed” by pharmacists who refused to fill their opioid scripts unless naloxone was also purchased. Patients around the country report similar experiences.   

Unintended Consequences

The drumbeat for naloxone comes at a time when sales are already booming. There were 556,000 naloxone prescriptions in 2018, twice as many as in 2017.

There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the overdose crisis and may in fact be making it worse. In a recent study published by SSRN, two economics professors warned of “unintended consequences” if naloxone becomes more widely available.

“We expect these unintended consequences to occur through two channels. First, the reduced risk of death makes opioid abuse more appealing, leading some to increase their opioid use — or use more potent forms of the drug — when they have naloxone as a safety net. Some of those abusers may become criminally active to fund their increased drug use,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Furthermore, expanding naloxone access might not in fact reduce mortality. Though the risk of death per opioid use falls, an increase in the number or potency of uses means the expected effect on mortality is ambiguous.”

The researchers said there were anecdotal reports of “naloxone parties” where attendees used heroin and prescription opioids to get high knowing they could be revived. News reports have also quoted first responders who are frustrated that the same opioid abusers “are saved again and again by naloxone without getting treatment.”

Researchers Call Kratom a Public Health Threat

By Pat Anson, PNN Editor

The herb kratom poses a public health threat and should not be sold as a dietary supplement, according to a team of researchers who say kratom should be regulated like a prescription drug because it has “opioid-like” qualities.

"Although it is not as strong as some other prescription opioids, kratom does still act as an opioid in the body," said William Eggleston, PharmD, a professor of pharmacy practice at Binghamton University in New York. "In larger doses, it can cause slowed breathing and sedation, meaning that patients can develop the same toxicity they would if using another opioid product.

“Our findings suggest kratom is not reasonably expected to be safe and poses a public health threat due to its availability as an herbal supplement.”

Eggleston is lead author of a recent study published in the journal Pharmacotherapy that looked at the growing number of calls about kratom to U.S. Poison Control Centers. In recent years, millions of Americans have discovered kratom and use it to self-treat chronic pain, addiction, anxiety and depression.

Eggleston and his colleagues identified 2,312 kratom exposures in the National Poison Data System (NPDS) from 2011 to 2018, with 935 cases involving kratom as the only substance.

The chief complaint for many of the calls was that kratom caused agitation, tachycardia (rapid heartbeat), drowsiness, vomiting and confusion. Infrequent but serious side effects included seizure, withdrawal, hallucinations, respiratory depression, coma, and cardiac or respiratory arrest.

KRATOM CALLS TO U.S. POISON CONTROL CENTERS

SOURCE: AMERICAN ASSOCIATION OF POISON CONTROL CENTERS

‘Significant Toxicity’

“Despite kratom’s growing popularity as a safe and natural self-treatment option for patients with OUD, our findings suggest there are concerns for significant toxicity. Reports of kratom exposures to the NPDS are rising and have already been associated with serious opioid toxicities, including seizures, agitation, and death,” researchers reported.

“According to the United States Dietary Supplement Health and Education Act of 1994, herbal and dietary supplements must contain ingredients that are reasonably expected to be safe. Our findings repudiate the idea that kratom meets this criterion. Kratom’s opioid effects put patients at risk for withdrawal, respiratory depression, and death.”

But critics say calls to poison centers are anecdotal, misleading and a poor choice for research.

“The data drawn from the Poison Control Centers are notoriously unreliable, inasmuch as they are anecdotal reports from the public that are gathered and reported in an unscientific fashion,” said Max Karlin, a spokesman for the Kratom Information & Resource Center. “In the absence of good data, you just end up with a garbage-in, garbage-out situation.”

“All the Eggelston paper shows is that the anti-kratom bias is deeply entrenched in conventional medical, pharmacological and government sectors,” said Jane Babin, PhD, a molecular biologist, patent lawyer and consultant to the American Kratom Association (AKA). “It seems to be more of the same unscientific attack on kratom. I don’t see anything in this that warrants their conclusion.

“AKA now estimates that there are 16 million kratom users in the U.S. based on data from Indonesia on how much kratom is exported to the U.S. annually. 2,312 exposures out of 16 million users is a pretty low percentage of users who have anything to report to poison control.”

The 2,312 calls about kratom over an 8-year period pale in comparison to calls about other substances. In the first six months of this year alone, over 13,400 calls were made to U.S. poison centers about children ingesting hand sanitizers or laundry detergent packets.

Kratom Scheduling

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. As a dietary supplement, kratom is loosely regulated in the United States, although federal agencies are engaged in a protracted public campaign against its use.

bigstock-Supplement-Kratom-Green-Capsul-227871193.jpg

The FDA says kratom is addictive, has opioid-like qualities and is not approved for any medical condition. The agency has also released studies showing salmonella bacteria and heavy metals contaminating a relatively small number of kratom products. 

The CDC recently linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The Department of Health and Human Services (HHS) has recommended to the DEA that kratom be classified as a Schedule I controlled substance – alongside heroin and marijuana — which would effectively ban it nationwide.

“At some level, we do need to have better control over it,” says study co-author Lewis Nelson, MD, a Professor of Emergency Medicine at Rutgers New Jersey Medical School. “We know that (kratom) has two big uses out there. One of them is for people to get high and the other one is to treat opioid withdrawal. Those are the real reasons people use it.

“Whether its an opioid or not an opioid, people use it do things that they would typically do with opioids, like pain, get high, and treat withdrawal. I think empirically we know it has enough of an opioid-like character that it’s being marketed and used that way.”

Lewis said kratom should be scheduled as a controlled substance, but not under Schedule I. He thinks it may be more appropriate to classify kratom as a Schedule II or III drug, where it could still be available by prescription.

“I would like to see that. If they could show this drug has benefits and we could understand and moderate the risk, I don’t see why it couldn’t be used like any other drug,” said Lewis, who is a longtime critic of opioid prescribing.

Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.
— Dr. Lewis Nelson

“Prove it works. Let’s create a safe product and let’s get it appropriately scheduled. Have it available by prescription. I don’t have a problem with that.”

But getting kratom approved by the FDA as a prescription drug would require years of clinical studies. Pharmaceutical companies may be reluctant to fund research on a natural substance that they may not be able to patent. And kratom users, long accustomed to buying it online or in smoke shops, dislike the idea of needing a doctor’s prescription.

In a 2016 PNN survey of over 6,400 kratom users, nearly 98 percent said they wanted kratom to remain available as a dietary supplement.  Over 70 percent said pharmaceutical companies should not be allowed to produce kratom-based drugs.  And nearly three out of four dispute the notion that it’s possible to get high from kratom.  

Lewis remains skeptical that people are not using kratom recreationally and that it should remain on the market as a dietary supplement.  

“I find it a little disingenuous to say we should leave this potentially unsafe drug on the market unregulated, just because some people already use it,” he told PNN.

5 Million U.S. Cancer Survivors Live with Chronic Pain

By Pat Anson, PNN Editor

Over five million cancer survivors in the United States live with chronic pain, a fast-growing population that is expected to double by 2040 due to the aging of the population, early cancer detection and advances in treatment, according to a new study by the American Cancer Society.

Chronic pain is one of the most common side effects of chemotherapy and other forms of cancer treatment, but until now there has been little information on its prevalence among cancer survivors.

Researchers looked at data from the National Health Interview Survey from 2016-2017 and found that about a third of cancer survivors (34.6%) have chronic pain. About one in six (16.1%) have “high impact” chronic pain (HICP) – defined as pain that limits life or work activities on most days.

Based on that survey data, researchers estimate the total number of cancers survivors in the U.S. at 15.5 million. About 5.39 million of them have chronic pain and 2.51 million have high impact chronic pain.

“We found the prevalence of chronic pain and HICP among cancer survivors to be almost double that in the general U.S. population. Chronic pain and HICP were more prevalent in survivors who were unemployed and who had low socioeconomic status, inadequate insurance, and had some specific types of cancer,” researchers reported in JAMA Oncology.

“The patterns of chronic pain that we observed in cancer survivors may be explained by barriers to cancer care and pain management as well as by the type and extent of cancer treatment received.”

One barrier to pain management stems from efforts to rein in opioid prescribing to prevent abuse and addiction. While the 2016 CDC opioid guideline is intended for “noncancer” patients, it is also applies to patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”

bigstock-Too-Many-Pills-272768.jpg

Two experts in oncology and palliative care at the University of Pennsylvania say the CDC’s inclusion of cancer survivors was a mistake because it is not uncommon for cancer pain to persist long after a cancer is treated.  

“Unfortunately, this arbitrary distinction is not consistent with the evidence of pain trajectory in cancer survivors,” Neha Vapiwala, MD, and Salimah Meghani, PhD, wrote in an op/ed also published in JAMA Oncology. “Similar levels of pain were reported in survivors who were still receiving cancer treatment and those who had completed active cancer treatment.”

It’s not uncommon for cancer patients undergoing active treatment to be denied pain medication. Many doctors are reluctant to prescribe opioids, regardless of the diagnosis.

“My cancer doctor will no longer prescribe pain meds for me because I now see a pain doctor. The pain doctor doesn't understand the new cancer drug I'm on and that the side effects of this drug are pain, so he is very reluctant to manage my cancer pain,” a patient with lymphoma told us. “Many days I wonder if it would just be better to let the cancer take its course than to be scrutinized and treated like a criminal.”

April Doyle is being treated for Stage 4 terminal breast cancer, but a Rite Aid pharmacist refused to fill her prescription for Norco because he was worried about being fined or even losing his job. April’s video about the experience went viral.

“I have to take 20 pills a day just to stay alive,” she explains in the video. “Every time I take my pain pill prescription there, they give me the runaround. They don’t have enough in stock or they need me to come back tomorrow because they can’t fill it today. Or something stupid. It’s always something and it’s always some stupid excuse.”

The American Cancer Society study found that chronic pain was most common among cancer survivors treated for bone, kidney, throat-pharynx and uterine cancers.  About half still had pain after their cancer treatment ended.

AMA Opposed to ‘Blacklisting’ of Doctors Over Rx Opioids

By Pat Anson, PNN Editor

The American Medical Association is hardening its opposition to public and private policies that seek to limit opioid prescribing. The AMA House of Delegates this week passed resolutions calling for prescribing guidelines to be amended to allow physicians to use their own clinical judgement to decide if higher doses of opioids are medically necessary. The AMA’s ruling body also called for an end to the “blacklisting” of doctors who prescribe high doses.

The AMA didn’t always feel this way about guidelines. When the CDC released its controversial opioid guideline in 2016, the AMA sent a letter to CDC Director Thomas Frieden that “applauded the CDC for treating the epidemic of opioid overdose deaths as a high priority.” And Patrice Harris, MD, a psychiatrist who chaired an AMA Task Force to Reduce Opioid Abuse, said the AMA was “largely supportive of the guidelines.”

Harris, who recently became the AMA President, now says the guidelines “have no basis in science.”

“Physicians can’t be expected to fight the epidemic with one hand tied behind their back, handicapped by policies that limit choices for patients and have no basis in science,” Harris said in a statement.

bigstock-Find-doctor-icon-80963057(1).jpg

The AMA House of Delegates finally took a stand against the CDC guideline last November, when it passed resolutions opposing the “misapplication” of the guideline by pharmacists, insurers, pharmacy benefit managers, states and regulatory agencies.  

Although the 2016 guideline is voluntary, it has resulted in many patients being forcibly tapered to lower doses, cutoff entirely or even abandoned by their doctors – all under the guise of preventing opioid addiction and overdoses.

This week’s resolutions by the AMA’s ruling body went a step further, calling for an end to the “inappropriate use” of the CDC guideline to set dosing limits and blacklist physicians who exceed them.  

RESOLVED that our AMA support balanced opioid sparing policies that are not based on hard thresholds, but on patient individuality, and help ensure safe prescribing practices, minimize workflow disruptions, and ensure patients have access to their medications in a timely manner, without additional, cumbersome documentation requirements.

RESOLVED that our AMA oppose the use of “high prescriber” lists used by national pharmacy chains, pharmacy benefit manager companies or health insurance companies when those lists do not provide due process and are used to blacklist physicians from writing prescriptions for controlled substances and preventing patients from having their prescriptions filled at their pharmacy of choice.

RESOLVED that our AMA incorporate into their advocacy that clinical practice guidelines specific to cancer treatment, palliative care, and end-of-life be utilized in lieu of CDC’s Guideline for Prescribing Opioids for Chronic Pain as per CDC’s clarifying recommendation.

The CDC’s so-called clarification came in a commentary published April 24 in The New England Journal of Medicine. Three authors of the guideline did not take any responsibility for the poor implementation of their recommendations, but acknowledged that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations.”

Nearly two months later, not a single word of the CDC guideline has been clarified or changed, and insurers, pharmacies and many states continue to enforce its voluntary recommendations as mandatory policy.

Doctors who prescribe high doses of controlled substances are also being blacklisted by the DEA and state medical boards, which routinely use prescription drug monitoring programs (PDMPs) to identify and target physicians who are considered “high prescribers.”

Federal prosecutors have also sent letters to hundreds of physicians warning them that their opioid prescribing practices could subject them to criminal prosecution — often without any evidence that their patients were harmed by the drugs.

Misleading CDC Study Links Prescription Opioids to Binge Drinking 

By Pat Anson, PNN Editor

A new study by the Centers for Disease Control and Prevention has found that over half of people who misuse prescription opioids also binge drink, increasing their risk of dying from an overdose.

“We are losing far too many Americans each day from overdoses,” CDC Director Robert Redfield, MD, said in a statement. “Combining alcohol and opioids can significantly increase the risk of overdoses and deaths.”

Binge drinking and misuse of opioid medication are never a good idea, whether done separately or in combination. Unfortunately, the CDC study is written in ways that mislead and further worsen the stigma associated with prescription opioid use. And it fails to acknowledge the role CDC itself has played in the growing use of alcohol for pain relief.

The study, published in the American Journal of Preventive Medicine, is based on survey of over 160,000 people who participated in the National Survey on Drug Use and Health from 2012 to 2014. After analyzing their answers, CDC researchers came to some sweeping conclusions about Americans getting high on pills and alcohol.

“Prescription opioids were responsible for approximately 17,000 deaths in the U.S. in 2016. One in five prescription opioid deaths also involve alcohol,” wrote lead author Marissa Ether, PhD, CDC Division of Population Health.

“More than half of the 4.2 million people who misused prescription opioids during 20122014 were binge drinkers, and binge drinkers had nearly twice the odds of misusing prescription opioids, compared with nondrinkers.”

alcohol-428392_640.jpg

The statement that prescription opioids “were responsible” for 17,000 deaths is misleading because it is based on data from death certificates and coroner reports that only indicate the medications were present or “involved” in overdoses. Other substances may have played a role or perhaps even caused those 17,000 deaths.

In 2016, over twice as many fatal overdoses involved heroin and illicit fentanyl, but CDC researchers “did not consider the use of illicit opioids” for their binge drinking study. Apparently, street drug users are teetotalers who do not drink.

And who were the binge drinkers who misused prescription opioids? They were recreational users of opioid medication who did not take the drugs for pain relief. “Misuse” in the study was defined as “use without a prescription or use only for the experience or feeling it causes.”

To be clear, pain patients with legitimate opioid prescriptions that are used appropriately were not included in the study. These patients are actually less likely to be binge drinkers — defined as four or more drinks by a woman, or five or more drinks by a man — and they are warned repeatedly not to mix their medications with alcohol. Including them would have significantly changed the study findings.

Patients Using Alcohol for Pain Relief

Perhaps the biggest oversight by CDC researchers is the 2012-2014 time frame chosen for their study – which is well before the agency released its controversial 2016 opioid prescribing guideline.

One of the key findings from a recent PNN survey of nearly 6,000 patients is that the guideline has limited their access to prescription opioids so severely that some are turning to alcohol for pain relief. Nearly one out of five patients surveyed said they had used alcohol for pain relief since the guideline came out.

“It has caused many pain patients to be cut off their pain medication,” one patient told us. “After losing my meds 16 months ago, I just started using alcohol and I never used alcohol. I don't like alcohol, but what are my options?” 

“Since my doctor stopped prescribing even my small amount of opioids I deal with days where I can’t even get out of bed because I hurt so much and I’m stuck turning to alcohol, excessive amounts of acetaminophen and NSAIDs,” another patient said. 

“The CDC guidelines are killing people,” one woman wrote. “My fiancé has been refused even the most mild stenosis treatment because he admitted using alcohol to treat his pain when he has no other treatment. He's mildly suicidal as well. We have two young kids.” 

“I lost a good friend to suicide because she was not able to get pain medications to relieve her pain and it was too much for her to handle,” a patient said. “Sadly, she is not the only one. I'm hearing about more and more. I'm also hearing about people turning towards alcohol.” 

“All they are doing is pushing chronic pain patients to find relief in other ways such as alcohol, illicit drugs or harming themselves to get the pain relief they do desperately seek,” wrote another patient. 

In other words, alcohol use is acceptable to the CDC — as long as it is not combined with prescribed opioid medication. This is your nation’s health protection agency at work.

Fibromyalgia Stole My Life, Kratom Gave It Back

By Mary Ann Dunkel, Guest Columnist

Fibromyalgia stole my life more than 28 years ago. I have severe chronic pain and fatigue that limits my activities of daily living. Unless you have experienced unrelenting severe pain 24 hours a day, you cannot know the horror of it.

I have been prescribed more pharmaceuticals than I can remember and suffered damaging side effects from them. I've participated in psychotherapy, aqua therapy, multiple pain management programs, acupuncture and hypnosis. None of these modalities brought me relief and for quite some time I was bedridden and dependent on family for care.

My doctors have prescribed me morphine, fentanyl, oxycodone, tramadol and other medications to control the pain. None of them worked for very long and I could see these prescriptions were going to lead to addiction. Often, I weaned myself off them and suffered through terrible withdrawal because the small amount of relief they gave was not worth the risk of addiction or overdose death. Bottom line is these narcotics were not effective in treating my chronic pain.

There were times when I thought about taking my life because I just couldn't get a break from the pain and didn't think I could take it any longer.

Then a friend introduced me to kratom. She had been consuming it for more than 10 years without side effects or becoming addicted to it. I started my own journey consuming kratom.

Kratom is not a drug. It is a dietary supplement. It does not heal any disease, but it has certainly improved my quality of life. I am having pain free days and my energy level is greatly improved. Kratom has restored my ability to have a normal life and I can enjoy all sorts of activities that make my life rich and full.

Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics. And I am devastated that the FDA is working to ban the only thing that has helped me in the past 28 years.

MARY ANN DUNKEL

MARY ANN DUNKEL

I am sick to death of reporters parroting the lies from the FDA and CDC. I implore you. The studies they have done are full of inaccuracies and half-truths. Independent studies of the autopsies in the so called kratom deaths have shown the victims had multiple medications in their systems. They also included a death caused by gunshot.

Eight leading scientists have studied kratom and found it to be safe. It has been used for hundreds of years without problem. It is not an opioid; it is related to the coffee plant. It does attach to the same receptors in the brain as opioids, but so do many other substances such as chocolate and milk.

I would suggest to you that the FDA wants it banned because it is cutting into Big Pharma's financial bottom line. People are finding the help they need without costly and deadly pharmaceuticals. I fear that if kratom is banned this country will see an epidemic of self-inflicted deaths by people who have no hope. Kratom would become a black market substance due to overreach by the government to protect the monies they get from pharmaceutical lobbies.

Please investigate these facts and do the right thing. Do a story on the positives of kratom.

bigstock-Tell-Us-Your-Story-card-with-c-78557009.jpg

Do you have a story you want to share on PNN? Send it 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.

Forced Opioid Tapering: ‘The Next Great Experiment’

By Pat Anson, PNN Editor

Last month the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication. The agency said it had received reports of “serious harm” to patients who’ve been suddenly cutoff, including withdrawal symptoms, uncontrolled pain, psychological distress and suicide.  

A new study published in the Journal of Substance Abuse Treatment shows just how common the practice is. And how millions of pain patients are being subjected to a public health experiment with hardly anyone keeping track of what happens to them.

“The United States went through a great ‘experiment’ of expanding treatment of pain with opioids which has proved to be disastrous for public health. We have entered the next great ‘experiment’ of discontinuing opioid medications among the millions of Americans who are currently taking them,” said lead author Tami Mark, PhD, senior director of behavioral health at RTI International, a non-profit research institute.

“Little is known about how many individuals are tapering off opioid medications, whether observed tapering follows any… guidelines, and the extent to which rapid tapering is associated with negative consequences.”

Mark and her colleagues looked at medical and pharmacy claims for nearly 500 Medicaid patients in Vermont who had high doses of opioid medication discontinued from 2013 to 2017.

All of the patients were prescribed a daily dose of at least 120 MME (morphine milligram equivalent) and over half had been on that high dose for over a year. 

Although most clinical guidelines recommend a “go slow” approach to opioid tapering – especially for patients on high doses – only 5 percent of the Vermont patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering.

bigstock-Young-Blond-Woman-With-Medicin-12068330.jpg

The Centers for Disease Control and Prevention recommends that patients on opioids be tapered only 10% a week, with even slower tapers of 10% a month for long-term users. Had those guidelines been applied in Vermont, most tapers would have taken up to a year to complete.

Half of Tapered Patients Hospitalized

What happened to the patients who were cut off? Nearly half were hospitalized or had an emergency room visit for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure. For tapered patients, the risk of being hospitalized was reduced by 7% for each additional week of tapering.

Researchers don’t know how many of the discontinued patients committed suicide or how many were referred to addiction treatment. Notably, less than one percent received medication assistance treatment (MAT) such as Suboxone.

The study did not look at why patients were taken off opioids or who initiated the discontinuation. But researchers believe some of the rapid discontinuations “may be due to a breakdown in the clinical relationship between physicians and patients” – suggesting the patients were forcibly tapered or abandoned by their doctors.

In its warning to doctors, the FDA strongly recommends that patients not be forcibly tapered and that patients and doctors should jointly agree to a tapering plan.

“Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients,” the FDA said.

Forced Tapering Widespread

How many patients have been forcibly tapered or discontinued is unclear, but it probably runs in the millions. A recent report from IQVIA found that there were 75 million fewer opioid prescriptions filled last year compared to 2014, with the biggest decline in high dose prescriptions. 

In PNN’s recent survey of nearly 6,000 pain patients, over 80 percent said they had been taken off opioids or had their dose reduced since the CDC released its controversial opioid guideline in 2016. Many were turning to other substances – both legal and illegal – for pain relief. And nearly half said they had considered suicide because their pain is poorly treated.

“I have been forced to taper to 90 MME. I had been stable and functional for 10 years at 135 MME. Now I can no longer work, and can barely take care of my children. I am considering suicide because my pain is unbearable,” one patient told us.

“I have been forcibly tapered by more than half and my pain is not being relieved at this dose. I am now unable to work or care for my children,” another patient wrote. “I live in constant anxiety (which worsens my pain) that I will be abandoned, refused any pain management, or reduced to a dose so low that taking my own life is the only way to escape the pain.”

“My forced taper was a little over a year ago. Before that I lived a small but functional life on high dose opioids. I took the same dose, from the same doctor for over a decade. Then I was forced off of 75% of my dose,” said another patient. “Once we got down to my current dose the medication was no longer enough to control my pain. I now live a tiny, nonfunctional life. I spend all my time in bed watching TV. I never leave the house. Showers are my worst enemy. And I am lucky. I wasn’t abandoned by my doctor.”

A noted critic of opioid prescribing calls reports like these exaggerations. Andrew Kolodny, MD, the Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), told Stateline that the number of doctors who are inappropriately tapering patients is likely very small and should not be blamed on the CDC.

"We have a very real problem in this country. But the CDC guidelines didn't cause it," Kolodny said. "The problem is that millions of Americans have been put on round-the-clock opioids at very high doses and for reasons that doctors now realize were not appropriate.

"What the FDA needs to tell doctors is that because it is so excruciating to come off of opioids, they need to be very selective about who they put on them.”

In a series of Tweets two years ago, Kolodny said patients on high doses should be forcibly tapered “even if patient refuses” and challenged assertions that forced tapering was risky and widespread.

Now Kolodny says he sympathizes with patients but claims they are being manipulated.

“Their emotions are real. But they’re being effectively manipulated to controversialize the CDC guidelines,” he told Stateline.

.jpg

Many of Kolodny’s colleagues disagree. Over 300 healthcare professionals warned in a joint letter last year that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.”