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.

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.

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.” 

Oregon Drops Opioid Tapering Plan

By Pat Anson, PNN Editor

An Oregon health panel has tabled a controversial plan that would have forced tens of thousands of Medicaid patients with neck and back pain to stop taking opioid medication. The Health Evidence Review Commission (HERC) voted unanimously to wait for additional studies to be completed later this year, which effectively delays any change in medical coverage under the Oregon Health Plan until 2022.

The forced tapering plan drew nationwide criticism from pain sufferers, patient advocates and pain management experts, who said it would “exacerbate suffering for thousands of patients.”

"Pain is complicated and different for everyone," said HERC chairman Kevin Olson, MD, in a statement. "We heard loud and clear that pain treatment and opioid tapering should be individualized based on the patient-clinician relationship. I am pleased that we were able to align the neck and back coverage with these principles."

If a patient with any chronic pain condition is not doing well with an opioid taper, HERC said the tapering should stop without consequence to the prescriber or patient.

But patient advocates say some doctors have already implemented HERC’s forced tapering proposal without waiting for it to be finalized.

“Many patients across Oregon have already suffered tapering from their opiate pain management or have been dropped by their physician as a result of this policy. Those patients who have already been affected deserve proper treatment for their medical conditions and must have their previous pain management regiments and care reinstated,” said Amanda Siebe, a pain patient and disabled activist who recently announced she was running for Congress in Oregon’s 1st congressional district.

“It's time HERC made up for the damage they've done to this community over the last 2 years, and give us the proper care and coverage we deserve to maintain functionality and quality of life. This fight won't be over for us until all patients are able to receive the pain management, care, and coverage they need and deserve.”

The HERC also voted unanimously to continue not covering treatment for five common chronic pain conditions, citing a lack of evidence on the effectiveness of any therapy, including opioids. The five conditions are chronic pain caused by trauma, post-surgical chronic pain, chronic pain syndrome, fibromyalgia and “other chronic pain.”

Patients advocates had supported a plan to cover those condition, not only with opioid therapy, but with alternative treatments such as physical therapy, acupuncture and yoga.

“The conditions being discussed are valid conditions, and I think they’re in need of medical treatment options. I think that opioids should be a part of those options,” Wendy Sinclair, a pain patient and co-founder of the Oregon Pain Action Group told the Bend Bulletin. “Doctors and patients need to work together and have those options available.”

HERC’s decision to reverse course on tapering was a significant and rare victory for the pain community, which rarely gets a set at the table or is listened to when political and regulatory decisions are made about opioid medication.

Last year over a hundred pain management experts signed a letter to HERC warning that its tapering plan would have been the most restrictive in the U.S. and was unsupported by treatment guidelines. That warning was recently echoed by the Food and Drug Administration, which said rapid tapering and forced discontinuation of opioids was causing “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.

Is Tramadol Just as Addictive as Other Opioids?

By Pat Anson, PNN Editor

Patients recovering from surgery who take the opioid tramadol have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids, according to a large Mayo Clinic study.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have been increasing because it is widely perceived as a “safer” opioid with less rick of addiction. The new study, published in The BMJ, appears to debunk that claim, at least for surgery patients.

Mayo Clinic researchers looked at health data for over 350,000 patients who were prescribed opioids after undergoing 20 common surgeries in the U.S. between 2009 and 2018. A little over 7% of the patients were still refilling opioid prescriptions 90-180 days later. When the researchers dug a little deeper into the data, they found that patients taking tramadol had a 6 percent higher risk of prolonged use compared to other opioids.  

"This data will force us to reevaluate our postsurgical prescribing guidelines," says lead author Cornelius Thiels, DO, a general surgery resident in Mayo Clinic School of Graduate Medical Education. "While tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids."

Tramadol is a synthetic opioid that was classified as a Schedule IV controlled substance by the Drug Enforcement Administration in 2014, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse.

Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

Over half (53%) of the patients in the Mayo Clinic study were prescribed hydrocodone, about a third (37.5%) received oxycodone (also a Schedule II drug) , and only 4% received tramadol.

"We found that people who got tramadol were just as likely as people who got hydrocodone or oxycodone to continue using opioids past the point where their surgery pain would have been expected to be resolved," said senior author Molly Jeffery, PhD, the scientific director of research for the Mayo Clinic Division of Emergency Medicine. "This doesn't tie to the idea that tramadol is less habit forming than other opioids."

Jeffery and his colleagues say the DEA and FDA should consider reclassifying tramadol to a level that better reflects the risk of prolonged use.

"Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention," said Thiels.

In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.

Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is an unscheduled drug in Canada, but Health Canada is currently reviewing its status.

Still No Relief in Sight for Canadian Pain Patients

By Marvin Ross, Guest Columnist

Last month the U.S. Centers for Disease Control and Prevention said the agency’s 2016 opioid guideline does not endorse rapid tapering or discontinuation of opioid therapy. The CDC was responding to mounting criticism that its controversial guideline was causing harm to patients, including uncontrolled pain, depression and suicide.

As a Canadian, I am envious and embarrassed, for it is not over for pain patients in Canada. Americans have had active advocates in the American Medical Association and hundreds of doctors signing a public letter of protest, which resulted in the CDC and Food and Drug Administration finally admitting that forcing people to go off opiates is not good practice.

Canadian docs have said little about this, so I decided to ask the main authors of Canada’s opioid guideline, which is pretty much a copy of the CDC’s. They had written in response to me last year in the Canadian Medical Association Journal that they had “concerns” about inappropriate tapering and would “monitor the emerging literature.” Only one replied to me this time, saying that they speak out whenever they can, but no one will listen to them.

One anonymous doctor going by the name of “doc2help” objected to a piece I did in Medium suggesting that Canadian doctors have lost their moral compass. He thinks I am ill informed and doing damage.

I also let the office of the Canadian Minister of Health know what the CDC and FDA have done, as Health Canada has the same regulatory powers for drug approvals as the FDA. The answer was that they are having internal discussions.

Meetings and discussions make the bureaucracy go round-and-round. The Minister of Health did recently announce the formation of a chronic pain task force, but it has a three year time frame for more meetings.

It is so much easier to blame patients and opioid prescribing, as Canadian authorities continue to do, even when most drug overdoses are the result of illicit fentanyl, not prescription opioids.

In Hamilton, Ontario, a medium sized city southwest of Toronto, opioid deaths are going up, while prescriptions are going down. Much of the illicit drugs in that city are due to pharmacy diversion, according to an excellent article in the Hamilton Spectator that revealed vast amounts of prescription drugs are making it onto our streets.

So far, 15 pharmacists have been caught peddling opioids illegally and Health Canada has found that over 1,400 Ontario pharmacies have reported missing drugs that they cannot account for. 

Dr. Anne Holbrook, director of clinical pharmacology at McMaster University, suggested it is patients who are selling their prescriptions on the street, but provided no studies to back up that claim when she spoke to the Spectator reporter. I have asked her directly and via the media relations department at McMaster University, but did not get a reply.  

Blaming patients is easy when you do not want to confront the fact that most street drugs are coming into the country illegally or being diverted by pharmacies.

A Toronto Star investigation found one Ottawa pharmacy that was responsible for putting at least 5,000 fentanyl patches on the street. The investigation found that between 2013 and 2017, nearly 3.5 million doses of prescription drugs disappeared from Ontario pharmacies. Over 200 Ontario pharmacists were disciplined by their professional body for diverting “massive amounts of deadly opioids.”

Our governments are ignoring all of this and blaming the poor chronic pain patients. Those of us in Canada will have to wait while the bureaucrats hold meetings and write papers before anything will be done.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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.

Doctors Prosecuted for Opioid Prescribing Should Fight Back

(Editor’s note: In 2016, Dr. Mark Ibsen’s medical license was suspended by the Montana Board of Medical Examiners for his opioid prescribing practices. Two years later, the suspension was overturned by a judge who ruled that the board made numerous errors and deprived Ibsen of his legal right to due process.)

By Mark Ibsen, MD, Guest Columnist

The headlines are pretty typical: “60 Doctors Charged in Federal Opioid Sting.” The story that follows will include multiple damning allegations and innuendos, including a claim by prosecutors that they are “targeting the worst of the worst doctors.”

Sometimes there is a trial, but often the doctors plead guilty to lesser charges and give up their license rather than mount a lengthy and costly legal defense.

Why are doctors losing every case to their medical boards and DEA? Are there that many criminal doctors? If so, what happened to our profession?

I see a pattern emerging: A doctor sees patients and treats pain in the course of their practice. As other doctors give up prescribing opiates for fear of going to prison or losing their license, the ones left end up seeing more and more patients.

They soon become the leading prescribers of opioids in their state and become suspect just based on the volume of opioids they prescribe.

Given that law enforcement and medical board investigators usually don’t have training in statistics (or medicine), they are unable to see that the number of pain patients remains the same, but there are fewer practitioners willing to treat them.

“The Criminalization of Medicine: America’s War on Doctors” was published in 2007, but is even more relevant today.   

“Physicians have been tried and given longer prison sentences than convicted murderers; many have lost their practices, their licenses to practice medicine, their homes, their savings and everything they own,” wrote author Ronald Libby. “Some have even committed suicide rather than face the public humiliation of being treated as criminals.”

Libby wrote over a decade ago about doctors’ homes and offices being raided, DEA agents posing as pain patients to entrap them, and law enforcement task forces being created to target doctors for fraud, kickbacks and drug diversion.

Sound familiar?

I was reviewing a case about a nurse practitioner in Michigan who recently had her license suspended because she prescribed opioids “contrary to CDC guidelines” and “ranked among Michigan’s highest-volume prescribers of commonly abused and diverted controlled substances.”

This unsubstantiated crap put out by the Michigan Board of Nursing and its investigator is unethical and immoral. It should lead to a mistrial in court or dismissal at hearings. 

Fight Fire With Fire

This is an Amber alert for physicians. While pejorative headlines contaminate the discourse, the prescriber’s reputation bleeds away. The Montana Board of Medical Examiners did this in my case, and since I knew that the board was relentlessly after my license for “overprescribing” opioids, I gave up any hope of fairness.

My proposal: Lawyers representing doctors must counter the negative headlines with their own, and doctors should use whatever goodwill is left to rally their staff and patients, counteracting the pressure to testify against the doctor. 

I used what was left of my bully pulpit to save my own license and freedom. How? My assistant assembled my patients in large crowds at my hearings. I also made myself available to the media to counter the narrative put out by Mike Fanning, the board’s attorney, who went so far as to publicly question my sanity.

Fanning’s title was special assistant Attorney General, which told me the medical board works for DOJ in my state. I knew this for sure when DEA agents came to my office and tried to intimidate me.

“Doctor Ibsen, you are risking your license and your freedom by treating patients like these.”

Patients like what?

“Patients who might divert their medicine.”

Might? Isn’t that everyone? What would you have me do?

“We can’t tell you, we’re not doctors.”

My plea to doctors: Let’s reinvent our defense. The DEA and medical boards have a formula. It’s winning. 

We need a new response: Fight back and hold on. Just like with any bully, reveal their game and fight fire with fire.

Dr. Mark Ibsen continues to practice medicine in Montana, but focuses on medical marijuana as a treatment. He no longer prescribes opioids. Six of his former patients have died after losing access to Dr. Ibsen’s care, three by suicide.

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.

House Panel Seeks Clinical Trials of Kratom

By Pat Anson, PNN Editor

At a time when several states and cities have banned kratom, a powerful congressional committee is recommending that the herbal supplement be studied in clinical trials because of its “potential promising results” in treating chronic pain.

In a report to Congress, the House Appropriations Committee recommends that the National Institutes of Health (NIH) conduct research on whether kratom can be used as an alternative to opioids in treating pain.

“The Committee requests that NIH expand research on all health impacts of kratom, including its constituent compounds, mitragynine, and 7-hydroxymitragynine. The Committee is aware of the potential promising results of kratom for acute and chronic pain patients who seek safer alternatives to sometimes dangerously addictive and potentially deadly prescription opioids.”

The committee also recommended that the Agency for Healthcare Research and Quality (AHRQ) spend $3 million on clinical trials of kratom and cannabidiol (CBD) as alternatives for treating pain, and that the trials be conducted in “geographic regions hardest hit by the opioids crisis.”

The panel said it was concerned that the continuing classification of cannabis as a Schedule I controlled substance was stifling research “at a time when we need as much information as possible about these drugs.”

“The Committee notes that little research has been done to date on natural products that are used by many to treat pain in place of opioids. These natural plants and substances include kratom and cannabidiol (CBD). Given the wide availability and increased use of these substances, it is imperative to know more about potential risks or benefits, and whether or not they can have a role in finding new and effective non-opioid methods to treat pain.”

The committee said the current state of pain management in the U.S. is “often inadequate for many patients” and that additional treatments were needed. It asked that Congress be given an update on the development of non-opioid chronic pain therapies in the next fiscal year.

To be clear, the 346-page report by the House committee is an ambitious “wish list” of hundreds of various projects that may or may not be included in a final congressional spending bill.  But the inclusion of funding for kratom research is significant, given the campaign against kratom by some public health offiicials.

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. In recent years millions of Americans have discovered kratom and use it as a daily treatment for pain, addiction, depression and anxiety.  

Although kratom is not an opioid, health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition. Last month the CDC said kratom was listed as the cause of death in at least 91 overdoses and the FDA said it discovered dangerous levels of heavy metals in dozens of kratom products.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide.

Ironically, HHS oversees both the NIH and AHRQ, the same agencies the House Appropriations Committee wants to fund for kratom research.   

Drug Diversion Widespread in Healthcare Facilities

By Pat Anson, PNN Editor

The Drug Enforcement Administration recently completed another National Prescription Drug Take Back Day, collecting over 468 tons of unused or expired medications. The idea is to get risky drugs – particularly opioids – out of medicine cabinets before they wind up on the streets.

“The current opioid crisis continues to take too many lives, and many people get their first pills to abuse from the home medicine cabinet,” said DEA New Jersey Special Agent in Charge Susan Gibson.

But the DEA’s Take Back program overlooks a growing problem in the healthcare industry: Opioid medications are increasingly being stolen before they even reach home medicine cabinets.

According to a new report by the healthcare analytics firm Protenus, over 47 million doses of medication were stolen in 2018 by doctors, nurses, pharmacists and other healthcare workers, an increase of 126% from the year before. Opioids were involved in 94% of the incidents, with oxycodone, hydrocodone and fentanyl the most common drugs stolen.

“For both doctors and nurses, the high stress of the profession, long shifts, fatigue, physical and emotional pain, along with easy access to controlled substances, contribute to why they might divert medications,” the report found.

“Drug diversion poses a great deal of harm to patients because it puts them at risk of being treated by care providers working under the influence of controlled substances as well as receiving the incorrect amount or type of medications.”

Among the incidents cited in the report are a Texas nurse stealing opioid medication from elderly patients and a Maryland pharmacist filling bogus opioid prescriptions in return for sexual favors. According to Protenus, the average amount of time it took to discover a case of healthcare drug diversion was 22 months, giving diverters plenty of time to continue their thefts and cover their tracks.

To combat in-house drug diversion, Protenus recommends that hospitals, pharmacies, nursing homes and other healthcare providers establish drug monitoring programs – similar to those used for patients – and educate their employees about detecting and preventing diversion.

“Drug diversion occurs in virtually every hospital and health system in America, but many are in denial that it is happening in their own organization,” said Russ Nix, Director of Drug Diversion Prevention at MedStar Health. “Very few resources exist today on how to identify and combat drug diversion, and what’s out there is siloed.”

Nix belongs to the advisory board of Healthcare Diversion Network, a new non-profit that has an online portal where healthcare employees can report drug thefts anonymously. The goal is to collect data and raise awareness about drug diversion in healthcare facilities. 

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals.”

— Tom Knight, Healthcare Diversion Network

“I think thefts out of home medicine cabinets happen, but I also know that thefts out of healthcare systems and hospitals happen,” said Tom Knight, Chairman of the Healthcare Diversion Network. “Many of those thefts are for self-use, where the person stealing is going to consume them themselves. But sadly, many of those thefts are where the person is planning to distribute them, typically for profit on the street illegally.

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals. There are numerous cases where people working in hospitals stole hundreds of thousands of doses that were sold on the street for years before they were eventually caught.”

Knight says about 10 percent of all healthcare workers are stealing opioids and other controlled substances. He told PNN there is no good data to indicate how much of the stolen medication sold on the street comes from medicine cabinets and how much comes from healthcare facilities or the drug distribution system.

“Pretty much anywhere they exist they’re being stolen. We’re trying to raise the visibility, particularly on the part of the healthcare facilities,” he said.

Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney General “is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

Cancer Patient's Rite Aid Video Goes Viral

By Pat Anson, PNN Editor

April Doyle was frustrated and angry when she left a Rite Aid pharmacy Monday in her hometown of Visalia, California. A pharmacist there had once again refused to fill her prescription for opioid pain medication, so she got into her car and tearfully recorded a video that she uploaded to Twitter.

“I’m frustrated and that’s why I’m crying,” Doyle said, looking into her cell phone camera. “I’ve had a hard time getting my pain pills filled from them.”

Doyle’s story is a familiar one to millions of pain sufferers, who often have trouble getting their opioid prescriptions filled at pharmacies across the country. But her story is a bit different. The 40-year old single mom has Stage 4 terminal breast cancer that has metastasized into her lungs, spine and hip.  Doyle’s oncologist wrote a prescription for Norco — an opioid medication — to relieve some of her pain.  

“And when you have metastatic cancer in your bones, you need it.  Because sometimes the pain is so much you can’t even function. And I just want to function. I want to be able to go to work and I want to be able to sleep. And I want to be able to do things with my child.  I just want it not to hurt all the time,” Doyle said.

Within days, Doyle’s 6-minute video would go viral on Twitter and Facebook, where it’s been viewed over 200,000 times.  She’d also get apologies from a Rite Aid vice-president, the store manager and the pharmacist who refused to fill her prescription.

Doyle was no stranger at that Rite Aid store. It’s right around the corner from her house and she’s been shopping there for 20 years. It’s where she’s been getting her prescriptions filled for chemotherapy, anti-depressants and anti-nausea drugs — all written by her oncologist. But Rite Aid always seemed to have trouble filling that prescription for Norco. 

“I have to take 20 pills a day just to stay alive,” Doyle 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.”

Federal and state prescribing guidelines – and those of insurers – specifically exempt cancer pain from restrictions on opioid medication.  But some cancer patients still get turned away at pharmacies. According to Doyle, the Rite Aid pharmacist told her he was worried about being fined or even losing his job if he filled her opioid prescription.   

Some of that caution is understandable. Rite Aid and other major pharmacy chains have recently been added as defendants in opioid lawsuits across the country. In the current climate of opioid hysteria, every step of the drug supply chain, from manufacturers to wholesalers to retailers is under scrutiny. Billions of dollars are at stake. Caught in the middle are pharmacists and patients like April Doyle.

“It’s not right. I’m not a criminal. I’m not a drug addict. I don’t even take them as often as my doctor says to take them. It’s not fair,” she said.

Astonished at Reaction

Doyle has been shocked at the response her video has gotten from the pain community. And surprised at how common her story is. Hundred of people left comments on Doyle’s Facebook page after watching her video.

“Stop giving your money to Rite Aid! You deserve dignity and great customer service,” one supporter wrote. “This whole opioid epidemic is making it impossible for those who medically need the meds. We all have our own story to share. This has to stop!”

“It’s hard to be sick and have people who don’t understand what you’re going through judge you,” said another supporter. “I hope you can find a pharmacy that will treat you with dignity and the compassion you deserve.”

“I know this oh too well trying to get my mom’s scripts filled when she was battling cancer running from store to store feeling and looking like a junkie. It was the most horrible part of it all!”  said another.

 “It’s astonishing the reaction it has gotten. I had no idea this was so common. It’s actually kind of sad how common it is,” Doyle told PNN. “It really struck a nerve with what’s apparently a big problem. I’m just dumbfounded by it.”

A Rite Aid spokesman said he could not comment on Doyle’s case.

“At Rite Aid, we are committed to providing high-quality care to all of our customers and patients. Rite Aid is not able to provide additional detail due to patient privacy,” Chris Savarese, Rite Aid Director of Public Relations said in an email.

Although the company has apologized to Doyle, she does not intend to go back to her neighborhood Rite Aid.

“I have decided to find a locally owned mom and pop pharmacy that really wants the business,” she said.

Is Fentanyl a Weapon of Mass Destruction?

By Lynn Webster, MD, PNN Columnist

Usually we think of bombs, missiles, rockets and dangerous chemicals as weapons of mass destruction (WMD). However, the military website Task & Purpose recently reported that James McDonnell, who heads the Department of Homeland Security’s WMD division, wants to classify fentanyl as a WMD.

McDonnell proposed this in a February memo to then-DHS Secretary Kirstjen Nielsen. The drug’s “high toxicity and increasing availability” make it “attractive to threat actors seeking nonconventional materials for a chemical weapons attack,” according to the memo.

There isn’t much evidence for classifying fentanyl as a WMD, but McDonnell’s suggestion could still find support for reasons that have more to do with politics than science.

According to federal law, weapons that can kill or severely injure "through the release, dissemination, or impact of toxic or poisonous chemicals, or their precursors" fall into the category of weapons of mass destruction.

McDonnell thinks fentanyl fits the definition. It is not clear that he is correct. And he neglected to mention that fentanyl has a legitimate medical use, too.

History of Fentanyl

Fentanyl is a powerful synthetic opioid typically prescribed to patients in acute pain or during surgeries. According to data from the National Center for Health Statistics, 48 million surgical inpatient procedures were performed in the United States in 2009. Most of those procedures involved administering fentanyl intravenously as an analgesic. 

Fentanyl was developed in 1960 by Belgian chemist Dr. Paul Janssen. The patent for fentanyl was obtained under his company name, Janssen Pharmaceutica. Fentanyl was first approved by the Food and Drug Administration in 1968 and introduced into the marketplace as an analog for Demerol, with plans that it would be used only for palliative care.

In 1978, I coauthored with my professor mentor, Dr. T.H. Stanley, a manuscript titled “Anesthetic Requirements and Cardiovascular Effects of Fentanyl” that described the use of high dose fentanyl for cardiac anesthesia.

The anesthetic technique we described allowed patients to undergo coronary artery bypass and valve replacement surgery more safely and with greater success because of fentanyl's unique pharmacologic properties. The technique was considered a seminal event in anesthesia for cardiac surgery.

Since the publication of that paper, millions of people have successfully undergone heart operations. The advance of using fentanyl in anesthesia may have helped some of those patients survive their heart operations.

It wasn’t until the late 1980s that testing was done for delivering fentanyl through a transdermal patch for the treatment of cancer-related pain and noncancer chronic pain. Later, oral transmucosal delivery of fentanyl was made available for cancer breakthrough pain. Each of these new uses of fentanyl exposed millions of Americans to the drug without evidence of an inordinate degree of harm if it was used as directed.

In contrast, nonpharmaceutical fentanyl has caused enormous harm. But as illicit use of the drug proliferates, so do myths about its dangers. McDonnell’s memo fits into an overarching narrative that bestows almost magical properties on fentanyl.

What's Behind the Fentanyl Panic?

The opioid crisis is real and the use of illicit fentanyl is often lethal. But mischaracterizing the effects of fentanyl may be only a political maneuver. 

In New York Magazine, Sarah Jones wrote about a 2017 Bloomberg News story that claimed fentanyl “is so potent that even a small amount — the equivalent of a few grains of salt — can be lethal.” 

“This isn’t really true,” wrote Jones. “You can’t get high or become ill simply by touching fentanyl, but police departments often claim otherwise. They report dramatic, but varied, symptoms that don’t mesh with established scientific evidence about fentanyl and the way it’s absorbed by the human body.” 

As Jones points out, Homeland Security’s WMD division has experienced a decline in funding because of the Trump administration’s focus on immigration and building a wall at the border. One way to reclaim some of that money for the WMD division is to build a case against fentanyl. 

Other drugs, such as ricin, pose greater risks and are probably more lethal than fentanyl as WMD’s. However, the word "fentanyl" packs a far larger emotional punch than ricin does because of the public's familiarity with it.  

WMDs are meant to kill the maximum number of people is the shortest amount of time. On the other hand, fentanyl -- even when it is laced with heroin -- is not intended to kill people. Drug cartels want to make money. Their goal isn't to murder their customers

Protecting Access to Legitimate Fentanyl 

The opioid crisis is now largely driven by nonpharmaceutical fentanyl and fentanyl analogs, not prescription fentanyl. Solving the opioid problem will require greater efforts to reduce the illegal production and distribution of illicit fentanyl. 

Could fentanyl be weaponized and used to attack citizens? Maybe, but not easily.  

The Pentagon realized the harm that an opioid attack could cause when the Russian military used aerosolized carfentanil -- a highly potent fentanyl analog --  against terrorists who had taken over a theater in Moscow in 2002. The drug killed dozens of innocent hostages and their captors, and it put the U.S. on notice that opioids could be weaponized.  

Before we classify fentanyl as a WMD, we need to know what that would mean for its legitimate use during surgery, or for cancer and chronic pain patients. Access to the medication for the treatment of pain must be part of the calculus in assessing if a relatively safe and effective drug should be classified as a WMD. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

What Next for CDC Opioid Guideline?

By Pat Anson, PNN Editor

The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.

A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients.

Although the guideline strongly recommends that daily doses of opioids not exceed 90 MME (morphine milligram equivalent), the guideline’s three co-authors say their advice was misinterpreted and that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages.”

A CDC media statement this week also claimed “the guideline does not support abrupt tapering or sudden discontinuation of opioids.” 

That was surprising news to Rob Hale, a Missouri man with late-stage Ankylosing Spondylitis, a degenerative and incurable form of arthritis.  Like many other pain patients, Hale’s relatively high dose of opioid medication was significantly reduced soon after the guideline’s release.  As a result, he is now bedridden.

“This is amazing news, if they really intend to follow through with it,” said Hale in an email. “God, I hope this is the beginning of a turnaround in prescribing policies.  I just feel for the hundreds of us who gave up and took their lives or died as a result of the last 3 years of cruelty.”

Saving Face

Why the CDC is acting now is unclear. Reports of patient harm began circulating soon after the guideline’s release in March 2016, and have only accelerated as insurers, pharmacies, states and practitioners adopted the guideline as mandatory policy. In a recent PNN survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide.

“I regard this CDC statement to be an effort to save face and maintain political dominance on an issue into which CDC improperly inserted itself under the influence of Andrew Kolodny and PROP,” said patient advocate Richard “Red” Lawhern, referring to the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing.

“The statement fails to engage with the underlying issues which render the Guidelines fatally flawed.  It fails to acknowledge the essential repudiation of the entire guideline concept by the American Medical Association, plus multiple prominent medical professionals.” 

“The CDC guidelines have been as harmful as predicted, and the silence over 3 years has been criminal. The ‘Who me?’ response is just as evil as the ignorant abuse of power that led to the crisis in the first place,” said Mark Ibsen, MD, a Montana physician whose license was suspended by the state medical board for “overprescribing” opioids. A judge overturned the board’s ruling.  

“Those who give a weak ‘mea culpa’ for misinterpretation of the guidelines are, in short, lying. The deaths of thousands of abandoned pain patients, including 6 of mine who lost access (to opioids), are on their hands,” Ibsen said. 

PNN asked a CDC spokesperson if the agency had received new information about patients being harmed by the guideline and received a vague response.  

“We have heard concerns from partners and stakeholders about policies and practices that are inconsistent with the 2016 Guideline and sometimes go beyond its recommendations. The misapplication of the Guideline can risk patient health and safety,” Courtney Lenard said in an email. “CDC authored this commentary to outline examples of misapplication of the Guideline, and highlight advice from the Guideline that is sometimes overlooked but is critical to safe and effective implementation of the recommendations.” 

The response was also vague when we asked if CDC would be directly contacting insurers, pharmacies and states to warn them about misapplying the guideline.

“CDC has engaged payers, quality improvement organizations, state health departments, and federal partners to encourage implementation of recommendations consistent with the intent of the Guideline,” said Lenard, citing a mobile app and a pocket guide to opioid tapering as examples of CDC outreach.

The agency also sent out a Tweet.

Lenard gave no indication that a revision of the guideline was imminent. She said the CDC was working with the Association of Healthcare Research and Quality (AHRQ) to evaluate “new scientific evidence” about the benefits and harms of opioids.  

“Results of these reviews will help CDC decide whether evidence gaps have been addressed and whether the Guideline should be updated or expanded for chronic or acute pain prescribing,” Lenard wrote. 

.@CDCgov #OpioidGuideline does not support abrupt tapering or sudden discontinuation of #opioids. Learn more in our recent @NEJM commentary: https://t.co/vK0ESNyGTU pic.twitter.com/TXZ2jDdMJB

— CDC Injury Center (@CDCInjury) April 24, 2019

Undoing the Damage

The American Medical Association – which took a stand against the “inappropriate use” of the guideline last year -- released a statement saying the CDC needed to work more closely with insurers.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs (pharmacy benefit managers),” said AMA President-elect Patrice Harris, MD.

“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”

Dr. Ibsen said the Drug Enforcement Administration was “the other elephant in the room” because it has weaponized the CDC guideline to demonize and prosecute doctors for prescribing high opioid doses. 

“Arresting and punishing doctors who treat the sickest pain patients. Civil asset forfeiture as used in dealing with criminal drug dealers. Equate physicians with a license to practice as equal to or below said criminal drug dealers,” said Ibsen, listing some of the tactics used by prosecutors.

“Charge physicians with one felony for every Rx they write, making absurdly dramatic charging documents and headlines against doctors who are left with no income or assets to defend themselves in a contaminated jury pool. Charge doctors with murder for prescribing medications to patients who fail to follow the directions.”

It’s not just the DEA. The National Association of Attorneys General recently declared that the dose and duration of opioid prescriptions should not be decided by doctors and that the CDC guideline should essentially be treated as law.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment,” warns a letter signed by 39 state and territory attorney generals. “As Attorneys General of states with high rates of prescription drug abuse among our youth, policy makers and prescribers must be encouraged to continue to pursue laws and practices that reduce the high volume of opioids in our communities.”

“The standard of care is now determined by prosecutors and juries,” says Ibsen.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

“It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.”

— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

What It’s Like to Be Forcibly Tapered Off Fentanyl

By Emily Ullrich, Guest Columnist

Although I have been on this chronic intractable pain, illness and medical refugee train for nearly a decade, I’ve been lucky to have the love and support my husband, family and wonderful people around the world that I've met through this shared anguish. They lift me up and allow me to lift them, when I can.

Right now, I'm holding onto them in utter panic, because they’re all that I have left.

About four years ago, I met a palliative care doctor, who had taken the time to read my 3-page health history. I take that paperwork with me to every visit to the ER or new doctor, so they can fully understand the things that I have tried, what worked, and what made things worse. No doctor had ever looked at it, until she did.

She approached me with zero judgment, and 100% sympathy and empathy. She actually cared about what I'd been through. I broke down sobbing, because I could finally let my guard down. I told her how my husband had to take a day off from work every month to drive me five hours and three states away, to see the only doctor I could find who was willing to treat my complicated needs. She told me I could see her instead. That was a tremendous gift.

Last year I began to sense that there was growing pressure on her about prescribing high doses of opioids, so I asked if I should worry about her cutting my meds or passing me off to another doctor. She reassured me that she would do no such thing.

Then came my visit one month later. I knew something was awry, because there was a case worker present for my appointment. My suspicions were confirmed when I was told the dose of my fentanyl patch would be tapered significantly lower. I was thrown into a tailspin.

With my doctor’s help and willingness to prescribe the meds and dosages that I needed, I had been able to achieve about a 4/10 on the pain scale, daily. I was able to participate in life again and do things that I love, like cooking, getting dressed up to go on a date with my husband, and other things that healthy people take for granted.

I was furious and traumatized that I was going to have to give up living my life. I still am.

On my next visit to see my doctor, she dropped another bomb. She told me that I had to choose between anti-anxiety meds and pain meds. Ironically, she was the one who put me on a higher dose of Xanax to help me cope with anxiety and insomnia. I felt betrayed.

I would not wish the hell of abruptly and simultaneously tapering off fentanyl and Xanax on anyone.  Even when I had a higher dosage, I still had pain flares that were not properly controlled. But since the taper began, I now have them daily.

I want this to be very clear: Fentanyl is a necessary medicine for many people with high pain levels. I have tried every other extended release medication known and none even touched my pain.

Fentanyl has gotten a bad reputation and patients who take it live with heavy stigma because the media usually report on fentanyl overdoses without distinguishing between illicit fentanyl and properly prescribed legal fentanyl.  

I would like to make a plea to the media: Stop the ignorant reporting and do your due diligence. By not distinguishing between legal and illicit fentanyl, you are causing even more strife for those of us who need the relief that only fentanyl medication brings.

I have still not gotten a clear reason for my doctor's decision to force a taper on me. I fear if I prod too much, she will totally cut me off or advise me to see someone else. This is making the struggle even worse, because even though we still have a pleasant relationship, I'm hurt and confused about this. I suspect it is being forced upon her.

As I wrote this, I had to take breaks for hours, sometimes days, because my pain is escalating to such a level that anxiety and insomnia are ravaging my mind and body. I have been in withdrawal (which, by the way, does not mean I am addicted to my medication, it means I'm physically dependent on it) for about four months.

As my medicine has been tapered, my life has crumbled. I get about two hours of sleep every five days. At times I get uncontrollable head shaking, leg kicking, arm flailing and vocal ticks. My pain gets so bad that I develop a full-body rash and migraines that last for days.

I don't know what is real and what my brain has concocted. I hold nonsensical conversations, like my grandparents did when they developed dementia. It is embarrassing and terrifying.

One night, while counting down the minutes until I could take my next dose of meds, I passed out from pain and anxiety, which scared my husband so bad that he called 911.

I hope that insurers, pharmacies and especially government officials who are infringing on doctors' ability to treat their patients, might read this and see that forcing tapers on patients is dangerous. There have already been many suicides because of them.

A gap is growing between many doctors and their patients. We know this is not “What's best for us.” It is actually a twisted way to make more money off the sick and vulnerable, forcing us to replace a medicine that is effective and safe when used responsibly with drugs that are ineffective, expensive and dangerous.

Emily Ullrich lives with Complex Regional Pain Syndrome (CRPS), chronic pancreatitis, endometriosis,  interstitial cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, depression, and other chronic illnesses. She is also a writer, filmmaker, activist, advocate, philanthropist and comic. As she is able, Emily devotes her time and energy fighting for pain patients’ rights.

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.

60 Arrested in Latest Crackdown on Rx Opioids

By Pat Anson, PNN Editor

Sixty people in five states face charges of illegal opioid prescribing and healthcare fraud in the latest federal crackdown on opioids. The arrests are the first since the Justice Department established an opioid strike force last year to concentrate on drug crimes in the Appalachian region.

The defendents include 31 doctors, 7 pharmacists, 8 nurse practitioners and 7 other licensed medical professionals.

“The opioid epidemic is the deadliest drug crisis in American history, and Appalachia has suffered the consequences more than perhaps any other region,” Attorney General William Barr said in a statement. 

“But the Department of Justice is doing its part to help end this crisis. One of the Department's most promising new initiatives is the Criminal Division's Appalachian Regional Prescription Opioid Strike Force, which began its work in December.  Just four months later, this team of federal agents and 14 prosecutors has charged 60 defendants for alleged crimes related to millions of prescription opioids.” 

The charges involve over 350,000 opioid prescriptions and over 32 million pills. A federal prosecutor claimed that was the equivalent of a dose of opioids for every man, woman and child in Ohio, Kentucky, Tennessee, West Virginia and Alabama.

In one case, a doctor and several pharmacists are accused of operating a pill mill in Dayton, Ohio. Over a two-year period, the pharmacy dispensed over 1.75 million pills. 

In Kentucky, a doctor operating a pain management clinic allegedly provided pre-signed, blank prescriptions to office staff who then used them to prescribe controlled substances when he was out of the office. 

And in Tennessee, a doctor who called himself the “Rock Doc” allegedly prescribed dangerous combinations of opioids and benzodiazepines, sometimes in exchange for sexual favors.

“Reducing the illicit supply of opioids is a crucial element of President Trump’s plan to end this public health crisis,” Health and Human Services Secretary Alex Azar said in a statement.  “It is also vital that Americans struggling with addiction have access to treatment and that patients who need pain treatment do not see their care disrupted, which is why federal and local public health authorities have coordinated to ensure these needs are met in the wake of this enforcement operation.”

A DOJ press release provided a list of hotlines, websites and other resources where effected patients can get addiction treatment. None of them, however, appear to offer pain management.

Pain patients are often the forgotten victims in law enforcement crackdowns on healthcare providers. Dawn Anderson, for example, a double amputee and diabetic, died last month in “sheer agony” because she was no longer able to get opioid medication from a pain management doctor who stopped practicing medicine after he was accused and convicted of healthcare fraud.    

Most Overdoses Don’t Involve Rx Opioids

The Appalachian region – and West Virginia in particular – has been ground zero in the opioid crisis. But a new study by researchers at West Virginia University shows just how much the crisis has shifted away from prescription opioids.

Researchers analyzed over 8,800 drug-related deaths in West Virginia from 2005 to 2017 and found that deaths involving fentanyl soared by 1,325% over that period.

From 2005 to 2014, prescription opioids were involved in almost 60% of drug related deaths in West Virginia, but from 2015 to 2017 they were only involved in about 30% of drug deaths.

West Virginians are now twice as likely to die from fentanyl than they are from oxycodone. Deaths linked to fentanyl, heroin, alcohol, alprazolam (Xanax) and cocaine outnumber those from oxycodone or any other opioid pain reliever.

Fentanyl and its analogs are synthetic opioids 50-100 stronger than morphine. They’ve become a scourge on the black market, where they are frequently mixed with heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

Reducing the supply of prescription opioids and locking up doctors isn’t going to solve the fentanyl problem.

"One of the proven ways to reduce overdoses is to decrease the number of people who are addicted and using. But with fentanyl, you could halve the number of addicts in West Virginia, and the overdose rate could still go up because the strength of the drug coming in is so much stronger and can vary widely from one day to the next," said Gordon Smith, MD, an epidemiologist in the West Virginia School of Public Health. "This is an absolute quandary."

West Virginia's increase in fentanyl-related deaths is part of a national trend. As the CDC reported, deaths from fentanyl overdoses spiked across the United States in 2015 and are still climbing. West Virginia leads the nation in fentanyl-related deaths and has the highest per capita rate of overdose deaths overall.

When Will Forced Tapering of Opioids End?

By Lynn Webster, MD, PNN Columnist

“Larry” recently wrote to me asking for advice. He describes himself as "virtually crippled totally" after having his opioid medication cutback.

"I am being forced tapered and the PA I now have will not budge one inch on the weaning, as he calls it. I hate him. I have never had a more callous doctor in my life," Larry wrote.

"What does one do in my situation? Blow my brains out? A[n] intentional overdose? I have two beautiful dogs that depend on me and a son who needs me. I have to stay here on planet Earth although I want out of here so bad I beg God to kill me every morning noon and night. It is my daily prayer."

Unfortunately, Larry is only one of many patients who are struggling to be heard by their providers. Physicians are under government pressure to adhere to the CDC’s 2016 opioid prescribing guideline.

Although the CDC designed its guideline as voluntary, government agencies interpreted it as a mandate instead. The Drug Enforcement Administration has pursued doctors who prescribe a level of opioids that exceeds the guideline's recommended daily limit of 90 MME (morphine milligram equivalent), even when no patients have been harmed.

According to Maia Szalavitz, writing for Tonic, Dr. Forest Tennant was one of the few physicians who still were willing to prescribe high-dose opioids for the sickest pain patients. The DEA raided his California office and home, allegedly because the agency had reason to believe some of his patients were selling their medication.

There simply was no evidence of that. But as a result of the raid, Dr. Tennant retired from clinical practice.

Szalavitz wrote that the raid "terrifies pain patients and their physicians, who fear that it could lead to de facto prohibition of opioid prescribing for chronic pain and even hamper end-of-life care."

Dr. Mark Ibsen in Montana had his license suspended by the state medical board for allegedly overprescribing opioids. According to Dr. Ibsen, the DEA warned him "he was risking his livelihood and could end up in jail if he kept prescribing." A judge later overturned the board’s decision.

As Dr. James Patrick Murphy, a Kentucky-based pain and addiction specialist, told the Courier-Journal, "many well-intended doctors are unfairly arrested 'all the time' in the hunt for those who recklessly contribute to patients' addictions and fatal overdoses."

As of this writing, The American University Law Journal plans to publish an alarming article by Michael Barnes, JD, about the raids on America’s top physicians.

Although few physicians are incarcerated for prescribing high dosages of opioids, many of them are threatened with losing their licenses to practice medicine. Doctors and pharmacists told a POLITICO survey that they felt enormous pressure to limit their prescriptions for painkillers. Their fear of the consequences of noncompliance with the CDC guideline exceeded their responsibility to treat patients with severe pain.

Second Thoughts About CDC Guideline

On April 1, the attorneys general of 39 states and territories wrote a letter on behalf of the National Association of Attorneys General to Dr. Vanila Singh of the U.S. Department of Health and Human Services. The letter expressed concern with the draft report of the Pain Management Best Practices Inter-Agency Task Force, which recommends changes in the CDC guideline to end the forced tapering of patients.

The attorneys general said "it is incomprehensible that officials would consider moving away from key components of the CDC guideline." Additionally, they expressed their hope that the report would be revised "to clearly state that there is no completely safe opioid dose."

Yet on April 9, the Food and Drug Administration issued a medical alert warning doctors not to abruptly discontinue or rapidly taper patients on opioid medication, because it was causing “serious harm” to patients, including uncontrolled pain, psychological distress and suicides.

Now it seems the CDC may be moving in the same direction.

Dr. Daniel Alford, a Professor of Medicine at Boston University, wrote a letter to the CDC asking it to address the misapplication of its guideline with a "public clarification." He was writing on behalf of Health Professionals for Patients in Pain, and 300 healthcare professionals signed his letter.

The CDC's response, published on April 10, echoed the FDA's statement. CDC Director Dr. Robert Redfield observed that the CDC guideline "offered no support for mandatory opioid dose reductions in patients with long-term pain." He reinforced the fact that the guideline was voluntary and that doctors should use their knowledge of their patients to determine which dosages were appropriate for them.

Dr. Redfield wrote that “CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms." And he agreed that "patients suffering from chronic pain deserve safe and effective pain management."

STAT News points out that the overzealous enforcement of the CDC guideline was indeed causing patients harm. "Denying opioids to patients who have relied on them — sometimes for years — may cause some to turn to street drugs, thereby increasing their risk of overdose," STAT warned.

According to The Washington Post, "Many patients have claimed that long-term use of the drugs is all that stands between them and unrelenting pain, and that they can take the medication without becoming dependent or addicted."

The CDC and the FDA now admit the guideline has been misapplied and mainstream media outlets are beginning to pick up the story. The question is: Will the DEA stop pursuing doctors who treat pain patients with levels of opioids that exceed the guideline's recommendations?

For Larry and other pain patients who have been forcibly tapered, the answer may be a matter of life and death.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

CVS Fined $535,000 for Filling Forged Opioid Prescriptions

By Pat Anson, PNN Editor

CVS Pharmacy has agreed to pay a $535,000 fine to resolve allegations that several of its Rhode Island stores filled dozens of forged prescriptions for Percocet, a potent opioid painkiller. It’s the latest in a series of fines the nation’s largest pharmacy chain has paid for violations of the Controlled Substances Act.

According to DEA investigators, CVS pharmacists filled 39 forged prescriptions for Percocet between 2015 and 2017 even though they “knew or had reason to know that the prescription in question was invalid or unauthorized.”

In a settlement agreement with the Department of Justice, CVS agreed to pay the fine while making no admission of any liability or wrongdoing. The company said it wanted to avoid the expense and uncertainty of going to trial. In return, the DOJ agreed to drop all civil or criminal prosecution of the case.

“DEA registrants like CVS have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substance Act,” said DEA Special Agent in Charge Brian Boyle. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and legal prescription.  Today’s settlement demonstrates DEA’s commitment to work with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”

It’s not the first time CVS has been accused of lax or fraudulent behavior involving opioid medication.

In 2017, CVS agreed to pay a $5 million fine to settle allegations that several of its pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

In 2016, CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioids. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

All of these cases were settled out of court.

In 2018, CVS angered pain patients when it began to limit the initial dose of opioids to 7 days’ supply for customers enrolled in CVS Caremark health plans. For both acute and chronic pain patients, CVS said daily doses of opioids should not exceed 90 MME (morphine milligram equivalent) and patients would be required to use immediate release formulations. CVS said it was making the CDC opioid guideline the “default approach” to prescribing opioids.

Last week, CDC Director Dr. Robert Redfield acknowledged for the first time the agency’s voluntary guideline was causing “unintended harms” and that patients should only be tapered to lower doses “if a patient would like to taper.”  

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Nothing in the guideline empowers pharmacists to set dose limitations. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide

Using Cannabis and Opioids Together May Not Be Such a Great Idea

By Roger Chriss, PNN Columnist

The opioid-sparing effect of cannabis is routinely touted as a reason for marijuana legalization. The hope is that cannabis combined with opioid medication will produce equal analgesia at lower opioid doses, thus reducing the risks associated with opioid therapy.

But evidence in favor of the opioid-sparing effect is largely pre-clinical and often involves animals or healthy volunteers, not the real world conditions that pain patients live with.

A recent study on rhesus monkeys, for example, at the University of Texas found that combining cannabinoids with morphine did not significantly increase the impulsivity or memory impairment of the monkeys.

A 2018 study by Ziva Cooper and colleagues on healthy cannabis smokers concluded that cannabis enhances the analgesic effect of oxycodone, suggesting there is a synergy between the two.

And a 2017 systematic review of over two dozen studies in the journal Neuropsychopharmacology reported “robust evidence of the opioid-sparing effect of cannabinoids.”

But evidence against the opioid-sparing effect of cannabis is mounting, based on clinical findings in real-world chronic pain patients.

Andrew Rogers of the University of Houston reported at the 2019 American Pain Society Scientific Meeting that chronic pain patients who used both prescription opioids and recreational marijuana showed higher levels of anxiety, depression and substance abuse problems than those who used opioids alone. There was no difference between the two groups in pain levels.

"The things psychologists would be most worried about were worse, but the thing patients were using the cannabis to hopefully help with — namely pain — was no different,” Rogers told MedPageToday. "Co-use of substances generally leads to worse outcomes. As you pour on more substances to regulate anxiety and depression, symptoms can go up."

A large Australian study in The Lancet Public Health found that cannabis use was common in patients with chronic non-cancer pain who were prescribed opioids, but “there was no evidence that cannabis use reduced pain severity or interference or exerted an opioid-sparing effect.”

This research, known as the Australia POINT study, followed over 1,500 chronic pain patients for almost four years. Although its methodology has limitations, it is one of the largest long-term studies of opioids and cannabis under real-world conditions.

“At each assessment, participants who were using cannabis reported greater pain and anxiety, were coping less well with their pain, and reported that pain was interfering more in their life, compared to those not using cannabis,” said lead author Gabrielle Campbell, PhD, of the University of New South Wales.

In other words, the opioid-sparing effect of cannabis seems not to work well in the real world, despite its apparent success under laboratory conditions. There are several possible factors at work.

First, laboratory conditions are artificial. Studies often use lab animals or healthy human volunteers. But people with chronic health conditions may be different. Or perhaps people who are experienced with cannabis and willing to spend a day in a laboratory being subjected to painful stimuli are different.

Second, laboratory studies are often short term, but chronic pain is long term. The cumulative risks of opioids and cannabis, as well as the complex interactions between them, may take time to unfold and discover. It is possible that an initial opioid-sparing benefit washes away quickly and is replaced by nontrivial risks.

Third, real-world studies emphasize patient outcomes, a factor that laboratory work cannot assess. Because outcomes are so important, studies that focus on them must be given greater weight. 

More research will be needed to sort out the effects of combining cannabis and opioids in chronic pain management. But at present, clinical studies point to more risks and harms than benefits. Perhaps a subset of patients or a particular combination of a specific opioid and cannabis preparation will change this. Or perhaps combining cannabis and opioids is not such a great idea. 

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.

Biden: ‘A Little Pain Is Not Bad’

By Pat Anson, PNN Editor

Former Vice-President Joe Biden, who appears close to announcing a run for president in 2020, may want to think twice about the message he’s sending to a large group of voters: chronic pain patients.

While speaking Thursday as part of a panel on the opioid crisis at the University of Pennsylvania, Biden said too many doctors “willy-nilly overprescribed” opioid pain relievers.

"A little pain is not bad," said Biden. “A lot of people can get addicted within five days.”

FORMER VICE-PRESIDENT JOE BIDEN

“We got here, I believe in part, because of the greed of the drug companies and the irresponsibility of them and, quite frankly, a lack of sufficient responsibility on the part of the medical profession,“ Biden said, adding that 215 million prescriptions for opioids were written in 2016.

“We desperately need people with chronic pain to have this access, but you cannot convince me anywhere near that is the case,” he said.

The 76-year old former senator also expressed regret about being a co-sponsor of the 1988 Anti-Drug Abuse Act, which created tougher sentencing guidelines for crack cocaine. Critics say the law sent a disproportionate share of African-Americans and other minorities to prison.

"The big mistake was us buying into the idea that crack cocaine was different from the powder cocaine, and having penalties ... it should be eliminated," Biden said, according to Delaware Online. “I’m sorry I didn’t know more about behavior.”

Biden’s knowledge about the opioid crisis appears dated. The vast majority of overdose deaths are now attributed to illicit fentanyl, heroin and other black market opioids, not pain medication. The number of opioid prescriptions has also been declining for several years and now stand at their lowest level since 2003.

Prescription opioids are not particularly risky if used responsibly, according to a recent study of over half a million Medicare patients who were prescribed the drugs. Over 90 percent had a negligible risk of an overdose. Even among “high risk” patients on high opioid doses, the risk of an overdose is less than two percent.  

A major review of studies on long term opioid therapy found that only 0.27% of patients were at risk of opioid addiction, abuse or other serious side effects. In another large study, The British Medical Journal reported that only 3% of opioid naïve patients (new to opioids) continued to use the drugs 90 days after a major elective surgery.

Biden’s advice to pain sufferers that “a little pain is not bad,” is reminiscent of a statement by former Attorney General Jeff Sessions, who told a Florida audience in 2018 that "people need to take some aspirin sometimes and tough it out.”

You can watch the opioid panel discussion on YouTube by clicking here.

More Overdoses Blamed on Kratom

By Pat Anson, PNN Editor

A new analysis by the Centers for Disease Control and Prevention lists the herbal supplement kratom as the cause of death in at least 91 overdoses in the U.S. from 2016 to 2017.  Multiple substances were involved in the vast majority of those cases, with over half of the deaths also linked to fentanyl, a synthetic and potent opioid that has become a scourge on the black market.

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. In recent years kratom has grown in popularity in the U.S. as a treatment for chronic pain, addiction, depression and anxiety.  

Although kratom is not an opioid, public health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition.

In the new study, CDC researchers analyzed over 27,000 fatal overdoses in 27 states between July 2016 and December 2017. Kratom was determined to be the cause of death by a medical examiner or coroner in 91 overdoses, with multiple substances detected in all but seven of them.

Heavy Drug Use

Most of those who died were apparently heavy drug users. In nearly 80 percent of the kratom-involved deaths, the decedents had a prior history of substance misuse and 11% had survived a previous overdose.  Fentanyl or fentanyl analogs were co-listed as a cause of death in 56% of the kratom-involved deaths. Heroin was co-listed in about a third of the kratom cases, followed by benzodiazepines (22%), a class of anti-anxiety medication, prescription opioids (20%) and cocaine (18%).

“I’m actually pleased that they are recognizing that when kratom is present in a decedent, it is usually with other substances. Instead of blaming kratom as the cause of death, it points to polysubstance use,” said Jane Babin, PhD, a molecular biologist and patent attorney. “If someone takes a lethal dose of fentanyl plus kratom, it is unreasonable to conclude that kratom was the cause of death.  The same could be said of a lethal dose of fentanyl plus anything else – cannabis, coffee, Tylenol, etc.  This is the same situation in many ‘opioid related’ deaths, where multiple substances are present.”

Babin has worked as a consultant to the American Kratom Association, an advocacy group of kratom vendors and consumers. She has disputed previous reports of kratom overdoses – attributing them to faulty lab tests and inexperienced coroners.

“When a coroner can’t find an obvious physical cause of death, they pin the death on kratom even though they don’t have a link between the cause and manner of death and what is known about kratom pharmacology,” Babin wrote in an email to PNN. “I think the bigger question that CDC and FDA need to address is why do these people take so many different substances, including prescription medications?  

“The answer is not simple and there is no quick fix.  It is easier to blame kratom or opioids and focus on those instead of addressing the complex problems of pain, mental illness and the circumstances of life that lead people to take multiple substances.  At least they ‘look’ like they are doing something.”

It was another CDC report in July 2016 that laid the groundwork for an attempted ban on kratom. The report called kratom "an emerging public health threat" due to a modest increase in the number of kratom-related calls to poison control centers. The following month, the Drug Enforcement Administration tried to schedule kratom as a controlled substance, something the agency backed away from after a public outcry.

Last week the Food and Drug Administration released a laboratory analysis that found dangerous levels of heavy metals in over two dozen kratom products. However, the agency did not consider the finding significant enough to order a recall. Kratom has never been listed as dangerous substance in the DEA’s annual National Drug Threat Assessment.

CDC Director Says Agency Will ‘Clarify’ Opioid Guideline

By Pat Anson, PNN Editor

CDC Director Robert Redfield, MD, has for the first time suggested that his agency may be preparing to make changes to its controversial opioid prescribing guideline.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” Redfield wrote in an April 10 letter to Health Professionals for Patients in Pain (HP3). 

Redfield was responding to a March 6 letter from HP3 signed by over 300 healthcare professionals urging the CDC to make a “bold clarification” of the voluntary guideline, which has been implemented as a mandatory policy by many insurers, pharmacies, states and practitioners. As a result, many chronic pain patients have been denied or forcibly tapered off opioid medication and become disabled or bedridden. Some have turned to alcohol and illegal drugs for pain relief.

The situation has become so dire, the Food and Drug Administration issued an unusual warning this week cautioning doctors not to abruptly discontinue or rapidly taper patients on opioid medication. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

ROBERT REDFIELD, md

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said in his letter, which was released a day after the FDA warning. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Redfield has been CDC director for a little over a year. The letter is his most extensive public comment to date on the opioid guideline, which was only intended for primary care physicians treating chronic, non-cancer pain. Redfield emphasized that doctors and patients should collaborate on tapering plans, but only “if a patient would like to taper.”

“The Guideline also recommends that that the plan be based on the patient’s goals and concerns and that tapering be slow enough to minimize opioid withdrawal,” Redfield said.

“We are so grateful to the CDC for its essential clarification,” said Sally Satel, MD, of the American Enterprise Institute and Yale University, who helped draft the HP3 letter. “Now it’s time for the federal, state, and non-governmental institutions that have invoked the CDC’s authority to push some traumatic changes to care to reverse course.”

‘Closing the Barn Door’

But critics wonder why it took the CDC three years to acknowledge that the guideline has been widely implemented beyond its initial intent.

“I find it striking that, while CDC has made statements from time to time about their intent that the guideline not be turned into legislation and regulations, this is the boldest statement they've made yet, and it's coming only after more than 35 states have legislated some part of the guideline, not to mention actions by payers,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management.

“If they truly did not anticipate that this was going to happen, then they were incredibly naive, because many of us made public statements predicting these outcomes at the time the guideline was released. I know there are some patient advocates who hope this will lead to the unwinding of some of the legislation, but I think that's a very long-term project. In other words, it's a bit like closing the barn door after the horse has already escaped.”

When it released its opioid guideline in 2016, the CDC pledged to evaluate its intended and unintended consequences and said it would make changes to the recommendations if needed. Redfield’s letter contains a 3-page enclosure that summarizes the agency’s efforts to evaluate the impact of the guideline. A careful reading of the enclosure, however, shows that most of the studies underway are not being conducted by the CDC itself and that they focus primarily on whether the guideline has been successful in reducing opioid prescriptions — not whether patients are being harmed by it.

“Honestly, I don't think it's such a bad thing that CDC is supporting outside work to assess the impact of the guideline. Having independent researchers who may not be as likely to feel a need to defend the guideline can only be helpful,” said Twillman.

“I sense this is a political delaying action to avoid having to admit that CDC was fundamentally wrong,” said Richard “Red” Lawhern, PhD, Director of Research for the Alliance for the Treatment of Intractable Pain (ATIP). “The Director of CDC letter has doubled down on several ‘initiatives’ which appear to assume that the original assumptions and declarations of the guidelines were correct -- which they weren't, and for which there is abundant published proof that they weren't.”

Lawhern wrote an open letter to Redfield this week, calling for CDC guideline to be revoked, not just clarified, because many of its key assumptions about the addictive potential of prescription opioids are wrong.

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many patients are hoarding opioids because they fear losing access to them and some are turning to other substances – both legal and illegal – for pain relief.