AMA Opposed to ‘Blacklisting’ of Doctors Over Rx Opioids

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Misleading CDC Study Links Prescription Opioids to Binge Drinking 

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

Patients Using Alcohol for Pain Relief

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

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

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

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

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

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

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

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

Doctor Accused of Overprescribing Opioids Fights to Keep Her License

By Pat Anson, PNN Editor

A northern California doctor who is beloved by many of her patients could lose her medical license because of allegations by the state medical board that she overprescribed opioid medication and other drugs. Dr. Corrine (Connie) Basch runs a solo primary care practice in Arcata, a small city in rural Humboldt county.

“They were looking to put a head on a spike so they could claim they were doing something about the opioid crisis,” Basch told PNN. “I am not considered a negligent doctor in town, nor am I a pill mill. And it would have taken them all of ten minutes to figure that out if they had asked anyone in my community if there was a problem here.”

A formal complaint against Basch by the Medical Board of California, first reported by the Lost Coast Outpost, centers on her treatment of five pain patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication. Although Basch had tapered them to lower doses, the complaint alleges the amounts are still excessive and the combination of drugs places the patients at risk of overdose and death.

Board Executive Director Kimberly Kirchmeyer is seeking the revocation or suspension of Basch’s license for excessive prescribing, gross negligence and failure to maintain adequate medical records.

At no point in the 25-page complaint is it alleged that any of Basch’s patients have overdosed or been harmed while under her care.  The board began its investigation of Basch in early 2018 but didn’t file the accusation until last month – suggesting it didn’t think there was any imminent threat to her patients.

“They went after me for no good reason, conducted an ‘investigation’ that was so obviously flawed, published a defamatory accusation on the Internet prior to giving me a chance to defend myself or even correct the factual errors, revealed private details of my patients’ cases on the Internet when those people live in a small town where people already know each other’s business, and would force a small town doc who treats poor people  to come up with several years’ income to defend herself and her license,” Basch said.   

DR. CONNIE BASCH

DR. CONNIE BASCH

All five of the patients in the medical board complaint were already on high doses of opioids and benzodiazepines before Basch started treating them. She tapered these “legacy” patients to lower doses, but some remained on opioid doses as high as 664 MME (morphine milligram equivalent) – well above the CDC guideline’s recommended ceiling of 90 MME.   

The CDC and FDA recently acknowledged that patients should not be forcibly tapered to lower doses and that doctors should “work with patients” before tapering or discontinuing opioids. Basch was already using that approach in her own practice. She says patients who’ve become tolerant to opioids should be weaned slowly and it could take 6-12 months just to get them off benzodiazepines.

“I’ve helped a lot of people get off pain meds,” she said. “Some of my patients stay on meds. I have a patient who is super functional on 145 MME. She’s comfortable, she can sleep through the night, and she works. I don’t see a need to lower her, except that she’s afraid. They’re all feeling insecure. They want to get off (pain meds) because there will be literally no one left to prescribe.”

Afraid to Prescribe

In recent years, California’s medical board has aggressively gone after doctors who prescribe opioids at high doses. The state’s controversial “Death Certificate Project” has resulted in threats of disciplinary action against hundreds of physicians, often years after they wrote an opioid prescription for a patient who fatally overdosed. Some doctors received warning letters even though the cause of death was suicide or involved multiple drugs – both legal and illegal.

These and other enforcement actions have had a chilling effect on doctors statewide.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” Dr. Robert Wailes, a pain specialist and chair of the California Medical Association’s Board of Trustees, told Kaiser Health News.

Should Basch lose her license or stop practicing, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

“There are now two docs I know of in our area who have retired early because of similar accusations, and another older doc who lives in a small coastal community south of us who is going through a similar thing right now,” said Basch. “There’s nowhere even to get primary care up here. And if you call and say you want to be a new patient and chronic pain is anywhere on your problem list, you are denied. So these people are literally going to be left with no one.” 

‘Medical Board Malpractice’

Basch has received over 300 letters of support from patients and several from colleagues in the medical community. Her attorney plans to present them as evidence to the medical board.

“Dr. Corrine Basch is my beloved primary care physician,” one patient wrote. “Taking away her right to assess her individual patients for risk vs benefit, forcing a bureaucratic, possibly ill-conceived set of ‘guidelines’ is what I consider Medical Board Malpractice.

“FEAR caused by actions such as yours are keeping legitimately suffering human beings from having a quality of life they deserve. THIS IS SHAMEFUL.”

“I have had my share of doctors over the years but I never had a doctor like Connie. She has ultimately saved my life and I am not just saying that,” wrote another patient who credits Basch for his sobriety after years of addiction to pills and alcohol.

“You don’t punish someone for doing the right thing and helping people get off of drugs. That is not how you fix the opiate problem plaguing America you do it by employing more people like Dr. Connie who knows the right way to get a person clean.”

Basch, who is 55, continues to practice and is gathering evidence to support her case. A hearing date has not been set on the medical board’s complaint.

“They went after the wrong person this time,” she says. “Shaming and humiliating doctors who have lived lives of service, and placing them in a position where they have to give up their calling because the cost of defense is too great late in their careers, is shameful.”   

Should Postpartum Pain Control Be a Crap Shoot?

By Lynn Webster, MD, PNN Columnist

Anticipating the birth of my second grandchild should have been a purely joyous time. My daughter was about to become a mother for the second time. The miracle of life would unfold again in our family, as it does for thousands of families, every day, all around the world.

My daughter was scheduled to have a repeat cesarean section (I am sharing this story with her permission). The first operation was uneventful, apart from the fact that it produced my first, adorable grandchild.

However, this time I was concerned that my daughter’s post-op pain might not be adequately treated. Since her first C-section three years ago, the hospital system where she delivers has made a public commitment to reducing the amount of opioids prescribed for acute pain by 40 percent.

I worried that the hospital’s choice to lessen the amount of drugs prescribed, rather than focusing on patients' clinical needs, might mean my daughter's need for pain control would be unmet.

The idea of my daughter enduring inadequately treated pain haunted me, as it would any father, but as a pain specialist, it may have troubled me even more. I have seen the unspeakable suffering that insufficiently managed pain can cause. I also know that inadequately treated acute pain can lead to chronic pain.

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The thought that my daughter might be the victim of the hospital’s well-intended attempt to reduce opioid use was highly unsettling to me, but there was little I could do about it. Doctor or not, I could not be sure that my daughter would receive the individualized treatment she deserved after her surgery.

So, several weeks before her scheduled operation, I advised my daughter to talk to her surgeon. Specifically, I asked her to find out how her post-op pain would be treated.

The irony of the situation was not lost on me. This was the first time in my career as a pain specialist and anesthesiologist that I had to worry a family member might suffer from ineffectually managed post-op pain. It was humbling. I felt as impotent and powerless as any other bystander.

I know the hospital system is addressing the number of people who abuse drugs, and their response may well be appropriate in some cases. But my daughter isn’t contributing to the problem. Why should she have to pay the price for the inappropriate behaviors of others?

Pain control was no longer only a professional concern for me. It was now very personal.

My fear was reinforced by a June 3 The Wall Street Journal article by Sumathi Reddy, “The Push for Fewer Opioids for New Mothers. In it, Reddy describes the national effort to reduce the amount of opioids used postpartum. 

Of course, opioids should not be used if there are safer and more effective alternatives. But some hospitals are taking aggressive steps to eliminate the use of any opioids. As a result, the individual needs of a patient may be lost in an effort to tackle a public health problem.

Something seems out of kilter with that line of thinking. It reminds me of the adage of not seeing the forest for the trees.

The American College of Obstetricians and Gynecologists (ACOG) recently published new guidelines for treating postpartum pain. The guideline does not exclude the use of opioids from post-op pain control. In fact, the recommendation for opioid use seems to be logical and consistent with patient-centered care.

Fortunately, my daughter’s OB is an excellent and caring clinician. Her approach is patient-centered, and she provided my daughter -- cautiously -- with the necessary analgesics to help her manage her recovery. My daughter did not like the way the medication made her feel, but without it she would not have been able to care for her newborn. 

An ACOG recommendation specifically states that postpartum pain management should involve shared decision-making. My daughter needed to understand the risks and benefits of opioids before deciding whether or not to accept them to treat her pain. This approach worked for her. The mother of my new, healthy, precious grandchild deserved no less.

All mothers across the world deserve the same level of care. I fear, in some cases, they may not be as lucky as my daughter. They may not receive the care they need, and the joy of giving birth may be superseded by the agony of unmanaged acute pain.

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Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is a former president of the American Academy of Pain Medicine, author of the award-winning book “The Painful Truth” and co-producer of the documentary “It Hurts Until You Die.” He lives in Salt Lake City with his wife and now two granddaughters.

You can find him 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.

Crackdown on Opioids and Benzodiazepines Ignores Their Benefits

By Roger Chriss, PNN Columnist

The overdose crisis is driving a lot of panicky policy to more closely regulate the prescribing of scheduled drugs, from oxycodone and other opioids to clonazepam and other benzodiazepines, which are used to treat anxiety.

A California doctor was recently accused of unprofessional conduct and could lose her license for prescribing “excessive amounts of opioid medications and benzodiazepines.” And a New Jersey doctor faces criminal charges for prescribing the so-called “Holy Trinity” of opioids, benzodiazepines and muscle relaxers.

The crackdown on opioids and benzodiazepines may help reduce overdose fatalities, but it also risks depriving people of beneficial drugs. Research is finding new benefits for familiar drugs that may slow diseases and improve quality of life.

In a recent Phase III clinical trial, a “novel” combination drug was shown to ease Charcot-Marie-Tooth disease. The drug – called PXT3003 -- provided “meaningful improvement” for people with a hereditary neuropathy that results in a progressive loss of sensation and motor function.

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This is a significant advance for people with Charcot-Marie-Tooth disease, which currently has no treatment. The FDA recently gave PXT3003 its “fast track” designation, which speeds the development of drugs for which there is an unmet medical need.

PXT3003 is a combination of three familiar drugs, naltrexone (an opioid receptor blocker), baclofen (a muscle relaxant), and sorbitol (an alcohol sugar). The how and why of this combination of drugs is not well-understood at present. The manufacturer Pharnext says there are “multiple main mechanisms of action” that improve nerve, muscle and immune cells.

In other words, research on existing drugs with known risk profiles has led to a novel treatment. Ordinarily, the use of an opioid and a muscle relaxant is regarded as clinically inadvisable and is actively counseled against in many prescribing guidelines.

Benzodiazepine Research

A similar outcome is occurring with long-term benzodiazepine therapy in congestive heart failure (CHF). An editorial in Psychotherapy and Psychosomatics reported that low-to-moderate doses of benzodiazepines “seem to be helpful in silent myocardial ischemia, angina, essential hypertension, and CHF, especially in patients with comorbid anxiety.”

This builds on research from Taiwan in 2014 showing that anti-anxiety medications are “associated with a decreased risk of cardiac mortality and heart failure hospitalization in patients after a new myocardial infarction.”

Long-term benzodiazepine therapy is already seen as important in the treatment of rapid eye movement sleep behavior disorder, a condition in which causes people to act out vivid and violent dreams, often injuring themselves or bed partners. Low-dose clonazepam therapy for months or even years turns out to be a highly effective treatment.

In the same fashion, benzodiazepines are used to treat stiff-person syndrome, a rare neurological disorder that causes extreme muscle rigidly and spasms that can make walking impossible. According to the National Institutes of Health, therapy to treat stiff-person syndrome includes “anti-anxiety drugs, muscle relaxants, anti-convulsants, and pain relievers.”

‘Political Interference’ in Medicine

But treatments for these disorders and the development of new regimens for other disorders may be impeded under current federal and state laws and guidelines. Recently a coalition of six physician groups called on state legislatures to end their “political interference” in the practice of medicine and the patient-physician relationship.

“The insertion of politics between patients and their physicians undermines the foundation of trust this relationship is built on and inhibits the delivery of safe, timely, and comprehensive care. Outside interference endangers our patients’ health by limiting, and sometimes altogether eliminating, access to medically accurate information and to the full range of health care,” the coaltion warned.

Physicians should never face imprisonment or other penalties for providing necessary care. These laws force physicians to decide between their patients and facing criminal proceedings.
— Coalition of physician groups

“Physicians should never face imprisonment or other penalties for providing necessary care. These laws force physicians to decide between their patients and facing criminal proceedings. Physicians must be able to practice medicine that is informed by their years of medical education, training, experience, and the available evidence, freely and without threat of criminal punishment.”

The statement was released by the American Academy of Family Physicians, American Academy of Pediatrics, American College of Physicians, American Congress of Obstetricians and Gynecologists, American Osteopathic Association and American Psychiatric Association.

As the past couple of years have shown, prescribing guidelines have a way of leading to blanket prohibitions. And a risk of blanket prohibitions is that we may miss important benefits.

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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.

Prescription Opioids Play Minor Role in Massachusetts Overdoses

By Pat Anson, PNN Editor

Two new studies in Massachusetts – one of the states hardest hit by the overdose crisis – highlight the role of multiple substances in most overdose deaths and how limiting the supply of prescription opioids has failed to reduce the number of drug deaths.

Researchers at Boston Medical Center's Grayken Center for Addiction analyzed toxicology reports on nearly 2,250 fatal overdoses involving opioids in Massachusetts between 2014 and 2015. Overdose data in Massachusetts is considered more reliable because it is one of the few states to extensively use toxicology testing.

Only 9 percent of the deaths in Massachusetts involved prescription opioids alone. Most of the overdoses (72%) involved illicit fentanyl or heroin, while one in five (19%) involved a combination of heroin, fentanyl or prescription opioids.

Other substances such as alcohol, marijuana, stimulants (cocaine and methamphetamine) and non-opioid medications (benzodiazepines and gabapentin) were also frequently involved.

“Using multiple substances, in addition to opioids, is the rule rather than the exception for opioid-related deaths,” researchers reported in the journal Drug and Alcohol Dependence.

“Our study draws attention to the heterogeneity of the problem at hand and that there is not a one-size-fits-all approach to addressing the overdose epidemic, which is increasingly driven by polysubstance use.”

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Over half of the Massachusetts overdoses involved someone with a diagnosed mental illness. Homelessness and a recent incarceration also raised the risk of a fatal overdose involving both opioids and stimulants.

"As a provider, these findings indicate a pressing need to address and treat not just opioid use disorder, but other substances that patients are misusing," said lead author Joshua Barocas, MD, an infectious disease physician at BMC. "To truly make a difference in reducing opioid overdose deaths, we must tackle issues such as homelessness and access to mental health services. This means not only investing in treatment but also implementing tailored programs that address the specific barriers to accessing care."

Opioid Prescriptions Down 39% since 2015

The number of opioid prescriptions has declined significantly in Massachusetts over the last four years, according to a recent report from the state’s Department of Public Health. In the first quarter of 2019 there were over 518,000 prescriptions filled for Schedule II opioids such as hydrocodone and oxycodone – a 39% decline from the first quarter of 2015.

But the decrease in prescriptions has failed to make much of a dent in Massachusetts’ opioid overdose rate, which peaked in 2016 with 2,100 deaths and remains stubbornly high.  

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

In 2018, nearly nine out of ten opioid-related deaths (89%) in the state involved illicit fentanyl, with cocaine (39%), heroin (32%), and benzodiazepines (40%) such as Xanax also commonly found.

Only about ten percent of the overdose deaths in the fourth quarter of 2018 involved prescriptions opioids, virtually unchanged from the 2014-2015 study.

Federal Task Force Releases ‘Roadmap’ to Treat Pain Crisis

By Pat Anson, PNN Editor

A federal advisory panel has released its final report on recommended best practices for acute and chronic pain management, calling for a balanced approach to pain treatment that focuses on individualized patient care – not rigid guidelines that triggered a pain crisis for millions of Americans.

“There is a no one-size-fits-all approach when treating and managing patients with painful conditions,” said Vanila Singh, MD, Task Force chair and chief medical officer of the HHS Office of the Assistant Secretary for Health. “Individuals who live with pain are suffering and need compassionate, individualized and effective approaches to improving pain and clinical outcomes. This report is a roadmap that is desperately needed to treat our nation’s pain crisis.”

Unlike previous federal efforts that focused primarily on limiting access to opioid medication while expanding access to addiction treatment, the 116-page report by the Pain Management Best Practices Inter-Agency Task Force took a more comprehensive approach to pain management that focused on the needs of patients, improving their quality of life, and establishing a “therapeutic alliance” between patient and clinician.   

The panel sought and received feedback from over 5,000 patients, advocates and healthcare providers on issues such as suicide, patient abandonment and the stigma associated with chronic pain. Several patient stories were incorporated into the final report.

Even longtime critics of federal pain care policies were impressed.

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“This report from the HHS Pain Management Task Force is exceptional, in my view. Rarely have I seen a report that is of such high quality, with such reasonable, common-sense recommendations,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “The willingness to recognize concerns expressed by people with pain and by healthcare providers is not something we have often seen, and it is refreshing to see those comments play an important role here.”

“I truly hope this is a huge step forward,” said Andrea Anderson, a pain sufferer and patient advocate. “I think there was much to be praised, such as the focus on individualized patient care, the need for multi-disciplinary treatment teams with care-coordination, a more robust focus on post-surgical pain management, an emphasis on moving complementary and integrative health approaches into the main stream of pain treatment, and the need for further education and research  on a number of important topics.”

No Repeal of CDC Guideline

The task force did not call for a repeal of the CDC’s controversial opioid prescribing guideline, but said the guideline should be clarified and updated with better evidence to supports its recommendations..

“The Task Force recognizes the utility of the 2016 CDC Guideline for many aspects of pain management and its value in mitigating adverse outcomes of opioid exposure. Unfortunately, misinterpretation, in addition to gaps in the guideline, has led to unintended adverse consequences. Our report documented widespread misinterpretation of the CDC Guideline — specifically, the recommendation regarding the 90 morphine milligram equivalents (MME) dose,” the report found.

“Educating stakeholders about the intent and optimal application of this guideline and re-emphasis of its core beneficial aspects are essential. Instances have been reported where the CDC Guideline was misapplied to the palliative care and cancer populations with pain and to providers who care for these patient populations.”

The task force called for a more “even-handed approach” to opioid prescriptions that allows doctors to use their own clinical judgement on how to treat patients.

“Various health insurance plans, retail pharmacies, and local and state governments are implementing the CDC Guideline as policy, limiting the number of days a patient can receive prescription opioids even when the seriousness of the injury or surgery may require opioids for adequate pain management for a longer period. A more even-handed approach would balance addressing opioid overuse with the need to protect the patient-provider relationship by preserving access to medically necessary drug regimens and reducing the potential for unintended consequences,” the task force said.

That kind of thinking is heresy to anti-opioid crusaders and politicians who consider the CDC guideline a cornerstone of the government’s war on drugs. Even before the task force report was finalized, 39 state and territory attorney generals wrote a letter of protest.   

“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 that causes nearly 50,000 deaths annually,” the letter warns. “It is incomprehensible that officials would consider moving away from key components of the CDC Guideline.”

Critics have also claimed that some task force members have a conflict-of-interest because of their financial ties to pharmaceutical companies. Oregon Sen. Ron Wyden (D) — who has received millions of dollars in campaign donations from healthcare companies and insurers — recently told Mother Jones that the task force was “being used as part of the industry’s broader effort to water down the CDC’s recommendations on opioid prescribing.”

The 29 members who served on the task force included representatives from the FDA, CDC, VA and Office of National Drug Control Policy; as well as academic and medical experts in pain management, addiction treatment, pharmacy, oncology, psychiatry and interventional medicine. There was only one patient advocate, Cindy Steinberg of the U.S. Pain Foundation.

Interestingly, Harold Tu, MD, the lone dentist on the panel, is the father-in-law of Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guideline. Tu voted in favor of the task force’s final report.

The report’s recommendations are voluntary and not binding on the Department of Health and Human Services or anyone else. The task force was created in 2016 by the Comprehensive Addiction and Recovery Act to “determine whether there are gaps in or inconsistencies between best practices for pain management.”

Those gaps have been identified. Whether anyone will get to work and fill them is unclear.

“I think the task force provided a very good analysis of the problem with recommendations that if implemented should help millions of Americans with pain and reduce the problem with opioids,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine and a PNN columnist.

“My concern is that there doesn't appear to be any teeth to the recommendations. I would like to have seen some specifics but that may have been too much to expect at this stage.”

Liability Trial of Opioid Drug Maker Could Set Precedents

By Jackie Fortier, Kaiser Health News

All eyes will be on Oklahoma this week when the first case in a flood of litigation against opioid drug manufacturers begins. Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

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Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

Rx Opioids ‘Useful Products’

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Food and Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths.

“Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News. KHN is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Pain Clinic Sign ‘Unauthorized and Untrue’

By Pat Anson, PNN Editor

A Florida-based chain of surgery centers and pain clinics says a sign that briefly appeared at one of its clinics implying that the company would no longer prescribe opioid medication is unauthorized and untrue.

The sign appeared in a window at Physician Partners of America’s Jacksonville clinic on May 14.  Someone took a picture of the sign and posted it online, where it was widely shared on Twitter and Facebook among pain patients, advocates and doctors.

“ATTENTION ALL PATIENTS,” the sign said in bold red letters. “Per our chief (medical) officer, Dr. Rivera, we will be starting to focus on interventional medicine only and we will not be managing medication. This will be fully effective within the next 30 days or less.”

For someone taking opioid medication for chronic pain, the threat of being cutoff is very real. The potential number of patients that would be impacted would also be significant. Physician Partners of America (PPOA) treats around 20,000 patients in Florida and Texas.

The problem with the sign is that it isn’t true, according to the company.

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“This sign was brought to our attention through social media. It was in no way authorized or approved by management, and its message is untrue. It resulted from an employee’s misinterpretation of our goal to reduce opioid dependence,” Maria Hickman, PPOA’s social media and content specialist, said in a statement on the company’s website.

“We recognize the opioid crisis backlash. As an organization, we sympathize with the plight of people who rely on, but who do not intentionally abuse, prescription opioid medications to manage their chronic pain. We aim to show them what we consider a better, safer way to reduce or eliminate pain.”

That “safer way” is interventional pain management, a more aggressive form of treatment that includes epidural steroid injections, nerve blocks, “minimally invasive” spinal procedures, Botox injections, spinal cord stimulators and stem cell therapy. Interventional methods are more expensive than pain medication, are not always covered by insurance, and many patients believe they are neither safer or effective.

PPOA said it would continue prescribing opioids to patients when it is appropriate, adding that they would be tapered to lower doses. “Patients are and will continue to be titrated down according to CDC guidelines; however, there is no cut-off date,” Hickman said.

That part of the company’s statement reflects a common misconception about the CDC’s controversial guideline, which is voluntary and does not mandate tapers. The 2016 guideline only recommends tapering “if benefits do not outweigh harms of continued opioid therapy” and explicitly says tapering should be voluntary, with the patient’s consent.

“Clinicians should emphatically review benefits and risks of continued high-dosage opioid therapy and should offer to work with patients to taper opioids to safer dosages. For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline says.

That part of the guideline has been so widely ignored that CDC Director Robert Redfield, MD, released a letter last month warning doctors not to taper patients without their consent.

“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.”

The marketing of Physician Partners of America clearly states a preference for interventional therapy over opioid medication, so patients who go to a PPOA clinic shouldn’t be surprised if tapering or discontinuation is recommended.

“At its foundation, PPOA uses interventional pain management modalities to treat pain at its source instead of masking it with medication,” the company says. “We have championed remedies to the opioid crisis in public forums, in the media, in televised town halls and at medical conventions. PPOA physicians strictly follow the prescribing laws of the states in which they operate.”

A new law recently went into effect in Florida limiting the initial supply of opioids to 3 days, with a 7-day supply allowed if it is medically necessary. However, the law only applies to acute, short-term pain.  Most of PPOA’s patients suffer from chronic back pain and other long-term chronic conditions.

American Pain Society Likely to File for Bankruptcy

By Pat Anson, PNN Editor

The board of directors of the American Pain Society (APS) is recommending to its members that the organization cease operations and file for bankruptcy, PNN has learned.

The APS is a non-profit, research-based organization that focuses on the causes and treatment of acute and chronic pain. Although many of its members are researchers and academics who are investigating non-opioid treatments for pain, the APS has been named as a defendant in numerous “spurious lawsuits” involving opioid prescriptions.

“Despite our best efforts, APS was unsuccessful in its attempts to resolve these lawsuits without the need for what will no doubt be lengthy and expensive litigation. The anticipated time-consuming and costly litigation combined with the declining membership and meeting attendance has created the perfect storm placing APS in a precarious financial position,” the board said in a letter sent to its members yesterday.

“Constrained by these unfortunate circumstances, we do not believe APS can continue to fulfill its mission and meet the needs and expectations of our members and community.”   

In order to proceed with a Chapter 7 bankruptcy filing, only 10% of the organization’s 1,173 active members need to approve the board’s recommendation. Assuming there are sufficient votes, an independent third party trustee would then be appointed by a bankruptcy judge and all lawsuits pending against APS will be subject to an automatic stay.

“This will allow APS to minimize legal expenses and maximize recoveries for its creditors, as opposed to future dissipation of assets in defending the lawsuits which have no end in sight,” the board wrote.

The APS membership vote will be tallied May 29th.

Sad day for U.S. pain research, education, advocacy and patient care,” APS member and Stanford University psychologist Beth Darnall, PhD, tweeted to her followers.

In recent years, thousands of lawsuits have been filed by states, cities and counties seeking to recover billions of dollars in damages caused by the “overprescribing” of opioid pain medication. The lawsuits initially focused on Purdue Pharma and other opioid manufacturers, but have recently expanded to include opioid distributors, wholesalers, pharmacies and professional medical organizations like the APS as defendants.

If the APS files for bankruptcy, it would be the second pain management organization to cease operations in recent months. In February, the Academy of Integrative Pain Management (AIPM) shutdown, largely due to financial problems.  

“It's really sad that pain organizations are failing,” said Bob Twillman, PhD, the former Executive Director of AIPM. “I'm not clear about the extent to which this was an anticipated or desired outcome of the lawsuits against opioid manufacturers, but it strikes me that an effort to say that we've been harming people by treating pain the wrong way has now eliminated two organizations focused on treating pain the way every guideline now says it should be treated, and on discovering new treatments that might obviate the need for opioids.”

Twillman says the shutdown of APS and AIPM will cause “significant gaps in the field” of pain management.

“The unintended consequences here may end up being quite ironic," he added.

Guilt by Association 

Like other professional medical organizations, APS relied on corporate donors to help pay for its annual meetings and widely respected publication, The Journal of Pain. That meant accepting nearly $1 million in donations from Purdue Pharma, Janssen, Depomed and other opioid manufacturers.

It also meant being targeted by lawyers and politicians in a campaign of guilt by association.

In 2018, APS was one of the medical societies and patient advocacy groups singled out by Missouri Sen. Claire McCaskill (D) in a Senate report that accused the organizations of being mouthpieces for opioid manufacturers. 

“Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use — and ultimately, the financial interests of opioid manufacturers,” the report found.

McCaskill’s report failed to mention that she accepted nearly $500,000 in campaign donations since 2005 from the national law firm of Simmons Hanly Conroy, which represents many of the plaintiffs involved in opioid litigation. It has named the APS as a defendant in several of those lawsuits, along with American Academy of Pain Medicine and American Geriatric Society “for working with the manufacturing defendants in promoting opioids to doctors and patients.”

Simmons Hanly Conroy was the third largest contributor to McKaskill during her losing bid for re-election last year, donating over $400,000, an amount seven times larger than it gave to another candidate in 2018, according to OpenSecrets.org.

According to its website, Simmons Hanly Conroy currently represents governmental entities in Illinois, Louisiana, Texas, and eight New York counties in opioid lawsuits. The law firm reportedly stands to collect one-third of the proceeds from opioid settlements, which could potentially reach $50 billion, according to a Bloomberg analyst.

‘Corrupting Influence’

APS is also mentioned in a congressional report released this week by Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY). The “Corrupting Influence: Purdue and the WHO” report accuses the World Health Organization of being unduly influenced by Purdue Pharma and other opioid makers when it developed guidelines in 2011 and 2012 to treat pain in adults and children.

“The web of influence we uncovered, combined with the WHO’s recommendations, paints a picture of a public health organization that has been manipulated by the opioid industry,” the report said. “The investigation revealed that multiple organizations that claimed to be independent patient advocacy groups, including the American Pain Society, received significant payments from opioid manufacturers.”

The report does not mention that Rep. Clark has also accepted significant payments from drug makers. According to OpenSecrets.com, Clark has received over $522,000 in campaign donations from the healthcare industry since 2013, including donations from Pfizer, Celgene, Takeda, Biogen, Vertex, AstraZeneca and Sanofi.

Rep. Rogers has received over $581,000 in campaign donations from the healthcare industry during his 30 years in Congress.