AMA: Pain Patients ‘Need To Be Treated as Individuals’

By Pat Anson, PNN Editor

The American Medical Association is once again calling on the CDC to scrap dosage limits and make other changes to its controversial 2016 opioid prescribing guideline.

In a letter sent Thursday to a top official at the CDC’s National Center for Injury Prevention and Control (NCIPC), the chair of the AMA’s board of trustees said pain sufferers “need to be treated as individuals” and should not be subject to dose limits. The CDC is currently preparing a revision and possible expansion of the guideline, a lengthy process that could take another year to complete.

“A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end. We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse,” wrote Bobby Mukkamala, MD, a Michigan surgeon and chair of the AMA board.

The CDC said last week that a record 93,331 Americans died of drug overdoses in 2020. Although the vast majority of those deaths involved illicit fentanyl, heroin and other street drugs, efforts at combating the overdose crisis continue to focus on patients, doctors and reduced opioid prescribing.

“Patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy,” said Mukkamala.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

The AMA has been warning about the “inappropriate use” of the guideline since 2018, when its House of Delegates adopted resolutions calling for the elimination of dose thresholds based on morphine milligram equivalents (MME). The CDC guideline recommends that daily doses not exceed 90 MME, a dose that some patients consider inadequate for pain relief.  

Recommendations a ‘Rough Guide’

At a meeting last week of the CDC Board of Scientific Counselors, one of the authors of the 2016 guideline said the MME thresholds were only meant to be “a rough guide” for prescribers and shouldn’t been seen as “absolutes.”

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of NCIPC.

Critics might wonder if the agency has learned anything in the last five years. A preliminary draft of a revised guideline still contains dose thresholds, recommending that doctors “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

An independent panel of outside advisors that reviewed the draft expressed concern about maintaining the dose thresholds, saying they would lead to more forced tapering of patients.

“Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the Opioid Workgroup said in its final report to CDC.

The workgroup also warned that the current draft revision of the guideline was “not balanced” because it focuses heavily on the risks and potential harms of opioids, with less attention paid to their potential benefits. The AMA called on the CDC to adopt the workgroup’s recommendations.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala said in closing his letter.

Opioid Income Redistribution

That view is not shared by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), which sent out a news release this week claiming that prescription opioids are largely responsible for the overdose epidemic.

“Tragically, prescription opioids still account for about 28% of all opioid-related deaths.  Prescription opioids also contribute to synthetic opioid deaths because many heroin and illicit fentanyl users developed their addiction from taking prescription opioids,” PROP claimed. ”Overprescribing of opioids continues to fuel this epidemic. Reducing new opioid prescriptions remains vitally important.”

At least four PROP board members, including founder Andrew Kolodny, MD, have testified as paid witnesses for plaintiff law firms involved in opioid litigation, making as much as $725 an hour. Those law firms stand to make billions of dollars in contingency fees as those cases near an end, with one recent settlement expected to result in a $26 billion jackpot for states, cities and counties. As PNN has reported, many of the lawyers involved in the cases are major political donors.

“Businesses can’t print cash, so where do politicians think the money for these payoffs will come from? The answer is customers in higher prices and workers in lower wages,” The Wall Street Journal said in an editorial.

“The opioid settlement is another example in a growing list of lawsuits that redistribute income from the larger society to rich plaintiff attorneys, who then help politicians with their campaign contributions, who then rehire the lawyers to help with more mass tort claims. Alas, it’s the American way.”

Insomnia Drugs Risky When Taken With Opioids

By Pat Anson, PNN Editor

Medications commonly prescribed to treat insomnia significantly increase the risk of death for older adults if the drugs are taken with opioids, according to new study.

Zopiclone, zaleplon and zolpidem – collectively known as “Z-drugs” – are sold under brand names such as Ambien, Lunesta and Sonata. Z-drugs are sedative-hypnotics and act in a similar way as benzodiazepines, but are considered safer because they belong to a different class of medication.

But after reviewing the medical records of over 400,000 Medicare patients aged 65 and older, researchers at Vanderbilt University Medical Center found that Z-drugs are nearly as risky as benzodiazepines. Patients using benzodiazepines and opioids had a 221% higher risk of death from any cause, while those taking z-drugs and opioids had a 68% increased risk of dying.

Benzodiazepines such as Xanax and Valium are primarily used to treat anxiety. Until recently, benzodiazepines were often co-prescribed with opioids to pain patients, a practice that is now discouraged because both drugs suppress respiration, which can lead to an overdose.

"Our findings indicate that the risks of benzodiazepine-opioid use go well beyond the recognized hazards of overdose. They also suggest that the z-drugs, thought to have better safety than the benzodiazepines, in fact are dangerous when prescribed in combination with opioid pain medications," said Wayne Ray, PhD, professor of Health Policy at Vanderbilt and lead author of the study published in PLOS Medicine.

"Our findings add urgency to efforts to limit concurrent prescribing of benzodiazepines and opioids. They also suggest that targeted warnings are needed to advise older patients and their providers regarding the potential risks of taking z-drugs with opioids."

Last year the Food and Drug Administration ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and overdose, particularly when the drugs are used with opioids or alcohol.   

In 2019, the FDA also ordered stronger warning labels for Z-drugs, but in that case it was to caution people about rare side effects such as sleepwalking, sleep driving and other risky behaviors.  

CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids

By Pat Anson, PNN Editor

An independent advisory panel is warning the CDC that a draft revision of its 2016 opioid guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients.

A 12-page report from the CDC’s Opioid Workgroup was discussed Friday during an online meeting of the agency’s Board of Scientific Counselors (BSC). The 23-member workgroup is composed primarily of physicians, academics and researchers involved in pain management, including some who advised the agency during the drafting of the original guideline.

CDC has not made public the revised draft guideline and has no plans to release it for public comment until later this year. The workgroup, however, has seen the draft and many of its members have issues with it.     

“Overall, many workgroup members felt that much of the supporting text of the guideline was not balanced and was missing key studies. Many workgroup members felt that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits of opioids, or the risk of not taking opioids or undertreating pain,” the workgroup report states.

“Many workgroup members noted how the guideline has a constant tension between public health benefits versus patient benefits. This issue is minimally addressed in the guideline and comes very late. Workgroup members felt it is important to directly address this tension between risks and benefits to public health versus individual patients.”

Although voluntary and only intended for primary care physicians treating chronic pain, the 2016 guideline’s recommended dose limits for opioids were quickly adopted as policy by many states, insurers, law enforcement, pharmacies and doctors of all specialties.

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses. Many new patients who need pain relief can’t even get opioids because their doctors refuse to prescribe them. Opioid prescriptions have fallen to their lowest level in 20 years, but drug deaths continue rising.

Not until 2019 did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. The newly revised guideline is not expected to be released until late 2022.

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused.”

— Dr. Deborah Dowell, CDC

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of the CDC’s National Center for Injury Prevention and Control (NCIPC), who co-authored the original guideline.

Dowell gave a brief outline of the guideline update to the BSC, noting that it’s recommendations are being expanded beyond chronic pain to include acute pain (pain lasting less than one month) and sub-acute pain (pain lasting 1 to 3 months).

She also disclosed the names of the five co-authors who are writing the update, briefly showing their names on a slide. They include Dowell herself, Kathleen Ragan, a CDC Health Scientist; Christopher Jones, PharmD, Acting Director of NCIPC; Grant Baldwin, PhD, Director of Overdose Prevention at NCIPC; and Roger Chou, MD, Director of the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which has received billions of dollars in research funding from the federal government.

The inclusion of Chou as an update co-author is likely to be controversial. As PNN has reported, Chou has been an outspoken critic of opioid prescribing and has numerous ties to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like Dowell, Chou was a co-author of the 2016 guideline.

“It is wildly inappropriate and unethical that someone with strong ties to the anti-opioid industry and who has significant financial conflicts of interest is leading this process,” Amy Partridge, an intractable pain patient, told the BSC. “The evidence review and guidance are therefore both inherently biased and should be struck in their entirety.”

Chou — who is a member of the BSC — acknowledged he has a conflict of interest at the start of the meeting and recused himself. “I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the director's update,” said Chou.

Chou’s recusal apparently only applied to his participation in the meeting, not to his continuing involvement in the guideline update or OHSU’s research.

Dose Recommendations Questioned

Some members of the Opioid Workgroup feel the current draft of the update is “not sufficiently patient-centered,” while others believe not enough attention was paid to disparities in pain care and lack of access to effective, non-opioid treatments.

One of the biggest issues for the workgroup is the revised guideline’s recommendation that initial opioid doses be limited to 50 morphine milligram equivalents (MME) per day and not be increased above 90 MME, which is essentially unchanged from the 2016 guideline. The workgroup believes the dose thresholds are arbitrary, based on poor evidence and should be “de-emphasized.”

“Many workgroup members voiced concern about the dose thresholds written into the recommendation. Many were concerned that this recommendation would lead to forced tapers or other potentially harmful consequences. Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the report found.

Dowell said the MME thresholds are only meant to be “a rough guide” and shouldn’t been seen as “absolutes.”

“We certainly are looking at language in the guideline and also looking at feedback about how to better communicate those nuances and their flexibility,” she told the BSC.

Worries About ‘Bad Policy’

Several workgroup members have issues with the recommendation that non-opioid therapies be used for “many common types of acute pain,” because it doesn’t distinguish between post-surgical pain that may require opioids and other types of short-term trauma that could be treated with non-opioid pain relievers. They warned the recommendations for treating acute pain “could be misinterpreted and translated into bad policy.”

The workgroup also took issue with recommended drug testing for anyone prescribed opioids for chronic pain. Their report says false results from urine drugs tests are common and could have “inappropriate negative consequences” for patients, while more accurate and expensive laboratory tests may not be covered by insurance.

Questions were also raised about prescription drug monitoring programs (PDMPs), particularly the use of algorithms and data mining to create risk scores for patients based on their drug history.

It's important to note that the workgroup’s role is strictly advisory. It had no direct role in writing the revised guideline and will not be involved in rewriting it, if changes are even made.

You can watch most of the meeting below (video courtesy of Peter Pischke):

The workgroup’s report drew both criticism and praise during the public comment period. Some speakers believe the guideline can’t be fixed and should be repealed.

“No matter the intent, goal or method that the CDC may desire with these guidelines and their purpose in the American healthcare system, the DEA will still manipulate them to serve their way,” said Margaret Rene Blake, a pharmacist and intractable pain sufferer. “As long as they exist, they can and will be misapplied. The way to stop the harm to patients, providers and the system is to repeal the guideline.”

One critic suggested the workgroup volunteers, who were unpaid, were swayed by the pharmaceutical industry.

“The OWG (Opioid Workgroup) comments perpetuate myths disseminated by opioid manufacturers. Claiming that the guideline focused heavily on the risks or potential harms of opioids, while less attention was focused on the potential benefits is certainly an industry friendly view,” said Adriane Fugh-Berman, MD, Director of PharmedOUT and a PROP board member, who was a paid expert witness in Oklahoma’s lawsuit against opioid manufacturers.

“Several statements in the OWG (report) are just wrong, including the claim that continuing and not tapering opioids avoids risks of poor analgesia, worsening function and suffering.”

Without seeing the revised draft guideline in its entirety, it’s hard to tell if any significant changes have been made to the original guideline. But judging from the workgroup’s report, the changes have been minor so far. The draft guideline continues to maintain that “nonopioid therapies are preferred” for both short and long-term pain, and that doctors should only consider opioids “if expected benefits for pain and function are anticipated to outweigh risks to the patient.”

There is also no indication what the CDC intends to do to persuade states, insurers, pharmacies, doctors and other federal agencies that they should amend opioid policies and laws that are based on the 2016 guideline.

Ending the War on Drugs Probably Won’t Help Pain Patients

By Roger Chriss, PNN Columnist

America’s war on drugs has been running for half a century and calls to bring it to an end are increasing. Lawmakers and public health experts are questioning federal and state policies that criminalize drug use, while the public generally supports less punitive measures to address drug abuse and addiction.

"The war on drugs must end,” said a recent editorial in The Lancet. “Decriminalisation of personal drug use, coupled with increased resources for treatment and harm reduction, alongside wider initiatives to reduce poverty, and improve access to health care, could transform the lives of those affected."

But ending the war on drugs probably won’t help people with chronic painful conditions. That’s because decriminalization of recreational drugs is not necessarily associated with full legalization – as is the case with marijuana -- while legalization of recreational drugs is separate from medical care with pharmaceutical prescriptions.

The debate about how to end the drug war is largely ideological at this point. In the new issue of The American Journal of Ethics, Carl Hart, PhD, author of the book “Drug Use for Grown Ups,” writes with colleagues that laws criminalizing drug use are “rooted in explicit racism.”

"We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation," they wrote.

But bioethicist Travis Rieder, PhD, author of the book “In Pain” about his experience with opioid-based pain management, wrote in the same journal that “ending the war on drugs does not require legalization, and the good of racial justice and harm reduction can be achieved without legalization.”

Yet another view comes from Stanford psychiatrist and PROP board member Anna Lembke, MD, who wrote in the Journal of Studies on Alcohol and Drugs that creating a “safe supply” of drugs by legalizing the non-medical use of prescription medication would be a mistake.

“The expanded use of controlled prescription drugs should not occur in the absence of reliable evidence to support it, lest we find ourselves contending with a worse drug crisis than the one we’re already in. No supply of potent, addictive, lethal drugs is ‘safe’ without guarding against misuse, diversion, addiction, and death,” said Lembke.

The Lancet points to Portugal as an example that other countries should follow. But contrary to common belief, Portugal has not legalized drugs. In Portugal, drug possession of no more than a ten-day supply is an administrative offense handled by so-called dissuasion commissions.

Portugal has not even legalized recreational cannabis. Medical cannabis is legal in Portugal, but only when prescribed by a physician and dispensed by a pharmacy if conventional medical treatments have failed. Personal cultivation of cannabis remains against the law.

Further, neither decriminalization nor legalization necessarily improves racial and social justice. For instance, the University of Washington’s Alcohol & Drug Abuse Institute reports that the legalization of cannabis in Washington state in 2012 has had no impact on reducing racial bias in policing and other disparities in the criminal justice system.

Broad drug decriminalization or legalization would likely have little impact on pain management. Healthcare professionals routinely prescribe medications that are illegal outside of clinical medicine, after weighing the risks and benefits for each patient. Patients are often monitored via pain contracts and drug testing, with some agreements even disallowing cannabis and restricting alcohol use for patients taking medications like opioids or benzodiazepines.

Physicians and pharmacies are under increasing scrutiny from law enforcement, insurers and regulators in the hope of curbing drug abuse. If decriminalization or legalization of drugs leads to more abuse, addiction and overdose, then the scrutiny could increase. So in an unexpected way, an end to the war on drugs could have negative impacts on pharmacological pain management.
 
Supporting an end to the war on drugs is a right and just action. But it would be a mistake to assume that an end to that war will necessarily bring a positive change to pain management. For that, it would be better to support physician autonomy and greatly expanded clinical research into pain management.

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.  

Pain Community Mourns Loss of Patient Advocate Erin Gilmer

By Pat Anson, PNN Editor

Erin Gilmer didn’t fail. The healthcare system failed her.

That’s what hundreds of Gilmer’s friends and followers are saying, as word spreads online about her death last week by suicide at the age of 38. Gilmer was a patient advocate and health policy attorney who intimately knew the problems faced by many chronically ill patients. She was one herself.

Gilmer lived with Type 1 diabetes, celiac disease, rheumatoid arthritis, neuropathy, carpal tunnel, depression and a string of other chronic health problems. According to friends, Gilmer was abandoned by doctors, could no longer work and was on disability. Lacking the financial resources to get good healthcare, she became increasingly despondent about her failing health.    

“I loved you more than you could know. I’m sorry for all the ways I failed. I’m safe now,” Gilmer tweeted @GilmerHealthLaw on July 7. It was her last post.      

“You haven’t failed me. There were many times you saved me. I hope that wherever you are, you’re safe & surrounded by love,” one follower responded.

“I don’t recall any ways you failed, but I treasure all of the difference you made in my life & the lives of many others,” said another.

“Erin, you haven’t failed at all. So many systems have failed you,” another follower tweeted.

In the days before she passed, Gilmer wrote frankly and honestly about her health issues, her posts reflecting a growing sense of finality.

ERIN GILMER

“I wish I could describe how bad the pain is but nothing seems adequate. I keep thinking it can’t possibly get worse but somehow every day is worse than the last,” Gilmer tweeted. “This pain is more than anything I’ve endured before and I’ve already been through too much. Yet because it’s not simply identified no one believes it’s as bad as it is. This is not survivable.”

According to fellow patient advocate Terri Lewis, Gilmer was labeled and shunned by doctors as a complex patient with mental health issues. 

“Like so many others, Erin's life was squandered. The loss of her unique talents, capacity, and learning is just unbelievable to me,” said Lewis. “I am angry that we find it acceptable to foster a system of siloed ‘healthcare’ that continues to reward marginalization and abandonment of persons with chronic multiple comorbidities. The death of Erin and so many like her was predictable, a matter of time in a system perfectly designed to fail chronic care needs. This was no error. The system is working as it is designed.” 

According to her blog, Gilmer received her law degree from the University of Colorado. She began her legal career in Texas as a disability rights attorney for several non-profit organizations. Gilmer also worked and consulted at Stanford University, the Patient Centered Outcomes Research Institute and the Agency for Healthcare Research and Quality (AHRQ). Gilmer moved back to Colorado and launched her own private legal practice in 2012, but was not able to work full time after becoming disabled. 

She turned to advocacy as an alternative — educating doctors and patients about the anxiety and stress many chronically ill patients experience while navigating a broken healthcare system. In one of the last posts on her blog, Gilmer wrote about “betrayal trauma.”   

“If we want people to trust health care, if we want people to heal from the chaos and pain of health care, if we want people to seek out care, we need to both understand the traumas we’ve endured, including betrayal trauma, and implement trauma informed care for all as soon as possible,” Gilmer wrote.

“Patients deserve better. Patients deserve fewer barriers to care and more compassion throughout care. Patients deserve to have their betrayal trauma acknowledged and repaired. Patients deserve to be believed and heard and treated with dignity and kindness.”

Revised CDC Opioid Guideline Not Expected Until Late 2022

By Pat Anson, PNN Editor

The long wait for the CDC to finally unveil changes to its controversial opioid guideline is going to be longer than we thought.

Even though an update to the 2016 guideline is the main topic on the agenda for a July 16th meeting of the CDC Board of Scientific Counselors (BSC), the agency has no plans to make the revisions public at that time. PNN reported earlier this week that the CDC was “expected to release a long-awaited draft of a revised guideline” during that meeting, but that is incorrect.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” Courtney Lenard, CDC spokesperson, wrote in an email. 

The “Opioid Workgroup” is an independent panel of physicians, academics and patients that was created last year to advise the CDC about revisions to the guideline. The panel had no direct role in rewriting the guideline and has only seen a draft of it.

According to the July 16 meeting agenda, at least three hours have been set aside for the BSC to receive an update on the guideline from CDC staff, followed by a discussion of the workgroup’s report. How such a lengthy discussion could occur without the revised guideline being made public is unclear.

When asked to explain, Lenard said only the “process and progress” of the revised guideline would be discussed. She also indicated the public may not see a draft version in the Federal Register until late this year, with the final, revised guideline not expected until late 2022.

“CDC anticipates that the draft updated Guideline will be posted for public comment by the end of 2021. This will provide another critical opportunity for diverse input from the public,” Lenard explained. “In 2022, after the public comment period has closed, CDC will revise the draft updated Guideline. CDC takes public comment seriously and will carefully consider this input while finalizing the update to the Guideline. Release of a final, updated Guideline is anticipated to occur in late 2022.”

People in pain and their advocates have been calling for major changes to the guideline ever since its 2016 release. Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended doses and limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  

As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide. While the CDC has acknowledged the problems the guideline has created, the agency had dragged its feet on offering solutions or making revisions.

“The refusal of CDC to make detailed interim reports on its progress in ‘re-writing’ their 2016 opioid guidelines was also evident in their February 2021 meeting of the Board of Scientific Counselors,” said patient advocate Richard “Red” Lawhern, PhD. “If repeated in the July 16th meeting, I would personally regard such a policy to be a major failure of process and public transparency, creating potential grounds for a federal lawsuit on grounds of agency fraud and malfeasance.”  

It cannot be overstated the amount of suspicion and distrust there is for the CDC in the pain community. A recent PNN survey of over 3,700 patients, doctors and caretakers found that over 90% believe the guideline did not improve the quality of pain care and failed to reduce opioid addiction and overdoses. Three out of four believe the entire guideline should be thrown out.

When asked if the CDC could be trusted to handle the revision of the guideline in an unbiased, scientific and impartial manner, over 89% said no.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.  

The War on Drugs Comes to the Doctor’s Office

By Mike Ludwig, Truthout

Ashley* lived with addiction and anxiety for years, but she was in recovery and making progress in 2017 after finding treatment at Jay Joshi’s clinic in northwestern Indiana. Joshi was known as a pioneer of telehealth visits for addiction patients that became widely used during the COVID pandemic, an expansion that lawmakers and the American Medical Association (AMA) are now pushing to make permanent.

Joshi prescribed Ashley buprenorphine, a standard for treating opioid addiction and preventing overdose. Untreated mental health conditions can play a role in drug addiction that is often overlooked, so Joshi set Ashley up with a psychologist through a telehealth service. On November 21, 2017, Ashley was at Joshi’s office for a telehealth therapy appointment with her psychologist when Drug Enforcement Agency (DEA) agents arrived with a search warrant.

At the time, Joshi was unaware that an undercover DEA agent had posed as a patient at his office to build a drug trafficking case against him. Agents took Joshi to a local police station for hours of questioning, where Joshi surrendered his DEA registration that allowed him to prescribe controlled substances — including buprenorphine.

When he returned from the police station, Joshi said Ashley was deeply traumatized. Ashley told Joshi that she protested the interruption of her therapy appointment, so a DEA agent pulled out a gun and ordered her onto the ground.

In grand jury testimony, former employees-turned-witnesses described the young primary care physician’s practice as sloppy and his patients as “addicts,” a deeply harmful and stigmatizing term for patients in recovery. Joshi was accused of operating a “pill mill” in the local media, a claim Joshi says was manufactured by the DEA.

Ashley and other patients were blacklisted by other local doctors, and without a buprenorphine prescription, Ashley relapsed and suffered fatal overdose. Stephanie, another patient who had stabilized and quit using heroin under Joshi’s care, also lost her prescription to buprenorphine. She soon died of an overdose after returning to heroin.

“Any patient who was associated with me or had my DEA registration number on their prescription history, other physicians didn’t want to see them,” Joshi said.

Opioid Prescribing Plummets as Overdose Deaths Rise

Since the early 2000s, rising rates of fatal drug overdoses breathed new life into the failing war on drugs. As they have during drug scares of the past, the government and mainstream media declared an “epidemic” of opioid addiction, and the crackdown on painkiller prescribing that followed injected the DEA — the federal law enforcement agency charged with waging the drug war — deep into the medical system. Opioid painkiller prescribing dropped sharply as a result, but the number of overdose deaths continued to rise before skyrocketing during the COVID pandemic.

To understand the crackdown, Truthout obtained multiple DEA search warrants and court records detailing law enforcement efforts to shut down pharmacies and clinics, and interviewed chronic pain patients and their advocates, doctors, researchers, pharmacists and people recovering from opioid addiction across the United States. Their advocacy and research are poking big holes in longstanding media narratives linking painkiller overprescribing of the past to rising rates of fatal drug overdose today.

A close look at the policing of opioids reveals a common theme of the war on drugs: Policymakers and drug police are harming the same people they claim to help. Like the drug war, the painful side effects of the opioid crackdown disproportionately fall on lower-income people and people of color, whether they use opioids for any reason or simply seek treatment for chronic pain. The prescribing crackdown appears to be exacerbating existing inequities in access to health care and addiction treatment, one reason why rates of fatal overdose are rising fastest in Black communities.

“I have seen how, in these public health crises, the people we sort of want to help become stigmatized and end up losing access to care,” said Kate Nicholson, a former civil rights attorney for people with disabilities and pain patients who founded the National Pain Advocacy Center, in an interview. “The way in which we wage the drug war disproportionately against communities of color means that they are likely to face much greater barriers to health care.”

Over the past decade, drug police began plundering data from private medical records services and statewide prescription monitoring databases to digitally surveil doctors, patients and millions of prescriptions. Often using federal prescribing guidelines that became a national controversy as a reference, drug cops with no formal medical training search for “red flags” in prescribing records, such as how far a patient travels to receive treatment or the total volume of controlled substances prescribed by a provider.

The investigations have led to raids on hundreds of clinics and pharmacies across the country. In some cases, doctors and pharmacists strike plea deals for reduced sentences. In other cases, respected physicians, pharmacists and addiction specialists are caught in the dragnet and forced to fight the DEA in court.

Doctors and pharmacists became increasingly wary of prescribing and dispensing opioids or even agreeing to treat patients prescribed opioids for chronically painful conditions in the first place. Others had their registrations to prescribe controlled substances revoked by the DEA pending rulings by the agency’s own administrative courts, or they closed their practices in fear of being raided and charged with drug trafficking.

In many cases, patients are left with nowhere to turn, especially if they are low-income and reside in areas with few medical providers to begin with. A 2019 study by the University of Michigan found that 40 percent of health care providers refused to see any new patients prescribed opioids.

Along with prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in 2016 that were widely misapplied and led to misguided restrictions on opioid prescribing in dozens of states, the law enforcement crackdown left patients living with chronic pain without medications they rely on, forcing some toward illicit opioids, such as heroin and fentanyl, which vastly increase the risk of overdose. Others die by suicide.

“I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal,” Nicholson said. “People are not just being force-tapered [off medication] … they can’t even get health care anymore, just because they need a prescribed opioid to treat pain.”

Both the legal and illicit markets for prescription painkillers shrank as a result of the crackdown and regulatory moves by the DEA. Illicit drugs such as heroin and counterfeit pills containing potent synthetic opioids replaced prescription painkillers in the illicit market. Opioid prescribing rates have plummeted since 2012, but rates of fatal drug overdose increased for years before briefly leveling off in 2018 as policymakers worked to make treatment more accessible.

Overdose deaths began rising again in 2019, and then the COVID pandemic hit, isolating patients and drug users from friends, family and health supports.

From October 2019 to October 2020, the number of overdose deaths recorded by the CDC surpassed 92,000, the highest level in decades.

“I hear from people every day who have been forced off their meds and have lost their ability to work and function and are suicidal.”

— Kate Nicholson, National Pain Advocacy Center

There are multiple factors and drugs besides opioids (methamphetamine, for example) behind the overdose epidemic. CDC overdose data is not always accurate, and overdose deaths often involve multiple drugs, including alcohol. Research shows that only a small percentage of overdose deaths are caused by prescription opioids alone.

Illicit drugs containing fentanyl are driving the historic rates of death in part because, unlike prescription drugs, they can vary widely in potency, particularly when law enforcement disrupts the supply. A 2020 study found that 57 percent of 2,887 military veterans who died of overdose or suicide had a prescription to painkillers that was cut off by their doctors.

“I believe that a lot of the industrial binary focus on stopping opioid prescriptions reflects a belief that that will somehow stop overdoses from happening … that if we just stop these patients from receiving the pills they are on, they will be protected,” said Stefan Kertesz, a physician and professor of preventative medicine at the University of Alabama who is studying links between reductions in prescribing and suicides. “That presumption just has not held up, so far.”

At the same time, the government has been slow to lift barriers to the most effective medications for treating opioid addiction and preventing overdose, methadone and buprenorphine, which are heavily scrutinized by police and surveilled by the DEA because they are also prescription opioids.

Nationally, less than 6 percent of doctors are allowed to prescribe buprenorphine under a special federal waiver that medical experts and advocates say must be removed to save lives. The waiver takes a day or so to obtain, but advocates say many doctors don’t bother due to the stigma around treating people with opioid addiction. Like Joshi, numerous doctors who do prescribe buprenorphine have been targeted by the DEA.

A study released in May by researchers in Oregon found that one in five pharmacies in counties with high rates of opioid overdose refuse to dispense buprenorphine. The problem is especially prevalent among independent pharmacies, which are often targeted over large companies by drug cops seeking out the latest “pill mill” to bust. Patients recovering from addiction say buprenorphine is often difficult to access even when it’s stocked by a local pharmacy due to stigma reinforced by fear of law enforcement.

A Safer Drug Supply Is Criminalized

In the final days of the Trump administration, James Carroll, President Trump’s drug czar, boasted that the “prescription opioid epidemic is now over.” A major decrease in opioid prescribing and related overdoses, Carroll said, was one of the administration’s major achievements. Critics were irate. How could the Trump administration claim victory when overdose deaths were ballooning on their watch?

Six months earlier, the AMA warned the Trump administration that the overdose crisis had never just been about prescription opioids, and the nation is now facing an unprecedented “multi-factorial” crisis driven by drugs such as illicit fentanyl. The government could no longer view the crisis through a “prescription opioid-myopic lens.”

Moreover, chronic pain patients are harmed by the crackdown and the CDC’s prescribing guidelines, which caused large numbers of patients to be forcibly tapered off their medication or cut off altogether, often against their will.

“There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none,” Kertesz said. “That’s crucial.”

Kertesz pointed to a new study showing that the net effects of policies that encourage doctors to lower the dose of opioids prescribed to patients are uncertain, but rapid discontinuation of opioid therapy is associated with increased risk of overdose and suicide.

Abrupt stoppage of opioid therapy has become the “norm,” Kertesz said, and those who argue that policies aimed at decreasing opioid prescribing over the past decade simply represent more “judicious prescribing” practices are misleading the public.

“There are 8 to 10 million people on long-term opioids, and a meaningful number of those people actually need to be on them, so setting up a system that by design abandons 1 to 10 million patients is not a good thing, but we have set that up,” Kertesz said.

“We have now set up incentives for doctors and pharmacists to avoid care for those people, many of whom have disabilities.”

“There is no evidence that forced stoppage of the individual’s medications leads to a better outcome, none. ”

— Stefan Kertesz, MD, University of Alabama

In 2018, senior analysts at the CDC revealed that for years, the number of overdose deaths the agency attributed to prescription opioids was vastly inflated due to problems with data collection classification. For example, deaths caused by illicit fentanyl were blamed on the prescription form of fentanyl, which is often used in emergency rooms.

Overdoses involving a combination of drugs were also misclassified. Last year, researchers concluded that, for over a decade, “millions of Americans” were “misled” by the CDC, politicians and the media to believe that the drug overdose crisis was driven by deaths caused by prescription opioids.

Patients prescribed opioids to treat long-term chronic pain are organizing across the country to overturn the CDC guidelines, and the debunking of CDC data and the AMA’s statement validated their cause. In interviews, multiple chronic pain patients said prescription opioids help them live more normal lives, but their lives became collateral damage of the war on opioid prescribing. Patients report that doctors refuse to treat them and pharmacies won’t fill their prescriptions, leaving them in disabling pain. Mothers are punished by hospitals after childbirth and even charged with crimes for continuing opioid therapy prescribed by a doctor during pregnancy.

“Opioids can be used safely during pregnancy, and we also know that when the response is immediately punitive or the application of the criminal legal system, there is actually far worse outcomes for babies and families, instead of being able to work that out with their doctor,” said Dana Sussman, deputy executive director of the National Advocates for Pregnant Women, in an interview.

Chronic pain patients and their advocates argue that the narrative linking opioid prescribing to the overdose epidemic is a “hoax,” and they are engaged in a pitched media battle with the “anti-opioid zealots” who pushed the CDC to discourage long-term opioid prescribing for anyone besides cancer patients and people dying in hospice.

Advocates point to research showing that rates of fatal drug overdose  correlate with economic decline  in many communities and have been rising rapidly since the late 1970s, not the mid-1990s when painkiller prescribing became more liberal thanks to campaigns by drug companies that have garnered plenty of headlines.

The prescribing debate is extremely emotional, with each side attacking the other over credentials and alleged ties to the pharmaceutical and biomedical industries. (Kertesz said he was attacked in the media by an “expert in the field” for simply announcing a study on deprescribing and suicides. “Attacking investigators in the absence of any knowledge of their work would not be customary behavior in any area of medicine,” he said in an email. “But in this topical area, it is.”)

“The way tapering is happening in the real world is just horrible, even for people who are using their medication appropriately,” Nicholson said.

‘Those Patients Went Through Hell’

As an addiction specialist working at an emergency room and poison control center in Ohio, Ryan Marino has plenty of experience on the front lines. The narrative that overprescribing is causing an overdose crisis is clearly overblown, Marino said, because reductions in prescribing has not brought down deaths.

Marino says he often sees patients who were prescribed high doses of opioids for years until their medication was abruptly tapered or cut off after CDC prescribing “guidelines” became public policy and even law in some states.

“Those patients went through hell … naturally, some turned to street drugs because it is so miserable to have opioids cut off, whether you have addiction or not,” Marino told Truthout. “Seeing those patients has cast an additional shadow over this overdose epidemic that we are seeing, because the over-reactionary response is now creating additional harms.”

Marino said the manufacturing and dispensing of opioids can be a real money-maker in a for-profit health system, and overprescribing played a role early on in the crisis. At the same time, prescription drugs are much safer to use than illicit heroin and fentanyl. Marino said there are good arguments for access to a safe supply of opioids — including prescription heroin for people at high risk of overdose — because people using regulated opioids under medical supervision are far less likely to die.

“We need some sort of regulation [of prescribing], but the oversight the DEA provides seems more in line with reducing prescribing than ensuring that prescribing is appropriate and ensuring that people have access to prescriptions,” Marino said. “The reality is, most people who were using Oxycontin never wanted to switch to heroin, and people who were using heroin never wanted to switch to fentanyl.”

Kertesz, who has worked closely with low-income and houseless patients, also takes a nuanced view of prescribing. Like Marino, Kertesz said there were problems with overprescribing in the past, when medications were heaped upon patients instead of affording them more holistic care.

However, abruptly cutting patients off from medicines they depend on can cause all sorts of problems, particularly for people who have trouble consistently accessing health care in the first place. Doctors must make prescribing decisions based on the particular needs of a patient, but the crackdown has siloed prescribing as either “appropriate” or potentially illegal.

“We have now set up an entire system to push a change to care that does not have evidence for being safe or effective for patients,” Kertesz said.

For example, law enforcement often sees a “red flag” when patients are prescribed high doses of opioids or combinations of controlled substances, even when the prescriber is simply continuing the patient on a long-term regimen. While scrutinized by drug police as a sign of criminal activity, Nicholson said some patients benefit from drug combinations under appropriate medical supervision.

Kertesz said assuming something “criminal” is going on when patients are prescribed higher doses of opioids or more than one psychoactive drug at a time is “a big leap.” The same goes for other “red flags” drug police look for in statewide prescribing databases and records kept by pharmacies.

“A patient who has filled a script in two pharmacies, or a patient who has traveled a distance … anybody who has multiple complex needs is already suspect, anyone who is rural by definition is suspect,” Kertesz said. “Pharmacists are trying not to lose their jobs, so they transfer all this stigma and burden to patients.”

There is a difference between “drug dependence” and “drug addiction.” Addiction is characterized by impulsive drug use despite adverse consequences. Physiological drug dependence results from the continued use of many medications — not just opioids. Addiction is rare in patients prescribed opioids for pain, and while long-term use can create dependence, the benefits can also outweigh the harms. People living with opioid addiction may also be seeking relief from untreated pain, trauma or mental anguish.

Either way, abruptly cutting people off from opioids is dangerous. That’s why methadone and buprenorphine are prescribed for opioid addiction and dependence. Both drugs stabilize patients and stave off painful withdrawal symptoms, which is crucial for preventing overdose.

Advocates say the nuance is lost on the DEA and other law enforcement agencies. Drug cops are laser-focused on opioid “diversion,” the idea prescription opioids are being sold and used outside of their intended purpose. Data on diversion varies by source; a 2017 federal survey found that less than 11 percent of people who misused prescription opioids bought them on the street or stole them from a pharmacy or medical facility.

If the rest are “misusing” their own prescriptions or obtaining them from friends and family — an idea that often offends pain patients — then anti-diversion efforts are effectively targeting prescribers and patients themselves.

For years, the government and mainstream media claimed diversion was the source of the overdose crisis, even as the data began telling a much different story. There is plenty of anecdotal evidence, for example, that buprenorphine is usually diverted to people living with addiction. Vermont recently decriminalized possession of buprenorphine without a prescription for that reason.

The crackdown on diversion created grey areas that turned doctors and pharmacists into suspected drug dealers and patients into suspected criminals. In an ironic way, it worked. Pills became harder to find on the street, but reducing the supply did nothing to treat chronic pain or addiction. Overdoses involving illicit opioids are surging, and a growing chorus of drug users and advocates declare that “every overdose is a policy failure.”

The DEA did not respond to a list of questions by the time this article was published.

‘They Look at Prescribing as a Crime’

Joshi ran a general medical practice in Indiana, and he prescribed opioids for chronic pain as well as addiction. The DEA claimed Joshi was writing more prescriptions for controlled substances than most doctors in Indiana; Joshi says he served a population with serious medical needs.

It was the undercover DEA agent’s job to pose as a “drug seeking” patient and catch Joshi in the act of prescribing and secretly record it on video. Joshi says he tended to trust his patients, but trusting the undercover agent was his downfall. He also suspects a former employee wrote fraudulent prescriptions before becoming an informant for the DEA, although he has been unable to prove it.

“They are transplanting people in the health care field as a drug-dealing ring, so I am the captain drug dealer; you snitch on me and you go free,” Joshi said.

Terrified, Joshi accepted a plea deal after he was indicted on multiple drug charges. However, the DEA’s case against him shifted over time and relied on inconsistent witness testimony, leaving a federal judge frustrated when the time came for sentencing, according to a review of court documents.

The DEA accused Joshi of recklessly prescribing controlled substances, but prosecutors were unable to produce evidence that his patients did not have legitimate medical needs for the drugs Joshi prescribed. Multiple patients testified that Joshi’s practice made serious improvements in their lives. A day before Joshi was indicted, his clinic was recognized by the National Committee for Quality Assurance for “patient-centered, coordinated care.”

“A lot of people have it a lot worse than I do; there really wasn’t any evidence in my case,” Joshi said. “They essentially made a bunch of false statements.… Just the act of prescribing, it was construed as a crime. They don’t look at the clinical decision-making behind a prescription, they look at prescribing as a crime.”

A young doctor with a new practice and a child on the way, Joshi admits that he made mistakes. After losing his registration to prescribe controlled substances, Joshi says he unknowingly broke state rules by hiring nurse practitioners to write prescriptions for his patients. He also wrote a handful of prescriptions under another doctor’s name. Joshi says he tried to find workarounds out of concern for his patients. He did not want their “continuum of care” to be interrupted, but the judge saw a violation of the law.

“I tried to do what was right for my patients, but that was a deviation against the regulatory policies,” Joshi said.

Joshi was sentenced to 15 months in prison for writing an unnecessary prescription to an undercover DEA agent. He got out a few months early on good behavior. By the time he was sentenced, many of his patients were receiving the same treatment they had received from Joshi from other doctors.

Stephanie and Ashley were not so lucky. Both women overdosed and died after law enforcement suddenly interrupted their medical care and their safe supply of medication ran out.

*Ashley’s name has been changed to protect her identity.

This article is part of Truthout's series, "The Policing of Pain: Inside the Deadly War on Opioids."

Copyright © Truthout. Reprinted with permission.

AMA Says CDC Opioid Guideline Still Harming Pain Patients

By Pat Anson, PNN Editor

It was nearly three years ago that the American Medical Association took its first public stand against the CDC’s controversial opioid prescribing guideline.

The AMA’s House of Delegates adopted resolutions calling for an end to the “misapplication” and “inappropriate use” of the guideline by many states, doctors, pharmacists and insurers who imposed hard limits on the amount of opioid medication patients could get, if they could get it at all. Many were left in excruciating pain.

Last year, the AMA went even further, with a 17-page letter to the CDC warning that it was “clear that the CDC Guideline has harmed many patients.”  

Even the CDC acknowledged the 2016 guideline “has been inappropriately cited to justify hard limits or cutting off opioids” and that cancer and surgery patients were suffering as a result.

To date, all of this hand-wringing has changed nothing, as the AMA’s new president recently acknowledged in an exclusive interview with PNN.

“Reports we get from patients and physicians suggest that problems remain. Despite CDC acknowledging that its guidelines should not be used as hard thresholds, there has been almost no effort by state legislatures, health insurance companies, pharmacy chains, or PBMs (pharmacy benefit managers) to evaluate the harmful effects of these one-size-fits-all laws,” said Gerald Harmon, MD, a South Carolina physician who was elected AMA president last month.

“The AMA continues to receive reports that the laws are used to deny, for example, prescriptions for opioid therapy for patients with cancer or in hospice as well as long-time, stable patients with chronic pain.”

DR. GERALD HARMON

Not only has the guideline harmed innocent patients, it failed to achieve its main goal of reducing the risk of opioid addiction and overdose. Opioid prescriptions have been cut to levels not seen in 20 years, while overdoses soared to record highs, fueled largely by illicit fentanyl and other street drugs, not pain medication.

Guideline Meeting

This month we may finally learn what the CDC intends to do after five years of its failed public health experiment, which has been conducted with virtually no effort by the agency to measure its impact on patients. On July 16, the CDC is expected to release a long-awaited draft of a revised guideline during a meeting of its Board of Scientific Counselors (BSC).

(Update: On July 8th, PNN was notified by CDC that the draft guideline would NOT be made public at the July 16th meeting, even though the agenda indicates most of the day will be spent discussing it.

“The draft updated Guideline will not be shared. The BSC Opioid Working Group report is what will be shared and discussed,” CDC spokesperson Courtney Lenard wrote in an email, adding that the public may not get a chance to see the updated guideline until late this year.) 

Although the CDC’s review of the guideline has been underway since 2019, the agency has disclosed no details about its plans, which may include new treatment recommendations for short-term acute pain, migraines and other chronic pain conditions. Even the AMA is in the dark about what the CDC is planning.

“Without seeing a specific proposal, we can’t speculate on what CDC might be considering. We will continue to work with CDC to ensure that any recommendations respect and support care for patients with pain. This includes encouraging CDC to make any drafts open to the public for comment to ensure that any revisions or additions do not make the same mistakes as the 2016 Guideline,” said Harmon.

One of the “mistakes” the CDC made was releasing the guideline during a secretive, ham-handed webinar. The agency also refused to disclose the names of its outside advisors, which included members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP).  

As recently as last year, the CDC declined to release memos, conflict-of-interest statements and other communications related to the 2016 guideline. Nearly 1,500 pages of documents provided to PNN under a Freedom of Information Act request were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank. 

The CDC is being a bit more transparent this time around. Early in its deliberations, the agency asked for and received nearly 5,400 public comments, most of them from patients who blame the agency for their poorly treated pain. The CDC also made public the identities of a diverse group of physicians, academics and patients appointed to an “Opioid Workgroup” that is advising the agency. Notably, the group includes no members of PROP.

The CDC has not yet disclosed who is writing the guideline revision, although early indications are that at least one of the original three authors is involved again.

“The AMA’s focus will be to continue to advocate that CDC revise its guidelines in an open, transparent manner,” said Harmon. “We continue to urge that CDC specifically remove recommendations tied to hard thresholds and make clear that its recommendations should not be used in state laws or policies implemented by health insurance companies, pharmacy chains, or PBMs.” 

Once a draft of the revised guideline is completed, there will be another public comment period later this year. The CDC may not finalize and release the updated guideline until early next year.

If you’d like to watch the July 16th CDC meeting online, you can register for it here.  

States Need to Protect Pain Patients From Uncaring Pharmacists

By Leslie Bythewood, Guest Columnist

The unthinkable just happened again.

A Walgreens pharmacist got away with refusing to fill my prescriptions. It’s the second time that has happened to me at a retail chain pharmacy; the first time was at a CVS pharmacy.

The Walgreens pharmacy manager called and said she would not be able to fill the two prescriptions my board-certified physician had submitted electronically; despite the fact my health insurance had given prior approval for the medications and the pharmacy has been filling them month after month since December 2020.

Contrary to my physician’s best judgment and clinical decision making, this new head pharmacist suddenly decides she cannot fill the prescriptions because:

• The prescriptions are not in keeping with good-faith dispensing

• The prescriptions are not appropriate or safe to dispense

• The pharmacy’s therapeutics committee red-flagged the prescriptions as being too high a dose

• North Carolina limits the number of tablets that can be dispensed each month

• Filling the prescriptions goes against the pharmacist’s professional judgment

When I realized that my pharmacist would not fill the prescriptions and refused to even discuss the matter with my doctor, I wasted no time filing an electronic complaint with the North Carolina Board of Pharmacy, hoping for some recourse short of having to get the prescriptions filled at another pharmacy.

But little did I know about a North Carolina Board of Pharmacy rule entitled “Exercise of Professional Judgment in Filling Prescriptions.” That esoteric rule says a pharmacist “shall have a right to refuse to fill or refill a prescription order if doing so would be contrary to his or her professional judgment.”

It also states that a pharmacist “shall not fill or refill a prescription order if, in the exercise of professional judgement, there is or reasonably may be a question regarding the order’s accuracy, validity, authenticity, or safety for the patient.”

Federal law also gives pharmacists a “corresponding responsibility” not to fill a prescription for controlled substances if they believe it is “not in the usual course of professional treatment.”

Basically, the Walgreens pharmacist had the audacity to call into question the validity of my prescriptions being for a legitimate medical purpose, which not only is an insult to my physician, but second-guesses and overrides his many years of medical judgment and authority.

Worse yet, the North Carolina Board of Pharmacy agent I spoke with said that “refusing to fill the doctor’s prescriptions is not a violation of the Pharmacy Practice Act.” She went on to say the board cannot force the pharmacist to fill a prescription if the pharmacist is not comfortable doing so.

Bottom line: In North Carolina and many other states, the patient and doctor have no recourse and no avenues for appeal if a pharmacist refuses to fill a prescription. The only path forward is to have the doctor submit the prescriptions electronically to another pharmacy.

What I find so unconscionable about this whole ordeal is that it doesn’t seem to matter one iota to the uncaring pharmacist that I am a certified pain patient and that my doctor’s prescriptions are entirely legitimate and medically necessary, as has been documented in my medical records.

Nor did it matter that I’ve been on the same opioid strength since December 2020 without any adverse side effects, or that I am highly tolerant of my medications (a physiologic state that does not equate with psychological addiction) and have no history of overdose, substance abuse disorder, misuse or addiction. 

The pharmacist’s ability to get away with overpowering my doctor with unsound, medically unsafe arguments is exactly why we need to enact laws at both the state and federal level to protect pain patients from this type of abuse.

Leslie Bythewood is a freelance writer who lives in North Carolina. Leslie has intractable cranial pain syndrome caused by idiopathic severe chronic migraines and clusters.

PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Most Sickle Cell Patients Face Stigma During ER Visits

By Pat Anson, PNN Editor

Nearly two-thirds of people with sickle cell disease in the U.S. feel judged and stigmatized when they visit an emergency department due to a pain flare, according to a new survey by Health Union.

About 100,000 Americans live with sickle cell disease (SCD), a genetic disorder that mainly affects people of African or Hispanic descent. SCD causes red blood cells to form in a crescent or sickle shape, which can create blockages in blood vessels that cause intense pain.  It’s not uncommon for someone with SCD to visit an ER a few times each year due to pain or complications such as anemia, stroke, infection and organ failure.

Health Union surveyed 111 people living with SCD to share their experiences dealing with the disease and how they are perceived by healthcare professionals, coworkers, teachers, friends and family members. Most said they did not feel judged or stigmatized by others – except when dealing with ER staff.

Many felt ER staff were rude, ignorant or misinformed about sickle cell disease, didn’t take their pain seriously, and believed they were drug seekers. Nearly half of those surveyed (43%) said they avoided going to the ER because they worried that people would judge them.

“A doctor judged me during a hospitalization. He stated I wasn’t in that much pain to be using Dilaudid. He also stated I was drug seeking because a sickle cell crisis can be managed with Motrin. His statement is not true!” one participant told Health Union.

Sickle cell patients had an entirely different take on their pharmacists, hematologists and primary care providers. Over half (53%) trusted their providers and felt their primary care doctors were friendly, understanding, easy to talk to, and provided excellent care.

"Navigating the healthcare system can already be complex, but undergoing such wildly different experiences can make access to reliable, timely, effective care even more difficult for people with sickle cell disease," said Olivier Chateau, Health Union's co-founder and CEO.

The finding that many people are not happy with their pain treatment in hospitals is not unique to sickle cell patients.  A 2016 PNN survey of over 1,250 hospitalized pain patients found that most felt they were labeled as addicts or drug seekers. Over 80% believed hospital staff were not adequately trained in pain management and over half rated the quality of pain care in hospitals as poor or very poor.  

A report last year by the National Academies of Sciences, Engineering, and Medicine found that sickle cell patients often face discrimination and stigma when navigating the healthcare system. The report found that SCD received little attention from the healthcare community compared to other chronic illnesses. To get proper treatment, many sickle cell patients have to educate themselves about their disease and become their own advocates.

The Health Union survey found that nearly three out of four sickle cell patients (73%) were currently using a prescription analgesic. Many others took prescription strength NSAIDs (35%), muscle relaxants (23%) or anti-anxiety/antidepressant drugs (16%). Only 5% said they experienced an issue with substance abuse.

Cutting My Opioid Dose in Half Left Me in Unbearable Pain

By Virginia Brandford, Guest Columnist

Imagine living with a rare genetic bone disease that has no cure and causes excruciating pain. Then imagine the medication that effectively alleviated that pain for 29 years is abruptly tapered and you are forced to take only half the dose your body has become dependent on.

Not only is the pain unbearable, but the resulting stress placed on the body prevents you from exercising or participating in physical therapy, which is vital to someone with alkaptonuria (AKU) to prevent chronic joint pain and inflammation.

AKU is known as “Black Bone Disease” because it turns bones black and brittle. It is the oldest metabolic disease on earth and has even been found in Egyptian mummies. Watch this video if you want to learn more about my disease.  

After being diagnosed with AKU, I was placed on a very high dose of morphine to stop my body from producing Homogentisic Acid (HGA). People like me born with AKU are missing an enzyme that prevents them from fully breaking down HGA.

When it accumulates at high levels, HGA devours my bones, turning them black and stripping the cartilage and cushions between them.

My longtime physician identified morphine as a pain medication that helped, without causing side effects. I was able to function again and live a decent life, in spite of having such a debilitating disease.

Virginia Brandford

But in 2017, many of the recommendations in the CDC opioid guideline were adopted in Hawaii as state law, and my doctor was driven out of practice. I cannot find a new doctor willing to prescribe the same dose of morphine. They all see my need for opioids, but they do not want to risk their livelihoods by taking me on as a patient. I am being harmed by the state and no one will do anything to help me!

Due to the morphine being reduced to half of my original dosage, the HGA accumulation has eaten two holes into my heart valves, resulting in a life-threatening heart condition. HGA has also accumulated in my spine, liver and kidneys.

I have endured irreparable damage by being forced off my old dosage of medication in such an inhumane manner. Every doctor I have been referred to has refused to accept me as a patient once they look over my medical records and see I have a rare genetic bone disease that requires opioids.

I have never abused drugs or alcohol in any form. I have comprehensive medical records, including MRIs and x-rays documenting my illness and treatment history. It will also show that for 29 years on the original morphine dose, my liver stayed strong and clean, compared to a patient who has been on a toxic medicine like Suboxone that is just as addictive.

Legitimate pain patients like me who never abused drugs are being treated like addicts and demonized for taking prescribed medicines from licensed doctors.

Please help me obtain the help I need before this disease spreads even more. I am totally bedridden and need help. I pray that a revision of the CDC opioid guideline will allow doctors to do their jobs again without being persecuted, and will give me back my life so that I can grow old with dignity.

Virginia Brandford lives in Hawaii. PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Follow Treatment Guidelines for Low Back Pain and Get Back to Work Sooner

By Pat Anson, PNN Editor

Employees with acute low back pain miss fewer days of work if they exercise, take over-the-counter pain relievers and are not prescribed opioid medication, according to a large new study of worker compensation claims in California.

"The closer people's care follows evidence-based guidelines, the faster their back pain resolves, by quite a bit," said Kurt Hegmann, MD, director of the University of Utah Rocky Mountain Center for Occupational and Environmental Health.

Hegmann and his colleagues analyzed insurance data for nearly 60,000 people with low back pain from 2009 to 2018, comparing their treatment to guidelines created by the American College of Occupational and Environmental Medicine. Those guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and physical therapy for low back pain, while frowning on the use of opioids or invasive procedures such as spinal injections.

The research findings, recently published in PLOS ONE, showed that people who didn’t follow treatment guidelines missed an average of 11 more days of work each year compared to those who only had recommended treatments.

Opioids were once commonly prescribed for low back pain, a practice that has fallen out of favor due to fears of addiction and overdose. In the nine years of the study, researchers found that opioid prescribing for low back pain declined by 86 percent, fueled in part by insurers who were unwilling to pay for the drugs.

"The reduction in opioids prescription is particularly impressive," Hegmann said. "In this case, the insurer is likely to not pay for opioids even if they are prescribed. It suggests what's possible when the 'carrot' of good health care is missed and instead the 'stick' of compliance with a guideline is in place."

Nearly two-thirds of the people included in the study received at least one non-recommended treatment, although adherence to treatment guidelines improved over time. In 2009, 10% were treated according to guidelines, but that rose to 18% by 2018.

Low back pain is the world’s leading cause of disability. It mostly affects adults of working age in lower socioeconomic groups, who often have physically demanding jobs.

Treatment guidelines for low back pain have changed considerably in the last 20 years. At one time, bed rest was commonly recommended, a treatment now seen as counterproductive. Moderate exercise and physical activity help people return to work sooner.

"Being out of work impacts many facets of your life," said first author Fraser Gaspar, PhD. "In addition to the physical disability that's causing the person to miss work, the worker is making less money, while they often incur additional costs and experience mental strain. Getting people back to their normal lives is really important, and our research shows that following guidelines makes that happen faster."

Are NSAIDs Really Better Than Opioids for Post-Operative Pain?

By Pat Anson, PNN Editor

There have been a rash of recent studies promoting the use acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) over opioids for post-operative pain.

One such study at a Houston hospital led surgeons to conclude that patients were better off with Tylenol. "This study provides us with a strategy to successfully manage pain after surgery using over-the-counter pain medication,” said Min Kim, MD, head of thoracic surgery at Houston Methodist Hospital.  

But critics point out that most of the studies never examine how patients feel about the effectiveness of their pain treatment — focusing instead on the number of opioid pills and smaller opioid doses being prescribed. Pain relief was a secondary consideration, if it was considered at all.

A rare exception to that is a study recently published in the Canadian Medical Association Journal (CMAJ), which found that ibuprofen and other NSAIDs gave better post-operative pain relief than the opioid codeine. In a systematic review of 40 clinical trials involving over 5,000 patients who had outpatient procedures, researchers said patients who took NSAIDs had lower pain scores 6 and 12 hours after surgery than patients taking low doses of codeine.

"In all surgery types, subgroups and outcome time points, NSAIDs were equal or superior to codeine for postoperative pain," wrote lead author Matthew Choi, MD, Associate Professor of Surgery at McMaster University in Ontario. "We found that patients randomized to NSAIDs following outpatient surgical procedures reported better pain scores, better global assessment scores, fewer adverse effects and no difference in bleeding events, compared with those receiving codeine.

“These findings are of general importance to any clinician performing painful medical procedures. The various trials in our meta-analysis evaluated a range of procedures, different NSAID types and various degrees of acetaminophen coadministration.”

But critics say the McMaster study also has flaws. The claim that “all surgery types” and “a range of procedures” were included in the analysis is misleading at best. Most of the studies — 28 of the 40 that were analyzed — involved dental surgery, a fact that is not sufficiently disclosed. The rest of the outpatient procedures were for plastic surgery and orthopedic corrections – which can hardly be compared to more serious surgeries that require more pain relief and days or weeks of recovery, not just 6 to 12 hours.      

Another issue is the use of codeine as a research subject. Stefan Franzen, PhD, a chemistry professor at North Carolina State who has an extensive background in biomedical research, questions whether low doses of codeine should even be compared to NSAIDs.

“I question the premise that codeine is the drug that is or should be used by dentists,” said Franzen, author of “Patient Z,” a book the examines the criminalization of pain care. “I read a few papers not cited by this report and they too do not find a great efficacy for codeine. Part of this may be dose. Most commonly they are using 30-60 mg of codeine, which is 5-10 mg of morphine. Not very much if you have severe pain.

“Codeine may be a poor choice, but it may also be a straw man. Why not use tramadol, for example?”

‘Manipulated Data’

Patient advocate Bill Murphy also has doubts about the selection criteria used in studies touting the benefits of non-opioid pain relievers. He believes some researchers cherry-pick evidence to support a conclusion they’ve already reached.

“Opioid sparing post-op surgery programs are nothing more than an attempt to solve a non-problem and in doing so, patients suffer needlessly. The data produced from such programs are very often manipulated by those who designed the program in an obvious attempt to skew the results in favor of a program they endorsed,” said Murphy, who helped get legislation passed in New Hampshire to ensure that pain patients have access to opioid medication.

Murphy has advocated on behalf of patients at Portsmouth Regional Hospital, which has an “Enhanced Surgical Recovery” program that significantly reduced the use of opioids. Instead of Vicodin, patients get Neurontin or nerve blocks for pain relief.

“I was personally called in to advocate on behalf of several patients who were left to suffer in pain following surgery only to have staff assure them their pain was being well managed,” Murphy explained in an email. “Surgeons and nurses reported they were doing very well with Portsmouth Regional’s new protocol for managing post-op pain when in fact, they were not doing ‘very well’ at all.

“These patients were in horrible pain. Of the three I spoke with, none were ever provided any relief. I was with one patient as she was discharged. She was in tears and moved at a glacial pace due to pain as her son and I helped her into his vehicle outside. It was heartbreaking to watch. Her adult son was furious. I stayed in touch with each patient for several weeks afterwards. Each suffered greatly, one was not making any gains in physical therapy due to her lasting pain.”

In 2019, only 11% of patients were prescribed an opioid while at the Portsmouth hospital, and less than 6% were discharged with an opioid prescription. Murphy says the hospital’s policy inevitably leads to some patients with poorly treated pain.  

“What Portsmouth Regional Hospital’s ‘Enhanced Surgical Recovery’ program was doing is akin to making patients bite down on a piece of wood, grind it out, and then convince them the whole experience was for their own good,” says Murphy.    

Did Pacira Lie to Investors or a Federal Judge?

By Pat Anson, PNN Editor

The war of words between Pacira BioSciences and the American Society of Anesthesiologists (ASA) continues to escalate, with new allegations that the drug company either lied to its investors or a federal judge.

New Jersey-based Pacira filed a lawsuit in April over three articles in the ASA journal Anesthesiology that disparaged Pacira’s flagship product Exparel, an injectable non-opioid analgesic used for postoperative pain. An editorial and two peer-reviewed research articles said Exparel worked no better than other bupivacaine products, even though it costs 10 times more.

Pacira filed a libel complaint against the ASA in federal court seeking a retraction and damages for “significant pecuniary harm.” The company said “multiple existing customers” had either stopped using Exparel or were considering it because of the journal articles.

If true, that would be a significant blow to Pacira, since Exparel accounted for 96% of the company’s revenues in 2020.

The ASA filed a motion last week asking a federal judge to dismiss the case, calling the lawsuit “an egregious and unjustified public relations campaign that seeks to chill scientific research and debate.”

‘Nothing to Worry About’

The ASA motion quotes a statement from a May 4 earnings call, in which Pacira CFO Charlie Reinhart told analysts that “we don’t have anything to worry about” and “actually things are going very, very well,” despite the negative reviews of Exparel in the medical journal.

In a preliminary report released last week, Pacira even boasted about sales of the drug. “Exparel sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales,” the company said in a statement that didn’t mention the lawsuit.

“In other words, Pacira is lying either to a federal judge or its investors,” the ASA said in a press release Monday.  

A Pacira spokesperson declined to respond to the ASA statement, telling PNN that “our corporate policy is not to comment on pending litigation.”

Exparel was first approved by the FDA in 2011 as a local anesthetic for post-operative pain in adults.  Its use has since been expanded to include children and as a nerve blocking agent.  Pacira says over 8 million patients have been treated with Exparel. The drug is primarily sold to hospitals and ambulatory surgical centers. One of the biggest purchasers is the U.S. Department of Defense.

In the past, Pacira has gone to great lengths to promote Exparel and silence critics.  In 2014, the company filed a lawsuit against the FDA after the agency sent a warning letter to Pacira for off-label marketing of Exparel. In 2020, Pacira agreed to pay $3.5 million to resolve allegations that it gave kickbacks to doctors to promote Exparel in research articles.

Did CDC Opioid Guideline Have ‘Unexpected Benefit’ for Surgery Patients?

By Pat Anson, PNN Editor

Since its release in 2016, the CDC’s opioid prescribing guideline has had a sweeping impact on pain management in the United States. Although only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioids have been widely adopted by states, insurers, pharmacies, hospitals and doctors treating all types of pain.

A new study published in JAMA Network Open documents how opioid prescribing for post-operative acute pain fell significantly in the first two years after the guideline’s release.      

Researchers looked at prescribing data for over 360,000 patients who had 8 common surgical procedures and found that the amount of opioids initially prescribed after surgery fell by an average of 16 percent. The decline for each patient was the equivalent 11 oxycodone 5mg tablets.  

“This study has important policy and practice implications. Although the primary focus of the 2016 CDC guideline was on opioid prescribing for chronic pain, our findings suggest that the guideline was associated with clinically relevant changes in patterns of opioid prescribing after surgery,” wrote lead author Tori Sutherland, MD, a Professor of Anesthesiology at the Perelman School of Medicine, University of Pennsylvania.

The study didn’t look at what alternatives surgery patients were given for pain management or whether they were satisfied with their pain relief. But because refill rates were unchanged after the guideline’s release, Sutherland and her colleagues concluded that “it is unlikely that guideline misapplication led to significant opioid underprescribing for surgical pain.”

An editorial also published in JAMA Network Open called the decline in opioid prescribing for post-operative pain “a promising trend” and said further cuts were needed to reduce the number of leftover pills.

“The 2016 CDC guideline for chronic pain may have provided an unexpected benefit to surgical patients by accelerating the alignment of opioid prescribing with amounts recommended in surgery-specific prescribing guidelines. Nonetheless, much room for improvement remains,” wrote lead author Mark Bicket, MD, an anesthesiologist at the University of Michigan School of Medicine.

“We have known for a long time that the average patient has been prescribed nearly twice as much opioid as they need, or will use, following surgery,” said Dr. Lynn Webster, a PNN columnist and pain management expert. “This unused medication has been a major source of diverted opioids that have contributed to the national illicit drug use problem. In this regard, their observation does suggest fewer drugs are available for diversion. That is a good thing.

“However, mean data does not take into account an individual’s need. Some patients need more medication than other patients for the same surgical procedure. It is unhelpful to use dose reduction as a measure of improved care. We should focus on using the appropriate amount of opioids for the appropriate length of time to achieve improved prescribing.”

Webster said it was speculative to suggest that the CDC guideline had an “unexpected benefit” for surgery patients. The best measure is whether overdose deaths are decreasing – and by that standard the guideline has been a failure. Five years after its release, opioid prescribing is at 20-year lows while overdose deaths are at record highs, fueled largely by illicit fentanyl and other street drugs.

“Cleary, the decline in opioids prescribed for post-op pain has not improved that outcome which is, arguably, the most important outcome to measure,” said Webster.

Opioid addiction is actually rare after surgery.  A large 2016 study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in 2018 found only 0.6% of patients who took opioids for post-operative pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.