AMA Scolded for Seeking Changes in CDC Opioid Guideline

By Pat Anson, PNN Editor

Eight months after the American Medical Association told the CDC that its controversial opioid guideline has “harmed many patients” and needs to be revised, an anti-opioid activist group has accused the AMA of employing false moral arguments to justify using opioid medication to relieve human suffering.

The letter from Physicians for Responsible Opioid Prescribing (PROP) to AMA President Susan Bailey, MD, takes issue with the AMA’s position that the U.S. “no longer has a prescription opioid epidemic” and instead faces an overdose crisis fueled by illicit fentanyl and other street drugs.

“These statements send a strong message that opioid prescribing for pain is no longer problematic, and that the CDC’s recommended guardrails are no longer needed. Nothing could be further from the truth,” says the PROP letter, which was signed by the organization’s board of directors.

“There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths.”

The CDC’s 2016 guideline was only intended for primary care physicians treating chronic pain, but its voluntary recommendations on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and doctors of all specialties. The guideline has not only failed to reduce drug deaths – which now stand at record highs – but federal health experts admit that widespread misuse of the guideline has caused “serious harm” to patients, including forced tapering, withdrawal, uncontrolled pain and suicide.    

PROP’s letter to the AMA goes even further than the CDC recommendations, suggesting that opioid medications should only be used for short-term acute pain and end-of-life care.  

“All moral, ethical, regulatory, legal and political arguments that opioids are needed so that people do not suffer needlessly should apply specifically to short-term pain management where there is proven benefit, and not to long term pain management where evidence of benefit is largely anecdotal, and there is compelling evidence of harm,” PROP said.

“Why then is the AMA applying the moral argument to the false premise that people will suffer needlessly if they do not have unrestricted access to opioids? By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer.”

AMA: ‘Misguided Focus’ on Opioids Harms Patients

To be clear, opioid addiction is rare in patients and the AMA never said that people should have “unrestricted access to opioids.” The AMA called for balanced and individualized care based on patient need, not one-size-fits-all guidelines that dictate dosages or the type of treatment everyone should get.    

In a February 19th letter to PROP, AMA President Dr. Susan Bailey said the group mischaracterized the AMA’s position on opioid treatment.

“When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors,” Bailey said.

“That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate.”

“Patients with chronic pain and patients with substance use disorder both need access to multimodal treatments for their medical care,” said Dr. Chad Kollas, a palliative care specialist who is an AMA delegate and Secretary of American Academy of Hospice and Palliative Medicine (AAHPM).

“AMA and AAHPM have recognized the importance of pursuing balanced opioid policy, policy that protects access to opioid analgesics for patients with medically legitimate needs for those medications, while also protecting the public safety and reducing potential harms of prescribed medications.”

Kollas said PROP’s belated response to the AMA’s position may be an attempt to deflect attention away from a recent report that found deaths due to illicit fentanyl soaring, while overdoses involving prescription opioids remained flat.  The research adds to a growing body of evidence suggesting the CDC opioid guideline was ineffective and misdirected.

Although opioid prescribing is at 20-year lows, PROP founder Dr. Andrew Kolodny has said prescriptions “still have a very long way to go” and should be reduced even further. Kolodny recently advised the World Health Organization in the development of a new guideline for treating chronic pain in children, which recommends that opioids only be given to children who are dying or in palliative care.

Slow Progress on Guideline Update

Faced with growing criticism of its own guideline, the CDC announced in 2019 that it was working on an update or possible expansion of its recommendations. Progress has been slow since then.  An advisory group appointed by the agency last summer has had only two preliminary meetings and will not review suggested changes to the guideline until next month, according to an update given Tuesday to the CDC’s Board of Scientific Counselors (BSC).

Draft guidelines are not expected to be available for public comment until the end of this year, meaning any revisions will likely not be finalized until 2022. Patient advocates told the BSC they were disappointed by the lack of progress.

“I would like to urge the members of this panel to please take seriously the issue of timely revision of the CDC guidelines for chronic pain. We have a catastrophe welling out across the country in a wholly marginalized and invisible group. On top of that, we are losing working physicians at a steady rate,” said Terri Lewis, PhD, a patient advocate and rehabilitation specialist. “Everybody is in the gun sights of policy that is not working for anybody. I beg you to please make this an urgent priority.”

Mexicans ‘Dying in Pain’ Because Rx Opioids Limited in U.S.

By Pat Anson, PNN Editor

Efforts to limit opioid prescribing in the United States are driving some Americans across the border to Mexico to purchase opioid medication, according to a new study that found shortages of painkillers in some of Mexico’s poorest regions.  

Mexico, along with many other third-world countries, have relatively low rates of opioid prescribing. Faced with international criticism that pain was going untreated, the Mexican government launched an initiative in 2015 to improve access to opioids for terminally ill patients in palliative care.

Doctors were allowed to write more prescriptions and there was expanded insurance coverage of opioids, which led to a steady increase in opioid dispensing in Mexico over the next few years – a period when opioid prescribing in the U.S. was falling sharply.

A team of researchers at UCLA, with funding from the U.S. National Institutes of Health, looked at prescription drug data in Mexico from 2015 to 2019. They found a steady increase in opioid dispensing nationwide, but the growth was concentrated in wealthier Mexican states and major metropolitan areas, particular those along the U.S. border. The research findings, published in The Lancet Public Health, suggest that some of the opioids intended for Mexican citizens wound up in American medicine cabinets.

"People in the poorest areas of Mexico are dying in pain," said lead author David Goodman-Meza, MD, an assistant professor of medicine at the David Geffen School of Medicine at UCLA. "A lot of work needs to be done to increase access to opioids for those who have a medical need for them in Mexico.”

Goodman-Meza and his colleagues found the highest opioid prescribing rates in Baja California, Mexico City, Nuevo Leon, Sonora and Jalisco. Fentanyl was the most frequently dispensed opioid medication, followed by methadone, morphine, tapentadol, oxycodone and hydromorphone.

Baja California, Nuevo Leon and Sonora all border the United States, and have a “heavy concentration of pharmacies” just a few miles away from San Diego, El Paso and other U.S. cities. The researchers noted that many of these pharmacies had an increase in opioid dispensing during the study period.

Although they did not examine cross-border purchase data, researchers believe “medical tourism” by Americans probably contributed to more opioid prescriptions being filled in Mexico.

"As the U.S. has tried to curb the epidemic related to prescription opioids by instituting structural mechanisms such as closing 'pill mills' and instituting prescription drug monitoring programs (PDMPs), individuals may be getting around them by going to Mexico to get opioids," Goodman-Meza said. "Continued surveillance at border crossings is necessary to avoid unmonitored entry of opioids into the U.S."

Unintended Consequences of PDMPs

Another unintended consequence of U.S. policy to limit opioid prescribing is that it may be forcing some patients to turn to illicit drugs.

A new study published in JAMA looked at state efforts to combat the opioid epidemic by using PDMPs to track opioid prescriptions. A team of Indiana University researchers found that while opioid misuse and “doctor shopping” by patients declined, drug deaths continued to increase, fueled largely by overdoses linked to illicit fentanyl, heroin and cocaine.    

“Heightened demand for diverted and illicit drugs might arise from limiting the supply of prescription opioids under certain conditions. These unintended consequences may occur if the fundamental causes of demand for opioids are not addressed and if the ability to reverse overdose is expanded without increasing treatment of opioid overdose,” researchers found.

“We believe that policy goals should be shifted from easy solutions (eg, dose reduction) to more difficult fundamental ones, focusing on improving social conditions that create demand for opioids and other illicit drugs.”

A 2019 study of PDMPs was more explicit, finding there was a “consistent, positive, and significant association” between them and heroin overdoses. A study conducted the previous year also found an increase in heroin deaths associated with PDMPs, along with a decline in overdoses linked to prescription opioids.  

CDC Focused on Rx Opioids While Fentanyl Deaths Soared 1,040%

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention documents an alarming increase in overdose deaths and how the agency’s 2016 prescription opioid guideline failed to stop the drug crisis from growing worse.

The study looked at fatal overdoses from 2013 to 2019, a period when U.S. drug deaths rose by over 56 percent, culminating with 70,630 Americans dying from overdoses in 2019.  

Deaths involving prescription opioids remained relatively flat during that period, while overdoses involving other substances rose, led by an astounding 1,040% increase in deaths linked to illicit fentanyl and other synthetic, mostly black market opioids. Overdoses involving heroin, cocaine and stimulants such as methamphetamine also rose.

DRUGS INVOLVED IN U.S. OVERDOSE DEATHS (2013-2019)

“Sharp increases in synthetic opioid- and psychostimulant-involved overdose deaths in 2019 are consistent with recent trends indicating a worsening and expanding drug overdose epidemic. Synthetic opioids, particularly illicitly manufactured fentanyl and fentanyl analogs, are highly potent, increasingly available across the United States, and found in the supplies of other drugs,” researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

“Similarly, psychostimulant-involved deaths are likely rising because of increases in potency, availability, and reduced cost of methamphetamine in recent years. The increase in synthetic-opioid involved deaths in the West and in psychostimulant-involved deaths in the Northeast signal broadened geographic use of these substances.”

The new CDC study adds to a growing body of evidence suggesting that the agency’s controversial opioid guideline has been ineffective and misdirected. While the guideline helped reduce the already shrinking supply of opioid medication – prescription opioid use is now at 20-year lows – drug deaths linked to illicit fentanyl and other substances kept rising. Overdoses hit a record high last spring.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a recent health advisory.

‘I Don’t Really Want to Die’

Many pain patients – including those who have used opioids safely and responsibly for years – now have difficulty obtaining opioid analgesics and live with untreated or poorly treated pain. A recent study found that nearly half of primary care clinics in the U.S. are unwilling to accept new patients on opioids, because they had either stopped prescribing them or feared scrutiny by law enforcement and regulators if they did.

“Why am I treated like a criminal for needing opioids? For 26 years opioids are the only treatment that allows me to have a life,” a pain patient recently told PNN. 

“My doctor stopped prescribing my pain medication without my consent, leading to rapid tapering and abrupt discontinuation. No medication and haven't heard from her since. She won't return my calls,” another patient said.  

“I'm at a very desperate point in my life,” said a patient with Complex Regional Pain Syndrome (CRPS). “The meds don't address my needs and I'm at my end. If something doesn't give right away, I will be gone! I don't really want to die but I feel that it is the only option left.” 

Some anti-opioid activists have turned a blind eye to pleas from patients and want opioid prescriptions reduced even further.

“Opioid scrips have been trending in a more cautious direction, (though we still have a very long way to go) while opioid OD deaths have soared. Some see this as a policy failure. They may not realize the main goal of more cautious Rx opioid use is to reduce incidence of OUD,” Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing (PROP), wrote in a recent Tweet.

But when asked by another poster if there have been declines in OUD — opioid use disorder — because fewer opioids are being prescribed, Kolodny said he didn’t know.

“OUD incidence isn't tracked. We're 25 years into an epidemic of OUD but still have lousy surveillance. So no hard data but if fewer people are exposed to a highly addictive drug, it's a safe bet that fewer people will become addicted,” Kolodny replied.

The CDC is currently working on an update and possible expansion of its opioid guideline – with the goal of releasing a revised guideline late this year. The agency’s Board of Scientific Counselors is holding a public hearing this Tuesday, February 16th to get an update from an “Opioid Workgroup” that is considering changes to the guideline. People interested in listening to the meeting online can register clicking here.

Acetaminophen Better Than NSAIDs for Acute Trauma Pain

By Pat Anson, PNN Editor

Acetaminophen (Tylenol) is superior to non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute pain in patients recovering from arm and leg trauma, according to new research published in the journal Academic Emergency Medicine. It’s the latest in a string of studies that recommend the use of non-opioid pain relievers for acute pain after discharge from a hospital.

The research is based on a study of 1,500 adults in the North African nation of Tunisia, nearly half of whom had bone fractures. Upon discharge from a hospital emergency department, the patients received either acetaminophen, a high-dose NSAID, or a combination of the two. Acetaminophen is commonly called paracetamol outside the United States.

After seven days, researchers found that nearly two-thirds (61.8%) of patients receiving paracetamol alone were “satisfied” or “very satisfied” with their pain relief. Only 11.4% required another oral pain reliever. The other two groups had similar satisfaction scores, but had lower rates of medication adherence. Side-effects such as vomiting and gastrointestinal pain were also more common in patients who received NSAIDs.  

“This study found that the combination of a high‐dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high‐dose NSAID alone for post-traumatic extremity pain,” wrote lead author Mohamed Amine Msolli, MD, an emergency room physician at Fattouma Bourguiba University Hospital in Tunisia.

“Taking into account its superior efficacy and tolerability, paracetamol appears to be the most suitable first‐line therapy for managing mild to moderate posttraumatic extremity pain after discharge from the ED.”

Opioid analgesics are not widely available in Tunisia and most other Middle East countries, and were not included in the study. Nevertheless, the study findings are being cited as evidence that paracetamol is superior to both NSAIDs and opioids in treating acute trauma pain.

“The surprising efficacy of paracetamol over an NSAID, as shown by a 6.4% lower need for additional oral analgesics, may impact prescribing practices,” Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center, said in a statement.

“Many ED patients who have a contraindication to NSAIDs but require analgesics upon ED discharge might be prescribed an opioid. Given the ongoing opioid epidemic, this study lends evidence to support the use of acetaminophen alone in such patients."

But the risk of long-term opioid use after an emergency room visit is actually quite low. A large 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

Acetaminophen also has risks that are not acknowledged in the Tunisia study. Excessive use of acetaminophen can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

WHO Guideline Only Recommends Opioids for Children Who Are Dying

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released new guidelines on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill and not expected to recover.

The 56-page guideline calls access to pain management a “fundamental human right,” while at the same time warning that “evidence of the effectiveness and safety of opioids is completely lacking in children.”

The guideline emphasizes the use of physical and psychological pain therapies, while taking a cautious approach to opioids. Morphine is only recommended for children in palliative care and those with “life-limiting” conditions for which there is no cure and “an early death is expected.”

“Children who are appropriately prescribed morphine for chronic pain in the context of end-of-life care or in children with life-limiting conditions, may require morphine for the management of intercurrent, acute or breakthrough severe pain,” the guideline states.

“Time-limited use of morphine in these contexts should be at the lowest appropriate dose and duration possible and must be regularly reviewed in order to ensure the fewest possible adverse events. Healthcare providers and caregivers need to perform frequent and repeated reassessments of pain and other symptoms, and the principles and relevant guidelines for acute pain management should be followed, including having an opioid stopping plan.”

The new recommendations for children between 0 and 19 years of age are a marked departure from previous WHO guidelines for chronic pain, which said that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Those guidelines were withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  A coalition of palliative care organizations objected, saying WHO caved-in to political pressure.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement. “Lack of availability and limited access to these medications for legitimate medical treatment is a human rights violation.”

‘Very Low Certainty’ of Evidence

Most of the recommendations made by a WHO advisory panel – the Guideline Development Group (GDG) — are vague, conditional and based on “very low certainty” of evidence. One of GDG’s members was Andrew Kolodny, MD, a psychiatrist and addiction specialist who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Despite an admitted “paucity of high-quality research” on how to treat pain in children, the GDG recommended that children be treated from a “biopsychosocial perspective” that incorporates physical therapy and psychological interventions such as cognitive behavioral therapy.  

“Children with chronic pain and their families and caregivers must be cared for from a biopsychosocial perspective; pain should not be treated simply as a biomedical problem,” the GDG said.

There is surprisingly little discussion in the guideline about the risks and benefits of non-opioid drugs such as acetaminophen. Some of the recommendations border on platitudes, such as treatment being “child and family-centered” and “tailored to the family’s values, cultures, preferences and resources.”

One area where the GDG is adamant is the importance of treating childhood pain to prevent it from becoming a lifetime problem.

“Exposure to chronic pain in early life may have implications for the incidence, severity and duration of chronic pain, and may be associated with long-term, maladaptive neurological changes,” the guideline warns.

“Chronic pain in childhood is associated with progression of pain into adulthood and potentially predisposes these children to other chronic health problems in later life. The negative impacts of chronic pain also extend to family members who report a higher burden of care and a detrimental effect on family function. As such, chronic pain during childhood has a very significant negative impact on the child over their life course as well as their wider family unit, making appropriate diagnosis and management essential.”  

The GDG said large, multi-center trials are needed to examine the safety and efficacy of virtually all pain management therapies. Additional research is also needed for children suffering from cancer pain and those with developmental and intellectual disabilities.

Former President Trump withdrew the United States from WHO last year in a dispute over its handling of the COVID-19 pandemic. President Biden reversed that decision on his first day in office.  

Nearly Half of Primary Care Clinics Won’t Take New Patients on Rx Opioids

By Pat Anson, PNN Editor

A new study has confirmed what many pain sufferers have known for years: many primary care physicians in the U.S. are reluctant to accept new patients taking prescription opioids for chronic pain.

Researchers at the University of Michigan used a “secret shopper” technique by posing as female patients who have been taking opioids for years to relieve pain. They called 452 primary care clinics in nine states, asking if the clinic was taking new patients.

If the answer was yes, the “patient” said she was covered by insurance and was looking for a new provider because her primary care physician had either retired or stopped prescribing opioids. Each clinic was called twice with one of the two scenarios.

Nearly half (43%) of the clinics said their providers would not prescribe opioids in either scenario, while less than a third (32%) said their primary care providers (PCPs) might prescribe in both cases.

The remaining 25% of clinics gave mixed signals about what they would do. Simulated patients who said their doctor had retired were twice as likely to be told the clinic might prescribe opioids, compared with those who said their provider had stopped prescribing for an unknown reason – a scenario that suggested the patient may have been abusing opioids.

“These findings suggest that primary care access is limited for patients taking opioids for chronic pain, and differentially further reduced for patients whose histories are suggestive of aberrant use. This denial of care could lead to unintended harms such as worsened pain or conversion to illicit substances,” researchers reported in the journal Pain.

Many of the clinics that refused to prescribe said it was due to new policies, fear of legal ramifications, or administrative burdens involved in writing opioid prescriptions.

The findings are similar to another “secret shopper” study by the same research team in 2019,  which found that 40% of primary care clinics would not accept new patients on opioids, no matter what kind of health insurance they had.

Lead researcher Pooja Lagisetty, MD, an internal medicine physician at Michigan Medicine, says the new findings suggest that primary care clinics should consider whether they are discriminating against patients on opioid therapy.

"We need to make sure we're training prescribers and their teams in addressing the systemic biases that this research highlights," says Lagisetty. "We shouldn't even be thinking about the reason that patients are giving when they seek to access care.

"Even if you think that someone is using opioids for a reason other than pain, or that long-term opioids are not an effective pain care strategy, those are exactly the patients we in primary are should be seeing."

A 2019 PNN survey of nearly 6,000 pain patients found that nearly three out of four had difficulty finding a doctor willing to treat their chronic pain. Over a third of patients in our survey said they’d been abandoned by doctors and 15 percent said they were unable to find a new doctor.

Contact Congress to Make Changes in Federal Pain Study

By Richard Lawhern, PNN Contributor

On January 20, I sent a letter by email to the Acting Director and senior staff of the Agency for Healthcare Research and Quality (AHRQ).  The letter requests the federal agency to immediately withdraw its recent review of prescription opioids and other treatments for short-term acute pain. 

Grounds for the request are clear evidence of unjustified anti-opioid bias by the authors and gross fatal errors of methodology – all of which invalidate the review as resource material for efforts to revise and expand the 2016 CDC opioid guideline.

The anti-opioid bias of Roger Chou and his co-authors is revealed by their selective cherry-picking of references that fail to explore the major effects of genetics in patient response to opioid therapy, as well as improperly generalized findings based on trials of weak opioids like tramadol, which were applied to all opioids.

The AHRQ authors also omit any exploration of serious side effects and mortality caused by non-opioid treatments such at acetaminophen.

But the most fundamental error in the methods of the AHRQ Review is improper use of “meta-analysis” to lump together data and outcomes from multiple small-scale studies of opioid therapy for acute pain. A major underlying assumption of meta-analysis is that patient response in each trial is distributed on a Normal (bell-shaped) curve. However, this assumption doesn’t work for patients treated with prescription opioids.

The distribution of patient outcomes is actually “bi-modal.” One group of patients may experience side effects from opioids, but very little short-term pain relief; while a second group may have substantial pain relief from just one dose of opioid medication. This reality invalidates the major findings of the AHRQ review.

A detailed critique of the AHRQ study is available on my website. Feel free to review and share this information with your personal physician.

AHRQ is fully aware of the errors noted above but has no intention of responding to demands for a correction of its malfeasance and fraud.  Thus, it may be necessary for the U.S. House Government Oversight and Reform Committee to direct AHRQ to withdraw or rewrite its review. 

Such an action has precedents.  In 2015, the Oversight Committee reviewed complaints from the Washington Legal Foundation and others concerning inadequate public hearings on the CDC’s proposed opioid guideline. The committee sent a letter to then-CDC Director Thomas Frieden asking him to explain why so much secrecy was involved in the drafting of guideline and why it wasn’t made publicly available.

Faced with a congressional inquiry, CDC reversed course by delaying the guideline’s release and publishing the draft in the Federal Register for a 30-day public comment period. A new advisory committee was also formed to review the guideline, which resulted in some changes to its final recommendations.

Urgent Action Request

A similar effort is urgently needed by pain sufferers and their advocates to bring the AHRQ review to the attention of Congress, specifically to the House Government Oversight and Reform Committee. Those who wish to involve the committee in corrective action should telephone any or all of the Congressional offices of committee members. 

It is very doubtful that the representatives will actually see anything you leave in their contact portals online. But short, focused telephone calls are harder to ignore. The telephone numbers for members of the House Committee can be found here. If you reach a staff member in their office, you might offer the following information:

1) Identify yourself and provide a call-back number. If you are a medical professional, state your qualifications (i.e. “I am a board certified physician” or “I am a former nursing professional now disabled by agonizing pain.”)

2) If you are a resident of the Representative’s district, say so. You don’t have to be a constituent to make your input.

3) Tell the staffer that you want to report fraud and abuse to the Representative and to the House Congressional Oversight and Reform Committee. 

“I want the Committee to demand corrective action from the Agency for Healthcare Research and Quality, in the same way it did in 2015 when it told the CDC to re-open its proposed opioid guideline to extended public review.”

“AHRQ published a review of treatments for acute pain in December 2020. The review is deliberately biased against the only therapies that work, deeply flawed by errors of scientific method, and outright fraudulent in its conclusions. This review must be withdrawn for independent review.”

4)  Thank the staffer for their time.  Ask “May I expect a callback from a member of the Representative’s staff?”

This is an opportunity to be heard, despite the lies being shouted by anti-opioid fringe groups like Physicians for Responsible Opioid Prescribing (PROP) and Shatterproof.

It is time for you to speak up!

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

Over-the-Counter Pain Meds and Gabapentin Recommended for Trauma Patients

By Pat Anson, PNN Editor

Over-the-counter pain medications and gabapentin are the best line of treatment for trauma patients suffering from acute short-term pain, according to new study at a Texas hospital that minimizes the use of opioids.

Researchers at the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center in Houston assessed two different combinations of non-opioid pain relievers in over 1,500 patients being treated for acute trauma, such as bone fractures and head injuries.

The treatment protocol that was deemed superior included a combination of inexpensive over-the-counter drugs such as acetaminophen and naproxen, with the nerve medication gabapentin (Neurontin). Opioids such as tramadol and oxycodone were only prescribed for breakthrough pain.

"Narcotics are not the mainstay of therapy for acute pain," said lead author John Harvin, MD, a trauma surgeon at the hospital and an associate professor at The University of Texas Health Science Center at Houston. "The research shows us that seriously injured people with acute pain can effectively be treated with an opioid-minimizing strategy."

The study findings, published in the Journal of American College of Surgeons, showed that a first-line pain regimen that used acetaminophen, ketorolac, naproxen, gabapentin or lidocaine patches reduced the use of opioids without a significant difference in pain scores. Only 62 percent of the patients were discharged with an opioid prescription.

"We used a generic pain regimen that is affordable at discharge. The discharge medications acetaminophen and naproxen can be bought over the counter. The only drug that requires a prescription is gabapentin and an as-needed opioid, if prescribed," Harvin explained.

The use of gabapentin as a treatment for acute pain is controversial, because recent studies show it has no significant analgesic effect and is increasingly being abused. In 2019, the Food and Drug Administration warned that serious breathing problems can occur in patients who take gabapentin with opioids or other drugs that depress the central nervous system.

But the use of gabapentin and over-the-counter pain relievers is now the standard treatment protocol for trauma patients at Memorial Hermann-Texas Medical Center, and physicians there are working to adapt it for the treatment of acute burn pain.

"The best way to decrease someone's risk for long-term (opioid) use is to minimize their exposure during hospitalization and at discharge, and we now know there are excellent non-opioid medications available that effectively treat pain,” said Harvin. “We know that culture change will take time and effort, but we're excited to be learning how to best leverage opioid-minimizing drugs to improve care, and to offer a new model that can be adopted by any trauma center."

The risk of long-term opioid use after an emergency room visit is actually quite low. A 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, a Mayo Clinic researcher. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

California Doctor Reluctantly Agrees to Probation for Opioid Prescribing

By Pat Anson, PNN Editor

After a two-year battle with the state medical board, a northern California doctor accused of overprescribing opioid pain medication has agreed to a settlement that allows her to continue practicing while under probation for the next 35 months.

“I settled because I could not afford the legal fees to fight it further and because I was offered a deal that allowed me to continue to prescribe as I see fit, so that no one would get cut off their meds suddenly,” says Corinne (Connie) Basch, MD, a primary care physician in Arcata, a small city in rural Humboldt county.

“I was afraid if I went to a hearing and tried to appear pro se (without an attorney) and somehow pissed off the judge I might wind up with a settlement that prohibited prescribing for a year, which was their initial proposal, and that there might be preventable deaths in my patient population as a result.”

If Basch’s medical license was suspended or revoked, 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.

The 2019 complaint against Basch by the Medical Board of California centered on her treatment of five patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication.

Although Basch tried to taper the patients to lower doses, the complaint alleges their dosages were still excessive and placed them at risk of overdose. No allegations were made that any of Basch’s patients were harmed while under her care.

DR. CORINNE BASCH

“I have a number of people who have been absolutely unsuccessful with every attempt to taper, for whom I was afraid,” Basch wrote in an email to PNN. “I also read some old decisions, basically convictions of doctors in my region. I read how the judges made their decisions: basically going completely on the credibility of this or that expert witness, imputing expertise on state expert witnesses who had not seen any patients for multiple years. 

“It was becoming increasingly clear to me that nobody was going to actually read any of the medical literature that objects to forced tapers and so on — that this whole thing was not going to be argued on its merits, that I was going to be perceived as a defensive miscreant, not as someone bound by conscience to make a different choice.”

Under the strict terms of her settlement, which takes effect today, Basch is required to keep detailed records of all controlled substances she prescribes, which must be “available for immediate inspection and copying” by board investigators. She must also take a series of educational classes on safe prescribing and medical record keeping, and have her practice monitored by another physician throughout her probation – all at her own expense.

Basch is worried about how she will pay for it all -- her entire income last year was $50,000 – but feels obligated to her patients to keep practicing.

“I have some guilt about caving, and also some fear about whether I can actually survive the financial costs of the probation, particularly in the middle of this pandemic which has been so incredibly expensive and challenging for my practice already, but ultimately I felt that I was going to be best able to protect my patients with this choice,” she said.

“As you can tell, I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.” 

Doctors Shamed for Prescribing Opioids

The California medical board has come under fire in recent years for its controversial “Death Certificate Project,” which resulted in threats of disciplinary action against hundreds of doctors who wrote opioid prescriptions for patients who fatally overdosed, sometimes years later.

The goal was to shame doctors to reduce opioid prescribing, but a recent study found that overdose deaths actually increased in the state after the project was launched. Many of the deaths involved street drugs, not prescription opioids.

Critics say the Death Certificate Project and other enforcement actions have had a chilling effect on doctors statewide.

“I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.”

— Dr. Corinne Basch

“Through your project, you have attacked many prominent, respected physicians, publicly shaming them as careless prescribers and threatening any doctors who had ever prescribed opioid pain medications for someone who ultimately died. This ‘witch hunt’ has caused many deaths and much suffering,” Kristen Ogden and other patient advocates with Families for Intractable Pain Relief wrote in a recent letter to the medical board.

“When you consider how many California physicians have left the practice of pain care, only a small percentage of the patients harmed have managed to continue to receive pain care at all. Most have not found any pain care, and are suffering agonizing lives for no reason. A few patients we knew have committed suicide because they did not find adequate care and were unable to live with the agony of untreated severe, constant intractable pain.”

The Death Certificate Project is now under review by the medical board and has been given the less inflammatory name of “Prescription Review Program.”

Basch was not targeted under program, but believes the board’s disciplinary actions against her and other doctors have only made the opioid crisis worse.  

“I feel there is a significant parallel to the medical board claiming to ‘do something about the opioid crisis’ and in fact doing the exact wrong thing, taking stable patients off of predictable prescribed medications and throwing them out to street supply which is increasingly adulterated and hazardous. This triumph of appearance over substance is at the root of so many wrongs in our current system,” Basch said.

“I do feel that the medical board should in some way be held accountable for their own negligence, for making policies and not monitoring the outcome, for doubling down on these policies even when the error has been pointed out to them. I am not sure how to get politicians interested in the situation, because it implies understanding the situation with enough depth to see that ‘opioids – bad’ is not a well- conceived policy.”

It’s High Time to Stop the Hurt

By Leslie Bythewood, Guest Columnist

Imagine waking up one morning with the worst pain you could ever dream up.

That’s what happened to me in 2000, only it would take another seven years before my now retired doctor broke the news that I had Arnold-Chiari malformation, a rare and incurable disease that causes unrelenting head pain.

A brain MRI revealed that my skull was squeezing my brain like a sponge, putting extreme pressure on the arteries in my brain. “It herniates out,” my doctor explained.

Fortunately, he was willing to prescribe opiates and my pain was well-managed for the next decade.

But in 2017, the year I became eligible for Medicare, I learned my doctor had opted out of that federal program, forcing me to find a new primary care physician. That’s when my life suddenly took a nosedive.

For the next year, four different physicians would attempt to taper me off opiates without my consent, causing my chronic pain to escalate exponentially and inflicting all sorts of adverse side effects from the anticonvulsants and antidepressants they prescribed.

I eventually found a caring doctor who understood my pain and immediately put me back on the tried-and-true opiate treatment plan that enabled me to function.

LESLIE BYTHEWOOD

One year later that doctor was forced to abruptly surrender his DEA license without justification, preventing him from prescribing opiates to any of his patients, including me. Nevertheless, undeterred and refusing to leave his patients in the lurch, he provided a soft landing by referring all of us to new doctors, enabling me to carry out my daily activities with no pain or intolerable side effects.

Opiates are the only class of medication that work for me and millions of other Americans with intractable pain, but it’s hard for many of us to find doctors willing to prescribe them. What caused the vast majority of doctors to go running the other way with their tails tucked between their legs was the 2016 CDC opioid guideline, which encourages cautious prescribing and arbitrary 90 MME dose limits.

Almost immediately after the guideline was released, patients could no longer count on their doctor to make informed clinical decisions about whether to prescribe opiates. The CDC had driven a big fat wedge between the doctor and the patient.

Many doctors never considered the CDC guideline as voluntary and viewed it as an unbending rule that tolerates no wiggle room. They gave their patients two choices: either taper off opiates or be dismissed for good.

The truth of the matter is that only a small percentage of patients become addicted to opiates. The vast majority take their medications as prescribed and are never at risk for addiction or overdosing. And that’s exactly why, despite the fact that opioid prescribing is at a 20-year low, the number of U.S. overdose deaths continues to soar, driven by street drugs such as heroin, cocaine, illicit fentanyl and methamphetamines, not pain medication.

The blame for this lies squarely with the CDC, DEA, Department of Justice and the news media, who continue to point the finger at doctors for “overprescribing” when the real culprit is street drugs. We don’t have an “opioid epidemic” at all. What we have is a street drug overdose epidemic, plain and simple.

The harm that’s been inflicted on millions of chronic pain patients needs to be rectified by throwing out the misguided CDC guideline and leaving it to the Food and Drug Administration to publish a new set of guidelines that do not encourage arbitrary dosage limits and restore the doctor-patient relationship.

But scrapping the CDC guideline doesn’t go far enough.

We desperately need federal and state laws that protect doctors and patients from the unwarranted, overreaching scrutiny of the DEA and ensure that patients with serious and debilitating diseases get adequate care without delay. Forced tapering and leaving people to suffer in pain are not the answer.

Once and for all, the war on drugs must come to a screeching halt. Restricting legitimate patients from access to opiates is not going to end the street drug overdose epidemic.

Leslie Bythewood is a freelance writer who lives in North Carolina.

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

Opioid Prescribing Limits Failed to Reduce Overdoses in British Columbia

By Pat Anson, PNN Editor

British Columbia’s opioid guideline failed to have any significant impact on overdoses, hospital admissions or deaths in the year after it was adopted, according to new research published in CMAJ Open. The study is the latest to show that opioid prescribing limits have been misdirected and ineffective in slowing North America’s opioid crisis.

The College of Physicians and Surgeons of British Columbia released strict professional guidelines for the “safe prescribing” of opioids and sedatives in 2016, after the Canadian province was hit by a wave of overdoses and deaths. The BC guidelines, which are similar to the CDC’s opioid guideline in the United States, warn doctors to be cautious about opioid prescribing and to avoid increasing doses over 90 morphine milligram equivalents (MME) per day.

Researchers at the University of British Columbia wanted to see how effective the BC guideline was in reducing overdoses, so they analyzed health data on over 68,000 patients on long term opioid therapy. A previous study by the same research team found a “modest” reduction in opioid use in the 10 months after the guideline was introduced, as well as more tapering.

Did the reduced prescribing result in fewer overdoses?  No.

Researchers found no significant change in opioid overdose hospital admissions, opioid overdose mortality, all-cause emergency department visits, all-cause mortality, or all-cause hospital admissions after the BC guideline was adopted. They also found no evidence that pain patients turned to street drugs after their opioid prescriptions were reduced or stopped.

“Concern has been expressed that policies focused on reducing prescribing of opioid analgesics could increase opioid-related deaths if patients unable to access prescription opioids for adequate pain relief turned to street drugs and were exposed to dangerously high levels of synthetic opioids. Our study did not find evidence that the standards and guidelines had the unintended consequence of increasing opioid overdose hospital admissions or opioid overdose mortality,” wrote lead author Richard Morrow, a senior research analyst at UBC.

Critics say the lack of evidence is proof that opioid prescribing has little to do with British Columbia’s overdose crisis.   

“The results are not unexpected and demonstrate the folly of limiting opioids to pain patients in a futile attempt to deal with overdoses from illicit street drugs. The policy has created considerable pain and anxiety along with a worsening quality of life for nothing,” said Marvin Ross, a patient advocate with the Chronic Pain Association of Canada. 

British Columbia’s Coroners Office expects 2020 to be a record breaking year for overdoses in the province, with about five drug deaths every day. A recent study found that the vast majority of BC’s overdoses involved illicit fentanyl and other street drugs. Only 2.4% of the nearly 1,800 fatal overdoses in BC from 2015 to 2017 involved opioid medication alone.

Stricter opioid prescribing policies have also been ineffective in slowing the overdose crisis in the United States. Prescription opioid use in the U.S. is at its lowest level in 20 years, while more Americans are dying from overdoses than ever before.

FDA Tightens Regulation of Fentanyl Medication

By Pat Anson, PNN Editor

Illicit fentanyl may be a deadly scourge on the black market, but for thousands of Americans in severe cancer pain, prescription fentanyl is an essential medicine. And for some, the potent synthetic opioid may soon be harder to obtain.

The U.S. Food and Drug Administration recently announced plans to tighten its Risk Evaluation and Mitigation (REMS) program for transmucosal immediate-release fentanyl (TIRF) products. TIRF medicines such as Actiq and Subsys are approved for breakthrough pain in cancer patients, who regularly take other opioids around-the-clock and are considered “opioid tolerant.”

TIRF lozenges, sprays and tablets are so effective that they’re often prescribed off-label for other types of breakthrough pain. The problem with that, according to the FDA, is that up to 55% of patients prescribed a TIRF medicine are not opioid tolerant and received a TIRF prescription for an unapproved use.

“Data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid tolerant,” FDA Commissioner Stephen Hahn, MD, said in a statement. “With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices. These changes will also improve our ability to monitor for adverse events and ensure safe use of these medicines.”

Under the strengthened REMS program, prescribers and pharmacies will be required to document a patient’s opioid tolerance for every TIRF prescription that is written or dispensed, including refills. A new patient registry is also being established for everyone who receives a TIRF medicine, so the prescriptions can be monitored for signs of misuse, addiction and overdose.

“All patients prescribed for outpatient use must be enrolled in the registry prior to receiving the first TIRF prescription. The Patient Enrollment Form is used to ensure that patients are aware of the registry requirement and that patients have been counseled appropriately about the safe use of the TIRF medicines, including the risk of respiratory depression, the need to be opioid tolerant as defined in labeling and proper storage of the TIRF medicines,” an FDA spokesperson explained in an email to PNN.

The email said the patient registry would not be available to law enforcement. Prescribing information will only be collected by TIRF manufacturers and will not publicly identify individual patients or prescribers.

“Collection of patient registry information is intended to help assure the safe use of these products, not for law enforcement purposes,” the email said. “FDA’s disclosure laws and regulations relating to information in FDA’s possession protect from public disclosure any information where the release would constitute a clearly unwarranted invasion of personal privacy.”

That pledge is noteworthy, because prescription drug monitoring programs (PDMPs) and other databases are being weaponized by law enforcement agencies to target physicians, pharmacies and patients who are deemed to be lawbreakers based on the dose and quantity of opioid prescriptions.

Fewer TIRF Prescriptions

Why the FDA is acting now is a bit unclear, because the number of people prescribed TIRF products has been declining for years, from about 14,400 patients in 2012 to just 4,700 patients in 2017. TIRF medications in 2017 accounted for just 0.02% of all opioid prescriptions dispensed at retail pharmacies.  

Reports of deaths and other adverse events from using the drugs have also fallen sharply. The FDA’s Adverse Events Reporting System received over 20,500 reports of adverse events involving Actiq in 2018, but there were only a few dozen cases in 2019.

“I would like to know what data the FDA has that prompted this action,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “TIRF opioids are rarely abused or associated with overdoses.”

Webster is also concerned that the additional paperwork and scrutiny by the REMS program may discourage doctors and pharmacists from writing or filling TIRF prescriptions. 

“Since TIRF opioids are only indicated for cancer related pain, more barriers to prescribing these medications may mean they will not be prescribed.  That would be unfortunate because the TIRFs are the most effective treatment for severe breakthrough pain,” Webster said. “I hope this policy is more than just checking a box for the FDA, and that they plan to measure the impact on patients' access to the medication and on their pain relief.”

The tougher REMS regulations for TIRF products go into effect in March 2021.

Gabapentinoids Riskier for Surgery Patients

By Pat Anson, PNN Editor

Another study is casting doubt on the use of gabapentinoids such as Lyrica (pregabalin) and Neurontin (gabapentin) for pain relief during and after surgery.

Gabapentioids are a class of nerve medication originally developed to treat convulsions, but the drugs are increasingly being used as a trendy alternative to opioids for acute and chronic pain. Some U.S. hospitals are even using gabapentinoids for surgical pain and have phased out or reduced the use of opioids.

In an analysis of over 5 million adults admitted for major surgery in the U.S. from 2007 to 2017, researchers at Harvard Medical School found that using gabapentinoids with opioids increases the risk of overdose, respiratory depression and other adverse events. Researchers say the additional risk was “extremely low” and would result in one additional overdose for every 16,000 patients.

“Our findings add to the growing evidence that gabapentinoids can potentiate the respiratory depressant effects of opioids,” researchers reported in JAMA Network Open. “The events were rare… (but) patients receiving multimodal pain management therapy that includes gabapentinoids should be closely monitored for possible respiratory depression.”

The study did not examine whether gabapentiniods were effective in treating surgical pain or if they improved the analgesic effect of opioids.

In an editorial also published in JAMA Network Open, a pain management expert said more studies were needed to see if gabapentiniods were worth the additional risk.

“The evidence in support of the analgesic benefit of gabapentinoids combined with opioids for postoperative analgesia is equivocal; there is no real support that adding gabapentinoids to opioid pain relievers offers additive, much less synergistic, enhancements to pain control,” wrote Joseph Pergolizzi, Jr, MD, Chief Operating Officer of NEMA Research.  

“Considering that combination analgesic regimens generally reduce overall opioid consumption, this study is important because it shows that this may not necessarily translate to reducing opioid-associated adverse events. As combination analgesia gains traction for in-hospital acute painful conditions, such as postsurgical pain, it is important to be guided by evidence rather than intuition.”

No Significant Analgesic Effect

A recent study by Canadian researchers also found little evidence to support the use of gabapentinoids for surgical pain.

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

These and other findings contradict guidelines published by the American Pain Society in 2016, which advocate “around the clock” use of gabapentin, pregabalin and other non-opioid drugs both before and after surgery.

The risk of becoming addicted or dependent on opioids after surgery is actually quite low. A 2016 study found that only 0.4% of elderly patients who were prescribed opioids for post-operative pain were still using them a year after their surgeries. Another study by Harvard researchers found that only 0.2% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Growing Concerns About Opioid Tapering

By Roger Chriss, PNN Columnist

A common belief about the opioid crisis assumes that patients develop a substance use disorder from taking opioid medication, and that many derive no long-term benefit from opioids and need to be tapered.

There is some truth to this, but reality is much more complicated.

First, not all patients who take opioids become addicted. The National Institute on Drug Abuse reports between 8 and 12 percent of patients prescribed opioids for chronic pain develop an opioid use disorder (OUD). Even that estimate may be too high, because the diagnosis of OUD is sometimes mistaken.  

In a recent study of 90 patients diagnosed with OUD at three Veterans Health Administration medical centers, physician Ben Howell and colleagues found that nearly a third of the diagnoses were probably wrong.

“Our study identified significant levels of likely inaccurate OUD diagnoses among veterans with incident OUD diagnoses. The majority of these cases reflected readily addressable systems errors,” researchers concluded. “If these inaccuracies are prevalent throughout the VHA, they could complicate health services research and health systems responses.”

Second, not all people who are tapered off prescription opioids improve. A new study in the Journal of Pain Research looked at 40 chronic pain patients who were tapered from an average daily dose of 80 MME (morphine milligram equivalent) down to 19 MME. The results were disappointing. There was only minor improvement in the patients’ cognitive function and no improvement in their quality of life, depression and anxiety.

There is at present no well-established approach to opioid tapering and little effort made to study patient outcomes.  In a recent paper, lead author Stefan Kertesz, MD, and colleagues say there is a “pill dynamic” approach to tapering that focuses on dose reduction alone.

"When a multi-faceted, complex health issue becomes a public health crisis, the desire to ‘solve’ or ‘mitigate’ takes hold with a momentum of its own. A crisis deserves no less. However, nationally adopted quality metrics have convinced some patients with pain that their survival and functioning are no longer concerns for the systems in which they receive care. This outcome is unacceptable," they concluded.

Patient Suffering and Suicides

The risks of forced opioid tapering are so urgent that nearly 100 physicians, academics and patient advocates recently published an open letter in the journal Pain Medicine warning of “an alarming increase in reports of patient suffering and suicides” caused by aggressive tapering:

“We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies — and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

We call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.”

The public health issue of opioid overdoses is complex, urgent and largely driven by street drugs, not pain medication. Opioid prescriptions are at 20-year lows, and the American Medical Association recently said it was “alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl.”

And as National Institute of Drug Abuse director Nora Volkow, MD, stated in a recent blog post:

“Although deaths from opioids continue to command the public’s attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis. We face a complex and ever-evolving addiction and overdose crisis characterized by shifting use and availability of different substances and use of multiple drugs (and drug classes) together.”

Opioid tapering is no more a universal good than opioid prescribing was a universal evil. And opioid tapering will no more solve the overdose crisis than opioid prescribing alone caused it. Instead, opioid tapering may harm the very people it is intended to help, and it may not help the crisis that it is motivated by. Better public health policy and clinical practice are urgently needed.

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. 

Do Prescription Opioids Increase Social Pain and Isolation?

By Pat Anson, PNN Editor

Long-term use of opioid medication may increase social isolation, anxiety and depression for chronic pain patients, according to psychiatric and pain management experts at the University of Washington School Medicine.

In an op/ed recently published in Annals of Family Medicine, Drs. Mark Sullivan and Jane Ballantyne say opioid medication numbs the physical and emotional pain of patients, but interferes with the human need for social connections.

“Their social and emotional functioning is messed up under a wet blanket of opioids,” Sullivan said in a UW Medicine press release.

Sullivan and Ballantyne are board members of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. Ballantyne, who is president of PROP, was a member of the “Core Expert Group” that advised the CDC during the drafting of its controversial 2016 opioid guideline. She has retired as a professor of pain medicine at the university, while Sullivan remains active as a professor of psychiatry.

In their op/ed, Sullivan and Ballantyne say it is wrong to assume that chronic pain arises solely from tissue damage caused by trauma or disease. They cite neuroimaging studies that found emotional and physical pain are processed in the same parts of the human brain.  While prescription opioids may lessen physical pain, they interfere with the production of endorphins – opioid-like hormones that help us feel better emotionally.

“Many of the patients who use opioid medications long term for the treatment of chronic pain have both physical and social pain,” they wrote. “Rather than helping the pain for which the opioid was originally sought, persistent opioid use may be chasing the pain in a circular manner, diminishing natural rewards from normal sources of pleasure, and increasing social isolation.

“To make matters worse, the people who need and want opioids the most, and who choose to use them over the long term, tend to be those with the most complex forms of chronic pain, containing both physical and social elements. We have called this process ‘adverse selection’ because these are also the people who are also at the greatest risk for continuous or escalating opioid use, and the development of complex dependence.”

Sullivan and Ballantyne say doctors need to recognize that when patients have both physical and social pain, long-term opioid therapy is “more likely to harm than help.”

“We believe that short-term opioid therapy, lasting no more than a month or so, will and should remain a common tool in clinical practice. But long-term opioid therapy that lasts months and perhaps years should be a rare occurrence because it does not treat chronic pain well, it impairs human social and emotional function, and can lead to opioid dependence or addiction,” they wrote.

Angry and Depressed Patients

It’s not the first time Sullivan and Ballantyne have weighed in on the moods and temperament of chronic pain patients. In a 2018 interview with Pain Research Forum, for example, Ballantyne said patients often have “psychiatric comorbidities” and become “very angry” at anyone who suggests they shouldn’t be on opioids.

“I’ve never seen an angry patient who is not taking opiates. It’s people on opiates who are angry because they’re frightened, desperate, and need to stay on them. And I don’t blame them because it is very difficult to come off of opiates,” she said.

In a 2017 interview with The Atlantic, Sullivan said depression and anxiety heighten physical pain and fuel the need for opioids. “People have distress — their life is not working, they’re not sleeping, they’re not functioning,” Sullivan said, “and they want something to make all that better.”

JANE BALLANTYNE MARK SULLIVAN

In a controversial 2015 commentary they co-authored in the New England Journal of Medicine, Sullivan and Ballantyne said chronic pain patients should learn to accept pain and get on with their lives, and that relieving pain intensity should not be the primary focus of doctors. The article infuriated both patients and physicians, including dozens who left bitter comments.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation,” wrote a patient.

Ballantyne and Sullivan’s op/ed in Annals of Family Medicine has yet to produce a similar response, either pro or con. The article was submitted to the journal over a year ago, but is only being published now.

Ballantyne disclosed in her conflict-of-interest statement that she has been a paid consultant in opioid litigation lawsuits, while Sullivan disclosed that he provided expert testimony for the states of Maryland and Missouri.

Other PROP board members have also found a lucrative sideline testifying in lawsuits. The organization is currently conducting a fundraiser to hire a new Executive Director to “take PROP's work to the next level.”