Fentanyl May Be Classified as Weapon of Mass Destruction

By Pat Anson, PNN Editor

The Trump Administration is considering labeling fentanyl as a weapon of mass destruction, according to a Homeland Security memo obtained by the military news website Task & Purpose.

"Fentanyl's high toxicity and increasing availability are attractive to threat actors seeking nonconventional materials for a chemical weapons attack," wrote James McDonnell, a DHS assistant secretary, in a February 22, 2019 memo prepared for then-Secretary Kirstjen Nielsen.

According to the memo, the FBI considers fentanyl “a viable option for a chemical weapon attack by extremists or criminals.”  The idea of labeling fentanyl a weapon of mass destruction (WMD) is also under consideration by the Department of Defense.

“Within the past couple years, there has been reinvigorated interest in addressing fentanyl and its analogues as WMD materials due to the ongoing opioid crisis,” McDonnell wrote.

DEA IMAGE

DEA IMAGE

Fentanyl is a synthetic opioid, 50 to 100 more potent than morphine, that is legally prescribed to treat severe chronic pain. In recent years, bootleg versions of fentanyl and its chemical cousins have flooded the black market, where they are often added to heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

According to the CDC, fentanyl is involved in more overdoses than another drug and was linked to 18,835 drug deaths in 2016. Most of the black market fentanyl is produced by drug labs in China and then smuggled into the U.S. from Mexico or shipped through the mail.  

Designating fentanyl as a WMD would enable Homeland Security to increase funding for sensors and other technology that can detect fentanyl being smuggled in vehicles, packages and shipping containers.

A WMD expert told Task & Purpose the idea of fentanyl being used as a weapon was a “fringe scenario” because there are dozens of toxic chemicals that can be easily weaponized.

"It reads like somebody is laying the administrative background for trying to tap into pots of money for detecting WMD and decontaminating WMD," said Dan Kaszeta. "It's an interdepartmental play for money, that's all it is."

An unnamed senior defense official quoted by Task & Purpose was also skeptical.

"Anybody with a college level degree in chemistry can manufacture chemical weapons agents," the defense official said. “I cannot see any scenario where a nation-state would use fentanyl on the battlefield, or for that matter, a terrorist using a really toxic chemical like fentanyl in an attack when they could just sell it for funding the purchase of firearms and explosives or steal an industrial chemical instead.” 

A 2016 research article published in JAMA Internal Medicine speculated that counterfeit pills made with fentanyl could be the work of a “malicious actor” trying to poison people.

“These highly potent pills could have been created by a malicious actor to intentionally poison consumers or attract the attention of law enforcement to redistributors,” wrote Traci Green, PhD, Boston University School of Medicine, and Michael Gilbert, MPH, Epidemico Inc

China recently agreed to ban all “fentanyl-related substances” by listing them as controlled substances. The move is meant to close a loophole that allowed drug labs to make novel variations of fentanyl that are not technically illegal.

60 Arrested in Latest Crackdown on Rx Opioids

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

Most Overdoses Don’t Involve Rx Opioids

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

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

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

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

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

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

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

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

When Will Forced Tapering of Opioids End?

By Lynn Webster, MD, PNN Columnist

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

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

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

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

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

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

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

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

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

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

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

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

Second Thoughts About CDC Guideline

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

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

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

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

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

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

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

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

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

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

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

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

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CVS Fined $535,000 for Filling Forged Opioid Prescriptions

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

All of these cases were settled out of court.

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

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

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

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

Biden: ‘A Little Pain Is Not Bad’

By Pat Anson, PNN Editor

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

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

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

FORMER VICE-PRESIDENT JOE BIDEN

FORMER VICE-PRESIDENT JOE BIDEN

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

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

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

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

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

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

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

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

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

CDC Director Says Agency Will ‘Clarify’ Opioid Guideline

By Pat Anson, PNN Editor

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

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

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

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

ROBERT REDFIELD, md

ROBERT REDFIELD, md

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

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

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

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

‘Closing the Barn Door’

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

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

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

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

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

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

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

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

CDC: Guideline ‘Not Intended to Deny Any Patients Opioid Therapy’

By Pat Anson, PNN Editor

A top official with the Centers for Disease Control and Prevention says the agency’s controversial opioid guideline was never intended to deny prescription opioids to chronic pain patients.

Deborah Dowell, MD, is one of the co-authors of the 2016 guideline and the chief medical officer for the CDC’s National Center for Injury Prevention and Control. In a February 28th letter made public this week, Dowell attempted to dispel the widespread belief that the guideline is a mandatory policy for all pain patients.  

“The Guideline is not intended to deny any patients who suffer with chronic pain from opioid therapy as an option for pain management. Rather, the Guideline is intended to ensure that clinicians and patients consider all safe and effective treatment options for payments,” Dowell wrote. “CDC encourages physicians to continue to use their clinical judgement and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment.”

Dowell’s letter was addressed to three medical associations – the American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH) and the National Comprehensive Cancer Network – which were concerned that the CDC guideline was being misapplied by insurers to patients with cancer and sickle cell disease.

In February, the three groups sent a joint letter to Dowell asking the CDC to release an immediate clarification that the guideline was not intended for patients in active cancer treatment.

“Although the CDC guideline clearly states that the guideline is not intended to apply to this population, many payers are still inaccurately applying the CDC guidelines to patients in active (cancer) treatment,” the letter said.

Dowell responded a few days later with her own letter -- stating that the guideline was never intended to deny “any patients” opioid medication, but that alternate pain therapies should be considered.

Her letter also noted that two clinical practice guidelines for cancer pain (here and here) have been published or updated since the release of the CDC guideline.

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“This clarification from CDC is critically important because, while the agency’s guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” ASCO Chief Executive Officer Clifford Hudis, MD, said in a statement.

“People with sickle cell disease suffer from severe, chronic pain, which is debilitating on its own without the added burden of having to constantly appeal to the insurance companies every time a pain crisis hits and the initial request is denied,” said ASH President Roy Silverstein, MD. “We appreciate CDC’s acknowledgement that the challenges of managing severe and chronic pain in conditions such as sickle cell disease require special consideration, and we hope payers will take the CDC’s clarification into account to ensure that patients’ pain management needs are covered.”

The CDC guideline is voluntary and only intended for primary care physicians treating chronic non-cancer pain. But after its release in March 2016, the guideline quickly metastasized throughout the U.S. healthcare system and became a mandatory policy for many insurers, pharmacies, states and practitioners.

‘Even Cancer Patients Suffer’

Many cancer patients who responded to PNN’s recent survey on the CDC guideline said they were denied opioid medication or not given enough for pain control.

“I'm fighting cancer a second time and I'm not being properly medicated, can't find a pain management (doctor) that will take me on. I have days where I am suffering and have no quality of life!” one patient wrote. 

“I'm a brain cancer patient and the CDC guideline has scared every doctor and oncologist in Connecticut. Even cancer patients suffer and they don't care because that's the law,” another said. 

“I was told two weeks ago that I have lung cancer and still cannot get anything for pain,” wrote another patient. 

“I had to go a year without pain meds and I am a stage 4 head and neck cancer survivor. The sudden withdrawal almost killed me,” said one patient. “Thank God I found a pain management doctor that understands head and neck cancer and the devastating effects it leaves forever. But even he is limited.” 

“I went through 6 weeks of chemo and radiation. My treatment caused muscle and joint pain that on some nights and days are so bad I wish I would have never survived my cancer. They have me on gabapentin. It is okay but does not stop the pain,” wrote another cancer survivor.

None of this is news to the CDC. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “some doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.” In a joint letter to the CDC, hundreds of healthcare providers also warned the agency that within a year of the guideline’s release “there was evidence of widespread misapplication” of its recommendations.

But except for an occasional letter -- like the one from Dowell -- there has been no systematic, publicized effort by the CDC to remind insurers, pharmacies and providers that the guideline is voluntary and exempts cancer patients. The agency has also failed to keep its pledge to study the impact of the guideline on patients and to revise it in future updates.

FDA Warns About Fast Opioid Tapers

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration issued an unusual warning Tuesday cautioning doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication.

The agency said in a statement it had received reports of “serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.” The harm includes withdrawal symptoms, uncontrolled pain, psychological distress and suicide.

The FDA gave no details on cases of patient harm but said it was tracking them and would require changes on opioid warning labels to help instruct physicians on how to safely decrease opioid doses.

“Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances,” the FDA said.

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In recent years, there have been an increasing number of anecdotal reports of pain patients committing suicide or turning to illegal drugs for pain relief. It is not clear why the FDA decided to act now, just days after the departure of former FDA commissioner Scott Gottlieb, MD.

In PNN’s recent survey of nearly 6,000 patients, over 80 percent said they had been taken off opioids or had their dose reduced. Nearly half said they had considered suicide because their pain is poorly treated and many were turning to other substances – both legal and illegal – for pain relief.

  • 11% obtained opioid medication from family, friends or black market

  • 26% used medical marijuana for pain relief

  • 20% used alcohol for pain relief

  • 20% used kratom for pain relief

  • 4% used illegal drugs (heroin, illicit fentanyl, etc.) for pain relief    

Last December, over a hundred healthcare professionals warned in a joint letter to the Department of Health and Human Services that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

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

Federal agencies widely differ on opioid tapering recommendations. The Centers for Disease Control and Prevention recommend a "go slow" approach, with a "reasonable starting point" being 10% of the original dose per week. Patients who have been on opioids for a long time should have even slower tapers of 10% a month, according to the CDC.

The Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks, although in some cases the VA suggests an initial rapid taper of 20% to 50% a day “if needed.”

In its warning, the FDA cautioned doctors that no standard opioid tapering schedule exists that is suitable for all patients.

When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient,” the FDA said. “Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.”

The FDA urged patients and doctors to report side effects from opioid discontinuation and rapid tapers at druginfo@fda.hhs.gov or to call 855-543-DRUG (3784) and press 4.

An Open Letter to the CDC Center for Injury Prevention

By Richard “Red” Lawhern, Guest Columnist

Dear Dr. Robert Redfield and Dr. Debra Houry,

By its passive refusal to conduct a thorough review of the impact and outcomes of its 2016 opioid prescribing guideline, the CDC’s National Center for Injury Prevention and Control is actively causing harm to hundreds of thousands of pain patients.   

Deserted by their doctors in a hostile regulatory environment, many are going into the streets seeking pain relief.  Possibly hundreds may already be dead of illegal fentanyl poisoning or suicide.  Military veterans, in particular, face draconian restrictions on the availability of safe and effective opioid medication therapy.   

And all for no good reason!

I suggest with every intention of professional and personal courtesy, that government organizations can no longer stand aside from this centrally important issue.  Such a stance will make you and other federal agencies accessories to state-sanctioned torture and negligent homicide.  That is unacceptable.   

As a former military officer, I respect a well-tried motto that I urge each of our regulators to take on as their own:   

      Lead, follow, or get out of the way! 

It has become clear that the CDC guideline must be immediately withdrawn for a major rewrite.  In its present form, the guideline is unjustifiably biased against opioid pain relievers, factually incomplete, in error on basic science, and founded on untested assumptions that do not hold up under any degree of careful scrutiny.   

The guideline is directly responsible for a vast regulatory over-reach by DEA and state authorities that is driving doctors out of pain management and denying safe and effective pain treatment for hundreds of thousands of patients.  

The CDC guideline has been publicly repudiated by no less an authority than the American Medical Association. Over 300 medical professionals have called for a rewrite of the guideline from the ground up. And a recent draft report by a federal task force calls for a reorientation of the guideline towards individualized patient-centered care, not the one-size-fits-all approach of the CDC. 

Multiple published papers have conclusively invalidated the guideline’s contention that there is a maximum dose threshold of risk for opioid addiction and overdose.   

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Likewise, contrary to assertions in the guideline, there are presently no validated long-term studies to support the use of non-opioid analgesics and NSAIDs, or the off-label prescribing of anti-seizure and anti-depressant drugs to treat pain. No Phase II or Phase III trials have been published on "alternative" techniques such as acupuncture, massage or meditation.  And there are no trials which directly compare these techniques to opioid therapy under documented protocols.  Alternative treatments can at best be regarded as adjuncts to be added to analgesic or anti-inflammatory treatment.  

Published papers also demonstrate that criteria used by CDC and other federal agencies to identify risk of opioid abuse or overdose have very limited predictive accuracy. These faulty criteria are now being used by Prescription Drug Monitoring Programs (PDMP’s) to "flag" patients presumed to be at risk, who are in fact not at risk but are being denied pain treatment due to false alarms.  

Opioids, Overdoses and Demographics 

We can now take this narrative a step further.  I have compiled overdose data directly from the CDC Wonder database and from the Agency for Healthcare Research and Quality Data. This data focuses specifically on deaths directly attributable to opioid-related overdoses or suicide. The chart below shows rates of mortality by age group from 1999 to 2017.

GRAPHICS BY RED LAWHERN

GRAPHICS BY RED LAWHERN

Note that the highest rates of opioid-related mortality are among youth and young adults, while the lowest rates are among people over age 55.  Moreover, mortality in youth has skyrocketed by 1,800% over 17 years, while remaining relatively stable in people 55 and older.

The chart below documents the contrast in opioid prescribing by age group in 2016.  Unsurprisingly, older adults and seniors are much more likely to experience chronic pain and are prescribed opioids at a rate nearly double that of young adults. These two demographic trends contradict the idea that opioid overdoses are linked to prescribing.  They’re not and the evidence proves it. 

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An updated analysis report further summarizes major themes we found in the overdose data.  The report reveals that “over-prescribing” of medical opioids was never a significant driver in opioid overdoses. There is no cause-and-effect relationship between rates of opioid prescribing versus rates of opioid overdose. In fact, it can be argued that in states where prescribing rates are highest, the trend may be in the opposite direction. 

The downward sloping red line in the chart below is called a "regression" line.  This is the trend line for the overdose and prescribing data from all 50 states in 2016. If there were a connection between high rates of opioid prescribing and overdoses, we’d expect the regression line to be pointing upward, not downward.

Overdose mortality rates are actually lower in high-prescribing states! 

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One plausible explanation for the downward sloping line is that in states where prescribing has been more suppressed, patients are being driven into unsafe street markets or are committing suicide when overwhelmed by pain.   

These findings have previously been published in the blog of Dr. Lynn Webster, former President of the American Academy of Pain Medicine and author of "The Painful Truth." 

The implications of this analysis are glaring: the National Center for Injury Prevention and Control has created a fatally flawed guideline which actively increases injury rather than reducing it.   

Taken in sum, the evidence reveals that key assumptions on which the CDC guideline is based are simply and conclusively wrong.  Continued refusal to reevaluate the guideline is morally, ethically, medically and legally wrong. The 2016 CDC guideline on opioids must be retracted.  NOW! 

(Editor’s note: Dr. Redfield is CDC Director and Dr. Houry is Director of the CDC National Center for Injury Prevention and Control. A longer version of this open letter has been sent by email to other federal agencies and officials.)

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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 and Director of Research for The Alliance for the Treatment of Intractable Pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Canada Forms Chronic Pain Task Force

By Marvin Ross

Canadian chronic pain patients were given a glimmer of hope this week when federal health minister Ginette Petitpas Taylor announced the establishment of a national task force to examine how to prevent and manage chronic pain and remove barriers to pain treatment.

“This is the first step in addressing the issue of chronic pain in this country,” Ginette Petitpas Taylor said at the annual meeting of the Canadian Pain Society in Toronto. “We have to recognize that Canada’s a big country and we certainly know there’s inconsistent services in provinces and territories, so I have to really have a good understanding of what’s available and what’s happening out there.”

One in five Canadians lives with chronic pain and -- like their counterparts in the U.S. – many have been on the receiving end of the crackdown on opiates.

After the U.S. Centers for Disease Control and Prevention released its 2016 opioid guideline, Canada followed with its own very similar set of recommendations, which were developed by a panel at McMaster University chaired by lead investigator Dr. Jason Busse, a chiropractor.

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Although the guidelines are voluntary, medical regulatory colleges across Canada have been pressuring their physician members to drastically reduce opioid prescribing and many doctors now fear for their licenses if they don’t comply.

Petitpas Taylor acknowledged that Canada’s response to the overdose crisis contributed to “stigmatizing attitudes and behaviours” about opioids and created barriers “that may prevent people with chronic pain from receiving the health services they need.”

She said the task force will consult with governments and advocacy groups, and provide an initial report to Health Canada in June, followed by two more in 2020 and 2021.

The panel has two co-chairs. Dr. Fiona Campbell is a pediatric anesthesiologist and Associate Professor in the Department of Anaesthesia & Pain Medicine at the University of Toronto. The other co-chair is Maria Hudspith, who is the Executive Director of Pain BC, a non-profit charity working to improve the lives of people in pain.

Both co-chairs have been on the syndicated Roy Green Show discussing the increasing problems faced by pain patients. In 2017, Campbell told Green that patients who need opiates should not be marginalized and that opiates should be used when all other treatment modalities have failed. Hudspith was a guest on the Green show last year and is well aware that patients have been forcibly tapered or cut off from opioids and often have problems finding care.

That gives me some hope, as does the fact that the other six members of the task force are a combination of medical specialists and pain patients themselves. But not everyone is pleased with the appointments or that the panel’s work will take up to three years.

“Of course, we are happy they are actually acknowledging chronic pain is an issue. However, the time frame is wrong and a little bit too late. We are also quite disappointed in the individuals who have been chosen to lead this task force,” said Barry Ulmer of the Chronic Pain Association of Canada. “Although we were consulted to a degree, it seems our voices were not heard to any large extent.” 

"My colleagues and I provided a list of names of pain physicians who have decades worth of practical experience and have worked diligently to hone their knowledge and skills. We were extremely disappointed not to see a single name from this list appointed to the task force,” said Ann Marie Gaudon, a social worker, pain patient and PNN columnist. 

“Additionally, while we appreciate the Minister's efforts in setting up this task force, solutions must be found now or there will be more deaths and increasing needless suffering. These severely pained and severely stigmatized patients who have been forced off of necessary medications just do not have three years to wait for more information that we already have. There is an extreme urgency here that is not being addressed as such."

Chronic pain in Canada costs up to $60 billion per year in direct health care costs and lost productivity due to job loss and sick days. 

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

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

39 Attorneys General Practicing Medicine Without a License

By Pat Anson, PNN Editor

Over 5,000 healthcare providers, patients, caretakers and advocacy organizations have left comments in the Federal Register on a draft report by a federal advisory panel known as the Pain Management Best Practices Inter-Agency Task Force. The comment period ended April 1.

Most of the comments – which you can see by clicking here – are supportive of the report, which recommends that pain management be balanced, multimodal and focused on individualized patient care. Opioid pain medication should be prescribed cautiously, if prescribed at all, according to the task force.

Those may sound like reasonable and prudent goals, but one aspect of the draft report has stirred controversy and it’s a familiar one: the CDC’s 2016 opioid prescribing guideline.

While commending its “useful general guidance,” the report found that that guideline has had many unintended consequences, including forced opioid tapering, patient abandonment and suicide. The task force said the guideline was never meant to be mandatory or to be used as a model by states, insurers and pharmacies, and better evidence was needed to support its recommendations.

The task force stopped short of recommending a wholesale revision of the guideline, but suggested a “more even-handed approach” to pain care was needed.  

“In essence, clinicians should be able to use their clinical judgement to determine opioid duration for their patients,” the report concludes.

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Those were fighting words to some anti-opioid crusaders and politicians who consider the CDC guideline a cornerstone of the government’s war on drugs.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment that causes nearly 50,000 deaths annually,” warns a letter signed by 39 state and territory attorney generals.  “It is incomprehensible that officials would consider moving away from key components of the CDC Guideline.”

‘They Have Overreached’

The AG’s letter shows a fundamental and perhaps willful ignorance of what the guideline is – a voluntary set of recommendations intended only for primary care physicians. The letter also demonstrates how politicians have grown accustomed to inserting themselves into pain management decisions normally left between patients and their doctors. In essence, the AG’s are saying that doctors should not be allowed to use their own clinical judgement and should rely instead on treatment guidelines.  

“The Draft Report proposes to rely solely on the judgment of providers regarding the dose and duration of opioid treatment. With annual overdose deaths in the tens of thousands, evidence-based recommendations, such as documentation and consultation, are necessary,” the AG letter states. “Similarly, the Draft Report states that duration of opioid treatment for acute pain, including trauma and surgery, is best determined by providers without the need for guidelines to inform appropriate decision-making.”

Critics say the AG’s are essentially practicing medicine without a license.

“The foxes watching the hen house want more hens to watch, more justification for their existence,” says Mark Ibsen, MD, a Montana doctor all too familiar with government intrusion into pain care. Ibsen’s medical license was suspended in 2016 over allegations that he overprescribed opioids, a decision later reversed by a judge.

“They have overreached. I hope someone else notices, and takes law enforcement out of the practice of medicine, where they’ve been screwing up medical care since 1914. Abolish the DEA. Let law enforcement catch criminals, not make them up out of thin air,” Ibsen said.

This isn’t the first time the National Association of Attorneys General has tried to meddle in pain care. In 2017, the organization sent a letter to health insurers asking them to take steps to reduce the prescribing of opioid medication.

Reducing the frequency with which opioids are prescribed will not leave patients without effective pain management options.
— National Assn. of Attorneys General

“Reducing the frequency with which opioids are prescribed will not leave patients without effective pain management options,” the 2017 letter states. “When patients seek treatment for any of the myriad conditions that cause chronic pain, doctors should be encouraged to explore and prescribe effective non-opioid alternatives, ranging from non-opioid medications (such as NSAIDs) to physical therapy, acupuncture, massage, and chiropractic care.”

In their latest letter, it’s no longer a matter of “should.” The AG’s say doctors “must be encouraged” to reduce opioid prescriptions and to recognize that opioids have “well established risks.”  

“The Draft Report should be revised to clearly state that there is no completely safe opioid dose, and that higher doses are particularly – and predictably – risky,” the AG’s wrote.

But most opioid medications are not particularly risky, as PNN reported in a recent study of over half a million Medicare patients who were prescribed the drugs. Over 90 percent had a negligible risk of an overdose. Even among “high risk” patients on high opioid doses, the risk of an overdose is less than two percent.

‘Too Much Money On the Line’

Critics also point out the AG’s have a political and financial interest in demonizing opioid medication. Most have signed on as plaintiffs in over 1,600 class action lawsuits filed by states, cities and counties seeking billions of dollars in damages from opioid manufacturers and distributors. Oklahoma Attorney General Mike Hunter – one of the AG’s who signed the letter criticizing the task force report --  recently reached an out-of-court settlement with Purdue Pharma for $270 million.  

“There is just too much potential money on the line. This is not an argument about truth, or evidence, or anything except money," says Andrea Anderson, Executive Director of the Alliance for the Treatment of Intractable Pain (ATIP).  

“Since the Purdue/Oklahoma settlement of $270 million, all the AG’s of every state involved in this opioid litigation will focus solely on their potential financial gains until they get their piece of settlement pie. This will come at the cost of needed revisions to the flawed CDC Guidelines and a return to clinical common sense. People can remember these AG’s when they vote.” 

According to OpenSecrets.org, the law firm of Simmons Hanly Conroy donated over $1 million to congressional candidates during the 2018 election cycle. Simmons Hanly Conroy represents dozens of states and local governments that are suing drug makers over their marketing of opioids, and would pocket one-third of the proceeds from any settlements, according to reports.

A recent PNN survey found the CDC guideline was having a harmful effect on both patients and healthcare providers. Over 85 percent of patients say the guideline has made their pain and quality of life worse. Nearly half have considered suicide. Over two-thirds of practitioners are worried about being sanctioned or prosecuted for prescribing opioids. Rather than risk going to prison, many have stopped treating pain, closed their practice or retired.  

Doctors Say Guidelines Exaggerate Effectiveness of Lyrica and Neurontin

By Pat Anson, PNN Editor

There is little evidence that gabapentin (Neurontin) and pregabalin (Lyrica) should be used off-label to treat pain and prescribing guidelines often exaggerate their effectiveness, according to a new clinical review in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids. The drugs were originally developed to prevent seizures, but their use has tripled over the past 15 years as more doctors prescribed them for a variety of chronic pain conditions. It is a common practice for doctors to prescribe drugs “off label” for treatments that are not FDA-approved.

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Gabapentin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder.  Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries, but it is also widely prescribed off-label to treat other types of pain.

The drugs are sold by Pfizer under the brand names Lyrica and Neurontin. The company has paid nearly $1 billion in fines for misleading and improper marketing of the drugs for off-label use.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” the doctors wrote.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Goodman and Brett say the wording in many medical guidelines “reinforces an inflated view of gabapentinoid effectiveness” by falsely claiming the drugs should be used to treat all types of nerve pain.

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“Another example is the 2016 guideline on opioid prescribing from the U.S. Centers for Disease Control and Prevention, which states broadly that gabapentin and pregabalin are first-line drugs for neuropathic pain, without further detail or specification,” they wrote. “Even for treatment of diabetic neuropathy (for which pregabalin is FDA approved and gabapentin is off-label), guideline conclusions tend to exaggerate effectiveness.”

Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are an increasing number of reports that the drugs are being abused and sold on the street.   

Goodman and Brett have sounded the alarm before about the drugs, warning in a 2017 commentary in the The New England Journal of Medicine that “gabapentinoids are being prescribed excessively.”

They say doctors should do a better job warning patients about the side effects of gabapentinoids and the drugs should be stopped if a patient reports little or no benefit.  They also think medical guidelines should be revised to stop the promotion of gabapentinoids for any pain labeled as neuropathic.

Study Finds 90% of Medicare Patients Have Little Risk of Opioid Overdose

By Pat Anson, PNN Editor

Current methods used to identify Medicare patients at high risk of overdosing on prescription opioids target many people who are not really at high risk, according to a team of researchers who found that over 90% of patients have little to no risk of overdosing.

"The ability to identify such risk groups has important implications for policymakers and insurers who currently target interventions based on less accurate measures,” said lead author Wei-Hsuan "Jenny" Lo-Ciganic, PhD, a professor of pharmaceutical outcomes and policy at the University of Florida, who reported her findings in JAMA Network Open.  

Lo-Ciganic and her colleagues at the University of Pittsburgh, Carnegie Mellon University and University of Utah studied health data on over half a million Medicare beneficiaries who filled one or more prescriptions for opioids between 2011 and 2015. The researchers identified which patients overdosed and then used machine-learning algorithms to analyzed their demographics and health records.

The computer models developed three risk groups that predict which patients are at risk of overdosing over a 12 month period.

  • Low risk patients (67.5%) have 0.006% risk of overdose

  • Medium risk patients (23.3%) have 0.05% risk of overdose

  • High risk patients (9.1%) have 1.77% risk of overdose  

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Put another way, out of 100,000 Medicare patients in the low risk group, six would have an overdose; while there would be 1,770 overdoses in a high risk group of the same size.

Not surprisingly, the computer models found that high doses of opioids and a prior history of substance abuse significantly raise the risk of an overdose. So does a person’s age, disability status and whether they are co-prescribed benzodiazepines. Patients who live in certain states (Florida, Kentucky or New Jersey) are also at higher risk.

Top 10 Predictors of Opioid Overdose

  1. Total MME (morphine milligram equivalent)

  2. History of substance or alcohol abuse

  3. Average daily MME

  4. Age

  5. Disability status

  6. Number of opioid refills

  7. Resident state

  8. Type of opioid

  9. Number of benzodiazepine refills

  10. Drug use disorders  

The study found that the machine-learning algorithms the researchers developed performed well in predicting overdose risk and in identifying patients with a low risk. Machine learning is an alternative analytic approach to handling complex interactions in large data.  It can discover hidden patterns and generate predictions in clinical settings. Based on their findings, the researchers concluded that their approach outperformed other methods for identifying risk used by the Centers for Medicare and Medicaid Services.

"Machine-learning models that use administrative data appear to be a valuable and feasible tool for identifying more accurately and efficiently individuals at high risk of opioid overdose," says Walid Gellad, MD, a professor of medicine at the University of Pittsburgh and senior author on the study. "Although they are not perfect, these models allow interventions to be targeted to the small number of individuals who are at much greater risk."

Dawn Anderson’s Desperate Plea for Help

DAWN ANDERSON

DAWN ANDERSON

(Editor’s note: Red Lawhern recently wrote a column about Dawn Anderson, a 52-year Indiana woman who died this month after a long battle with chronic pain and illness. Dawn was a double amputee and diabetic. We may never know the precise cause of her death, but as Red points out, Dawn died in “needless agony” because her pain was poorly treated.      

Last September, Dawn wrote a letter to her longtime primary care provider and shared a copy of it with PNN. Her letter is essentially a plea for help. Dawn asked the primary care doctor to take over her pain management because she was no longer able to get opioid medication from Dr. Paul Madison, a pain specialist who ran afoul of the law and stopped practicing medicine.    

Dawn wanted the letter published and her family has agreed because they want her story to be heard.)

A Letter to My PCP From His Chronic Pain Patient

Dear Doctor, 

You and I have been together, side by side for many years. You have been my doctor. I have been your patient.  You have cared for me during my most vulnerable times. You know my most precious secrets regarding my physical and mental capacities.  I have shared openly and honestly from my heart. You have saved my life not once, not twice, but numerous times. 

The pain I have endured has been stressful, exhausting, depressing and life changing.  You had tried your best to control my pain. Thank you for your referral to pain management.  This has been my experience.

I was promised by numerous pain management physicians my pain would resolve and I would be walking upright.  I knew it was puffing as no doctor could make such a promise.  Each time seeing a new pain management specialist, I went through numerous non-opiate medications.  Lyrica, Elavil, Cymbalta, Neurontin -- the list goes on and on. They tried numerous alternative treatments. Physical Therapy, Occupational Therapy, Acupuncture, Acupressure, epidural injections, trigger point injections, caudal injections, radiofrequency nerve ablations. Not only did these cost lots of money, it took lots of my time and energy.  Most did not work.  Some gave relief that was short lived. 

Many of the doctors I had seen tried opiate medications.  I was on high dose Methadone when you referred me to the pain specialists. The Methadone made me so drowsy. It allowed me to sleep but it did not relieve the pain.  I was forced from pain doctor to pain doctor.  When one could not fulfill the promise of relieving the pain and having me walking upright, I was discharged from the service with a letter saying my condition was too complex and they would no longer see me. Or I would get the famous, “I don't know what else to do for you.”

Many of the opiates I was prescribed did not relieve the stabbing intractable pain I was experiencing.  One pain center refused to see me because I was discharged from one service and scheduled the appointment 28 days later.  I was accused of drug seeking.  I was in no way seeking drugs, I was seeking relief from the pain that kept me thinking I would be better off dead.

After the second amputation and surviving septic shock, I had no hope. I was so tired of the pain, the hospitalizations, the medications, the embarrassment of crawling around like a dog, the quality of life that I no longer had.  I couldn't even wipe my own butt.  But there was something about that granddaughter who was recently born that I needed to hold onto some type of hope things would get better.

Midwest Pain Management was my last hope.  I explained everything I had endured as far as pain treatments, the type of pain I was having and all the locations my pain was affecting.  I was slowly weaned off Methadone.  Again, I had to go through all those previous alternatives, previous medications, previous treatments.

The last trigger point injection I received caused an abscess about the size of a grapefruit.  I had to get the abscess drained, get placed on antibiotics and the doctor refused to do any further injections for fear of more infections and septic shock. The only option at this point was again, the opiate based medications. 

Now understand when you agree to go on opiate medication, you sign a pain contract. Basically limiting you to one doctor prescribing opiates, one pharmacy to obtain the opiate, monthly urine drug screens, and occasional pill counts which means the office can call you any time and you must go in with your pill bottle. 

Although many of the opiates caused drowsiness, they did not control the pain.  After almost two and a half years of trying different drugs at different doses, this pain doctor was able to find the right drug at the right dose that relieved my pain and not cause extreme drowsiness.  I was able to start doing things I did prior to both legs being amputated.  I was able to live on a daily basis without being so drowsy and unable to focus.  I began to have hope as I was able to care for my family, take care of the house, start paying the bills again, look forward to going on vacation. 

This was 8 years ago. I have remained on the same drug and the same dose for those 8 years.

You have seen me at my most desperate times. You have seen me when all I could do was focus on all the pain I was having.  And you can attest for the last 8 years, my pain has been under control and has not been a topic in our office visits until now.

You and I have always spoken with honesty and sincerity.  You have always called my pain doctor my drug dealer.  Although I have always smirked when you say it, it hurts my heart because I feel if it wasn't for this pain doctor who never gave up trying old treatments, new treatments, questionable treatments, I would have killed myself many years ago. 

The quality of life I had on high dose opiate medication relieved that excruciating stabbing pains in my back, stumps and hips.  I may not be walking upright but I was walking with minimal pain.  Until recently, you and your office did not even know I had a wheelchair.  How do you think I was able to do that?  I was able to do that because I was taking the pain medication my so-called drug dealer prescribed for me.  I never once abused them, misused them, diverted them, overdosed on them. 

Since the decrease and removal of the long acting medication, my quality of life has greatly diminished.  It is so painful to walk with the prosthetics. It hurts to bend, it hurts to stand. The pain has returned and again, all I can focus on. Being in constant pain is exhausting, depressing, and taking my will to live. 

You may see this as being addicted to the medication.  I see this as being addicted to the quality of life I had when my pain was under control. The life where I could put on my prosthetics, go shopping, go out in the yard and rake my leaves. The life where I enjoyed being around others without having constant pain to focus on.  That life where I loved to plan and go on cruises to the Caribbean. That life that no longer exists.

I feel like there is nowhere to turn, no one to help. I know there is a life where all this pain I am experiencing can be relieved with one medication. I am desperate to get that life back.

Sincerely,

Dawn Anderson

(Editor’s note: How did Dawn’s doctor respond? “I brought him the letter and have not received any communication from him. Just sad. He has been my doctor for decades,” Dawn wrote in an email last October. “I'll fight until I can't fight any longer. I have lost over 40 pounds and my muscles keep getting weaker.”

Dawn died on March 11, 2019. She is survived by her husband, two daughters and three granddaughters.)

What Doctors Say About CDC Opioid Guideline

By Pat Anson, PNN Editor

Over two-thirds of healthcare providers are worried about being prosecuted for prescribing opioid medication and many have stopped treating chronic pain, according to a new survey by Pain News Network on the impact of the CDC’s opioid prescribing guideline. One in four providers say they’ve lost a pain patient to suicide since the guideline was released in 2016.

A total of 68 doctors and 89 healthcare providers participated in the online survey. While that’s a relatively small sample size in comparison to the nearly 6,000 patients who took the survey, the providers come from a broad spectrum of healthcare, including pain management, primary care, palliative care, surgery, pharmacy, nursing and addiction treatment.

The CDC guideline discourages the prescribing of opioids for chronic pain and cautions doctors not to exceed a daily dose of 90 morphine milligram equivalents (MME) because of the risk of addiction and overdose. Although voluntary and only intended for primary care physicians, the guideline has been widely implemented as mandatory throughout the U.S. healthcare system.

Many doctors believe the guideline limits their ability to treat patients and has not improved the quality of pain care in the United States.  

“There are reasonable elements to the guidelines which should be preserved. However, setting an upper dose limit, especially one so low, severely interferes with titrating the opioids to their most effective doses, which is often much higher than 90 MME,” said a pain management doctor.

“The guidelines became hard rules for many insurance companies and pharmacies. Patients with pain have suffered in consequence,” said a palliative care doctor. 

“I see chronic pain patients all day that do not have their pain well controlled. It is heart breaking,” said another provider.

HAS CDC GUIDELINE IMPROVED QUALITY OF PAIN CARE?

“They are horribly ill-conceived. If we thought our previous approach to pain management was flawed, we surely will soon realize that these guidelines are worse,” said a pain management physician. “A patient told me two weeks ago that his friend needs repeated (coronary bypass) surgery, but now the hospital system treats post-surgical pain with Tylenol. This is barbaric.” 

An addiction treatment doctor summed up his feelings about the guideline with two words: “Misguided and draconian.”

Pain Contracts and Drug Tests

Nearly two-thirds of providers surveyed require patients to sign a “pain contract” before they get opioids. Over half have discharged a patient for failing a drug test or not following the rules. And nearly one in five mistakenly believe the guideline is mandatory.

  • 64% require patients to sign a pain contract or take drug tests

  • 52% have discharged patients for failing drug test or not following rules

  • 45% use more non-opioid therapies

  • 18% believe CDC guideline is mandatory

  • 17% refer more patients to addiction treatment

  • 10% stopped treating chronic pain patients

  •   7% closed practice or retired due to concerns about opioids

“I feel like the blow-back to the CDC guideline is just as misplaced as the misuse of it. The recommendations are good science,” said a pharmacy provider. “There are lots of people - prescribers, pharmacists, insurance companies, law enforcement - who have misapplied the guidelines and are practicing poorly with them as an excuse. That is not the fault of the guidelines themselves, but the fault of poor education and dissemination.”

“These guidelines came from people that do not serve as clinicians to patients,” said one provider. “I have witnessed patients being abruptly cut off from medications they've been on for years and without any notice. Some have gone through extreme withdrawal to the point of death from the complications of withdrawal.”

Disparity in Prescribing

The survey found a wide disparity in how providers have adjusted to the guideline’s recommendations.

Nearly half still prescribe opioids above 90 MME when they feel it’s appropriate, while 20 percent only prescribe at or below the 90 MME threshold. Fourteen percent have stopped prescribing opioids altogether.

“We are getting dumped on by all the PCP’s (primary care providers). They no longer want anything to do with patients on opioids,” said a pain management doctor. “What is medicine coming to that the number of opioids is more important than a patient’s well-being?”

“Acute pain is now being undertreated, as well as many who have been denied pain control with opiates. These patients are being harmed. All of us prescribers know that the majority of overdoses are from illegal opiates from other countries. We are not stupid,” wrote a provider who works in urgent care.

HOW HAS CDC GUIDELINE AFFECTED YOUR OPIOID PRESCRIBING?

Chilling Effect

Doctors are well aware they are under scrutiny. The Drug Enforcement Administration and other law enforcement agencies monitor prescription drug databases (PDMPs) to track opioid prescriptions. While PDMPs were initially promoted as a way to protect physicians from “doctor shopping” patients, they are now routinely used by the DEA to identify, threaten and raid the offices of doctors who prescribe high doses – even when there is no evidence of a patient being harmed by the drugs.       

“PDMPs are tracking prescribing based upon CDC guidelines. That has an adverse effect upon prescribers who end up being profiled and in jeopardy of arrest and prosecution,” a doctor wrote.

“They have weaponized the political and legal manifestations of appropriately treating chronic pain,“ said a pain management doctor.

“They have shamed high dose long term opioid patients and treat the prescriber like a bad guy. They are clueless to the fact that majority of deaths have always been street addicts and not legit pain patients. The guidelines embolden medical regulators to come after doctors, resulting in chilling effect on prescribers,” said an addiction treatment doctor.

The crackdown has also had a chilling effect on pharmacies and insurers, who are just as eager to stay out of trouble. Nearly three out of four providers (73%) say they’ve had a pharmacy refuse to fill an opioid prescription and 70 percent say an insurer has refused to pay for a pain treatment.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one provider.

“The insurance companies are acting beyond the CDC guidelines with their hard limits on dosing, even sending threatening letters to doctors,” said a physician. 

“Pharmacies and insurances are dictating how we treat our patients without the medical ability or authority to make diagnosis or treatment plans. Each patient is different,” wrote one provider. 

“The guideline is extremely narrow-minded and reactionary. Yes, opioid addiction has become a huge problem, and yes, some physicians are partially to blame because of inappropriate prescribing, but plenty more physicians prescribe opioids appropriately. Now many of those doctors are scared to do their job, leaving patients in unnecessary pain,” said a doctor.

Biased CDC Advisors

Many providers believe the guideline advisors assembled by the CDC were biased and unqualified to make recommendations for pain management. Their initial meetings were closed to the public and the agency refused to disclose who the advisors were. Later it was revealed that five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, were involved in developing the guideline, including two that belonged to a key committee that helped draft it.

“They are an abomination that has been foisted on the world by PROP via the CDC and have no real clinical or evidence based background, yet are carried forward by political and bureaucratic purveyors of untruth,” said a pain management doctor.

“I believe this guideline was made by a panel without any pain doctors. How can they know what is best? They have contributed to stigma, and now patients instead of safely being monitored by pain clinics are turning to the streets and dying from illegal opioids. The CDC then uses that data to inflate the so-called epidemic,” said another provider.

“The CDC never weighed the information from the pain treating community. The consequences were predictable. Poor quality of life for the pain patients and continuation of the opiate epidemic from imported fentanyl. The guidelines were a travesty,” a pain management doctor wrote.

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“The CDC did not have the legal authority to issue the guidelines in the first place. They should be declared unconstitutional and burned. Dosing should be following the FDA published guidelines for a particular medication,” said a pharmacy provider.

‘Where Are the Followup Studies?’

When it released the guideline in 2016, CDC said it was “committed to evaluating the guideline” and would make revisions if there were unintended consequences. A CDC spokesperson recently told PNN several studies are underway evaluating the guideline, but gave no indication that any changes are imminent.

“Where are the followup studies to monitor the incidence of patients committing suicide, looking for illicit drugs on the streets, overuse of NSAIDs, (acetaminophen) with organ damage and death, increased disability, loss of quality of life, overuse of alcohol and tobacco, worsening of co-morbid conditions due to weight gain, inability to exercise or sleep, adverse effects on relationships?” asked a pain management doctor. “The guidelines are effective at saving money for the payors. That, I fear, is why there is no serious effort to revise the guidelines.”

For a breakdown of some of the other key findings from our survey, click here. To see what patients had to say about the guideline, click here. Our sincere thanks to everyone who took the time to participate.

What Pain Patients Say About CDC Opioid Guideline

By Pat Anson, PNN Editor

Are there better and safer alternatives than opioids for chronic pain?

That’s one of the questions posed in PNN’s latest survey on the CDC’s opioid prescribing guideline. The guideline states that “no evidence shows a long-term benefit of opioids” and recommends physical therapy, cognitive behavioral therapy, massage and a number of non-opioid medications as safer and more effective treatments.

People in pain disagree. Nearly 7 out of 10 patients tell us there are no better or safer treatments for chronic pain than opioids.

But the numbers tell only part of the story. Most of the 5,885 patients who responded to our survey left detailed comments on how the CDC guideline has affected them.  

Many have lost access to opioid medications after using them responsibly for years. They feel abandoned by the healthcare system.

Some are bedridden due to physical pain, but also live with the emotional suffering that comes from losing jobs, financial security, marriages and friends.

Many are suicidal. And a few have turned to street drugs.

ARE THERE BETTER AND SAFER ALTERNATIVES THAN OPIOIDS FOR CHRONIC PAIN?

We thought the comments below were important for you to see. They are representative of the thousands that we received. The comments are edited for clarity and to protect the patients’ identities.  

‘I Have Lost So Much’

“I am now only able to use Tylenol for my multiple, severe chronic pain conditions. In two years, I have had to quit working, I am homebound, mostly bedridden. I am severely depressed, think about suicide daily as my only remaining option for pain management. I have severe insomnia due to the pain. I have developed severe hypertension and cardiac arrhythmia due to the constant severe pain and twice have suffered sudden cardiac arrest. The cardiologist said there is no underlying cardiac conditions, it is due to long term, unmanaged, severe pain.”

“I have been diagnosed with over 30 different conditions and a rare muscular disease. I spent thousands on doctors and natural treatments. Now, I have to suffer until I die. I have missed out on so much and lost so much. In bankruptcy, lost my business, could not go to Thanksgiving or Christmas, but the worst was I could not go to my daughter’s wedding. My life has become PAIN and my bed. As Americans we are supposed to have freedom. The right to choose what’s best for our pain. Each individual is different. The government should not choose what medication we should not take or how much.”

“You have no idea what it feels like to hurt, every single day. To be accused of being a drug addict for needing opioids. I have tried physical therapy. I have tried essential oils and Epsom salt baths. I have tried acupuncture and going to a chiropractor. I have tried every single alternative, but nothing helps the debilitating bone pain. I think of suicide, often. The opioids don't even get us high, it barely helps with the pain. At least with them, we can lead somewhat of a life. Right now I can barely work, let alone live. Your guidelines help no one but yourselves. People will always find a way to abuse something. But you guidelines are not hurting them. They are hurting us. You, are hurting us.”

“People with chronic/intractable pain just want to have some form of quality life. We want to live our lives. We want to be able to work, run errands like grocery shopping, clean our homes, cook food and take care of our families. I don't mention a social life as that is even difficult with good pain management. These guidelines are stripping people of their dignity, self worth and will to live, not to forget the shame and humiliation for needing narcotic pain medication in order to live.”

‘American Genocide’

"I am ashamed that my chosen career in Public Health has actively created a campaign based on false data.  The fact that the ‘prescription’ drug epidemic was based on both the legal and illegal drug statistics was openly stated at every public health presentation I attended. That more accurate breakdowns have now been published has not altered the campaign, since grant monies have been awarded to organizations based on the inaccurate info, and those organizations must follow-through with the original requirements to get their money. Although they knew that data on suicides and the impact on pain patient quality of life would need to be measured, information systems to gather this information were not put into place.” 

“A prescription opioid was the only medication that worked for me. I went through every non-narcotic drug before my doctor would even prescribe opioids. These guidelines have made doctors scared to write pain med prescriptions.  Never in my life did I think I would live in a country that has legalized the torture of millions of American citizens by withholding necessary pain medication. This is beginning to look like the start of an American genocide of chronic pain/ill people.”

“I believe everyone has a right to be pain free. Every person has a different pain tolerance and to deny them medication for their pain should be absolutely illegal. People who are denied pain medication WILL find another way to handle their pain, and WILL be more likely to overdose and possibly die. Denying prescription pain medication will not stop people from finding it somewhere else, it will only increase their desperation to find another way to get it.”  

I'm scared. I am a senior citizen. I cannot afford to go on like this. I am now afraid to see a physician because I am using Heroin for pain. I do not have a addictive personality. It is the only substance I use and only enough to barely function. I am frightened. I am ashamed. The one thing the CDC was attempting to halt has sent numerous pain patients down the road of underpasses and scary encounters to try and keep functioning as we used to before we were treated like addicts.”

“I have lost good friends because of the CDC guidelines. I have had 4 friends commit suicide because they could not deal with their day to day pain levels. I had a friend who broke his ankle bad enough that the bone was sticking out and he had to have surgery and they told him to take Advil and Tylenol afterwards. This is starting to be barbaric and inhumane.” 

‘Living on Borrowed Time’

“I have been fortunate. My doctor continues to treat me, prescribe my meds, and help when there is a problem getting prescriptions filled. However, many of my friends have had problems ranging from doctors discharging them to pharmacists refusing to fill their prescriptions and more. One of my friends committed suicide when her pain meds were taken from her and she could no longer live with her pain. I feel so fortunate that I'm not having these problems, but then I wonder if I'm living on borrowed time.” 

“My spine specialist informed me one year ago he would no longer be doing pain management due to the DEA. I have not been able to find another pain doctor.  I am 55 years old. I spend 75% of my days in bed suffering. Even taking a shower puts me in tears. My house is a mess. I only go to the grocery store and my primary care provider when I have to. I have had multiple injections in my back, have tried every OTC med but nothing helps. When I was on opioids I passed my urine screens, my medication was never off count. I took them as prescribed. WHY AM I BEING NEGLECTED? DON'T I HAVE THE RIGHT TO BE TREATED FOR MY PAIN?”

“I have chronic pain due to multiple spine surgeries and fibromyalgia. I am on Medicaid and unable to work. I was on the same dose of opioids through a pain management physician for over 10 years with no issues whatsoever. I was able to work, raise my children (single mom) and have a life. I now have been cut back so far that I have to choose whether or not I want a good night’s sleep. The CDC guidelines have completely left the chronic pain community out to dry.”

‘Doctors Have a Responsibility’

“Please please please tell doctors they have a responsibility to provide pain medication to patients whose lives are being destroyed by chronic pain. I've lost everything because I got hurt at work. I used to run marathons and triathlons. Now my my blood pressure has skyrocketed, I gained 30 pounds, I lost my independence, I have no social life, I lost my sex life, and as a result of all these things I finally lost my wife of ten years. The guidelines needs to emphasize the need for people like me to have access to pain meds because so far, every doctor I have come into contact with since my injury has ignored that part of the guidelines. If you want to see a doctor's eyes glaze over and watch them stop listening to you, just mention pain medication.”

“My doctor was placed under investigation by the DEA for overprescribing. His practice was for high risk pain patients (many receiving end of life care), so he was red-flagged for a high volume of opioid Rx’s. As a result multiple chain pharmacies refuse to fill his scripts, Medicare & Medicaid patients were dropped with only 30 days notice, and he had to start tapering all other patients no matter our diagnosis. My insurance has refused to reimburse my prescriptions and half my disability check now goes to pay for them. I have no quality of life, it hurts to do everything, even basic self-care. I was openly mocked by doctor at a recent visit to the emergency room when I said I had a pain level of 7. He told me I wouldn’t get my fix from him. I had fractured my back in a rollover car accident.”

“Four years ago I was diagnosed with a B cell Lymphoma cancer. At that time my cancer doc prescribed pain meds for the broken vertebrae the cancer caused and the pain that the chemo caused. I came out of remission recently and started another round of treatment. My cancer doctor will no longer prescribe pain meds for me because I now see a pain doctor. The pain doctor doesn't understand the new cancer drug I'm on and that the side effects of this drug are pain, so he is very reluctant to manage my cancer pain. Many days I wonder if it would just be better to let the cancer take its course than to be scrutinized and treated like a criminal.”

“I am 88 years old and the dosage of medication I was given before these guidelines went into effect gave me a decent quality of life and I was able to endure the severe chronic pain I have had for years. I am now in a nursing home with a 38-year-old doctor who refuses to treat my pain. I feel helpless and fear I am going to remain in this nursing home much longer than I would like. I am also angry, in pain and have become depressed due to my situation. I have thought of suicide, often. I recall our lawmakers and others stating they did not want to do anything to keep the elderly from suffering due to these changes. I am here to tell you that they missed that goal by a long shot. As an elderly man, I should have the right to take what I need to live out my last bit of time on this earth as comfortable as possible. These guidelines have made that impossible.”

For a breakdown of some of the key findings from our survey, click here.  To see what doctors and other healthcare providers are saying about the guideline, click here.

Survey: CDC Guideline Having ‘Horrendous’ Impact on Pain Patients

By Pat Anson, PNN Editor

The CDC opioid prescribing guideline has harmed pain patients, significantly reduced their access to pain care, and forced many patients to turn to alcohol and other drugs for pain relief, according to a large new survey of over 6,000 patients and healthcare providers by Pain News Network. 

Today marks the third anniversary of the CDC guideline, which discourages the prescribing of opioid medication for chronic pain. Although voluntary and only intended for primary care physicians, the guideline has been implemented as mandatory policy by many states, insurers, pharmacies and throughout the U.S. healthcare system. The survey found many unintended consequences for both patients and providers.

Over 85 percent of patients say the guideline has made their pain and quality of life worse. And nearly half say they have considered suicide because their pain is poorly treated.

“The guidelines are affecting legitimate patients in a horrendous way while the actual addicts are just turning to street drugs,” said one pain sufferer.  “My quality of life has been so drastically reduced I attempted to take my life last year. Fortunately, I was found before I could bleed out but every single day has been an absolute struggle.”

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Over two-thirds of healthcare providers are worried about being sanctioned or prosecuted for prescribing opioids. Rather than risk going to prison, many have stopped treating pain, closed their practice or retired.

“Many of those doctors are scared to do their job, leaving patients in unnecessary pain, both acute and chronic. Tapering patients on chronic stable doses of opioids because some people abuse opioids is not just unjustified, it’s cruel and harmful,” a doctor wrote.

The PNN survey was conducted online and through social media from February 17 to March 15.  A total of 5,856 patients and 157 doctors and other healthcare providers in the U.S. participated.

Asked if the guideline is helpful or harmful, 96 percent of respondents said it has harmed pain patients — a startling verdict for an agency with a mission statement that says “CDC saves live and protects people from health threats.”

“Cannot understand or know why the CDC will not speak out on the harm done to undertreated, denied and abandoned patients,” one patient said.

“It was a criminal act. The outcome was foreseen, the guidelines were written in secret, and the carnage that we predicted has come to pass,” said an emergency medicine physician.

“They should be revoked. People are suffering and committing suicide due to inability to tolerate suffering. This is inhumane,” another provider wrote. “It blemishes CDC’s reputation.”

HAS CDC GUIDELINE BEEN HELPFUL OR HARMFUL TO PAIN PATIENTS?

Opioid Prescriptions Declining

Opioid prescriptions in the U.S. have been declining for several years and now stand at their lowest level since 2003. The drop in prescriptions appears to have accelerated since the CDC guideline was released in 2016.

Eight out of ten patients said they are being prescribed a lower dose or that their opioid prescriptions were stopped. Many indicated they were forcibly tapered off opioids without an effective alternative.

“I had my pain under control until my doctor told me he was cutting my pain meds by half,” a patient said. “He lied to me, he cut them by 85% and now I am home ridden! The CDC guidelines are a disaster to the chronic/intractable pain patients.”

“I have lost all quality of life and many days I no longer want to live with this pain,” another patient wrote. “I've never abused my meds, yet I'm being treated like a drug addict.”

“VA doctors are afraid to prescribe any opioids or narcotics, because of mandatory education courses given to all VA doctors,” a nurse with the Veterans Administration said. “The veterans are not being treated for chronic pain. Suicides have increased!”

“Our doctors should not have to choose between treating their patients in a safe meaningful way or feeling like they could lose their licenses to practice,” another patient said.

HOW HAS CDC GUIDELINE AFFECTED YOUR OPIOID PRESCRIPTIONS?

Patient Abandonment

It’s not just opioids that patients are losing access to. Nearly 9 out 10 pain patients report problems finding a doctor that’s willing to treat them. Many say they’ve been discharged or abandoned by a doctor or had problems with a pharmacy or insurer. Only a small percentage of patients have been referred to addiction treatment.

  • 73% of patients say it is harder to find a doctor

  • 15% unable to find a doctor

  • 34% abandoned or discharged by a doctor

  • 27% insurer refused to pay for a pain treatment

  • 27% pharmacy refused to fill an opioid prescription

  • 5% given a referral for addiction treatment

“As an RN in pain management I have seen decreased quality of life, increased pain and anxiety for patients. Providers fear for their license and livelihood. My staff spends HOURS on the phone trying to authorize scripts,” a nurse wrote.

“Most doctors in our area are refusing to prescribe any opioids, even the pain management doctors. This is forcing some patients to buy street drugs,” a primary care physician said.

Desperate Measures

The widespread denial of care has many patients taking desperate measures for pain relief. One in five are hoarding opioid medication because they fear losing access to the drugs. Many others are using alcohol, marijuana or the herbal supplement kratom for pain relief. A small percentage are using illicit drugs. Few have found medical treatments that work as well as prescription opioids.

  • 22% of patients hoarding opioid medication

  • 11% obtained opioid medication from family, friends or black market

  • 26% used medical marijuana for pain relief

  • 20% used alcohol for pain relief

  • 20% used kratom for pain relief

  • 4% used illegal drugs (heroin, illicit fentanyl, etc.) for pain relief

  • 2% found other treatments that work just as well or better than Rx opioids

“I know seven people personally that have gone to the streets to get pain relief. Four of them died because it was mixed with fentanyl. Two committed suicide,” one patient said.

“Since my doctor stopped prescribing even my small amount of opioids, I deal with days where I can’t even get out of bed because I hurt so much and I’m stuck turning to alcohol, excessive amounts of acetaminophen and NSAIDs,” another patient wrote. “Kratom has been the omly thing that has helped my pain.”

“I have been without a prescription for two years and have been getting medication on the street. I cannot afford this and I have no criminal history whatsoever. I have tried heroin for the first time in my life, out of desperation and thank God, did not like it. It was stronger than anything I need to help with pain,” wrote another patient.

Addiction and Overdoses Still Rising

While the guideline appears to have significantly reduced the dose and quantity of opioid prescriptions, patients and providers overwhelmingly believe it has failed to reduce opioid addiction and overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, but over half of the deaths involved illicit fentanyl or heroin, not prescription opioids.

“They are attacking the wrong problem. Pain patients are under strict scrutiny by their doctors and therefore have an addiction rate lower than the general population. The large numbers of deaths are among those who are using heroin and other illegal drugs,” one patient wrote.

“As a retired substance abuse counselor, these new guidelines do nothing to stop the real addict. It only hurts those of us in chronic pain,” said another patient.

“What happened to care for the elderly, disabled and sick?” asked one patient. “We are not the problem. The amount of prescription pain medicine has significantly gone down but the overdoses are continuing to rise. This is targeting the wrong people!”

HAS CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

Guideline Revisions Needed

An overwhelming majority (97%) of patients and healthcare providers believe the CDC guideline should be revised. When it released its recommendations in 2016, the agency said it was “committed to evaluating the guideline” and would make future updates “when warranted.” A CDC spokesperson recently told PNN there are several studies underway evaluating the impact of the guideline, but gave no indication that any changes are imminent.

Patients and providers say the the guideline is misunderstood, based on faulty evidence and needs revision.

“It is a falsified document created only to satisfy political pressure which demanded such a report. There is no medical/scientific evidence to support the conclusions made in the document,” a patient wrote.

“The CDC needs to correct their glaring error. They need to make sure that every doctor in America is re-educated and reassured that they can treat people with serious pain disorders without being jailed,” said another patient. “The CDC needs to stand up and admit their mistake, they need to correct the damage.”

“While the guidelines are useful, they should not have been made into mandatory rules followed by states and insurers. The patients with chronic pain issues are suffering. Can we revisit them?” asked a palliative care doctor.

SHOULD CDC GUIDELINE BE REVISED?

For more survey results and comments on the guideline, see “What Pain Patients Say About CDC Opioid Guideline” and “What Doctors Say About the CDC Opioid Guideline.”

Over 6,200 people responded to PNN’s survey. In tabulating the results, we did not include the responses of caretakers, spouses and friends of patients or those who live outside the U.S. We greatly appreciate everyone who participated and will be releasing more survey results in coming days.

Oregon’s Opioid Tapering Plan Delayed

By Pat Anson, PNN Editor

A controversial plan that could force thousands of Medicaid patients in Oregon off opioid pain medication has been put on hold because of a medical expert’s potential conflict of interest.

Oregon Health Authority (OHA) Director Patrick Allen asked the Health Evidence Review Commission (HERC) to table a final vote on changes in opioid policy until his agency could get an independent review of the recommendations.

At issue is a task force plan to limit Medicaid coverage of opioids to just 90-days for fibromyalgia and lower back pain. Patients currently on opioids longer than 90 days would be required to taper off the medications and switch to alternative therapies such as acupuncture and physical therapy that would be covered by Medicaid.

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The plan has drawn nationwide criticism from chronic pain patients, advocates and pain management experts who say forced tapering would “exacerbate suffering for thousands of patients.”

Allen said he learned this week that Dr. Catherine Livingston, a family medicine physician who serves as a contracted medical consultant to HERC, is also a paid consultant to the Kaiser Center for Health Research and the National Institute of Drug Abuse. Livingston helped draft the opioid coverage proposal.

“I have requested the HERC to remove a chronic pain management proposal from today’s agenda to allow OHA time to seek independent review to ensure no potential conflicts of interest compromised the way the chronic pain benefit proposal was developed for the HERC’s consideration,” Allen said in a statement.

“It is vital for the Oregon Health Plan to cover safe and effective therapies to help people reduce and manage chronic pain. Yet it is also vital that Oregonians have full confidence in the decisions the HERC makes to assess the effectiveness of health care procedures.”

No timetable was set for the independent review. At a HERC hearing earlier this week, The Bend Bulletin reported that state officials defended the opioid policy change.

“I think the potential harms associated with opioids have become clear,” said Dr. Dana Hargunani, chief medical officer for the Oregon Health Authority. “Harms shown by the evidence about tapering are less clear.”

But in a joint letter signed by over 100 pain management experts, Dr. Sean Mackey, chief of pain medicine at Stanford University, urged the commission not to mandate “non-consensual forced tapering.”

“We fear the HERC’s proposal is, in essence, a large-scale experiment on medically, psychologically and economically vulnerable Oregonians, at a moment when Oregon has already seen a significant reduction in opioid prescribing and prescription opioid-related deaths,” Mackey wrote. “The evidence supports that this proposal represents an alarming step backward in the delivery of patient-centered pain care for the state of Oregon.”

Other members of the task force questioned the distinction between forced and voluntary tapers.

“I can’t tell you whether the tapers I do in my practice are voluntary or involuntary,” said Dr. Roger Chou, a professor of medicine at Oregon Health & Science University who was one of the co-authors of the controversial CDC opioid prescribing guideline.  “I explain why I think that’s important, that it’s a safety issue, and I guide them through the process. I try to be empathetic, but they don’t want to taper.

“I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them.”

Steep Decline in New Opioid Prescriptions

By Pat Anson, PNN Editor

The number of doctors writing new prescriptions for opioid pain medication has fallen by nearly a third in recent years, according to a large but limited study that documents a dramatic shift in opioid prescribing patterns in the U.S.

Researchers at Harvard Medical School studied health data for over 86 million patients insured by Blue Cross Blue Shield from 2012 to 2017, and found that first-time prescriptions for patients new to opioids – known as “opioid naïve” patients -- declined by 54 percent.

At the start of the study, 1.63% of Blue Cross Blue Shield patients were being treated with new opioid prescriptions. Five years later, only 0.75% were.

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The study also found a shrinking pool of doctors willing to start opioid treatment. The number of doctors who prescribed opioids for opioid naive patients decreased by nearly 30 percent, from 114,043 to 80,462 providers.

The research findings, published in The New England Journal of Medicine, do not provide any context on the patients’ health conditions or the severity of their pain and injuries. As such, it is a data-mining study that provides no real information on the harms or benefits of opioids.

"The challenge we have in front of us is nothing short of intricate: Curbing the opioid epidemic while ensuring that we appropriately treat pain," lead investigator Nicole Maestas, PhD, an associate professor of health care policy at Harvard Medical School, said in a statement. "It's a question of balancing the justified use of potent pain medications against the risk for opioid misuse and abuse."

First-time prescriptions for opioids are usually used to treat short-term acute pain caused by trauma, accidents or surgery. They rarely result in long-term opioid use or addiction, but have become a major target for healthcare policymakers and anti-opioid activists. Several states have adopted regulations that limit the initial supply of opioids to 7 days or less.

While the number of doctors starting opioid therapy has fallen dramatically, Harvard researchers say many are still engaged in “high-risk prescribing” – which they defined as new prescriptions for more than 3 days’ supply or a daily dose that exceeds 50 morphine milligram equivalent (MME).

More than 115,000 of these “high-risk prescriptions” were written monthly for Blue Cross Blue Shield patients. Over 7,700 of the prescriptions exceeded 90 MME per day, a dose that researchers say puts patients at a substantially higher risk of an overdose. The study did not identify whether any of those high-dose patients experienced an overdose.

Opioid prescriptions in the U.S. have fallen sharply since their peak in 2010, but have yet to slow the rising tide of overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

Risky Combination: Opioids and Gabapentin

By Pat Anson, PNN Editor

Opioid medication significantly reduces low back pain, but opioids should not be used in combination with gabapentin (Neurontin) because of their limited effectiveness and potential for abuse, according to the authors of a small new study presented at the annual meeting of the American Academy of Pain Medicine.

"In these days, when we are focusing on reduction of opioids due to opioid crisis in the U.S., gabapentin could be an important part of multimodal non-opioid pain management," N. Nick Knezevic, MD, of the University of Illinois in Chicago told MedPage Today. "However, it should not be given to all patients since the effectiveness in chronic pain patients, particularly in those with low back pain, is limited."

KAISER HEALTH NEWS

KAISER HEALTH NEWS

In a retrospective study, Knezevic and his colleagues looked at 156 patients with low back pain; half of whom were treated with opioids alone and the other half with a combination of opioids and gabapentin.

“According to our study, the combination of gabapentin with opioids was not statistically superior in providing pain relief, in contrast to opioids alone, in patients with chronic pain. Our results are in line with recent guidelines for low back pain treatment that reflect the need to assess the recommendation of gabapentinoids for chronic pain in patients already taking opiods to mitigate risk factors of abuse and overdose,” researchers found.

Gabapentin is an anticonvulsant that was originally developed as a treatment for epilepsy, but is now widely prescribed for a variety of chronic pain conditions. Its use in primary care as a treatment for chronic back and neck pain has risen by 535% in the last decade, despite little evidence of its effectiveness.

"The fact that anticonvulsants are often advertised to be effective for 'nerve pain' may mislead the prescriber to assume efficacy for low back pain or sciatica," Oliver Enke, MD, of the University of Sydney, told MedPage.

A 2018 study by Australian researchers found that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea. Another recent study found that combining gabapentin with opioid medication significantly raises the risk of dying from an overdose than opioid use alone.

There have been increasing reports of gabapentin being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

The CDC’s opioid prescribing guideline recommends gabapentin as a safer alternative to opioids, without saying a word about its potential for abuse or side effects.

A 2017 commentary in the The New England Journal of Medicine warned that gabapentinoids -- a class of nerve medication that includes both gabapentin and pregabalin (Lyrica) -- are being overprescribed.

"We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” wrote Christopher Goodman, MD, and Allan Brett, MD. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain."