The authors of influential federal guidelines for opioid prescriptions for chronic pain said Wednesday that doctors and others in the health care system had wrongly implemented their recommendations and cut off patients who should have received pain medication.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” the researchers wrote in a paper published in the New England Journal of Medicine.

They said some health care players had used the guidelines to justify an “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages,” when the guidelines did not actually endorse those policies. The authors did not identify stakeholders other than clinicians who they said have misapplied their guidance, but advocates have also accused insurance companies and state agencies of using the guidelines to inappropriately withhold treatment from some patients.

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The new paper comes three years after the Centers for Disease Control and Prevention published the prescribing guidelines, which were meant for primary care physicians treating chronic pain in adults. It follows growing appeals from patient advocates, pain doctors, and some addiction experts for the CDC to clarify that its guidelines were just recommendations. Advocates have argued that strict limits on prescriptions were leaving patients who had been on stable dosages for years unable to stay on their regimens and sometimes pushed them to illicit opioids or even suicide.

The authors of the 2016 guidelines — Dr. Deborah Dowell and Tamara Haegerich of the CDC, and Dr. Roger Chou of Oregon Health and Science University — said in their new essay the recommendations were not meant to be used to withhold drugs from people who need them, and outlined instances of their misapplication.

One example: The guidelines say that “clinicians should … avoid increasing dosage” to 90 or more morphine milligram equivalents per day or to “carefully justify” such a decision. That did not mean prescribers should automatically cut dosages that were already above that threshold, the authors say, “yet it has been used to justify stopping opioid prescriptions or coverage.”

“We know little about the benefits and harms of reducing high dosages of opioids in patients who are physically dependent on them,” they wrote.

Still, the researchers say patients who are able to safely decrease their doses face lower risks of overdose, and some experts believe that long-term opioid use actually increases pain sensitivity.

The 2016 guidelines were meant for patients suffering from chronic pain not tied to cancer, palliative care, or end-of-life care. But in the new paper, the authors said that there were reports of them wrongly affecting care for other patients, including those with cancer or during acute sickle cell crises.

The authors also emphasize that the guidelines should not be applied to the doses of medications that are used to treat opioid addiction.

In parts, the new essay reads as a defense of the guidelines, which are voluntary but have faced heavy scrutiny in the years since they were published. The authors note that their original paper features suggestions for treating patients on high-dose opioids, including how to taper prescriptions safely while minimizing withdrawal symptoms. “Though some situations, such as the aftermath of an overdose, may necessitate rapid tapers, the guideline does not support stopping opioid use abruptly,” they write. They also argue that actions by some clinicians, such as halting opioid prescriptions or no longer seeing chronic pain patients, “could represent patient abandonment.”

The federal guidelines were an effort by the CDC to implement safer prescribing practices among primary care physicians, who write the vast majority of painkiller prescriptions. They seem to have accelerated the decline in outpatient opioid prescribing that began in 2012, experts say.

An analysis published last fall found that in January 2012, nearly 6,600 opioid prescriptions were dispensed per 100,000 people, but that fell to 4,240 by December 2017. From March 2016 until December 2017, an estimated 14.2 million fewer prescriptions were filled than if previous trends continued. There were nearly 1.3 million fewer high-dose prescriptions written, as well.

The new essay is not the only step taken by the CDC to clarify its guidelines.

After physician groups argued that insurers seized on the guidelines to deny treatment for some patients, the agency in February wrote to the American Society of Clinical Oncology, the American Society of Hematology, and the National Comprehensive Cancer Network to acknowledge that clinicians and insurers should also consider the clinical practice guidelines each group has issued. The CDC reply was released publicly on April 9.

The Food and Drug Administration announced this month it is providing clinicians more information about how to safely decrease doses for patients who are dependent on opioid medications.

The CDC also recently responded to an ad hoc group of physicians, who call themselves HP3: Health Professionals for Patients in Pain, who have urged the agency to clarify the “misapplication” of its guidelines. The group organized a letter signed by more than 300 doctors who complained the guidelines harm patients with severe pain who may have been taking high doses of opioids for years without becoming addicted.

In an April 10 reply, CDC Director Dr. Robert Redfield wrote that the agency was “working diligently to evaluate the impact” of the guidelines and “clarify its recommendations to help reduce unintended harms.”

One former member of the CDC panel that established the guidelines, Dr. Lewis Nelson, who chairs the Department of Emergency Medicine at Rutgers New Jersey Medical School, says the new essay is “basically, the FAQ that goes along with the policy statement.”

“It’s very clear that when the guidelines were being assembled, a lot of attention was paid to the fact that people shouldn’t be rapidly tapered off opioids, because it leads to a terrible withdrawal syndrome and complicates their lives,” he said. “But it wasn’t just doctors who misinterpreted the guidelines. It was also regulators and legislators. Unfortunately, some must have just read the bullet points.”

A few of the HP3 organizers have relationships to industry. Among them is Dr. Daniel Alford, a professor of medicine at Boston University, which runs a continuing medical education program called Scope of Pain that receives backing from opioid makers. Another is Dr. Richard Dart, who directs the Rocky Mountain Poison and Drug Center and also heads the RADARS System, which tracks prescription drug abuse and is supported, in part, by subscriptions from pharmaceutical companies, including opioid makers.

Such ties prompted concern from Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group.

“I think the CDC is simply reiterating what is in the guidelines,” he said. “But the only thing that troubles me is they might be accepting these reports of misapplication of the guidelines as accurate, when I believe they’ve been exaggerated. There’s been an effort to ‘controversialize’ the guidelines.”

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  • The Opioid Guidelines–with prescribing limits of 90 mEq of morphine, which are far below the effective dosage necessary to treat many forms of severe pain–were derived from Gary Franklin’s study of Workers Comp patients, This is a group whose data–which I shouldn’t have to remind readers of this site–is NEVER extrapolated to other populations, due to their unique variables. Even surgical studies add disclaimers that the data cannot be used for other populations, and yet…

    Of all populations, that of chronic pain patients is the least appropriate, given factors like WC financial incentives for malingering and the subjective aspect of pain, and the level of suicide in WC patients being adversely affected by loss of self-esteem, physical function, and more substantial income with serious injuries. And, the type of injuries, legitimate or otherwise, do not parallel the conditions of the chronic pain group. Many WC patients have musculoskeletal conditions which are known to be better addressed by nonopioid treatment, while there are medical conditions that are never represented in their group in the broader population which absolutely require them.

    Kolodny has been saying his exaggerations re the risks of opioid addiction are now being vindicated, in contrast to ‘decades of medical research’, and is carrying this off only because he was placed in the position to alter the perception of data. He used 3K OD deaths that resulted from state-mandated transitions of MA pts to cheaper methadone (also from Franklin’s data) to claim an alarming 16% increase (from 15K to 18K vs. the 433K from tobacco-related sources) when initiating his ‘war,. Those non-addiction related deaths provided him the opportunity to announce an epidemic, and he ran with it, This has been enormously lucrative for him, while the deaths have more than doubled, due to pain patients and abusers alike resorting to tainted street heroin.

    These are real human lives. Having injuries–which in many of these cases are due to service to this country–does not make persons disposable, which the current approach assumes. And, while capitated reimbursement makes this whole arrangement far more profitable for medical groups, I firmly believe those engaging in this level of cruelty will be held accountable, or find their own families suffering as a result, as cancer and MVAs occur everywhere, and the cessation of opioid manufacture in the US is well underway.

    Anyone with serious experience with the substance abuse population knows how disingenuous the deflection of blame to prescription opioids, vs. their own recreational use is. (There is increasing understanding , of course, that in a minority of cases, there a likely neurological susceptibility to addiction, which may be treatable in the near future, while there is a plethora of sound research substantiating that addiction to opioids taken for pain, rather than euphoria, are rarely addictive.)

    The following is personal experience related to this issue:

    My professional experience included Pain Management, Clinical Research, evaluation of Substance Abuse treatment and facilities, and implementing one of the initial pilot studies in capitation and subsequent cost-effective management of patient care. (I have several degrees in different areas.)

    A number of years ago, due to capitated incentives, my shoulder cartilage was dissolved–completely, bilaterally. The orthopod involved remarked that he’d possibly seen one shoulder like it in his thirty year career (of exclusively shoulders) and what a mind over body person I must be. The condition is described as ‘devastating’ and has destroyed my life. I’ve lost my home, my ability to work, my ability to do every activity I love and enjoyed. (This result seems to affect only those highly physically active, and, unfortunately, unlike myself, usually young.)

    I saw the leading specialist in the US, who laughed in my face when I asked if, after bilateral shoulder replacements and rigorous rehab, I could go off opioids, saying how bad my condition was and that i’d need to be on them for life, not what I wanted to hear. (I was a fitness advocate, runner, salsa dancer, etc.)

    I was initially treated by a PCP at KP, who was also a runner (more accomplished than I) and who responded to the input from the specialist, after four years of inadequate dosage, with a dosage, over the 60 of oxy equivalent to the OG, at a level that enabled me to function. (I won’t discuss the losses of those years, but deeply resent what this meant for my dogs.)

    After losing my home (and my dogs had passed) I moved to a city where some of the research was done on this type of damage, only to be completely unable to receive pain treatment and going through withdrawal without anyone able to even check on me. I hoped I’d be able to function afterwards without pain address. Ha! Withdrawal was easy compared to the pain after the opioids completely cleared–it was, and is, far worse than just before my appendix was about to rupture and that of a precipitous delivery with an hours repair sans medication. It was unbelievable.

    And, hyperalgesia has now been debunked by several mega-analyses. So, opioid usage didn’t cause this. I also never became addicted, I”ve never once had any euphoria, or cravings. Anyways, I’m only alive due to an online product.

    I contacted my former Kaiser PCP and was told if I returned to KP and Oregon–which I would only do to again receive treatment–he ‘would not prescribe opoids’, at all, fully aware of my condition (Aside from the cruelty–this is a form of insurance fraud, under capitation. Since my work was to bring medical groups and hospitals into this, I’m very aware of how this works.) The leading specialists, not just in reference to my case, have stated the only recourse for this, even with one shoulder with this damage is ‘to limit motion and take opioids’. I can’t limit motion, I haven’t family to assist.

    I have specific goals before I give in to the pain and call it quits. The day the product helping me is unavailable will, however, be my last. It was all I could do to stay alive until the product arrived before. I couldn’t handle it again. (And I thought that delivery was bad…)

    You can join me in living like this through one driver losing control when you step out of a shop, or you can work to put things right in the US before the generic manufacturers cease all production, the reason Kolodny was brought to the CDC. Under Azar, Lilly (with a 200 million pmt to Pfizer) invested ~2 billion in a NGFI prototype which had such serious adverse effects the FDA wouldn’t approve it. It’s now been fast-tracked and its only competition? Generic oral opioids.

    I’m one of probably tens of thousands. This is effectively genocide.

  • My Dr retired at the end of November 2018, so I had to go cold turkey off of my methadone 10mg til I thought I found another Dr but he took me off of them in 28 days. Which I found out later that he went bout this the wrong way. Is there anything I can do? I am seeing someone right now but you might as well be giving me candy cause she thinks that 7.5 325 Vicodin is going to work cause I only get 84 of them so that comes out to be 1 every 8 hrs, she is wrong. When you are used to being on methadone for 10 yrs then go to Vicodin it’s not working. I got in a bad car wreck and surgery didn’t work. I need someone’s help. I was doing just fine on them plus it helped with my breathing cause I have COPD. Now I get out of breath easier and faster than when I was on the Methadone.
    Thank you for your time and consideration in this matter.
    Stacy Bouvia

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