Amid a rising toll of opioid overdoses, recommendations discouraging their use to treat pain seem to make sense. Yet the devil is in the details: how recommendations play out in real life can harm the very patients they purport to protect. A new proposal from the Centers for Medicare and Medicaid Services to enforce hard limits on opioid dosing is a dangerous case in point.

There’s no doubt that we needed to curtail the opioid supply. The decade of 2001-2011 saw a pattern of increasing prescriptions for these drugs, often without attention to risks of overdose or addiction. Some patients developed addictions to them; estimates from the Centers for Disease Control and Prevention range from 0.7 percent to 6 percent. Worse, opioid pills became ubiquitous in communities across the country, spread through sale, theft, and sharing with others, notably with young adults.

The prescribing tide has turned: Private and governmental data show that the number of prescriptions for opioids has been falling since 2012. Reassuringly, federal surveys show that misuse of pain relievers bottomed out in 2014-15.

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Nevertheless, the CDC produced a guideline in 2016 that recommended shorter durations for opioid prescriptions and the use of non-drug treatments for pain. It also suggested keeping opioid doses lower than the equivalent of 90 milligrams of morphine. As the guideline acknowledged, its recommendations reflected weak scientific evidence. Problematically, it was silent on how to care for patients already receiving doses higher than the 90 milligram threshold.

To its credit, the guideline endorsed treating patients as individuals, not numbers. A CDC official wrote to one patient that the guideline “is not a rule, regulation, or law. … It is not intended to take away physician discretion or decision-making.”

Unfortunately, these mitigating features were undermined by intemperate publicity that vilified opioids for pain. Opioids for pain “are just as addictive is heroin,” proclaimed CDC Director Dr. Tom Frieden. Such statements buttress a fantasy that the tragedy of opioid overdoses and deaths will be solved in doctors’ offices, primarily by upending the care of 5 to 8 million Americans who receive opioids for pain, even when most individuals with opioid addiction did not start as pain patients.

The progression of the guidelines from “voluntary” to “enforceable” has culminated in a draft policy from CMS. It would block all prescriptions above the CDC threshold of 90 milligrams unless complex bureaucratic barriers are surmounted. Many pharmacy plans are already enforcing this approach. Under that plan, many patients suffering with chronic pain would lose access to the medicines they are currently taking, all in the name of reversing a tide of death increasingly defined by non-prescribed opioids such as heroin and fentanyl.

The logic of doing this is untested. There have been no prospective clinical studies to show that discontinuing opioids for currently stable pain patients helps those patients or anyone else. While doing so could help some, it will destabilize others and likely promote the use of heroin or other drugs. In effect, pain patients currently taking opioids long-term have become involuntary participants in an experiment, with their lives at stake.

Turning the voluntary guidelines into strict policy is unfortunate for three reasons.

First, it reflects a myopic misunderstanding of addiction’s causes, one at odds with a landmark report issued by the US surgeon general in November 2016. While the supply of drugs matters, whether people develop addiction to opioids reflects diverse factors including age, biology, and whether their lives include opportunities for rewarding activities like work and family or lacks those opportunities. Restricting prescriptions through aggressive regulation invites the outcomes seen in Prohibition, 90 years ago. To be fair to Prohibition, cirrhosis deaths did decline. But echoing that era’s gangsters and moonshine, we now face a galloping criminal trade in drugs of greater potency and lethality. Overdoses have skyrocketed, mostly from heroin and illicit fentanyl. In a Massachusetts review of overdoses, just 8 percent of those who had overdosed had received opioid prescriptions in the prior month.

Second, we have alternatives to bureaucratic controls. These include promoting and paying for treatments that de-emphasize pills. Important work by the Department of Veterans Affairs shows how to identify patients with elevated risk for harm from opioids and how to mitigate the risks.

Third and most troubling is the increasingly inhumane treatment of patients with chronic pain. Fearing investigation or sanction, physicians caring for patients on long-term opioids face a dire choice: to involuntarily terminate prescriptions for patients who are otherwise stable, or to carry on as embattled, unprotected professionals, subject to bureaucratic muscle and public shaming from every direction.

In this context, we cannot be surprised by a flurry of reports, in the press, social media, and the medical literature describing pain patients entering acute withdrawal, losing function, committing suicide, or dying in jail. The CMS policy, if adopted, will accelerate this trend.

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Many of our colleagues in addiction medicine tell us they are alarmed by the widespread mistreatment of pain patients. We receive anecdotes every week from physicians and pharmacists, most of them expert in addictions, describing pain patients who have involuntarily lost access to their pain medications and as a result have been reduced from working to bedridden adults, or who have become suicidal.

This loss of access occurs several ways. A pharmacy benefit program may refuse to cover the prescription because it has already enacted the changes that CMS is proposing to make mandatory. A physician may feel threatened by employers or regulators, and believes his or her professional survival depends on reducing opioid doses — involuntarily and without the patient’s consent — to thresholds that the CDC itself described as voluntary and not mandatory. Or state regulators have imposed such burdensome requirements that no physician in a given region can sustain prescriptions for their patients. Such patients are then “orphaned,” compelled to seek treatment from other physicians across the country.

Given the expertise in addiction among these physicians, it should be particularly worrisome that they believe the present pill-control campaign has gone too far. And yet, the ethics are clear: It should never be acceptable for us to countenance the death of one patient in the avowed service of protecting others, even more so when the projected benefit is unproven.

Surgeon General Dr. Vivek Murthy made an underappreciated declaration in a recent interview with the New England Journal of Medicine. “We cannot allow the pendulum to swing to the other extreme here, where we deny people who need opioid medications those actual medications. … We are trying to find an appropriate middle ground,” he said.

As addiction professionals, we agree wholeheartedly.

Stefan G. Kertesz, MD, and Adam J. Gordon, MD, are physicians in both internal medicine and addiction medicine. Dr. Kertesz is an associate professor of preventive medicine at the University of Alabama at Birmingham School of Medicine; Dr. Gordon is a professor of medicine at the University of Pittsburgh School of Medicine and editor of the journal Substance Abuse. The views expressed here are their own and do not reflect positions held by their employers.

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  • This is so true.It is going to hurt all people that are taking their medicine correctly.About 99%.This will only demonize innocent folks.Very wrong!!

    • I think one of the most important things an individual can do regarding this issue is to try to spread facts & common sense on this topic to as many people as you can. By all means contact every elected official you can get to listen. Post on comments threads when inaccurate or hysteria-drien narratives are published. If we have to do it one mind at a time, it is too important not to do all we can.

      Ask them by what mechanism depriving law-abiding patients of pain meds will improve the behavior of criminals – or of the pain patients are just human sacrifices in the moral panic called the war on drugs.

      Ask, “ls the fact thst it’s illegal the only reason you don’t inject heroin? With recent examples of legalization of marijuana not leadingvto mayhem, why would ending prohibition on far less popular drugs have more dire consequences?

      After the government made Sudafed more complicated than buying a gun, and meth is still as available as ever in the black market, is it not suspicious that the people who were recently telling us that meth was the most destructive black market drug are now shouting, “Look over there! Opiates” Might this not be intended to distract from the drug war’s decades of failure to either tighten the black market or reduce the problematic behavior our society labels “addiction?”

      With literally dozens of federal & state agencies doing drug war/12 steps promotion, might their claims about the dangers of drugs possibly be influenced by the fact that a drug war cease fire might mean having to get a real job?

      Do you know 2/3 of Americans live in jurisdictions where an elected coroner – often with no medical or science credentials- 2/3 of their offices having no in-house toxicology lab, 2/3 no tissue lab, 1/3 no xray inhouse have legal authority to choose what goes on a death certificate? Almost no Americans get autopsied – even Justice Scalia’s “death investigation” was a single phone call to anelected coroner who never saw the body or death scene & declared his desth a heart attack. Just because someone who uses opiates dies doesn’t mean the opiates caused the death. In fact, unlike many common products from laundry soap to baby aspirin, opiates have no reliable deadly dose. Opiate OD takes 1-12 hours and if interrupted, leaves no lasting harm. The kind of so-fast-the-needle is in the arm deaths are from anaphylaxis or Stevens Johnson syndrome caused by contamination or cutting agents.

      For more facts & data counter to drug war narratives, check out
      truth0rDARE.com
      And
      The Shaffer Drug Library

    • Trish just made a lot of great points. I’d like to fill in one item on which Trish was a bit sketchy: Most politicians and media ignoramuses assume that Opioid Addiction causes “Opioid Deaths”. The mortality statistics contradict this belief. Where we see the highest rate of so-called “opioid deaths” is in the 2 states that have the highest rate of amphetamine addiction. NOT the states that have high rates of opioid addiction. I wrote a paper on this to the FDA last year, and I provide 2 pages of links to various Federally-funded research proving my point. The reason that the Sinaloa Cartel is making huge profits on methamphetamine and also on illicitly-made fentanyl, is that their customers who become addicted to methamphetamine, develop side effects that they try to treat by mixing booze, opioids, benzodiazepines, and barbiturates to try to relieve those side effects. It’s the fact that these folks are taking dangerous mixtures of drugs to fight off the side effects of the methamphetamine, that’s causing the high death rates. None of the users really know the potency of each of the drugs in the mixture, nor do they know how the drugs interact. If volunteers did this in a medical research laboratory, where rescue equipment was available to help them breathe, etc., more of the volunteers would survive. When people do these dangerous medical experiments at home, no one is around to rescue them and they die.

      Our DEA complicates this issue because it legalized amphetamines to treat the ADHD disease. But in states where cannabis has become legal, many or most adults who suffer ADHD, have switched to cannabis, because they don’t like the amphetamine side effects and preferred quitting amphetamines entirely. So there are 2 complications at work, that must be overcome.
      1. A lot of people who self-treat with cannabis for ADHD, are attacking pain patients who need opioids, because they think the cannabis they personally need for their ADHD, might help relieve pain, and they hope that by attacking pain patients, they can trick politicians into not attacking people who need cannabis. This is a stupid and short-sighted approach to the problem, because politicians are perfectly happy to attack anybody, if there’s money in it. Patients need to join together in support of our rights, not fight each other. Getting the cannabis people to stop thinking “Cannabis VS Opioids” and start thinking “Patients Helping Patients” is the key to successful activism.
      2. Our DEA has misled America’s parents, by repeating the falsehood that amphetamines are safer than cannabis. Amphetamines are synthetic stimulants just like crack cocaine. They can be lethal all by themselves. And their side effects are dangerous. Nobody has ever taken a lethal dose of cannabis…although folks with schizophrenia and some other rare conditions can have serious distress from the drug. DEA needs to amend it’s public statements to comply with the known facts on cannabis, and the longer DEA fails to do that, the more serious the consequences.

      If you are curious, you can find my paper on the Academia.edu website or do a Google search for my name and get pointed right to it.

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