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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  • I heartily applaud the work of Stefan Kertesz and Adam Gordon, though I might not entirely agree on the issue of “over-prescribing” — which I personally consider to be an urban myth. However, my main message to readers in this long thread, is that help is on the way. The following is a long newsletter shared with members and associates of the Alliance for the Treatment of Intractable Pain. You can look us up online.

    For anyone who wasn’t able to tune in November 28th to “Matt Connarton Unleashed”, our program went very well after we got past a few communications problems. Several patients asked questions via the program Facebook chat space, adding a lot to the discussion. You may download the 95-minute edited streaming audio, below.

    This program was carried real-time on comcast cable, fm radio, impNation, itune, iheart, and facebook live. The link below will take you to the archived audio.

    We touched upon a very wide range of topics including these:

    – CDC data prove America’s opioid crisis wasn’t started by doctors over-prescribing to people in pain. “Over-prescribing” is an urban myth shouted by fringe element anti-opioid zealots. The risk of being diagnosed with a substance abuse disorder or being prescribed opioids for periods exceeding 13 weeks after surgery is less than 0.6%. And a lot of these “diagnoses” are mistaken due to poorly trained doctors failing to recognize emerging chronic pain from failed surgical procedures.

    – Enormous harms have been done by government policies suppressing use of opioids in managing pain, and driving doctors out of pain management practice. There is evidence that patients deserted by their doctors are being driven into street markets where they are being killed by illegal fentanyl in counterfeit pills.

    – Recent resolutions published by the American Medical Association deeply contradict the 90 MMEDD safety review threshold proposed in 2016 CDC Guidelines on opioid prescribing. No doctor should be censured or investigated solely because he or she prescribes opioids at high doses for patients who need them. Other than actual patient deaths while under treatment, the US DEA has no objective criteria for determining whether a doctor is actually prescribing too much or without appropriate care.

    – Diversion of opioid prescriptions to people who aren’t valid patients is a real public issue. But the greatest volume of diversion is probably due to corporate drug distributors who have ignored the high volumes of drugs being shipped into zip codes that have no possible medical market for them. Diversion also occurs from home medicine closets by theft or being given to an under-insured relative — but that volume is likely much lower than corporate diversion.

    – One Facebook inquirer followed up to ask if patients faking their pain might be diverting a lot of drugs they get from doctors, for resale on the street. My response was that it probably happens in a few cases, but the numbers are quite small. By contrast, State Prescription Drug Monitoring Programs don’t appear to have made any difference at all in opioid related deaths. Dr Jeffrey Singer of the Cato Institute has published articles which challenge the idea that PDMP’s have saved even a single life.

    – The Alliance has petitioned the HHS Centers for Medicare and Medicaid to suspend its authorizations to Medicare Part D insurers to require soft and hard safety edits at 90 and 200 MMEDD, respectively.

    – Your Alliance has also filed a formal complaint against the CDC with the HHS Office of the Inspector General, on grounds of gross misbehavior, malfeasance, and fraud in their secretive and biased process behind the writing of the 2016 guidelines.

    – Matt and I touched on special problems of US Veterans, and suppression of data which demonstrate the negative impact of Veterans Health Administration practice guidelines on treatment of chronic pain — up to and including patient medical collapse and suicide.

    – Finally we’re seeing a dawn of common sense in the draft recommendations of the HHS Inter Agency Task Force on Best Practices in Pain Management:

    – There is no one size fits all patient

    – Each patient must be evaluated and treated an individual

    – There is clear evidence that opioids are appropriate for some patients and that addiction is rare in people managed on these medications

    – There is no evidence supporting mandated opioid tapering for legacy patients who are otherwise stable.

    – Greater emphasis is warranted on integrated care, adding non-drug therapies which help some people, some of the time.

    – It is as important to treat depression as it is to treat pain. 8.5% or more of all US suicides involve people with a history of treatment for severe pain.

    – Our public health crisis with opioids is not really one of medical exposure. It is largely a crisis of economic despair and families in collapse, fueled by the hollowing out of communities in rust belt, far west, and deep southern States. To deal with this crisis, we must be prepared to ask much larger and more subtle questions about the redevelopment of our labor force and our economic infrastructure as a country. The recent legislation passed by Congress is a nice down payment on making addiction treatment more available. But it doesn’t begin to approach needed levels of funding to reinvest in America.

    – In order for public policy on pain treatment to change — even after the AMA’s sweeping announcements — there will still be a fight. Federal and State regulations won’t be rolled back overnight. Tens of thousands of patients will need to look up the phone numbers of their Senators and Representative, the offices of their Governors and State legislators, to send a message. “I’m a chronic pain patient. The restrictive policies of my government are killing me and hundreds of thousands of others like me who have been denied effective pain care. I want your boss to commit to being a part of the solutions for this crisis. If the legislator isn’t willing to do that, then pack their bags because we’ll send them home!”

    Your voices are being heard. Your Alliance continues to work on your behalf to seek balanced public policy, acknowledging the need to address chronic pain at the same time as we try to solve America’s public health problem with addiction.

    Please feel free to share these links in your pain communities.

    Best Regards,
    Red

    https://www.spreaker.com/user/ipmnation/matt-connarton-unleashed-11-28-18?fbclid=IwAR1tF_kBmHeJJ6GCvLEdVgeatvbSST4kh8MAg7pL6zB05A-M8YVceuAaFhE

    Matt Connarton Unleashed 11/28/18
    w/Dr. Red Lawhern, Jon Hopwood
    http://www.spreaker.com

    And finally one other recent public media event: I also interviewed on November 21, with Dr Peter Breggin (aka “the conscience of psychiatry”) on the Progressive Radio Network. The archived audio stream of our program (#379) can be found at https://breggin.com/the-dr-breggin-hour-archives/

    • Dr. Lawhern, It was a pleasure to see your comment this morning. I’m thankful you have been putting in such efforts on the behalf of pain patients, and countering narratives that only exist to encourage the public to continue to support the drug war. It’s been obvious to me for a while that the data the CDC publishes doesn’t support the beliefs about the effects of opiates on individuals and society that our government promotes.

      One point that needs to be stressed in these discussions is that “opiate death” is not a conclusion based on a scientific investigation. It’s a bureaucratic category, a blank on a government form, often filled in by someone with no medical or scientific credentials, and almost always without an autopsy. (In 2007, one coroner in Indiana was elected and serving while in high school.http://www.wthr.com/article/amanda-barnett-indianas-youngest-death-investigator).

      The person with the legal authority to fill in cause-of-death doesn’t even have to show evidence to back up the cause. The late Justice Antonin Scalia’s death was ruled by the coroner to be a heart attack, with no examination of the body or the scene, during a single phone call.

      Just because someone who uses opiates dies, that doesn’t mean it’s the opiate that caused the death – the individual could have been hit by a bus or died of pneumonia, as in the cases of 59 people who died in MN between 2016-2015, who had pneumonia and opiate prescriptions, which the CDC said in a Dec 2016 report should have been counted as pneumonia deaths. What kind of deadly epidemic requires scraping around for a couple dozen deaths from years past?
      (https://www.painnewsnetwork.org/stories/2017/5/1/the-medias-addiction-to-opioids)

      Even if there is an autopsy, without an accurate time of death, postmortem redistribution of any opiates or metabolites leads to inaccurate results. Even a perfectly done and accurate postmortem test showing a high amount of opiate or metabolite doesn’t mean that’s what killed the person, if the person had tolerance to have survived such an amount.

      Also important is the fact that most people who die in the U.S. are not autopsied. “Opiate death” can be put on the death certificate if the person had a prescription at the time of death, or if there’s equipment in the room, or if a loved one mentions to the investigator that the person had a history of using, (https://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_10.pdf) or even if the coroner just decides it is, as in this case, in which a later autopsy showed no opiates:
      https://www.pbs.org/wgbh/pages/frontline/post-mortem/real-csi/

      The U.S. has 2432 offices that have the legal authority to declare a deceased person’s cause of death. Of those offices, 2/3 have no medical examiners, but elected coroners, mostly without requirements for medical or scientific training. Also, 2/3 of those offices have no in house toxicology lab, 2/3 have no in house histology lab, and 1/3 have no x-ray equipment. Death investigation offices, whether run by MEs or coroners, are chronically under-staffed. The data collected from these offices vary from place to place and year to year as there’s no consistence in what is collected – one office one year may only tabulate “overdose deaths”, others may list 10 different drugs, but those offices don’t count the same 10 drugs.(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm)

      When the Harrison Act was being debated in Congress, the discussion centered on people getting hooked, and protecting pain patients – not about opiates being particularly deadly. It was during the 1940s, when black marketeers began cutting heroin, initially with quinine, that the too-quick-to-pull-out-the-needle deaths began to be noticed – but that was due to rapid respiration constriction due to the quinine, or in cases where someone injected after drinking alcohol. Today, there are numerous cutting agents that can cause anaphylaxis or Stevens Johnson Syndrome, which cause a death far different from the actual, easily-interrupted, opiate overdose consisting of slowed breathing leading to lower oxygen levels leading to less signals from brain to lungs, and so on. If this process is interrupted and the person survives, there is no ongoing damage to any organs (compare that to tobacco, which can kill decades after the individual quits, and can cause irreparable damage to every organ system in the body).

      Another thing to consider is why the states that allow for execution by lethal injection don’t use opiates, now that two of the drugs formerly so used are no longer available? There was one attempt, in Ohio in 2014, using hydromorphone and Midazolam, during which the condemned man gagged for 26 minutes. (https://www.newsweek.com/2014/05/16/states-go-great-lengths-find-lethal-injection-drugs-249154.html).

      I think the “opiate death epidemic” is a collection of bad data and misdirection that persists and is spread because it is compatible with the need for draconian government intervention to keep this supposedly deadly substance out of the hands of a supposedly vulnerable population. Meanwhile, 104 years of drug prohibition of varying levels of severity and always varying levels of enforcement, have led to only one drug being removed from the black market, and that was only because it was still under patent, so the government only had to convince a single manufacturer to stop production of quaaludes. To keep such a failure going requires that bad information be given a lot more attention than actual facts.

  • How can the Federal Government put a cap on anyone’s medication when none of them have medical backgrounds?? They are creating a monster, as a patient who does comply with everything, I have never dropped a dirty drug test, always have the correct amount of pills when counted, they should not be putting me in the same category as those who don’t comply, now I my meds are being cut in half, I will be in so much pain and I’m scared, my Dr knows this and agrees, they should monitor the Drs closely and the patients, and those who are not compliant with all the rules should be titrated off of them. People will resort to suicide, or buying them off the streets, making the drug dealers very rich people. They did not think this through very well. I just got my life back by being pain controlled, came out of a very dark place and back to a good life, now that is all being taken away from me because of others who are stupid enough to take drugs not prescribed to them and they overdose and we who really need them are going to be the one’s who suffer for it. IT IS NOT RIGHT. HOW DO WE FIGHT THIS? I don’t want to ever go to that dark place again but it looks like I am being forced to. I wish they could step in to my body for just 15 minutes without anything for pain, they would be on the floor balled up screaming for help. But I guarantee they will get what they and their family members will get what they need!!! I want to file a petition to stop this law but I don’t know how. God Bless those who are in pain… you are in my prayers.

  • 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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