A

mid 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.

advertisement

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.

Newsletters

Sign up for our First Opinion newsletter

Please enter a valid email address.

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Since I’ve last commented, things have gone from bad to impossible. I’m losing my fight. It’s hard enough to deal with my own pain and issues but when I should be helping my husband, who is disabled and in pain as well, I’m falling miserably. I’m so far behind on everything now that in overwhelmed and don’t even know where to start. You see, we’re one of the families that falls between the cracks. We make $30 a month too much for food stamps, $70 a month too much for assistance with our electric and we struggle every single day just to get through. I’ve been in pain management over 17 years and my husband over 14. If u had my meds back where they were, I’d be teaching again and getting everything caught up. We wouldn’t have nearly the problems we’re having now. We’d actually have a car that was dependable and had ac. We’d have a heat pump so we wouldn’t be so cold in winter and hot in summer. We wouldn’t be living the high life, but we’d be able to live like average people. I’m tired of it all. I didn’t ask to live in pain. I served my country during Desert storm and this is how I came back. VA is slowly killing me not just by cutting my pain meds either. There isn’t anything I can do anymore and the little hope I had is fading away. So where does everybody turn when things are just too much? I know some will say God, but right now I feel as though God has left the building and won’t be coming back any time soon. Just need to find a way to see a little hope again cause I’m not seeing anything!

    • Steph, I am sorry – and disappointed with my country – that you and your husband are in the situation you describe. I have a friend who is a veteran who was run over by a truck, leaving him totally disabled, with injuries from his head to his knees, and he is basically stuck with treating his pain with acetaminophen and alcohol (I try to convince him not to use them together because of the danger to his liver). The VA doctor won’t treat his pain unless he gives up alcohol, but if he gives up alcohol, he’s in pain all the time. He even went out of state to a rehab the VA set up – and they kicked him out of the rehab because he has diabetes and his blood sugar was high. The VA acts like this was him failing rehab. But my question is if the rehab is a medical facility, why was it not equipt to deal with an actual medical problem – diabetes & high blood sugar? He’s so discouraged right now.

      There are many hundreds of thousands of people in this country who are getting inadequate – or no – pain treatment. People who have done nothing wrong – people like you who want to treat the pain so as to be able to make a productive contribution to our society. But the war on drugs treats pain patients like criminals because it’s easier. Easier than going after criminals (doctors, insurers, pharmacies and patients are all well-documented, unlike criminals who don’t get business licenses, degrees in medicine or pharmacology, etc), and easier than admitting the war on drugs has failed – continuously, expensively, and at a cost to our constitutional rights and protections – and most of all it has made America the kind of place where nobody seems to notice the cruelty of denying medication to law-abiding people with medical conditions that cause severe pain.

  • Very sad situation, people like us through no fault of there own, are being punished along with abusers. Dr.’s are afraid to prescribe them because of the DEA and their “war” on drugs. My Uncle who had decided to die instead of aggressive treatment as long as he was not in pain was denied them at Fairfax Hospital. It’s a good thing I wasn’t there. My mother put him in hospice which solved the problem but the guy at Fairfax evidently said he couldn’t do it. It’s getting to the point where I think it’s inhumane. It was a Dr. who told me it was the DEA instead of the FDA. Maybe with clinics opening at drug stores it could be dispensed on a weekly basis in prescribed quantities and it’ll dissuade drugsters from abusing them. Most just moved to unregulated drugs, heroin etc. , leading to quicker death not to mention criminal activity. All the money on this ridiculous war on drugs could be used for education, prevention, and rehabilitation, instead of making criminals super wealthy or dead. Anyway, poor people in pain are now being treated like trash. sad. Might be wrong on who’s causing it but follow the money trail to congress and their leaning on agencies which started a few years ago

    • John, it’s clear your heart is in the right place, and you have sympathy for law-abiding pain patients. But your comment shows how far war-on-drugs ideology has soaked into our society. Your suggestion to distribute prescriptions on a weekly basis is exactly the kind of thing that makes life unnecessarily harder for pain patients, in the name of the war on drugs. We are supervised at a level similar to people on parole after being incarcerated for a serious crime. At my most recent visit to the pain clinic, I was informed that instead of every 8 weeks, they’re changing my appointments to every 4 weeks, just out of “caution” because of current politics. Already, the war on drugs has made it so that instead of being treated for pain by the specialist in the condition that causes me pain (which would make sense, and such a doctor would have understanding of why the condition is painful, and the fact that there are no treatments like surgery, massage, physical therapy, etc., that can give me relief) or my GP, who is knowledgeable about all my medical history, I have to go to a pain clinic, as if pain requires a specialist on top of the specialist for my actual condition. BTW, the pain clinic is in a different state from the one I live in, because my state views pain treatment as not necessary (I don’t think any of the politicians who decided this have any medical credentials). Besides going/paying for a visit every 4 weeks (many actual parolees have parole office visits every 3 months), the urine tests to prove I use/don’t sell my meds are $200 each. I’m only allowed to use one pharmacy, and have to show ID every time I pick up meds – from a pharmacist who has been there so long she doesn’t have to look up my birth date, insurance plan, middle name. If it were about my condition, I doubt I’d need more than one visit per year with the GP, or to be super cautious, the specialist. My actual medical condition isn’t the kind of thing that requires close monitoring, and I know what changes would signal the need to be checked by the specialist.

      The CDC published information that proves that prescription opiates are not contributing to the black market problems that are used as justification to act like restrictions on pain patients will have any effect at all on the black market that 104 years (and counting) of drug prohibition has failed to dent.

      The thing that amazes me most of all is that there are so many people in our government, and the general public, who have become convinced by drug warriors that tight restrictions on law-abiding pain patients is actually a viable strategy for the drug war. I don’t see any logical way that decades-long black market in illicit drugs or the people who frequent the black market will be impacted by depriving people of pain treatment (meds that make it possible for people who would otherwise be immobilized by pain to live a productive life, have a job, run a household, care for children).

    • Just as I clicked “send” for the above comment, it occurred to me that the medical condition that causes my pain, is the subject of appointments and lab on a very infrequent basis, while the single symptom, pain, accounts for easily more than 90% of all the appointments, tests, and pharmacy visits of my entire household. It has been this way since I was diagnosed with my condition (which took about a year). It stuns me that I spend so much time and money and worry based on a single symptom of a condition that is possible for me to ignore most of the time – as long as I am able to treat pain, and occasionally treat related problems such as nausea.

  • So I had my valium taken away to treat my depression . Now I’m having my pain pills taken away after having my lower back l4/l5 cut on twice. I now have no quality of life left. If I did not have my Son I would have put a gun to my head long ago. I’m just sick of this so called life and I have seen a shrink for over 12 years now. She tells me my Depression will not get better until I get my pain under control. So how can I get my pain under control without my medication it’s not working for me.

    • Mark, you are another example of the pointless cruelty that is being inflicted on law-abiding pain patients – as if it’s going to make any difference in the behavior of criminals. Even if they take every single pain pill away from every single pain patient in the country, this will do nothing to accomplish any reduction in black market sales of outlawed drugs. The CDC reported years ago that prescription drugs are not contributing to the existence of the back market.

      I think we pain patients need to clearly communicate to the public the depth of the cruelty of depriving people of pain medication, and the fact that there is no possible useful outcome from inflicting this cruelty on law-abiding people with painful health problems. Perhaps we could coordinate to mail letters to the president all on the same day. I’m thinking real, physical snail-mail letters that would arrive as one big pile in the mail – and maybe the press could be tipped off that this pile of mail is coming.

  • Good question from fellow pain warrior- These “pain contracts” what is in it for us when we are compliant? Should at least be able to know that we can feel confident in having out pain controlled. The toying with formulation and forced tapers etc have caused many of us our livelihood and more. My dad was an attorney. Contracts are meant to have mutual benefits and legal assurances for BOTH parties. Where’s ours?

    • So-called pain contracts are a cruel joke. Even if a patient fulfills every single demand made by the contract, that patient has no guarantee that the people who presented the patient with the contract will continue to provide pain control. I have a condition that is incurable and causes severe pain. After the only available surgery didn’t stop the pain, the pain treatment was handled for many years by my GP. One day I go for a visit and my doctor tells me that due to a change in the law he would be forced to prescribe according to arbitrary limits set by his employer, less than 1/3 the dose I’d been on for 17 years. I got him to admit it wasn’t a new law (He’s an honest person, so that wasn’t hard to do). Now I have to go to a pain clinic, which at my last visit told me that instead of visits every 8 weeks, I now have to go in every 4 weeks – not because of any infraction on my part, but because they are “tightening up” procedures out of fear.

      Here’s a link to a bit of dark humor on the topic of pain contracts: http://truth0rdare.com/2018/03/31/a-couple-of-painful-laughs/

  • The CDC fails to acknowledge and address the suffering of many tax paying, law abiding Americans who have been able to remain functional and productive despite painful and or debilitating conditions thanks to an effective, appropriate and well managed Rx opioid plan for conditions in which no effective treatment is currently available . Unfortunately and tragically many patients requesting continuation of their long term pain medications are being dismissed,ignored and avoided by their own Doctors leaving them in dispair and with no effective alternatives. I hope the FDA revisits and re-evaluates it’s currently unreasonable mandates in order to allow Doctors to continue treating their patients with respect, compassion without the fear of retaliation.

  • I have fibromyalgia, tendonitis, diabetes, bipolar, arthritis and went to doctor with a tendon-muscle injury causing severe pain. I requested oxycodone for temporary pain control so I can sleep. Doctor said too many regulations, suck it up, take tramadol. I was told by my “Doctor” to SUCK IT UP.

  • I HAVE BEEN PERSCRIBED 7.5 LORITAB FOR 18 YRS NEVERABUSED TOOK AS PERSCRIBED FOR BACK PAIN DUE TO A INJURY FROM A HORSE FALL AND IT WORKED NOW I LIVE IN PAIN DAILY UNLESS I CAN FIND SUBSITUTES IN THE STREETS OR OVERSEAS THERE HAS TO BE A PROGRAM FOR PEOPLE IN MY SITAUATION THE COST IN STREET AND FROM OUT OF COUNTRY IS EXTREME AND IS PUTTING PEOPLE IN FINANCIAL RUINS ANY SUGGESTIONS PLZ!!!!

    • John,
      I’m so VERY sorry for what’s happening to you! Most people with pain are in the same boat. What state do you live in? Are you able to travel?

  • I’m confused. I need some clarification. I have severe chronic pain due to Peripheral Neuropathy, more specifically, Charot-Marie-Tooth disease(CMT), and I live in Texas. I was put on Social Security Disability because of CMT 11 years ago, therefore, I’m on Medicare. I’ve been on all kinds of opioid and non-opioid medication constantly for 12 years. I FINALLY found a medication about 4 years ago that makes it possible for me to have some sort of function in my life and giving me some semblance of independence. I need to know to whom, without a doubt, to whom this new 90mg law applies. Is it a state or federal law, or is it a Medicare law? My Pain Mgmt doctor is trying to slowly get me down to 90mg, and after 2 changes I’m completely miserable. Soon I’ll be suicidal because that’s how I was before my doctor prescribed Nucynta to me 4 years ago. Do I have any options?

    • Dear Kelly:
      This is not a law at all. CDC is a research lab with no regulatory powers at all. A lobbyist group petitioned the FDA, which is the agency with regulatory authority over all drugs, proposing that pain drugs be limited to 100 milligrams “morphine equivalent” per day. The FDA refused, asking the lobbyists to clarify what they meant by “morphine equivalent”. This is an important question because drugs take effect and then wear off at different rates of speed, so it’s incorrect to call a weight of one drug equivalent to another, unless the speed of taking effect is also considered. And that speed of taking effect varies with the patient’s weight and metabolism. Instead of correcting all of these errors, the lobbyists waited for 3 years and then tricked the CDC into publishing their junk science as a Guideline.

      I have asked a federal judge to order an investigation of the lobbyists wrongdoing. You may contact me directly for more information at bob@givepainavoice.org.

Sign up for our Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.

Privacy Policy