A public health document that counsels physicians to not overprescribe opioids would seem to be an unlikely candidate for attack. Yet the Centers for Disease Control and Prevention’s “Guideline for Prescribing Opioids for Chronic Pain,” published in 2016, has attracted constant criticism since its inception. The attacks come from two directions: groups and physicians who receive money from opioid manufacturers and patients with chronic pain.

Until the CDC began drafting the guideline, opioid manufacturers had a firm grip on what the government said about opioids. The Food and Drug Administration parroted industry messaging on chronic pain and rejected mandatory opioid-related training for physicians. Industry lobbyists orchestrated the creation of a 19-member panel at the National Institutes of Health to coordinate pain research. Many of the panelists were heavily beholden to the pharmaceutical industry.

In contrast, the CDC applied strict conflict-of-interest restrictions to the authors of its opioid prescribing guideline. When the impeccably evidence-based draft was released, the pharmaceutical-industry-funded Washington Legal Foundation accused the CDC of failing to follow administrative processes. The Academy of Integrative Pain Management demanded that Congress investigate how the CDC had developed the guideline. A probe by the House Committee on Oversight and Reform, however, found that the CDC had done nothing wrong.

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After receiving a barrage of complaints from the industry-friendly NIH panel, the FDA, and industry-funded advocacy groups that disparaged both the drafting process for the guideline and its content, the CDC delayed release of the guideline and opened a 30-day public comment period.

A 2017 analysis of the 158 organizations that submitted comments found that opposition to the guideline was significantly higher among organizations funded by opioid makers, life sciences companies, and those whose funding was unknown than among organizations not funded by industry. Notably, none of the organizations funded by opioid makers disclosed their funding.

That was exposed in a 2018 Senate report. In response to a request from then-Sen. Claire McCaskill (D-Mo.), the top five opioid manufacturers revealed almost $9 million in funding of pain groups between 2012 and 2017. According to the report, the “direct link between corporate donations and the advancement of opioid-friendly messages” is evidenced in the groups’ comments.

Some industry-friendly messages were not subtle. The American Academy of Pain Management, which received more than $1.2 million from opioid manufacturers over six years, was dismissive of opioid-associated deaths, stating “… to limit access to opioids because a small minority of people who use them develop a substance use disorder and/or suffer fatal respiratory depression, may be exacerbating the suffering of a far greater number of people whose pain goes unrelieved.”

In its comment, the American Cancer Society’s Cancer Action Network, which received $168,500 from opioid manufacturers, accused the CDC of a lack of transparency, weak evidence, and “failure to adhere to proper methodology in developing the guideline.” In fact, the guideline used a systematic approach of the best evidence available.

Maintaining pain patients on high doses of opioids is a consistent demand of both industry-funded organizations and pain patients. The American Academy of Pain Medicine (not to be confused with the American Academy of Pain Management), a recipient of $1.2 million from opioid manufacturers over six years, criticized recommendations of daily dosing limits, citing the proposed upper limit given in the guidelines as “an arbitrary dose.” The American Pain Society, recipient of almost $1 million, stated in its comment that “these thresholds are clearly arbitrary and without scientific basis.” And the American Society for Pain Management Nursing, which received more than $300,000, commented that it was “concerning to set a maximum dose.”

The assault continued after the guideline was published. Bob Twillman, executive director of the American Academy of Pain Management, lamented about “the apparent lack of response by CDC to comments submitted by the Academy and numerous other pain management organizations and advocates.” The American Academy of Pain Medicine’s president, Dr. Daniel Carr, claimed that “the CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence.”

Fresh attacks surfaced in 2019. A letter written to the CDC called for “a bold clarification about the 2016 Guideline — what it says and what it does not say.” Penned by Health Professionals for Patients in Pain (HP3), a group created for the purpose of challenging the guideline, the letter avoided direct attacks on the CDC while bemoaning the “misapplication” of the guideline. The letter’s authors claimed, without evidence, that “draconian and often rapid involuntary dose reductions” implemented by physicians, health care systems, and insurers are driving pain patients to the street to obtain opioids and contributing to patient suicides.

A distinction between street drug users and “legitimate” users of opioids is made by both industry and pain patients. Demonizing “abusers” is an industry tactic. As Richard Sackler, the former chairman and president of Purdue Pharma, the maker of OxyContin, put it in documents disclosed in litigation, “we have to hammer on the abusers in every way possible. They are the culprits and the problem. They are reckless criminals.”

While some of those who signed the HP3 letter have close ties to industry, many of the 300 signatories were well-intentioned health care professionals who did not realize the letter echoed marketing messages. They were used by the organization in much the same way opioid manufacturers use pain patients: as cover for industry efforts to maintain chronic pain as a market for opioids. The HP3 letter, which doesn’t oppose any facts in the CDC guideline and also provides no data supporting its claims, was covered by the New York Times, the Washington Post, Rolling Stone, and other media outlets.

Curiously, when PharmedOut, the Georgetown University Medical Center project that we represent, sent the CDC a letter supporting the guideline signed by seven national organizations and 364 health care providers and allies in May 2019, it received no press coverage.

The formation of HP3 came on the heels of the publication of an article by a conflict-laden group convened by the American Academy of Pain Medicine Foundation. Both the AAPM Foundation and most of the members of what it grandly called a “consensus panel” are funded by opioid manufacturers. The article refutes nothing in the CDC guideline but instead complains about its “misapplication” and — once again — dosing limits: “Daily dosage ceilings, if implemented as hard limits, may promote abrupt dose reductions in patients on high doses, which risks withdrawal symptoms, hyperalgesia [increased sensitivity to pain], and self-medication with more hazardous alternatives.”

Three cancer organizations, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the American Society of Hematology, protested that although cancer-related pain was specifically excluded from the guideline, some cancer survivors were being denied opioids even though their chronic pain was related to cancer or cancer treatment.

All of these critics misrepresent the guideline, which never calls for dosage limits, dosage ceilings, forced tapers, fast tapers, or limiting opioids in people living with cancer.

In response to the HP3 letter, CDC Director Robert Redfield merely thanked the organization for its concern and reiterated what the guideline states: that abrupt or involuntary tapering is not what the best evidence recommends. Absurdly, HP3 called Redfield’s letter a “bold clarification.”

Dr. Debbie Dowell, a CDC medical officer and an author of the guideline, also responded to the cancer organizations, acknowledging that previously treated cancer patients were not specifically mentioned in the guideline. Dowell and the two other guideline authors responded to critics in the New England Journal of Medicine in April 2019, again reiterating that “… the guideline does not support stopping opioid use abruptly.”

Their NEJM article does say that misimplementation of the guideline could cause harm — a statement that was immediately spun by Dr. Sally Satel, a co-founder of HP3, as a “forceful and humane variant” of the HP3 letter.

Continuing attack

Criticism of the guideline follows a consistent pattern: no evidence provided to refute any statement in the guideline and no evidence provided for the critics’ claims. The eerily similar attacks on the guideline, and the subsequent spinning of the CDC’s we-meant-what-we-said responses to critics as some kind of admission of error or inadequacy, raise the question of whether this is a coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.

There’s certainly a credible motive for opioid manufacturers to do this: The CDC guideline is an effective, evidence-based tool that has helped decrease inappropriate and dangerous prescribing of opioids for chronic pain patients.

Here’s the next line of attack on the CDC guideline: a competing report on opioids and pain management by the Department of Health and Human Services Pain Management Best Practices Inter-Agency Task Force. This report opposes many of the CDC’s recommendations and devotes an entire section to criticizing the CDC guideline. The task force includes many nongovernment members financially tied to opioid manufacturers — conflicts comprehensively outlined in a letter by Sen. Ron Wyden (D-Ore.), the ranking member of the Senate Finance Committee.

Letters of protest about the task force’s non-evidence-based draft report included a strongly worded letter from 39 attorneys general stating pointedly, “While this crisis continues, it is incomprehensible that officials would consider moving away from key components of the CDC Guideline …” Nonetheless, the task force overwhelmingly voted to approve a final draft on May 9, 2019. The final report was released on May 30.

A government-funded report that opposes the CDC opioid prescribing guideline is a major coup for opioid manufacturers. The fact that organizations and individuals funded by opioid manufacturers have stepped up their protests of the guideline in recent months is probably not a coincidence.

Opposition from chronic pain patients

Chronic pain patients have also criticized the CDC guideline. Most of the more than 4,000 comments the CDC received during the open comment period were from individuals. Although most chronic pain patients are not being paid by industry, their stories may be used by organizations paid by industry to advocate for doing away with recommended limits on opioid doses or duration.

Pain patients are important to opioid manufacturers because the bulk of opioids are consumed by people living with chronic pain. A crackdown on opioid pill mills has left many pain patients without access to the opioids they depend on, and finding a new physician willing to supply high-dose opioids is difficult. So-called legacy patients who are dependent on opioids certainly need access to these medications. They also need specialized care to taper down from dangerously high doses and multimodal pain treatment. But their advocacy for unlimited access to opioids for themselves may be used to justify new, ongoing opioid prescriptions for chronic pain patients — who will then become future generations of opioid-dependent patients.

As far as real solutions for the opioid epidemic, the authors of the CDC guideline offer one in their NEJM article: “Starting fewer patients on opioid treatment and not escalating to high dosages in the first place will reduce the numbers of patients prescribed high dosages in the long term.”

It is essential that we not abandon patients on long-term opioids — but it is also important that we not create more of them. Opioid manufacturers stand to lose substantial profits with the widespread adoption of the CDC guideline. Public health, however, benefits from the guideline, and attacks on it bear industry’s fingerprints.

Ben Goodwin is a research assistant at PharmedOut, a research and education project at Georgetown University Medical Center. Judy Butler is a research fellow at PharmedOut. Adriane Fugh-Berman, M.D., is the director of PharmedOut and a professor in the department of pharmacology and physiology and the department of family medicine at Georgetown University Medical Center. She also serves as an expert witness at the request of plaintiffs in cases regarding pharmaceutical marketing practices.

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  • The misrepresentations and falsehoods in this article are staggering. The authors are either completely ignorant about this subject or they are strongly biased against opioids. Maybe both.

    The leadership at Georgetown University should be embarrassed to have these authors associated with its medical center. STAT should be embarrassed for publishing such blatant misrepresentation of medical facts.

    A couple of specific comments:

    “When the impeccably evidence-based draft was released…” Please show me the scientific evidence that supports a 90 MME daily dose limit… or any single daily dose limit for all patients. It doesn’t exist.

    “As far as real solutions for the opioid epidemic, the authors of the CDC guideline offer one…” It is truly distressing that anyone who is in any way associated with healthcare could possibly support this supposed solution, which would increase suffering for and reduce the quality of life of millions of Americans.

    I have finally reached the point where I now wish that those who oppose opioid prescribing would be stricken with the same never-ending severe intractable chronic pain my wife has suffered for more than 20 years. I guarantee every one of them would reverse their perspective if that happened.

    • You are not alone. The anti-opioid zealots will regret the BS they are stirring up now. I know they have mothers, fathers and grandparents suffering with pain causing diseases. Some of the Zealots have gray hair and only an accident away from needing the very drug they have demonized. Well, a demon, called PAIN is lurking right under their feet. Karma is real.

  • Mexican drug gangs replacing heroin with cheaper fentanyl is what’s killing the vast number of people like Prince and Tom Petty, NOT those on long term prescription opioid treatment. My entire body burns in pain all the time, only mitigated by Lyrica and opioids combined. After the guidelines came out, my doctor terminated the opioids cold turkey. Everyone is different, but these guidelines created a handy one-size-fits-all set of rules for physicians to hide behind to minimize the risk of malpractice should one of their patients die. Instead of tailoring each treatment to each patient, fearing for their license and coverage, they’ve allowed their patients to live substandard lives of misery and disability.

  • Here again we have limited the vocabulary to just “chronic pain”. There is something much worse that affects 10% of the population and that is “intractable pain” and also “cancer pain.” The the last two vary little in that cancer is followed by death and intractable pain is not. I have submitted articles about different algorithms with break thru medications but they go ignored by both ATIP and other groups. If you are not a pain patient YOU do not understand this. You cannot relate. Just like legislators who know nothing. It does not matter if you have PhD behind your name. I have worked in pharma and seen PhD that could not analyze their way out of a piss soaked bag. At least try and cover all your bases.

  • I don’t know whether to hope the life we live as chronic pain patients be placed on the authors of this column, or to pray it doesn’t. The authors make it sound as if the CDC guidelines are perfectly adequate and reasonable, that is, until you live in a body that never releases you from pain.
    I agree the drug manufacturers marketed their drugs in an unscrupulous manner. I know for them it’s all about money, and they couldn’t care less about hurting people.
    I agree that people, like these authors , are also blind to the suffering those guidelines have caused, but me and my millions of fellow chronic pain patients who live it every day, trapped in bodies we can not get out of, forced to bear the agony of chronic pain can tell you what kind of hell that is. Obviously, we don’t matter.
    I tell you what does matter: past all the rhetoric of political squabbling, name calling, finger pointing, and fist waving, are real human beings. Real people who actually have brains, who have been given freedom of choice by God. Most of us are adults, and I feel those adults make their own choices. There are always going to be addicts and there are always going to be chronic pain patients. I am perfectly capable of deciding what I want to put in my body. I do not need any government entities telling me what I can and can’t do. Besides, after almost a century of laws regarding drug regulations and putting people in prison has not changed a thing. People are going to do as they please. If you are going to use opiates for recreation, nothing is going to stop you. What makes me so angry, though, is that those of us who try to follow the law are getting demonized, urine tested, treated like we are trash, all because we just want our pain controlled.
    Instead of writing such an inflammatory piece, where all you see is black and white, why not concentrate on a real solution?
    Because until you live with real, unadulterated pain, every day of your life, you have no clue what you are actually talking about.

  • Is this article real? I cannot believe that “professionals” and experts actually wrote this inaccurate and quite honestly corrupt article.
    I’m NOT a paid activist, I only became an advocate because of what I have to witness everyday with my elderly veteran father. This article makes the claim that force tapers/fast tapers don’t happen. That is absolutely false! I watched painfully as the VA not only fast forced tapered my father without consent or compassion but it was an inhumane and UN American! I’m not going to list all of my dads problems with pain what I’m going to say is what he has done to try and improve his condition on his own. His issues are his back. Everything and anything you name he has or had. He’s been through 12 back surgeries, have had every injection to man, even has a spinal stimulator. he’s complied with every mandate in his pain management program from pill counts to urinalysis and has passed every time.
    He was on high dosage RX opioids for over 13 years, and just last year the VA force tapered him. Mind you while he was on opioids he had an extremely productive and active life. Since then my once active father is now bedridden in excruciating pain! He’s been hospitalized 4 out of the last 5 months with heart failure. The most recent episode his heart doctor disclosed to us his problem with his heart is from his increase in pain!!! It’s pain that has caused my dad to be diagnosed with heart failure/ attributed to it!
    The VA CDC DEA and those who wrote this article I hold responsible for my fathers increased deteriorating health. He was a compliant CPP who was on a VA prescribed pain management program and they took it away from him.
    Those of you responsible I pray one day will be held responsible.

  • The CDC, the DEA, any federal or state agency has no business being involved with the relationship I have with my physician and the amount of opioids we decide together is best at keeping my pain controlled and keeping me functional. The CDC Guidelines was the first in many steps that were taken to severely deteriorate chronic pain patient’s quality of life. Many people are under-treated or not treated at all. This is barbaric.

    The guidelines were arbitrary and misapplied.

    I received nothing by advocating to ditch those guidelines. I am not a big company. I am not a big organization. I am just one chronic pain patient who continues to speak out for my rights and the rights of others in my same situation.

  • I would guess you could find articles for and against the CDC guidelines if you look. But I would also guess that the person or persons who wrote this article have never had to live with chronic pain. My problems started at a younger age and I was put on different anti-inflammatory meds muscle relaxers anti-depressants etc and was put through physical therapy SEVERAL times I was put on pain management when it was determined my back problems were inoperable the physician had me on extremely high doses of opiates plus soma Xanax I failed a drug screen and received a letter not to come back but not before getting pneumonia and going into respiratory failure I was on a vent for four days I saw my pain management doctor once after with no change in scripts then received the letter. I started self medicating and eventually had myself admitted to a inpatient rehab. Now I managed to stay out of pain management for three years until I slide and fell in my kitchen. My back and neck pain just got worse and worse until I couldn’t get out of my bed without crying and I finally consented to go to a pm doctor after a few rounds of steroid injections that wasn’t working. I was completely honest about my history and requested pill counts drug screens and for my spouse (who doesn’t even like to take an ibuprofen) be part of our plan. I also over the years have refused dosage increases and requested dosage decreases. But I bet you won’t find that in anyone’s notes. I am aware of my age and that my back and neck are not suddenly going to heal or become operable. Now these are not my only painful diagnosis I have been so with fibromyalgia degenerative disc arthritis and I have a small brain tumor that is being monitored along with several lesions on my brain migraines and optic migraines I have been on the same meds with a small increase in the fall that is taken back to normal dosage after a couple of months because the change in weather from warm to cold is hard on me. However since the CDC guidelines my long acting med was taken away and the short acting was increased to four times a day which that extra dose a day does not make my life any easier. The original plan was working now I am feeling punished for needing pm. I already have a new dr and all the other ones around me have either been arrested or put under investigation so needless to say they are dropping like flies. Even the ones who haven’t gotten in any trouble are so terrified of the DEA they have just shut their doors. I think you all couldn’t care less about us and want us to die then you want have to worry about paying our social security or disability of which I have neither. So I say thanks CDC addiction is in the genes just because we require pm doesn’t make us addicts. I don’t share sell or give my meds away and I take them as prescribed and even though they aren’t working that well my doc doesn’t care either because now they can tell me how I feel based on my imaging (xrays mri’s etc) I was informed that they had listened to their patients for to long and now it was time to tell us how we feel not us tell them this made me very upset because I know we all have different ways of handling pain and our bodies metabolizes medications differently so how can you tell me how I feel andhow a med is gonna work for me. So all the changes going on with pm docs because of these guidelines is not affecting those people out there ODing on Fentanyl and heroine so how is it helping?!?!?

  • Ben Goodman’s statement “It is essential that we not abandon patients on long-term opioids — but it is also important that we not create more of them”
    Is all the proof you should need to see that while his article may be well intentioned his logic is extremely flawed.

    Is he saying that Legacy Chronic Pain Patients were created by opioids? And that by limiting the Prescribing of opioids we can prevent the creation of new Pain Patients? This is ludicrous!

    Pain patients need relief from their suffering due to their various diseases. Opioids are what allow them to move about and participate in some semblance of a functional life. Often, even with Opioids they are still struggling with disease. Importantly though, without these life giving medications they are bed bound or worse, contemplating their only way out of their relentless, intractable PAIN.

    Unless Ben can somehow miraculously cure all future painful maladies that inflict humanity there will ALWAYS be a need for pain management. Centuries of human suffering and the subsequent use of herbs and whatever nature could provide to relieve it, has taught us that OPIOIDS are the very best at relieving Pain. Centuries of use and suddenly, without anything its equal to replace it we must abandon its use because a few zealots think we should.

    His equating Opioid Manufactures with Pain Patients like there is some devious underhanded connection is like saying the Girl Scouts have some dubious connections with cookies! His statement “patients are important to opioid manufacturers because the bulk of opioids are consumed by people living with chronic pain.” Ya think?! Of course we are their MARKET. Of course they have a stake in this, it’s their business! It seems Ben doesn’t understand how the market place works.

    Pain Patients, Doctors, Pain Organizations, Pain Clinics, Pain Centers and yes the makers of the medicine that so effectively treats and manages Pain are being directly and detrimentally affected by these “misapplied” and what I would call ill advised CDC “guidelines”.
    Why wouldn’t these stake holders get involved in trying to stop what had been an aggressive and egregious assault against all involved! Doctors offices are being raided, Clinics are being shutdown, Patients abandoned, Forced Tapers, DEA destroying careers and letting the courts figure out who is innocent but by then it’s too late.

    Most importantly Suicides by our Veterans and other Americans who by no fault of their own NEED pain medications to function.
    SUICIDES are REAL and the numbers have jumped. The CDC knows this, they track these numbers but also add them to their “opioid related deaths” to further their own agenda. How convenient. They can erroneously claim opioid related deaths are increasing without sharing the fact that the death could’ve been someone who was shot but if they had even the slightest amount of opioid in their blood (even legally prescribed ) they count it as a opioid death.

    By the way, the CDC used to be a federal agency that tracked contagious DISEASES. And yet, they made these guidelines in direct opposition to the FDA’s science-backed-data and recommendations. They should’ve stayed in their own lane but one only needs to read “ Violation of a Nation” to learn why they did what they did.

    Mr. Goodman’s article is not revealing in any way and ironically he and his organization are just as vested in this health debacle as the rest of us. We are simply two opposing sides of the same coin. We could look at all the connections of people like Goodman or Kolodny who are adamant that opioids are evil and the public should be protected. We would find that many of the so called experts have direct links to Recovery Centers or Rehabs or perhaps even interests in companies that make the “good” narcotics like Buprenorphine. Which you should know many of these people are pushing as the answer to their manufactured opioid crisis. Yes, it’s theirs, they made it, they own it. And they make money off of it.

    Data doesn’t lie. Opioid Prescribing is WAY down and deaths from Illicit drug use like Heroine and Fentanyl are WAY up. The truth is the real crisis is out on the streets and if they really cared about saving people their focus would be on helping the people with substance abuse disorders and not denying Patients their Dr. prescribed medications.

    It’s obvious that Pain Patients, Doctors and Opioid Manufacturers were the easy targets in their war on drugs. They needed the easy targets.
    They know they can’t stop illicit drugs from coming into this country. They know they can’t stop people from dying in the streets from them either. They can however be proactive and jump on the ant-opioid train and appear to be helping the children. It’s the same old sad story. Follow the money. PROP and organizations like PharmedOut who Ben Goodman is a research assistant have vested interests in keeping Pain Patients from their life giving medications. Without this “crisis” they can’t prop each other up, hold lucrative conferences, gain federal support and funding.
    So let’s all just be real about it.

    The Federal government, nor some jump on the band wagon ad hoc agency should ever be allowed to nose their way in between Doctors and Patients.

    If we the people allow them to do this, we can be certain they won’t stop at opioids.

  • I am appalled that anyone would print these falsities. Because of the CDC I was left to writhe in agony post-surgery in spite of being an older, responsible person who worked my entire life and paid the salaries of the CDC workers who forced this insanity upon an unsuspecting America. This is going to be looked back on as the insane out-of-control government overreach driven by the misguided fringe element which is PROP. I expect that very soon every physician across America is going to turn their back on PROP and Kolodny – his brief spot in the sun is going to come crashing down around him when no one will want to be associated with his sinking ship. And the misguided folks who authored this article the same.

  • What a gianormous pile of garbage this is. The CDC is corrupt and allowed a anti opioid activist organization, prop, to design their opioid guidelines. These guidelines are full of crap. Almost every point is speculative. and those speculative comments are actually considered strong opinions by the CDC. What a freaking corrupt joke the CDC has become under Redfield.

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