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.

advertisement

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.

advertisement

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.

  • Thus article is so biased, ignorant and devoid of genuine content that I didn’t even finish reading it. Another ultra conservative, right-winged Christian with a pulpit. This is our America, folks: corrupt, with huge proportions of the population that are dumber than a stump, and democracy-hating. Fascism, here we come!

  • Physicians in the PROP organization have financial ties to medications, like Suboxone, used for nearly evey rehab in the United States. Yet, I do not see this article shining a light on that conflict of interest. If you want to call out corruption, don’t try to hide the main one creating this hysterical response to the “illicit opioid epidemic” while conveniently bashing on chronic pain patients and those lobbying for proper medical care for these patients.

    Chronic pain patients are now being told to do yoga, acupuncture, or Reiki therapy instead of medication. Chronic pain patients are being told to meditate and “think happy thoughts” instead of being properly treated. Chronic pain patients are told to “just go hiking and get fresh air” when they can barely “hike” to their bathrooms. It’s like being told to find the Fountain of Youth or the Holy Grail. These things won’t work alone and are nearly impossible to do if your pain is so great that you seriously consider suicide to escape the pain.

    Yes, addiction is sad and destructive. But not treating legitimate patients is also sad and destructive. But it is also cruel and spiteful to purposefully neglect patients because some unknown strangers misused a medication. Should we limit Viagra and other ED medications because of their misuse by people? Should we limit cough medications and laxatives because of the small percentage of people who misuse them? Should we all just suffer instead of letting anyone get ahold of any medications because of the nebulous possibility of potential misuse?

    Alcohol is far worse and kills far more people every year but that is an acceptable drug. Alcohol is far more destructive to families. Yet, Alcohol is advertised on TV and socially acceptable.

  • According to this article its a conflict of interest to advocate for pain care while receiving funding from pharmaceutical or life sciences organizations.

    HOWEVER, the author has a conflict of interest on the opposite side: receiving funding by groups in litigation against the pharmaceutical and life sciences industry:

    “She also serves as an expert witness at the request of plaintiffs in cases regarding pharmaceutical marketing practices.”

    So why should we even believe what the authors are stating here WITHOUT any evidence?

  • I have stenosis in my neck and lower spine and need surgery on both be cause of my disk herniation and degeneration and my sciatica down both legs to my feet are mentally and physically driving me nuts. I have arthritis in my whole spine with 1 1/2 bone spurs sticking off my spinal canal and now arthritis in all joints. My ankles have so much bone spur build up it kills me just to move them and I need double knee replacements because my knees are bone on bone. My left rotator cuff is totally gone and I have ruptured all tendons in my left shoulder. They have tapered my meds despite me not being able to take acetaminophen because of my liver and I retain water so bad I take 80mg lasix daily to relieve my water retention so taking ibuprofen or steroids is out of the picture because they make me swell up with water. I’m sick of these know it alls calling us drug seekers to relieve pain when they think it’s all in our heads. They want to give shots in the joints but you can only get so many before that becomes issues. I wish someone could take all us pain patients up and head this to supreme court or something to fix this disastrous situations. Makes me not even want to be here anymore but I love my family and I will keep fighting till we the chronic pain patients win this battle. God help all of us.

    • The stories from actual pain patients are horrific.

      I was given haldol as an alternative to opioids in the ER after tearing my rotator cuff. It was two days before I regained consciousness. I need surgery to repair the damage but refuse to get it because the only ortho in my area has a post-op plan that includes OTC medications and “a referral to pain management, if needed.”

      I’ve dealt with the pain management team before. I spent two weeks being told to ignore my 98 year old neighbor’s screams of agony. I was threatened with legal action if I actually gave him a gun to end his misery. He was receiving hospice care for bone cancer and was only suppose to last hours not weeks. The pain management team limited him to Tylenol because he was a suicide risk. He was a suicide risk because they refused to treat his pain.

      Policy makers should listen to my story and to the stories of others like me because they reflect an ongoing public health crisis. Skilled researchers should go back to PubMed and do a comprehensive meta-analysis of the data that is available. The FDA warning on gabapentin’s effect on the respiratory system should be enough to put the CDC and other agencies on notice that something is seriously wrong.

      I don’t know what studies the authors have or have not read but I know the scientific research is far more complex and nuanced than what has been presented here. It’s standard industry practice for drug manufacturers to pay for research and development. It is also standard industry practice for drug manufactures to sponsor support groups for patients. If we were to discount all of that research because it was industry funded, innovation would come to a standstill.

      Chronic pain patients are not pushing for unlimited opioids. They’re demanding appropriate pain management prescribed by a competent physician. The slight risk of addiction to opioids is not enough to justify using anti-psychotic medications to treat shoulder pain or Tylenol to treat bone cancer pain. Yet that’s where we’re at.

  • I am a chronic pain pt. who has been on high dose opioids for many years. I had already( my choice) reduced the amount by 1/2 when the D.E.A. started harassing pharmacist and pain doctors. The extra work of documenting and justifying mine and all other pt. medication finally cause them to close the pain clinic. I had them send 8 referrals before I found another doctor and he only accepted me as a pt. if I agreed to reduce the
    amount of medication every month until it was less than the C.D.C. guidelines. At the same time the pharmacy (the second one to close on me) I was using closed and no one would fill my prescription. I have both phoned and personally visited dozens of pharmacy’s only to be treated like a criminal and refuse to fill my prescription…. I have much more to say but I unable to at this time as the stress of thinking about this is exacerbating my pain…sorry

    • Dennis, can you send an email explaining your situation to the American Medical Association? They are assisting pain refugees like yourself, please reach out and see if they can help you with this, the email address is opioidtaskforce@ama-assn.org Have you tried a disability office in your area, in your state? Even if you are not disabled you are still being discriminated against and they might be able to assist you in locating a pharmacy, this is getting ridiculous when American citizens cannot fill legitimate medically necessary prescriptions for legal medications! Please try to hold on Dennis, change is coming, the millions of patients in this country, from cancer patients to post-surgery to people suffering from serious illness and injury will not accept this interference in standard humane modern medical care. Contact the pharmacy board in your state and ask them for help in locating a pharmacy that will fill your prescription, tell your doctor what is going on and ask them to assist you, they must have pharmacies they work with regularly and can tell you where to take your prescription. Contact your state representative in your district and ask for help, ask for constituent services. And join twitter, there is a large pain community. When people like you have problems, they use twitter to reach the pharmacy chain accounts asking for help or telling about the discrimination and sometimes abuse they have experienced in their stores, and it gets results. If you are using insurance, call them to help you, if it is medicare they also can help. I wish I could help you myself, but please, join social media and search for chronic pain and you will find us, we are working diligently to restore humane standards of medical care, alongside doctors, researchers, academics, reporters, and your fellow patients. We WILL get through this. All of this can be done online, maybe a few phone calls.

  • I think PROP may go down sooner rather than later.
    They stepped over the bounds and health care systems
    are probably going to hear about it.
    Stick together to keep it happening.

  • LIES! This piece is PROPaganda. FIX the mess you have created – millions of us are suffering needlessly!! This is a fluff piece and the “facts” are not facts but opinions of the zealots trying to cash in on a billion dollar new drug and industry – opioid use disorder, addiction medicine and now every patient is an addict and the pain management doctors are using the CDC guidelines to Force titrate off stable doses under 150MME!!! I thought that was why we were referred to Pain Management – because we require longer term and over 90MME dosages to manage our intractable pain? We are FED UP!!! #CPPSRFEDUP

Comments are closed.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy