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.

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • If opioid overprescribing was the cause of an increase in overdose rates, why are overdose rates still continuing when prescription rates have been coming down since 2012?

  • Pill mills and overprescribing of opiates has long been over. According to the CDC since 2016 opiate prescribing has been at lowest in 20 years. True there was abuse of oral opiates when pill mills and easy access existed. The absolute facts now are:
    – The leading cause of opiate related deaths are from illegally manufactured fentanyl. This epidemic is worsening, more lives are being lost, and yet anti opiate advocates simply ignore this;
    – Deaths related to opiates are almost never from opiate ingestion alone. Taking enough oral pain medication to result in vital sign depression would lead to death from acetaminophen toxicity long before hypoventilation. Deaths involving oral opiates are seen when other CNS depressants are taken with the opiate;
    – Responsible, medically supervised use of opiates is not life threatening. Addiction is not life threatening and is a reality of living with severe disabling pain. Abuse can be life threatening but we are talking about the responsible use of opiates for a patient with documented severe pain;
    – Failure to treat pain is medical neglect and cruel;
    – The evidence does not support short term use causes addiction for the patient with real pain and,
    – big Pharma and others benefit from the withdrawal of cheap oral opiates from the market because this makes way for profit from the new expensive opiate alternative drugs. Profit is also being made from ridding market of cheap oral opiates in the increased sale of detox drugs and price gouged narcan.
    There is a place for responsible opiate use and it is for severe acute and chronic pain. We have entered a dark time in medicine where we feel entitled to tell patients essentially “suffer” and deny them pain relief. It is barbaric to deny opiates to post surgical or trauma patients for instance. It is also barbaric to deny opiate management to patients such as those with a sickle cell crisis or pain from chronic pancreatitis. Are we really creating a healthcare system that denies comfort and pain relief?

  • Whataboutism- Please STOPPNow
    “Pill Mills” are NOT the issue. Please don’t pretend that this idiocy of torturing people in pain and taking away their medicine based on fake stats and Kolodny and PROP’s lies about the efficacy of Rx opioid medicine has anything to do with ILLEGAL activity of a few outliers. The anti-opioid zealotry groups are spreading fact-free proclamations and conclusions based on their biases. They lie about Rx opioid medicine death rates (factually almost non-existent when taken as prescribed). They lie about addiction rates (.62% to 2%). Kolodny, the Dr Mengele of pain care, calls hydrocodone a “heroin pill”. They are in LOVE with Suboxone (but not the generic form Buprenorphine)- FOLLOW THE MONEY. They lie about pretty much everything that doesn’t agree with their science free “facts”. They lie about opioid deaths (claiming addicts are created by pill pushing doctors who create addicts who od & die). They lie about the rate of addiction. They lie about their so-called expertise.
    They also appear to not give 2 s___s about people who use these safe and effective medicines to lead fuller and more productive lives.

  • When STOPPNow was holding peaceful protests in front of the pain clinics aka “pill mills” in Broward County Florida (BTW there were 150 in the one county) They were prescribing Oxycodone 30 mg; the largest dose I saw was 308, along with Xanax and Soma to everyone who walked in the door with cash. Xanax is of course a benzodiazepine – this was the cocktail that was given all day every day to every patient. I don’t know if a benzodiazepine is what your meant instead of barbiturate. Both the benzodiazepine and opiate are CNS depressants. The CDC does state they should not be co-prescribed if it can be avoided. STOPPNow the Opiate Epidemic.

  • An opinion s all you have stated. RX is NOT the cause of the majority of opioid related deaths but rather illegal fentynl, heroin and the illegal obtaining/using of RX opioids. Maybe the lack of press on your opioid stance is the most disconcerting complaint for you but the fact that millions of pain folks suffering because of the lack of press on their issues is of actual concern as it has dramatic effects for us.
    CPPs and Veterans have more than opinions to offer. The Opioid Guidelines were horribly misused and threw CPPs /Vets and more under the bus in favor of those who suffer from addiction. When Kolodny etc.. cannot have discourse with dissenting opinions or answer questions that don’t suit his/their narrative something is very wrong. When confronted advocates say we don’t mean to interfere with CPPs etc… but it absolutely has and is, they say nothing about that impact. You gloss over it just like the rest just to say you mentioned it but discount the reality just the same. There is a measured response to all issues. Your article is more about bruised academic ego than about actual academia.
    CDC lists any death where any opioid was found in blood even if it wasn’t the cause of death. Lets have some true STATS. Additionally, their report shows an increase of near 20% in psychostimulant deaths. That gets no press either cuz its not the cool optic of opioids you have all jumped on.
    Also, this lack of pain tx is causing multiple issues for pain patients.
    First, there are these new cattle clinics that people are run through where they are offered injections or make that more like forced, then they must do expensive UAs as they are tested monthly for every possible drug known to man even if its been more tham 3 yrs and never had a dirty UA( talk about docs making $$) and tapered down or ff meds cuz thats what is the sexy outcome not what is good medicine.
    State and Federal law are working toward outlawing pain meds so yes, people are fighting back.
    You are a researcher. Why not resarch effects of long-term opioids on patients? There are no studies but only opinions and Im not so sure insurance companies arent behind sponsoring those.
    I agree there are some docs who over prescribe but suffering in unnecessary pain is not a gold standard outcome. Acetaminophen can damage your body easily. No studies have shown the same for opioids taken as directed
    I am an MSW who worked in law enforcement till my neck was broken on the job. I have worked with lots of addicts. So I have knowledge of street use. In the 70s early 80s it was heroin, then came cocaine and crack followed by meth and now we are back to opioids but its the illegal and powerful fentynl as the main culprit. Without focus on that and tar heroin, your STATS on street opioid deaths will not change.
    I suffered for 8 yrs through failed surgeries and after. I was ready to use my glock to end it. You have no idea how 24/7 pain can effect you. My doc then told me addicts do illegal things to get drugs while people who are dependent use them as intended for a better life. So I started my opioid regiment. It made my life totally better. I can work part time, I don’t cancel every social event with friends/family, and I don’t need antidepressants. My bp is not off the chart due to pain. Its been 21 yrs. I even volunteered to go down on my RX amount and did about 5 yrs ago. I honor my pain contract. Im followed by my doc, case mgr, insurance mgr, pharmacist as well as state Prescription Monitoring Program. If you think its easy to get RXs, its not. And I do know what pain is as I had 2 kids without drugs. You likely don’t know this side. I also did 7 yrs of acupuncture, multiple types of PT, multiple injections( they never helped but Id get desperate and hope) massage etc.. I still do massage and acupuncture when in a more flared state. A few appointments would have no effect.
    I know a young vet who was blown up with IED. He had a RX for Vicodin that he used whenever his pain was too bad. That RX would last about 4 months. When he went back to doc a few yrs ago and asked for refill it was refused. Absolutely no opioids! You think this is reasonable? Its crazy to force people to live with pain when we have the meds to treat it. Of all the addicts I knew over 20 yrs no one started from a RX script given for tooth extraction or surgery.
    So there is good that comes from Big Pharma, too. That needs to be acknowledged or all of the arguments you have are biased. And that is not good academia.

  • When I read the 2016 Guidelines the Peer Review of them showed that they were based on poor or non-existent data, flawed and should be rewritten.

    Chronic Pain patients are dying because of these 2016 CDC Guidelines. Most long-term CP Patients have tried all forms of treatment to stop their pain. In my case: I tried everything from numerous NSAIDs, acupuncture, TENS, PT, Bio-feedback, chiropractic, massage + for a year before I opted for back surgery. A spinal fusion and laminectomy at L5-S1. The surgery was a failure and I came out of it worse off. A piece of bone graft is impinging a nerve and cannot be removed. After 3 surgical attempts I was told there is no medical fix. For someone who was about to be a Personal Trainer and was an avid bike rider, weight lifter this was devastating.

    I have been getting pain relief from Fentanyl patches since 2003. For 13 years my dosage is the same, I do not crave or need more. I do not get high or doctor shop. I do NOT get anything from Big Pharma and consider the implications that CP Patients do as an insult. These drugs are all we got long-term to give us some kind of life. What do you people want? For people in pain to lie in the street writhing in pain or to just go away and die? The National Socialists in Germany in the 1930’s used euthanasia as a way to rid society of those they deemed a burden. Is this what your end game is?

    Addicts have been shown statistically to obtain their opioids through illegal means, to mix them with other chemicals and to crave and use more to get high. This is a major difference between CP Patients who are monitored, tested and put in a database to combat doctor shopping. Addicts need to take responsibility for their drug use. It is not the fault of opiate manufacturers that they abuse drugs. There will always be some who will be addicts, laws will not stop this. In Portugal where all drugs are legal they found addiction and abuse LOWERED as opposed to when they were outlawed.

    Is it not a conflict of interest that you at Georgetown University Medical Center are 90% US Government funded and you are defending the work of another US Government entity, the CDC? Are you a mouthpiece for the CDC? Is there something you hope to gain by this relationship?

  • TO THE AUTHORS,

    Folks, you can’t be serious in expecting we not allow more patients to use opioids for chronic pain. Tell this to the military- just let battlefield wounded suffer. My brother is one of these warriors. He’s has safely and responsibly taken opioids for chronic pain since 1969. How has he not become addicted or overdosed? You need to find out. This Is imperative.

    Your emotions are out of control. The overdose “epidemic” is two separate things:

    1. People illegally taking drugs to get high who are fundamentally irresponsible (and engaging in criminal acts by using).

    2. Responsible pain patients who have increased quality of life and physical functioning through pain attenuation. Opioids are best for chronic pain, IF doctors teach their patients how to be safe and responsible (most figure it out on their own)- Overdose Risk Reduction. The CDC will research this I submit.

    You are conflating and confusing the two above sets.

    You saying in effect, “Since motor vehicle accidents kill, and injure so many people, let’s make driving one a crime. Get rid of all cars, buses etc.”. Won’y work in the real world folks.

    What about “preventable medical errors”? They kill 170,000 to 250,000 or more a year. This is by far the worse “epidemic”, so why are you picking on the elderly and disabled via-a-vis decrying their use of opioids? It’s a crime in most states to cause injury to children, the elderly and adults with disabilities folks even by omission, i.e, depriving them of opioids.

    To achieve “no opioid status” you’ll have to change the very way America views injured workers, the disabled, those with incurable diseases and the like. In other words, Americans will continue to have injuries and disabilities and chronic pain that necessitate opioid treatment. Millions of pain patients have safely take opioids long term and have never overdoses or become addicted. How do you account for this?

    I’m afraid you’ve been mesmerized by those in America who hate the injured and disabled and diseased and want to see these “weaker” people suffer and be eliminated. This is a Hitlerian philosophy that has no place in modern America folks.

    Regards,
    Charles Bruscino
    Research and Advocacy

  • Another concern regarding this physician over-response to the 2016 “guidelines” ( apparently misinterpreted by doctors as “law”) is that none of the suggested alternatives for treatment ( i.e. acupuncture, massage, capsaicin, etc) are covered by insurance companies. These alternative treatments are very expensive and unaffordable for many . ( Capsaicin is approx $11.00 a bottle and I use 3 a week. Massage is at least $70 an hour; Acupuncture is $110). Physical Therapy is only covered for short periods of time and these treatment blocks are often suspended by weeks of bureaucratic bs as you wait for further authorizations. (These prices are from rural Ga.). I was once turned down as a candidate for PT because I “had already had it” and “it didn’t fix the problems” ( ie the ” unfixable” prior spinal fractures , stenosis, herniations, and spinal impingement).
    The results of this malpractice circus ( the malpractice is in violating the oath “do no harm”… in this case doing nothing IS doing harm” )has been clearly presented in other responses. Since we are now in this mess, how to address getting alternative treatments reimbursed by insurance companies?

    • The reason that insurance companies won’t cover alternative therapies is because overwhelmingly nearly ALL studies show that they just don’t work for *most* people. Whereas opioids do work, safely and effectively, for 99% of people without any problems.

      I agree that people in pain should have access to all the tools in the toolbox. Including opioids in conjunction with or instead of alternative therapies, however each patient desires.

  • How is it possible to stuff this much malice, ignorance, and bias in one article? People are committing suicide to escape their agony from incurable conditions now, because of lie mongers behind opioid hysteria. Someone with Lupus or severe rheumatoid arthritis shouldn’t blast their brains out because their physician is too afraid of a DEA raid to write for pain relief from opioids. And yet here we are. And yet here Statnews is, publishing this BS. It’s disgusting. Be ashamed of yourselves!

Your daily dose of news in health and medicine

Privacy Policy