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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  • My name is Michael Springer. I am 70 years old. Most of my more troubling symptoms were steadily increasing in their severity while I was working with a Special Agent to expose criminal activities and corruption in State government. I have been diagnosed with a constellation of rare diseases but none of them are related to lifestyle choices. Individually they are some of the most difficult conditions to diagnose and treat. The combination of rare diseases and medications I have to take create a broad range of additional symptoms. Some of the medications I have to take pose significant health risks, others can interfere with attempts to control another disease or manage my symptoms. Some of the procedures and medications can aggravate existing symptoms and damage vital organs but since my mid 20s pain has always been present.

    I hold a graduate degree from UC Davis, was licensed as a registered nurse in 1973 and nurse practitioner in 1977, provided clinical services for over 30 years in underserved rural and urban settings, for and with local public health programs, worked as a Consultant for the California Department of Health Services for nine years and trained in epidemiology. Over the years I have testified as an expert witness for the Office of the Attorneys General, before two Grand Jurys, State administrative law judges and in criminal and civil proceedings.

    I have no affiliation with big pharma but have worked with and within the US public health system for over 40 years. I find the diatribe; “Industry-funded attacks on the CDC’s opioid prescribing guideline are eroding public health” to be trite and a weak defense in response to the justifiable blow back that should have been anticipated before releasing the poorly thought out “Opioid Prescribing Guidelines”. This is by far the greatest debacle that CDC has ever embarked on in the past 40+ years.

    For the past 4 decades I have worked with people who have dedicated their lives to finding solutions to public health problems. Over the years I have developed a great deal of respect for the CDC – that was until I read the “Guidelines”. The “Guidelines” uses the data for deaths related to opiates such as fentanyl and heroin that are bought on the street and uses that information to justify CDC’s war on clincians who provide opiates and other medications to patients who suffer from chronic, intractable, stabbing, burning, grinding, shocking, bone-on-bone pain. Pain causes loss of sleep, increased risk for heart disease, cancer, divorce, job loss and burdening other family members are just some of the outcomes that are not mentioned by the CDC.

    There are a few clinicians who may possibly over-prescribe opiates to their patients but citing the thousands of deaths that are related to the use of illegal opiates from China, Pakistan, etc. is dishonest. I wrote to the CDC several months after the “Guidelines” were published. I actually got a call from a CDC employee! She was very pleasant and articulate but after I told her that the “Guidelines” pose an undue burden on people who are tormented by pain day and night she told me that there will be no changes to the “Guidelines”.

    This classification of medication is only used when nothing else will help control a patient’s pain. Patients go through many years of palliative care, physical therapy, dorsal column stimulators, oral anti-inflammatory medications, exercise, over the counter medications, surgeries and sessions with psychologists. When these interventions fail to stop the unrelenting, grinding, intense stabbing and burning associated with peripheral neuropathies and the radicular pain associated with the impingement of the nerves between two vertebra or secondary to spine surgery or shingles they are given a prescription for an opiate because there is little more that can be done to relieve the patient’s pain.

    Unfortunately the “Guidelines” do not reflect an understanding of how to apply the long standing scientific evidence that has been derived from expert clinicians who help patients manage pain in a clinical setting. In addition to the purposely misleading scientific “facts” that supposedly provide the rationale for disseminating the “Guidelines” nation wide without taking the time to create multiple focus groups made up of patients and their physicians . The “Guidelines” offer no viable alternative to the opiates that patients desperately need to manage their pain. Six months ago I was told that pain is just part of life and patients should just accept it. Whoever the puppet master might be, they have no idea of what they are doing.

    As an example I will use my own experience in attempting to control the various kinds of pain I have lived with for over 30 years. I have Stage II renal disease. It was caused by the high doses of aspirin and ibuprophen I had taken almost every day since my mid-20s. If I want to avoid renal dialysis I can no longer take any of the NSAIDs. If I am forced to use NSAIDs the cost for dialysis will be enormous but that could have been avoided if I was allowed to use other pain medications.

    Between 2000 and 2012 my creatinine and BUN were trending upward. After a consultation with a nephrologist in 2012 I began taking codeine. The physician I was seeing prescribed 240 tablets of acetaminophen with 30mg of codeine. At first I took only one every 4 hours. Since that dose did not decrease my pain he told me to take two tablets of the 30mg of codeine every 4 hours. I did what he told me but after a year it was obvious that I needed something else to manage my pain. Four years ago I was given a prescription for 15mg tablets that contained morphine. Because it did nothing to blunt my pain I was told to increase the dose to 60mg every four hours. Eventually we came to the conclusion that I am non-responsive to opiates.

    Approximately two years before my morphine trial, a new medication was approved for the treatment of pain. The name of the medication is Nucynta. I was given a prescription for tablets that contained 50mg of Nucynta. For no logical reason Nucynta is classified as a Class II opiate but it has none of the attributes that others to use them for. The fact is that Nucynta has no extrapyramidal effects such as euphoria, it is still listed as a Class II drug. Because it is a Class II medication I have to submit to monthly evaluations and treated like some kind of street junkie.

    One of the absurdities is that I am 70. Given my medical history I will be lucky to live to the age of 80. Why would the CDC want to stop the elderly in the US to live through their sunset years in pain? And lastly the “Guidelines” were so poorly conceived and written that it has created opportunities for attorneys to file law suits against institutions like Kaiser Permanente, Renown, the VA, and many others. Retract the “Guidelines” now before anyone else gets hurt.

    Michael Springer, RN, PHN, NP, MHS

    • WEll put Michael. Please see Calif. Penal Code Section 368 conquering abusive and neglectful injuries to disabled adult s and the elderly. I’m in Texas now but lived in California for 40 years. Texas Penal Code Section 22.04 is supposed to protect vulnerable people- Injury to a Child, Elderly Person or Person with Disabilities.

      Please see California Welfare and Institutions Code Section 15600 ET SEQ for abuse, neglect and exploitation laws. Most states have similar law.

      Please also see the Older Americans Act, the Americans with Disabilities Act and the related Supreme Court OLMSTEAD decision, as well as the Elder Justice Act. These laws stress that “community inclusion” is the intent of these laws and decision and states are responsible for keeping vulnerable adults in their own homes allowing us to interact with non-disabled people, among other t activities that non-disabled and non-elderly people enjoy such as family, friends, community events, owning a home, working, etc.

      I am 66 and have been disabled with osteoarthritis since 1997. My pains are so pervasive high I can’t live without pain medicine. I’ve been mostly cut off recently due to the hysteria, irrationality and paranoia created by the CDc Guideline. The Veterans Administration seems to be worse about pain meds.

      Millions of pain patients have safely take these drugs for years and sometimes decades. The CDc and FDA admitted this in their April and May press released about the “misapplication” and “misinterpretation ” of the Guideline “harming responsible pain patients. There is hope if we all speak up as you have done. We can’t save the lives of addicts by harming responsible pain patients and driving some of us to suicide as the “final pain relief option”.

      Abuse, neglect, exploitation and discrimination ;awds may further save pain patients from the hooligans masquerading as objective scientist and experts. You may contact me at @justitiadebiles. I won’t give up too easily. Keep up the excellent writing and advocacy Michael. Bless you.

  • Soooo, Fugh-Berman is a plaintiffs consultant … therefore she is in no way biased??? Tell these pricks to get an MD and actually take care of patients who are in so much pain that they actively consider suicide as an alternative. When I want the opinion of a pharm researcher, I will give it to them.

  • Ok John,
    You know PROP were consultants. CDC know has a vetting process for the likes of Andrew and Jayne. Not pain specialists but set out to make money by calling everyone an addict. And Andrew sells malpractice insurance to physicians. You probably know this already but do you see the link??? He defrauded a government entity the CDC and should be in Leavenworth. He is heavily invested in addiction medicine and Addiction centers of America. If they ever go his hard drive we would know what he was up to. FDA rejected the 90 mme limit. The only reason it went as far as it did is because it was on CDC letterhead. If you have intractable pain there is a Federal Law that assures you can get medicine from a doctor unless the state you live in is corrupt.
    Intractable pain laws.
    https://drpattyschronicintractablepainandyou.wordpress.com/intractable-pain-treatment-laws-and-regulations/
    One thing for sure. In his lifetime he will need an opiate for pain. Karma is real and he is a criminal narcissist.

  • Chronic pain patients already on higher doses of opioids and have been responsible citizens with a decent “quality of life” have become collateral damage!!! I dont care how many times you re-write these guidelines, Doctors are fearful of DEA retribution and are force-tapering and refusing to write prescriptions, forcing CPP’s into withdrawal and even suicide! The government needs to stay out of the doctors office!!!

  • Tim, I meant people like kolodny and ballentyne… Very thankful for pain advocates like you and others here. Its impossible for me to understand why so many are trying to deny suffering pain patients there opioids.

  • This article is so full of b.s., I don’t even know where to start. First of all, the CDC guidelines were not built on evidence based data, and what data was used was grossly misrepresented and full of errors. Second, these guidelines have done grave damage to the chronic pain community, and done nothing to address the real problem, which is illegal street drugs. Third, regardless of what the guidelines said, they were widely misapplied, enacted into law, forced patients to taper with no choice, forced doctors out of practice, and provided a tool for the DEA to arrest doctors in legitimate practices. Patient/physician relationships have been completely destroyed. Furthermore, if you want to make claims about “someone” making money, how about you investigate Kolodney and his friends, who had a huge opportunity to make money by touting the wonders of Suboxone while patients were forced off opiates. There wasn’t one pain doctor on the “guideline panel”, and frankly, the CDC deserves every bit of criticism they’ve received for the suffering and suicides they’ve caused!

    • Perfectly phrased! Encapulates my feelings on the article and the stupidity of the guidelines exactly.

  • I am an “legacy” patient I think you’d say after 25 yrs of medically needed opioid dependency. I would love to stand up for fellow chronic pain patients. Or testify. I after my primary retired and had an acute major fracture at that moment started to get tapered against my will. I kept asking , why are you torturing me?? What medical reason have you to do this?? To no avail. I will and am ready to do what I can. For my self and society. With no financial gain.
    Im not affiliated with any corporation..I hurt. I have no options. Medicate me for PAIN

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