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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  • Certaintistic expertcentrists, like Mr Goodwin, have failed to serve people in pain well. If they did-this and so many other conversations and reports on opioids and pain care- not to mention the 19,000+ clinical trials on opioids wouldnt be necessary. The truth is, experts and government failure is apparent- and have experts or government reformed the politics , morals, or virtue epistemology of pain care? Of course not. On the contrary they have become ever more certain and authoritarian and relegated people in pain to moral and civil vagabondage. It is clear that the experts and government do not believe people in pain have the ability to make their own decisions and so they wish to decide for us- despite their lack of vision, their poor visionless research and policies that fail to consider acceptability to the governed. We have met the enemy and it is regulatory and market failure. It is shameful that experts wish to blame people in pain for their neglect and carelessness.

  • The unintended consequences of the CDC guidelines IE Force tapering has left me bedridden and chair bound for well over a year-and-a-half I’m done with Society you can kiss my ass

  • The “Authors” of this distasteful argumentative article clearly have a “Vested Interest” relating to the fatally flawed non-science based, non-evidence based CDC Guidelines. If you want to talk about “Ties” to Big Pharma and Monetary financial gain…Then why dont you disclose in this article the Fact that one of the major anti-opioid group leaders of PROP who was also a Key Author of the CDC Guidelines owns major stock in a little medication known as “Suboxone” a drug which is used for Opioid Addiction and withdrawal. But of course that wasnt mentioned anywhere. Addiction Specialists and anti-opioid lobbyists of the PROP organization have No business whatsoever drafting let alone releasing any type of Nationwide Opioid Guidelines or Policy. What’s next parents who have lost a child to an alcohol related car crash drafting Nationwide policy for alcohol guidelines and setting daily maximum alcohol limits to whatever limit they choose? Might as well… it’s no different than PROP anti-opioid lobbyists writing nationwide Opioid Guidelines. Chronic pain patients have been left to suffer a horrific existence due to the authors of the CDC guidelines own personal opinions and beliefs coupled with monetary financial gain in Suboxone stocks. Every single person who took part in the writing of those Guidelines should be held fully and severely accountable for all the pain related Suicides, death, harm, and suffering of millions. One day Karma will be served.

  • It seems strange that the CDC. Which pushes people towards getting injections of drugs. For any and every reason. Now attacks people in severe pain.. Is it only because someone supper wealthy, or the child or grandchild of a high level government worker, died from taking pain medication which has set off this Witch hunt. I say this because so many elderly, veteran’s of war, people with cancer, or chronic pain sufferers seem to be the ones “chronically injured”, by this attack on pain medications. the CDC. Took the easy way out of this battle. Attacking and injuring all people. INSTEAD the CDC should have implemented teams of investigators. Using their own soldiers of selected officers. And started the investigative search to find the suppliers. While still in full action. And setting appropriate finds to cover the cost of investigations. If the CDC says it never meant to harm Chronic pain existing patient’s. Then make it Perfectly clear. Out loud telling Doctors they will not be punished in anyway for the continuing care of their paitents, That are in need. Having signed contracts and doing drug testing periodically… as it is now.. Doctor’s are making tons of money from insurance companies, medicaid & medicare. Charging for pain injections, or surgeries.. continually. ( even though the pain patient is hurting worse from the injections & surgeries that either do not work or make them worse. THE poor patient is to afraid to confront the pain center’s or doctor’s, in fear of losing what little pain meds they are given. They live in fear and silence. ” it is a prison for them, A PAINFUL PRISON, of TOUCHER. And yet they are afraid to speak up… Is this acceptable for you? iF Not, Then stop the drug suppliers in the streets. And limit pain meds after surgeries. But first. Stop the butchering & toucher of. Innocent patients on pain medications. That were made for them. Give them back their lives.

  • Why would CDC target chronic pain when data show meds left over from short-term prescriptions are the source of diverted opioids? It’s obvious that the guidelines are PROP’s revenge for FDA’s refusal to incorporate all of their changes to the 2012 revised opioid labeling.

    You ignore the fact that many patients with chronic pain who take high doses of opioids have genetic defects in the CYP450 system. This can be easily tested. The 90 mme “maximum dose” is irrational.

    Thou doth protesteth too much: “they are GUIDELINES, not law/regulations.” Yet that’s exactly how state legislatures, medical boards, insurance companies and the DEA regard them. They are applied indiscriminately and hurt people with incurable chronic illnesses, even the dying. This is outrageous.

    CDC violated all federal laws regarding advisory groups and their influence on national policy. NONE of their meetings were announced in the Federal Register. NONE of their meeting minutes were published. NONE of the core expert group (CEG) was a federal employee. The Guidelines were first opened to public review in a webinar, without a written version, and CDC accepted comments for 24 hours (later extended to 48 hours).

    The guidelines were based on the “best available evidence,” all of which is acknowledged to be of level IV quality, the lowest rating.

    Jane Ballantyne MD, a member of the group of “experts” who drafted the guidelines, is a paid consultant for Cohen Milstein, a law firm which is soliciting cities to hire them to sue manufacturers for allegedly fueling the opioid overdose crisis. CDC explicitly states that none of their “advisers” has financial conflicts of interest.

    The CDC is supposed to protect the health of ALL Americans. They failed.

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