By Pat Anson, PNN Editor
The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.
A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients.
Although the guideline strongly recommends that daily doses of opioids not exceed 90 MME (morphine milligram equivalent), the guideline’s three co-authors say their advice was misinterpreted and that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages.”
A CDC media statement this week also claimed “the guideline does not support abrupt tapering or sudden discontinuation of opioids.”
That was surprising news to Rob Hale, a Missouri man with late-stage Ankylosing Spondylitis, a degenerative and incurable form of arthritis. Like many other pain patients, Hale’s relatively high dose of opioid medication was significantly reduced soon after the guideline’s release. As a result, he is now bedridden.
“This is amazing news, if they really intend to follow through with it,” said Hale in an email. “God, I hope this is the beginning of a turnaround in prescribing policies. I just feel for the hundreds of us who gave up and took their lives or died as a result of the last 3 years of cruelty.”
Why the CDC is acting now is unclear. Reports of patient harm began circulating soon after the guideline’s release in March 2016, and have only accelerated as insurers, pharmacies, states and practitioners adopted the guideline as mandatory policy. In a recent PNN survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide.
“I regard this CDC statement to be an effort to save face and maintain political dominance on an issue into which CDC improperly inserted itself under the influence of Andrew Kolodny and PROP,” said patient advocate Richard “Red” Lawhern, referring to the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing.
“The statement fails to engage with the underlying issues which render the Guidelines fatally flawed. It fails to acknowledge the essential repudiation of the entire guideline concept by the American Medical Association, plus multiple prominent medical professionals.”
“The CDC guidelines have been as harmful as predicted, and the silence over 3 years has been criminal. The ‘Who me?’ response is just as evil as the ignorant abuse of power that led to the crisis in the first place,” said Mark Ibsen, MD, a Montana physician whose license was suspended by the state medical board for “overprescribing” opioids. A judge overturned the board’s ruling.
“Those who give a weak ‘mea culpa’ for misinterpretation of the guidelines are, in short, lying. The deaths of thousands of abandoned pain patients, including 6 of mine who lost access (to opioids), are on their hands,” Ibsen said.
PNN asked a CDC spokesperson if the agency had received new information about patients being harmed by the guideline and received a vague response.
“We have heard concerns from partners and stakeholders about policies and practices that are inconsistent with the 2016 Guideline and sometimes go beyond its recommendations. The misapplication of the Guideline can risk patient health and safety,” Courtney Lenard said in an email. “CDC authored this commentary to outline examples of misapplication of the Guideline, and highlight advice from the Guideline that is sometimes overlooked but is critical to safe and effective implementation of the recommendations.”
The response was also vague when we asked if CDC would be directly contacting insurers, pharmacies and states to warn them about misapplying the guideline.
“CDC has engaged payers, quality improvement organizations, state health departments, and federal partners to encourage implementation of recommendations consistent with the intent of the Guideline,” said Lenard, citing a mobile app and a pocket guide to opioid tapering as examples of CDC outreach.
The agency also sent out a Tweet.
Lenard gave no indication that a revision of the guideline was imminent. She said the CDC was working with the Association of Healthcare Research and Quality (AHRQ) to evaluate “new scientific evidence” about the benefits and harms of opioids.
“Results of these reviews will help CDC decide whether evidence gaps have been addressed and whether the Guideline should be updated or expanded for chronic or acute pain prescribing,” Lenard wrote.
Undoing the Damage
The American Medical Association – which took a stand against the “inappropriate use” of the guideline last year -- released a statement saying the CDC needed to work more closely with insurers.
“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs (pharmacy benefit managers),” said AMA President-elect Patrice Harris, MD.
“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”
Dr. Ibsen said the Drug Enforcement Administration was “the other elephant in the room” because it has weaponized the CDC guideline to demonize and prosecute doctors for prescribing high opioid doses.
“Arresting and punishing doctors who treat the sickest pain patients. Civil asset forfeiture as used in dealing with criminal drug dealers. Equate physicians with a license to practice as equal to or below said criminal drug dealers,” said Ibsen, listing some of the tactics used by prosecutors.
“Charge physicians with one felony for every Rx they write, making absurdly dramatic charging documents and headlines against doctors who are left with no income or assets to defend themselves in a contaminated jury pool. Charge doctors with murder for prescribing medications to patients who fail to follow the directions.”
It’s not just the DEA. The National Association of Attorneys General recently declared that the dose and duration of opioid prescriptions should not be decided by doctors and that the CDC guideline should essentially be treated as law.
“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment,” warns a letter signed by 39 state and territory attorney generals. “As Attorneys General of states with high rates of prescription drug abuse among our youth, policy makers and prescribers must be encouraged to continue to pursue laws and practices that reduce the high volume of opioids in our communities.”
“The standard of care is now determined by prosecutors and juries,” says Ibsen.