Evidence Used to Justify CDC Opioid Guideline ‘No Longer Present’
/By Pat Anson, PNN Editor
Anti-opioid activists and public health officials have long argued that opioid “overprescribing” fueled the overdose crisis in the United States, causing drug deaths to surge to record levels.
“This rise is directly correlated with increased prescribing for chronic pain,” Dr. Jane Ballantyne, then-president of Physicians for Responsible Opioid Prescribing (PROP), wrote in a 2015 letter to the National Institutes of Health.
That claim was repeated the following year by the CDC when the agency released its controversial opioid guideline. “Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” then-CDC director Dr. Thomas Frieden said in a news release.
But a new analysis debunks the overprescribing myth, finding the “direct correlations” cited by Frieden, Ballantyne and others are no longer valid, if they ever were.
In a study recently published in Frontiers of Pain Research, independent researchers Larry Aubry and B. Thomas Carr examined opioid prescribing trends and overdose deaths from 2010 to 2019, using the same data sources that the CDC guideline is based on.
“The direct correlations used to justify the CDC guideline… are no longer present,” they reported.
Aubry and Carr found that opioid prescribing, when measured in morphine milligram equivalents (MME), was in steep decline years before the guideline was even released. That trend accelerated even further when regulators, insurers and healthcare providers started following the CDC’s recommendations.
If the overprescribing theory were true, you would expect drug deaths to go down as opioid sales did. But in subsequent years, overdoses linked to prescription opioids stayed flat and drug deaths surged even higher. In research terms, that is known as a “negative correlation” -- a trend not supported by facts.
Looking at data from all 50 states, Aubry and Carr found “significant negative correlation” in 38 states between overdoses and prescription opioids, and a positive correlation in only 2 states. In 10 states, there appeared to be no relationship at all. That calls into question ones of the primary recommendations of the CDC guideline; that daily opioid doses not exceed 90 MME.
“This recommendation is not supported by the available data. Regression analyses of (total opioid deaths, opioid overdose deaths, opioid treatment admissions, and prescription opioid sales) among patients receiving doses of at least 90 MME/day show significant negative relationships, indicating that lower (prescription opioid sales) in this high-dosage cohort do not correspond to lower death rates,” Aubry and Carr reported.
The CDC estimates that over 107,000 people died of overdoses in 2021, well above the 63,600 drug deaths reported in 2016, the year the guideline was released.
Negative Correlation Between Overdoses and Opioid Prescribing
sOURCE: FRONTIERS OF PAIN RESEARCH
Patient Outcomes Not Being Monitored
Even more concerning is that the CDC does not appear to be tracking the impact of its 2016 guideline on pain patients, even as it prepares a long-delayed update to the guideline. As PNN has reported, the CDC ignored warnings from its own consultants that the agency “should consider conducting more research” on patients, many of whom were abruptly tapered or abandoned by their doctors after the guideline’s release.
“Reasonable judgment would dictate tracking and reporting of chronic pain patient outcomes (deaths, suicides, returns in benefits, reported pain, function, etc.) for individuals since the guideline or the guideline update. However, there appears to be no publicly available evidence that a monitoring process is required or is planned to measure and confirm outcomes,” Aubry and Carr wrote.
PROP is not following the data either. In a recent debate, PROP board member Adriane Fugh-Berman claimed that pain patients addicted to prescription opioids were still fueling the overdose epidemic, even though illicit fentanyl and other street drugs are linked to the vast majority of deaths.
“Those patients went to the street. They got addicted to heroin. The reason those deaths went up is because the illicit supply of opioids has become laced with fentanyl and has become highly dangerous,” Fugh-Berman said, without citing any evidence. “It’s not that prescription opioids have nothing to do with it. Many patients started on prescription opioids ended up on the streets looking for heroin. They’re dying because the illicit opioid products have become extremely dangerous. That’s what’s killing people.”
Fugh-Berman is not an unbiased observer. She and at least five other PROP board members have testified as paid expert witnesses in opioid litigation cases, making as much as $850 an hour for their testimony blaming drug makers for the opioid crisis.
A recent analysis of overdose deaths in 2020 found that prescription opioids ranked well behind illicit fentanyl, alcohol, cocaine, methamphetamine and heroin as the leading cause of drug deaths.
At least one critic of opioid prescribing feels it’s time to change the focus on why so many Americans are overdosing. Beth Macy, who wrote the best-selling book “Dopesick,” says drug use has changed.
“At this point, too much attention is focused on stemming the oversupply of prescription opioids. We now have a generation of drug users that started with heroin and fentanyl.”
“At this point, too much attention is focused on stemming the oversupply of prescription opioids,” Macy writes in her new book, ‘Raising Lazarus.’ “We now have a generation of drug users that started with heroin and fentanyl.”
As for the CDC, a spokesperson tells PNN the agency won’t publish its guideline revision until late this year, nearly seven years after the original guideline was released.
“CDC is currently in the process of revising the draft update to the 2016 Guideline based on comments received during the public comment period and peer review. We anticipate the final Guideline will be released later this year,” the spokesperson said.
