FDA’s Draconian Opioid Plan Rebukes CDC

The Food and Drug Administration (FDA) isn’t saying so, but its plan to create federal guidelines for prescribing opioid is an implicit rebuke to the Centers for Disease Control and Prevention (CDC).

FDA Commissioner Scott Gottlieb, M.D., announced August 22 that FDA has contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop “evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain resulting from specific conditions or procedures … Ultimately, our public health goal is to support more rational prescribing practices.”

CDC officials “have taken an initial step in developing federal guidelines on pain management and the use of opioids,” the FDA announcement said. “Our work seeks to build on that work by generating evidence-based guidelines where needed … indication-specific and … based on prospectively gathered evidence,” the announcement said.

The FDA added that its plan and the CDC guideline “are highly complementary and serve adjacent goals.”

That last is difficult to imagine.

The CDC guideline, issued in 2016 and revised in 2017, has drawn wide criticism as it has evolved into a de facto standard. Data, and anecdotal evidence from a wide variety of sources, suggest that while some physicians may still prescribe too much, under-prescribing may have already become a larger issue:

“Prescription opioid volumes peaked in 2011 at the equivalent of 240 billion milligrams of morphine and have declined by 29% to 171 billion,” said an IQVIA Institute report, “Medicine Use and Spending in the U.S. – A Review of 2017 and Outlook to 2022“, in April 2018. “The decline in the number of retail opioid prescriptions accelerated to 10.2% during 2017, while high doses declined by 16.1%. The highest doses of prescription opioids declined by over 33% during the past two years.”

“New FDA Initiative Implies CDC Opioid Guidelines Are Not Evidence-Based,” said a headline at the libertarian-leaning Cato Institute the day after the August 22 FDA announcement. “Unfortunately,” the article said, “these (CDC) guidelines have been used as the basis for many new prescribing regulations instituted at the state-level and proposed on the federal level.” Medical organizations have spoken out against “federal prescription limits that are based upon an inaccurate interpretation of the flawed CDC guidelines,” the Cato report said.

The liberal Huffington Post has also been on CDC’s case over the guidelines. A July 11 headline and sub-head: “The Government’s Solution To The Opioid Crisis Feels Like A War To Pain Patients – As the feds crack down on opioid prescriptions, patients are taking their own lives, doctors are losing their jobs and overdose rates continue unabated.”

Another HuffPost article July 5, 2018, titled, “There’s Another Opioid Crisis We Don’t Talk About And I’m Trapped In The Middle Of It,” was written by a patient, who said, “I have been fighting chronic back pain for the past 18 years and have been using opioids for the past eight. I am not addicted to the medication and do not take any more than my doctor prescribes.”

A recent scholarly article took issue with the entire focus on prescriptions in the fight against opioid abuse:

“Will strict limits on opioid prescription duration prevent addiction? Advocating for evidence-based policymaking” was the headline over a July 11, 2018 paper in Substance Abuse Journal, Volume 38, 2017 – Issue 3:

“The intense focus on prescribing as the nidus for policy interventions reflects a hope that today’s opioid addiction crisis will be reversed by restricting the prescription opioid supply. Such efforts are likely to obtain less traction now that other opioids such as heroin and illicitly manufactured fentanyl have come to dominate the crisis … As legislators and regulators pursue 2 new numeric targets—prescribed days of pills and morphine milligram equivalents—they do so without prospective data to show what results these initiatives will yield.

“With increasing anecdotal reports of harm to patients summarily cut off from opioids, there is some reason for concern. There are no trials showing that addiction itself is averted based on 2 versus 8 days of opioids for a patient seen in an emergency room. Similarly, no prospective data show that involuntary opioid taper or discontinuation in stable pain patients is to their benefit, even as we have witnessed a tide of reports of suicide and paradoxical overdose. Finally, even as deaths from illicit fentanyl and heroin skyrocket, increasing by 72% and 21% over the period 2014–2015, society has fixated on easier, though questionable, pill targets.”