April 09, 2019
By Richard “Red” Lawhern, Guest Columnist
Dear Dr. Robert Redfield and Dr. Debra Houry,
By its passive refusal to conduct a thorough review of the impact and outcomes of its 2016 opioid prescribing guideline, the CDC’s National Center for Injury Prevention and Control is actively causing harm to hundreds of thousands of pain patients.
Deserted by their doctors in a hostile regulatory environment, many are going into the streets seeking pain relief. Possibly hundreds may already be dead of illegal fentanyl poisoning or suicide. Military veterans, in particular, face draconian restrictions on the availability of safe and effective opioid medication therapy.
And all for no good reason!
I suggest with every intention of professional and personal courtesy, that government organizations can no longer stand aside from this centrally important issue. Such a stance will make you and other federal agencies accessories to state-sanctioned torture and negligent homicide. That is unacceptable.
As a former military officer, I respect a well-tried motto that I urge each of our regulators to take on as their own:
Lead, follow, or get out of the way!
It has become clear that the CDC guideline must be immediately withdrawn for a major rewrite. In its present form, the guideline is unjustifiably biased against opioid pain relievers, factually incomplete, in error on basic science, and founded on untested assumptions that do not hold up under any degree of careful scrutiny.
The guideline is directly responsible for a vast regulatory over-reach by DEA and state authorities that is driving doctors out of pain management and denying safe and effective pain treatment for hundreds of thousands of patients.
The CDC guideline has been publicly repudiated by no less an authority than the American Medical Association. Over 300 medical professionals have called for a rewrite of the guideline from the ground up. And a recent draft report by a federal task force calls for a reorientation of the guideline towards individualized patient-centered care, not the one-size-fits-all approach of the CDC.
Multiple published papers have conclusively invalidated the guideline’s contention that there is a maximum dose threshold of risk for opioid addiction and overdose.
https://www.painnewsnetwork.org/stories ... prevention
Likewise, contrary to assertions in the guideline, there are presently no validated long-term studies to support the use of non-opioid analgesics and NSAIDs, or the off-label prescribing of anti-seizure and anti-depressant drugs to treat pain. No Phase II or Phase III trials have been published on "alternative" techniques such as acupuncture, massage or meditation. And there are no trials which directly compare these techniques to opioid therapy under documented protocols. Alternative treatments can at best be regarded as adjuncts to be added to analgesic or anti-inflammatory treatment.
Published papers also demonstrate that criteria used by CDC and other federal agencies to identify risk of opioid abuse or overdose have very limited predictive accuracy. These faulty criteria are now being used by Prescription Drug Monitoring Programs (PDMP’s) to "flag" patients presumed to be at risk, who are in fact not at risk but are being denied pain treatment due to false alarms.
Opioids, Overdoses and Demographics
We can now take this narrative a step further. I have compiled overdose data directly from the CDC Wonder database and from the Agency for Healthcare Research and Quality Data. This data focuses specifically on deaths directly attributable to opioid-related overdoses or suicide. The chart below shows rates of mortality by age group from 1999 to 2017.
Note that the highest rates of opioid-related mortality are among youth and young adults, while the lowest rates are among people over age 55. Moreover, mortality in youth has skyrocketed by 1,800% over 17 years, while remaining relatively stable in people 55 and older.
The chart below documents the contrast in opioid prescribing by age group in 2016. Unsurprisingly, older adults and seniors are much more likely to experience chronic pain and are prescribed opioids at a rate nearly double that of young adults. These two demographic trends contradict the idea that opioid overdoses are linked to prescribing. They’re not and the evidence proves it.
An updated analysis report further summarizes major themes we found in the overdose data. The report reveals that “over-prescribing” of medical opioids was never a significant driver in opioid overdoses. There is no cause-and-effect relationship between rates of opioid prescribing versus rates of opioid overdose. In fact, it can be argued that in states where prescribing rates are highest, the trend may be in the opposite direction.
The downward sloping red line in the chart below is called a "regression" line. This is the trend line for the overdose and prescribing data from all 50 states in 2016. If there were a connection between high rates of opioid prescribing and overdoses, we’d expect the regression line to be pointing upward, not downward.
Overdose mortality rates are actually lower in high-prescribing states!
One plausible explanation for the downward sloping line is that in states where prescribing has been more suppressed, patients are being driven into unsafe street markets or are committing suicide when overwhelmed by pain.
These findings have previously been published in the blog of Dr. Lynn Webster, former President of the American Academy of Pain Medicine and author of "The Painful Truth."
The implications of this analysis are glaring: the National Center for Injury Prevention and Control has created a fatally flawed guideline which actively increases injury rather than reducing it.
Taken in sum, the evidence reveals that key assumptions on which the CDC guideline is based are simply and conclusively wrong. Continued refusal to reevaluate the guideline is morally, ethically, medically and legally wrong. The 2016 CDC guideline on opioids must be retracted. NOW!
(Editor’s note: Dr. Redfield is CDC Director and Dr. Houry is Director of the CDC National Center for Injury Prevention and Control. A longer version of this open letter has been sent by email to other federal agencies and officials.)
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