Comment posted to "Today’s Opium Wars And Their Consequences: Was The Government Out To Lunch?"

Comment posted to "Today’s Opium Wars And Their Consequences: Was The Government Out To Lunch?"

https://www.acsh.org/news/2023/01/19/today%E2%80%99s-opium-wars-and-their-consequences-was-government-out-lunch-16810

I speak and write as a 25-year unpaid volunteer patient advocate and subject matter expert on public policy for regulation of opioid analgesics and clinicians who employ them. I have no financial conflicts of interest or Industry affiliations. From that background I find much in Barbara Billauer's article to agree with. This is a public conversation that America needs to have. However, there are also nuances that we need to add to her thesis.

First: about medical patients becoming addicted.

As Dr Nora Volkow (Director of the National Institute on Drug Abuse) and a co-author informed us in 2016, "Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids -- even those with preexisting vulnerabilities. Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV). However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes."

See https://www.nejm.org/doi/full/10.1056/NEJMra1507771 for the full article.

I agree that a few hundred doctors and pharmacies operated pill mills during 2000-2010. Those pill mills pumped millions of prescriptions through street resellers to non-medical users. However, only 8.2% of recreational drug users ever used OxyContin during their lifetime, and recent research shows OxyContin was only 3% of Rx opioid pills sold between 2006 and 2012. Thus a nuanced question that we need to ask is "did pill mills make a measurable difference in rates of addiction or accidental death involving drugs?"

My provisional answer is "probably not."

Answering this nuanced question is hard. There is no common evidentiary standard for reporting drug-related deaths in the National Vital Statistics System, across all US counties. Qualifications of county medical examiners and coroners vary greatly (some are not even doctors). Many counties are funded inadequately to perform postmortem toxicity screens for the chemical analogs of fentanyl. Interpreting tox screens is itself a complex art. The eight categories in cause of death statistics are not mutually exclusive. The great majority of drug-related deaths involve multiple toxic substances and alcohol. The number of deceased persons who can be traced to a State Prescription Drug Monitoring Program is a small fraction of all drug-related deaths, and the fraction of prescriptions that are current is even smaller.

None of these patterns are typical of chronic pain patients who are receiving adequate treatment. While pain is clearly a factor influencing illegal or non-medical use of drugs, the opposite is simply not true.

Within major uncertainties in mortality attribution, what seems clear is that prescribing by doctors has not been shown to be a significant factor in our so-called opioid crisis.

See https://www.acsh.org/news/2023/01/09/doctors-prescribing-their-patients-did-not-create-us-opioid-crisis-16787

At the height of the pill mill era, (roughly 2008), accidental deaths attributed specifically to prescription opioids were overshadowed by unspecified narcotics and unspecified drugs generally -- by a ratio of nine to one. It is, of course, possible that many narcotics-related deaths were unreported. But we simply cannot know the details of this issue from currently available reporting procedures.

In 2010 to 2019, after six key states mandated reporting of opioid prescriptions to Prescription Drug Monitoring Programs, and DEA belatedly began prosecuting pill mills, opioid prescribing fell precipitously while drug-related deaths continued to explode on an exponential curve. A fascinating subtext for this observation is that US DEA and US CDC both knew of the sudden disappearance of any apparent correlation between prescribing and mortality in 2010 -- and ignored it as they plunged onward in their respective anti-opioid witch hunts.

The exponential mortality curve and demographic factors surrounding it were presented in a DEA Drug Diversion conference in 2019. See graphic in my comment below.

There is much to say about the intrusion of law enforcement (particularly US DEA) into pain medicine. Among many other sources, Cathleen London, MD, CIPP/US offers a wide-ranging overview in her prize winning paper in the Journal of Legal Medicine:

https://www.tandfonline.com/eprint/NF3SWG9YPXWCIP77HFSD/full

"DoJ Overreach: The Criminalization of Physicians"

As London observes, the FDA some few years back published a proposed standard for establishing that a clinician's prescribing is "outside the usual course of professional practice" ... and then retracted that standard without explanation despite Congressional inquiries and criticism. We can speculate that publication of a standard would have protected clinicians from DEA persecution -- something that the Agency had no intention of doing.

In my view, DEA is now operating as a Racketeer Influenced and Corrupt Organization under the meaning of Federal RICO laws. The practice of asset confiscations levied against clinicians is arguably an unconstitutional violation of legal due process, intended to deny doctors the resources they need for effective court defense. Likewise, there are indications that the Agency is actively trying to ignore the consequences of the June 2022 Ruan Vs United States Supreme Court decision, sharply limiting the grounds under which a clinician may be convicted for prescribing outside the bounds of accepted medical practice.

In short, I concur with many of the author's conclusions. At least two Agencies of the US government are now engaged in a substantive campaign of misinformation and public health policy misdirection, and destroying millions of lives in the process. 100 million US pain patients deserve better. It is time for the madness to stop.

Richard A. Lawhern, PhD

Patient Advocate