Comment on DEA Proposal for Production Quotas on Schedule I and II Controlled Substances
Richard Lawhern
Subject Matter Expert in public policy for regulation of opioid pain relievers and physicians who prescribe them. 28 years experience and thousands of contacts in social media support groups for people in pain.
The US DEA has announced a request for comments on their proposed 2024 production quotas for Schedule I and Schedule II controlled substances, with a submission deadline December 4. The announcement may be found at
The following is a draft of comments that I intend to submit by November 24th.
Comment on “ Proposed Aggregate Production Quota 2024 (2023-24282) DEA1228
Richard A Lawhern, PhD.
November 2023
This comment responds to the request notice posted in the US Federal Register on November 3, 2023 by the US Drug Enforcement Administration.
ABSTRACT:
Proposed reductions of production quotas for medically prescribed opioid pain relievers are without basis in either science or ethics. It is glaringly evident from multiple sources that quotas need to be expanded, not reduced. Efforts by DEA to regulate the practice of pain medicine have deeply harmed millions of patients and their clinicians. Members of DEA senior management may have individual legal liability for false assumptions and assertions underlying proposed quotas.
Author’ Note Extensive references noted in these comments should be presented to reviewers as elements of the body of evidence that contradicts the logic and content of the proposed reductions in production quotas.
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Facts pertinent to production quotas for prescription opioid pain relievers include the following:
1. There is no statistically significant cause-and-effect relationship between rates of opioid prescribing and either rates of hospitalization for opioid toxicity or rates of mortality in which a prescription opioid is a contributing factor
References:
Aubrey L and Carr BT, “Overdose, opioid treatment admissions and prescription opioid pain reliever relationships: United States, 2010–2019” , Frontiers in Pain Medicine, Augusts 4, 2022, https://www.frontiersin.org/articles/10.3389/fpain.2022.884674/full
Jalal J, Buchanach JM, Roberts MS, Balmert :C, Zhang K, and Burke DS, “Changing dynamics of the drug overdose epidemic in the United States from 1979 through 2016” Science, Vol 361, Issue 6408, 21 September 2018, https://www.science.org/doi/10.1126/science.aau1184
Nadeau SE, Wu JK, and Lawhern RA, “Opioids and Chronic Pain: An Analytical Review of the Clinical Evidence” Frontiers in Pain Research, August 17, 2021, https://www.frontiersin.org/articles/10.3389/fpain.2021.721357/full
“Reduced” rates of prescription opioid consumption in the US are an artifact of unjustified and malicious DEA prosecutions against clinicians -- not a reduction in medical need. US DEA has mounted a campaign of intimidation and harassment against clinicians who prescribe opioid pain relievers. The result has been the departure of thousands of clinicians from pain management practice, and denial of pain care to millions of US citizens in dire need. Reduced rates of prescription thus reflect actions of the DEA itself.
References:
Maia Szalavitz, “Opioid Addiction Is a Huge Problem, but Pain Prescriptions Are Not the Cause -- Cracking down on highly effective pain medications will make patients suffer for no good reason” Scientific American, May 2016 https://blogs.scientificamerican.com/mind-guest-blog/opioid-addiction-is-a-huge-problem-but-pain-prescriptions-are-not-the-cause/
Maia Szalavitz, “Entire Body is Shaking”- Why Americans With Chronic Pain are Dying”, New York Times Opinion, January 3, 2023, https://www.nytimes.com/2023/01/03/opinion/chronic-pain-suicides.html
London C, “DoJ Overreach – The Criminalization of Physicians”, Journal of Legal Medicine, Vol 41, 2021, Issue 3-4 https://www.tandfonline.com/eprint/NF3SWG9YPXWCIP77HFSD/full?target=10.1080/01947648.2022.2147366
Jeffrey Singer and Colleen Cowles, “War on Us: How the War on Drugs and Myths about Addiction Have Created a War on All of Us”, Cato Institute Events (Interview), March 18, 2020, https://www.cato.org/events/war-us-how-war-drugs-myths-about-addiction-have-created-war-all-us
Jeffrey Miron, Greg Sollenberger, and Laura Nicolae, “Overdosing on Regulation – How The Government Caused the Opioid Epidemic”, Cato Institute, February 14, 2019, https://www.cato.org/policy-analysis/overdosing-regulation-how-government-caused-opioid-epidemic#
Singer J and Burrus t, “Cops Practicing Medicine – the Parallel Histories of Drug War I and Drug War II”, Cato Institute, November 29, 2022, https://www.cato.org/white-paper/cops-practicing-medicine#
3. Estimated volume of diverted prescription opioids should support expanded – not reduced - production quotas. Prescription Drug Monitoring Programs created in 2010-2012 have effectively shut down pill mills that were once responsible for almost the entire volume of diverted medical opioids. A hostile regulatory climate - largely created by DEA - has sensitized the few remaining pain management clinicians to any possibility that a patient might be shamming pain in order to obtain prescriptions for street resale. Further reduction of production quotas serves only to further harm patients.
4. Assumptions underlying DEA reduction of production quotas for Schedule I and Schedule II prescription opioids are grossly wrong on science. Over-prescribing of opioids by clinicians to their patients is not now and never has been a significant cause of the widely hyped US “opioid crisis”.
Two figures extracted from references above provide conclusive proof of this lack of relationship: .
From Figure 1, we learn that numbers of prescription opioid related deaths remained constant from 2010 to 2019 while both hospitalizations and deaths involving all types of opioids (legal and illegal) rose steadily throughout the decade. At the same time, total sales of opioids (characterized by Morphine Milligram Equivalent Dose per capita) dropped by 55%.
Figure 2 informs us that prescription opioid analgesics are only one of seven contributing factors in exponentially rising mortality associated with all drugs. Prescriptions have never been the dominant factor in opioid-related mortality, even during the pill mill era of 2000-2010. While diverted pharmaceutical-grade opioids may have contributed to increases of US addiction during the pill mill era, their marginal contribution to mortality is lost in the noise of illegal street drugs,
Any reasonable observer must conclude from available data that rising US rates of addiction and drug-related mortality are driven by neither pharmaceutical diversion nor even illegal supply. The US addiction debacle is instead a consequence of what has come to be called a “crisis of hopelessness”.
Addiction is driven by demand for distractions from anxiety and depression, which are in turn generated by conditions in which people live. Socio-economic determinants of health include 50 years of stagnation in real wages, automation or overseas outsourcing of formerly manual labor jobs, the hollowing-out of rural and inner city communities, and rising income and wealth inequality. Against these forces, reductions of indispensable opioid medications have no rational prospect of reducing addiction or mortality from illegal street drugs.
References:
Lawhern, R, “The Real Cause of America’s Opioid Crisis: Doctors Are Not to Blame, KevinMD, March 22, 2023, https://www.kevinmd.com/post-author/richard-a-lawhern
Volkow N and McClellan AT, “Opioid Abuse in Chronic Pain -- Misconceptions and Mitigation Strategies, ” New England Journal of Medicine, March 31, 2016 http://www.nejm.org/doi/full/10.1056/NEJMra1507771
Extract:
“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 among those with preexisting vulnerabilities (Table 3). 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.
Lawhern, R: “Doctors Diagnosing Addiction – Are the Blind Leading the Blind?” Archives of Medicine, European Society of Medical Doctors, publication pending,
Satel S, National Affairs, Nr 55, Spring 2023 “The Truth About Painkillers”, https://nationalaffairs.com/publications/detail/the-truth-about-painkillers .
Oliva EM, Bowe T, and Tavakoli, et al, “Development and Applications of the Veterans Health Administration’s Stratification Tool for Opioid Risk Mitigation (STORM) to Improve Opioid Safety and Prevent Overdose and Suicide”. Department of Veterans Affairs, “Psychological Services” 2017, Vol 14, No 1, pp 34-49. Available for purchase through American Psychological Association, APA Psych Net, https://psycnet.apa.org/doiLanding?doi=10.037%2Fser0000099
Anson, P, “Study Finds Low Risk of Overdose From Prescription Opioids”, Pain News Network, October 23, 2023 https://www.painnewsnetwork.org/stories/2023/10/23/study-finds-low-risk-of-overdose-from-prescription-opioids
Lawhern R, “Doctors Diagnosing Addiction – Are The Blind Leading the Blind?” pending publication in Archives of Medicine of the European Society of Medical Doctors, November 2023.
An Issue of DEA Legal Liability
Data portrayed in Figure 2 are important in the present context for a larger reason than the contradiction they offer to production quota proposals of the DEA. The fact is that DEA has known of this data for the past four years. Figure 2 was published in a DEA Diversion Control Division conference, in February 2020:
Reference Guzman, AR, “Drugs of Abuse and Trends”, Practitioner Diversion Awareness Conference, US DEA and Federation of State Medical Boards, February 22-23, 2020, https://www.deadiversion.usdoj.gov/mtgs/pract_awareness/conf_2020/feb_2020/guzman.pdf
Continued DEA refusal to embrace expansion of prescription opioid production may thus comprise deliberate misinformation, patient abuse and malfeasance that are actionable under law.
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About the Author:
Richard A Lawhern is a healthcare writer and subject matter expert on US public health policy concerning regulation of opioid analgesic pain relievers and clinicians who employ them in managing their patients’ pain. He has 26 years’ experience in this field, and has authored or coauthored over 200 papers, articles, and interviews in a mixture of peer reviewed medical journals and popular media.
Readers who may wish to endorse this comment when submitted, may do so by emailing the following information to lawhern@hotmail.com:
Your name
Your clinical degrees and qualifications if any
Your status as a chronic pain patient, if you are one.
Likewise feel free to submit your own comments via the Federal Register link at the top of this article.
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1yThey know all this. They don't care about any actual opioid issues. They care about demonstrating their control over our lives. They are sick sick sick excuses for humans beings.
Columnist at Pain News Network
1yI commented on the Federal Register as an individual.
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1yYou’re my Hero
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1yThanks from millions Mr. Red Lawhern, PhD. Important note you mentioned on personal legal liability exposore for incompetent performance on individual Bureaucrat involvement. Perhaps your letter may be addressed also to include the DOJ, FDA, CDC etc. Such may keep the buck from being passed to a dead end. I understand all are involved - the FDA hands the envelope to the DEA, who then announces the winners.
Business Owner at Peachy Clean, Pottstown PA Post construction/renovation cleanup & rental turnovers.
1yThank you again, Red. Another problem is the FDA who is ignoring reports of pain medicine shortages and stated that demand for next year would be down, which I find to be disturbing, to say the least.