(The Drug Enforcement Administration is taking comments on its Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances. One of our contributors, Jeff Edney filed his comments on Saturday September 21st here.)

A DEA document states: “As a result of considering the extent of diversion, DEA notes that the quantity of FDA-approved drug products that correlate to diverted controlled substances in 2018 represents LESS THAN ONE PERCENT of the total quantity of controlled substances distributed to retail purchasers.”

The US population grew by 0.6% in the last year, so assuming your specified maximum 1% diversion – 0.6% growth = 0.4% max you should be reducing less than 0.5% or none at all, not 10%. Further, there are national shortages of analgesics and this will only make matters worse, discouraging people to undergo elective surgeries and wind up on social security disability instead. People are committing suicide every day.

What we need is an increase in analgesics to reduce suicides including many veterans who just cannot take the pain anymore, and stop driving law-abiding citizens to resort to illicit street drugs, further exacerbating the fatalities from overdoses. Prescriptions have declined 35% nationally since 2012. What is the correlated reduction in overdoses? Have they decline 35% with prescriptions? We don’t see that in the public domain data. Overdoses are up nationally. Isn’t that a hint that mandated quota reductions are fundamentally misguided? Production quotas force honest law-abiding citizens to seek pain relief from Mexican cartels than from qualified MDs or DOs who actually know how to prescribe FDA approved analgesics.

Please target the real problem – illicit fentanyl (carfentanyl and others), heroin, meth, and cocaine, and do not reduce the pain medications that our wounded veterans, hospice patients, cancer patients, people with severe health conditions, and surgical patients.

The reduction in opioid production also violates the CDC guidelines that started this process as noted in the Alford letter of 10 April 2019: “The guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm. The Guideline includes recommendations for clinicians to work with patients only when patient harm outweighs patient benefit from opioid therapy. The guideline on high dose prescribing focuses on initiation.”

No correlation exists between opioid prescribing and fatalities. Cutting back on prescriptions is counter-productive and sheriffs from multiple states report it is driving seniors and those with chronic health conditions to resort to street drugs, further compounding the problem, so the knee jerk reaction is to tighten limits even more, and further perpetuate the overdose problem. If the rationale is that kids get addicted from prescriptions after wisdom tooth surgery, then address that problem, but don’t take opioids away from hospice patients, cancer victims, and the disabled who suffer genetic disease such as autoimmune disorders.

Per this article, if accurate, we had 47,600 Opioid deaths in 2017 of which 28,400 were due to Fentanyl (mostly illicit by the description in this article and 15,482 deaths from heroin, so 47600-28400-15482 = 3,718 deaths from prescription opioids. Compare 3.718 deaths from prescription = 7.8% of all of the total opioid deaths, while mostly illicit fentanyl plus heroin account for 92.2%. In fact, I posit that if the 3,718 deaths from prescriptions which includes both intentional overdoses (suicide) and stolen drugs are magically reduced to 0, the net total deaths will be much higher than 47,600 due to forcing law-abiding patients with severe health conditions to resort to the much more dangerous street drugs. Assume this ration of 92.2/7.8 = 11.82 relative hazard ratio x 3718 = 43,949 + 28,400 + 15.482 = 87,831 deaths. So instead of a best-case scenario reduction of 7.8%, we wind up with a net increase of +85% increase in fatalities.

Production quotas limits will ultimately increase overdose fatalities, which is exactly what we are seeing both at national and state levels. While prescriptions have fallen 35% nationwide, overdose deaths have soared higher. This article below seems to suggest why this is true. Hopefully, the magnitude of the increase in overdose fatalities would be less than the hazard ratio indicates, but there is little doubt the sign would be different (a net increase no matter how large is a bad outcome borne of unintended consequences). For example, not everyone would resort to street drugs (ideally none but that isn’t realistic).

Please have a heart for the most unfortunate members of our society and revisit this recommendation. Hospice patients, cancer patients, post-op surgical patients, wounded veterans, nursing home residents, and disabled people protected by ADA and those with serious health conditions need these medicines you want to take 10% away from.

Jeff Edney is a member of the Alliance for the Treatment of Intractable Pain. Jeff is a former Director of Engineering (disabled), chronic pain victim & advocate and is married with pre-med son.

(If you want to comment to the DEA, you can go here.https://www.regulations.gov/comment?D=DEA-2019-0008-0001&p=1)

Let us know if you plan to comment and what you think of Jeff’s approach.

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