Over the years, I have had the privilege of forging a wonderful professional relationship with Ed Thompson, President of Pharmaceutical Manufacturing Research Services, Inc. Ed has been featured on CBS-TV 60 Minutes for his expertise on the opioid epidemic. Opioid epidemic: Did the FDA ignite the crisis? — “60 Minutes” – CBS News. I have attended Federal Drug Administration (FDA) meetings with him — one in particular was the approval of Purdue Pharma’s highly addictive and criminally marketed, OxyContin for children. We sat in an almost empty auditorium without elected senators, congressmen, attorneys general or advocates in attendance — no outrage.
The attached letter dated November 14 was forwarded to the DEA by Ed Thompson as Docket No. DEA-1051P/DEA-2022-0120-0001 requesting a public hearing prior to the publication of the 2023 Quota final order on the oxycodone HCl Quota.
Some of the eye-opening highlights of Ed Thompson’s letter to the DEA are:
National Institute of Health (NIH) reports 10.3 million people use prescription opioids nonmedically.
Drug Enforcement Agency (DEA) calculates only 0.3% diversion.
23 states refuse to supply Prescription Drug Monitoring Program (PDMP) data.
Yet, states file countless numbers of lawsuits against industry for oversupplying opioids.
No state governor, attorney general, or director of health has requested a reduction in opioid supply.
2021 recorded the highest annual number of opioid overdoses and deaths.
In their Federal Register notice, DEA defines diversion as “all distribution dispensing, or other use of controlled substances for other than legitimate medical purposes.” Nonmedical use of prescription opioids is not a legitimate medical purpose, but was rejected by the DEA in calculating diversion.
DEA willfully makes no reference to the millions of people reported to National Institute of Health (NIH) as engaging in nonmedical use of prescription opioids. DEA’s estimated diversion accounts for 0.30% of oxycodone HCl Quota.
DEA additionally eliminated 62% of the US population in calculating diversion and is knowingly oversupplying opioids, including oxycodone HCl, in the 2023 Quota. 23 states refused to respond for the 2023 Quota even after being individually contacted by DEA: California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Maine, Massachusetts, Minnesota, Missouri, Nebraska, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Vermont, Washington, West Virginia, Wisconsin and Wyoming. These states should be excluded from federal opioid recovery funding until they become compliant.
Despite the increased prevalence of illicit heroin and fentanyl over the past decade, prescription opioids remain a critical element of the larger opioid epidemic.
There is still insufficient scientific or substantial evidence for using opioids in the treatment of chronic pain. The CDC confirmed this fact in the CDC’s 2016 opioid prescribing guidelines.
Beginning in the 1990’s, efforts to improve treatment of pain failed to adequately take into account opioids’ addictiveness, low therapeutic ratio, and lack of documented effectiveness in the treatment of chronic pain.
It has become increasingly clear that opioids carry substantial risks and uncertain benefits, especially as compared with other treatments for chronic pain.
DEA and the states are complicit in perpetuating the epidemic by allowing the overproduction, oversupply, and overprescription of opioids. The proposed 2023 oxycodone HCl quota — virtually unchanged from 2022 — cannot be justified to the public and must be significantly reduced. Returning the oxycodone HCl Quota to pre-epidemic levels would significantly reduce harm and loss of life.
To downplay the DEA’s complicity in fueling the opioid/fentanyl epidemic destroying families throughout the U.S., there is a “photo wall” in the DEA Headquarters in Arlington, VA showcasing the victims of the epidemic. Outrage? None as the DEA focuses on “grief and bereavement” and not being held accountable for “the fox being in the henhouse.
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