NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
Walter F Wrenn, III, MD., Norman J Clement RPh., DDS.
Several years ago it was announced that the United States was having a drug crisis. There was an increase in so-called overdose deaths. A knee-jerk reaction took place with legislators enacting laws and government agencies issuing guidelines.
The blame game began with pharmaceutical companies and physicians accused of fueling this epidemic.
The DOJ/DEA began a successful campaign resulting in the arrest and conviction of health care providers using hastily enacted laws and misinterpretation of the 2016 CDC guidelines for treating patients with opiate pain medication. State AG’S obtained large cash settlements from pharmaceutical companies.
Yet in spite of all this, there was an increase in overdose deaths even as there was a decrease in opiate prescription medication. 93,000 people died from drug-related causes in 2020.
All these events occurred because there was not a full understanding of the pathophysiology of opiate addiction and No one from DOJ/DEA was interested in finding out the reason.
Risk of Death From Opioid Treatment
In a comprehensive study reported by Frontiers | Opioids and Chronic Pain: An Analytic Review of the Clinical Evidence | Pain Research :
“The rise in prescription opioid-associated mortality from ~6,500/year in 1999 to 17,500/year in 2011 (37) (Figure 1) generated widespread concern about the risks of opioid use and paved the way for the idea that opioid over-prescribing was responsible for the opioid crisis.
However, two things have been missing from this conversation: (1) the statistical contribution of increasing numbers of patients being prescribed opioids; and (2) the number of annual deaths related to prescribing by pill mills, in which opioid use is not adequately medically supervised.
It is an absolute risk, not proportional risk, that matters for an individual patient and practitioner when considering a treatment (38). The estimated annual opioid-associated case fatality rate with prescription of >100 MMED is 0.25% (39) and rises to 0.5% in those receiving >400 MMED (40).
The results of epidemiologic studies are congruent with these findings. In the North Carolina study of Dasgupta et al. (41), the estimated annual mortality associated with oxymorphone (the drug with the highest associated mortality) was 0.54%/year.
In this study, annual mortality rose more or less linearly with opioid dose (without an inflection point), reaching a maximum of 0.80% (95% CI 0.55–1.10) at 650 MMED.
This study could not distinguish between deaths associated with opioids prescribed chronically for treatment of chronic pain and deaths associated with “one-off” prescriptions obtained by opioid abusers on the other. Only 51% of decedents had an active opioid prescription on the day of death and 24% had no record of being dispensed an opioid in the prior year, a finding replicated in other studies (42, 43).”
DOJ/DEA CRIMINALIZATION OF MEDICAL TREATMENT HAS RESULTED IN DEATH
Medical decisions were made by individuals outside of the medical profession. Medical decisions were made before studies about the problem were ever done. To date, nothing has been done to correct the problem.
Health care providers who prescribed opiate pain medication or prescribed medication to treat opiate addiction are in jail.
Insurance companies and physicians have misinterpreted the 2016 CDC guidelines depriving patients of life-sustaining opiate pain medication resulting in an increase in overdose deaths and suicide. Physicians now refuse to prescribe opiate pain medication because of roadblocks like prior authorization requirements and physician arrest.
Treatment of opiate-dependent individuals with Suboxone has been slowed due to physician arrest and insurance company roadblocks. We need a pause on all legal proceedings against physicians who lost their medical and DEA licenses upon being charged with various crimes before they were convicted.
We need to recognize that addiction can’t be legislated. Criminalizing medical treatment interferes with the doctor-patient relationship and is harmful to our system of medical care. Drug overdose deaths and death from suicide add continue to rise.
YOU ARE WITHIN THE NORMS