WARNING!!! WARNING!!! WARNING!!! TO ALL PROVIDERS AND PATIENTS: MEET REBECCA DELFINO, AMERICA’S MOST DANGEROUS LAW PROFESSOR AND PAIN HEALTHCARE POLICY MAKER; Part-1

RE-published and reported by youarewithinthenorms.com

NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS MD, PH.D., IN THE SPIRIT OF 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 KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., 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 NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

PAPPA’S GOT A BRAND-NEW EMPTY BAG

FROM YALE LAW AND POLICY REVIEW

SPRING 2023

INTER ALIA

The Misinformed & Misguided Prescription Abuse Prevention Act: A Response to Delfino

Tuesday, February 7, 2023 – 10:45a

*Robert Capodilupo & Jacob James Rich*

*

The opioid crisis continues to ravage communities across the United States, which has motivated policymakers to seek interventions that reduce reckless medical practices that put patients in danger of addiction. In her Yale Law & Policy Review Article, The Prescription Abuse Prevention Act: A New Federal Statute to Criminalize Overprescribing Opioids, Rebecca A. Delfino proposes novel legislation to reform how the federal government prosecutes doctors who overprescribe controlled substances. However, many of the statistics Delfino cites to justify her legislation, such as “[s]eventy percent of [opioid overdose] deaths involve an opioid that a doctor legally prescribed,” are not supported by the literature. This comment corrects the errors presented in Delfino’s Article and presents novel data describing the origins of the opioid crisis. According to the National Household Survey on Drug Abuse (NHSDA), Purdue Pharma’s OxyContin was rarely used for nonmedical purposes in the late 1990s and early 2000s. Overall, given that opioid prescribing has decreased every year over the past decade, further reductions in prescribing that follow Delfino’s proposed Prescription Abuse Prevention Act may further exacerbate opioid overdoses by orienting both pain patients and recreational users to illicit alternatives, like heroin and fentanyl.

Introduction

” The opioid crisis continues to ravage communities across the United States. In 2020, a record 91,799 people died of a drug overdose,^[1] with 68,630 of these deaths attributed to opioids.^[2] Even as policymakers appropriate unprecedented resources to reduce drug-related mortality,^[3] the overdose crisis persists with no end in sight.

In her Yale Law & Policy Review Article, The Prescription Abuse Prevention Act: A New Federal Statute to Criminalize Overprescribing Opioids, Rebecca A. Delfino proposes novel legislation to reform how the federal government prosecutes doctors who overprescribe controlled substances.^[4] 

According to Delfino, her Prescription Abuse Prevention Act (PAPA) would improve on current law by “offering a more specific and contextual legal framework focused on the expertise of the medical prescriber … [to] provide much-needed clarity in the law, thereby allowing legitimate prescribers to continue to treat patients in pain.”^[5]

While PAPA has the noble intention of punishing doctors who knowingly overprescribe drugs that cause the death of a patient, its unpredictable implied-malice standard^[6] will only further breed uncertainty for physicians.^[7] 

In turn, as physicians indiscriminately reduce prescribing to avoid potential liability under PAPA, legitimate patients who can no longer access opioids legally may turn to the black market to meet their medical needs, increasing their risks of overdosing on more dangerous opioids like heroin and illicit fentanyl.^[8] Because PAPA fails to clarify the criminal-liability standard for physicians, it will not ameliorate the opioid crisis and may very well exacerbate it by orienting both medical and recreational users to the illicit market.

FAMILY PUB NIGHT RECCA DELFINO, ESQ

In the case of Rebecca Delfino, Esq, from her video presentation in “Faculty Publication Night,” I’m reminded of a statement written by Paul de Kruif, 1926 in the treatment of Yellow Fever and slightly modified that describes her dilemma:

“…The stark difference between well-intentioned ignorance and understanding. Ignorance can be a killer in the hands of people with the best intentions, while knowledge can enable people to prevent or treat disease. It is often better to say nothing until that knowledge is obtained…”

…norman j. clement rph., dds

I.              Correcting the Record on the Opioid Crisis

Before turning to how PAPA could yield harmful unintended consequences, we would first like to address the errors in Delfino’s Article that mischaracterize the nature and causes of the opioid crisis. Because the Article’s policy prescription relies on the premise that the “all-too-common conduct [of] overprescribing opioids”^[9] is a leading cause of overdose mortality,^[10] it is necessary to evaluate the validity of this claim.

This premise is more tenuous than Delfino suggests. Beyond hairsplitting over the Article’s at-times inaccurate history of American drug policy,^[11] we are concerned with its problematic mischaracterization of the rise of opioid prescribing in the United States and the state of the relevant literature discussing addiction—especially that which was available in the 1990s when OxyContin first entered the market.

Like many popular accounts of the opioid crisis,^[12] Delfino claims that the now-infamous Porter & Jick study^[13] “laid the groundwork for the marketing practices that spawned the opioid crisis in the United States.”^[14] While Porter & Jick’s letter to the editor in the New England Journal of Medicine itself presents insufficient evidence to support the efficacy of opioid treatments—and was incautiously misrepresented by pharmaceutical companies “to minimize the risk of addiction in the use of opioids”^[15]—Delfino is wrong to suggest that there was a “dearth of peer-reviewed replicable scientific research and clinical studies on the efficacious applications of opioids.”^[16] 

FROM WAOK RADION, ATLANTA, GA MARCH 16, 2023 PAIN CARE PROVIDERS TARGETED

In fact, many studies published before the introduction of OxyContin in 1996 supported Porter & Jick’s findings that opioid addiction is rare in medical patients with no history of addiction.^[17] More recent research has supported the specific claim that the rate of addiction for patients prescribed opioids with no history of substance abuse is less than one percent.^[18] 

However, Delfino characterizes the literature in the 1980s and 1990s as a “research gap filled to a large extent by the Porter and Jick letter” and blames “[t]he diminished role of the federal government in funding drug science.”^[19] 

Neither of these statements is true. In addition to the aforementioned literature indicating the efficacy of opioids during this period, funding for the National Institutes of Health—the government agency responsible for medical research—quadrupled between 1980 and 1999.^[20]

“if you torture the data for long enough, you can make them say anything.”…I believe that is exactly what US CDC and DEA have been doing with their deliberate conflation and mischaracterization of research results on medical prescribing versus opioid-involved overdose mortality. 

…richard lawhern ph.d

As much of the literature from both the late-twentieth century and the present day share the letter’s conclusion that the “development of addiction is rare in medical patients with no history of addiction,”^[21] it is inaccurate for Delfino to describe this letter as the preeminent source of the academy’s understanding of opioids without acknowledging the breadth of the relevant literature.^[22] 

Though Porter & Jick’s study was not especially rigorous, Delfino’s neglect of considering more thoroughly researched findings from that period renders her account of the evidence used to justify early opioid prescribing incomplete.

Indeed, Delfino’s focus on the relationship between physician prescribing and opioid misuse might lead one to believe that “nonmedical pain reliever use,” the type of opioid abuse that is related to overprescribing, has been increasing for some time.

On the contrary, non-medical prescription-pain-reliever use has remained overly stable for at least the past two decades.^[23] Although OxyContin was introduced in 1996 and Purdue Pharma’s marketing campaign subsequently increased its market share within the industry of pain relievers that contain oxycodone,^[24] only 9.0% of all nonmedical opioid users in 2001 reported ever using OxyContin during their lifetime.^[25] 

A review by Kolodny et al. describes a rise in non-medical opioid use following the introduction of OxyContin, with over 2.5 million people initiating first use of opioids in 2001.^[26] However, much of this reported rise was likely due to major changes in survey methodology^[27] and any real change would have been almost entirely driven by codeine, which 71.9% of past-year nonmedical prescription opioid users reported using during their lifetimes in 2001.^[28] 

Indeed, this reported spike in non-medical pain reliever use was accompanied by new developments in the entertainment industry said to “glamorize and promote the mixture” of codeine with soft drinks,^[29] which motivated the Drug Enforcement Administration (DEA) to indict a group of medical professionals for illegally distributing 1.4 million tablets of hydrocodone and 2,100 gallons of promethazine with codeine in 2004.^[30]

Overall, it is not clear that non-medical opioid use has significantly changed since 1990. Even if the one reported spike in nonmedical pain reliever use between 1999 and 2001 was not entirely due to changes in survey design, this increase was not due to OxyContin exposure.”

NOTE

A Three-Part Series from Robert Capilupo and Jacob James Rich’s article from the Yale Law and Policy Review, Spring 2023, refuting Loyola Marymount Law Professor Rebecca Delfino proposed policy changes in the handling of prescription Narcotic Analgesics (Opioid Medications) See Part-1, Part-2, and Part-3

FOR NOW, YOU ARE WITHIN

THE NORMS

** Robert Capodilupo, Yale Law School, J.D. expected Spring 2023; M.Phil., Magdalene College, University of Cambridge, A.B. magna cum laude in Government, Harvard College. Jacob James Rich, Cleveland Clinic Center for Value-Based Care Research; Reason Foundation Drug Policy Project; Case Western Reserve University School of Medicine, Ph.D. expected Spring 2025; M.A., Eastern Michigan University; B.S., Eastern Michigan University. The Authors would like to thank Professor Jonathan H. Adler, Professor Jeffrey A. Miron, Dr. Jeffrey A. Singer, and Professor Kate Stith for their helpful feedback on earlier drafts of this Essay. The Authors are particularly grateful to Isaiah Ogren for his fantastic work on this Essay as Executive Editor for Inter Alia and to Karissa Kang and Amir Perk for demonstrating exceptional academic integrity in agreeing to publish this response.

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Will Rogers__

“The problem ain’t what people know. It’s what people know that ain’t, so that’s the problem.”