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., 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., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, 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., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, 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
HOW HAVE FEDERAL PROSECUTORS HISTORICALLY PURSUED CASES AGAINST PHYSICIANS FOR PRESCRIBING CONTROLLED SUBSTANCES?
- Historically, the regulation of medical practice, including the dispensing of controlled substances, has been primarily a state function, overseen by State Medical Boards. These boards were considered the authoritative bodies for determining the standard of care and when a physician’s conduct fell outside the scope of acceptable practice. Federal involvement, through agencies like the DEA and the Controlled Substances Act (CSA), was understood to regulate the drugs themselves and prevent illicit trafficking, not to dictate the practice of medicine or turn good-faith medical disputes into federal crimes. The “good-faith” defense for doctors, meaning they prescribed in the course of their professional practice with a legitimate medical purpose, has been a part of federal law for over 100 years, dating back to the Harrison Narcotics Act of 1914.
WHAT IS THE THREE-PRONGED APPROACH FEDERAL PROSECUTORS HAVE ALLEGEDLY USED TO SECURE CONVICTIONS AGAINST PHYSICIANS IN “SCOPE OF PRACTICE” CASES?
- According to the source, federal prosecutors have been employing a three-pronged approach that has resulted in a high rate of guilty verdicts (9 out of 10) in “scope of practice” cases against physicians. This approach relies on:
- (1) the broad and often subjective phrase “not for a legitimate medical purpose,”
- (2) the testimony of a hired government expert to challenge the physician’s medical judgment, and
- (3) the ability to demonstrate substantial wealth of the accused physician, which can potentially influence a jury’s perception. This method is criticized for bypassing the traditional state-level regulation of medical practice and turning differences in medical opinion into criminal matters.
HOW DOES THE USE OF THE “NOT FOR A LEGITIMATE MEDICAL PURPOSE” STANDARD IN FEDERAL PROSECUTIONS IMPACT PHYSICIANS?
- The use of the phrase “not for a legitimate medical purpose” by federal prosecutors is a central point of contention. This standard, while present in regulations, is described as “ambiguous” and “open to varying constructions.” Applying this vague standard in criminal prosecutions, especially without a strong scienter requirement (proof that the physician knew they were acting outside the scope of practice), can make it difficult for physicians to know when their conduct crosses a legal line. It risks criminalizing good-faith medical judgments and deterring physicians from prescribing necessary controlled substances, particularly in complex pain management cases, due to the fear of severe penalties.
WHAT IS THE SIGNIFICANCE OF THE SUPREME COURT CASE RUAN V. UNITED STATES REGARDING THE PROSECUTION OF PHYSICIANS?
- Ruan v. United States is a crucial case that addresses the required mental state (mens rea) for convicting physicians under 21 U.S.C. §841 for unlawfully dispensing controlled substances. The Supreme Court held that the statute’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause. This means that once a physician presents evidence that their conduct was authorized (e.g., by possessing a DEA registration and issuing a prescription), the government must prove beyond a reasonable doubt that the physician knew they were acting in an unauthorized manner or intended to do so. This ruling rejects the idea that physicians can be convicted merely by showing they prescribed outside an objective “usual course of practice” standard, emphasizing the need for proof of subjective intent or knowledge of illegitimacy.
HOW DOES THE RUAN DECISION ADDRESS THE BALANCE BETWEEN FEDERAL AND STATE AUTHORITY IN REGULATING MEDICAL PRACTICE?
- The Ruan decision implicitly reinforces the principle of federalism, acknowledging that the practice of medicine is traditionally regulated by the states. By requiring the government to prove a physician knowingly or intentionally acted outside their authority, the ruling moves away from a standard that could allow federal prosecutors to criminalize conduct based on differing medical opinions or deviations from a subjective “standard of care,” which are typically matters for state medical boards and civil courts. The Court’s emphasis on scienter suggests that federal criminal jurisdiction under the CSA is primarily aimed at conduct akin to drug dealing and trafficking, not good-faith medical decisions, even if those decisions are later deemed incorrect by others.
WHAT CRITICISMS ARE LEVELED AGAINST THE USE OF MORPHINE MILLIGRAM EQUIVALENTS (MME) IN GUIDING OPIOID PRESCRIBING POLICIES?
- The MME metric is criticized for being a flawed and overly simplistic tool for guiding opioid prescribing. It was originally intended for converting dosages when switching between different opioid medications, but even for this purpose, its application can be inaccurate as individual patient responses to different opioids can vary significantly regardless of MME. The main criticism is the assumption that MME accurately reflects the “strength” or effect of different opioids across all individuals, which is demonstrably false. The reliance on MME in policy and practice is seen as contributing to a “one-size-fits-all” approach that does not account for individual patient needs and can lead to inadequate pain management.
HOW ARE PRESCRIPTION DRUG MONITORING PROGRAMS (PMPS) AND DATA ANALYTICS BEING USED IN THE CONTEXT OF CONTROLLED SUBSTANCE REGULATION AND ENFORCEMENT?
- Prescription Drug Monitoring Programs (PMPs) were initially developed as medical decision tools to help physicians see other scheduled medications a patient was receiving. However, the source indicates that PMP data is now being used by law enforcement to support indictments against physicians. Furthermore, the CSA authorizes the DEA to track prescribing data, and private for-profit companies are utilizing this data, running it through proprietary algorithms, to assist the government in both criminal and civil proceedings related to prescribing habits and patient utilization of controlled substances. This raises concerns about the shift in the purpose and use of PMP data from a medical tool to an enforcement tool.
WHY IS THE UNITED STATES DESCRIBED AS THE ONLY COUNTRY IN THE WORLD MASS INCARCERATING PHYSICIANS, AND WHAT IS THE ALLEGED REASON FOR THIS?
- The source claims that the United States is unique in mass incarcerating physicians for prescribing controlled substances, with some doctors receiving sentences far exceeding those given to prolific drug traffickers. This is not attributed to a disproportionate number of criminal doctors in the US, but rather to the manner in which federal prosecutors have been allowed to litigate these cases. The three-pronged approach and the appeal to jury emotions in the context of the opioid crisis are cited as reasons for the high conviction rates. The fundamental issue is seen as federal prosecutors overstepping their authority by acting as “super experts” to determine what constitutes acceptable medical practice, a role traditionally held by state medical boards.
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Timeline of Main Events (Based on Provided Text)
2013:
- The Substance Abuse and Mental Health Services Administration (SAMHSA) releases a report stating that “Nearly 80 percent of recent heroin initiates had previously used prescription pain relievers nonmedically.” This is the origin of the “80% statistic.”
- Media outlets, policymakers, and advocacy groups begin to misrepresent the SAMHSA statistic, claiming that “80% of heroin users started with a prescription from their doctor.”
- Organizations like Physicians for Responsible Opioid Prescribing (PROP) use the distorted statistic to advocate for more restrictive prescribing guidelines.
2016:
- SAMHSA releases a short report indicating that over 53% of people who misused prescription pain relievers obtained them from friends or relatives, while 37.5% got them from a healthcare provider.
- The National Institute on Drug Abuse (NIDA) reviews data and concludes that heroin use is rare among individuals who use prescription opioids as directed.
- The Centers for Disease Control and Prevention (CDC) releases its opioid prescribing guideline, which is influenced by the misrepresented “80% statistic” and leads to widespread forced tapers and patient abandonment.
- Volkow & McLellan publish an article in the New England Journal of Medicine, estimating the risk of addiction during chronic opioid therapy to be generally low (0.6% to 8%).
2017:
- Cicero et al. publish research in PubMed suggesting that the new DSM-5 criteria for Opioid Use Disorder (OUD) may lead to a high rate of false positives in patients maintained on chronic opioid therapy.
2018:
- Politico Magazine publishes an article highlighting the misrepresentation of the “80% statistic.”
- NIDA reiterates that heroin use is uncommon in people who use prescription opioids as directed.
- Pain News Network publishes an article questioning the validity of the “80% statistic.”
2019:
- Cicero et al. publish an analysis in “Addictive Behaviors” showing that by 2015, 32% of individuals entering treatment for OUD reported initiating opioid use with heroin, a significant decline from earlier periods. This study indicates a shift in opioid use initiation patterns.
Ongoing (Implied):
- The myth of the “80% statistic” continues to be used to justify restrictive prescribing policies, push pain patients off medication, and expand Suboxone markets.
- The opioid multidistrict litigation (MDL) benefits from inflated OUD numbers linked to prescription opioids.
- Abatement funds allocated to combat the opioid crisis are sometimes distributed based on the number of people labeled with OUD, potentially incentivizing over-diagnosis.
- Pain patients experience widespread abandonment, stigma, NarxCare flagging, and increased suicidality due to policies influenced by the false narrative.
- Illicit fentanyl becomes the primary driver of overdose, not prescribed opioids.
- Advocates call for the retirement of the “80%” statistic and demand evidence-based care that distinguishes between medical opioid use and nonmedical opioid use.
April 20, 2025:
- The provided text, “Debunking the Lie: ‘80% of Heroin Users Started with a Prescription from Their Doctor’,” is published, explicitly challenging the false statistic and outlining its harmful consequences.
Cast of Characters (Principle People Mentioned)
- SAMHSA (Substance Abuse and Mental Health Services Administration): A U.S. government agency that collects and analyzes data on substance use and mental health. Their 2013 report is the original source of the misinterpreted “80% statistic.”
- PROP (Physicians for Responsible Opioid Prescribing): An organization that advocated for more restrictive opioid prescribing guidelines, using the distorted “80% statistic” to support their arguments.
- NIDA (National Institute on Drug Abuse): A U.S. government agency that conducts and supports research on drug abuse and addiction. Their research contradicts the claim that most heroin users start with prescription opioids used as directed.
- Cicero, T.: A researcher who co-authored studies in 2017 and 2019 that provided data challenging the link between prescribed opioids and heroin initiation and highlighted potential issues with DSM-5 OUD criteria in pain patients.
- Volkow, N. & McLellan, A.: Authors of a 2016 New England Journal of Medicine article that estimated the relatively low risk of addiction from opioids prescribed for pain when used appropriately.
- Claudia A. Merandi & Bev Schechtman: Founders of “The Doctor Patient Forum,” which published the provided text, actively working to debunk the “80% statistic” and advocate for pain patients.
- Indivior: A pharmaceutical company that markets Suboxone, a medication for opioid use disorder. The text suggests they benefited from the expanded definition of OUD driven by the false narrative.
Frequently Asked Questions on the “80% Heroin Users Started with a Prescription” Myth
Q1: What is the “80% statistic” about heroin use, and where did it originate?
The “80% statistic” refers to the widely circulated claim that approximately 80% of heroin users initially became addicted through prescription opioids provided by their doctors. This statistic originated from a 2013 report by the Substance Abuse and Mental Health Services Administration (SAMHSA). However, the report’s actual finding was that “nearly 80 percent of recent heroin initiates had previously used prescription pain relievers nonmedically.” The key distinction is the term “nonmedically,” which includes using prescription opioids without a prescription or in ways not directed by a doctor (e.g., to get high, taking higher doses). This statistic was frequently misrepresented to suggest that legitimate medical prescriptions were the primary gateway to heroin addiction.
Q2: What is the critical difference between “nonmedical use” and prescribed medical use of opioids, and why is this distinction important in understanding the 80% statistic?
“Nonmedical use” of prescription opioids, as defined by SAMHSA, involves using these medications without one’s own prescription or solely for the experience or feelings they cause. This includes obtaining pills from friends or relatives, buying them illicitly, taking leftover medication to get high, or using doses higher than prescribed. In contrast, “prescribed medical use” refers to patients taking opioids under the supervision of a doctor, as directed for a legitimate medical condition such as pain management. The “80% statistic” specifically referred to prior nonmedical use, not instances where individuals were legitimately prescribed opioids. Misrepresenting this data to imply that prescribed use led to heroin addiction unfairly stigmatized pain patients and mischaracterized the pathways to heroin use.
Q3: Has the data on opioid initiation changed since the 2013 SAMHSA report? If so, what do more recent studies indicate about how people begin using heroin?
Yes, data on opioid initiation has changed significantly since 2013. More recent studies, including a 2019 analysis by Cicero et al., indicate a decline in the percentage of individuals entering treatment for heroin use who report initiating opioid use with prescription drugs. By 2015, this study found that 32% of people entering treatment for opioid use disorder reported heroin as their first opioid, not prescription pills. This demonstrates that the pattern of opioid initiation has shifted, and the “80% statistic” is now outdated and no longer reflects the primary pathway to heroin use, which is increasingly linked to illicit opioids like fentanyl.
Q4: How has the misinterpretation of the “80% statistic” been used to influence policy and practice related to opioid prescribing and pain management?
The false narrative that 80% of heroin users started with a prescription has been used to justify several restrictive policies and practices. These include the implementation of stricter prescribing guidelines, which have led to forced tapering and abandonment of patients on long-term opioid therapy. It has also fueled the expansion of Prescription Drug Monitoring Programs (PDMPs) and risk-scoring tools that can stigmatize and deny care to pain patients labeled as “high risk” based on their prescription history. Furthermore, this inflated statistic has been leveraged in opioid litigation to strengthen claims against pharmaceutical companies and distributors, and to expand the market for medication-assisted treatment (MAT) like Suboxone, sometimes inappropriately for individuals who were not truly addicted.
Q5: What are some of the real-world negative consequences experienced by pain patients as a result of the widespread belief in the “80% statistic”?
The belief in the “80% statistic” has had severe negative consequences for pain patients. Many have faced forced and rapid tapering of their opioid medications, leading to withdrawal symptoms, increased pain, and decreased functionality. Others have been completely abandoned by their doctors due to fears of regulatory scrutiny or legal repercussions. Patients have also been subjected to increased surveillance through PDMPs and flagged as “high risk,” resulting in denial of care, cancellation of procedures, and unwarranted accusations of drug-seeking behavior. This has led to significant stigma, a breakdown of trust between patients and the healthcare system, and tragic outcomes such as increased rates of depression, suicidality, and a turn to the illicit drug market out of desperation for pain relief.
Q6: How did changes in terminology and diagnostic criteria, such as the shift from “drug abuse” to “misuse” and the introduction of DSM-5’s Substance Use Disorder (SUD) criteria, contribute to the misrepresentation of opioid-related issues and impact pain patients?
The shift from terms like “drug abuse” to more neutral terms like “misuse,” while intended to reduce stigma, inadvertently blurred the lines between nonmedical use, occasional deviations from prescribed use, and actual addiction. The broad definition of “misuse” by agencies like SAMHSA could encompass a wide range of behaviors, including taking an extra pill for breakthrough pain, leading to inflated statistics that didn’t necessarily indicate addiction. Similarly, the DSM-5’s consolidated Substance Use Disorder (SUD) criteria, while aiming to represent addiction as a spectrum, could lead to “false positives” in patients on long-term opioid therapy who exhibited physiological dependence (tolerance and withdrawal) without true addiction. These changes in language and diagnosis made it easier to mislabel pain patients and inflate the numbers of people supposedly affected by opioid misuse and addiction, further fueling the false narrative.
Q7: Beyond the flawed “80% statistic,” what does current evidence suggest about the primary drivers of the ongoing overdose crisis in the United States?
Current evidence overwhelmingly indicates that the primary driver of the ongoing overdose crisis is the proliferation of illicitly manufactured fentanyl and other synthetic opioids in the drug supply, often mixed with or disguised as other drugs like heroin, cocaine, and counterfeit pills. While prescription opioid misuse has played a role in the broader opioid crisis, the surge in overdose deaths in recent years is largely attributable to the increased availability and potency of these illicit substances. The focus has shifted away from prescription opioids as the main culprit, highlighting the need for harm reduction strategies, addressing the illicit drug market, and providing treatment for substance use disorder related to these substances.
Q8: What actions can advocates, healthcare professionals, and the public take to challenge the “80% myth” and promote a more accurate understanding of opioid use and pain management?
Advocates, healthcare professionals, and the public can take several crucial actions to challenge the “80% myth.” Firstly, it is essential to stop repeating the statistic and actively correct it when encountered in discussions, media, or policy documents, emphasizing its misinterpretation of the original data and its outdated nature. Secondly, it’s important to advocate for evidence-based policies that distinguish between legitimate medical use of opioids for pain and nonmedical use or substance use disorder, avoiding one-size-fits-all approaches that harm pain patients. Healthcare professionals should prioritize individualized care, while policymakers should focus on data accuracy and avoid using flawed statistics to justify restrictive measures. Finally, educating others about the truth behind the “80% myth” and the real drivers of the overdose crisis is crucial in fostering a more informed and compassionate understanding of these complex issues.
I have an article about Dr. Akula’s conviction that I think you would be interested in publishing concerning U.S. District Judge Lance Africk’s corruption.
Send it to me and call me