CONTROLLED SUBSTANCES

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February 03, 2026

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NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT MS., MBA., 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 WILLIE GUINYARD BS., IN THE SPIRIT OF ERLIN CLEMENT SR.,  JOSEPH WEBSTER MD., MBA, IN THE SPIRIT OF RICHARD KAUL, MD., BEVERLY C. PRINCE MD., FACS., IN THE SPIRIT OF LEROY BAYLOR,   JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, IN THE SPIRIT OF WALTER F. WRENN III, MD.,  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

Ronald T. Libby, Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers, Cato Institute Policy Analysis no. 545, June 16, 2005.

Libby’s analysis painted a concerning picture of the DEA’s crackdown on prescription painkillers. He argues that the agency’s actions are driven by unfounded fears, flawed data, and a self-serving financial structure, and ultimately result in the denial of essential medical care to millions of pain patients.

Mostimportantly, the DEA’s actions have made it increasingly difficult for legitimate pain patients to access the medication they need. Doctors, fearing investigation and prosecution, are reluctant to prescribe opioids, even to patients with severe chronic pain. This has left many patients suffering needlessly or resorting to dangerous alternatives.

​UNDERTSANDING MALLINCKRODT NARCOTIC PHARMACUETICAL PRODUCTION AND IT’S ROLE IN PAIN HEALTHCARE

Mallinckrodt Pharmaceuticals produces the world’s most diverse line of bulk medicinal controlled substances and is a world market leader. Our controlled substance product line includes natural opiates such as morphine sulfate and codeine phosphate.

Mallinckrodt offers semi-synthetic controlled substances such as hydrocodone, hydromorphone, and oxycodone obtained by chemical synthesis from natural opiates which are used to treat higher levels of pain than natural opiates. In addition, opioid antagonist products such as naloxone and naltrexone are available.

Synthetic-based products include methylphenidate and fentanyl, a strong synthetic controlled substance used to relieve moderate to severe pain, methadone for heroin (opiate) addiction and methylphenidate to treat Attention Deficit/Hyperactivity Disorder (ADHD).

In addition, Mallinckrodt is the world’s largest producer of noscapine products an opium alkaloid deravative which is used primarily in the cough/cold market internationally but sadly limited in the Unites States. Briefing Doc: The DEA’s War on Prescription Painkillers

THE MALLINKRODT LIST REASON BEHIND THE IDIOITIC LOGIC OF D.E.A. IN RESTRICTING FDA-APPROVED AND LEGALLY PRESCRIBED NARCOTIC ANALGESICS FROM HOSPITALS, PHARMACIES, AND PHYSICIAN’S OFFICES

Main Themes:

• The undertreatment of pain in the United States. Libby argues that millions of Americans suffer from undertreated pain due to the government’s aggressive prosecution of doctors who prescribe narcotic painkillers.
• The DEA’s shift in focus from illicit drugs to prescription painkillers. Libby criticizes the DEA’s decision to target pain doctors as part of its “war on drugs”, arguing that it has created a climate of fear that prevents doctors from adequately treating their patients.
• The questionable justification for the DEA’s OxyContin campaign. Libby challenges the DEA’s claims about an “OxyContin epidemic” and argues that their data are flawed and risk assessments are inflated.
• The harmful effects of the DEA’s crackdown on pain management. Libby details the negative impact of aggressive DEA tactics on the doctor-patient relationship, including patient distrust and fear of being labeled an addict.
• The problematic nature of the DEA’s Diversion Control Program. Libby criticizes the program’s self-financing structure and lack of accountability, which he argues incentivizes targeting doctors for asset forfeiture.

Most Important Ideas/Facts:

• Untreated pain is a significant problem: “The American Pain Foundation… puts the number [of Americans suffering from pain] at 75 million—50 million from serious chronic pain (pain lasting six months or more), and an additional 25 million from acute pain caused by accidents, surgeries, and injuries.”
• Fear of prosecution deters doctors from treating pain: “A 2001 study of California doctors found that 40 percent said their fear of an investigation affected how they treated chronic pain.”
• The DEA’s focus on OxyContin mirrors the Harrison Act: “The OxyContin Action Plan bore a remarkable resemblance to the Harrison Act in that it enabled the federal government to prosecute physicians who prescribed an otherwise legal narcotic drug, due to unfounded fears of a ‘dope menace’ sweeping the country.”
• The DEA’s data on OxyContin deaths are misleading: “The DEA counts as an “OxyContin-related death” any death in which oxycodone is detected without the presence of aspirin or Tylenol… Obviously the mere presence of OxyContin in the system of the deceased, or the mere mention of the drug by friends or family members is far from verification that OxyContin… actually caused a premature death.”
• Media hype has contributed to fear of painkillers: “It would be difficult to overstate how much the Sentinel series contributed to nationwide OxyContin fears.”
• The DEA’s Diversion Control Program is self-financing and incentivizes targeting doctors: “It is a perverse system that allows law enforcement officials to keep the assets of suspected drug defendants for their own, local police departments.”
• The DEA has lowered its evidentiary standards: “The DEA continues to lower its evidentiary standards, making it nearly impossible for many doctors to determine what is and isn’t permitted.”
• Aggressive DEA tactics damage the doctor-patient relationship: “The DEA’s aggressive investigative procedures poison the doctor-patient relationship from both sides.”
• Doctors are being prosecuted despite lack of evidence of intent to profit: “The DEA now insists that prosecutors do not have to prove a doctor’s malicious intent or desire to profit from narcotics diversion to secure a conviction.”

Key Quotes:

• Dr. Russell K. Portenoy: ““The medical ambiguity is being turned into allegations of criminal behavior… We have to draw a line in the sand here, or else the treatment will be lost, and millions of patients will suffer.””
• Asa Hutchinson: “Hutchinson announced that the DEA would reallocate many of its resources from illegal drugs in urban areas to illicit prescription drugs in rural areas in order to address the emerging opioid threat.”
• Temple pharmacology professor Robert Raffa: “The idea that your mom will go into a hospital, be exposed to morphine, and automatically become an addict is just plain wrong.”
• Professor David Brushwood: “Five years ago, if law enforcement saw a problem beginning to develop… they would very early on go to the doctor or pharmacist and say, ‘We think there’s a problem here.’ By the same token, physicians or pharmacists felt comfortable calling law enforcement and saying, ‘Something strange is going on. Come help us out.’ It was a culture of early consultation. The early consult is gone.”

Conclusion:

DEA Tactical Diversion Squads (TDSs) investigate suspected violations of the CSA and other Federal and state statutes pertaining to the diversion of controlled substance pharmaceuticals and listed chemicals. These unique groups combine the skill sets of Special Agents, Diversion Investigators, and a variety of state and local law enforcement agencies. They are dedicated solely towards investigating, disrupting, and dismantling those individuals or organizations involved indiversion schemes (e.g., “doctor shoppers,” prescription forgery rings, and practitioners and pharmacists who knowingly divert controlled substance pharmaceuticals).

Between March 2011 and March 2014, DEA increased the number of operational TDS’s from 37 to 66. With the expansion of TDS groups across the United States, the number of diversion-related criminal and administrative cases has increased significantly.

7 In NFLIS, a “case” is a law enforcement investigation; a “report’’ is an analysis of an exhibit pertaining to an investigation. There are typically many reports in a single case.

1. What is the main issue discussed in the source?

The source, “Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers”, criticizes the Drug Enforcement Administration’s (DEA) aggressive crackdown on physicians who prescribe opioid painkillers. The author argues that this approach has created a climate of fear among doctors, leading to the undertreatment of pain for millions of Americans while doing little to address the root causes of prescription drug abuse.

2. Why is the DEA targeting doctors who prescribe painkillers?

The DEA argues that a small group of doctors is overprescribing painkillers, leading to a rise in addiction and diversion to the black market. Facing criticism for its perceived ineffectiveness in reducing the illegal drug supply, the DEA shifted its focus to prescription drugs, viewing doctors as easier targets compared to illicit drug dealers.

3. What is the evidence for an “OxyContin epidemic”?

The DEA’s claims of an “OxyContin epidemic” are based on flawed data and questionable methodology. The agency’s criteria for “OxyContin-related deaths” are broad, often attributing deaths to OxyContin based on mere presence of the drug without conclusive evidence of causation. Furthermore, the DEA fails to account for the significant number of OxyContin tablets that are stolen or diverted through channels other than doctors’ prescriptions.

4. How has the media contributed to the problem?

The media has largely accepted and amplified the DEA’s narrative about the dangers of prescription painkillers, often using sensationalistic language and failing to provide balanced reporting. This has contributed to public fear and misunderstanding about the legitimate medical use of opioids for pain management.

5. What are the consequences of the DEA’s crackdown for pain patients?

6. How does the DEA investigate doctors suspected of overprescribing?

The DEA uses a “red flag” system to identify doctors for investigation. However, these red flags are often subjective and based on circumstantial evidence, leading to investigations of legitimate physicians. The agency employs aggressive tactics like surveillance, undercover agents posing as patients, and reviewing billing practices, creating an adversarial relationship with the medical community.

7. Is there a difference between physical dependence and addiction?

Yes, pain specialists make a critical distinction between physical dependence and addiction. Patients taking opioids for pain management may develop physical dependence, meaning their body requires the medication to function normally. However, this is distinct from addiction, which is characterized by compulsive drug-seeking behavior and harmful consequences. The DEA often fails to recognize this difference, leading to the misclassification of pain patients as addicts.

8. What are some solutions to the issues presented in the source?

The source advocates for several policy changes, including:

• Clearer guidelines and evidentiary standards for DEA investigations of physicians.
• Increased education and training for law enforcement officials on the legitimate medical use of opioids.
• Protection for pain patients from prosecution and harassment.
• Reform of asset forfeiture laws to prevent the abuse of power by law enforcement.
• Increased funding for research and development of alternative pain management therapies.

Ultimately, a more balanced and compassionate approach is needed to address the complex issue of prescription drug abuse while ensuring that legitimate pain patients have access to the care they need.

Timeline of Events

Early 20th Century (Progressive Era)

• 1880s-1920: Narcotics are unregulated and widely available in the United States.
• 1914: The Harrison Act criminalizes the non-medical use of opium, morphine, and cocaine, effectively turning drug-addicted citizens and their doctors into criminals.
• 1914-1938: 25,000 doctors are arrested under the Harrison Act for prescribing narcotics to addicts. Public opinion turns against doctors, viewing them as enablers of addiction rather than healers.
• 1970: The Harrison Act is repealed and replaced with the Drug Abuse Prevention and Control Act (DAPCA).
• 1975: The Supreme Court ruling in U.S. v. Moore upholds the criminalization of doctors treating addicts by prescribing controlled substances, confirming that doctors can be prosecuted for prescribing outside the “usual course of professional practice.”

Late 20th Century

• 1990s: The DEA focuses its resources primarily on illegal black market drugs like heroin, cocaine, and marijuana in urban areas.
• 1997: Positive media coverage highlights the undertreatment of pain and the efficacy of opioid therapy when properly administered.
• Late 1990s: Concerns about prescription drug abuse begin to emerge.

2000s

• 1999-2001: Congress criticizes the DEA for lack of progress in reducing the illegal drug supply. The Department of Justice rebukes the DEA for goals inconsistent with the National Drug Control Strategy, prompting the DEA to seek a new front for the War on Drugs.
• 2001:The DEA launches the OxyContin Action Plan, targeting the prescription painkiller OxyContin.
• Negative media coverage begins, linking OxyContin to heroin and fueling public fear.
• The Orlando Sentinel publishes a series on OxyContin overdoses, later found to be flawed and misleading, but significantly contributing to nationwide OxyContin fears.
• 2002:The DEA reallocates resources from illegal drugs in urban areas to prescription drugs in rural areas, focusing on combating the “illegal diversion” of legal medication.
• The DEA expands its reach through partnerships with state and local law enforcement agencies via task forces.
• The DEA justifies its OxyContin campaign by using flawed data and questionable interpretations of “OxyContin-related deaths.”
• 2003:The DEA doubles licensing fees for doctors and pharmaceutical companies to fund the Diversion Control Program, making doctors financially responsible for investigating colleagues.
• The DEA uses the threat of imprisonment to coerce pain patients into turning in their doctors.
• The National Association of Diversion Investigators (NADDI) conference focuses on targeting pain specialists and seizing their assets.
• Florida, fueled by the Sentinel series, becomes one of the most restrictive states for pain treatment.
• 2004:The DEA disavows its own pamphlet providing guidance to pain specialists on legal prescribing practices, reinforcing doctors’ fears of prosecution.
• Dr. William Hurwitz is convicted for prescribing opioids, despite no evidence of malicious intent or profit from diversion.
• Dr. Frank Fisher is acquitted of murder, fraud, and manslaughter charges after years of legal battles and asset seizures.
• 2005:The National Association of Attorneys General expresses concern to the DEA about its aggressive pursuit of physicians and the chilling effect on pain treatment.
• Media continues to perpetuate OxyContin fears despite evidence suggesting other sources of illicit drugs.

Cast of Characters

Government Officials & Agencies

• Drug Enforcement Agency (DEA): The federal agency responsible for enforcing drug laws. The DEA shifted its focus to prescription painkillers, particularly OxyContin, in the early 2000s, leading to aggressive investigations and prosecutions of doctors.
• Asa Hutchinson: DEA administrator during the launch of the OxyContin Action Plan. He played a key role in framing the narrative of OxyContin as a dangerous, widely abused drug, comparing it to heroin and cocaine.
• Glen A. Fine: Inspector General of the Department of Justice who questioned the DEA’s focus on illegal drugs and suggested they combat prescription drug abuse.
• Mark Lytle: U.S. Attorney who compared Dr. William Hurwitz to a street-corner crack dealer during his indictment.
• James McDonough: Florida director of drug control who praised the (flawed) Orlando Sentinel series on OxyContin and highlighted Florida’s aggressive actions against doctors.

Doctors

• Dr. William Hurwitz: Virginia pain specialist who was indicted on 60 counts, compared to a “street-corner crack dealer,” and ultimately convicted and sentenced to 25 years in prison despite evidence suggesting his patients deceived him.
• Dr. Russell K. Portenoy: Pain specialist and pioneer in opioid pain therapy who criticized the DEA’s crackdown on pain doctors, arguing it would harm patients in need of pain relief.
• Dr. Frank Fisher: California physician who was falsely accused of murder, fraud, and drug diversion, enduring years of legal battles and asset seizures before being acquitted.
• Dr. John F. Lilly: Orthopedist and pain clinic proprietor investigated for diversion, accused of running a “pill mill.”
• Dr. James Graves: Former Navy flight surgeon convicted on four counts of manslaughter for prescribing oxycodone.
• Dr. Sarfraz Mirza: Convicted of trafficking in OxyContin.
• Dr. Asuncion Luyao: Prosecuted for prescription overdose deaths (case ultimately ended in a mistrial).
• Dr. Eli Schneider: Physician whose assets were seized before any charges were filed, highlighting the practice of asset forfeiture before due process.
• Dr. Ghassan Haj-Hamed: Kentucky physician whose clinic was accused of diversion, forcing him into a settlement with the DEA due to the financial strain of asset seizures.

Other Key Figures

• Doris Bloodsworth: Orlando Sentinel reporter who wrote the widely criticized series on OxyContin deaths, later resigning after the series’ inaccuracies came to light.
• Richard Paey: Florida pain patient with multiple sclerosis who was sentenced to 25 years in prison for possessing a large quantity of pain medication, even though it was for personal use.
• David Brushwood: University of Florida professor of pharmacy and lawyer who criticized the DEA’s shift to aggressive tactics and the breakdown of the previously cordial relationship between law enforcement and medical professionals.
• Detective Dennis M. Luken: Member of the Warren-Clinton Drug Task Force and treasurer of NADDI who advocated for seizing doctors’ assets to bolster law enforcement budgets.

Organizations

• National Association of Medical Examiners: Provided data on “OxyContin-related deaths” to the DEA, which was later criticized for its methodology and interpretation.
• National Association of Drug Diversion Investigators (NADDI): Organization focused on investigating and prosecuting pharmaceutical drug diversion, playing a key role in training law enforcement to target physicians.
• National Association of Attorneys General: Expressed concern about the DEA’s aggressive approach to fighting diversion and its negative impact on pain patients’ access to treatment.

This timeline and cast of characters provides a comprehensive overview of the key events and individuals involved in the DEA’s crackdown on prescription painkillers. It highlights the shift in the DEA’s focus, the flawed data and media coverage used to justify their campaign, the aggressive tactics employed against doctors and patients, and the consequences of this approach, including the chilling effect on pain treatment and the erosion of the doctor-patient relationship.

Enforcement: Diversion Groups

When the DEA was established in 1973, DEA regulated 480,000 registrants. Today, DEA regulates more than 1.5 million registrants. The expansion of the TDS groups has allowed Diversion Groups to concentrate on the regulatory aspects of enforcing the Controlled Substances Act. DEA has steadily increased the frequency of compliance inspections of specific registrant categories such as manufacturers (including bulk manufacturers); distributors; pharmacies; importers; exporters; narcotic treatment programs. This renewed focus on oversight has enabled DEA to take a more proactive approach to educate registrants and ensure that DEA registrants understand and comply with the Controlled Substances Act and its implementation.

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**Source: Ronald T. Libby, Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers, Cato Institute Policy Analysis no. 545, June 16, 2005.