THE PDMP: IN UNITED STATES v. DR. NEIL KAMAL ANAND, MD ET AL., DOJ PROSECUTION OF A “911 AMERICAN HERO,” TARGETED BY D.E.A. TACTICS OF DATA MANIPULATION LACK OF UNIVERSALITY STANDARDS AND CONFIRMATION BIAS

from 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., 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

Confirmation bias in surveillance

This collection of excerpts centers on the Prescription Drug Monitoring Programs (PDMPs) and their effectiveness, particularly concerning opioid prescribing.

It explores the capabilities and limitations of using machine learning and predictive modeling with PDMP data to identify aberrant behavior, often for law enforcement purposes like the D.E.A.’s work of Pre-crime ideology, which intervenes to punish, disrupt, incapacitate, or restrict those deemed to embody future crime threats. The term precrime embodies a temporal paradox, suggesting that a crime has not occurred and that the crime that has not occurred is a foregone conclusion.

A key theme is the inherent biases and limitations in PDMP algorithms, which primarily track negative indicators and lack data on positive patient outcomes or illicit drug use, leading to a confirmation bias in surveillance.

What are Prescription Drug Monitoring Programs (PDMPs) and what is their primary function?

PDMPs are statewide electronic databases that collect information on dispensed prescriptions for controlled substances from pharmacies.

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This data typically includes the date the prescription was written and filled, patient information, prescriber details, pharmacy information, the specific medication, dosage, quantity, days’ supply, and payment source.

The primary function of PDMPs is to enhance the capacity of regulatory, law enforcement, and public health agencies to collect and analyze data to identify potential non-medical use and diversion of controlled substances by patients and to detect problematic prescribing and dispensing practices.

They can also help track legitimate prescribing patterns.

Detailed Timeline of Main Events:

Early 20th Century:

• 1939: California establishes the oldest continuously operating Prescription Drug Monitoring Program (PDMP). These early programs are paper-based and collect limited information, primarily used as a regulatory tool for enforcing drug laws. The Wizard of Oz was also released by Metro Goldwyn Mayer (MGM)

Early 2000s:

• The U.S. Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) begin advocating for establishing and expanding more sophisticated PDMPs.
• 2002: The Harold Rogers Prescription Drug Monitoring Discretionary Grant Program is created by the Department of Justice Appropriations Act to assist states in developing PDMPs. The program receives funding in subsequent years.
• 2002: A GAO report highlights that state monitoring programs are useful for reducing drug diversion.

Mid-2000s:

• August 2005: Remarks made in Kentucky highlight the value of KASPER (Kentucky All Schedule Prescription Electronic Reporting) in identifying over-prescribing and doctor shopping.
• 2006: An independent evaluation of Kentucky’s PDMP notes the impact of the program on oxycodone distribution compared to states without active PDMPs (Florida and Tennessee).

Late 2000s:

• A national evaluation comparing states with and without PDMPs finds that proactive PDMPs are associated with slower growth in the per capita availability of prescription pain relievers and stimulants.
• A study comparing PDMP states with non-PDMP states finds that PDMP states have decreases in opioid shipments.
• 2009: An analysis by Wyoming’s PDMP begins to show a decline in individuals meeting the threshold for doctor shopping as PDMP utilization increases.
• 2010: A study of medical providers in Ohio emergency departments shows that 41% of those given PDMP data altered their prescribing for patients receiving multiple simultaneous narcotic prescriptions.
• 2010: A survey of users of Kentucky’s PDMP (KASPER) finds that PDMP reports aid clinical practice and lead to prescribers and pharmacists refusing to prescribe or dispense controlled substances based on the information.
• December 20, 2010: A cost-benefit analysis of a PDMP in Wisconsin is released.
• December 3, 2010: Recommendations for increased collaboration between prescription monitoring and prevention efforts are produced for SAMHSA.

2011:

• The FY 2011 Harold Rogers Prescription Drug Monitoring National Training and Technical Assistance Program solicitation is announced by the Bureau of Justice Assistance (BJA). This program aims to provide training and technical assistance to PDMP grantees and other stakeholders.
• March 2011: The Surgeon General’s Expert Panel on Prescription Drug Abuse in Youth discusses PDMP roles.
• March 2011: Research indicates the economic costs of nonmedical use of prescription opioids.
• May 19, 2011: Deadline for applying for funding under the FY 2011 Harold Rogers PDMP National Training and Technical Assistance Program.
• May 2011: A perspective from Kentucky highlights using PMP data in drug diversion investigations.
• January 2011: Nevada’s pre-criminal intervention program, which utilizes PDMP data, is highlighted.
• March 2011: A case study on using PDMP data in an outpatient addiction treatment setting is released.
• August 2011: The role of PMP data in Kentucky drug courts is examined.
• September 27, 2011: The Director of SAMHSA sends a letter to colleagues regarding PDMPs and opioid treatment programs.
• September 2011: Florida PDMP is implemented, leading to a decline in doctor shopping in subsequent fiscal years.
• December 2011: Virginia medical examiners utilize PMP data in drug-related death investigations.

2012:

• PDMPs are gaining recognition as an important tool to improve medical care quality and contain the prescription drug abuse epidemic.
• June 2012: Project Lazarus utilizes PDMP data to mobilize and measure community drug abuse prevention.
• September 2012: A report highlights that state PDMPs are making gains in tracking Rx misuse.
• December 2012: A meeting on PDMPs and Third Party Payers is convened by the PDMP Center of Excellence.
• As of July 2012, 29 states allow their Medicaid, Medicare, or state health programs to have access to PDMP data. However, data sharing with private health insurers is limited, with Michigan being the only known state to provide such data.
• Washington State implements PDMP data sharing with its Medicaid and workers’ compensation programs, revealing significant issues like same-day and overlapping prescriptions.

2013:

• March 2013: Arkansas PDMP is initiated, leading to a significant drop in individuals meeting a threshold for doctor shopping.
• April 2013: Tennessee implements a mandate for prescribers to check the PDMP before first prescribing certain controlled substances, resulting in a decline in doctor shopping.
• June 2013: New York implements a similar mandate, substantially decreasing doctor shopping rates.
• July 2013: 31 states indicate they allow access to PDMP data by their Medicare, Medicaid, state health insurance programs, and/or health care payment/benefit providers or insurers, but the extent of data use is largely unknown.
• Updated April 2013: The PDMP Center of Excellence at Brandeis University releases a briefing on PDMP effectiveness, highlighting positive impacts on doctor shopping, diversion, and prescribing behaviors in various states.
• By the last quarter of 2013, Ohio saw a significant drop in doctor shopping rates after passing legislation in 2011 requiring prescribers to check the PDMP.
• Wyoming’s PDMP data indicates a continued decline in doctor shopping in 2013 compared to 2009.

2014:

• Research in Florida indicates reductions in prescription opioid diversion following recent legislative interventions, likely aided by the PDMP.
• SAMHSA is funding pilot PDMP-to-EHR/HIE interoperability projects.

2016:

• The 21st Century Cures Act adds section 520(o) to the FD&C Act, establishing criteria to determine whether software is “Non-Device CDS.”

2020:

• The opioid dispensing rate reaches its lowest point in 15 years.
• The DEA solicits bids for a surveillance program with “unlimited access” to prescription data, but no contract is awarded.

RANNAZZISI’S TIME LINE

Pre-2001:

• Late 1990s: High levels of opium poppy cultivation in Afghanistan.
• 1999: UN Security Council demands the Taliban turn over Usama bin Laden.
• December 2000: UN Security Council imposes new measures against the Taliban, demanding an end to the provision of sanctuary to terrorists and the closure of training camps, also banning military assistance.
• 2000: The Taliban implements a nationwide ban on poppy cultivation using coercion and promises of future development assistance.
• August 2001: Reportedly, poppy cultivation decreased dramatically in Afghanistan due to the Taliban ban, from 82,000 hectares to 8,000 hectares. However, this causes economic hardship for farmers in debt.
• September 2001: The Opium market value begins to rise significantly after the Taliban ban.

2001:

• October 2001: The United States invades Afghanistan. The resurgence of opium cultivation began due to factors like peasant debt incurred during the Taliban ban.

2002:

• Early 2002: Poppy cultivation starts to rebound in Afghanistan.
• April 2002: The Karzai administration announces a policy of compensated eradication of poppy crops, offering $250 per jerib (later increased to $350). This is widely seen as a strategic misstep, potentially linked to corruption.
• April 2002: Kabul-based officers in the Counter Narcotics Police of Afghanistan (CNPA) reportedly have no equipment, radios, or vehicles.
• July 2002: The UK and US issue a joint demarche to President Karzai on counternarcotics.
• Late 2002: UK officials advocate for creating a 100-soldier eradication force and seek US support, including from President Bush.
• December 2002: Lieutenant General Dan McNeill, commander of coalition forces, rejects the UK’s plan for an eradication force.

2003:

• February 2003: The DEA reopened its country office in Kabul but was initially reluctant to operate outside due to security and a lack of Afghan partners, focusing on intelligence and interdiction in neighboring countries.
• July 2003: UK officials develop a preliminary plan to clarify the roles of counternarcotics law enforcement stakeholders, envisioning intelligence, operations, and investigations units.
• December 2003: The director of Afghanistan’s Counter Narcotics Directorate (CND), Mirwais Yasini, requests support for an Afghan-led eradication force.
• 2003: Poppy cultivation spreads to 28 provinces, up from 24 in 2002.
• 2003: Counternarcotics law enforcement and interdiction budget is less than $3 million.

2004:

• 2004: INL creates the Central Poppy Eradication Force (CPEF), later renamed the Afghan Eradication Force (AEF) and then the Poppy Eradication Force (PEF), contracting DynCorp. This is against the wishes of Afghan authorities and the US/UK embassies.
• 2004: The Vertical Prosecution Task Force (VPTF) is established (later renamed the Criminal Justice Task Force – CJTF).
• Late 2004: Law enforcement officials begin pressing for military and air support for counternarcotics operations.
• 2004-2014: DOD funds the largest portion of interdiction-related expenditures.

2005:

• March 2005: DEA launches the Foreign-Deployed Advisory and Support Teams (FAST) program, deploying agents with military forces for interdiction operations.
• April 2005: In Maiwand district of Kandahar, the CPEF is blockaded by protesting farmers.
• December 2005: Afghanistan’s Narcotics Law establishes the Central Narcotics Tribunal.

2006:

• January 2006: The Government of Afghanistan releases its “National Drug Control Strategy.”
• Autumn 2006: British Army General David Richards, commander of ISAF, tells President Karzai that aerial spraying is “absolutely not the right thing to do.”
• November 2006: The US plans to test aerial spraying in Nangarhar province.
• 2006: The budget for counternarcotics law enforcement and interdiction increases significantly.

2007:

• February 2007: US Representative Ileana Ros-Lehtinen highlights conflicting views and bureaucratic battles hindering US anti-narcotics policy.
• February 2007: Acting Director of USAID Office of Economic Growth notes the limited effectiveness of alternative livelihoods programs.
• August 2007: The US releases a new counternarcotics strategy focusing on increased development assistance, intensified interdiction/eradication, and integration of counternarcotics into counterinsurgency.
• October 2007: ISAF changes its operations plan, permitting military forces to directly engage in counternarcotics operations targeting insurgency-linked entities (effective October 2008).
• November 2007: It becomes apparent the US plans to test aerial spraying in Nangarhar, with the support of Governor Gul Agha Shirzai.
• 2007: The Counter Narcotics Justice Center (CNJC) is scheduled to be completed but is finished in 2009.
• 2007: UNODC coins the term “poppy-free provinces” for those with less than 100 hectares of cultivation.

2008:

• October 2008: ISAF military forces are permitted to directly engage in counternarcotics operations targeting insurgency links.
• October 2008: NATO Secretary General announces NATO will step up counter-narcotics efforts in Afghanistan.
• December 2008: DOD issues a memorandum on international counternarcotics policy.
• 2008: The US interagency Afghan Threat Finance Cell is established (operates until 2014).
• 2008: Poppy cultivation in Helmand Province reaches its peak at 103,590 hectares.
• 2008-2013: Heroin seized at the US Southwest border increases over 300 percent.
• 2008-2011: Poppy cultivation in Helmand Province falls to 63,307 hectares.

2009:

• 2009: The Counter Narcotics Justice Center (CNJC) is completed.
• 2009-2012: Increased military and civilian personnel (“surge”) bring more resources for counterdrug activities, particularly in key poppy-growing provinces like Helmand.

2010:

• February 2010: Operation Moshtarak increases ISAF and ANDSF presence in Marjah, Helmand Province, leading to a significant drop in poppy cultivation in the area between 2010 and 2011.
• July 2010: Helmand Governor Mangal initially declares he will no longer seek support for wheat seeds and fertilizer for the Helmand Food Zone (HFZ), leading the UK to cut its budget. USAID later fills the funding gap when the governor changes his mind.
• 2010: The budget for counternarcotics law enforcement and interdiction peaks at $627 million.

2011:

• March 2011 – March 2014: DEA increases the number of operational Tactical Diversion Squads (TDSs) in the US from 37 to 66.

2012:

• 2012: An estimated 1.6 million drug analysis records are reported to participating US NFLIS state and local laboratories.
• 2012: Significant increases in opioid pain medication analyses by NFLIS-reporting labs compared to 2001: oxycodone (275%), hydrocodone (197%), morphine (334%).

2013:

• January – June 2013: NFLIS data shows a significant increase in heroin reports and cases in the US.
• June 2013: SIGAR audits the Afghan Special Mission Wing (SMW).
• December 2013: 49 US state laboratory systems, 96 local, and one territorial are participating in NFLIS.

2014:

• April 2014: Testimony to a US House subcommittee highlights the link between prescription drug abuse and rising heroin use in the US.
• 2014: MCN begins implementing a revised Good Performers Initiative (GPI) II, but it is phased out before coming into effect, and GPI is discontinued.

2015:

• 2015: A drug use survey in Afghanistan estimates 2 to 2.5 million drug users, with 1.3 to 1.6 million (5% of the population) being opiate users. Toxicology tests indicate high rates of drug use in households and among the Afghan National Police (ANP).
• October 2015: The Afghan National Drug Action Plan 2015–2019 is released.
• 2015: DEA FAST teams cease operating in a military-style raid capacity.

2016:

• 2016: Continued high levels of opium poppy cultivation in Afghanistan.

2017:

• Last quarter of 2017: The Afghan Special Mission Wing (SMW) flies 316 sorties, with 92% focused on counterterrorism and 8% on counternarcotics.

2018:

• SIGAR continues to report on US reconstruction efforts in Afghanistan, including counternarcotics.

DR. NEIL K. ANAND, MD Timeline of Events

• Summer 1993: Neil Anand completes organic synthesis of Squalamine at Rensselaer Polytechnic Institute (RPI).
• May 1996 – April 1997: Neil Anand completes sequencing of the Nitrogen Fixing Gene in Cyanobacteria at RPI.
• 1995 – 1997: Neil Anand attends the six-year medical program at Rensselaer Polytechnic Institute (RPI), earning a B.S., magna cum laude.
• Summer 1998: Neil Anand studies the effects of the priming of Neutrophils’ Superoxide Production at Albany Medical College.
• July – August 2000: Neil Anand researches the effects of nutritional interventions in head and neck cancer patients receiving radiation therapy.
• August 2000: Neil Anand presents research at “Radiation Oncology Update 2000” in Albany, NY.
• August 2000 – February 2001: Neil Anand conducts a clinical study of prostate cancer patients receiving pre-irradiation therapy.
• 1997 – 2001: Neil Anand attends Albany Medical College, earning an M.D. in May 2001.
• July 2001 – July 2002: Neil Anand completes an Internal Medicine Internship at NY University Downtown Hospital, NY.
• September 11, 2001: Neil Anand receives the NYU Hero’s Award for work done at the World Trade Center.
• January 2001 – May 2012: Neil Anand serves as a Lieutenant Commander in the US Naval Medical Corps, receiving an Honorable Discharge and specializing in Regional Anesthesia at Walter Reed Army Hospital.
• July 2002 – July 2005: Neil Anand completes an Anesthesiology Residency at Thomas Jefferson University Hospital, Philadelphia, PA.

• May 2005: Neil Anand lectures and presents a poster at the Society of Obstetric Anesthesia and Perinatology in Palm Springs, CA.
• May 2005: Neil Anand’s publication “Anesthetic Management of Malignant Hyperthermia Susceptible Patients Requiring Cesarean Section on the Same Day” is published in Anesthesiology.

• June 10, 2005: Neil Anand receives the Joseph Seltzer Award for Best Academic Resident from Thomas Jefferson Hospital.
• September 2005: Neil Anand lectures at the 6th Annual Symposium of Anesthesia History in Cambridge, England.
• 2005: Neil Anand publishes “Anand NK, Maguire DP. Anesthetic Implications for Patients with Rate-Responsive Pacemakers. Seminars in Cardiothoracic and Vascular Anesthesia”.
• 2005: Neil Anand publishes “Gift of the Gorgons: A History of Neuromuscular Blocking Agents from the Jungle to the OR, International Symposium on the History of Anesthesia”.
• July 2005 – July 2006: Neil Anand completes a Cardiothoracic Fellowship at the University of Miami Medical Center, Miami, FL, and conducts a clinical study of Dexametomidine in Outpatient Transesophageal Echocardiography.
• August 2006 – April 2007: Neil Anand is an Assistant Professor in Cardiovascular and Thoracic Anesthesiology at West Virginia University School of Medicine.
• April 2007 – November 2008: Neil Anand works at Enloe Medical Center in Chico, CA, as a Partner at Northstate Anesthesia Partners.
• November 2008 – October 2009: Neil Anand serves as Medical Director at Alliance Recruiting and Locums Inc.

• March 2009 – March 2010: Neil Anand is the Primary Cardiothoracic Anesthesiologist at Florida Medical Center Heart Institute in Fort Lauderdale, FL.
• March 2010 – February 2012: Neil Anand worked as a Partner at Lower Keys Medical Center in Key West, FL, and as a per diem physician at Albany Medical Hospital in Albany, NY.
• February 2012 – Present: Neil Anand is a Cardiothoracic Anesthesiologist at Aria Health in Philadelphia, PA.

• February 2013 – July 1, 2015: Neil Anand works as a Cardiothoracic Anesthesiologist at Deborah Heart and Lung Hospital, NJ.
• February 2013—Present: Neil Anand is the Chief of Pain Management at the Institute of Advanced Medicine Surgery (Roxborough Hospital/ Lower Bucks Hospital (former)/ Jefferson Frankford Hospital).
• May 2013: Neil Anand is a Keynote Speaker at the “Future of Medical Technology” event in Novosibirsk, Russia.
• July 2016: Neil Anand presents “Genicular Nerve Ablation with Phenol: A Paradigm Shift” at the AAPI Research Symposium during the 34th Annual Convention.
• June 2017: Neil Anand presents “Popliteal Nerve Block in Guillain-Barre Syndrome” at the AAPI Research Symposium during the 35th Annual Convention in Atlantic City, NJ.
• July 2017: Neil Anand founds/becomes Medical Director of Ezdispensing LLC/ezdispensing.com.

• August 2017: Neil Anand founds/becomes Medical Director of Integrity Dispensing LLC/integritydispensing.com.
• November 2017: Neil Anand participates in a Research Panel Discussion & Presentations on Genicular Nerve Ablation with Phenol for Chronic Knee Pain and the successful use of Popliteal Nerve Steroid Injection in a patient with Guillain-Barre Syndrome Chronic Pain at the American Society of Regional Anesthesia in Orlando, Florida.
• September 2018 – Present: Neil Anand serves as Chief of Anesthesiology at the Ambulatory Endoscopic Surgery Center of Bucks County.
• Employment (ongoing as of the CV date): Neil Anand has successfully completed 700+ Heart and Lung Surgeries.

DRUG DEALER IN A WHITE COAT

Ongoing: PDMP

• PDMPs evolve from passive data collection to sophisticated electronic databases that analyze information and apply algorithms to assess patient risk.
• Law enforcement agencies like the DEA utilize PDMP data for surveillance of prescribers, dispensers, and patients, raising concerns about potential overreach and impact on legitimate medical practice.
• Third-party payers increasingly seek access to PDMP data for various purposes, including fraud detection, quality improvement, and cost reduction, but concerns about data privacy and misuse exist.
• The definition and calculation of Morphine Milligram Equivalents (MME) per day are shown to have significant variability, impacting how high-dose patients are identified and potentially affecting policy and legal interpretations.
• Research highlights the limitations of relying solely on PDMP data and MME calculations without considering patient characteristics, benefits of opioid use, and social determinants of health.
• Concerns are raised about the potential for “predictive policing” based on PDMP data to disproportionately impact certain patient populations and lead to unintended harmful consequences.

morphine milligram equivalents (MME)

critical limitations and biases inherent in how opioid prescribing and use are assessed using metrics like

In politics and economics, a Potemkin village is any construction (literal or figurative) whose sole purpose is to provide an external façade to a country that is faring poorly, making people believe that the country is faring better. The term comes from stories of a fake portable village built by Grigory Potemkin, former lover of Empress Catherine II, solely to impress the Empress during her journey to Crimea in 1787.

A significant limitation is the lack of a universally standardized method for calculating MME per day despite its widespread use in guidelines and regulations. The conversion factors used to determine equivalent analgesic effects have also been adopted to represent toxicological risks, even though they are based on pain relief and not necessarily on overdose risk.

According to Nasburn Dasgupta despite its widespread use and integration into law, there are at least four distinct, often overlooked, methods for calculating daily MME.

This variation in calculation, stemming primarily from different interpretations of “day” in the metric, leads to substantial discrepancies in identifying high-dose opioid users, impacting research, policy, and clinical practices.

Different definitions of “day” in the “MME per day” calculation can lead to substantial variations in the determined daily dose for the same patient, potentially misclassifying patients as high-dose or not. 

Dasgupta demonstrates how these different definitions yield conflicting results when analyzing the same patient data and comparing opioid prescribing patterns across states. 

Dasputa points out, “Algorithms based solely on data related to opioid dispensing and use, without considering patient characteristics, benefits of treatment, or alternative sources of opioids, are inherently biased towards finding ‘risk of harm.”

He further argues that the lack of standardization undermines the validity of MME as a clinical metric and calls for greater transparency in reporting the specific calculation method used. 

FEDERAL INMATE (19519424)

VOLKMAN PAUL H 

MEDICAL DOCTOR, PH.D., BOARD CERTIFIED EMERGENCY MEDICINE, PAIN MANAGEMENT FELLOWSHIP TRAIN, 4 LIFE TERMS

Paul H. Volkman, MD, Ph.D., is a 78 year old MD (The University of Chicago, 1974), with a PhD in Pharmacology and Toxicology (The University of Chicago, 1972), board certified in Emergency Medicine, Pediatrics, and Pain Management, and Fellowship Trained in Clinical Pharmacology (The University of Chicago, 1975-77). 

Dr. Paul H. Volkman, MD., practiced Emergency Medicine, Pediatrics, Family Medicine, and Pain Management for 42 years, and despite the fact that he provided overwhelming expert testimony in medical malpractice lawsuits for 17 years, he was convicted of “Drug Trafficking and sentenced to 4 life terms (totaling 850 years).*

Dr. Volkman stated he has been in federal prison for 12 years for purportedly issuing controlled substance prescriptions to my pain patients “without a legitimate medical purpose.” However, in June 2022, the United States Supreme Court case No: 20-1410 of Drs. Xiuli Ruan and Shakeel Khan overturned their convictions; Held Section 841’s

“Knowingly or intentionally,” mens rea applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his or her conduct was “authorized,” the Government must prove beyond a reasonable doubt that the de- fendant knowingly or intentionally acted in an unauthorized manner. Pp. 4–16.. [ref.1]

Volkman’s Case Demonstrates the Problematic Nature of “Scope of Practice” OVERREACH Prosecutions:

The Case of Paul H. Volkman, MD, Ph.D, addresses an impermissible invasion of the federal government into state affairs where the practice of medicine is solely regulated by state medical boards (pg 3) and demonstrated the problematic nature of scope of practice prosecution based on D.E.A.’s pre-crime criminal forensic, computerized, artificial bits of intelligence cannot measure or determine scienter while no published documents verified the validity and reliability of an artificial intelligence’s measure of a human mind’s scienter.

The Physicians Against Abuses (PAA) filed an Amicus Curiae Brief to support Xiulu Ruan, a petitioner, before the United States Supreme Court, arguing that the Overreach of Federal Prosecutors is improperly intruding into the realm of medical practices, which is traditionally and legally regulated by state medical boards. They contend that without medical expertise or direct regulatory authority over medical practice standards, federal prosecutors are ill-equipped to determine what constitutes a legitimate medical purpose or falls outside the “scope of professional practice.”

“It is not the federal government that regulates the practice of medicine and thus no federal prosecutor should be permitted to argue in court that a physician criminally violated the standard of care unless and until a criminal referral is generated by the state medical board where the accused physician practices.” (p. 3)

We normally characterize this interpretive maxim as a presumption in favor of ‘scienter,’ by which we mean a presumption that criminal statutes require the degree of knowledge sufficient to ‘mak[e] a person legally responsible for the consequences of his or her act or omission.’” (quoting Black’s Law Dictionary 1547 (10th ed. 2014), brackets in the decision).

Dasgupta:

“This “less is better” bias can lead to a focus on reducing opioid use by comparison within a dataset, rather than identifying true harm or considering individual patient needs. “

“Yale Law and Policy Review”

Most importantly, an article, “The Misinformed & Misguided Prescription Abuse Prevention Act: A Response to Delfino,” by Robert Capodilupo and Jacob James Rich, published in “Yale Law and Policy Review” — Inter Alia (Spring 2023), the authors pointed out that, while opioid prescribing has declined over the past decade, total opioid deaths have skyrocketed because of a spike in illicit opioid overdoses. 

• his conviction occured before the wide use of pdmp but did D.E.A.’s use of involved “MME”

How are PDMP data being used by law enforcement, particularly the D.E.A. and what are some potential concerns related to this?

Law enforcement agencies, including the D.E.A. utilize PDMP data to surveil the prescribing habits of healthcare providers, dispensing practices of pharmacies, and controlled substance histories of patients. Statistical models are sometimes used to identify aberrant patterns that may indicate criminal activity, such as fraudulent billing or medication abuse.

The D.E.A can only investigate crimes where they can look for them, and PDMP data provides a basis for investigations into patients, prescribers, and pharmacies involved with opioids. A key concern is that predictive modeling used by these algorithms doesn’t predict future behavior of individuals but rather what the D.E.A. will do in response to patterns associated with past opioid prescribing deemed aberrant.

Furthermore, algorithms lacking comprehensive patient data and focusing primarily on “harms” associated with opioid use will lead to biased outcomes. Accoding to Dr. Terry Lewis, “PDMPs, initially intended for safety, have become surveillance tools, leading to “vicarious harms” on those whose data is targeted.”

How are third-party payers (insurers) increasingly utilizing PDMP data, and what are this trend’s potential benefits and risks?

Third-party payers, including Medicaid, Medicare, workers’ State and local police departments, compensation programs, and increasingly private insurers, notwithstanding States restricting and/or monitoring birth control, are gaining access to and utilizing PDMP data.

This allows them to monitor enrollees who may be “doctor shopping” or obtaining or dispensing “large quantities,” of controlled substances, identify those in need of substance abuse treatment, detect potential fraud and abuse, and improve the overall quality and cost-effectiveness of care. By analyzing bulk PDMP data, payers can identify issues like overlapping prescriptions and cash-paid prescriptions obtained on the same day as those paid by insurance.

However, concerns have been raised about a potential “chilling effect” on legitimate prescribing if data is not used prudently and appropriately. Risks are also associated with this increased access, including the need for safeguards to ensure data is used as preliminary indicators rather than definitive proof of wrongdoing, and the importance of considering various interventions beyond simply referring cases to special investigative units.

Pre-crime ideology intervenes to punish, disrupt, incapacitate, or restrict those deemed to embody future crime threats. The term precrime embodies a temporal paradox, suggesting that a crime has not occurred and that the crime that has not occurred is a foregone conclusion.

In practice, that principle has led to “the understanding that an injury is criminal only if inflicted knowingly.” Id.; see also Elonis v. United States, 575 U.S. 723, 734 (2015) (“[W]rongdoing must be conscious of being criminal.” (quoting Morissette v. United States, 342 U.S. 246, 252 (1952))). See Morissette v. United States, 342 U.S. 246, 250, 72 S. Ct. 240, 96 L. Ed. 288 (1952) (“The contention that an injury can amount to a crime only when inflicted by intention is no provincial or transient notion. 

The Government, through the National Benefit Integrity Medic (NBI MEDIC) engages in Pre-Crime, criminal forensics, data analytics, artificial intelligence, and computer programs, with titles like “Multi-Prescriber Vulnerability”, “Pill Mill Doctor” project, Trio Prescriber 1.0 and 2.0, Doctor Shopper Prescriber, Pill Mill Prescriber 2.0, Subsys Analysis, Death Analysis, Peer Comparison, Prescriber Schedule II Controlled Substances Risk Assessment 1.0, Pharmacist Clinical Reviews, Subsys Analysis, Death Analysis, Predictive Model Learning Analytics Tracking Outcome (PLATO) tool and Peer Comparison PLATO Profile.

Steven Spielberg’s film Minority Report, loosely adapted from the story, brought the concept to wider public attention. 

Modern computer scientists and philosophers argue against the possibility of pre-crime predictions of human behaviors. They believe artificial intelligence is incompatible with a human mind due to violations of the Church-Turing thesis, Taski’s undefinability theorem, and Godel’s incompleteness theorems.

Clarence Darrow

“…putting people into prison will not help sick people get well, whereas giving them medicine will…”

It is as universal and persistent in mature systems of law as belief in freedom of the human will and a consequent ability and duty of the normal individual to choose between good and evil.”

Regulatory Considerations and Future Directions: Evaluating Third-Party Payer Use:

Study the impact of third-party payer access to PDMP data and develop process and outcome measures to evaluate its effectiveness and identify best practices.

According to Ashley Rogers, a pain care activist and supporter of Dr. Neil Anand, MD, (aka THE RED HEAD MAKING GOOD TROUBLE),*** the PDMP fails to take clinical information such as genetics (pharmacy-genomic).

For example, the MC1-r gene found in individuals with Red Hair, Albinos, may be more sensitive to certain types of pain and can require higher doses;

“…NIH Research has shown that people with red hair perceive pain differently than others. They may be more sensitive to certain types of pain and can require higher doses of some pain-killing medications. However, studies suggest that their general pain tolerance may be higher. People with red hair also respond more effectively to opioid pain medications, requiring lower doses. 

People with red hair have a variant of the melanocortin-1 receptor (MC1R) gene. This gene controls the production of melanin, the pigment that gives skin, hair, and eyes their color. The cells that make melanin produce two forms—eumelanin and pheomelanin. People with red hair produce mostly pheomelanin, which is also linked to freckles and fair skin that tans poorly...”

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**at the trial of Dr. Neil K. Anand, MD Prosecutors demanded the sitting Judge to have both Ms. Rogers and her Husband along with activists Dr. Christopher Russo, MD removed from the court room, as the prosecution team were very visibly upset by their presence. The group further reports the U.S. Marshall Service had been over heard saying “the Red Head is trouble,” was ordered to be extremely agressive as they further ordered the group to sit up with their hands in front of them throughout the course of these proceeding in the U.S. Federal District Court in Philadelphia.

FDA Regulation of CDS Software

FDA Regulation of CDS Software: The FDA is examining whether PDMP software and related risk scoring tools meet the definition of a “medical device” and are therefore subject to FDA regulation, particularly if they provide specific diagnostic or treatment outputs or directives.

“FDA is ‘responsible for protecting the public health by ensuring the safety, efficacy, and security of . . . medical devices . . .’”

“[S]oftware function that identifies patients with a possible diagnosis of opioid addiction based on analysis of patient-specific medical information… is a device function. It does not meet Criterion 3 because it provides a specific diagnostic or treatment output or directive.”

Importance of Defining “Day” in MME Calculations: Researchers emphasize the significant impact of how the “day” component is defined in MME per day calculations on identifying high-dose patients and evaluating interventions. Definition 2 (“on therapy days”) is suggested as a more face-valid approach.

“So we’ve so far concentrated on the Mme. Part of the Mme. Per day metric. What we haven’t considered is the denominator, the word day. So to borrow a line from the musical Rent, the fundamental question is, How do we measure a day in a patient’s life?”

Need for Transparency and Validation in Algorithms: PDMP software should provide clear information about the inputs, algorithms, datasets, and validation used to generate risk scores and recommendations to enable independent evaluation by healthcare professionals.

“In order to describe the basis for the recommendations, regardless of the complexity of the software and whether or not it is proprietary, the software output or labeling should provide adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation.”

Funding and Interoperability: Federal funding programs support the development, implementation, and interoperability of PDMPs across states and with EHRs.

“BJA’s Harold Rogers PDMP grants have supported interstate interoperability for almost a decade…”

Conclusion:

PDMPs represent a complex and evolving tool in addressing prescription drug abuse and improving patient safety. While evidence indicates their potential effectiveness in specific areas like reducing doctor shopping and informing prescribing, significant concerns remain regarding their use as surveillance tools, the potential for algorithmic bias, and the lack of standardization in key metrics.

Future efforts should focus on enhancing data quality, ensuring transparency in algorithmic processes, establishing best practices for data sharing with third-party payers with appropriate safeguards, and evaluating the impact of PDMPs on public health and individual patient care.

The nuances in calculating MME per day and the potential for misclassification highlight the need for careful consideration in policy and enforcement related to opioid prescribing.

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REFERENCES:

Cast of Characters and Brief Bios:

• Jed Nitzberg: A DEA Supervisory Diversion Investigator who, in a webinar, denies that the DEA uses PDMPs to “troll” for suspicious patients and providers, stating they require a case and a subpoena.
• Elizabeth Chiarello, PhD: An Associate Professor of Sociology at Saint Louis University who critiques PDMPs, arguing they have become surveillance tools that turn pharmacists into “undercover cops” who police patients.
• Dr. Nabarun Dasgupta: A researcher who presents findings on the variability in calculating Morphine Milligram Equivalents (MME) per day and its implications for identifying high-dose opioid users, policy, and potential misclassifications. He advocates for transparency in MME calculations and suggests Definition 2 (on therapy days) as a more face-valid approach. He also raises concerns about the use of MME in overdose mortality studies due to its basis in analgesic effect rather than toxicology.
• Beth Darnall: Participates in the discussion following Dr. Dasgupta’s presentation, highlighting the variability in MME calculations and asking for recommendations for clinicians and researchers to minimize this.
• Chad D. Kollas, MD, FACP, FAAHPM: Medical Director of Supportive & Palliative Care at Orlando Health Cancer Institute, who presents on the influence of PROP and CDC on failed national opioid policy, suggesting issues with the policy landscape surrounding opioid prescribing.
• Sharon Reif: Senior Scientist at the Institute for Behavioral Health, Brandeis University, affiliated with the PDMP Center of Excellence.
• Nick Reuter: Senior Public Health Advisor, Division of Pharmacologic Therapy, Substance Abuse and Mental Health Services Administration (SAMHSA).
• Ian Reynolds: Senior Associate, Pew Prescription Project, Pew Charitable Trusts.
• Anne Rogers: Data & Research Manager, Maine PDMP.
• Becky Salay: Trust for America’s Health.
• Dr. Dale Slavin: Associate Director for Programs, Acting Director for Safe Use Initiative, Center for Drug Evaluation and Research, Food and Drug Administration (FDA).

• Jeane Tuttle: Pharmacist Program Manager, Department of Veterans Affairs (VA).
• Don Vogt: PDMP Administrator, Oklahoma PDMP.
• Dongchun Wang: Economist, Workers Compensation Research Institute.
• Chris Watson: Captain, U.S. Department of Health and Human Services, Indian Health Service (IHS).
• Sarah Wattenberg: Senior Advisor on Substance Abuse Policy, Office of the Assistant Secretary of Health, Department of Health and Human Services.
• Gary Wirth: Pharmacist and Contracting Officer Representative, Medicare Drug Benefit Group, Medicare Part D, Centers for Medicare and Medicaid Services (CMS).
• Mike Wissel: Pharmacy Specialist, Michigan PDMP.
• Bruce Wood: Assoc General Counsel & Director of Workers Compensation, American Insurance Association.
• H. Westley Clark: Director, Substance Abuse and Mental Health Services Administration (SAMHSA), who communicated the potential roles of PDMPs.
• The PDMP Center of Excellence at Brandeis University: An organization that studies and provides information on the effectiveness and implementation of Prescription Drug Monitoring Programs.
• The Bureau of Justice Assistance (BJA): A component of the U.S. Department of Justice that provides funding and support for PDMP initiatives through programs like the Harold Rogers PDMP National Training and Technical Assistance Program.
• The Drug Enforcement Administration (DEA): A federal law enforcement agency that utilizes PDMP data for investigating drug diversion and misuse.
• Third Party Payers (Insurers, Medicaid, Medicare, Workers’ Compensation): Entities that have an interest in PDMP data for purposes of medical necessity review, fraud detection, and potentially cost reduction.