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. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, 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., TERENCE SASAKI, 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
CITIZEN PETITION
The Center for U.S. Policy (“Petitioner”) submits this Citizen Petition under the Federal Food, Drug and Cosmetics Act (“FD&C Act”) to request the Commissioner of the U.S. Food and Drug Administration (“FDA”) to deem the Bamboo Health (“Bamboo”) NarxCare software a misbranded device and take administrative action to prevent serious, adverse health consequences and death
STATEMENT AND FINDINGS
NarxCare is a clinical decision support (“CDS”) software product that meets the definition of a “device” under the FD&C Act. Yet, based on a search of FDA’s publicly available databases, it appears that the device’s manufacturer, Bamboo, is in violation of several provisions of the Act and its implementing regulations. Specifically, before introducing NarxCare into interstate commerce, Bamboo did not comply with the establishment registration, device listing, or premarket notification requirements set forth in Section 510 of the Act.1
Therefore, FDA should deem NarxCare a misbranded device and take appropriate administrative action to prevent serious, adverse health consequences or death. As explained herein, such administrative action is particularly important given that Bamboo’s software has fundamentally altered the practice of medicine in the U.S. to the detriment of patients with a legitimate need for controlled prescription medications and the health care providers who treat such patients.
JENNIFER OLIVA ESQ
”..DEA’s Prescription Drug Monitoring Program (PDMP) predictive platforms deserve serious scrutiny because they are the only law enforcement-developed digital surveillance systems that health care providers have ever utilized to diagnose and treat patients. Providers may rely on unvalidated PDMP risk scores to make prescribing decisions because they view those scores as clinically useful…”
GOT IT RIGHT
STATEMENT AND FINDINGS
.
Many states’ PDMP laws require health care providers (“HCPs”) and pharmacists to query the PDMP under certain circumstances, such as the first time an opioid prescription is issued, upon issuing an opioid prescription with a dose exceeding a specified level, or upon set intervals for patients treated for pain.
As recognized by law enforcement Bamboo, “[m]any PDMPs started as law enforcement tools, but most have migrated to a clinical decision support focus with hopes that providers and pharmacists will more carefully consider and manage the risks and benefits of opioids and other controlled substances.”
Indeed, today’s PDMPs are no longer passive data collection and storage programs, but rather sophisticated electronic databases that store and analyze vast amounts of information and apply algorithms to score patient risk for controlled substance misuse and to guide treatment decision.
JENNIFER OLIVA ESQ
“…In addition, law enforcement agencies like the DEA utilize PDMP data to surveil prescribers, dispensers, and patients and determine whether providers are prescribing or dispensing controlled substances to patients to warrant a criminal investigation..
…Given the potential consequences of being deemed an overprescribed or over dispensed by the DEA, ranging from criminal investigation to controlled substance licensure suspension and revocation to arrest and incarceration, it is fair to conclude that PDMP surveillance impacts prescribing and dispensing decisions…”
GOT IT RIGHT
STATEMENT AND FINDINGS
Serious, Adverse Health Consequences and Death
Many states’ PDMP laws require health care providers (“HCPs”) and pharmacists to query the PDMP under certain circumstances, such as the first time an opioid prescription is issued, upon issuing an opioid prescription with a dose exceeding a specified level, or upon set intervals for patients treated for pain.11
As recognized by Bamboo, “[m]any PDMPs started as law enforcement tools, but most have migrated to a clinical decision support focus with hopes that providers and pharmacists will more carefully consider and manage the risks and benefits of opioids and other controlled substances.”12
Indeed, today’s PDMPs are no longer passive data collection and storage programs, but rather sophisticated electronic databases that store and analyze vast amounts of information and apply algorithms to score patient risk for controlled substance misuse and to guide treatment decisions.13
WE NEED SENATORIAL HEARINGS TO HOLD DEA ACCOUNTABLE
LAW PROFESSORS JENNIFER OLIVA, ESQ AND KELLY DINEEN, ESQ
“…The DEA’s software criminal forensic tools use evidentiary plausibility standard that misrepresents the statutory, beyond a reasonable doubt, criminal evidence standard. A public/private partnership named HFPP (Healthcare Fraud Prevention Partnership) selects physicians based on race, gender, age, financial assets, real estate, and nation of origin as a suspect class, preventing those physicians from practicing medicine in a race or gender-neutral manner by coordinating selective enforcement of the Controlled Substance Act…
Under the “State Involvement Doctrine,” such behavior is improper because the software scheme violates the 14th Amendment, the Equal Protection Clause of the U.S. constitution. The software data analytic services or data is sold to HFPP for cash or in-kind data information.
The HFPP uses the data analytics used to manufacture probable cause to induce and coordinate criminal proceedings via an improper standard of evidence. Such behavior occurred in violation of 5 C.F.R. § 2635.501 – 503 (Subpart E – Impartiality in Performing Official Duties)..”
GOT IT RIGHT
STATEMENT AND FINDINGS
In 33 years as an assistant United States attorney, Pratt has prosecuted some of Michigan’s most “notorious narcotics traffickers and corrupt healthcare providers.” It is said that Wayne F. Pratt, Chief of the Health Care Fraud Unitfor the U.S. Attorney’s Office for the Eastern District of Michigan, has saved Medicare nearly $1 billion and has done more to fight health care fraud than almost anyone else in the U.S. Department of Justice.
Since becoming fraud unit chief in 2010, the federal officials have successfully prosecuted more than 50 doctors and 30 pharmacists for felony violations involving fraud, controlled substances, and kickbacks.
However, a decade of Blue Cross Blue Shield’s influence has twisted Chief Prosecutor AUSA Pratt’s body and mind; he has indicted healthcare providers based on Blue Cross Blue Shield’s precious bidding. The love and hate relationship with his “precious” Master, Blue Cross Blue Shield, has gradually corrupted him like Gollum by the ring’s power. And like Gollum, he has come to love and hate himself.
AUSA WAYNE PRATT ESQ.
LAW PROFESSOR KELLY DINEEN…”Several insurance companies encouraged the CDC to impose limits on doctors prescribing Oxycontin and to taper their patients. Opioids are very expensive. The insurance companies were fortified in their erroneous belief by the efforts of a certain organization of doctors who are not pain management specialists.
GOT IT WRONG
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STATEMENT AND FINDINGS
Bamboo’s software has fundamentally altered the practice of medicine and disproportionately impacts certain patient populations. PDMPs were not designed to replace prescribers’ professional judgement, diagnose health conditions, or dictate patients’ course of care.
Yet, law enforcement agencies like the DEA utilize PDMP data to surveil HCPs’ prescribing habits, dispensers’ practices, and patients’ controlled substance histories.38 If deemed an “over-prescriber” or “over-dispenser” by the DEA, individuals may be subject to administrative and criminal investigation, controlled substance registration suspension and revocation, and in some cases, arrest, asset seizure, prosecution, and incarceration.39
Out of fear of being labeled as an opioid over-prescriber and having to defend against administrative and criminal allegations, providers are pressured to change their prescribing habits.40 Indeed, “research demonstrates that PDMP risk scoring coerces clinicians to force medication tapering, discontinue prescriptions, and even abandon patients without regard for the catastrophic collateral consequences that attend to those treatment decisions.”41
This fear has provoked prescribers to drop or decline patients with pain and other patients for whom opioids and other controlled substances are medically necessary.42 In 2020, the opioid dispensing rate reached its lowest point in 15 years.43 Effectively, the software has played a significant, and often unwarranted, role in the choice not to prescribe opioids.
As a result, many patients have been left without access to medically necessary treatments.44 In recent years, the percentage of patients undergoing opioid dose tapering has increased substantially.45
JENNIFER OLIVA ESQ
GOT IT RIGHT
KELLY DINEEN ESQ
GOT IT RIGHT
GOT IT RIGHT
NEIL ANAND, MD
GOT IT RIGHT
JUANDOLYN STOKES
GOT IT RIGHT
CATHLEEN LONDON, ESQ
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GOT IT RIGHT
HELEN BOREL, RN, Ph.D
DEFINITELY GOT IT RIGHT
Zachery Siegel
GOT IT RIGHT
LINDA CHEEK, MD
WALTER F. WREEN, MD
BOTH GOT IT RIGHT
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FOR NOW, YOU ARE WITHIN
THE NORMS
END NOTES
3 Centers for Disease Control and Prevention, Provisional Drug Overdose Death Counts, NATIONAL CENTER FOR HEALTH STATISTICS (Feb. 15, 2023), https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
4 D’Souza, et al., Prescription Drug Monitoring Program.
5 Id.
6 Id.
7 Substance Abuse and Mental Health Services Admin., Prescription Drug Monitoring Programs: A Guide for Healthcare Providers, 10 IN BRIEF, 1, 1 (2017), https://store.samhsa.gov/sites/default/files/d7/priv/sma16-4997.pdf. 8 Jennifer Oliva, Dosing Discrimination: Regulating PDMP Risk Scores, 110 CALIFORNIA LAW REVIEW 47, 75 (2022) (citing Substance Abuse and Mental Health Services Administration, IN BRIEF, Prescription Drug Monitoring Programs: A Guide for Healthcare Providers 1,1 (2017)).
9 Id. at 75 (citing Prescription Drug Monitoring Program Training & Tech. Assistance Ctr., History of Prescription Drug Monitoring Programs 1, 3 (Mar. 2018), https://perma.cc/X3KX-GE4F).
10 D’Souza, et al., Prescription Drug Monitoring Program.
11 Appriss Health, Up Front, Every Patient, Every Time 1, 3, https://perma.cc/K2S4-Z88Z.
12 Id.
13 Oliva, supra note 8, at 76 (citing Substance Abuse & Mental Health Serv. Admin., Prescription Drug Monitoring Programs: A Guide for Healthcare Providers, at 1).
36 Oliva, supra note 8, at 100. 37 Id.
38 Id. at 51.
39 Id.
40 Id. at 79 (citing Kelly K. Dineen & James M. Dubois, Between a Rock and a Hard Place: Can Physicians Prescribe Opioids to Treat Pain Adequately While Avoiding Legal Sanction?, 42 AM. J. L. & (2016)).
41 Id. at 1.
42 Id. at 78 (citing Rebecca Haffajee et al., Mandatory Use of Prescription Drug Monitoring Programs, 313 JAMA 891, 891–92 (2015)).
43 Ctr. For Disease Control & Prevention, U.S. Opioid Dispensing Rate Maps
Print, https://www.cdc.gov/drugoverdose/rxrate-maps/index.html (last reviewed Nov. 10, 2021).
44 Oliva, supra note 8, at 78 (citing Cato Institute, The Myth of an Opioid Prescription Crisis (Sept.-Oct. 2017), https://www.cato.org/sites/cato.org/files/serials/files/policy-report/2017/9/cpr-v39n5-4.pdf
45 Joshua Fenton, Trends and Rapidity of Dose Tapering Among Patients Prescribed Long-term Opioid Therapy, 2008-2017, 2 JAMA NETWORK OPEN 1,1 (Nov. 5, 2019), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2755492.
LETTER TO RON CHAPMAN ON VICTORY OVER DEA IN COLUMBUS GA, US VS DR. THOMAS SACHY
FROM GEORGINE ROBERTSHAW: MAY 2023
Congratulations.
“There are so many pain patients in our country currently suffering (and I do mean “suffering”) from debilitating conditions because of the CDC and DEA. The tactics used by the DEA make it appear as though we are living in China or Russia!
The CDC only sought advisement from biased, anti-opioid zealots when they wrote their “2016 Opioid Guidelines.” Faced with study after study repudiating them (including their own statistics), whether it’s because of pride or possible fear of admitting to advisement from only unqualified consultants in writing the outrageous Guidelines, they won’t do the appropriate thing and trash them. Pain patients and their doctors were NEVER the cause of the drug crisis in this country.
They chose the “easiest targets” to fight the crisis, but as most people know, drug overdoses have continued to skyrocket in spite of huge reductions in prescribing and manufacturing of opioid medications, which proves that these two groups were never the cause!
Congress also needs to investigate the ‘backdoor’ tactics the CDC used in writing the Guidelines, and the VA and States must not blindly follow them and should immediately trash any Guidelines they instituted that were based on the CDC Guidelines. Someone needs to answer for all of the deaths and suicides of pain patients who were stripped of their pain medications and could not handle the pain any longer–many of them our veterans, who deserve much better.”
ANGELA GREEN- JOHNSON, WLMER LEON PH.D.
(NUPE) LEROY BAILER
ESPECIALLY GOT IT RIGHT
ORDER OF THE COIF
*ORDER OF THE COIF*
ORDER OF THE COIF !!!
STAND DOWN
