sections republished from kevinMD,
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
“…Bamboo’s software has fundamentally and wrongfully altered the practice of medicine in the U.S. to the detriment of patients with a legitimate need for controlled prescription medications and the healthcare providers who treat such patients…”
Our patients’ stress is not the result of an orchestrated set of practice guidelines or a comprehensive clinical policy but rather one government agency’s crude, broad-stroke technique to mitigate a public health crisis through manufacturing limits — the gradual and repeated rationing of how much opioids can be produced by legitimate entities. … They do not understand why we, doctors whom they trust, send them on wild goose chases. They do not understand how pharmacies fail to provide the medications they need to function. They do not understand why the system makes them feel like “drug seekers.”
ADDENDUM TO THE SUMMARY OF THE REPORT TO THE FDA FURTHER POINTS OUT:
As healthcare predictive algorithms, including Prescription Drug Monitoring Programs (PDMP), expand their reach beyond traditional enforcement of healthcare regulations, the concept of a social credit score has emerged as a powerful but controversial tool.
Like predictive policing, social credit scores use an individual’s behaviors, online activity, and social interactions to assess their perceived trustworthiness and risk to society. They are also used as fodder for the prosecution of healthcare providers.
The widespread adoption of predictive tools like social credit scores, predictive policing, and PDMP algorithms is changing how societies define criminality and risk.
physical dependence and addiction
“DEA authorizes DEA-registered practitioners to treat patients according to their professional medical judgment under a standard of medical practice generally recognized and accepted in the United States.
The distinction that seems especially difficult for law enforcement officials and policymakers
According to the 2005 Ronald Libby Executive Summary Report, Treating Doctors as Drug Dealers, The Drug Enforcement Administration’s War on Prescription Painkillers:
The distinction that seems especially difficult for law enforcement officials and policymakers to make is between physical dependence and addiction.
A patient incapacitated by pain will naturally become dependent on any medication that gives him relief, but such dependency is quite different from addiction.
Opioid therapy can give patients the freedom to lead everyday lives, whereas addiction ruins lives. Confusing the two situations can be tragic.
The DEA defines an “addict” as “any individual who habitually uses any narcotic drug to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control about his addiction.”(122)
One important example is the DEA’s conception of an addict, which includes what pain specialists call “pseudoaddicts”—pain patients who require opiates to lead an everyday life.
Pain specialists, however, make an important distinction between patients who depend on opiates to function normally—to get out of bed, tend to household chores,
….and hold down jobs—and addicts who take drugs for euphoria and whose lifestyles deteriorate as a result of taking opiates instead of improving. The DEA makes no such distinction. By classifying pain patients as addicts, the agency can pursue their doctors as “distributors.”
However, these systems do not make communities safer because they confuse who is most likely to commit a crime with who is most likely to be arrested.
Instead, they are amplifying systemic biases and entrenching the surveillance and punishment of already marginalized populations.
If we are to create fair and just societies truly, we must recognize the difference between predicting crime and predicting arrest and reform these systems before they become tools of institutionalized exclusion.
1. NarxCare is not a non-device CDS.
NarxCare does not satisfy any of the criteria outlined in section 520(o)(1)(A)-(E) of the FD&C Act for non-device CDS products.
b. NarxCare does not satisfy section 520(o)(1)(B).
Section 520(o)(1)(B) applies to a software function that is intended for maintaining or encouraging a healthy lifestyle and that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. NarxCare is not intended to maintain or encourage a healthy lifestyle, and its intended use is related to the mitigation or prevention of disease.
As the FDA explains in its guidance on 520(o)(1)(A)-(D), the FDA considers a product with an intended use for maintaining or encouraging a “healthy lifestyle” to mean a product with an intended use that encourages or maintains a “general state of health or healthy activity,”
Section 520(o)(1)(C)(iii) applies to a software function intended to serve as electronic patient records, so long as, among other things, “such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.”
c. NarxCare does not satisfy section 520(o)(1)(C).
However, NarxCare is intended to interpret or analyze patient records for the purpose of the mitigation or prevention of SUDs, including the disease of opioid use disorder. Therefore, the software does not satisfy section 520(o)(1)(C).
DR. MARK IBSEN, MD., ON EXAMPLE OF PHARMACIST OVERREACH
The system, with flawed data, not only leads to the unjust prosecution of minority physicians in a biased fashion but also targets minority patients—the “undesired,” “deplorable,” including racial and ethnic minorities, children, and the elderly.
A notable example involved Dr. Muhamad Aly Rifai, whose case was highlighted in a November 14, 2022, DOJ press release. The DOJ’s claims focused on Medicare fraud allegations, casting Dr. Rifai as a significant figure in healthcare fraud.
It is time to lock out law enforcement from the PDMPs unless they have a subpoena and a specific LAWFUL REASON to need the data for a specific case. The individual’s healthcare data, as is their relationship with their provider, is private. The government needs to lock down healthcare now, protecting it before they destroy it... renee blare, PharmD
Such public statements can have lasting impacts on the reputations of healthcare providers, much like financial credit scores affect personal financial standing.
Although the DOJ intends to protect public resources, the consequences of these statements are often disproportionate and damaging.
In USA v. Muhamad Aly Rifai, the prosecution claimed that psychiatric services provided lawfully and accurately to the dispensable elderly in rural Pennsylvania were “not medically necessary” despite severe psychiatric illness and suicidal ideation.
In USA v. Bothra, the DOJ called 25,000 minority patients, who are inner-city Detroit residents with significant disabilities, “addicts,” even though many of these patients have longstanding chronic pain issues related to true physical disease.
Center-for-US-Policy-FDA-Citizen-Petition-copy-1Download
NarxCare does not satisfy FDA GUIDELINES
The United States Department of Justice (DOJ) has had a long tradition of using “social scandal” in its press releases touting the prosecutions of U.S. physicians.
With some success, the DOJ has capitalized on advancements in utilizing social credit scores to shore up its activity in pressuring physicians accused of malfeasance related to health care services.
Once a scandalous press release from the DOJ is launched onto the World Wide Web, it is there forever with all the unjust and untrue allegations in it: “Lehigh Valley psychiatrist stole from Medicare,” the DOJ proclaimed in the press release dated November 14, 2022, as if Muhamad Aly Rifai, MD, were the sole reason why the Medicare system is going to become insolvent in the next few years.
Such pronouncements and allegations sully the social credit score of the unjustly accused, much like how bankruptcy due to medical debt destroys the financial credit score of an American today. These social credit scores are often touted as a way to enhance public safety by claiming to predict who is most likely to commit a crime.
However, this claim is deeply flawed. Social credit systems are far more adept at predicting who is most likely to be indicted or arrested than identifying actual criminal behavior. This critical distinction blurs between prevention and profiling, justice and surveillance.
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Notes* Muhamad Aly Rifai is a practicing internist and psychiatrist in the Greater Lehigh Valley, Pennsylvania. He is the CEO, chief psychiatrist, and internist of Blue Mountain Psychiatry. He holds the Lehigh Valley Endowed Chair of Addiction Medicine. Dr. Rifai is board-certified in internal medicine, psychiatry, addiction medicine, and psychosomatic medicine. He is a fellow of the American College of Physicians, the Academy of Psychosomatic Medicine, and the American Psychiatric Association. He is the former president of the Lehigh Valley Psychiatric Society.
d. NarxCare does not satisfy section 520(o)(1)(D).
Section 520(o)(1)(D) applies to a software function intended for “transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results . . . unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings.”
NarxCare does not satisfy 520(o)(1)(D) because to the extent it could be construed as incorporating data from a clinical laboratory or other medical devices, the software is intended to interpret or analyze PDMP and non-PDMP data to produce predictive risk scores for SUDs, including the disease of opioid use disorder.
The U.S. Government’s war on doctors is seen by many as a grave transgression. As we navigate the murky waters of legal battles, the timeless wisdom of the world’s most outstanding physician, John Locke, serves as a guiding light.(1)
His philosophy of individual rights and limited government provides a rallying cry for defending the rights of medical practitioners against governmental overreach. It reminds us that the pursuit of justice must always be tempered with respect for individual liberties.
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Note**Case 2:23-cv-02527-GEKP Document 32 Filed 05/09/24 Page 3 of 22
1) human volition, 2) human agency, 3) human action initiation, 4) human intention, 5) human decision, 6) human inhibition and control, 7) as well as the phenomenology of human agency. The disclosure of the Government’s FOIA documents is necessary for impeachment at jury trial because the timing of conscious intention may not accurately reflect a human being’s decision-making process. The disclosure of Government’s FOIA documents in determining how the Government’s criminal forensic tools predict human conscious intention is important because if a human being’s brain initiates actions before humans are mindful of the decision, then it raises questions about the role of human consciousness in initiating actions and the nature of human free will.
Plaintiff Anand, a natural-born son of the State of Pennsylvania, intends to challenge and impeach the Government’s predictive criminal forensic tools at jury trial within the Commonwealth of Pennsylvania and Third Circuit, established by William Penn. William Penn originated Pennsylvania Law and United States Constitutional Law based upon the philosophy of Dr. John Locke after Penn defeated the country of England in a criminal trial, and whose subsequent Bushel’s Case (1670) 124 E.R. 1006 established beyond question the independence of the trial jury in evaluating new or novel criminal forensic sciences.
The Third Circuit ruled that the complexity of a legal case “is not a constitutionally permissible reason for striking a party’s jury demands.” In re Japanese Electronic Products Antitrust Litigation 631 F.2d 1069 (3d Cir. 1980). Due process “requires some fair assurance that the jury’s findings of fact and applications of legal rules are reasonably correct. When a jury cannot understand the evidence and the legal rules, it cannot provide this measure of assurance.” Due process, the Third Circuit explained, “guarantees a comprehending factfinder.” In re Japanese Electronic Products Antitrust Litigation 631 F.2d 1069 (3d Cir. 1980)
There are only friends no more. But who knows what happens between the two if everyone, arriving at night, pretends a goodbye?”
“One of the most important principles underlying the CSA and its implementing regulations is that to be valid, every prescription for a controlled substance must be based on a determination by an individual practitioner that the dispensing of the controlled substance is for a legitimate medical purpose in the usual course of professional practice—United States v. Moore, 423 U.S.C. 122 (1975) and 21 CFR 1306.04(a). Federal regulations do not define the term legitimate medical purpose, nor do they set forth the standards of medical practice. It is up to each. “
From: Thomas W. Prevoznik, DEA Deputy Administrator Diversion Control Division, LETTER To: Richard A. Lawhern, Ph.D. DATED FEBRUARY 12, 2021
e. NarxCare does not satisfy section 520(o)(1)(E).
Section 520(o)(1)(E) sets forth four additional criteria a software function must satisfy to be considered non-device CDS and excluded from regulation as a medical device. FDA’s guidance on Subsection (E) summarizes the four criteria and establishes defined terms as follows:
Non-device CDS software functions do not acquire, process, or analyze images, signals from an in vitro diagnostic device (IVD), or patterns or signals from a signal acquisition system (Criterion 1). Non-Device CDS software functions display, analyze, or print medical information (Criterion 2) to provide recommendations about a patient’s care to an HCP user
(Criterion 3)… Non-Device CDS software functions provide sufficient information about the basis for the recommendations to the HCP user so that the user does not rely primarily on any of the recommendations to make a clinical decision about an individual.
“…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…”
BAMBOOZLED BY “BAMBOO”
i. Criterion 3
” Concerning Criterion 3—software functions “intended for supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition”—FDA’s guidance states:
FDA interprets Criterion 3 to refer to software that provides condition-, disease-, and patient-specific recommendations to an HCP to enhance, inform or influence a health care decision but is not intended to replace or direct the HCP’s judgment . . .
[I]n cases where a software function provides a specific preventive, diagnostic or treatment output or directive, the software function fails Criterion 3 because it is not intended to support or provide recommendations under section 520(o)(1)(E)(ii) . . .
FDA considers [the level of software automation] when determining whether a software function is being used to enhance, inform, or influence an HCP’s decision-making (satisfying Criterion 3) or, rather, to substitute, replace, or direct the HCP’s judgment (failing Criterion 3)
CLINICAL RESULTS OF PDMP AUTOMATION BIAS
To demonstrate how predictive policing and health care social credit scores suffer from the alignment problem, we explore how often they are misaligned with the values of fairness and justice, reflecting entrenched inequalities rather than delivering unbiased assessments.
A Puerto Rican fellow physician, Dr. Antonio Reyes Vizcarrondo, was accused of false billing when a staffing company billed on his behalf for the same services he had billed for. He was accused of using the proceeds “for his pleasures and expenses.”
After languishing for nearly five years under indictment, the government dropped the charges on the eve of the trial after discovering that the staffing company did not have authorization to bill on behalf of Dr. Reyes Vizcarrondo. Because social credit scores rely on past data, they perpetuate the same biases found in traditional criminal justice practices, disproportionately labeling individuals from certain racial, ethnic, or economic backgrounds as risky.
This means that even benign actions, such as having low credit scores or associating with individuals deemed “high-risk,” can lower one’s social credit score, triggering increased scrutiny or even penalties like restricted access to health care services or increased surveillance.
I WAS ABUSED BY A WALGREENS PHARMACIST: HE LOOKED AT MY PRESCRIPTION AND CALLED ME A DOPE ADDICT
These outcomes are not necessarily tied to actual criminal behavior but to a perception that certain individuals or communities are inherently more suspicious. The confusion between predicting who will commit a crime and who will be arrested mirrors the facts detailed in the 2020 Netflix documentary Coded Bias.
These biases have translated into several targets, including Dr. Mohamed Aly Rifai, Dr. Neil Anand, Dr. Lesly Pompy, Dr. Lonnie Joseph Parker, and Dr. Felix Brizuela. However, unlike in movies, today’s systems do not have clairvoyance—they have data, and that data is flawed, and the system is rigged.
ACCIDENT VICTIM TREATED LIKE DIRT BY PHARMACIES
Automation bias is the propensity of humans to over-rely on a suggestion from an automated system . . . Automation bias may be more likely to occur if the software provides a user with a single, specific, selected output or solution rather than a list of options or complete information for the user to consider. In the former case, the user is more likely to accept a single output as correct without considering other available information to inform their decision-making.
This understanding of automation bias informs the FDA’s interpretation of “support or provide recommendations” in Criterion 3 and its interpretation that Non-Device CDS software functions allow an HCP to independently review the basis for the recommendations presented by the software so that they do not rely primarily on such recommendations, as described in Criterion 4 . . .
From: Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: KEVIN NICHOLSON, RPH. DATED NOVEMBER 04, 2019
“The DEA lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine. The DEA DEA has not promulgated new regulations regarding the treatment of pain.
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: Richard A. Lawhern, Ph.D. DATED FEBRUARY 12, 2021
While DEA is the agency responsible for enforcing the CSA, DEA does not act as the Federal equivalent of a state medical board overseeing the general practice of medicine and lacks the authority to issue guidelines that constitute advice relating to the general practice of medicine.”
[S]oftware that provides a specific preventive, diagnostic, or treatment output or directive . . . would not satisfy Criterion 3. FDA interprets the purpose of such software functions as not supporting or providing recommendations to an HCP, but rather as directing the HCP to take a specific action and substituting for their judgment . . .
Note that the FDA considers software that provides information that a specific patient “may exhibit signs” of a disease or condition or identifies a risk probability or score in a particular disease or condition as providing a specific preventive, diagnostic, or treatment output. Therefore, such software would not satisfy Criterion 3. . .
[A] [s]oftware function that identifies patients with possible
FDA is “responsible for protecting the public health by ensuring the safety, efficacy, and security of . . . medical devices . . .”74 A “device” subject to FDA regulation includes “an instrument . . . , machine . . . , or other similar or related article . . . which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease . . .”
diagnosis of opioid addiction based on analysis of patient-specific
medical information, family history, prescription patterns, and geographical data . . . is a device function. It does not meet the Criterion.
Three, because it provides a specific diagnostic or treatment output or
Similar to the examples emphasized above, NarxCare’s algorithms analyze patient-specific medical history and prescription patterns drawn from the PDMP (i.e., number of providers, number of pharmacies, MMEs dispensed, overlapping prescription days, and potentiating medications) and non-PDMP information, which may include criminal history, payment method, and geographical data, to “calculate a patient’s risk of a host of outcomes, including overdose and addiction.”104
“…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…”
In other words, the software produces risk score outputs intended to prevent accidental drug poisonings and the disease of opioid use disorder and other SUDs.
NarxCare’s risk scores are also susceptible to automation bias, given that prescribers increasingly fear potential legal repercussions related to prescribing opioids and other controlled medications.
For example, a prescriber who sees a report with a moderate to high NarxScore or overdose risk score very likely could, without further investigation of the patient’s health record, interpret the score as a “do not prescribe” directive and decide not to prescribe an opioid medication to a patient with pain.
In short, NarxCare does not just influence prescribers and dispensers when determining whether a controlled medication is appropriate for a patient and the associated risks to that individual—it often replaces their judgment altogether. Therefore, NarxCare cannot satisfy section 520(o)(1)(E)(ii) of the FD&C Act.”
I. ACTION REQUESTED
The Petitioner asks FDA to
(1) deem Bamboo’s NarxCare software a misbranded device;
(2) issue a Warning Letter to Bamboo;
(3) commence mandatory recall procedures with respect to the NarxCare software; and
(4) take any other prompt action the agency deems appropriate to prevent serious, adverse health consequences or death.
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 the FDA’s publicly available databases, Bamboo, the device’s manufacturer, appears to be 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.
“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.”
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