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., 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
“…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 health care 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.”
THE SUMMARY OF THE REPORT TO THE FDA STATES:
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,”
DR. MARK IBSEN, MD., ON EXAMPLE OF PHARMACIST OVERREACH
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 is private, as is their relationship with their provider. The government needs to lock down healthcare now, protecting it before they destroy it.
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).
Center-for-US-Policy-FDA-Citizen-Petition-copy-1Download
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 one of the world’s greatest physicians, 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’s a reminder that the pursuit of justice must always be tempered with respect for individual liberties.
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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 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 conscious 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 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 is unable to 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)
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.
I am thoroughly SICK of the news talking about FENTANYL, and when they do, they show PILLS ON A FRIGGING PHARMACY COUNTING TRAY. GET A CLUE, MEDIA.
There are only friends no more. But who really 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 Assistant 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) in order 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
” With respect to Criterion 3—software functions “intended for the purpose of 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/or patient-specific recommendations to an HCP to enhance, inform and/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, and/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
“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.
From: Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: KEVIN NICHOLSON, RPH. DATED NOVEMBER 04, 2019
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.
Thomas W. Prevoznik, DEA Deputy Assistant Administrator Diversion Control Division, LETTER To: Richard A. Lawhern, Ph.D. DATED FEBRUARY 12, 2021
“DEA authorizes DEA-registered practitioners to do so, to treat patients according to his or her professional medical judgment under a standard of medical practice that is generally recognized and accepted in the United States.
ABUSED BY A WALGREENS PHARMACIST: HE LOOKED AT MY PRESCRIPTION AND CALL ME A DOPE ADDICT
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.”
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 . . .
[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 . . .
ACCIDENT VICTIM TREATED LIKE DIRT BY PAHRMACIES
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 risk score for a specific 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
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.”
“…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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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 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.
“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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