VENDOR DATA FRAUD: BAMBOOZLED BY “BAMBOO” STUDY SHOWS DEA HAS OPERATED AS A CRIMINAL ENTERPRISE RESULTING IN THOUSAND OF DEATHS AND FALSE IMPRISONMENT OF DOCTOR’S

“…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…”

…from Center of US Policy Report to. FDA April 28, 2023

reported by

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, 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., LEROY BAYLOR, JAY K. JOSHI MD., MBA, 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 KILLINGSWORTH, RENEE BLARE, RPH, 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

THE STUDY PROVES DR. NEIL ANAND, MD. EARLIER OBSERVATIONS OF DATA ANALYTICS WERE THE LYNCH PINS TO DEA’s CRIMINALITY

Doctors Neil Anand, MD’s First Letter on “Narxcheck Scores as a Predictor of Unintentional Overdose Deaths”

From: Neil Anand <cardiacgasman@gmail.com>
Date: Thu, Sep 17, 2020 at 2:02 PM
Subject: Peer Review Request of Raw Data- Verification of statistics utilized to publish narxcheck score as a prediction of unintentional overdose death
To: <cflansbaum@appriss.com>

Mr. Flansbaum,

I am doing a peer review validity check of your retrospective study, NarxCheck Score as a Predictor of Unintentional Overdose Death.  Can you please send me the raw data for me to verify your data and results?  I have attached to this email Appriss publication referral to you for request of the raw data for independent analysis and study.  If I could also have the contact information for the individuals involved in the statistical calculations involved, I would appreciate it.

Sincerely,

Neil Anand M.D. 

CITIZEN PETITION TO FDA

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.

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.”

“…Our achievements are but trophies and scalps and they learned to target those with ambition, those with drive, those who refuse to be subjugated, and when these doctors have suppressed the others will know to remain silent and get in line…” 

…dr. norman j clement Rph, dds

THE VIDEO BELOW FROM SAS ANALYTIC TO FIGHT OPIOID ABUSE IS BUT ANOTHER EXAMPLE OF VENDOR FRAUD TO THE TAXPAYER, MISBRABDED SOFTWARE TOOLS USED BY DEA-DOJ THAT HAS RESULTED IN THOUSANDS DEATHS AND INJURIES (listen)

The Center for U.S. Policy further states in its Petition to the FDA:

NarxCare is not non-device CDS.

“NarxCare does not satisfy any of the criteria set forth in section 520(o)(1)(A)-(E) of the FD&C Act for non-device CDS products.

a. NarxCare does not satisfy section 520(o)(1)(A).

Section 520(o)(1)(A) applies to a software function that is intended to provide certain types of administrative support for healthcare facilities.

NarxCare is not intended to provide administrative support of a health care facility, including “the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefits eligibility, population health management, and laboratory workflow.”

Rather, it is integrated into PDMPs and used as clinical decision support with respect to prescribing and dispensing controlled prescription medications. Therefore, NarxCare does not satisfy 520(o)(1)(A) of the FD&C Act.“

Doctors Neil Anand, MD’s Second Letter on “Narxcheck Scores as a Predictor of Unintentional Overdose deaths”

From: Neil Anand <cardiacgasman@gmail.com>
Date: Fri, Sep 18, 2020 at 3:51 PM
Subject: Fwd: Undeliverable: Peer Review Request of Raw Data- Verification of statistics utilized to publish narxcheck score as a prediction of unintentional overdose death
To: <kwhalen@appriss.com>, <dspeights@appriss.com>, <ksastry@appriss.com>

Dr. Speights and Mr. Sastry,

I have been trying to obtain the raw data used to generate the calculations used in the results of the paper, NarxCheck Score as a Predictor of Unintentional Overdose Death.  I need to analyze the raw data for independent verification of the results.  This paper was previously published with an unrecognized sampling error that has been corrected. Please provide the unrecognized sampling error that was utilized in your previous publication.  If you could also forward the information on the peer reviewers who have reviewed the data to date, it would be greatly appreciated. 

If there has been any analysis by the Food and Drug Administration concerning the use of the score in patient treatment, I would also require the contact information and analysis performed for independent verification purposes.  I also have some general questions on the population and samples as well as other questions concerning the descriptive and inferential statistics utilized. 

I also have interests in regression, correlation analysis, and predictive analytics so some guidance on the results of those analytical tools utilized in your study would help me in my own independent analysis.  I tried to reach out Carl Flanbaum as described in an excerpt of the study below but was told that this person was no longer with the company.

Sincerely,

Neil Anand M.D.   

I AM DR. Paul Volkman, MD., PhD

THE AMERICAN TAXPAYER HAS BEEN BAMBOOZLED BY BAMBOO AND THE DEA THE PANDEMIC CAUSED BY DOCTOR OVERPRESCRIBING IS

FALSE

The Center of US Policies petition states:

“There is evidence that Bamboo is in significant violation of the FD&C Act and FDA regulations that could justify FDA enforcement action if not promptly resolved. Therefore, FDA should issue Bamboo a Warning Letter requiring it to comply with all applicable provisions of the Act and FDA regulations to prevent serious, adverse health consequences and death.”

Additionally, there is a reasonable probability that NarxCare could cause serious, adverse health consequences or death for people with a legitimate need for controlled prescription medications, given that

(1) NarxCare is used millions of times per day;

(2) the software has a significant impact on prescribers’ and dispensers’ judgment regarding treatment with controlled medications;

and (3) reducing access to medically necessary treatments can have devastating outcomes, as described in Section II-C above, especially in light of the nation’s drug poisoning crisis.

Therefore, FDA should commence mandatory recall procedures to limit the threat of serious adverse health consequences and death of patients who are negatively impacted by NarxCare.

FDA should take prompt action to prevent serious, adverse health consequences or death.

The FDA should promptly take appropriate action within its authority, including issuing a Warning Letter and commencing mandatory recall procedures to prevent serious adverse health consequences or death.

III. Conclusion

For the reasons discussed above, the Petitioner asks FDA to deem NarxCare a misbranded device and promptly take appropriate administrative action to prevent serious, adverse health consequences and death.

I AM DR. Terence Sasaki, MD

I AM HARVEY JENKINS, MD

I AM, Vilisini GANESH, MD, CURRENTLY IN FEDERAL PRISON FOR 63 MONTHS

I AM DR.SHIVA AKULA, MD

I AM NORMAN J CLEMENT RPH, DDS OWNER OF PRONTO PHARMACY

DONATE LEGAL DEFENSE

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FOR NOW YOU ARE WITHIN

THE NORMS

I AM DR. LINDA CHEEKS, MD

VICTIM DEA-DOJ DATA analytics VENDOR FRAUD

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