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
IF THERANOS WAS A FRAUD
Elizabeth Holmes has reported to prison to begin her 11-year sentence for defrauding investors in her blood-testing Silicon Valley start-up Theranos. She could have faced up to 20 years in prison for each charge, the maximum sentence legal experts had said.
Holmes was found guilty of duping investors into believing that Theranos had developed a revolutionary medical device that could detect a multitude of diseases and conditions from a few drops of blood.
“..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 healthcare providers who treat such patients...”
Wearing a beige sweater, jeans, and sneakers, the 39-year-old mother of two was directed into Federal Prison Camp in Bryan, Texas, by Federal Bureau of Prisons staff minutes before a 2 pm court imposed for Tuesday, May 29, 2023, deadline.
THEN
The articles read: Federal prosecutors depicted Holmes as a charlatan obsessed with fame and fortune. In seven days on the witness stand, she cast herself as a visionary trailblazer in male-dominated Silicon Valley who was emotionally and sexually abused by her former lover and business partner, Sunny Balwani.
Theranos – a notoriously secretive company – shared very little about its blood-testing machine with the public or medical community. That did not put off investors.
“They bought what Holmes was selling and put hundreds of millions of dollars into the company. Former Secretaries of State Henry Kissinger and George Shultz were on its board. At one time, Theranos was worth over $10 billion, and Holmes was the nation’s youngest self-made female billionaire.” The Federal Indictment alleges:
“…that Holmes and Balwani defrauded doctors and patients
(1) by making false claims concerning Theranos’s ability to provide accurate, fast, reliable, and cheap blood tests and test results, and (2) by omitting information concerning the limits of and problems with Theranos’s technologies. The defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests, including the tests for calcium, chloride, potassium, bicarbonate, HIV, Hba1C, hCG, and sodium. The defendants nevertheless used interstate electronic wires to purchase advertisements intended to induce individuals to purchase Theranos blood tests at Walgreens stores in California and Arizona.
Through these advertisements, the defendants explicitly represented to individuals that Theranos’s blood tests were cheaper than blood tests from conventional laboratories to induce individuals to purchase Theranos’s blood tests.
According to the indictment, the defendants also allegedly made numerous misrepresentations to potential investors about Theranos’s financial condition and its future prospects…”
However, there is no evidence any person other than investors was physically harmed or that serious, adverse health consequences or death resulted from its use, or that using this fraudulent generated data could lead to the arrest and prosecution of physicians.
BAMBOOZLED BY BAMBOO HEALTH, WHERE ARE THE DOJ PROSECUTORS?
Yet, thousand people are dead and are have dying especially Veterans as of the direct result of erroneous misbranded data generated by Bamboo Health Narxcare Software system.
Even more tragically thousands of our best and brightest healthcare clinician, providers, Physicians, e.g., Nero-Surgeons, Psychiatrist, Anesthesiologists, Pharmacists, Dentists, Nurse Practitioner, languish in Prison all around America because of (Narxcare Software) fraudulent Algorithms and generated data.
“…FDA should deem NarxCare a misbranded device and take appropriate administrative action to prevent serious, adverse health consequences or death…”
So, how is it that The Department of Justice Prosecutors haven’t held accountable Bamboo Health, as they’ve done against Holmes and Balwanni’s Theranos?
Prosecutors, utilize the erroneous data analytics generated by Narxcare to targeting healthcare providers for healthcare fraud and asset forfeitures.
Most, importantly Bamboo Health System has made billions dollars from their ill-gotten gains.
To this date and given the overwhelming evidence of Vendor Fraud, death, being/having been committed by Bamboo Heath System “Narxcare Software,” no person from this company has been investigated, prosecuted, or sentence to prison in the manner the government targeted both Holmes and Balwanni.
Bamboo Health Systems, now owned by Experian, the Credit monitoring private agency (that allegedly maintains all of the Narxcare Date off-shore to get around Hippa), clearly has “BAMBOOZLED,” the American Taxpayer, on its Narxcare Software program, designed to prevent patients from receiving duplicate medication.
For some reason, Narxcare became weaponized and has been used against physicians whose prescription practices differ from other physicians.”
“…based on a search of the FDA’s publicly available databases, it appears that the device’s manufacturer, Bamboo, violates several provisions of the Act and its implementing regulations…”
WHAT IS NARXCARE?
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, it appears that the device’s manufacturer, Bamboo, violates 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.
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THE CENTER FOR US POLICY CITIZENS PETITION
Action Requested
On April 28, 2023, The Center for U.S. Policy (“Petitioner”) submitted 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.”
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.
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 healthcare providers who treat such patients.
THE AMAZING DOUBLE STANDARD OF JUSTICE
The Holmes and Balwani trials also laid bare the pitfalls of one of the go-to moves of Silicon Valley entrepreneurs — conveying a boundless optimism regardless of whether it’s warranted, known as “fake it ‘til you make it.” That ethos helped hatch groundbreaking companies such as Google, Netflix, Facebook, and Apple — the latter co-founded by one of Holmes’ heroes,
DOES JUSTICE EVEN EXIST
Dr. Walter F. Wrenn, MD of Philadelphia, found himself under-targeted by fraudulent Narxcare Data.
“Today, most States in America have instituted a drug monitoring program. The question we have to ask ourselves is whether this is a violation of HIPPA.
Who legally can access this data?
What role does the DEA play?
Is using this data to arrest and prosecute physicians a violation? I believe that it is a violation of HIPPA, as we understand it. The program was designed to prevent patients from receiving duplicate medications. For some reason, it became weaponized and has been used against physicians whose prescription practices differ from other physicians.”
The prosecutor aims to get a conviction and make those accused of a crime leary of seeking a trial. The defense attorney aims to avoid trial and get paid without having to prepare for a trial. A win-win for lawyers but a betrayal to the client who has been charged unfairly and becomes the victim of the deal.
The term “Justice is Blind” implies that a person charged with a crime receives a fair evaluation of the charges and a fair trial after the evidence is presented.
Holmes spent the Memorial Day weekend with husband, Billy Evans, and their children near their home in San Diego before surrendering to authorities in Texas. She has also been ordered to pay $452m in restitution to out-of-pocket investors, including Rupert Murdoch and Betsy DeVos.
Walter F. Wrenn, MD, states:
For years I’ve heard the term, “Justice is blind.” When I entered the criminal justice system, I found that Justice does not exist. It’s not about right or wrong. It’s about the art of the deal.”
FOR NOW, YOU ARE WITHIN
THE NORMS
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