The Need for Regulatory Oversight of Laboratory Developed Tests (LDTs) in Drug and Alcohol Testing

mllangan1's avatarDisrupted Physician

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Laboratory Developed Tests

Questions about the accuracy and marketing of Laboratory Developed Tests (LDTs) led to last years debate on whether or not  the U.S. Food and Drug Administration (FDA) should regulate a subset of diagnostic tests currently exempted from oversight. Designed to bring clinical tests to market such as those for rare diseases that the costly FDA process would otherwise preclude,  the LDT pathway bypasses Federal regulation and oversight.  The LDT pathway additionally bypasses any semblance of accountability. It is an honor system and, as with any honor system, it is a system that can be exploited by the dishonorable.

Questions about the validity of these tests raised concerns over patient safety and this led to a call for oversight.  Among those asking for regulation were  Massachusetts Senators Edward J. Markey and Elizabeth Warren.

Opponents of regulation argued that  the LDT  pathway enables new and pioneering tests to be developed quickly and improve patient…

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Disrupted Physician 101.1: The “Impaired Physician Movement” and the History of the American Society of Addiction Medicine (ASAM)

via Disrupted Physician 101.1: The “Impaired Physician Movement” and the History of the American Society of Addiction Medicine (ASAM)

Misconduct at Massachusetts Medical Board–need to drain this swamp sooner rather than later. Election year is nigh!

Screen Shot 2017-12-22 at 8.34.36 PMLord Acton warned that we should not make moral allowances for powerful people just because they are powerful. If a common man murdered someone, Acton explained, he should hang. But when a king or queen murders, we make allowances for it. “I would hang them higher than Haman, for reasons of quite obvious justice, still more, still higher, for the sake of historical science” Acton wrote.  The same dynamic applies here.

One thing is for certain.  There should be zero-tolerance for forensic fraud perpetrated by those in positions of power.   This is  worse than Annie Dookhan as her victims were abstractions.  She did not see the damage that resulted from her laboratory misconduct.

And as far as I can find, these documents are the most elaborate and complete representation of the mechanics of forensic fraud available and show the sequential steps between the requesting party and complicit lab.   The documents also show how easy laboratory misconduct is accomplished as well as the moral detachment of the involved parties.

Bertram knew these where crimes and God help me I am not going to let the unctuous bastard get away with it.  Problem for him is that there is no defense and time has a way with catching up with justice.

Bertram was  also informed  that since 2011 there have been multiple suicides related to these same allegedly falsified  tests  including several doctors here in Massachusetts (one who was my friend!).  These deaths are solely on his head.  He needs to  be called on it and he will.   The laboratory fraud is as equally abhorrent as those who engage in it, those who deny it and those who ignore it.  . One other thing is for certain: When  this racket is exposed (and it will be most likely in 20018) the record will show who knew what and when.   It will be indefensible.  And those involved need to be held to account.  Let us make sure of it.

 

Source: Defending MA BORM Deb Stoller’s Five-Year Concealment of Fraud–Nothing Left but Logical Fallacy and Lies

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“Sham Peer Review”–Informative Discussion of the Underhanded Tactics Used by the Morally Disengaged Bullies Who Have Occupied the Medical Profession

mllangan1's avatarDisrupted Physician

Dr.  Lawrence Huntoon lectures on the common tactics used by the enemy forces who have taken an uninvited seat at the table of power in the regulation and control of the noble profession of medicine.  Collectively this band of nitwits and thugs  represent an enemy occupation and the damage has been ruinous to both the science and the art.  Clinical decision making has been reduced to algorithmic pathways and binary options that throw knowledge base and clinical acumen out the window and replaced them with  a heap of feel-good bottom-line poorly constructed dictates. These simple-minded marauders are nothing more than idiots with sticks but they’ve bamboozled the citizenry,  sweetheart-swindled the politicians and Robber barroned  their  morally disengaged  logical  fallacy into bandwagon reality under the rhetoric of cost containment and public welfare.

An enemy force has occupied our turf and it has indeed been ruinous.  Pride, integrity and enlightenment  have been…

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Regulatory capture and the critical need for Federal Trade Commission (FTC) Investigation of Medical Licensing Boards

mllangan1's avatarDisrupted Physician

But in this Court, what Diff’rence does appear!
For every one’s both Judge and Jury here;
Nay, and what’s worse, an Executioner.

William Congreve, The Double-dealer

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Please donate to this effort below.  Your contribution can and will make a difference.  https://www.gofundme.com/PHPReform

Regulatory capture is a form of government failure that occurs when a regulatory agency created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating and introduced in an article by George J. Stigler in 1971 entitled The Theory of Economic Regulation. The main idea of the article can be summarized in Stigler’s (1971: 3) affirmation that:

“…as a rule, regulation is acquired by the industry and is designed and operated primarily for its benefits.”

The basic hypothesis of Stigler is that an industry may use—or rather abuse—the coercive public power of the State…

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Request Medical School Administrators Question PHP Authority to Prevent Future Medical Profession Brain Drain

mllangan1's avatarDisrupted Physician

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Physician Health Programs (PHPs) are now targeting medical students and the stories I am hearing are heartbreaking.   Medical students who do not fit the diagnostic criteria for psychological problems or Substance Use Disorder (SUD) are being diagnosed with psychological problems and SUD in a closed system absent the usual safeguards of transparency, regulation and oversight.  No accountability exists.  None.   PHPs and their affiliated drug and alcohol testing labs and “approved” assessment and treatment centers have created a culture of impunity and immunity. The “tone at the top” is unethical and unjust and by targeting medical students this illegitimate authority is now snuffing out many brilliant and talented doctors before they even become doctors. I have heard from many medical students who are not able to afford the unneeded treatment being mandated by medical schools for issues that are resolved, trivial and even non-existent as described below.  Continued deference to this authority could be…

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During this Christmas week and Holiday Season– please consider making a contribution to a worthwhile cause!

via During this Christmas week and Holiday Season– please consider making a contribution to a worthwhile cause!

During this Christmas week and Holiday Season– please consider making a contribution to a worthwhile cause!

Please donate here:  https://www.gofundme.com/PHPReform

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Michael, thank you for your years of effort – you have made a huge difference to hundreds (thousands?) of us individually, and have changed the system. I wish I had 45K to fund you. I discovered the Disrupted Physician in April and have read every post and link. It has given me hope and strength as I work to recover and rebuild my life. -Kathryn Neraas M.D.

Michael, I have witnessed your efforts for 2-3 years now and I completely understand what you’re trying to do. Your work is so important. I have been doing similar work and wish I could donate enough to keep you able to do this as long as it takes until this is resolved completely. Talking to brick walls is expensive. Something needs to give.–Tom Gleason


With a team of criminals and incompetents running the show unconscionable misconduct inevitably ensues.  The malfeasance and unprofessionalism in state physician health programs (PHPs) and medical boards is staggering.  One can only hope that, in time, a wiser system will emerge.  I have been told the audit of the Robert Harvey’s  sham  “physician health and compliance unit”  is going to proceed.  This is good news and what the state auditor is going to find ( barring outside interference from those fattening and battening off this racket) is that incorrigible corruption has remained unchecked for decades.   The dissembling reach of the odious individuals is tremendous.    They have deliberately denied victims justice and permitted the physician health predators to roam free among the vulnerable for decades.   The Massachusetts Board of Registration in Medicine needs a drastic  rejiggering as do many others.  The corruption needs to be addressed,   the cognitive dissonance needs to end and the heinous individuals responsible need to be held accountable for their misdeeds.   We have made significant gains in exposing this corruption over the past few years and the  I am counting on you to please contribute whatever you can.  I need to raise some immediate funds (a few thousand dollars ) to meet a December 31st deadline that is going to create a significant setback if I do not do so.  So please get this out and help.

 

  https://www.gofundme.com/PHPReform

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Physician health programs: ‘Diagnosing for dollars’?

Screen Shot 2017-10-02 at 2.46.00 AM“PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.”

via Physician health programs: ‘Diagnosing for dollars’?