The Need for Regulatory Oversight of Laboratory Developed Tests (LDTs) in Drug and Alcohol Testing
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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Letters From Those Abused and Afraid
via Letters From Those Abused and Afraid
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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!
Lord 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.
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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
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
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
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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“Injustice anywhere is a threat to justice everywhere.” -MLK
Please donate to my gofundme campaign here: https://www.gofundme.com/PHPReform
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Request Medical School Administrators Question PHP Authority to Prevent Future Medical Profession Brain Drain
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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Disrupted Physician 