Heightened perceptions of defeat and entrapment are known to be powerful contributors to suicide.23,24 The “Cry of Pain” model 25,26 specifies that people are particularly prone to suicide when life experiences are interpreted as signaling defeat which is defined as a sense of “failed struggle” or loss of social position and resources.. The person is unable to identify an escape from or resolution to a defeating situation, a sense of entrapment proliferates with the perception of no way out, and this provides the central impetus for ending ones life.
There is also evidence that rescue factors such as social supports may play a role in preventing suicide. These rescue factors act buffers to protect against suicide in the face of varying degrees of life stress.27,28 The study of female physicians revealed meetings to discuss stressful work experiences as a potential protective factor, 29 and support at work when difficulties arose appeared to be a protective factor for the male physicians.30 Research involving Finnish physicians found that control over one’s work and organizational justice were the most important determinants of work-related wellbeing.31,32 Organizational justice is related to fairness and refers to an individuals perception of an organizations behaviors, decisions, and actions and how these influence one’s own attitudes and behaviors and has been identified as a psychosocial predictor of health and wellbeing3334 Low organizational justice has been identified as a notable risk factor for psychological distress and depression.35,36
Although no reliable statistics exist, anecdotal reports suggest an alarming upsurge in physician suicide. This necessitates a reappraisal of known predisposing risk factors such as substance abuse and depression but also requires a critical examination of what external forces or vulnerabilities might be unique to doctors and how they might be involved in the descent from suicidal ideation to suicidal planning to completed suicide.
Depression and Substance Abuse Comparable to General Population
Depression and substance abuse are the two biggest risk factors for suicide. The prevalence of depression in physicians is close to that of the general population 1,2 and, if one looks critically at the evidence based literature, substance abuse in medical professionals approximates that of the general population. Controlled studies using DSM diagnostic criteria suggest that physicians have the same rates (8-14%) of substance abuse…
Although the current use of these tests is limited to the criminal justice system and professional monitoring programs this may soon change as the American Society of Addiction Medicine is proposing a “new paradigm” of zero-tolerance random widespread drug and alcohol testing. This is outlined in the ASAM White Paper on Drug Testing and described by Robert Dupont in his keynote speech before the Drug and Alcohol Testing Industry Association (DATIA) annual conference in 2012.
The ASAM White paper states drug testing is “vastly underutilized” throughout healthcare and describes the use of drug testing “within the practice of medicine and, beyond that, broadly within American Society.”
As the consequences of a single unregulated “forensic” test result can be grave, far-reaching and even permanent it is critical that these tests be included in the debate on regulation of LDTs.
Evidence based medicine is not restricted to randomized trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.11
Expert opinion is the lowest level of evidence available in the EBM paradigm.12,13 Fortunately, the scientific method and Cochrane type critical analysis of the available evidence is a tool to help people progress toward the truth despite their susceptibilities to unconscious confirmatory bias or conscious confirmatory distortion .14 Unfortunately, no one has used these tools address they panoply of tests of unknown validity that have already entered the market ; poised to be used on virtually everyone.
The laboratory developed test (LDT) pathway does not require proof of test validity, that the test is actually testing for what it claims to be testing, and with no FDA oversight a lab can claim any validity it wants in marketing a test. There is no accountability.
Proponents of regulation argue that this lack of oversight is a direct threat to patient safety and the status quo represents the best interests of the companies selling and profiting unregulated tests. Opponents of regulation argue that requiring oversight is a direct threat to patient safety and represents the best interests of those paying for these tests (insurers) who will restrict what tests are covered based on saving money.
This debate focused on the reliability and validity of a number of clinical tests currently marketed with unverified claims of accuracy such as those used for prenatal screening and Lyme disease. The debate has become…
To have striven, to have made an effort, to have been true to certain ideals — this alone is worth the struggle. We are here to add what we can to, not to get what we can from, life. – William Osler
Diagnostic Medicine
Diagnostic medicine is the process of identifying the condition or disease that a patient has and ruling out conditions or diseases the patient does not have through assessment of the patient’s signs, symptoms, and results of various diagnostic tests.
Diagnostic Test Accuracy
Diagnostic test accuracy is simply the ability of the test to discriminate among alternative states of health (Zweig and Campbell, 1993).
If a test’s results do not differ between alternative states of health, then the test has insignificant accuracy; if the results do not overlap with other states of health then the test has perfect accuracy. Most tests accuracies fall between these two extremes.
The intrinsic accuracy of a test is measured by comparing the test results to the “true condition status.”
‘True condition status” refers to one of two mutually exclusive states. Either acondition is present or it is absent.
We determine true condition status by means of a “gold standard” which is a source of information completely different from the test under evaluation which tells us the true condition status of the patient.
Say we want to develop a new rapid test for detecting strep throat. Strep throat is caused by the Streptococcus bacteria. Although more common in children and adolescents it can occur in people of all ages. Strep throat is one of many possible causes of sore throat and pharyngitis. It is contagious and can cause complications such as rheumatic and scarlet fever. Treatment with antibiotics can shorten the course of the disease and reduce the risk of complications.
A throat culture is obtained by swabbing the patient’s throat with a cotton swab. The sample is then sent to the lab where it is cultured. If strep is present it will grow on the culture and look as below. The bacteria either grows on the culture or it doesn’t. A throat culture is the “gold standard” for diagnosing strep throat. The problem is it may take two days to get back.
Sensitivity and Specificity
The two most important measures of diagnostic test accuracy are sensitivityand specificity.
The probability that a test will be positive in someone with the condition = Sensitivity
The Probability that a test will be negative in someone without the condition = Specificity
For diagnosing strep throat we want our test to be as close as possible to the gold standard in terms of both sensitivity and specificity.
Sensitivity and specificity can be illustrated by a table with two rows and two columns. This simple Decision Matrixwhere the rows summarize the data according to the true condition status of the patients and the columns summarize the test results. This table is called a “count table” because it indicates the numbers of patients in various categories. The total number of patients with and without the condition is, respectively n\ and n0; the total number of patients with the condition who test positive and negative is respectively s\ and s0; and the total number of patients without the condition who test positive and negative is respectively r\ and ro.
The total number of patients in the study group N, is equal to N = si+so+rx+ro, or N = n\ + no·
The true condition status is symbolized by the variable D, where D = 1 if the condition is present and D= 0 if the condition is absent.
Test results indicating the condition is present are called positive; those indicating the condition is absent are called negative.
Test results are symbolized by the variable T, where T =1 denotes positive test results and T= 0 denotes negative test results.
The sensitivity (Se) of a test is its ability to detect the condition when it is present.
We write sensitivity as Se = P(T = 1 | D = 1), which is read:
“sensitivity (Se) is the probability (P) that the test result is positive (T = 1), given that the condition is present (D = 1).”
Among the n\ patients with the condition, s\ test positive; thus, Se = s\/n\.
The specificity (Sp) of a test is its ability to exclude the condition in patients without the condition.
We write specificity as Sp — P(T = 0 | D — 0), which is read:
“specificity (Sp) is the probability (P) that the test result is negative (T = 0), given that the condition is absent (D = 0).”
Among no patients without the condition, ro test negative; thus, Sp — TQ/UQ
False Negative and False Positive Tests
There are consequences associated with all test results.
False Negative Tests: If a test falsely indicates the absence of a condition in someone who truly has it then treatment can be delayed or not provided.
The consequences of a false negative strep test depend on what we do with it. Serious consequences can arise if we use our new strep test as the sole basis for subsequent decision making. Putting complete trust in the negative test result would lead to no antibiotic treatment provided to a patient with Strep and can lead to continued illness, spread of the disease and complications that would not have occurred if antibiotics were provided. The patient could potentially get rheumatic or scarlet fever.
If the new test is negative but a culture was drawn the false results could delay treatment by a couple days or so but treatment is nevertheless provided. The consequences are likely to be minimal. It is highly unlikely a patient would get rheumatic or scarlet fever as, although a little later, they are still being treated with the proper antibiotics.
False Positive Tests: If a test falsely indicates the presence of a condition in someone who does not truly have it then unnecessary tests and treatments can occur. Incorrect treatment and false labeling of patients can also occur.
In the case of a false positive strep test, a patient may undergo a course of antibiotics when they do not need them. Although the patient may suffer side-effects from the antibiotics the severity and duration of any of these consequences are minimal.
The importance of a Diagnostic Accuracy in testing is directly proportional to the tests potential to cause patient consequences and harm.
Diagnostic Medicine uses a patient’s signs, symptoms and the results of various diagnostic tests to arrive at a diagnosis.
In diagnosing strep throat a good clinician will take into account a number of variables in consideration of a differential diagnosis and base testing and treatment on the preponderance of information supporting or opposing the diagnosis.
For strep throat using the new test in addition to a throat culture, history and careful physical exam and basing the decision to prescribe antibiotics on clinical acumen based on the overall picture is the best approach. The test can be considered a piece of the puzzle but does not define it. Therefore the risk of a false positive or false negative is minimal as it is just one data point.
Diagnostic accuracy is necessary if a test is being used as the basis for further tests and treatment. If a test is being used as the sole basis for further tests and treatment it needs to be accurate. If the results of a test can cause significant patient harm or death then it needs to be either 100% accurate or combined with other highly accurate tests to confirm the diagnosis.
The specificity of a test is particularly important as a false positive can result in unneeded interventions and treatment. Stand-alone tests used in diagnosis and treatment need to be both sensitive and specific. Diagnostic accuracy is a product of consequences of false-negative and false positive tests.
Diagnostic Research Methodology
Research to discover the accuracy of a diagnostic test should be straightforward; administer the test to a group of people and see if it works.
The test being tested is the “index test”. Results of the index test are compared with the results of a “gold standard” reference test.
The research question is, “How accurately do index test results predict the (true, gold standard) reference test results?”
Diagnostic test accuracy studies require a sample of subjects who have been given the test under evaluation, some form of scoring of the tests findings and a reference or “gold standard” to which the test findings are compared. Examples include autopsy reports, surgery findings and pathology results from biopsy findings.
The gold standard for a patient’s true disease status may not always be available. A brain biopsy could be considered a gold standard for diagnosing Alzheimer’s disease but is neither practical nor humane.
The Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool is a set of fourteen questions that investigate the methodologic quality of scientific studies that quantify diagnostic test performance.
The questions identify research methodologies known to bias the accuracies research discovers.
Multiple factors need to be considered in evaluating the diagnostic accuracy of a test including diagnostic validation and verification. Is the test testing what it is supposed to be testing for and are we doing it correctly?
Diagnostic accuracy of a test necessitates a reference standard, The reference standard can be the best available method for establishing the presence or absence of a condition (such as the throat culture for strep throat) or a combination of methods (imaging, neuropsychological testing, clinical exam, etc. in Alzheimer’s disease.
Any test that is going to be used as a basis for decisions that impact other human beings needs to be validated before it is introduced on the market. The literature needs to be reviewed critically and trials must be designed using objective evidence that validates the test is testing for what it purports to be and verifies the correct methodology of the test. Verification that the test is being collected, handled, stored, transported and processed correctly is requisite.
Cutoff levels, , cross-reactivity and myriad other issues need to be worked out prior to bringing a diagnostic test to market.
The reliability, validity and accuracy of drug test results needs to be known prior to using a test. Specificity and sensitivity must be known prior to using a test on any population.
This should go without saying as to do anything else would be irresponsible and careless.
References
Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 7: systematic reviews and meta-analyses of diagnostic accuracy studies Pain Physician 2009, 12(6):929-963. PubMed Abstract | Publisher Full Text
Jaeschke R, Guyatt G, Lijmer J: Diagnostic tests. In Users’ guides to the medical literature: a manual for evidence-based clinical practice. Edited by Guyatt G, Rennie D. AMA Press; 2002:121-140.
Streiner DL: Diagnosing tests: using and misusing diagnostic and screening tests.J Pers Assess 2003, 81(3):209-219. PubMed Abstract | Publisher Full Text
Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J: The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003., 3(25) http://www.biomedcentral.com/1471-2288/3/25webcite
GCP, good clinical practice; GCLP, good clinical laboratory practice; GLP, good laboratory practice; STARD, standards for reporting of diagnostic accuracy. See Section III, 2.13 From Nature Reviews Microbiology 4, S20–S32 (1 December 2006) | doi:10.1038/nrmicro1570
An attorney must have a factual basis for alluding to, offering or relying on evidence and that factual basis may not be wishful thinking. There are two requirements for a factual basis — an attorney’s subjective belief and objective evidence to support that belief. It has now been established that no objective evidence exists. Not a shred of it. Not a single chronologically consistent data-point!
On June 3, 2016 Governor Baker signed House Bill 4333 imposing greater accountability on state agencies when responding to public records requests. This includes shorter time frames to respond to requests (10-days for most), the provision of complete and legible records and appointing a Primary Records Access Officer to handle such requests. The new Public Records Law also subjects agencies to sanctions for failure to comply.with the new law.
On January 9, 2017 I submitted a Public Records Request through the Executive Office of Health and Human Services (EOHHS) Website for a dozen or so documents that had been submitted for board hearings but never directly addressed and containing textual content with evidence that was never weighed. Moreover, many of the documents provided direct evidence of crimes (no other is evidence needed).
All of these documents were provided to Board counsel Deb Stoller.
Oppression that is clearly inexorable and invincible does not give rise to revolt but to submission. Simone Weil
The AMA Code of Medical Ethics opinion 8.032 states:
“Physicians should disclose their investment interest to their patients when making a referral, provide a list of effective alternative facilities if they are available, inform their patients that they have free choice to obtain the medical services elsewhere, and assure their patients that they will not be treated differently if they do not choose the physician-owned facility.”
There are three ways a person can pay for health services: 1.) government Health Plans ; 2.) private health plans; and 3.) out-of-pocket
Government and private heal plans have regulations that are consistent with the AMA Code of Medical Ethics opinion 8.032 and the key concepts are: 1) No taking money for referrals 2) Referrals should be based on medical necessity 3) Referrals should be based on the best providers. Government regulations are the most restrictive. Stark Law and the Anti-kickback Statute provide very detailed “safe harbor” rules which must be followed. Congress enacted a physician self-referral law in 1993 after learning the incidence of radiology procedures and physical therapy greatly increased when the patient’s physician had an ownership interest in the facility or clinic. This law is the result of legislation introduced by Representative Fortney (Pete) Stark (D-CA), then Chairman of the U.S. House Ways and Means Health Subcommittee. An earlier self-referral law (“Stark I”) had been enacted for clinical laboratory services only. The self-referral law prohibits Medicare and Medicaid payments when a physician refers any of ten “designated health services” (DHS) to an entity where the physician has a financial relationship including clinical laboratory services and inpatient hospital services. Physician Self-Referral Law [42 U.S.C. § 1395nn] Anti-kickback regulations apply to anyone who “knowingly and willfully offers, pays, solicits, or receives remuneration in order to induce business reimbursed under the Medicare or Medicaid programs.” Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)] makes it a crime to pay for referrals in the Federal healthcare system. ( Section 1128B(b) of the Social Security Act ). False Claims Act [31 U.S.C. § § 3729-3733] makes it illegal to submit claims for payment to Medicare or Medicaid that you know or should know are false or fraudulent. Private health plans (including “self-funded” health plans) also have a restrictive set of rules and private-pay restrictions may mirror Stark Law or the Anti-kickback Statute, and will either be set forth in a provider agreement, or in a claims processing manual; compliance with which the physician may be asked to certify. Patient out-of-pocket (where the patient is solely responsible and pays out of pocket for an ancillary service) have no meaningful restrictions and this opens the door for abuse. The physician health program model is based on a simple coercive extortion scheme. In a paradigmatic case of coercion—the mugger who demands “your money or your life” the victim is better off handing over the money than losing their life. Coercion characteristically involves threats by which the coercer proposes to make the victim worse off unless they do as the coercer demands. In the 1990s some entrepreneurs within the “impaired physicians movement” discovered they could demand “your money or your medical license” and coerce doctors into paying for unneeded assessment and treatment that lasted three-times longer than normal folks and needed to be paid out-of-pocket. With no regulation from government or private insurers they could do whatever they want and they did.
The simple extortion scheme from the 1990s has now grown to around two dozen “PHP-approved” assessment and treatment centers and state boards require that only “PHP-approved” facilities be used and specifically excludes non “PHP-approved” facilities. The preferred facilities engage in “diagnosis rigging” and false diagnoses to warrant unneeded treatment. The labs are willing to engage in laboratory misconduct and will create a falsely positive test at client request. It is a closed incestuous system in which the PHP serves as the Axis of Control and everything is kept not just close-to-the-cuff” but up the sleeve. This has led to pathological opportunism and promiscuous interaction between the PHPs-assessment center-lab conglomerate, regulators and medical boards and the legal profession which includes attorneys ostensibly representing doctors who will not bite the hand that feeds them-mostly carpetbagger board attorneys and former AAGs who hopped over to the more lucrative side doctors who are actually carpetbaggers who hopped over to the other side after proving to the racket they had no scruples and the current pseudosymbiosis damages everyone but the psychopaths, bullies and clowns lining their pockets from the racket.
One thing is for certain. When society gives power of diagnosis and treatment to individuals within a group schooled in just one uncompromising model of addiction with the majority attributing their very own sobriety to that model, they will exercise that power to diagnose and treat anyone and everyone according to that model.The birth of Addiction Medicine as an ABMS accepted discipline is sure to be a success for the LDT drug and alcohol testing and 12-step assessment and treatment industry, but its spawn is sure to be an inauspicious mark on the Profession and Guild of Medicine and a bane of society for years to come.
So much for the in utero diagnostic assessment–This teratoma has been birthed!
The Second Coming
W.B. Yeats
Turning and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world,
The blood-dimmed tide is loosed, and everywhere
The ceremony of innocence is drowned;
The best lack all conviction, while the worst
Are full of passionate intensity.
Surely some revelation is at hand;
Surely the Second Coming is at hand.
The Second Coming! Hardly are those words out
When a vast image out of Spiritus Mundi
Troubles my sight: somewhere in sands of the desert
A shape with lion body and the head of a man,
A gaze blank and pitiless as the sun,
Is moving its slow thighs, while all about it
Reel shadows of the indignant desert birds.
The darkness drops again; but now I know
That twenty centuries of stony sleep
Were vexed to nightmare by a rocking cradle,
And what rough beast, its hour come round at last,
Slouches towards Bethlehem to be born?
The validity and reliability of opinions lie in their underlying methodology and evidence base. Reliance on the personal authority of any expert or group of experts is the fallacy of appeal to authority and a more apt and accurate twitter caption to the photo above would be Algernon Sidney’s 1683 statement that:
“Implicit Faith belongs to Fools, and Truth is comprehended by examining Principles”
“How a healing profession heals itself #FSMB2016 partnerships #FSPHP trust and faith in oversight and system.”
Within the the allotted 140 character twitter limit this succinct observation is nevertheless very revelatory. Both systems and the oversight of systems demand accountability and answerability to outside and independent agencies. Trust and Faith are not in the equation. Why has this lesson not been learned?
Answerability requires the obligation to answer questions regarding decisions and actions. Accountability requires transparency, explanation and justification. What was done and why? Standards, rules, regulations, codes, laws and other objective benchmarks need to be applied by outside actors. This is critical. It is the very essence of…
Bertram also claims PHS has not committed any crimes because they have not been charged with any crimes. This is called denying the antecedent or inverse error. It is a logical fallacy where the consequent is an indicative conditional claimed to be false because the antecedent is false. ( A, then B; not A, therefore not B). If it is raining, then the grass is wet.It is not raining.Therefore, the grass is not wet.The argument is invalid because there are other reasons for which the grass could be wet such as spaying it with a hose. There are multiple reasons for which someone who committed a crime has not been charged with a crime.There is always a time-frame between the two and many who commit crimes never get caught. Luck, stealth, cleverness, and multiple other variables might be involved. Jimmy Savile molested and raped scores of children for decades and he was never caught. As a major fundraiser for hospitals this fiend had free rein to prey on sick and helpless little kids in hospital beds .
Stoller was provided direct evidence of crimes over five years ago. It is precise, clear and repugnant. How many careers have been derailed since that time? How many innocent people have died by suicide since that time? As a state agent it is Stoller’s duty to report a crime when she sees a crime. A criminal investigation should have ensued. Overlooking corruption allows it to fester and spread and that is exactly what she did. She concealed it. This is top-down corruption also. Sanchez is past President of the Federation of State Physician Health Pr0grams (FSPHP) and his accomplice is the VP of Laboratory Operations at the drug testing lab-an unethical tone-at-the-top if there ever was one.
Some day a real rain will come and wash all the scum off the streets- Robert De Niro
Massachusetts Public Records – House Bill 4333
On June 3, 2016, Governor Charlie Baker signed into law the first update to Massachusetts’s public records law since 1973. The law seeks to make government entities more accountable, accessible, and efficient in their management of requests for information and mandates that each state agency delegate at least one employee to be a “records access officer.” The bill also imposes a shorter timeframe to respond to record requests. Agencies have a 10-day window to produce the requested documents or to respond and if they refuse or are unable to produce a record within 10 days they must notify the requestor and if an agency agrees to provide records outside the 10 day window it only has 15 days to do so.