Why are we tolerating the use of junk science against those in the medical profession? A direct question that begs for a direct answer.

 “That everyone shall exert himself in that state of life in which he is placed, to practice true humanity towards his fellow men, on that depends the future of mankind.” – Albert Schweitzer 
“By and by never comes” –St Augustine

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“A day’s impact is better than a month of dead pull”-Justice Oliver Wendell Holmes, Jr.

 I am looking for a few honest and credible statisticians, biostatisticians or epidemiologists who want to make a difference in the spirit  of service and helping others.  I can’t pay you but you would be combating injustice, corruption and dishonesty.   You would be doing your part in helping the Medical Profession, honest and decent doctors, our country and  perhaps our future.  

It is only a few public policy steps and minor changes in state regulatory statutes before what is described in the ASAM White Paper on Drug Testing comes to fruition.  Before we know it the Drug and Alcohol Testing Industries “New Paradigm” as described here by Robert Dupont will be ushered in as it did with doctors; not with a bang but a whimper.  From the ASAM white Paper:

“THIS WHITE PAPER ENCOURAGES WIDER AND “SMARTER” USE OF DRUG TESTING WITHIN THE PRACTICE OF MEDICINE AND, BEYOND THAT,BROADLY WITHIN AMERICAN SOCIETY. SMARTER DRUG TESTING MEANS INCREASED USE OF RANDOM TESTING* RATHER THAN THE MORE COMMON SCHEDULED TESTING,* AND IT MEANS TESTING NOT ONLY URINE BUT ALSO OTHER MATRICES SUCH AS BLOOD, ORAL FLUID (SALIVA), HAIR, NAILS, SWEAT AND BREATH WHEN THOSE MATRICES MATCH THE INTENDED ASSESSMENT PROCESS. IN ADDITION, SMARTER TESTING MEANS TESTING BASED UPON CLINICAL INDICATION FOR A BROAD AND ROTATING PANEL OF DRUGS RATHER THAN ONLY TESTING FOR THE TRADITIONAL FIVE-DRUG PANEL.”

To prevent this future drug testing dystopia, that includes testing schoolchildren, we need to take a step back and analyze the reliability and credibility of the “evidence-base” behind these multiple non-FDA approved forensic drug and alcohol tests and testing devices the ASAM proposes be used on the population at large utilizing the Medical Profession as a urine collection agency and bypassing forensic drug testing protocol by calling this “evaluation” and treatment rather than “monitoring” and punishment. New definitions, loopholes, secrecy and subterfuge are the bread and butter of these prohibitionist profiteers.

Amazingly, there has been no Academic review of these tests, let alone a Cochrane type critical analysis.  It is essentially untapped territory.  In addition there has been no Institute of Medicine type Conflict of Interest Analysis.  And that is why I am asking for help from statisticians, biostatisticians and epidemiologists.  The task would entail a review of the literature prior to the introduction of these tests for evidence base of forensic applicability (there essentially is none) and a review of the literature peri-and post marketing of these devices to assess the reliability and credibility of the underlying methodology and ascertain the evidence-base.  The goal would be publication in both academic journals and presentation to the general public through media publication with the assistance of investigative journalists and other writers. The goal is to get the truth out about these tests and allow both the medial profession and public at large to awaken to the menace this presents to medicine, our society and our future.

 Lack of Evidence-Base, Bias and Conflicts of Interest:  Making the Data Fit the Hypothesis

I am no epidemiologist or statistician but as with pornography I know junk-science when I see it.  Almost all of these tests were introduced with little or no evidence-base and, as with most of their endeavors, they did it below board via loopholes and cutting corners.

The overwhelming majority of papers are small, methodologically flawed, non-randomized, non-blinded  retrospective studies in that appear to make the data fit the hypothesis.   The authors can invariably be linked to those profiting from the tests of the testing process ( the patent holder, doctors associated with the drug testing labs, ASAM or FSPHP, Robert Dupont, Greg Skipper, etc.)

 

Ethyl Glucuronide (EtG) was introduced in 1999 as a biomarker for alcohol consumption,1 and was subsequently suggested as a tool to monitor health professionals by Dr. Gregory Skipper because of its high sensitivity to ethanol ingestion.2   

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Described as the  “innovator of EtG as an alcohol biomarker,” Skipper and  Friedrich Wurst,  “convinced” NMS labs in Pennsylvania “to start performing EtG testing in 2002.

The study most often cited as 100% proof that there is 100% accuracy in EtG testing proving alcohol consumption involved a mere 35 forensic psychiatric inpatients in Germany that was published in 2003.3  

Shortly thereafter the Physician Health Programs began using it in monitoring doctors and other professional monitoring programs soon followed.

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Up until the birth of the EtG tests used for forensic drug and alcohol monitoring had to go through the arduous, expensive and necessary FDA approval process.   The LDT pathway was designed to develop simple tests with little risk that have  low market potential (i;e. the cost of the normal FDA approval process would prohibit them from coming to market).  The LDT pathway was designed to improve patient care and help improve diagnosis and treatment. It was not designed for forensic tests.  LDT approval does not require in vivo testing.  It is essentially an honor system and to develop an LDT it is not even necessary to prove that the test is actually testing what it is purportedly testing for (validity).

So with little to no evidence base they introduced the EtG, had it developed and marketed as a LDT in collusion with unscrupulous labs, and then began using it on physicians being monitored by State PHPs. This then spread to other monitoring organizations in which there was a large power-differential between those ordering the tests and those being tested (criminal-justice, other professional monitoring programs).  These biomarkers have never been used in Federal Drug Testing, SAMHSA approved, DOT, and other organizations where unions or other organizations are present and looking out for the best interests of those being tested.

Another example of how this group removes accountability.  There has been essentially no oversight or regulation of LDTs.  Although there was a recent push for regulation of these tests the Drug and Alcohol Testing Industry Association lobby made sure that forensic tests would be exempt.

They then began publishing “research” on the EtG using the physicians being monitored as subjects. Many of the studies promoting the EtG and other biomarkers can be found  in  Journals that are linked to organizations that are linked to AA and were organized to educate the medical community.

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These small, methodologically flawed studies amount to little more than opinion pieces but   This “evidence-base” is predominantly in biased journals published by biased medical “societies.  
The EtG was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash4,5, hand sanitizer gel6, nonalcoholic beer7, and nonalcoholic wine.8  Sauerkraut and bananas have even been shown to cause positive EtG levels.9
The United States Substance Abuse and Mental Health Services Administration warned against using a positive EtG as primary or sole evidence of drinking for disciplinary or legal action.10  The Wall Street Journal in 2006 reported the problems with the EtG to the general public.11   
Screen Shot 2014-03-23 at 10.45.36 PMAs any rational authority would do, the majority of monitoring agencies abandoned the EtG after these flaws were revealed. The PHPs did not.  They continued to use the EtG on doctors uninterruptedly by telling them to avoid any products that could potentially contain alcohol; a ubiquitous substance in the environment. Since that time they have justified and rationalized (EtG)2,12 13  use by sequentially raising cutoff levels from 100 to 250 to 500 to 1000 to 2000 to now unknown and adding other LDTs as “confirmation tests such as Ethyl Sulfate (EtS)14,15 Phosphatidyl-Ethanol ( Peth)16 17 and other devices such as the Subcutaneous Remote Alcohol Monitoring Bracelet (SCRAM) and, their newest device the Cellular Photo Digital Breathalyzer (CPDB) that has recently been launched, just like the EtG Screen Shot 2014-02-23 at 10.00.22 PMwith little to no evidence base other than a pilot study done by Greg Skipper and Robert Dupont.18 
A  2013 article published in an ASAM incubated journal Alcoholism: Clinical and Experimental Research promotes the Phosphatidyl-ethanol (PEth ) test to confirm drinking.16  The study was done on physicians being monitored by the Alabama Physician Health Program who tested positive for EtG/EtS alcohol biomarkers. It is co-authored by Robert Dupont, Greg Skipper, and Friedrich Wurst and involved 18 subjects who tested positive for EtG/EtS of whom 7 claimed they did not drink.  After finding that 5 of the 7 tested negative for PEth they concluded that “positive PEth testing following positive EtG/EtS results confirms recent drinking.  Hard to wrap your head around the science in that one.Screen Shot 2014-04-30 at 1.06.53 PMSkipper is also using both Scram ankle bracelets and the CPDB monitoring in pilots in the Human Interventional Motivational Study (HIMS) Program that was developed in 2009 to “identify, treat and, eventually, re-certify airline pilots with substance abuse problems. 
 
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The Cochrane Collaboration does systematic reviews of the literature using conscientious, explicit, and judicious criteria to in order to produce and disseminate only high quality and evidenced based health care, exclude bias, and enhance transparency. The Cochrane database is a current and evolving database that includes the accuracy of diagnostic tests and is internationally recognized as the standard in evidence based health care.  This benchmark for evidence based health care and systematic reviews, records just 5 controlled trials under the topic ethyl glucuronide.8,19-21 These 5 studies represent the only high-quality evidence regarding EtG applying to EtG. Information provided by the five studies suggests the following, and only the following:

  1. EtG and EtS measurements increase with alcohol ingestion.
  2. The window of detection is shorter than what is commonly proposed (80 hours).
  3. Individual values are variable both within and between subjects.
  4. Non alcoholic wine can cause positive levels.

Notably, there are no studies that fit Cochrane Criteria, other than non-alcoholic wine, that look at the pharmacokinetics of EtG or EtS in terms of dose-response curves, cut-off levels, specificity drug and food interactions, or modes of ingestion.

SAMHSA notes that there is little research on PEth and that EtG, EtS, and PEth “do not have a strong research base,” and that “it is not known at this time how the test results might be affected by the presence of physical diseases, ethnicity, gender, time, or the use of other drugs. Until considerable more research has occurred, use of these markers should be considered experimental.”

Phosphatidylethanol (PEth), SCRAM, and the  yields no data as a test in the Cochrane library.

SAMHSA notes that there is little research on PEth and that EtG, EtS, and PEth “do not have a strong research base,” and that “it is not known at this time how the test results might be affected by the presence of physical diseases, ethnicity, gender, time, or the use of other drugs. Until considerable more research has occurred, use of these markers should be considered experimental.”

Evidence based medicine (EBM) can be defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.22

Medical progress and scientific advancement is occurring so fast that the volume of medical literature is expanding at a rate of greater than 7% per year.23

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.22  

Expert opinion is the lowest level of evidence available in the EBM paradigm.24,25

Fortunately, the scientific method is a tool to help people progress toward the truth despite their susceptibilities to confirmation bias and other errors.26

Unfortunately, due to a confluence of factors (including political) this has not been done.  But, unless we want a  future as envisioned by Robert Dupont and explained in the the ASAM White Paper on Drug Testing we need to act now.  This is not a “New Paradigm” but a “New Inquisition.”

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  1. Wurst FM, Kempter C, Seidl S, Alt A. Ethyl glucuronide–a marker of alcohol consumption and a relapse marker with clinical and forensic implications. Alcohol Alcohol. Jan-Feb 1999;34(1):71-77.
  2. Skipper GE, Weinmann W, Thierauf A, et al. Ethyl glucuronide: a biomarker to identify alcohol use by health professionals recovering from substance use disorders. Alcohol Alcohol. Sep-Oct 2004;39(5):445-449.
  3. Wurst FM, Vogel R, Jachau K, et al. Ethyl glucuronide discloses recent covert alcohol use not detected by standard testing in forensic psychiatric inpatients. Alcohol Clin Exp Res. Mar 2003;27(3):471-476.
  4. Costantino A, Digregorio EJ, Korn W, Spayd S, Rieders F. The effect of the use of mouthwash on ethylglucuronide concentrations in urine. J Anal Toxicol. Nov-Dec 2006;30(9):659-662.
  5. Reisfield GM, Goldberger BA, Pesce AJ, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after intensive exposure to high ethanol content mouthwash. J Anal Toxicol. Jun 2011;35(5):264-268.
  6. Rosano TG, Lin J. Ethyl glucuronide excretion in humans following oral administration of and dermal exposure to ethanol. J Anal Toxicol. Oct 2008;32(8):594-600.
  7. Thierauf A, Gnann H, Wohlfarth A, et al. Urine tested positive for ethyl glucuronide and ethyl sulphate after the consumption of “non-alcoholic” beer. Forensic Sci Int. Oct 10 2010;202(1-3):82-85.
  8. Hoiseth G, Yttredal B, Karinen R, Gjerde H, Christophersen A. Levels of ethyl glucuronide and ethyl sulfate in oral fluid, blood, and urine after use of mouthwash and ingestion of nonalcoholic wine. J Anal Toxicol. Mar 2010;34(2):84-88.
  9. Musshoff F, Albermann E, Madea B. Ethyl glucuronide and ethyl sulfate in urine after consumption of various beverages and foods–misleading results? Int J Legal Med. Nov 2010;124(6):623-630.
  10. Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
  11. Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
  12. Wurst FM, Skipper GE, Weinmann W. Ethyl glucuronide–the direct ethanol metabolite on the threshold from science to routine use. Addiction. Dec 2003;98 Suppl 2:51-61.
  13. Wurst FM, Alling C, Aradottir S, et al. Emerging biomarkers: new directions and clinical applications. Alcoholism, clinical and experimental research. Mar 2005;29(3):465-473.
  14. Anton RF. Commentary on: ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcoholism, clinical and experimental research. Jul 2014;38(7):1826-1828.
  15. Hernandez Redondo A, Schroeck A, Kneubuehl B, Weinmann W. Determination of ethyl glucuronide and ethyl sulfate from dried blood spots. International journal of legal medicine. Jul 2013;127(4):769-775.
  16. Skipper GE, Thon N, Dupont RL, Baxter L, Wurst FM. Phosphatidylethanol: the potential role in further evaluating low positive urinary ethyl glucuronide and ethyl sulfate results. Alcoholism, clinical and experimental research. Sep 2013;37(9):1582-1586.
  17. Hahn JA, Dobkin LM, Mayanja B, et al. Phosphatidylethanol (PEth) as a biomarker of alcohol consumption in HIV-positive patients in sub-Saharan Africa. Alcoholism, clinical and experimental research. May 2012;36(5):854-862.
  18. Skipper GE, Thon N, DuPont RL, Campbell MD, Weinmann W, Wurst FM. Cellular photo digital breathalyzer for monitoring alcohol use: a pilot study. European addiction research. 2014;20(3):137-142.
  19. Hoiseth G, Bernard JP, Stephanson N, et al. Comparison between the urinary alcohol markers EtG, EtS, and GTOL/5-HIAA in a controlled drinking experiment. Alcohol Alcohol. Mar-Apr 2008;43(2):187-191.
  20. Wojcik MH, Hawthorne JS. Sensitivity of commercial ethyl glucuronide (ETG) testing in screening for alcohol abstinence. Alcohol Alcohol. Jul-Aug 2007;42(4):317-320.
  21. Sarkola T, Dahl H, Eriksson CJ, Helander A. Urinary ethyl glucuronide and 5-hydroxytryptophol levels during repeated ethanol ingestion in healthy human subjects. Alcohol Alcohol. Jul-Aug 2003;38(4):347-351.
  22. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. Jan 13 1996;312(7023):71-72.
  23. Norwitz ER, Greenberg JA. Promoting evidence-based medicine. Rev Obstet Gynecol. Summer 2008;1(3):93-94.
  24. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. Feb 25 2009;301(8):868-869.
  25. Straus SE, Green ML, Bell DS, et al. Evaluating the teaching of evidence based medicine: conceptual framework. BMJ. Oct 30 2004;329(7473):1029-1032.

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Where have you gone, Morris Fishbein? Our nation turns its lonely eyes to you.

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I count no man a Philosopher who hath not, be it before the court of his Conscience or at the assizes of his Intellect, accused himself of a scurrilous Invention, and stood condemned by his own Judgement a brazen Charlatan.’
      Robert Burton, The Anatomy of Melancholy (1621)

Morris Fishbein M.D. (July 22, 1889 – September 27, 1976) was the editor of the Journal of the American Medical Association (JAMA) from 1924 to 1950 and in 1961 became the founding Editor of Medical World News, a magazine for doctors. In 1970 he endowed the Morris Fishbein Center to encourage the study of the history of science and medicine.

Fishbein  was also notable for exposing quacks such as  John Romulus Brinkley, a physician (in the diploma-mill sense of the word–he paid $500 for diploma he purchased from the Eclectic Medical University of Kansas City, Missouri) who in 1917 pioneered the notion of the goat testicle “transplant” as treatment for erectile dysfunction. The procedure involved removing the testicles of young goats and sewing them to the abdominal walls and scrotal tissues of men without any attempt to connect either the nerves or blood vessels of the “grafted” tissues.

Clinically useless, Brinkley made a fortune over the next decade through his goat gonad rejuvenation procedure.  Although he never finished his degree at Bennett Medical College in Chicago (where he left after his third year) and often operated while inebriated, Brinkley became one of the most famous doctors in the United States.  He claimed that his procedure cured 27 ailments including emphysema, acne and obesity.   It didn’t cure or even impact any of them.    What planting goat parts into people did do was solely self-serving.  It lined  Brinkley’s pockets and fed his ego and in doing so killed a lot of patients.  His operation was often lethal.

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Dr. John, R. Brinkley

Throughout his career this phony surgical grifter found himself incessantly challenged by Quack-buster extraordinaire Dr. Morris Fishbein.  Relentless in his pursuit of exposing the fakery, fraud and pseudoscience of this charlatan and quack, he eventually succeeded.

I am well aware of the criticisms of Dr.Fishbein–many are valid, some are exaggerated and some are utter nonsense.  He was, after all, human.

That being said, however, in the final rendering  Dr. Morris Fishbein left the profession of medicine a better place for having been here.  The same cannot be said of Dr. John R. Brinkley.

Similarly, the same cannot be said of Dr. Henry Andrews Cotton, M.D.,  (1876 – May 1933) a psychiatrist and Medical Director of New Jersey State Hospital at Trenton who used the emerging medical theory of infection-based psychological disorders to pull patient’s teeth under the premise they were suspected of harboring infections.  If this failed he subsequently removed the tonsils, sinuses, testicles, ovaries, gallbladders, stomachs, spleens, and cervixes of his patients. If these maneuvers failed Cotton then went for the colon–with special emphasis on the right side of the hindgut, which, he declared, had particularly ”decadent tendencies.”

From 1907 to 1930 he killed hundreds of patients and maimed many more.  Cotton reported cure rates as high as 85%. His fame in the U.S. spread rapidly and it took decades before his alarmingly high post-operative death rate of over 30% (mostly from peritonitis) raised any red flags.

Illustration of a mouth with teeth removed from Cotton's book The defective delinquent and insane: the relation of focal infections to their causation, treatment and prevention.

Illustration of a mouth with teeth removed from Cotton’s book The defective delinquent and insane: the relation of focal infections to their causation, treatment and prevention.

The same can also not be said of  Dr, Walter Jackson Freeman II, M.D. (November 14, 1895 – May 31, 1972), a neurologist without surgical training who pioneered the ice-pick lobotomy in the U.S.. and performed nearly 3500 of them in 23 states.  Seeking a faster way to perform the procedure, Freeman adopted Amarro Fiamberti’s transorbital lobotomy and perfected it by using ice picks hammered into the frontal lobes through the back of each eye socket.   Without anesthesia he was able to do these procedures  quickly and outside the operating room.   And in doing so he popularized the lobotomy in the U.S..  I’ve seen the results of Freeman’s work.  During a workup of a patient who I was consulting on for dementia an MRI revealed bilateral atrophic genu of the corpus callosum.   The patient and his family initially denied any history of prior brain surgery or injury but on further questioning recalled having something done to him in college that left him with two black eyes.  He said he was suffering from depression over his final exams and this was done to him at the student medical clinic during the same time frame Freeman was traveling to college campuses in his lobotomobile offering his services.   Neither the patient nor his family realized he had had a lobotomy.  Many of Freeman’s victims were children as young as 12.

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Dr. Freeman and his “lobotomobile”

The Medical Follies

The following quotes are taken from The Medical Follies, by  Dr. Morris Fishbein. He writes:

“Folly in the singular is recorded as weakness of intellect, foolishness, imbecility, etc. But in the plural, whatever it may retain of the singular, it has taken upon itself a new glory. ‘The Follies,’ after two decades of association with the theater, have come to mean entertainment—a spectacle, bright, flashing, exotic, devoid of plot, nude of truth and easy to enjoy except by those to whom still adheres some early piety.

“The incompetent or unprincipled physician, licensed to practice medicine by a too complaisant State is the greatest menace to scientific medicine – as great a menace as all the cultists put together.”

“Now, scientific medicine offers no such system. It aims, by the utilization of all available knowledge, to determine the cause of disease, and then, by the use of all intelligent methods, to benefit and heal the disease. It does not promulgate any theory or principle to the exclusion of established facts. It does not say, for example, that all disease arises in the spine and all disease can be healed by manipulating the spine….”

“The great fallacy of all the ‘systems’ of disease and their healing lies in this ‘all or nothing’ policy. When that policy runs counter to demonstrable facts the result is invariably disaster.”

What do Brinkley, Cotton and Freeman all have in common?  They all gained public recognition and became rich from what they did, Scarcely anyone doubted them publicly in the medical profession,  and they all practiced unmitigated and unmolested murder for decades before any red flags were raised.  In all likelihood all three were also sociopaths.

In the final rendering  Dr. Morris Fishbein left the profession of medicine a better place for having been here.  Brinkley, Cotton and Freeman most assuredly did not.  Sociopaths seldom do.

Junk-Science in the Medical Profession: The Resurgence of Polygraph “Lie-Detection” in an age of Evidence-Based Medicine

Junk-Science in the Medical Profession: The Resurgence of Polygraph “Lie-Detection” in an age of Evidence-Based Medicine.

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Circa 1995

The article below was published in the now defunct magazine Gray Areas almost twenty years ago. (Vol. 4, No. 1, Spring 1995 pp. 75-77).   Antipolygraph.og founder George Maschke noted in 2008 that article “makes a good introduction to the pseudoscience of polygraphy” and “the criticisms of polygraphy remain valid today.”  They still do.

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The Art of Deception: Polygraph Lie Detection

By Michael Lawrence Langan, M.D.

I’d swear to it on my very soul, If I lie, may I fall down cold.”

– Rubin and Cherise
(Hunter/Garcia)

The accuracy of polygraphic lie detection is slightly above chance. Nevertheless, State and local police departments and law enforcement agencies across the United States are devoted proponents of this unscientific and specious device. In addition, the American public seems to lend an implicit credence to the “lie detector” as evinced by its ubiquitous use on television crime shows and in “whodunit” literature. It is given overt attributions of credibility on tabloid type talk shows and news shows. For example, in the highly publicized case of Tonya Harding a reporter stated, not with removed objectivity but with sardonic grin and mocking emphasis, that the accused had failed two polygraph tests. The implied assumption is that if the person has failed the polygraph test, then therefore he or she is guilty regardless of other evidence. Bottom line. Culpa ex machina. End of story.

Lie detection by the polygraph is based on the premise that the act of telling a lie causes specific, universal, and reproducible physiological responses as manifested by the autonomic nervous system. (Saxe, 1991) These physiological responses, which are largely outside the influence of voluntary control, are then measured by the polygraph instrument. The polygraph itself is simplistic in design. It consists of several devices which are attached to the subject to record blood pressure, pulse, respiration, and galvanic skin response (which is related to perspiration). The results are then recorded on a moving paper by a “kymograph.” Hence any change of one of the autonomic nervous system variables will be recorded on the paper as a change from baseline. The polygraph examiner then interprets the tracing. A characteristic change from baseline on a relevant question is interpreted as a lie.

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In fact, the polygraph test does measure autonomic nervous system activity. The role of the autonomic nervous system with its sympathetic and parasympathetic branches is well defined within the field of medicine, and was well described by the French physician Claude Bernard over a century ago. The primary role of the autonomic nervous system is to maintain bodily homeostasis to allow the individual to exist in a changing environment.

Simplistically described, the autonomic nervous system is a part of the peripheral nervous system which consists of a variety of outgoing nerve pathways that regulate important physiological functions generally outside of voluntary and conscious control. Thus, respiration, body temperature, heart rate, digestion, sweating, and blood pressure are all, partly or entirely, regulated by the autonomic nervous system. It is divided into sympathetic and parasympathetic branches which have contrasting functions in terms of effect. The sympathetic branch increases heart rate, respiratory rate, blood pressure, and perspiration. It is active at all times but varies with the constantly changing environment, and is especially active during rage or fright and prepares the body for the so called “fight or flight” phenomenon. Many of these reactions are caused by the release of epinephrine. The parasympathetic nervous system, on the other hand, is primarily involved with conservation and restoration. It is the sympathetic branch of the autonomic nervous system that the polygraph measures in terms of its activity. Thus, from a medical perspective it is entirely valid that the polygraph will accurately measure sympathetic nervous system activity with its instrumentation.

The false assumption of the polygraph test is that dishonesty is the sole cause of sympathetic arousal during a polygraph examination. Deception is a cognitive phenomenon that cannot be measured. Indeed, throughout the entire history of medicine there has not been a single scientific study that demonstrated evidence that a cognitive phenomenon (such as love, hatred, truth, altruism, jealousy) could be measured. Since, in the complex realm of truth and deception, there is no known physiological response that correlates with lying, then there is no validity to the test. Although the act of lying can elicit fear and anxiety via the sympathetic nervous system, so can multiple other confounding and complex emotional factors including stress, embarrassment, anger, and fear. “Deception itself cannot be measured directly.” (Steinbrook, 1992) In addition, each individual differs in autonomic lability. Some people stay calm with a gun at their head. While others get autonomically excited, with heart thumping and palms sweating at simply shaking someone’s hand.

In reality, the examination itself is inherently designed to elicit fear and anxiety. It is an interrogation. If this fear and anxiety are recorded on a relevant question, then you have failed that question according to the polygraph “experts.”

The polygraph technique begins with a pre-test. After a sixth-grade level lecture on the nervous system and a proclamation of the test’s infallibility, the examiner will go over all of the questions that have been formulated.

These questions consist of control questions, relevant questions, and irrelevant questions. The subject will then be attached to the polygraph equipment and the formal testing begins.

The most crucial questions on the polygraph examination, or “Control Question Test,” are the control questions and relevant questions. The control questions are garnered from the suspect by asking him an innocuous question which could not be truthfully denied. For example, “Have you ever thought of hurting someone?” or “Have you ever lied to anyone?” The responses to the control questions will elicit some degree of autonomic activity which can then serve as a baseline for which to compare subsequent questions. The relevant questions pertain to the actual investigation at hand. The magnitude of responses to relevant questions and control questions as compared with the irrelevant questions is then interpreted, in a non-blinded manner, by the examiner. The assumption is, that if you are prevaricating, the relevant questions will cause a greater response than the control questions. So if the question “Have you ever been late for an appointment?” (control question) elicits less of an emotive response on the polygraph equipment than “Did you murder and rape your girlfriend?” (relevant question) you have failed the test. And, according to the American Polygraph Association (APA) you are lying. Assuming the subject is innocent, it is fairly obvious that he would respond with more emotional autonomic activity to a question regarding a recently deceased loved one than he would an inquiry about punctuality. Obvious to everyone, that is, but the APA.

The APA is a professional organization for polygraph examiners who have complete faith in the accuracy of the test. They have their own trade journalPolygraph in which they report scientifically worthless studies and brandish anecdotes of the wonders of their trade. The majority of these members can pride themselves on completing a 6 week to 6 month post- high school training course in the art of polygraphy. They have no formal training in medicine, psychology, physiology, or behavior; the very disciplines on which the testing is based. The majority of them cater to the legal system wherein their economic livelihood depends.

Since they are primarily paid to identify guilty suspects, motivational factors may play a part in their eagerness to find the guilty suspect. (Kleinmuntz, 1987)

The accuracy of any test is determined by that test’s sensitivity (ability to find a positive) and specificity (ability to find a negative). A polygraph examiner will ardently tell you that the exam has somewhere in the neighborhood of a 95% sensitivity rate. This means that if 100 guilty suspects are given a polygraph exam, 95 of them will be detected through the test. Only five of the 100 will be a false negative and not be detected by this miraculous method. Likewise they will claim a similar specificity rate, and state that if you are telling the truth then you have almost a 100% chance of being cleared by the test. John Reid, the inventor of the Control Question Test claimed 99% accuracy. (Reid and Inbau, 1977)

This is clearly not accurate. The polygraph was not subjected to much critical and scientific investigation until the last two decades. (Saxe, et al., 1983) Since this time there have been a number of studies of sound scientific design and methodology which clearly refute the high specificity and sensitivity that polygraph advocates claim. These studies have appeared in reputable peer-reviewed journals and not trade publications. Horvath, for example, reported a sensitivity of 76 percent and a specificity of 52 percent. (Horvath, 1977) This means that out of 100 liars 76 of them will be detected by the polygraph. What is astonishing though is the specificity of 52 percent. This means that out of 100 people who are not lying, 52 will be identified as telling the truth while 48 of the honest individuals will be branded as liars. The odds are similar to that of a coin toss which would have a specificity of 50 percent. Barland and Raskin’s study actually demonstrated a specificity of 45%. Worse than a coin toss. (Barland and Raskin, 1976) Multiple other studies have shown similar results. (Brett, et al., 1986, Kleinmuntz and Szucko, 1984, Lykken, 1984).

The polygraph examiner likens his “skill” to that of the radiologist reading a chest X-Ray or a cardiologist interpreting an EKG. (Barefoot, 1974) This analogy is not only ridiculous but, in fact, if a medical test had a similar sensitivity and specificity to that of the polygraph examination it would simply not be used in the field of medicine. They will cite the fact that the polygraph has been used in the United States for greater than 70 years as if longevity is directly related to validity. They will state that they have personally administered hundreds or thousands of these tests, and have almost never been wrong, as if total number of tests given constitutes accuracy.

They are so convinced of the accuracy of the polygraph that they regard opponents of polygraphy as communists and do-nothing professors. (Arther, 1986) It doesn’t occur to them that someone with a Ph.D. and years of research experience, in the very subjects they ignorantly dabble in, may know something more than they do.

It is astounding that the criminal justice system has institutionalized and perpetuated a so called “technology” that lacks scientific evidence and is in fact rejected by the scientific community. It is as ludicrous as procuring the so called “love meter” machine from the amusement park which measures galvanic skin response and placing it in the courtroom. But in a backward legal system which has been known to use psychics to help with unsolved murders and has allowed the mentally retarded to serve as jurors, it is not entirely surprising.

The tool is useful to them, however, in that 25 to 50 percent of examinees will, under the tense psychological pressure of the exam, confess to the misdeed at hand. (Lykken, 1981, Lykken, 1991) Persuaded that they have been proven dishonest by “scientific” means they give up hope. It is usual for the polygraph examiner to interrogate the subject who has failed the test. They will state that there is no way now to deny the objective guilt demonstrated by this impartial and unbiased scientific device, and that the only available option is to confess.

The assessment by the polygrapher is genuinely convincing because, sadly, he believes it himself. Thus the instrument is clearly useful as a confession inducing device. One wonders, over the past 70 years, how many false confessions have been obtained in this way from innocent persons.

In summary, the polygraph is a ludicrous implementation of pseudo-science at its worst. The members of the APA are non-scientists practicing science, and the consequences are often dire. Lykken reports the cases of three men who were convicted of murder largely due to the polygraph examiner’s testimony that in their “expert opinion” they had failed the test. All three were subsequently found to be innocent. (Lykken, 1991) Polygraph examiners ignore such cases or rationalize that they are due to the rare incompetence of some examiners.

The continued use of polygraphic lie detection has the potential to cause much harm to those who are judged dishonest by its results. The specificity and sensitivity are not dissimilar to that of a coin toss. Innocent suspects have about a 50/50 chance. One failure is all it takes to ruin your life. Since the 1923 Federal Court decision of Frye vs United States (293 F 1013 [DC Cir 1923]), polygraph evidence has not been admissible in federal court cases because there was deemed a lack of scientific validity to the test. This travesty however is still used widely by the state court system. Furedy characterizes the continued use of polygraphy as a serious “social disease.” (Furedy, 1987) State laws regarding abuse of the polygraph must change, and it is time for the medical and scientific communities to educate lawmakers and policy makers about the true validity of this perversion of science. It must be forever banished to the same realm of parapsychology as the Ouija Board, phrenology, and palmistry. The relatively conservative American Medical Association’s Council on Scientific Affairs recommended that the polygraph not be used in pre-employment screening and security clearance. (Council on Scientific Affairs, 1986) It is time to extend this recommendation across the board, and put the greater than 3000 anachronistic polygraph examiners in the United States out of business.

Meanwhile, if you are asked to take a polygraph test–don’t do it. Those involved in the criminal justice system, including lawyers, are largely uneducated in the realm of scientific scrutiny and experimental methodology.

They may not separate science and pseudo-science, and erroneously believe that the polygraph is an accurate scientific instrument. Their interactions are with polygraph examiners who proselytize its use, and they have little or no interaction with scientists, psychologists, and physicians who refute its use. Refuse to take the test and educate them. Cite the Frye doctrine, go to the medical library, copy the scientific articles which belie its validity, and present them to whomever requested you to take the test. State that the principles and assumptions underlying polygraphy are not supported by our understanding of psychology, neurology, and physiology. Then put the burden of proof on their heads. Tell them to present you with scientific evidence that corroborates the validity of the test. There is simply no rational basis for a machine to detect liars.

References

Arther RO. 1986. The polygraph’s enemies: An update. Journal of Polygraph Science. 20: 133-136.

Barefoot J. 1974. The Polygraph Story. Cluett Peabody and Co., New York.

Barland, G, Raskin D. 1976. Validity and reliability of polygraph examinations of criminal suspects (Report 76-1, Contract 75 NI-99-0001).

Brett AS, Phillips M, Beary JF. 1986. Predictive power of the polygraph: Can the “lie detector” really detect liars? The Lancet. 1: 544-547.

Council on Scientific Affairs. 1986. Polygraph. Journal of the American Medical Association. 256: 1172-1175.

Furedy JJ. 1987. Evaluating polygraphy from a psychophysiological perspective: a specific-effects analysis. Pavlovian Journal of Biological Sciences.22: 145-151.

Horvath F. 1977. The effect of selected variables on interpretation of polygraph records. Journal of Applied Psychology. 62: 127-136.

Kleinmuntz B. 1987. The predictive power of the polygraph: The lies lie detectors tell. Journal of the American Medical Association. 257: 189-190.

Kleinmuntz B, Szucko J. 1984. A field study of the fallibility of polygraphic lie detection. Nature. 308: 449-450.

Lykken D. 1984. Polygraph Interrogation. Nature. 307: 681-684.

Lykken DT. 1981. A tremor in the blood: Uses and abuses of the lie detector. McGraw-Hill, New York.

Lykken DT. 1991. Why (some) Americans believe in the lie detector while others believe in the guilty knowledge test. Integrative Physiological and Behavioral Science. 26: 214-222.

Reid JE, Inbau FE. 1977. Truth and deception: The polygraph (“lie detector”) technique. Williams & Wilkins, Baltimore.

Saxe L. 1991. Science and the CQT polygraph: A theoretical critique. Integrative Physiological and Behavioral Science. 26: 223-231.

Saxe L, Dougherty D, Crosse T. 1983. Scientific validity of polygraph testing: a research review and evaluation. Conference: OTA-TM. U.S. Congress Office of Technology Assessment.

Steinbrook R. 1992. The polygraph test – A flawed diagnostic method. The New England Journal of Medicine. 327: 122-123.

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Transcription and HTML by AntiPolygraph.org

Published in Gray Areas, Vol. 4, No. 1 (spring 1995), pp. 75-77. This article may also be downloaded as a 1 mb scanned PDF file.https://antipolygraph.org/articles/article-053.pdf


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Junk-Science in the Medical Profession: The Resurgence of Polygraph “Lie-Detection” in an age of Evidence-Based Medicine

Disrupted Physician

33755_1527129670651_5081648_n Circa 1995

The article below was published in the now defunct magazine Gray Areas almost twenty years ago. (Vol. 4, No. 1, Spring 1995 pp. 75-77).   Antipolygraph.og founder George Maschke noted in 2008 that article “makes a good introduction to the pseudoscience of polygraphy” and “the criticisms of polygraphy remain valid today.”  They remain valid in 2014.

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The Art of Deception: Polygraph Lie Detection

By Michael Lawrence Langan, M.D.

I’d swear to it on my very soul, If I lie, may I fall down cold.”

– Rubin and Cherise
(Hunter/Garcia)

The accuracy of polygraphic lie detection is slightly above chance. Nevertheless, State and local police departments and law enforcement agencies across the United States are devoted proponents of this unscientific and specious device. In addition, the American public seems to lend an implicit credence to the “lie detector” as evinced by its ubiquitous use on television crime shows and…

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When to Doubt a Scientific Consensus

The 12-red flags below are very applicable to American Society of Addiction Medicine (ASAM) related consensus and public policy.    When viewed through this lens the science and research all falls apart.

(1) When different claims get bundled together.
(2) When ad hominem attacks against dissenters predominate.
(3) When scientists are pressured to toe the party line.
(4) When publishing and peer review in the discipline is cliquish.
(5) When dissenting opinions are excluded from the relevant peer-reviewed literature not because of weak evidence or bad arguments but as part of a strategy to marginalize dissent.
(6) When the actual peer-reviewed literature is misrepresented.
(7) When consensus is declared hurriedly or before it even exists.
(8) When the subject matter seems, by its nature, to resist consensus.
(9) When “scientists say” or “science says” is a common locution.
(10) When it is being used to justify dramatic political or economic policies.
(11) When the “consensus” is maintained by an army of water-carrying journalists who defend it with uncritical and partisan zeal, and seem intent on helping certain scientists with their messaging rather than reporting on the field as objectively as possible.
(12) When we keep being told that there’s a scientific consensus.

Peddling Fiction

  • Anyone who has studied the history of science knows that scientists are not immune to the non-rational dynamics of the herd. Many false ideas enjoyed consensus opinion at one time. Indeed, the “power of the paradigm” often shapes the thinking of scientists so strongly that they become unable to accurately summarize, let alone evaluate, radical alternatives. Question the paradigm, and some respond with dogmatic fanaticism.
  • So what’s a non-scientist citizen, without the time to study the scientific details, to do? How is the ordinary citizen to distinguish, as Andrew Coyne puts it, “between genuine authority and mere received wisdom? Conversely, how do we tell crankish imperviousness to evidence from legitimate skepticism?” Are we obligated to trust whatever we’re told is based on a scientific consensus unless we can study the science ourselves? When can you doubt a consensus? When should you doubt it?
  • Your best bet is to look at…

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Integrity and Accountability—Defend the MRO Procedurally, Ethically or Legally and win 100 Volumes of the Classics in Medicine Library and Salk and Sabin Autographs!

Screen Shot 2015-06-18 at 11.46.50 PMIntegrity and Accountability—The Declining State of Physician Health and the Urgent Need for Ethical and Evidence-Based Leadership.

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Sabin and Salk Autographs

“The incompetent or unprincipled physician, licensed to practice medicine by a too complaisant State, is the greatest menace to scientific medicine – as great a menace as all the cultists put together.”  —Dr. Morris Fishbein  (The Medical Follies.  New York:  Boni Liverlight, 1925 p. 71)

“There is no place in science for consensus or opinion, only evidence”  —Claude Bernard


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Sabin, Salk and the Classics in Medicine Library

Polio is nearly a thing of the past thanks to to Dr. Jonas Salk and Albert Sabin. In 1952 Salk discovered and developed the first successful vaccine for polio and combined with Albert Sabin’s 1961 oral vaccination the duo effectively obliterated the contagious polio virus.  Once a deadly threat to our  country and future there were 93,000 cases of polio reported in the U.S. Between 1952 and 1953 alone. ElaineBurnsBut thanks to Sabin and Salk the last case of naturally occurring polio in the U.S. occurred in 1979.

 
full body respirator or “iron lung” needed to treat patients whose respiratory muscles became paralyzed by polio

October 23, 2014 was the centenary of Jonas Salk’s birth and in honor of his 100th birthday I am sponsoring a contest to win framed autographs of both Jonas Salk and Albert Sabin as seen above.  In addition,  you will receive 100 volumes of the Classics in Medicine Library published by Gryphon Editions whose “mission is the preservation of the literary and intellectual heritage of the noble professions that we serve”

These are exact facsimiles of the original classics bound in leather and include works by William Osler, Harvey Cushing and Paul Dudley White.

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Background

According to British sociologist G. V. Stimson the  “impaired physician movement” is characterized by a “number of evangelical recovered alcoholic and addict physicians, whose recovery has been accompanied by involvement in medical society and treatment programs.” Their “authoritative pronouncements on physician impairment is based on their own claim to insider’s knowledge.”

In this regard Dr. Wayne Gavryck, M.D. is a prototypical example.

An ex-alcoholic with a history of malpractice, Gavryck quit drinking through Alcoholics Anonymous, became “board certified” in “Addiction Medicine” and became involved with the Massachusetts PHP,  Physician Health Services, Inc. (PHS) where he has been an Associate Director since 1988.  He serves as their Medical Review Officer (MRO).

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The “impaired physician movement” has gained tremendous sway through the American Society of Addiction Medicine and the Federation of State Physician Health Programs.  The ASAM is not a valid medical specialty but a “special interest group” that represents the chronic relapsing brain disease with lifelong abstinence and 12-step recovery model of addiction and the companies that profit from it financially ( drug and alcohol testing labs,  12-step inpatient assessment and treatment centers) and politically  (Drug War advocates,  Anti -Medical Marijuana advocates).   The impaired physician movement gained a seat at the table of power in medicine by bamboozling regulatory and administrative medicine.   This illegitimate and irrational authority is in charge of almost every state PHP in the United States.     ASAM physicians joined their state PHPs, gained power, and then removed those who did not agree with the groupthink and doublethink.  Blind obedience and control  are favored over fairness, truth and evidence-base.   As with other states under the FSPHP, blindly obedient doctors are kept on while those who  question the science  and ethics of the groupthink are removed.  The  PHP-Drug Testing Laboratory and  “PHP approved” assessment and treatment center industrial complex requires a Medical Review Officer of blind faith who places the goals of the FSPHP above all other considerations including the Hippocratic Oath.  The system requires doctors who are willing to participate in “moral disengagement” of wrongdoing including professional, ethical and legal violations.    To erect this scaffold they have put in place barriers to exposure and accountability. By declaring themselves “experts” they have used logical fallacy to temporize  deflect and otherwise stifle accountability. With no oversight or regulation they are, in fact, accountable to no one.   The appeal to authority and esoteric knowledge is an effective means of  extinguishing valid concerns.  Complacent that this is a group of benevolent organizational purpose those who should know better and could do something about it rationalize their apathy and indifference.   A necessary step in exposing and addressing this  problem is imposing accountability.    If an organization is able to  engage in conduct that is the antithesis of accepted professional guidelines and standards of care,  in violation of professional and societal mores and codes-of-conduct and  is illegal then there is a systemic problem.  This problem can fortuitously be addressed by examining standards of care, conduct and criminal codes for breaches.   If a breach is found then it needs to be explained and justified.  One of the tactics of the FSPHP is to deflect criticism under the logical fallacy of appeal to authority.  We are the experts. We know better.  That is where it usually ends.   But accountability requires both the provision of information and justification of actions.  My hypothesis is that this group is committing fraud, violating ethics and flouting the law in an irrefutable manner.  If this is not true then my hypothesis should be able to be refuted.  It cannot.  And for that reason I am putting my money where my mouth is.


Accountability

In all fairness,  If Gavryck can justify his actions either procedurally, ethically or  legally and back it up by any written protocol, guideline or standard then he wins and I will refrain from any more criticisms.  In addition I will hand deliver to him the Salk and Sabin autographs and 100 volumes of the classics in medicine, apologize and remove this entire blog.

Accountability requires both the provision of information and justification of actions.  One way of examining this is to look at the body professional and ethical standards and state and federal law.   The FSPHP has blocked the provision of information regarding drug-testing.  Although it has taken over three years I have obtained the all of the information pertaining to a July 1, 2011  test that should have immediately been rejected by the MRO. It is an invalid test.

Dr. Gavryck violated every conceivable procedural guideline and standard-of-care there is for an MRO,  the Medical Review Officer Certification Council’s Codes of Ethical Conduct and both State and Federal Law.   This can be ascertained by looking at the documentation.  I have done this and found hundreds of documents that support the accusation that as an MRO Wayne Gavryck breached protocol, engaged in unethical behavior and broke the law.  Prove me otherwise with just one credible source and  the prizes are yours.

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Contest Rules

Your job is to review the documentary evidence and records from PHS, Quest Diagnostics and USDTL and assess the actions and decisions made by the MRO.S)

If you can show that  these decisions were the result of  legitimate reasoning based on published guidelines or protocol, ethically defensible or did not break any laws and cite one credible source that concurs with this point of view then you have won.

If you can show that these decisions were the product of legitimate and thoughtful reasoning in accordance with established guideline, ethical codes then I will hand-deliver the items to you.

 If you can justify, support or defend the actions of the Medical Review Officer (MRO):

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  2. Ethically; 

  3. or Legally;IMG_0577 - Version 2 

You win all of the prizes! Simple as that!

In fact, If you can support  just one of these the entire lot is yours.

If you can show Dr. Gavryck did not breach any and all published Standards-of-Care and Professional Protocols and Guidelines regarding drugs-of-abuse testing, OR that he did not violate any and all Codes of Conduct and Ethical Guidelines of the Medical Profession from Hippocrates to the American Medical Association OR that he did not violate multiple State and Federal Laws you win Salk and Sabin autographs and all of the books.

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All of the documents and details regarding the forensic fraud, concealment, coverup and deliberate misrepresentation to a state agency under color of law can be seen here:

Integrity and Accountability—The Declining State of Physician Health and the Urgent Need for Ethical and Evidence-Based Leadership.

To Review:   Any and all drug testing requires chain-of-custody.   “Forensic” drug testing differs from “clinical”drug testing because the consequences of a falsely positive test can be grave and far reaching.  Because the results of  a positive test can result in the loss of rights and liberties of the person taking the test it is essential that it be done correctly.  False-positive tests are unacceptable so strict chain-of-custody procedure and MRO review assure specimen integrity.    This provides accountability and the custody

The custody-and-control form records chain-of-custody and is given the status of a legal document as it has the ability to invalidate a test that lacks complete information.  The job of the MRO is to invalidate specimens without intact chain-of-custody.

The MRO job is fairly simple.  If a lab reports a positive test for any substance the MRO must check that the signatures, dates, times and other information on the custody-and-control form are correct and per protocol.  Chain-of-custody must be accurate and complete.   The MRO looks for “fatal flaws” on the chain-of-custody form.  If a “fatal flaw is present then the test is invalidated and the test is not reported as “positive” but “invalid.”

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The sole  job of the MRO is to ensure that the drug testing process and chain-of-custody procedure is followed to the letter.  The MRO reviews the Custody and Control form for accuracy and completeness.  The MRO also rules out any other possible explanations for a positive test (such as legitimately prescribed medications).  Only then is a test reported as positive.

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The legal issues involved in forensic testing mandate MRO review. According to The Medical Review Officer Manual for Federal Workplace Drug Testing Programs

“the sole responsibility of the MRO is to”ensure that his or her involvement in the review and interpretation of results is consistent with the regulations and will be forensically and scientifically supportable.”

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Corruption is misuse of entrusted power.  It occurs when those who have been given authority to carry out expected goals instead use their position and power to benefit themselves and others close to them. Abuse of power is particularly egregious when that person is doing the opposite of what he or she is supposed to do.

Accountability is necessary to prevent corruption and necessitates both the provision of information and justification for actions;  what was done and why?   The other defining factor of accountability is the ability of outside actors to punish and sanction those who commit misconduct or wrongdoing.    Without these constraints corruption is inevitable.

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Although Gavryck may serve PHS, it is not in the capacity of a certified medical review officer; by my count  the documentary evidence alone shows that he violated four of the seven Medical Review Officer Certification Council Codes of Ethical Conduct.  In addition to violating the MRO  Ethical Conduct he violated every other code I can think of from the Hippocratic Oath to the AMA Code of Ethics. and everything in between.

As the MRO for PHS Gavryck’s responsibility is simple.  He is supposed to verify that the chain-of-custody  of the sample was intact before reporting a test as positive.

This is indefensible on all levels (procedurally, ethically and legally). The documents show with clarity that this was not accident or oversight, but intentional and purposeful misconduct

There should be zero-tolerance for forensic fraud of this sort.   Those of integrity and moral compass would agree.     Transparency, regulation, and accountability are necessary.  It is an issue that needs to be acknowledged and addressed not ignored and covered up.

If Dr. Gavryck can give a procedural, ethical, or legal explanation of what was done then I stand corrected. Just one will suffice. If he cannot then this needs to be addressed openly and publicly.   And whether he was involved in the original fraud or not is irrelevant. As the MRO for PHS it is his responsibility to correct it–however late the hour may be.

Perhaps Dr. Gavryck needs to see some of the damage he has caused in order to take this responsibility. Known as a “bag man” who simply rubber stamps positive tests at the request of Linda Bresnahan, much like Annie Dookhan, he does not see the damage that is caused. Forensic fraud has grave and far reaching effects and in this case has severely impacted many people and include patient deaths. Perhaps Dr. Gavryck needs to take a “moral inventory” and see that this this type of behavior causes real damage to real people and put a face on it.

Please help me get this exposed, corrected, and rectified. The physicians of Massachusetts deserve better than this.

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Against the Rising Tide: Looking for Biostatisticians and Epidemiologists to help shape Drug-Testing Policy to be more Evidence-Based

Wanted!–a Few Honest Statisticians, Biostatisticans and Epidemiologists who want to make a difference..

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It is only a few public policy steps and minor changes in state regulatory statutes before what is described in the ASAM White Paper on Drug Testing comes to fruition.  Before we know it the Drug and Alcohol Testing Industries “New Paradigm” as described here by Robert Dupont will be ushered in.  From the ASAM white Paper:

“THIS WHITE PAPER ENCOURAGES WIDER AND “SMARTER” USE OF DRUG TESTING WITHIN THE PRACTICE OF MEDICINE AND, BEYOND THAT,BROADLY WITHIN AMERICAN SOCIETY. SMARTER DRUG TESTING MEANS INCREASED USE OF RANDOM TESTING* RATHER THAN THE MORE COMMON SCHEDULED TESTING,* AND IT MEANS TESTING NOT ONLY URINE BUT ALSO OTHER MATRICES SUCH AS BLOOD, ORAL FLUID (SALIVA), HAIR, NAILS, SWEAT AND BREATH WHEN THOSE MATRICES MATCH THE INTENDED ASSESSMENT PROCESS. IN ADDITION, SMARTER TESTING MEANS TESTING BASED UPON CLINICAL INDICATION FOR A BROAD AND ROTATING PANEL OF DRUGS RATHER THAN ONLY TESTING FOR THE TRADITIONAL FIVE-DRUG PANEL.”

Backed by the multi-billion dollar drug and alcohol testing, assessment and treatment industry the public policy positions of the American Society of Addiction Medicine (ASAM) have invariably passed. There has been little if any meaningful opposition.

To prevent this future drug testing dystopia, that includes testing schoolchildren, we need to take a step back and analyze the reliability and credibility of the “evidence-base” behind these multiple non-FDA approved (Introduced as Laboratory Developed Tests (LDTs) to bypass FDA approval) “forensic” drug and alcohol tests and testing devices (The alcohol biomarkers EtG, EtS, PEth; SCRAM (Subcutaneous Remote Alcohol Monitoring Bracelet);CDPB (Cellular Digital Photo Breathalyzer); and Hair Testing- Psychemedics, etc.) the ASAM proposes be used on the population at large.  These tests include nail, hair, saliva, breath, blood and urine and they plan on utilizing the Medical Profession as a urine collection agency by calling this testing a “medical evaluation” rather than “monitoring” for drug and alcohol use.   This change in semantics enables them to bypass the usual forensic drug testing protocol (that includes strict chain-of-custody collection and MRO review) designed to minimize false-positives because the results of erroneous test can be grave and far reaching.  According to the ASAM white paper the “clinical” collection of specimens as is good enough as the results of a positive test will result in “treatment” rather than “punishment.”

Amazingly, there has been no Academic review of these tests, let alone a Cochrane type critical analysis.  It is essentially untapped territory.  In addition there has been no Institute of Medicine type Conflict of Interest Analysis.  

And that is why I am asking for help from statisticians, biostatisticians and epidemiologists.  The task would entail a review of the literature prior to the introduction of these tests for evidence base of forensic applicability (there essentially is none) and a review of the literature peri-and post marketing of these devices to assess the reliability and credibility of the underlying methodology and ascertain the evidence-base.  The goal would be publication in both academic journals and presentation to the general public through media publication with the assistance of investigative journalists and other writers. The goal is to get the truth out about these tests and allow both the medial profession and public at large to awaken to the menace this represents.
 I can’t pay you but you would be combating injustice, corruption and dishonesty.   You would be doing your part in helping the Medical Profession, honest and decent doctors, our country and  perhaps our future.  

Science vs. Pseudoscience

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Wanted!–a Few Statisticians, Biostatisticians and Epidemiologists who want to make a difference in Medicine, Society and our Future

 “That everyone shall exert himself in that state of life in which he is placed, to practice true humanity towards his fellow men, on that depends the future of mankind.” – Albert Schweitzer 
“By and by never comes” –St Augustine

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“A day’s impact is better than a month of dead pull”-Justice Oliver Wendell Holmes, Jr.

 I am looking for a few honest and credible statisticians, biostatisticians or epidemiologists who want to make a difference in the spirit  of service and helping others.  I can’t pay you but you would be combating injustice, corruption and dishonesty.   You would be doing your part in helping the Medical Profession, honest and decent doctors, our country and  perhaps our future.  

It is only a few public policy steps and minor changes in state regulatory statutes before what is described in the ASAM White Paper on Drug Testing comes to fruition.  Before we know it the Drug and Alcohol Testing Industries “New Paradigm” as described here by Robert Dupont will be ushered in as it did with doctors; not with a bang but a whimper.  From the ASAM white Paper:

“THIS WHITE PAPER ENCOURAGES WIDER AND “SMARTER” USE OF DRUG TESTING WITHIN THE PRACTICE OF MEDICINE AND, BEYOND THAT,BROADLY WITHIN AMERICAN SOCIETY. SMARTER DRUG TESTING MEANS INCREASED USE OF RANDOM TESTING* RATHER THAN THE MORE COMMON SCHEDULED TESTING,* AND IT MEANS TESTING NOT ONLY URINE BUT ALSO OTHER MATRICES SUCH AS BLOOD, ORAL FLUID (SALIVA), HAIR, NAILS, SWEAT AND BREATH WHEN THOSE MATRICES MATCH THE INTENDED ASSESSMENT PROCESS. IN ADDITION, SMARTER TESTING MEANS TESTING BASED UPON CLINICAL INDICATION FOR A BROAD AND ROTATING PANEL OF DRUGS RATHER THAN ONLY TESTING FOR THE TRADITIONAL FIVE-DRUG PANEL.”

To prevent this future drug testing dystopia, that includes testing schoolchildren, we need to take a step back and analyze the reliability and credibility of the “evidence-base” behind these multiple non-FDA approved forensic drug and alcohol tests and testing devices the ASAM proposes be used on the population at large utilizing the Medical Profession as a urine collection agency and bypassing forensic drug testing protocol by calling this “evaluation” and treatment rather than “monitoring” and punishment. New definitions, loopholes, secrecy and subterfuge are the bread and butter of these prohibitionist profiteers.

Amazingly, there has been no Academic review of these tests, let alone a Cochrane type critical analysis.  It is essentially untapped territory.  In addition there has been no Institute of Medicine type Conflict of Interest Analysis.  And that is why I am asking for help from statisticians, biostatisticians and epidemiologists.  The task would entail a review of the literature prior to the introduction of these tests for evidence base of forensic applicability (there essentially is none) and a review of the literature peri-and post marketing of these devices to assess the reliability and credibility of the underlying methodology and ascertain the evidence-base.  The goal would be publication in both academic journals and presentation to the general public through media publication with the assistance of investigative journalists and other writers. The goal is to get the truth out about these tests and allow both the medial profession and public at large to awaken to the menace this presents to medicine, our society and our future.

 Lack of Evidence-Base, Bias and Conflicts of Interest:  Making the Data Fit the Hypothesis

I am no epidemiologist or statistician but as with pornography I know junk-science when I see it.  Almost all of these tests were introduced with little or no evidence-base and, as with most of their endeavors, they did it below board via loopholes and cutting corners.

The overwhelming majority of papers are small, methodologically flawed, non-randomized, non-blinded  retrospective studies in that appear to make the data fit the hypothesis.   The authors can invariably be linked to those profiting from the tests of the testing process ( the patent holder, doctors associated with the drug testing labs, ASAM or FSPHP, Robert Dupont, Greg Skipper, etc.)

 

Ethyl Glucuronide (EtG) was introduced in 1999 as a biomarker for alcohol consumption,1 and was subsequently suggested as a tool to monitor health professionals by Dr. Gregory Skipper because of its high sensitivity to ethanol ingestion.2   

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Described as the  “innovator of EtG as an alcohol biomarker,” Skipper and  Friedrich Wurst,  “convinced” NMS labs in Pennsylvania “to start performing EtG testing in 2002.

The study most often cited as 100% proof that there is 100% accuracy in EtG testing proving alcohol consumption involved a mere 35 forensic psychiatric inpatients in Germany that was published in 2003.3  

Shortly thereafter the Physician Health Programs began using it in monitoring doctors and other professional monitoring programs soon followed.

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Screen Shot 2014-11-29 at 5.16.18 PMLaboratory Developed Tests -A Loophole to Avoid FDA Approval and Accountability

Up until the birth of the EtG tests used for forensic drug and alcohol monitoring had to go through the arduous, expensive and necessary FDA approval process.   The LDT pathway was designed to develop simple tests with little risk that have  low market potential (i;e. the cost of the normal FDA approval process would prohibit them from coming to market).  The LDT pathway was designed to improve patient care and help improve diagnosis and treatment. It was not designed for forensic tests.  LDT approval does not require in vivo testing.  It is essentially an honor system and to develop an LDT it is not even necessary to prove that the test is actually testing what it is purportedly testing for (validity).

So with little to no evidence base they introduced the EtG, had it developed and marketed as a LDT in collusion with unscrupulous labs, and then began using it on physicians being monitored by State PHPs. This then spread to other monitoring organizations in which there was a large power-differential between those ordering the tests and those being tested (criminal-justice, other professional monitoring programs).  These biomarkers have never been used in Federal Drug Testing, SAMHSA approved, DOT, and other organizations where unions or other organizations are present and looking out for the best interests of those being tested.

Another example of how this group removes accountability.  There has been essentially no oversight or regulation of LDTs.  Although there was a recent push for regulation of these tests the Drug and Alcohol Testing Industry Association lobby made sure that forensic tests would be exempt.

They then began publishing “research” on the EtG using the physicians being monitored as subjects. Many of the studies promoting the EtG and other biomarkers can be found  in  Journals that are linked to organizations that are linked to AA and were organized to educate the medical community.

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These small, methodologically flawed studies amount to little more than opinion pieces but   This “evidence-base” is predominantly in biased journals published by biased medical “societies.  
The EtG was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash4,5, hand sanitizer gel6, nonalcoholic beer7, and nonalcoholic wine.8  Sauerkraut and bananas have even been shown to cause positive EtG levels.9
The United States Substance Abuse and Mental Health Services Administration warned against using a positive EtG as primary or sole evidence of drinking for disciplinary or legal action.10  The Wall Street Journal in 2006 reported the problems with the EtG to the general public.11   
Screen Shot 2014-03-23 at 10.45.36 PMAs any rational authority would do, the majority of monitoring agencies abandoned the EtG after these flaws were revealed. The PHPs did not.  They continued to use the EtG on doctors uninterruptedly by telling them to avoid any products that could potentially contain alcohol; a ubiquitous substance in the environment. Since that time they have justified and rationalized (EtG)2,12 13  use by sequentially raising cutoff levels from 100 to 250 to 500 to 1000 to 2000 to now unknown and adding other LDTs as “confirmation tests such as Ethyl Sulfate (EtS)14,15 Phosphatidyl-Ethanol ( Peth)16 17 and other devices such as the Subcutaneous Remote Alcohol Monitoring Bracelet (SCRAM) and, their newest device the Cellular Photo Digital Breathalyzer (CPDB) that has recently been launched, just like the EtG Screen Shot 2014-02-23 at 10.00.22 PMwith little to no evidence base other than a pilot study done by Greg Skipper and Robert Dupont.18 
A  2013 article published in an ASAM incubated journal Alcoholism: Clinical and Experimental Research promotes the Phosphatidyl-ethanol (PEth ) test to confirm drinking.16  The study was done on physicians being monitored by the Alabama Physician Health Program who tested positive for EtG/EtS alcohol biomarkers. It is co-authored by Robert Dupont, Greg Skipper, and Friedrich Wurst and involved 18 subjects who tested positive for EtG/EtS of whom 7 claimed they did not drink.  After finding that 5 of the 7 tested negative for PEth they concluded that “positive PEth testing following positive EtG/EtS results confirms recent drinking.  Hard to wrap your head around the science in that one.Screen Shot 2014-04-30 at 1.06.53 PMSkipper is also using both Scram ankle bracelets and the CPDB monitoring in pilots in the Human Interventional Motivational Study (HIMS) Program that was developed in 2009 to “identify, treat and, eventually, re-certify airline pilots with substance abuse problems. 
 
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The Cochrane Collaboration does systematic reviews of the literature using conscientious, explicit, and judicious criteria to in order to produce and disseminate only high quality and evidenced based health care, exclude bias, and enhance transparency. The Cochrane database is a current and evolving database that includes the accuracy of diagnostic tests and is internationally recognized as the standard in evidence based health care.  This benchmark for evidence based health care and systematic reviews, records just 5 controlled trials under the topic ethyl glucuronide.8,19-21 These 5 studies represent the only high-quality evidence regarding EtG applying to EtG. Information provided by the five studies suggests the following, and only the following:

  1. EtG and EtS measurements increase with alcohol ingestion.
  2. The window of detection is shorter than what is commonly proposed (80 hours).
  3. Individual values are variable both within and between subjects.
  4. Non alcoholic wine can cause positive levels.

Notably, there are no studies that fit Cochrane Criteria, other than non-alcoholic wine, that look at the pharmacokinetics of EtG or EtS in terms of dose-response curves, cut-off levels, specificity drug and food interactions, or modes of ingestion.

SAMHSA notes that there is little research on PEth and that EtG, EtS, and PEth “do not have a strong research base,” and that “it is not known at this time how the test results might be affected by the presence of physical diseases, ethnicity, gender, time, or the use of other drugs. Until considerable more research has occurred, use of these markers should be considered experimental.”

Phosphatidylethanol (PEth), SCRAM, and the  yields no data as a test in the Cochrane library.

SAMHSA notes that there is little research on PEth and that EtG, EtS, and PEth “do not have a strong research base,” and that “it is not known at this time how the test results might be affected by the presence of physical diseases, ethnicity, gender, time, or the use of other drugs. Until considerable more research has occurred, use of these markers should be considered experimental.”

Evidence based medicine (EBM) can be defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.22

Medical progress and scientific advancement is occurring so fast that the volume of medical literature is expanding at a rate of greater than 7% per year.23

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.22  

Expert opinion is the lowest level of evidence available in the EBM paradigm.24,25

Fortunately, the scientific method is a tool to help people progress toward the truth despite their susceptibilities to confirmation bias and other errors.26

Unfortunately, due to a confluence of factors (including political) this has not been done.  But, unless we want a  future as envisioned by Robert Dupont and explained in the the ASAM White Paper on Drug Testing we need to act now.  This is not a “New Paradigm” but a “New Inquisition.”

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  1. Wurst FM, Kempter C, Seidl S, Alt A. Ethyl glucuronide–a marker of alcohol consumption and a relapse marker with clinical and forensic implications. Alcohol Alcohol. Jan-Feb 1999;34(1):71-77.
  2. Skipper GE, Weinmann W, Thierauf A, et al. Ethyl glucuronide: a biomarker to identify alcohol use by health professionals recovering from substance use disorders. Alcohol Alcohol. Sep-Oct 2004;39(5):445-449.
  3. Wurst FM, Vogel R, Jachau K, et al. Ethyl glucuronide discloses recent covert alcohol use not detected by standard testing in forensic psychiatric inpatients. Alcohol Clin Exp Res. Mar 2003;27(3):471-476.
  4. Costantino A, Digregorio EJ, Korn W, Spayd S, Rieders F. The effect of the use of mouthwash on ethylglucuronide concentrations in urine. J Anal Toxicol. Nov-Dec 2006;30(9):659-662.
  5. Reisfield GM, Goldberger BA, Pesce AJ, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after intensive exposure to high ethanol content mouthwash. J Anal Toxicol. Jun 2011;35(5):264-268.
  6. Rosano TG, Lin J. Ethyl glucuronide excretion in humans following oral administration of and dermal exposure to ethanol. J Anal Toxicol. Oct 2008;32(8):594-600.
  7. Thierauf A, Gnann H, Wohlfarth A, et al. Urine tested positive for ethyl glucuronide and ethyl sulphate after the consumption of “non-alcoholic” beer. Forensic Sci Int. Oct 10 2010;202(1-3):82-85.
  8. Hoiseth G, Yttredal B, Karinen R, Gjerde H, Christophersen A. Levels of ethyl glucuronide and ethyl sulfate in oral fluid, blood, and urine after use of mouthwash and ingestion of nonalcoholic wine. J Anal Toxicol. Mar 2010;34(2):84-88.
  9. Musshoff F, Albermann E, Madea B. Ethyl glucuronide and ethyl sulfate in urine after consumption of various beverages and foods–misleading results? Int J Legal Med. Nov 2010;124(6):623-630.
  10. Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
  11. Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
  12. Wurst FM, Skipper GE, Weinmann W. Ethyl glucuronide–the direct ethanol metabolite on the threshold from science to routine use. Addiction. Dec 2003;98 Suppl 2:51-61.
  13. Wurst FM, Alling C, Aradottir S, et al. Emerging biomarkers: new directions and clinical applications. Alcoholism, clinical and experimental research. Mar 2005;29(3):465-473.
  14. Anton RF. Commentary on: ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcoholism, clinical and experimental research. Jul 2014;38(7):1826-1828.
  15. Hernandez Redondo A, Schroeck A, Kneubuehl B, Weinmann W. Determination of ethyl glucuronide and ethyl sulfate from dried blood spots. International journal of legal medicine. Jul 2013;127(4):769-775.
  16. Skipper GE, Thon N, Dupont RL, Baxter L, Wurst FM. Phosphatidylethanol: the potential role in further evaluating low positive urinary ethyl glucuronide and ethyl sulfate results. Alcoholism, clinical and experimental research. Sep 2013;37(9):1582-1586.
  17. Hahn JA, Dobkin LM, Mayanja B, et al. Phosphatidylethanol (PEth) as a biomarker of alcohol consumption in HIV-positive patients in sub-Saharan Africa. Alcoholism, clinical and experimental research. May 2012;36(5):854-862.
  18. Skipper GE, Thon N, DuPont RL, Campbell MD, Weinmann W, Wurst FM. Cellular photo digital breathalyzer for monitoring alcohol use: a pilot study. European addiction research. 2014;20(3):137-142.
  19. Hoiseth G, Bernard JP, Stephanson N, et al. Comparison between the urinary alcohol markers EtG, EtS, and GTOL/5-HIAA in a controlled drinking experiment. Alcohol Alcohol. Mar-Apr 2008;43(2):187-191.
  20. Wojcik MH, Hawthorne JS. Sensitivity of commercial ethyl glucuronide (ETG) testing in screening for alcohol abstinence. Alcohol Alcohol. Jul-Aug 2007;42(4):317-320.
  21. Sarkola T, Dahl H, Eriksson CJ, Helander A. Urinary ethyl glucuronide and 5-hydroxytryptophol levels during repeated ethanol ingestion in healthy human subjects. Alcohol Alcohol. Jul-Aug 2003;38(4):347-351.
  22. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. Jan 13 1996;312(7023):71-72.
  23. Norwitz ER, Greenberg JA. Promoting evidence-based medicine. Rev Obstet Gynecol. Summer 2008;1(3):93-94.
  24. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. Feb 25 2009;301(8):868-869.
  25. Straus SE, Green ML, Bell DS, et al. Evaluating the teaching of evidence based medicine: conceptual framework. BMJ. Oct 30 2004;329(7473):1029-1032.
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