Mandating Drug-Testing of Unknown Validity while removing the procedural safeguards of forensic drug testing: The plan to introduce junk-science lab tests into the healthcare system and randomly drug test students in schools

screen-shot-2016-12-04-at-11-38-32-pmAs a physician-patient relationship renders drug testing “clinical” rather than “forensic” the consequences become “treatment” rather than “discipline.”  And that is the real reason behind all of this.    A positive “forensic” test in most employee random drug screening programs today will result in an “assessment” for substance abuse.  Most EAPs allow a choice in where that assessment takes place.  The model this system is based on, Physician Health Programs. do not allow choice as evaluations are mandated to “PHP-approved” assessment centers; a rigged game.A positive “clinical” test will result in the same thing under the ASAM White Paper proposal.  But the assessment will be at an ASAM facility and if a Substance Use Disorder (SUD) is confirmed it will result in mandated abstinence of all substances (including alcohol) and lifelong spirituality involving 12-step recovery   And by using the healthcare system as a loophole and calling this testing “clinical” rather than “forensic” the ASAM will have successfully introduced widespread testing of a variety of Laboratory Developed Tests (LDTs) of unknown validity while removing  the safeguards provided by forensic testing including chain-of-custody and MRO review.

Source: Mandating Drug-Testing of Unknown Validity while removing the procedural safeguards of forensic drug testing: The plan to Introduce Laboratory Developed Tests into Mainstream Healthcare

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The drug and alcohol testing and treatment industry plan to use the medical profession as a urine collection agency to bypass procedural protections: The ASAM White Paper on Drug Testing and the “Future of American Drug Policy.”

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Before the  2012 Drug and Alcohol Testing Industry Association (DATIA) annual conference, Dr. Robert Dupont delivered a speech entitled “Drug Testing and the Future of American Drug Policy.”    He describes a “New Paradigm” for substance abuse treatment that enforces “zero tolerance for alcohol and drug use”  enforced by monitoring with frequent random drug and alcohol tests in which any positive test is  “met with swift, certain” consequences.” The paradigm is based on the current Physician Health Programs blueprint.  Dupont states:

“…physician health programs , have set the standard for effective use of drug testing. These pioneering state programs provide services to health care professionals with substance use disorders. The programs are run by physicians, some of whom in recovery themselves. PHPs feature relatively brief but highly focused treatment followed by active lifelong participation in the 12-step fellowships of Alcoholics Anonymous and Narcotics Anonymous. The key to the success of the PHP system of care management is the enforcement of the standard of zero tolerance for any alcohol or other drug use by intensive long-term random testing for both alcohol and drugs with swift and certain consequences for even a single use of alcohol or any other drugs of abuse. PHPs use drug panels of 20 or more drugs. The PHPs commonly use EtG and EtS tests to detect recent alcohol use. Similar comprehensive programs have been developed for commercial pilots and attorneys. These innovative programs of care management produce unprecedented long-term, outcomes.”

Physician Health Programs use a doctor’s medical license as “leverage” in what they call “contingency management.”   What this means is that a doctor who is being monitored by a PHP must comply with any and all demands of the PHP under threat of being reported to the state Medical Board and immediate suspension of  licensure. Dupont wants to extend this model to other populations including our elderly, our pregnant mothers, college and high school students and schoolchildren.

The 2013 American Society of Addiction Medicine White Paper on Drug Testing describes the organizational structure of the “New Paradigm” and this includes utilizing the medical profession as a urine collection agency for their drug and alcohol testing and the loophole they plan to exploit is this:  When a doctor-patient relationship exists drug and alcohol testing is rendered “clinical” rather than “forensic”so the consequences of a positive test can legitimately be called  “treatment” rather than punishment.  Because addiction is currently defined as a disease, addicts must be “treated” (which in the United States is more often coercive than voluntary), and “cured” (which is defined as remaining abstinent). When the disease concept is not strictly reserved for medical conditions but is expanded to any and all drug and alcohol use.

The proposed system bypasses the strict chain-of-custody and Medical Review Officer requirements designed to ensure accuracy and minimize false-positives.  These strict protocols are used by essentially all employee assistance programs (EAPs) in workplace drug testing programs.    Forensic drug testing is tightly regulated because the results of a positive test can be grave and far reaching and erroneous results are unacceptable.

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THE ASAM PAPER DESCRIBES MANDATED DRUG-TESTING FOR PATIENTS IN A NUMBER OF SPECIALTIES INCLUDING ADOLESCENT MEDICINE, PSYCHIATRY, OBSTETRICS, AND GERIATRICS.  CONTINGENCY MANAGEMENT WILL INVOLVE “THE POTENTIAL FOR LOSS OF CURRENT OR DESIRED EMPLOYMENT, OR THREATENED LOSS OF OR RESTRICTIONS ON A PROFESSIONAL OR COMMERCIAL LICENSE, OR LEGAL AND FORENSIC NECESSITY.”
 “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.”

Federal workplace drug testing is done in accordance with mandatory guidelines. This testing is regulated using FDA approved tests with established sensitivity, specificity and cutoff levels.  FDA approval requires rigorous research and proven validity.    The FDA requires valid scientific evidence (with both clinical and analytical validation).

The  Federation of State Physician Health Programs (FSPHP), the group currently in managerial control of state physician health programs in 47-states,  has introduced non-FDA drug testing via a loophole that removes all accountability.  The EtG, EtS, and PEth tests were introduced as  Laboratory Developed Tests (LDTs) with little to no evidence base through pathway  developed for “clinical” tests of low market potential that would not otherwise be developed due to the prohibitive cost of the FDA approval process.  An LDT  does not even require testing in humans (“in vivo”) or even proof that the test is testing what it claims to be testing (validity) for.  It is an honor system and without FDA oversight a lab can can claim anything they want about these tests with no accountability. They do not have to provide any proof of what they claim or justify what they claim.     After partnering with labs to develop these tests, the FSPHP then convinced the Federation of State Medical Boards they were valid and accurate tests that were necessary to detect a bogus cadre of drunk and drugged doctors able to hide their impairment and who were protected by a “code of silence.”    This bogus danger was then used to convince state Medical Boards to use these unvalidated tests on doctors in state physician health programs.

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(Source: ASAM Physician Health News March 2015)ASAM Physician Health News March 2015)

The ASAM white paper contains the following quote minimizing the critical role of the MRO in drug testing.   They feel clinical testing is good enough.

Unlike forensic drug testing where the test results must be able to meet rules of evidence in administrative, civil or criminal proceedings, clinical drug testing* is part of a patient examination performed by a clinician with whom the patient is in a therapeutic relationship. The testing is used for the purposes of diagnosis, treatment, and the promotion of long-term recovery. Clinical drug test results must meet the established standards of medical practice and benefit the therapeutic relationship, rather than meeting the formal legal requirements of forensic testing. Drug testing in medicine employs the same sound procedures, safeguards, and systems of information management that are used for all other health-related laboratory tests, tests on which life-and death medical decisions are commonly made.

Changing Public Policy and Regulatory Authority to Increase Power and avoid Accountability

 The Federation of State Physician Health Programs has been able to construct this scaffold with no meaningful opposition and below the public radar. They have done this by removing accountability at multiple levels.  By preventing access to information and erecting a system without oversight no consequences exist to deter misconduct and abuse.  The same tactics and strategies will be used as they expand this to other populations.

The Federation of State Physician Health Programs trumpets the the 12-step chronic relapsing brain disease model of addiction as defined by A.A. because it supports the drug and alcohol assessment, testing and treatment industries goals of more and more testing and treatment. For example  a 2011 FSMB Policy on Physician Impairment identifies, defines and essentially legitimizes “potential impairment” and “relapse without use.”

A PHP Should be empowered to conduct an intervention based on clinical reasons suggestive of potential impairment.  Unlike the Board which must build a case capable of withstanding
legal challenge, a PHP can quickly intervene based on reasonable concern."

“Empowered” to conduct an “Intervention” for reasons “suggestive” of “potential” impairment means a doctor can be pulled out of practice for anything.  It essentially gives them carte blanche authority. Due process and fundamental freedoms of choice are removed.

in 2011 The ASAM issued a Public Policy Statement on coordination between PHPs, regulatory agencies, and treatment providers recommending  that  only “PHP approved” treatment centers be used in the assessment and treatment of doctors.  A recent audit of the  North Carolina PHP found financial conflicts of interest and no  documented criteria for selecting the out of state treatment centers they used.  The common denominator the audit missed was that the 19  “PHP-approved” centers were all ASAM facilities whose medical directors can be seen on this list.

The FSMB House of Delegates adopted an updated Policy on Physician Impairment at their 2011 annual meeting distinguishing “impairment” and “illness”  stating that Regulatory Agencies should recognize the PHP as their expert in all matters relating to licensed professionals with “potentially impairing illness.”

According to the FSPHP, physician illness and impairment exist on a continuum with illness typically predating impairment, often by many years.”

The policy extends PHP authority to cover physical illnesses affecting cognitive, motor, or perceptive skills, disruptive physician behavior, and “process addiction” (compulsive gambling, compulsive spending, video gaming, and “workaholism”). It also defines “relapse without use” as “behavior without chemical use that is suggestive of impending relapse.”

G. Douglas Talbott defines  “relapse without use”  as  “emotional behavioral abnormalities” that often precede relapse or “in A A language –stinking thinking.”  AA language has entered the Medical Profession and no one seems to have even noticed.

The FSPHP political apparatus exerts a monopoly of force. It selects who will be monitored and dictates every aspect of what that entails.  It is a, in fact, a  rigged game.

The Need for Regulation, Oversight, and Accountability

Accountability is necessary to prevent corruption and requires both the provision of information and justification for actions. What was done and why?   Accountability also necessitates consequences-the ability of outside actors to punish and sanction those who commit the misconduct.  Without these constraints corruption is inevitable.

In  2012 Drs. John Knight and Wes Boyd recommended the medical community outside of PHPS provide oversight and demand accountability.  In  Ethical and Managerial Considerations Regarding State Physician Health Programs  they noted the financial conflicts of interest between PHPs and their “approved  centers,  coercion and abuse and even possible violations of the Nuremberg Code of Medical Ethics yet their paper generated little interest in the medical community.  The North Carolina PHP audit  revealed financial conflicts-of-interest and no oversight by the state medical society or board and that abuse of doctors could occur undetected due to the complete absence of accountability.  State Auditor Beth Woods told  the British Medical Journal in a recently  published article that the state program had holes in it “big enough to drive a truck through.”

In  Ethical and Managerial Considerations Regarding State Physician Health Programs Knight and Boyd state:  “Because PHP practices are unknown to most physicians before becoming a client of the PHP, many PHPs operate outside the scrutiny of the medical community at large. Physicians referred to PHPs are often compromised to some degree, have very little power, and are, therefore, not in a position to voice what might be legitimate objections to a PHP’s practices.”  And when objections do occur many take the side of the PHP, complacent in their belief that these are just altruistic and competent doctors just helping sick colleagues and protecting the public and valid complaints are deemed nothing more than “bellyaching.  In reality the ethical and criminal misconduct occurring in PHPs rivals that of Dr. Farid Fata,  the Detroit Oncologist who intentionally misdiagnosed patients with cancer so he could make money off unnecessary chemotherapy treatment.  Dr. Fata’s egregious betrayal of trust and unconscionably vile acts resulted in an appropriate response.

Screen Shot 2015-04-13 at 9.53.44 AMThe exact same misconduct is being perpetrated by PHPs but being overlooked, justified or otherwise ignored.  Dr. Fata intentionally misdiagnosed patients with cancer who did not have cancer so he could give them chemotherapy to make money.   PHPs are intentionally misdiagnosing substance abuse and behavioral disorders in physicians who do not have them in order to give them unneeded treatment and force them into monitoring contracts for profit and control.

This  undermines the very integrity of the profession.  It is particularly vile when the betrayal of trust involves doing the opposite of what was entrusted.   Abuse of positions of power, trust and influence in the field of medicine need to be both prevented, recognized and addressed.    Oversight, regulation and accountability are essential  if this is going to be accomplished.  There are no exceptions.   Policies and procedures must be enforced in a consistent manner.

The medical boards, medical societies, and departments of health have given the state PHPs carte blanche control and absolute power.  They refuse to even investigate accusations and they have convinced law enforcement that this is a parochial matter best handled by within the medical profession. As a result, valid complaints of crimes are not taken seriously.  This refusal to investigate  or even acknowledge valid and factual complaints of professional misconduct has not only prevented the exposure of  wrongdoing and corruption but deepened it.    The Federation of State Physician Health Programs and “Like-minded docs” must be recognized for what they are.  Front-groupsscreen-shot-2016-10-04-at-3-49-21-pm for the drug and alcohol assessment, testing and treatment industry.   This is glaringly obvious and you don’t have to look that deep to figure it out.  And these are the very same groups being proposed as advocacy bodies for addiction treatment and public policy change.  It is not that hard to figure out what they will be advocating for –more diagnoses, more testing and more treatment.

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The American philosopher Eric Hoffer noted:

“The only way to predict the future is to have power to shape the future. Those in possession of absolute power can not only prophesy and make their prophecies come true, but they can also lie and make their lies come true.” 

The “PHP-blueprint”  is built on the very foundation Hoffer describe and unless you want mandated randomized  non-FDA approved drug and alcohol testing with “swift and certain” consequences at future visits with your doctor you will need to speak up.

This occurred in the medical profession rapidly and with little notice and that is exactly what will happen here.

 “Every time we turn our heads the other way when we see the law flouted, when we tolerate what we know to be wrong, when we close our eyes and ears to the corrupt because we are too busy or too frightened, when we fail to speak up and speak out, we strike a blow against freedom and decency and justice.” 

Robert F. Kennedy

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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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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.
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