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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EtG–The Rosie Ruiz of Bent Science and Bad Medicine

The Displacement of the idea that facts and evidence matter, by the idea that everything boils down to subjective interests and perspectives is — second only to American political campaigns — the most prominent and pernicious manifestation of anti-intellectualism in our time. — Larry Laudan, Science and Relativism (1990)Screen Shot 2015-03-19 at 11.55.08 PMOn April 21, 1980 Rosie Ruiz appeared to win the 84th Boston Marathon’s female category with a time of 2:31:56.  Her time would have been the fastest female time in Boston Marathon history and and the third-fastest female time ever recorded in any marathon.

“Miss Ruiz, an administrative assistant for Metal Trading Inc. in Manhattan, received the traditional laurel wreath, a medal and a silver bowl for her victory,” According to the New York Times

Ruiz was unknown in the running world and her victory raised suspicions.  After studying marathon photographs she didn’t appear in any of them until the very end and conducting interviews.

The problem was that, according to Runners World: “Ruiz had dropped out of the race, hopped on the subway, got off about a mile from the finish line, and ran in from there.”   It is believed Ruiz intended to jump in in the middle of the pack but miscalculated when she joined so close to the end not realizing she was ahead of the other 448 female runners.Screen-Shot-2014-12-29-at-10.16.38-AM

Marathon officials stripped Ruiz of her title on April 29, 1980, and named Jacqueline Gareau of Canada the women’s division champion with a time of 2:34:28.  It was later discovered that she had also taken the subway during part of the New York City Marathon which qualified her for the Boston Marathon.  In 1982 she was caught stealing money from her employer and was subsequently caught selling drugs to an undercover officer in Florida.


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In the early 1950’s it was discovered that a small fraction of ingested alcohol in rabbits gets metabolized by conjugation with glucuronic acid to form Ethyl Glucuronide (EtG)..1,2 The potential of EtG as a marker for alcohol consumption was recognized in the 1990s and analytical methods for its determination were developed in urine, blood and hair.3-5

It’s use as a marker of alcohol consumption in forensic settings was subsequently suggested by Dr. Friedrich Wurst based on studies showing that urine EtG could be detected after complete elimination of alcohol from the body (up to 80 hours), and he suggested the alcohol biomarker be utilized in forensic monitoring to improve public health.   6,7

Wurst et al note that a “marker of high sensitivity and specificity capable of monitoring patients in treatment for alcohol or other drug abuse” could “improve therapy outcome and quality of life in patients, increase safety at work places and in traffic, avoid harm to the unborn during pregnancy (fetal alcohol syndrome) and reduce costs by making therapy more effective and reducing productivity loss.”7

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A literature search from 1952 to 2002 yields one conclusion and once conclusion only; EtG measurements increase with alcohol ingestion. There are no studies considering what other factors might increase EtG measurements.

The false logic takes the following form:

  • Premise: Event A occurred after (or with) event B.
  • Conclusion: Therefore, event A caused event B.

But in 2003 Wurst and Gregory Skipper, M.D., FASAM, Medical Director of the Alabama Physician Health Program reported at an international meeting of the American Medical Society that EtG provided proof of alcohol consumption as much as 5 days after drinking an alcoholic beverage and that there are now a substantial number of studies in the world literature that support the clinical importance and reliability of EtG as a marker of recent alcohol consumption.8

“In the future it will be negligent not to test for EtG when monitoring recovering alcoholics,” reported Dr. Skipper.8

Also, in 2003, Skipper pitched the test to National Medical Services, Inc. (NMS labs) who then developed it as a Laboratory Developed Test (LDT).9

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Because of its high sensitivity the newly marketed test was suggested as a tool to monitor health care professionals by Skipper in 2004.10   Skipper then approached the Federation of State Medical Boards and pitched the test to them proposing it be used in the assessment and monitoring of doctors by state Physician Health Programs.   In a stunning example of policy entrepreneurship a market was created and filled simultaneously.

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“Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs11 published in the Journal of Medical Licensure and Discipline in 2004 found that “surreptitious alcohol use was a significant concern” for state Physician Health Programs (PHPs) yet no “best methods for detecting alcohol use.” The 36-question phone interview was conducted with directors of PHPs in 46 states regarding current methods of drug testing and notes:Screen Shot 2015-03-20 at 4.06.32 AM

“Because alcohol is the most frequently abused substance adequate monitoring for alcohol is a major concern. During rehabilitation and recovery, the potential for alcohol abuse may increase due to the lack of efficient screening tests. The ingestion of alcohol while in aftercare is a violation of the contractual agreement made with the monitoring program and may lead to relapse and/or abuse of other psychoactive substances, thus rendering the practitioner unsafe to practice their profession. Therefore, alcohol detection remains an important component of contract compliance and sobriety.”

Screen Shot 2015-03-19 at 9.09.39 PMThey conclude that: “EtG can be detected in urine as long as 18 hours after blood alcohol levels reach zero and demonstrates exceptional specificity (100 percent) and sensitivity because even small amounts of alcohol (7 g, or less than one alcoholic beverage) can be detected.”

This very same issue of the Journal of Medical Licensure and Discipline contains an article written by Skipper concerning new marker to detect alcohol use in “recovering physicians” that “has recently been introduced in the United States and an assay for EtG is now commercially available.”12

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Skipper states that “EtG is not detectable unless alcohol has been consumed” and notes the “usefulness of the test was affirmed in one study involving psychiatric inpatients”Screen Shot 2015-03-19 at 9.09.15 PM

An EtG above 500 renders it “extremely unlikely” that alcohol was not ingested and adds “ In any event, if testing is positive” in monitored doctors it is advisable to refer them for further in-depth evaluation by clinicians or programs skilled and adept at evaluating physicians.”

In Bending Science: How Special Interests Corrupt Public Health Research13, Thomas McGarity and Wendy Wagner describe how special interest groups scheme to advance their own economic or ideological goals by using distorted or “bent” science to influence legal, regulatory and public health policy.

The authors describe a “separatist view” of the world that assumes scientific research is sufficiently reliable for public policy deliberations and legal proceedings once it flows out of the realm of science through a pipeline in which the scientific community has ensured through rigorous peer-review and professional oversight that the final product that exits the pipeline is unbiased and produced in accordance with the norms and procedures of science.

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This view does not consider the possibility that the scientific work exiting the pipeline could be distorted and contaminated by biasing influences.

If we look at this through the lens of “bent science” several issues arise including a failure to adhere to the norms and standards of toxicology and forensic drug and alcohol testing, an absence of evidence base and glaring conflicts of interests.

Norms and Standards of Toxicology and Forensic Drug Testing

On September 15, 1986 President Ronald Reagan signed Executive Order 12,564 requiring that the urine of federal employees in “sensitive” jobs be sampled randomly for illegal drugs. In 1988 Congress followed with the Drug-Free Workplace Act and drug testing became common organizational practice by the mid 1990s. Most followed the federal norms and procedures in their testing.

The Department of Health and Human Services (DHHS) had established specific cutoff levels that define a positive result.   These values were developed to help eliminate false-positive results.14 The cutoff levels were originally established at a drug concentration that produced an analytic signal some multiplicative factor above the noise level (the signal obtained from drug free urine).

“The concept of cutoff for major urine screening programs has two basic applications: the lower limit of reliable testing based on the techniques involved in the testing and the lower limit of reliable testing based on the possibility of interference from medications, foodstuffs, environmental exposure, or endogenous processes.”15

“Urine Drug Testing in Clinical Practice: Dispelling the myths & Designing Strategies cautions about “caveats to interpretation.” “As with any unexplained test result, it is important to clarify the interpretation with someone knowledgeable in clinical toxicology.”16

Evidence Base

What was in the pipeline when the EtG was proposed as a forensic monitoring tool can be illustrated below:

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Taking Advantage of a Loophole

The EtG was developed by NMS labs as a “Laboratory—Developed Test” or LDT. The LDT pathway does not even require proof of validity, that the test is actually testing for what it claims to be testing, and with no FDA oversight a lab can claim any validity it wants in its marketing and sales, and they did.   Proponents for regulation of LDTs argue this lack of oversight is a direct threat to patient care and safety. An viewpoint piece in JAMA states that a   “patient’s life or death could hinge on whether a single, unregulated diagnostic test result is meaningful.” 17

In the case of EtG Skipper arbitrarily chose a value of 100 as a cut-off for EtG. The rationale behind this value is not cited. Interference with foods, medications and environmental exposures had not been worked out. The results were predictable.

Aftermath was Predictable and Therefore Avoidable

The case of EtG is exemplifies ‘policy entrepreneurship” and “bent science” at its worst. It shows how junk-science can be introduced into the market without any real difficulties or meaningful opposition and how self-interest is promoted in defiance of science in an effort to manipulate public policy. This is nothing more than opportunist exploitation of the regulatory framework and the FSMB eagerly complied.   Without this “regulatory sanctification” none of these tests would have ever made it to market.

EtG was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash18,19, hand sanitizer gel20, nonalcoholic beer21, and nonalcoholic wine.22

“Exposure to ethanol-containing medications, of which there are many, is another potential source of “false” positives.

Forbidding patients/subjects access to such medications may be unrealistic, and even unwise.”23

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.24 The advisory states:

“Although positive biomarker results should be taken seriously, use of certain biomarkers, such as EtG, is now warranted as stand-alone confirmation of relapse because research has not yet established an acceptable standard to distinguish possible exposure to alcohol in various commercial products from consumption of alcoholic beverages.”

The Wall Street Journal in 2006 reported the problems with the EtG to the general public.25

The authors of a 2011 study demonstrating that hand sanitizer alone could result in EtG concentrations of 1998 concluded that:

“in patients being monitored for ethanol use by urinary EtG concentrations, currently accepted EtG cutoffs do not distinguish between ethanol consumption and incidental exposures, particularly when urine specimens are obtained shortly after sustained use of ethanol containing hand sanitizer.”26

images-5Sauerkraut and bananas have even recently been shown to cause positive EtG levels.27

A 2010 study found that consumption of baker’s yeast with sugar and water28 led to the formation of elevated EtG above the standard cutoff.images-6

EtG can originate from post-collection synthesis if bacteria is present in the urine.29 Collection and handling routines can result in false-positive samples.30

EtG varies among individuals.31 Factors that may underlie this variability include gender, age, ethnic group, and genetic polymorphisms.

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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 internationally recognized as the standard in evidence based health care.   It records just 5 controlled trials under the topic ethyl glucuronide.22,31-33

These 5 studies represent the only high-quality evidence regarding EtG to date. Information provided by the five studies suggests the following, and only the following:

  1. EtG 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.

During this time period any rational authority would have admitted error and removed the test from the market. Skipper’s approach was to keep raising the cutoff level from 100 to 250 to 500 to 1000. With EtG paving the way for other laboratory developed tests he then added “confirmatory” LDTs such as EtS and PEth. The EtS was found to have the same problems and PEth inevitably will but this is now a billion dollar market and they plan on using these tests on almost everyone including kids.

There has been no academic, public policy or conflict of interest analysis of all of this. As probably the worst case of bent-science in history there needs to be.

  1. Kamil A, Smith JN, Williams RT. A New Aspect of Ethanol Metabolism: Isolation of ethylglucuronide. Biochemical Journal. 1952;51:32-33.
  2. Kamil IA, Smith JN, Williams RT. Studies in detoxication. L. The isolation of methyl and ethyl glucuronides from the urine of rabbits receiving methanol and ethanol. The Biochemical journal. Jun 1953;54(3):390-392.
  3. Schmitt G, Aderjan R, Keller T, Wu M. Ethyl glucuronide: an unusual ethanol metabolite in humans. Synthesis, analytical data, and determination in serum and urine. Journal of analytical toxicology. Mar-Apr 1995;19(2):91-94.
  4. Schmitt G, Droenner P, Skopp G, Aderjan R. Ethyl glucuronide concentration in serum of human volunteers, teetotalers, and suspected drinking drivers. Journal of forensic sciences. Nov 1997;42(6):1099-1102.
  5. Aderjan RE. Ethyl glucuronide. A non-volatile ethanol metabolite in hair. 1995.
  6. Wurst FM, Seidl S, Alt A, Metzger J. [Direct ethanol metabolite ethyl glucuronide. Its value as alcohol intake and recurrence marker, methods of detection and prospects]. Psychiatrische Praxis. Nov 2000;27(8):367-371.
  7. Wurst FM, Seidl S, Ladewig D, Muller-Spahn F, Alt A. Ethyl glucuronide: on the time course of excretion in urine during detoxification. Addiction biology. Oct 2002;7(4):427-434.
  8. Martin DM, G.E. S, Costantino A. Alcohol Use Can Now be Detected for Days Rather than Hours Using a New Test, Ethyl Glucuronide. 2003; http://www3.firstlab.com/media/16032/EtGFirstLabReport.pdf.
  9. Skipper G. “Urine Luck” Overview of New Drug Testing Technologies and Conundrums. http://gregskippermd.weebly.com/uploads/7/4/7/5/74751/skipper.urine_luck_2014_aaap_meeting.pdf. Accessed March 17, 2015.
  1. 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.
  2. Jansen M, Bell LB, Sucher MA, Stoehr JD. Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs. Journal of Medical Licensure and Discipline. 2004;90(2):8-13
  1. Skipper G, Weinmann W, Wurst F. Ethylglucuronide (EtG): A New Marker to Detect Alcohol Use in Recovering Physicians. Journal of Medical Licensure and Discipline. 2004;90(2):14-17.
  2. McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
  3. US Department of Health and Human Services. Mandatory guidelines and proposed revisions to mandatory guidelines for federal workplace drug testing programs: notices. Federal Register. April 13, 2004;69(71):19659-19660.
  4. Clark HW. The role of physicians as medical review officers in workplace drug testing programs. In pursuit of the last nanogram. West J Med. May 1990;152(5):514-524.
  5. Resnick RB, Volavka J, Freedman AM, Thomas M. Studies of EN-1639A (naltrexone): a new narcotic antagonist. Am J Psychiatry. Jun 1974;131(6):646-650.
  6. Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science. JAMA : the journal of the American Medical Association. Jan 5 2015.
  7. Costantino A, Digregorio EJ, Korn W, Spayd S, Rieders F. The effect of the use of mouthwash on ethylglucuronide concentrations in urine. Journal of analytical toxicology. Nov-Dec 2006;30(9):659-662.
  8. Reisfield GM, Goldberger BA, Pesce AJ, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after intensive exposure to high ethanol content mouthwash. Journal of analytical toxicology. Jun 2011;35(5):264-268.
  9. Rosano TG, Lin J. Ethyl glucuronide excretion in humans following oral administration of and dermal exposure to ethanol. Journal of analytical toxicology. Oct 2008;32(8):594-600.
  10. 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.
  11. 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.
  12. Jatlow P, O’Malley SS. Clinical (nonforensic) application of ethyl glucuronide measurement: are we ready? Alcohol Clin Exp Res. Jun 2010;34(6):968-975.
  13. Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
  14. Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
  15. Reisfield GM, Goldberger BA, Crews BO, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after sustained exposure to an ethanol-based hand sanitizer. Journal of analytical toxicology. Mar 2011;35(2):85-91.
  16. 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.
  17. Thierauf A, Wohlfarth A, Auwarter V, Perdekamp MG, Wurst FM, Weinmann W. Urine tested positive for ethyl glucuronide and ethyl sulfate after the consumption of yeast and sugar. Forensic Sci Int. Oct 10 2010;202(1-3):e45-47.
  18. Helander A, Olsson I, Dahl H. Postcollection synthesis of ethyl glucuronide by bacteria in urine may cause false identification of alcohol consumption. Clinical chemistry. Oct 2007;53(10):1855-1857.
  19. Helander A, Hagelberg CA, Beck O, Petrini B. Unreliable alcohol testing in a shipping safety programme. Forensic science international. Aug 10 2009;189(1-3):e45-47.
  20. Sarkola T, Dahl H, Eriksson CJ, Helander A. Urinary ethyl glucuronide and 5-hydroxytryptophol levels during repeated ethanol ingestion in healthy human subjects. Alcohol and alcoholism. Jul-Aug 2003;38(4):347-351.
  21. 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 and alcoholism. Mar-Apr 2008;43(2):187-191.
  22. Wojcik MH, Hawthorne JS. Sensitivity of commercial ethyl glucuronide (ETG) testing in screening for alcohol abstinence. Alcohol and alcoholism. Jul-Aug 2007;42(4):317-320.

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Policy and Regulatory Decision Making in the Medical Profession: A Framework to Identify the influence of Special Interest Groups and “Bent” Science

content-1 In  Bending Science: How Special Interests Corrupt Public Health Research 1  Thomas McGarity and Wendy Wagner describe how special interest groups scheme to advance their own economic or ideological goals by using distorted or “bent” science to influence legal, regulatory and public health policy.

The authors describe a “separatist view” of science and policy that assumes scientific research is sufficiently reliable for public policy deliberations and legal proceedings when it reaches them.  This is illustrated as a pipeline in which it is presumed  the scientific community has properly vetted the information flow through rigorous peer-review and professional oversight.  The final product that exits the pipeline is understood to be unbiased and produced in accordance with the professional norms and procedures of science.   The reliability, integrity and validity of the final product is indubitably accepted.Screen Shot 2015-02-05 at 10.49.27 AMThe separatist  view does not consider the possibility that the scientific work exiting the pipeline could be intentionally shaped and contaminated by biasing influences as it flows through the pipeline.  When this occurs the final product exiting the pipeline is distorted or “bent” and bent science can result in bad decision making and bad policy.

Bent science starts with a pre-determined outcome and works backward from a desired result. It is not true science. Those orchestrating the deception (“benders”) use a variety of tactics and strategies to shape, package and spin science to support their own hidden agenda and suppress opposing science.

Benders attempt to hide, dismiss and debunk contrarian research and unsupportive science.  Benders will attack and harass the science and scientists that pose a threat to their interests. Using carefully crafted studies designed to confirm a desired outcome, the pre-determined conclusions are subsequently promoted and publicized to the relevant stakeholders who are often unable ( or sometimes unwilling) to discern real science from junk-science.

Misinformation, propaganda, and deception are disseminated in a variety of venues. Public relations firms are used to manipulate public perception and freelance writers are hired  brandish favorable consensus statements.  Authoritative reviews and critiques are ghostwritten under the names of  “outside experts” who profit both monetarily and by adding a high-profile publication to their resume.

Opinion is paraded as fact and with a dearth of professional oversight the charade usually goes unnoticed and unopposed.

Data-dredging, cherry picking, confirmatory bias, confirmatory distortion, fabrication, falsification, exaggeration, and a whole host of deceptive tactics are used to work backward from an already determined result.

Any information that contradicts the answer is manipulated, undermined, suppressed or downplayed; even if it is the result of real science and evidence-based research; even if it is the truth.  Professional procedure, protocol and ethics are off the table.  It is an underhanded free-for-all. Bare knuckle boxing. Trash your opponents work and label it junk-science. Undermine the integrity of your opponents.  Use ad hominem attacks to question the opponents motives. Claim the scientists are hacks on the take.  Start rumors about them. Screen Shot 2015-02-05 at 10.50.32 AM Loudly claim you are the one who is evidence based. Proclaim professionalism and authority.  Quibble. Move the goalpost.   Nit-pick and split hairs.  Proclaim over and over and over again you are the one who is evidence based.

And the problem is it usually works.  It is an unfair playing field.  When no meaningful barriers are in place to detect cheating and identify cheaters they usually win.

Bending science can have serious and sometimes horrific consequences and multiple examples including the Tobacco and pharmaceutical industry are given in the book.

Calling for immediate action  to reduce the role that bent science plays in regulatory and judicial decision making, the authors emphasize the assistance of the scientific community is necessary in designing and implementing reform.

“Shedding even a little light on how advocates bend policy -relevant science could go a long way toward remedying these problems.  Indeed, precisely because the advocates have overtaken the law in this area, heightened attention to the social costs of bending science could itself precipitate significant change.”

But there are difficulties in challenging bent science including a general lack of recognition of the problem. With an absence of counter-studies to oppose deliberately manufactured ends-oriented research this would be expected.

Bent science involves the deliberate manufacturing of a pool of  information designed to promote a specific agenda.  A level playing field would require a pool of opposing research specifically addressing that agenda.  In reality this requires both the incentive and the power to do so–an unlikely scenario short of an equally well funded competitor or sufficient public concern about the problem.

In fact counter-forces are often nonexistent. Investigatory techniques developed and promoted by the FBI crime lab (such as firearms identification and intoxication testing) is one example described in the book.  These techniques evolved with little meaningful oversight from the larger scientific community and could be badly bent but there is no meaningful pool of information to disprove them.  The authors aptly state that   “defendants in most criminal cases lack resources to mount effective challenges, much less undertake their own counter-research.”

And part of the “art” of bending involves swaying public opinion and the mainstream media is typically aligned with the benders so opposing viewpoints seldom make the headlines.

Additionally, there is no meaningful oversight or avenue to pursue accountability. No systems exist to prevent, catch and publicly expose bent-science or those who bend science.

The influence of special interest groups on the practice of medicine is unknown.  No one has examined the role of bent science in the rules, regulations, policies and decisions made by those who are in charge of the standards of medical practice and professional behavior of doctors but as a regulated profession governed by the  decisions and policies of regulators it is certainly possible.

Regulation of the Medical Profession

Alexis de Toqueville once observed that a key feature of American government was the decentralized character of administration. “Written laws exist in America,” he wrote, “and one sees the daily execution of them; but although everything moves regularly, the mover can nowhere be discovered. The hand which directs the social machine is invisible.”2

Administrative law is the body of law that allows for the creation of public regulatory agencies and contains all of the statutes, judicial decisions and regulations that govern them. Administrative agencies implement their powers in the form of rules, regulations, orders and decisions.   State medical boards are the regulatory agencies responsible for the licensure and discipline of physicians. They grant the right to practice medicine in the form of a medical license and each state has Medical Practice Act that governs and defines the practice of medicine. The medical board is empowered to take action against a doctor for substandard care, unprofessional behavior and other violations as defined by the state Medical Practice Act.

Administrative Code governs the licensure and disciplinary process and the State Administrative Procedure Act governs the legal process (due process, discovery, etc.). Regulatory changes are enacted through procedural, interpretive and legislative rules.

Both medical practice acts and administrative procedure acts are subject to change.  Changes in medical practice acts can redefine what is acceptable practice and what constitutes professional behavior. This can increase the power and control these agencies have over doctors both professionally and socially.

Changes in Administrative practice acts can decrease what rights a doctor has if this power and control is abused.  Changes in the wording of administrative code and administrative practice acts can have profound implications in these rights including due-process, timeliness of being heard, rights to appeal decisions and time-constraints for judicial review.

And when these changes occur they do so silently.  The hand that directs the machine is indeed invisible.  The consequences, however, are not.  These changes not only impact those touched by the hand but can have a systemic impact on the entire profession.

State medical practice acts as well as administrative practice acts and code are susceptible to change and therefore susceptible to the influence of special interest groups benefitting from such change.  Regulation of the medical profession is thus susceptible to bent science.

Bent Science and the Medical Profession

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The impact of bent science on the regulation of the medical profession has not been studied. As a profession governed by regulatory agencies medicine is certainly not immune to the influence of special interest groups who could in turn influence public policy and regulatory decisions, rules and regulations to benefit their own interests.

Making sound decisions about regulation calls for an understanding of the problem it is intended to solve. This demands methodologically sound science and evidence-based facts arrived at through rigorous peer review and professional oversight. The science on which policy decisions are made must be reliable and unbiased. Legitimate policy must be based on recognized and legitimate institutions and experts.

If the information regulatory agencies rely on to discipline doctors and protect the public is unreliable then serious consequences can occur.

It would be beneficial to look for changes in public policy, guidelines, rules and regulations involving the medical profession and examine the reasons behind them. When did the problem present? Who presented it? Was it based on methodologically sound and accurate data?  What organizations do the problem presenters represent?  What organizations or individuals aligned or associated with the presenters might benefit?  What are the consequences?  Who is harmed?

Howard Becker describes the role of “moral entrepreneurs,” who crusade for making and enforcing rules that benefit their own interests by bringing them to the attention of the public and those in positions of power and authority under the guise of righting a society evil.8   

The mechanics and mentality is similar to the science benders and, as discussed below,  they use some of the same techniques.

Moral entrepreneurs take the lead in labeling a particular behavior deviant and spreading this label throughout society.  They associate the behavior of some group with a society evil, affix an easily recognizable label to it and then express the conviction that the evil must be combated.  Labeled as being outside the central core values of consensual society, the deviants in the designated group are perceived as posing a threat to both the values of society and society itself.

Activities can rise to the level of ‘social problems” when harm or danger is attributed to those activities and governmental powers are called upon to put an end to those harms. Bent science requires convincing others of a viewpoint and the likelihood of this occurring increases when the activity that is identified as a problem resonates with underlying societal concerns and anxieties.  The problem is then endorsed by experts who give legitimacy to such claims.3,4 This legitimacy results attracts media attention which further enforces support from both the public and policy makers.5,6  

As a result any bent science directed at regulatory and public policy decision making should be clearly visible.

The sociologist Stanley Cohen used the term ”moral panic” to characterize the amplification of deviance by the media, the public, and agents of social control.7 According to cultural theorist Stuart Hall, the media obtain their information from the primary definers of social reality in authoritative positions and amplify the perceived threat to the existing social order. The authorities then act to eliminate the threat.9 The dominant ideas or ideologies are reproduced by relying on the opinions of the defining authority and then spread through the media.

An internet search of what labels have been affixed to doctors in association with a threat to society there are three.  A google search of “impaired physician” yields 20, 600 results; “disruptive physician” yields 17, 400 results; and “aging physician” yields 27, 800 results. A large number of these articles, opinion pieces and reviews associate impaired, disruptive and aging physicians with patient death and other adverse events, medical error, and malpractice.   The labels affixed to these physicians have been characterized as a major threat to public health and the rhetorical tools used in many of these articles seems aimed at increasing public anxiety.

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A PubMed search yields 154 results for the “impaired physician”; 47 results for the “disruptive physician”; and 19 results for the “aging physician.”  Many of these are opinion pieces written by the same group of physicians and aimed at hospital administrators, regulators and those involved in the legal or business aspects of medicine.

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There is, in fact, no evidence based research that associates the impaired, disruptive or aging physician with any adverse events. The “impaired,” “disruptive” and “aging” physician labels  as evinced by a quick google search seem escalated far beyond the level warranted by the existing evidence.

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The “impaired” and “disruptive” labels have taken on the status of moral panic and the “aging” label, which is being associated with cognitive impairment, seems to be heading in that direction. The number of articles being published and lectures being given on the dangers of cognitively impaired doctors is increasing.  It has not yet reached the level of public awareness the impaired and disruptive have.

To acknowledge that the current level of concern about these labels is exaggerated is not to suggest they do not exist. They do.  But the disparity between the evidence-base, or lack thereof, and the level of concern warrants further investigation.

To be clear,  doctors who are impaired by drug and alcohol abuse need to be removed from practice to protect the public and receive treatment;  doctors who are abusive to others or engage in behavior that threatens patient care need to be held accountable for their actions; and doctors who are cognitively impaired due to dementia need to be removed from practice and evaluated by the proper specialists.  If a diagnosis of dementia is confirmed then they need to be removed from practice.

What is the motivation behind the “impaired,” “disruptive” and “aging” physician labels and the multiple articles linking these labels to patient harm and medical error?  There is no data driven evidence so where does it come from?   Could moral entrepreneurs be behind it?  If so then there should be evidence  of bent science and to examine this we must look for evidence that these labels have been used to influence regulatory decisions, rules, regulations and policy.

And with the recently archived Journal of Medical Regulation this task can be easily accomplished.

The Journal of Medical Regulation as Timeline and Framework for Policy Evaluation

The Federation of State Medical Boards (FSMB) is a national not-for profit organization that gives guidance to state medical boards through public policy development and recommendations on issues pertinent to medical regulation. Shortly after its founding in 1912, the Federation of State Medical Boards began publishing a quarterly journal addressing issues relating to medical licensing and regulation of doctors. First published in 1913 as the Quarterly of the Federation of State Boards of the United States, the publication has undergone several name changes and publication schedules. From1921 to 1999 it was published monthly as the Federation Bulletin. In 1999 it was changed to the quarterly Journal of Medical Licensure and Discipline and in 2010 was revised to the Journal of Medical Regulation The Journal of Medical Regulation is in the process of archiving all issues dating back to 1913.

Presently every paper dating back to 1967 is available online and the archival organization and availability of full articles published sequentially over the past half-century is historically invaluable.   As the official journal of the national organization involved in the medical licensing and regulation of doctors, this archival organization allows for an unskewed and impartial examination in both historical and cultural context. We can identify when particular issues and problems were presented, who presented them and how.

The Journal of Medical Regulation archives provides a structured context to examine these issues in their historical and cultural context.  This facilitates a retrospective analysis.  As a timeline it allows identification of when the issues were presented.  It also allows us to look at the events preceding the problem, who benefited from them, and the consequences. Could these factors be involved in influencing the regulation of medicine and shaping the medical profession? Could bent science have been involved in regulatory and administrative changes that have significantly impacted the rights and well-being of doctors and how the profession of medicine is defined?  Could some of the current problems such as the marked increase in physician suicide, sham-peer review, and physician burnout be the result of bent science?  If bent science is contributing to bad policy and bad decision making then it need to be exposed and addressed.  Bent science is bad medicine and if it exists then we need to urgently shine a light on it.

  1. McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
  2. de Toqueville A. Democracy in America. New York: Penguin Books; 1984.
  3. Blumer H. Social Problems as Collective Behavior. Social Problems. 1971;18:298-306.
  4. Stone DA. Causal Stories and the formation of policy agendas. Political Science Quarterly. 1989;104:280-300.
  5. Best J. Threatened Children, Rhetoric and Concern about Child Victims. Chicago University of Chicago Press; 1990.
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  2. Cohen S. Folk Devils and Moral Panics: The Creation of the Mods and Rockers (New Edition). Oxford, U.K.: Martin Robertson; 1980.
  3. Becker H. Outsiders: Studies in the Sociology of Deviance. New York: Free Press; 1963.
  4. Hall SC, Critcher C, Jefferson T, Clark J, Roberts B. Policing the Crisis: Mugging, the State, and Law and Order. London: Macmillan; 1978.

 

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