Month: March 2015

Bent Science and Bad Medicine: The Medical Profession, Moral Entrepreneurship and Social Control

mllangan1 4 Comments

mllangan1's avatarDisrupted Physician

IMG_9005The Medical Profession, Moral Entrepreneurship, and Social Control

Sociologist Stanley Cohen  used the term “”moral panic” to characterize the amplification of deviance by the media, the public, and agents of social control.1  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.   Belief in the seriousness of the situation justifies intolerance and unfair treatment of the accused.   The evidentiary standard is lowered.

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. 2

And according to cultural theorist Stuart Hall, the media obtain their information from the primary definers of social…

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Report: Shortage of 90,000 Physicians by 2025

mllangan1 3 Comments

Hoosier Econ's avatarHoosier Econ

tireddoctor

In a report prepared for the Association of American Medical Colleges a grim outlook was given concerning physician supply in the United States. Here is what was found:

    Demand for physicians continues to grow faster than supply, leading to a projected shortfall of
    between 46,100 and 90,400 physicians by 2025

The report can be read here. Much of the shortage will be from stronger demand of people getting on Obamacare.

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Backfire Step 1: Expose the Injustice–Forensic Fraud being committed by PHPs in Collusion with Corrupt Labs

mllangan1 11 Comments

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I will be putting up a survey shortly and want to hear your stories.  One of the recurrent themes I keep hearing from those victimized by PHPs is falsified drug and alcohol tests.   Attached is an example of what they are capable of.

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Quote by Dr. Greg Skipper, MD, FASAM, FSPHP

Remember, this group has essentially removed themselves from accountability in drug and alcohol testing via the use of Laboratory Developed Tests (LDTs), a loophole which avoids FDA approval and oversight.   Whereas most drug testing is transparent and held accountable, the PHPs use testing that is opaque, unregulated and accountable to no one.  Accountability demands both the provision of information and justification for ones actions. PHPs block both.  While most drug-testing requires the immediate provision of information if the test is questioned (as it should be), PHPs have put forth the logical fallacy that doctors have some sort of inherent expertise in toxicology and pharmacology and can “figure out” how to circumvent the testing process if they were to get copies of their lab results.  They block this provision of information.  And even if this information is ultimately provided, as seen below,  no outside organizations exist to hold them to account.  They do not have to justify their actions to anyone.  No safeguards exist to assure integrity and honesty of the sample.   No safeguards exist to assure the integrity and honesty of those ordering the sample either.

The documents below show forensic fraud.  This is undeniable and indefensible. It does not take a toxicologist or Medical Review Officer to understand what “chain-of-custody” is and that “updating” one constitutes misconduct, fraud and (as seen here) criminal activity.   These documents were obtained 5 months after a falsified test was ordered by Linda Bresnahan, Director of Operations at Physician Health Services, Inc. (PHS, inc.) the Massachusetts PHP via fax no less.  The blood test was drawn on July 1, 2011.  On July 19th, 2011 Ms Bresnahan requests (through the PHP secretary Mary Howard) that an already positive test for the alcohol biomarker phosphatidylethanol be “updated” with  ID # 1310 and a “chain-of-custody. (which is an oxymoron-a “chain-of-custody” by definition cannot be “updated.”  Unveleivably the lab does it without hesitation or any apparent compunction.   The documents speak for themselves.  ID # 1310 just happens to be my ID number.  When I complained that no one ever accused me of ever having an alcohol problem she replied:

“You have an Irish last name-good luck finding anyone who will believe you!” 

For a more detailed analysis see here, here and here.  And where was the Medical Review Officer during all of this?  Good question and one he will not answer!  And no one else is holding him to account.   This needs to change.

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1. Supression of Dissent: Basic Information

2. The keys to backfire

• “Reveal: expose the injustice, challenge cover-up

• Redeem: validate the target, challenge devaluation

• Reframe: emphasize the injustice, counter reinterpretation

• Redirect: mobilize support, be wary of official channels• Resist: stand up to intimidation and bribery”

via Helpful resources for those abused and afraid — via www.bmartin.cc .

US Legal Research – Concerns about Medical Boards

mllangan1 1 Comment

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http://uslegalresearch.org/2015/02/27/medical-boards/

rumikern's avatarCPR - The Center for Physician Rights

I am very enthused to learn that an independent organization, US Legal Research, is conducting preliminary research into abuse of physicians by medical boards.

I strongly urge all visitors to check out their blog and submit your story. If concerned about privacy (as one understandably would be), you can request that such be held private and used for information-purposes only. But please visit their blog regularly and comment.

see: Supreme Court Ruling Could Limit Medical Board Authority.

via Concerns about Medical Boards.

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Doctor Suicides

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usissuescom's avatarUS Issues

cropped-bob-shapiro.jpg   By Bob Shapiro

I recently watched a rerun of House, a TV show about a hospital diagnostic team (great show – worth your time). In one episode, one of the doctors on the team inexplicably commits suicide.

Today, I read an article by a doctor, who just started following my blog, talking about physician suicide. I was very surprised to find out that doctors “die by suicide at twice the rate of their patients….The fact is each year we lose over 400 doctors to suicide—that’s like an entire medical school gone,” according to physician, Pamela Wible.

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American Doctors Are Killing Themselves and No One Is Talking About It–By Gabrielle Glaser via the Daily Beast

mllangan1 10 Comments

Screen Shot 2015-03-23 at 7.31.40 PMVia the Daily Beast:   http://www.thedailybeast.com/articles/2015/03/23/american-doctors-are-killing-themselves-and-no-one-is-talking-about-it.html

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Excerpt:

“Doctors who acknowledge problems with substances or mental health are typically referred to a physicians health program, or PHP. These organizations evaluate, monitor, and treat physicians. Established initially in the 1970s, PHPs, which exist in almost every state, were intended to divert physicians suffering from alcohol or drug problems from censure from their state medical boards. PHPs are incorporated as nonprofits and have autonomy from the boards. But some PHPs breach confidentiality if they fear a doctor is a danger to the public. And some state medical boards also fund their PHPs. Since the boards hold the keys to licensure, many say this is a conflict of interest.

There are growing concerns about whether PHPs have the right approach to the job. They typically send doctors to rehab programs rooted in the faith-and-abstinence principles of Alcoholics Anonymous. While AA’s 12 steps might work for some with alcohol-use disorders, critics say most PHP recommendations are ill suited for patients with mental health problems.

J. Wesley Boyd, a Harvard psychiatrist who left his post as assistant director of the Massachusetts PHP over a disagreement about practices there, says PHPs routinely intimidate their clients. In an article he co-wrote for the Journal of Addictions Medicine in 2012, Boyd noted that many doctors who seek or are referred by colleagues for treatment are mandated to attend pre-selected rehabilitation facilities for 60 to 90 days. Afterward, they must agree to monitoring and drug testing, typically at their own cost. When doctors resist PHP recommendations, they risk losing their livelihood and their licenses.”

For full article see:  http://www.thedailybeast.com/articles/2015/03/23/american-doctors-are-killing-themselves-and-no-one-is-talking-about-it.html

Need Signatures: Please Sign Petition and Call (617-727-6200) MA State Auditor Suzanne Bump to Demand Audit of Corrupt Physician Health Services and the MA BORM Physician Health and Compliance Unit

mllangan1 4 Comments

Good news! I was contacted by State Auditor Suzanne Bump’s office yesterday and they are taking this seriously and want to hear from those who have been targeted or harmed by Physician Health Services, Inc., the Massachusetts Physician Health Program in complicity with the Massachusetts Board of Registration in Medicine’s Physician Health and Compliance Unit headed by Attorney Deb Stoller. If you have been coerced into unneeded assessment and treatment at a “PHP-approved” assessment center, been the victim falsified neuropsychological or cognitive testing, forensic fraud or otherwise been abused, harassed, threatened, intimidated or otherwise harmed they want to hear your story. If you are afraid of retribution or retaliation you can remain anonymous, call from a blocked number and refrain from giving any information that could potentially identify you. Please contact me by email and I will give you the name and number of who to call.

mllangan1's avatarDisrupted Physician

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The Petition can be found here.  Or better yet, sign the petition and call her at 617-727-6200.   The evidence that Physician Health Services, Inc. (PHS) is committing crimes has been free-floating for the past two years.   It has been posted on Reddit, Twitter, Facebook, Linkedin, blogged, faxed, and phoned.  The response?  Absolute silence.

The procedural, ethical and criminal violations are clear and many.     The incontrovertible evidence has been directly delivered to individuals who can and should address this but for some reason do not.  This is not a matter of opinion folks but a matter of fact.    Time and time again we hear of  egregious misconduct hidden for decades because of  cognitive dissonance and blinkered apathy.

What evidentiary standard is required for action?   Over the past three years and under a lot of duress I have obtained indefensible documentary prima facie  

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When Dentists Go Too Far: North Carolina Board of Dental Examiners v. Federal Trade Commission

mllangan1 3 Comments

Screen Shot 2015-03-17 at 12.25.17 PMhttp://www.forbes.com/sites/georgeleef/2015/03/04/eeoc-keeps-its-losing-streak-intact-reinforces-the-case-against-administrative-law/

The recent strike down of anticompetitive regulation in N.C. dental case opens the door to antitrust litigation against other state Regulatory Agencies such as Medical Boards.

The Federation of State Physician Health Programs has set up a “hidden” system of coercion and control using various methods (policy and moral entrepreneurship, changes in state medical practice acts and administrative procedure, misuse of health law, etc.) to create a system that lacks oversight and regulation. As a power unto themselves they are accountable to no one.

Although originally funded by medical societies and staffed by volunteer doctors in order to help sick colleagues and protect the public, any system can be subverted for profit and power, and these programs have been taken over by groups representing the multi-billion dollar drug and alcohol testing, assessment and treatment industry and become reservoirs of bad medicine and fraud. All manner of abuse can be hidden under a veil of benevolence. Although most are afraid to speak publicly under fear of punishment and retaliation (“swift and certain” consequences, summary suspension) I have herd from many many doctors in multiple states. Their stories are all the same.

In addition to misconduct related to the non-FDA laboratory developed tests (they themselves introduced into the market using a loophole that bypasses FDA approval) there are reports of coercion into unneeded evaluation and treatment at a couple dozen or so “PHP-approved” facilities under threat of loss of licensure.

Reports to a state PHP can be done anonymously with confidentiality guaranteed to the reporter. Any report will result in a meeting with the state PHP and if they feel a licensee is in need of an assessment they require it be done at a “PHP-approved” assessment center.

As non-profit tax exempt corporations, PHPs do not provide clinical assessments. They can only recommend assessments.  State Regulatory Agencies (Medical Boards, Nursing Boards, etc.) have accepted the PHPs requirements of limiting assessments to those approved by the PHP.   In fact many states mandate assessments to solely  “PHP-approved” assessment centers under threat of summary suspension of a professional license.

An Audit of the North Carolina PHP by State Auditor Beth Woods, however,  found financial conflicts-of-interest in the use of these predominantly out-of-state assessment facilities to which the N.C. PHP was referring and the state Medical Board was requiring.  Woods requested the qualitative indicators and quantitative measures used to  “approve” these assessment centers from the N.C. PHP but they were unable to produce any documentation showing any quality indicators or objective criteria existed!  The best response they could come up with was “informal” methods and “reputation.” The full audit can be seen here.

Imagine if the FDA gave this reply if  asked to provide the criteria used to “approve” medications or medical devices in the “FDA-approval” process!

Making matters even worse, the Medical Director of the N.C. PHP, Dr. Warren Pendergast was serving as President of their national organization, the FSPHP at the time of the audit.

The simple fact is no criteria exist.

A recent class action lawsuit in Eastern Michigan found this same pattern of referral to out-of-state assessment and treatment centers ( Marworth, Talbott, Hazelden. Promises,etc.)

State referrals to “PHP-approved” facilities has become a matter of public policy. Both the American Society of Addiction Medicine and the Federation of State Medical Boards have issued public policy statements stating that only “PHP-approved” centers be utilized by Regulatory Agencies in the assessment and treatment of their licensees.  Moreover, these policies specifically exclude “non-PHP-approved facilities and often involve a limited time-frame.  No choice, no appeal and no bartering.  Do it. Do it now and if you don’t suffer the consequences.

These public policy statements can be seen in the 2011 ASAM “Public Policy Statement on Coordination between Treatment Providers, Professionals Health Programs and Regulatory Agencies” and the 2011 FSMB “updated Policy on Physician Impairment.”  Many state Regulatory Agencies have strictly adhered to these policy recommendations.

What this means is that  states are mandating evaluations at  “PHP-approved” facilities even though there is no documentable or plausible reason for doing so.  No measurable criteria exist as to how the list of “approved” facilities were “approved” yet they have “cornered the market,” removed choice and created an imposed monopoly under threat of loss of professional licensure.

In reality no official “PHP-approved” list exists.  Neither does any objective published criteria for approving them.  At the same time state Regulatory Agencies and Boards are forcing evaluations on licensed professionals at these couple-dozen or so facilities.  They are excluding patient autonomy and choice violating the fundamental freedoms of the individual and informed consent.

All semblance of due process has been removed.  If  a plausible reason existed (i.e. they met some minimum standard of credentialing, quality or patient outcome) for referring to a proscribed list of assessment centers it could be arguably justified.  Without such criteria, and in light of the economic and ideological conflicts of interest involved, it is patently unjustifiable.

Even more disturbing is, as Drs. John Knight and J. Wesley Boyd (who collectively have more than 20 years experience as Associate Directors at the Massachusetts PHP, PHS, Inc.) pointed out in their 2012 paper published in the Journal of the American Society of Addiction Medicine,  many of these facilities are willing to “tailor” the diagnosis and recommendations of an evaluation to fit the wishes of the PHP.    “Tailoring” an assessment and recommendations to anything other than what the true data show is healthcare fraud.  It is, in fact,  the political abuse of psychiatry.

PHPs started out as “Physicians Health Programs” but many are transitioning to “Professionals Health Programs”  to widen the net.  For example in Michigan  and Florida the state PHP covers all health care practitioners from Acupuncturists to Veterinarians. PHPs have also entered non -healthcare employee assistance programs (EAPs) such as the aviation industry and the grand plan is expansion to  non-healthcare professions. They are doing this by claiming remarkable success rates and brandishing themselves as the “gold-standard” of substance abuse treatment.   Interestingly, the same individuals claiming how successful PHP programs are are the same individuals profiting from the drug and alcohol testing they introduced.  Anyone with any sort of license is at risk.

So whether you cut hair, teach, take care of patients or even drive a car they could be coming after you next and they don’t have to convince you of the validity and reliability of their services–they only need to convince those who regulate your license and, as we have seen, they are very accomplished at persuasion in this department.

And that is why we need more state audits of PHPs and Medical Boards.  The starting point is simple. Request from the state PHP and Board  a  list of “PHP-approved” facilities and the criteria by which they were approved. What should be a simple reply will undoubtedly not be as they will not be able to provide either.

djhensel's avatarArticle 8

Antitrust litigation hasn’t disappeared, but rather changed its focus. Instead of targeting the great railroad empires of the late 19th century, today’s antitrust efforts focus on more minute industries, like dentistry.

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Elizabeth Blackwell MD

mllangan1 1 Comment

“It is well worth the efforts of a life-time to have attained knowledge which justifies an attack on the root of all evil . . . which asserts that because forms of evil have always existed in society, therefore they must always exist . . .”

“A blank wall of social and professional antagonism faces the woman physician that forms a situation of singular and painful loneliness, leaving her without support, respect or professional counsel.”

.–Elizabeth Blackwell, M.D.

medmuseum's avatarmuseum of medicine & health

EBlackwell1905

Elizabeth Blackwell, Joseph Stanley Kozlowski, 1905. Syracuse University Medical School Collection.

Elizabeth Blackwell (1821-1910) was the first woman to gain a medical degree (MD) from Geneva College in New York State in 1849. She came from a liberal non-conformist Bristol family who had immigrated to America in 1832. She rejected marriage and decided to study medicine after a dying friend pleaded for a woman doctor. She was rejected by twelve colleges and only accepted at Geneva College as an ‘experiment’. Even after she qualified she was barred from the state medical society and any institutional post. Rejected by every hospital she applied to for surgical training, she decided to open her own dispensary which later became the New York Infirmary for Women & Children (1857), the first hospital founded and run by women. She was joined by her sister Dr Emily Blackwell (1826-1910) and Dr Marie Zakrzewska (1829-1902) who had…

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EtG–The Rosie Ruiz of Bent Science and Bad Medicine

mllangan1 27 Comments

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 Programs”11 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.

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