gets it yet.”
gets it yet.”
Questions about the accuracy and marketing of Laboratory Developed Tests (LDTs) have led to the current debate whether the U.S. Food and Drug Administration (FDA) should regulate a subset of diagnostic tests currently exempted from oversight. Designed to bring clinical tests to market that the costly FDA process would otherwise preclude, such as those for rare diseases, the LDT pathway bypasses Federal regulation and accountability. Questions about the validity of these tests have raised concerns over patient safety and a call for oversight. Among those asking for regulation are Massachusetts Senators Edward J. Markey and Elizabeth Warren.
Opponents of regulation argue the LDT pathway enables new and pioneering tests to be developed quickly and improve patient care. A recent viewpoint piece published in JAMA opposing regulation noted such advances have occurred “in large part because of the nimbleness of relatively small clinical and academic laboratories that can quickly respond to new medical findings and patient needs by rapidly and safely developing and improving laboratory-developed tests.”
But the LDT pathway does not require proof of test validity, that the test is actually testing for what it claims to be testing, and with no FDA oversight a lab can claim any validity it wants in marketing the test. There is no accountability. Proponents of regulation argue that this lack of oversight is a direct threat to patient safety and, as an opposing viewpoint piece in JAMA notes, a “patient’s life or death could hinge on whether a single, unregulated diagnostic test result is meaningful.”
The debate has focused on the reliability and validity of a number of clinical tests currently marketed with unverified claims of accuracy such as those used for prenatal screening and Lyme disease. Notably absent from the discussions are the vast number of Laboratory Developed Tests tests being used for “forensic” drug and alcohol testing with the current FDA draft guidance stating simply:
Numerous “forensic” tests of unknown validity using urine, blood, hair, fingernails breath and saliva have been developed and brought to market as LDTs since the first one was introduced in 2003 when ASAM physician Dr. Gregory Skipper, then Medical Director of the Alabama Physicians Health Program, “convinced the initial lab in the USA, NMS near Philadelphia to start performing EtG testing.”1 With essentially no evidence base Skipper then claimed the alcohol biomarker “appeared to be 100 percent specific” in detecting covert use of alcohol for several days after ingestion based on a study he coauthored that involved a mere 35 forensic psychiatric inpatients in Germany, all male2
Using an arbitrary cutoff level of 100 ug/L the EtG was marketed as a valid and reliable test and blindly tested on those being monitored by programs not beholden to the strict protocol and procedure dictated by the Mandatory Guidelines for Federal Workplace Drug Testing that most Employee Assistance Programs (EAPs) adopted. In other words, the test was used on those who possessed little power or had their power removed.
The test was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash3,4, hand sanitizer gel5, and nonalcoholic wine.6 Sauerkraut and bananas have even been shown to cause positive levels.7
Shortly after the EtG debuted, complaints began to accumulate from individuals testing positive who adamantly proclaimed they did not drink. Steadfast in their trust of expert opinion and the claimed accuracy of EtG, the complaints of the accused were largely disregarded by those doing the monitoring. People lost their licenses, jobs, careers, and reputations. Others lost their freedom or had their children taken away. It is unknown how many died by suicide.
There have been multiple lawsuits filed since the introduction of the EtG including a class-action suit, but these were inevitably met with a well-funded and deep legal defense and their “experts.” The labs have taken a “stand your ground” position yielding either dismissals or in favor of the defense. As a new to the market lab with no prior evidence-based research in forensic testing prior to its implementation and use for forensic testing, the proponents of EtG testing had no meaningful opposition in terms of a scientific body of facts and evidence and no credible voice to present it. With the only “experts” in EtG validity being those who introduced and promoted its use there were no counter-forces. Those suffering the consequences of a false-positive test had no recourse. But as the toll of mayhem increased it eventually reached a tipping-point where others began to take notice.
In 2006 the Wall Street Journal reported the problems with the EtG to the general public,8 and SAMHSA issued an advisory stating that “legal or disciplinary action based solely on a positive EtG…. is inappropriate and scientifically unsupportable at this time. These tests should currently be considered as potential valuable clinical tools, but their use in forensic settings is premature.”9
Since that time Skipper has served as expert witness in close to 46 administrative hearings 22 criminal 14 custody and 1 Federal class action suit.
But this did not stop the Federation of State Physician Health Programs from using the EtG on physicians being monitored. Instead they instructed doctors to avoid anything potentially containing alcohol including hand sanitizer which a 2011 study found could result in EtG concentrations of almost 2000 ug/L. 10 To continue to justify the use of EtG they added other LDTs as confirmation tests of LDTs such as EtS and PEth– Junk Science to confirm junk science. Nonsensical smoke-and-mirrors antithetical to science and evidence-based medicine.
Since the birth of the EtG a variety of tests have been introduced and marketed as LDTs utilizing nails, blood, hair, breath and urine—all with unknown validity but marketed without constraint. No regulation, oversight or accountability exists.
The newest gadget they are using on doctors is the Cellular Digital Photo Breathalyze which he is promoting in the same manner as the EtG after a study he co-authored with Robert Dupont on just 12 subjects.
Although the current use of these tests is limited to the criminal justice system and professional monitoring programs this may soon change as the American Society of Addiction Medicine is proposing a “new paradigm” of zero-tolerance random widespread drug and alcohol testing. This is outlined in the ASAM White Paper on Drug Testing and described by Robert Dupont in his keynote speech before the Drug and Alcohol Testing Industry Association (DATIA) annual conference in 2012.
The ASAM White paper states drug testing is “vastly underutilized” throughout healthcare and describes the use of drug testing “within the practice of medicine and, beyond that, broadly within American Society.”
As the consequences of a single unregulated “forensic” test result can be grave, far-reaching and even permanent it is critical that these tests be included in the debate on regulation of LDTs.
Evidence based medicine is not restricted to randomized trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.11
Expert opinion is the lowest level of evidence available in the EBM paradigm.12,13 Fortunately, the scientific method and Cochrane type critical analysis of the available evidence is a tool to help people progress toward the truth despite their susceptibilities to unconscious confirmatory bias or conscious confirmatory distortion .14 Unfortunately, no one has used these tools address they panoply of tests of unknown validity that have already entered the market ; poised to be used on virtually everyone.
It is only a few public policy steps and minor changes in state regulatory statutes before what is described in the ASAM White Paper on Drug Testing comes to fruition. Before we know it the Drug and Alcohol Testing Industries “New Paradigm” as described here by Robert Dupont will be ushered in. From the ASAM white Paper:“THIS WHITE PAPER ENCOURAGES WIDER AND “SMARTER” USE OF DRUG TESTING WITHIN THE PRACTICE OF MEDICINE AND, BEYOND THAT,BROADLY WITHIN AMERICAN SOCIETY. SMARTER DRUG TESTING MEANS INCREASED USE OF RANDOM TESTING* RATHER THAN THE MORE COMMON SCHEDULED TESTING,* AND IT MEANS TESTING NOT ONLY URINE BUT ALSO OTHER MATRICES SUCH AS BLOOD, ORAL FLUID (SALIVA), HAIR, NAILS, SWEAT AND BREATH WHEN THOSE MATRICES MATCH THE INTENDED ASSESSMENT PROCESS. IN ADDITION, SMARTER TESTING MEANS TESTING BASED UPON CLINICAL INDICATION FOR A BROAD AND ROTATING PANEL OF DRUGS RATHER THAN ONLY TESTING FOR THE TRADITIONAL FIVE-DRUG PANEL.”
Backed by the multi-billion dollar drug and alcohol testing, assessment and treatment industry the public policy positions of the American Society of Addiction Medicine (ASAM) have invariably passed. There has been little if any meaningful opposition.And that is why I am asking for help from statisticians, biostatisticians and epidemiologists. The task would entail a review of the literature prior to the introduction of these tests for evidence base of forensic applicability (there essentially is none) and a review of the literature peri-and post marketing of these devices to assess the reliability and credibility of the underlying methodology and ascertain the evidence-base. The goal would be publication in both academic journals and presentation to the general public through media publication with the assistance of investigative journalists and other writers. The goal is to get the truth out about these tests and allow both the medial profession and public at large to awaken to the menace this represents. I can’t pay you but you would be combating injustice, corruption and dishonesty. You would be doing your part in helping the Medical Profession, honest and decent doctors, our country and perhaps our future.
“The hardest thing to explain is the glaringly evident which everybody has decided not to see”
― Ayn Rand, The Fountainhead
The Birth of Junk-Science in Drug and Alcohol Testing
The attached article concerns the reliability of hair-strand tests routinely accepted in child welfare cases in Ontario as evidence of parental drug or alcohol abuse. A positive test can lead to loss of parental custody of children.
The risk for false-positive results appears to be higher in women because of the higher use of alcohol-based hair products and the limitations of these tests are addressed in the article.
Almost 98% of ingested alcohol is eliminated through the liver in an oxidation process that involves its conversion to acetaldehyde and acetic acid, but the remaining 2% is eliminated through the urine, sweat, or breath.1
Ethyl Glucuronide (EtG) was introduced in 1999 as a biomarker for alcohol consumption,2 and was subsequently suggested as a tool to monitor health professionals by Dr. Gregory Skipper, M.D., because of its high sensitivity to ethanol ingestion.3
This minor metabolite of alcohol was reported by Skipper, M.D. and Friedrich Wurst, M.D., in November 2002 at an international meeting of the American Medical Society, to provide proof of alcohol consumption as much as 5 days after drinking an alcoholic beverage, well after the alcohol itself had been eliminated from the body.
In his study Dr. Skipper arbitrarily chose a value of 100 as a cut-off for EtG. The rationale behind this value is not cited.
In 2003, because of these and other reportedly remarkable results (e.g., positive findings, confirmed by admissions by the tested individuals, after traditional urine tests had registered negative), Skipper pitched the test to National Medical Services, Inc. (NMS labs) and it was developed as a Laboratory Developed Test (LDT).
So began EtG testing began in the United States, and this paved the way for the hair tests described. The urine EtG test introduced by Skipper is the index case and prototype for an array of unproven forensic tests introduced to the market as LDTs.
The LDT Pathway was not designed for Forensic Drug and Alcohol Testing. It is an Unregulated Industry.
The LDT pathway was developed for laboratory tests that would not otherwise come to market due to the prohibitive costs of FDA approval (for example a test for a rare disease).
Bringing an LDT to market does not require testing in humans (in vivo). Nor does it require that it be shown the test is testing for what it is purportedly testing for (validity). It is essentially an honor system. It was not designed for “forensic” testing but for simple testing with low risk.
None of this testing is approved by the FDA. It is essentially an unregulated industry.
NMS became a leading proponent of EtG testing and, starting in 2003, began publishing claims promoting the absolute validity and reliability of the EtG in detecting alcohol. Akin to the vitamin and supplement industry those promoting and selling the tests could say anything they want—and they did.
NMS initially established a reporting limit or cutoff of 250ng/ml at or over which EtG test results would be reported as “positive” for drinking alcohol. This was later upped to 500ng/ml, then 1000 ng/ml.
NMS reported it as the “Gold Standard” claiming any value above 250 ng/ml indicated “ethanol consumption.”
It was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash4,5, hand sanitizer gel6, nonalcoholic beer7, and nonalcoholic wine.8
As the cutoff value got higher they added another minor metabolite of alcohol, EtS, as a “confirmatory” LDT.
The authors of a 2011 study demonstrating that hand sanitizer alone could result in EtG and EtS concentrations of 1998 and 94 mug/g creatinine 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 uine specimens are obtained shortly after sustained use of ethanol containing hand sanitizer.”9
Sauerkraut and bananas have even recently been shown to cause positive EtG levels.10
A 2010 study found that consumption of baker’s yeast with sugar and water11 led to the formation of elevated EtG and EtS above the standard cutoff. EtG can originate from post-collection synthesis if bacteria is present in the urine.12 Collection and handling routines can result in false-positive samples.13
“Exposure to ethanol-containing medications, of which there are many, is another potential source of “false” positives.15
Problems Exposed by Wall Street Journal and SAMHSA
On August 12, 2006, The Wall Street Journal published a front-page article, titled “A Test for Alcohol – And Its Flaws.”.16
Quoting Dr. Skipper, among others, the article includes:
“Little advertised, though, is that EtG can detect alcohol even in people who didn’t drink. Any trace of alcohol may register, even that ingested or inhaled through food, medicine, personal-care products or hand sanitizer.”
“The test ‘can’t distinguish between beer and Purell’ hand sanitizer, says H. Westley Clark, director of the Federal Substance Abuse and Mental Health Services Administration. . . ‘When you’re looking at loss of job, loss of child, loss of privileges, you want to make sure the test is right”, he says…”
“Use of this screen has gotten ahead of the science,’ says Gregory Skipper…”
Methinks Dr. Skipper might have realized this when he initially proposed it as an accurate test after a pilot study done on only a handful of subjects. Or perhaps when he used the LDT pathway to bypass FDA approval and oversight.
On September 28, 2006, SAMHSA, a federal agency that is part of the U.S. Department of Health and Human Resources, issued an Advisory, which on the first page contained a “grey box” warning, as follows:
“Currently, the use of an EtG test in determining abstinence lacks sufficient proven specificity for use as primary or sole evidence that an individual prohibited from drinking, in a criminal justice or a regulatory compliance context, has truly been drinking. Legal or disciplinary action based solely on a positive EtG, or other test discussed in this Advisory is inappropriate and scientifically unsupportable at this time. These tests should currently be considered as potential valuable clinical tools, but their use in forensic settings is premature.”17
Bias has been identified as a large problem with drug trials.18 Industry-sponsored research is nearly four times as likely to be favorable to the company’s product as NIH-sponsored research.19 As an example, one survey of seventy articles about the safety of Norvasc (amlodipine) found that 96% of the authors who were supportive of the drugs had financial ties to the companies that made them.20
Imagine if this was a drug and not a drug-test.
Essentially Greg Skipper and the FSPHP arm of ASAM launched a very lucrative joint business venture with a commercial drug-testing lab. They introduced the test via a loophole as a laboratory developed test. An LDT has no FDA regulation so the lab was able to promote, market and sell these tests with no meaningful oversight or accountability. Quest Diagnostics and USDTL are now working with the FSPHP and engaging in the same scheme.
The lab then contracted with state licensing boards and their state PHPs (who designed, implemented and managed drug and alcohol testing programs for nurses and doctors). A mutually beneficial scheme for the labs (who collect the samples) and the PHPs (who utilize, interpret and report the results.
EtG, EtS, Scram, PEth, Soberlink–all unsupported junk science introduced by prohibitionist profiteers without conscience.
How many lives were ruined by this test? How many careers were lost, families shattered and futures erased. I would venture to say a lot. Just look through all of the legal cases as I have. It is unconscionable. Sociopathic profiteering.
How many committed suicide feeling helpless, hopeless and entrapped?
At the end of a talk entitled Addicted Professionals: intervention, Evaluation and Treatment, Skipper presents a slide reading “Reporting or Assisting a Troubled Peer? These doctor’s can’t help themselves….” followed by graphic images of physician suicide. (see torrance_meeting_2 (4) ). It is for shock value and morbid humor and it is grotesque. He could not care less that these were human beings with wives, husbands, children and hopes and dreams.
How many scenes like this were repeated across the country because this guy gamed the system to get an ultra-sensitive test with abysmal specificity for a ubiquitous organic compound approved and marketed as a “forensic” test?
Forensic testing needs to be as close to 100% specific as possible because the results of a positive test can be grave and far reaching. Getting this test (and all the others) approved and marketed through a loophole and then getting the state Boards and Federation of State Medical Boards to approve them by moral entrepreneurship is unconscionable. Using the LDT pathway is just another example of how the “impaired physician movement” removes accountability and culpability by bending, ignoring or otherwise making their own rules.
In a February 2007 article in the magazine “New Scientist,” Dr. Skipper is quoted
“…there is not yet an agreed threshold concentration that can be used to separate people who have been drinking from those exposed to alcohol from other sources. Below 1000 nanograms of EtG per millilitre of urine is probably ‘innocent’, and above 5000 booze is almost certainly to blame. In between there is a “question zone…”
No Dr. Skipper—it is you who is most certainly to blame. And what of all the people whose lives you ruined by introducing junk science with no evidence base via a regulatory loophole?? “probably innocent?” Shame on you Dr. Skipper…. Shame..shame..shame.