Laboratory Developed Tests

Press Release | Forensic Science Misconduct: A Dark and Cautionary Tale | @csidds

mllangan1 4 Comments

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FORENSICS and LAW in FOCUS @ CSIDDS | News and Trends

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Don’t expect a “whodunnit” version of CSI victories in this Op-ed blog article about a darker side of the forensic sciences. It is from an author with ample forensic credentials and experience from both within and outside criminal courts of the US. The article has topics ranging from the continued use of outdated or grossly over hyped “CSI” methods, ethical and moral failures in some forensic groups, to the criminal courts inability to understand much of anything about what is “real ” versus self-serving personal opinion called “science.” A measure of proof confirming these systemic problems is the article’s presenting a glimpse into the multi-million dollar costs to taxpayers for damages won by those wrongfully convicted with the help of court-qualified forensic testimony. Some optimism about better scientific scrutiny is presented but the institutional inertia resisting legitimate change in some forensic organizations, government agencies, and criminal  justice institutions is still…

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Integrity and Accountability—Going on two months and no winners stepping forward. Defend the MRO Procedurally, Ethically or Legally and you win all the prizes

mllangan1 9 Comments

As the Medical Review Officer (MRO)  for the Massachusetts state Physician Health Program (PHP), Physician Health Services, Inc. (PHS, inc.), Dr. Wayne Gavryck’s responsibility is simple.  He is supposed to verify that the chain-of-custody  in any and all drug and alcohol testing is intact before reporting a test as positive.

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Note Dr Gavryck is: 1. Certified by ASAM; 2. A .Certified Medical Review Officer (MRO) who “serves PHS in this capacity.” Although Dr. Gavryck serves PHS I would beg to differ on the MRO function. Accessed from PHS Website 1/15/2015 http://www.massmed.org/Physician_Health_Services/About/PHS_Associate_Directors/#.VM1dZlXF-hY

 

 

 

 

 

 

 

 

 

Dr. Gavryck evidently did not do that here.  In fact for more than a year he helped cover up an alcohol test that was intentionally fabricated at the behest of PHS Director of Operations Linda Bresnahan (who told me when I confronted her with the fact that I have never had or ever even been suspected of having an alcohol problem “you have an Irish last name–good luck finding anyone who will believe you!”

It took a formal complaint with the College of American Pathologists to get the truth out.  The whole fiasco can be seen here and here.

What Gavryck and his co-conspirators did is egregious and ethically reprehensible.  It shows a complete lack of moral compass and personal integrity.  What was done from collection to report to coverup  and everything in-between is indefensible on all levels (procedurally, ethically, and legally).

The documentary evidence shows with clarity that this was not accident or oversight.  It was intentional and purposeful misconduct.  I think everyone would agree that there should be zero-tolerance for forensic fraud in positions of power.    Any person of honor and civility would agree.

Transparency, regulation, and accountability are necessary for these groups.   It is an issue that needs to be acknowledged and addressed not ignored and covered up.

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

Perhaps Dr. Gavryck needs to see some of the damage he has caused in order to take this responsibility. Known as a “bag man” who simply rubber stamps positive tests at the request of Sanchez and Bresnahan (much like Annie Dookhan)  he does not see the damage that is caused. Forensic fraud has grave and far reaching effects and in this case has severely impacted many people and include patient deaths.

Perhaps Dr. Gavryck needs to take a “moral inventory” and see that this this type of behavior causes real damage to real people and put a face on it.

It is people just like this who are killing physicians across the country.   The body count is vast and multiple.  And those who are caught doing dirty deeds such as this need to be held accountable.

Please help me get this exposed, corrected, and rectified.  The doctors of Massachusetts and the doctors of this entire country deserve better than this.

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

 

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The MRO Code of Ethics--Seems like Dr. Gavryck's breaking them in sequential order!

The MRO Code of Ethics–Seems like Dr. Gavryck’s breaking them in sequential order!

 

Still looking for Statisticians, Biostatisticians and Epidemiologists to debunk Junk-Science

mllangan1 9 Comments

photo 1Wanted!–a Few Statisticians, Biostatisticians and Epidemiologists who want to make a difference in Medicine, Society and our Future.

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

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

 

The Plan to introduce non-FDA approved drug and alcohol tests into the Healthcare system and require doctors drug-test ALL PATIENTs including students and kids!

mllangan1 28 Comments

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The Plan to introduce non-FDA approved Laboratory Developed Tests (LDTs) into the Healthcare system and require doctors drug-test ALL PATIENTs including students and kids!

The ASAM plans to introduce non-FDA approved “forensic”  Laboratory Developed Tests (LDTs) into mainstream healthcare via a loophole.    This same group introduced most of these tests through a loophole and now they want to drug-and alcohol TEST EVERYBODY including STUDENTS AND KIDS through another loophole!   These tests are of unknown reliability and accuracy.  The LDT pathway does not even require proof that the test is even valid  (i.e. that the test is actually testing for the substance it claims to be testing) but with no FDA oversight or regulation the labs can claim anything they want in marketing it and they do.

If a doctor collects a test on a “patient”  the test is rendered “clinical” rather than “forensic” and by deeming this drug-testing  “clinical” rather than “forensic”  they can then call the consequences of a positive test “treatment” rather than “punishment.  ” It is via this loophole they plan to introduce and unleash the panoply of junk-science tests currently being used on other groups who have no say in the matter (probationers, parolees, private professional monitoring groups, etc. ) onto the general population at large.    A boon for the Drug and Alcohol Testing Industry Association and the assessment and treatment industry but a bane to the rest of society.    And to prevent this from happening more people need to be talking about this.

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

mllangan1 19 Comments

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Chain-of-Custody refers to the document or paper trail showing the collection, control, transfer, analysis and disposition of laboratory tests.  It is the written documentation of a specimen from the moment of collection to the final destination to the review and reporting of the final results.   The multi-part chain-of-custody form or “custody and control” form is part and parcel of this process. It contains stickers to sign and seal the specimen so that it cannot be tampered with and the form itself is signed by the appropriate parties as the test specimen travels from place to place. Information is added to the form as it travels from person to person.  It has been given the status of a legal document as it has the ability to invalidate a specimen with incomplete information.  Once the sample is analyzed it is reviewed by a Medical Review Officer (MRO) for final review. In the case of a positive test it is the responsibility of the MRO to ascertain an intact  chain-of-custody, determine whether an alternative explanation exists for the positive test such as a prescribed medication, and then and only then report the test as a “true positive.”

The MRO looks for what are called “fatal flaws” and,  should one be present, invalidates the test.  A fatal flaw requires the test be rejected as it were never drawn.  It invalidates it and it cannot be used. screen-shot-2013-12-19-at-12-20-46-pmAny and all drug testing requires strict  chain-of-custody procedures. It documents not only the whereabouts of the specimen at any given time but the management and storage of the specimen. This is important because time and temperature can influence the results of certain tests.  One such test is alcohol.

Specimen integrity is critical in forensic drug testing, but so too is the integrity of the people involved.

Forensic Versus Clinical Drug Testing

According to the ASAM White Paper on Drug Testing, clinical drug-testing “employs the same sound procedures, safeguard, 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.”  In the box below they describe the multiple safeguards in place and requirements demanded of “forensic” drug testing but do not mention the reason these uncompromising and multiple specifications exist is to protect the donor from a false accusation of drug or alcohol use.  They proceed to define “clinical drug testing” as “part of a patient examination performed for the purposes of diagnosis, treatment, and the promotion of long term recovery” noting that clinical testing “must meet the established standards of medical practice and benefit the therapeutic relationship, rather than meeting the formal legal requirements of forensic testing.”  The authors then state that the “majority of drug testing done today” includes both forensic and clinical elements using individuals on parole and probation as examples.

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From the ASAM White Paper on Drug Testing

The logical fallacy here is striking.  It is comparing apples and oranges.  After detailing the specific quality assurance safeguards designed to prevent the donor of a drug or alcohol test from being falsely accused of illicit use, the authors give a general  definition and purpose of  “clinical” testing  then state that when testing for drugs the systems in place are up to snuff as they are already being used to make  “life-and-death medical decisions.”  The take-home message is that “forensic” testing is unnecessary hyperbole designed for legal challenges. The clinical lab  systems in place are used for critically  important testing and can therefore be used for drug-testing–after all, parolees and probationers don’t require it.

Forensic guidelines were developed in collaboration with occupational and environmental medicine specialists, clinical and forensic toxicologists, pathologists and others and the recommended  requirements agreed upon by this consortium exists solely to  assure validity and accuracy in the testing process.  These requirements exist to protect the donor and If the “clinical” testing context fit the bill then “forensic” testing would not have evolved.

Labs ordered clinically in the course of patient care are interpreted within the context of multiple other pieces of data.  Lab errors occur all the time and are interpreted in that context. Oftentimes a lab will not fit with the clinical picture and, when that happens, a repeat lab is ordered for verification.  Specimens get collected in the wrong tube and specimens get lost but in the clinical setting they simply get reordered and there are no consequences to patient care.   In contrast drug testing is an all-or-none one-shot test and the results have consequences. It is for that reason they must be valid.  Chain-of-custody and MRO review are critical and that is why most drug-testing programs follow the forensic protocol.  And the example of non-forensic drug-testing  parolees and probationers is misleading.   Any Employee Assistance Program that has a union or some other group looking out for their best interests uses strict “forensic” guidelines.   Parolees and probationers have no power  and have no choice.  Besides, the  National Association of Drug Court Professionals uses the Laboratory Developed Tests these same people introduced to test  individuals on probation or parole in the criminal justice system just as they do in the PHPs.

The  ASAM 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, sweatand 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”

As a physician-patient relationship renders drug testing “clinical” rather than “forensic” the consequences become “treatment” rather than “discipline.”  And that is the real reason behind all of this.    A positive “forensic” test in most employee random drug screening programs today will result in an “assessment” for substance abuse.  Most EAPs allow a choice in where that assessment takes place.  The model this system is based on, Physician Health Programs. do not allow choice as evaluations are mandated to “PHP-approved” assessment centers; a rigged game.

A positive “clinical” test will result in the same thing under the ASAM White Paper proposal.  But the assessment will be at an ASAM facility and if a Substance Use Disorder (SUD) is confirmed it will result in mandated abstinence of all substances (including alcohol) and lifelong spirituality involving 12-step recovery   And by using the healthcare system as a loophole and calling this testing “clinical” rather than “forensic” the ASAM will have successfully introduced widespread testing of a variety of Laboratory Developed Tests (LDTs) of unknown validity while removing  the safeguards provided by forensic testing including chain-of-custody and MRO review.

 

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Junk Science and the Need for Regulatory Oversight of Forensic Laboratory Developed Tests

mllangan1 14 Comments

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Laboratory Developed Tests

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:

  • “At this time, FDA will continue to defer oversight of the use of these tests in the forensics (law enforcement) setting to the existing system of legal controls, such as the rules of evidence in judicial proceedings and other protections afforded through the judicial process.”

The Birth of EtG:  The Introduction and Marketing of Laboratory Developed Tests for “Forensic” Drug Testing  Via a Lucrative Loophole

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  

Screen Shot 2014-02-24 at 10.08.19 PMUsing 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

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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.

Page from the Talbott Recovery Center list of products containing alcohol that doctors are required to avoid due to interference with EtG testing

Page from the Talbott Recovery Center list of products containing alcohol that doctors are required to avoid due to interference with EtG testing

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.

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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.

Expanding Laboratory Developed Tests to Test Everyone:   The ASAM White Paper on Drug-Testing and the  “New Paradigm” 

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.

  1. Skipper G. Exploring the Reliability, Frequency, and Methods of Drug Testing: What is Enough to Ensure Compliance?:   Alcohol Markers and Devices. 2013; http://www.fsphp.org/Skipper, Exploring the Reliability Frequency and Methods 2 Presentation.pdf.
  2. Wurst FM, Vogel R, Jachau K, et al. Ethyl glucuronide discloses recent covert alcohol use not detected by standard testing in forensic psychiatric inpatients. Alcohol Clin Exp Res. Mar 2003;27(3):471-476.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
  9. Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
  10. 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.
  11. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. Jan 13 1996;312(7023):71-72.
  12. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. Feb 25 2009;301(8):868-869.
  13. Straus SE, Green ML, Bell DS, et al. Evaluating the teaching of evidence based medicine: conceptual framework. BMJ. Oct 30 2004;329(7473):1029-1032.
  14. Haack S. Defending Science–Within Reason: Between Scientism and Cynicism. Amherst, N.Y.: Prometheus Books; 2003.

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

mllangan1 11 Comments
 “That everyone shall exert himself in that state of life in which he is placed, to practice true humanity towards his fellow men, on that depends the future of mankind.” – Albert Schweitzer 
“By and by never comes” –St Augustine

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Evidence based medicine is not restricted to randomized trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.22  

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

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

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

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

mllangan1 16 Comments

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The juxtaposed documents in and of themselves reveal a number of red flags.  How does one “revise” a chain-of-custody”?    If you do a google search you will not find “chain-of-custody” as an object of the verb revise. It is an oxymoron.  A document or opinion can be revised.  A chain-of-custody, by its very definition, cannot.  This collusion to fabricate a positive test has coined a new oxymoron—“revised chain-of-custody.”     Go ahead and look it up. It is a novel one.     As it should be.

What these documents show is, in fact, indefensible ethically, procedurally and legally.  The first document signed by Dr. Luis Sanchez, past President of the FSPHP and past Medical Director of Physician Health Services, Inc.  (PHS) was sent to the Board of Registration in Medicine on December 11, 2012 and is notable for two statements.   The letter from Dr. Sanchez asserts that “Yesterday, December 10, 2012, Physician Health Services, PHS received a revision of a laboratory test result,” but it did not matter because PHS was {unaware} ” of any action taken by the Massachusetts Board of Registration in Medicine as a result of the July 28th, 2011 report.   However, based on the amended report, PHS will continue to disregard the July 21st PEth test result.”

The second document, addressed to Dr. Luis Sanchez, is dated October 4, 2012 (67 days earlier) and shows the first document to be a bald-faced lie.

On July 28h 2011 Dr. Luis Sanchez reported to the Medical Board that I had a positive alcohol test.

Although I knew that Dr. Sanchez had fabricated the test I  had no way of proving it. I requested the “litigation packet,” which records “chain-of-custody” from collection to analysis in August of 2011.  At first they  refused.  PHS then tried to dissuade me (“it will be costly, involve attorneys, etc). Finally they agreed but threatened me with “unintended consequences.”

I was finally able to get a copy of the “litigation packet”  in December of 2011.  Remarkably, it  showed that Sanchez had requested my ID # and a “chain-of-custody” be added to an already positive specimen. I reported this to the Board but they ignored it. I also filed a complaint with the College of American Pathologists.Screen Shot 2014-11-06 at 11.17.32 PM

On October 23, 2012 Sanchez reported to the Medical Board that I was “noncompliant” with requirements with A.A.  meetings that I was supposed to go to as a direct result of the positive test and my license to practice medicine was suspended as a result in December 2012.

On December 10, 2012 I contacted the College of American Pathologists who told me the test was “amended” from “positive” to “invalid” on October 4, 2012. I confronted Sanchez and PHS and they said they did not know anything about it.

The following day, December 11, 2012, they sent out a letter saying that the test was invalid but that they were “unaware of any action taken against my license as a result of the test.”  

The documents show that on  July 19th, 2011 Sanchez requested my ID # 1310 and a “chain-of-custody” be added to an already positive specimen and on October 4th 2012 the test was “appended” to “external chain of custody not followed per standard protocol.”

Please note again that  Dr. Sanchez stated on December 11, 2012 that he “just learned” about this on December 10, 2012. He reported me to the Board as “noncompliant” on October 23, 2012 and my license was suspended in December 2012.   These documents show he had full knowledge that the test was invalid and as an agent of the Board this is under “color of law.”   Both he, and PHS, need to be held accountable for this.

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Lies, Lies, and More Lies

10:19:12-Verbal Compliant Noncompliance f:u written 10:19:12–BORM Complaint Committee

The contradictory documents from Sanchez alone constitute a crime (withholding information in concealment and providing false information to a state agency).  But what he did is far far worse.

I just obtained the October 4th document. Although I knew it existed, PHS suppressed it and refused to acknowledge it.   But in response to a complaint I filed against PHS and the labs it was revealed by USDTL that the test in question (phosphatidyl-ethanol) was not sent as a “forensic” specimen but collected as a “forensic” specimen, then changed to a “clinical” specimen at the request of PHS Program Director, Linda Bresnahan.   The specimen was kept at the collecting lab (Quest) for 7 days as a  “clinical” specimen, then sent to the analyzing lab (USDTL) with specific instructions from Quest to process it and report it as a “clinical” specimen.  PHS then used it as a “forensic” specimen by reporting me to the Board of Registration in Medicine and  requesting I undergo an evaluation for alcohol abuse.

As a “clinical” specimen it is rendered “Protected Health Information” (PHI) and thus under the HIPAA Privacy-Rule.   So with the help of the College of American Pathologists I requested my PHI from both Quest and USDTL. Quest refused (for obvious reasons) but USDTL complied.   And that is how I was able to obtain the October 4th document revealing that Dr. Sanchez lied to the Medical Board.     I would love to hear him, or PHS MRO Wayne Gavryck, defend the indefensible (and unconscionable).

Dr. Sanchez is correct when he pleads ignorance of any action taken by the Board as a result of the July 21st PEth result.   It was his report to the Medical Board  that I was “noncompliant” with attending AA meetings (that I was supposed to go to as the direct and sole result of the positive test)   that he reported to the Board just two weeks after the October 4th appended test.

The test was sent as a “clinical” specimen intentionally. PHS is not a clinical provider but a monitoring agency. They cannot send clinical samples.   But since clinical samples are “protected health information” and under HIPAA the lab had to give me the records and here you have them.

The distinction between “forensic” and “clinical” drug and alcohol testing is black and white.  PHS is a monitoring program not a treatment provider.  The fact that a monitoring agency with an MRO asked the lab to process and report it as a clinical sample and then used it forensically is an extreme outlier in terms of forensic fraud.  The fact that they collected it forensically, held it for 7 days and changed it from “forensic” to “clinical” to bypass strict “chain-of-custody” requirements  deepens the malice.  The fact that they then reported it to the Board as a forensic sample and maintained it was forensic up until now makes it egregious.   But the fact that the test was changed from “positive” to “invalid” on October 4th, 2012 and Sanchez then reported me to the Board on October 23rd 2012 for “noncompliance,” suppressed it and tried to send me to Kansas for damage control makes it wantonly egregious.   (they didn’t think I’d ever find out).

Add on that the fact that I’ve been questioning the validity of the test since day 1 and they violated the HIPAA Privacy Rule over and over and this is reckless and major health care fraud.

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Fax from PHS to USDTL on July 19th, 2011 asking that my ID #1310 be added to an already positive test and a “chain-of-custody” be “updated”

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USDTL complies with PHS request to and adds my ID #1310 and a date of collection (July 1, 2011) to an already positive specimen

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No date of collection, no unique identifier linking specimen to me. Multiple “fatal flaws.”

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I file complaint with CAP January 12, 2102. CAP forces USDTL to amend test from “positive” to “invalid” which they do on October 4, 2012. PHS conceals this fact until December 11, 2012

Letter from Chief of Toxicology at MGH–Ignored by PHS, USDTL, and the BORM         11:5:12-Dr. Flood Letter–Ignored by PHS:USDTL:BORM

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Physician sues Quest Diagnostics for forensic drug test fiasco

mllangan1 1 Comment

Massachusetts physician Dr. Michael Langan has filed a lawsuit against Quest Diagnostics, alleging the lab giant was negligent and engaged in fraud and deceit in its handling of his forensic drug test sample.

http://pathologyblawg.com/pathology-news/pathology-vendors/quest-diagnostics/physician-sues-quest-diagnostics-forensic-drug-test-fiasco/?utm_source=rss&utm_medium=rss&utm_campaign=physician-sues-quest-diagnostics-forensic-drug-test-fiasco