The importance of reliability, validity and accuracy in all medical and laboratory testing–there are no exceptions

March 30, 2017March 30, 2017mllangan1 Leave a comment

Diagnostic test accuracy is simply the ability of the test to discriminate among alternative states of health (Zweig and Campbell, 1993).

If a test’s results do not differ between alternative states of health, then the test has insignificant accuracy; if the results do not overlap with other states of health then the test has perfect accuracy. Most tests accuracies fall between these two extremes.

The intrinsic accuracy of a test is measured by comparing the test results to the “true condition status.”

‘True condition status” refers to one of two mutually exclusive states. Either a condition is present or it is absent.

We determine true condition status by means of a “gold standard” which is a source of information completely different from the test under evaluation which tells us the true condition status of the patient.

Source: The importance of reliability, validity and accuracy in all medical and laboratory testing–there are no exceptions

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

December 5, 2016December 5, 2016mllangan1 2 Comments

screen-shot-2016-12-04-at-11-38-32-pm 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.

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

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

October 4, 2016December 4, 2016mllangan1 1 Comment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Need for Regulation, Oversight, and Accountability

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

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

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

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

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

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

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The American philosopher Eric Hoffer noted:

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

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

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

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

― Robert F. Kennedy

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Request Medical School Administrators Question PHP Authority to Prevent Future Medical Profession Brain Drain

February 16, 2016February 16, 2016mllangan1 10 Comments

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Physician Health Programs (PHPs) now targeting medical students–More sheep for the slaughter

The attached article entitled “Medical school drug testing is a moral and scientific failure” opposes testing medical students for drugs and alcohol but things are going to get a whole lot worse.

In the past six-months I have been contacted by an increasing number of medical students searching for help after being trapped in quagmire of their state physician health program (PHP). Each of them had either been referred to a “PHP-approved” assessment center or had already had an evaluation recommending inpatient treatment.

Some of these students were subjected to non-FDA approved laboratory developed tests including hair testing for marijuana metabolites and the alcohol biomarker EtG. These typeof tests can detect substances that were used days, weeks and even months prior to testing.

Medical students and physicians are just as likely to have experimented with illicit substances in their lifetimes as their age and gender matched peers.¹

Although medical students as a group drink slightly more alcohol than the general population, the pattern and prevalence of alcohol, dependence is consistent with their age mates in the general population.¹ ²

Like it or not recreational and experimental drug use is widespread in young adults and most of them “grow out of it” and the 21st Amendment repealed the Volstead Act in 1933. Alcohol is legal and those that can handle it have a right to a round of beers after a long day or imbibe a cocktail with a dinner date. But according to the prohibitionist profiteers and moral preeners any drug or alcohol use is a sign of “potentially impairing illness” that must be addressed and treated early to prevent an inexorable slide into a chronic relapsing brain disease and abstinence and lifelong adherence to the principles 12-step spirituality are the only way to do so.

An old joke asks “How does a doctor define an alcoholic?” Answer–“anybody who drinks more than he does.” How does a PHP define an alcoholic? Answer –anybody who walks through the front door.

In reality, a zero-tolerance paradigm utilizing this type of testing would be ruinous. With recreational and experimental drug use common in young adults a profession that refuses to accept anyone who tests positive for drugs will exclude large numbers of brilliant, talented individuals. Dismissing highly talented people in medicine for what might be a one-off recreational non problematic drug experience would retard its advance.

The use of these non-FDA approved tests of unknown validity should not be allowed to begin with but there needs to be a concerted direct attack on their use on medical students or the brain-drain on the profession will bring it back to the dark ages. The ASAM White Paper on Drug Testing proposes imposing this system with mandatory drug testing by the healthcare system from childhood to old age. College loans are proposed as “leverage” for college students in this “contingency management” paradigm so a lot of promising students could be weeded out before even applying to medical school. Forget GPA and MCATS as the primary criteria for medical school admission will be sobriety and clean urine screens..

Diagnosing disease without meeting the diagnostic criteria for that disease.

None of the students who contacted me seemed to fit the diagnostic criteria for the diagnosis given to them stories which were articulate, detailed and sincere. All cases involved either a naive mistake or isolated incident.

One student made the disastrous revelation to a PHP director who had just given a class lecture that she had smoked marijuana with her high school friends in her home state of Colorado. She was then called in by the PHP and referred for an evaluation at an out of state facility where she was diagnosed with “marijuana dependence” based on a positive low level THC metabolite on a hair follicle test. She was told she was in denial and inpatient treatment was recommended. Although she admitted to occasional weekend marijuana use there were absolutely no problems in any realm of her life. It is self-evident that impairment due to drugs or alcohol impacting someones capacity to work or function needs to be addressed but the penalty imposed on her for her private behavior was to end her career in medicine before it even started. The medical school administration mandated she either complete the treatment required by the PHP or she would not be able to enroll the following semester and not being able to come up with the up-front out-of-pocket cost for treatment she was not able to return to the medical school and has decided to pursue a different career.

Another student was anonymously reported to the PHP for smoking marijuana at a weekend party which resulted in a similar assessment and recommendation for inpatient treatment. After spending 3 months at a facility in Alabama he is now under monitoring contract with his PHP but returned to school.

Healthy student asks for help in his organizational skills–ends up with a psychiatric and substance abuse diagnosis

After reading an advertisement in the state medical society newsletter promoting work-life balance a second-year medical student contacted his state PHP to obtain advice on his problem with “procrastination.” Classes and working part time in the endocrinology lab left him with little time and he found himself slacking off on his exercise routine and burning the midnight oil before test nights. He told the PHP director about his history of depression after his father died immediately before his freshman year at college. That October he became overwhelmed with sadness and missed his dad and hometown. He sought help from the campus physician who prescribed prozac which was discontinued in a years time without return of any symptoms.

Realizing there were no classes in work-life balance but only a support group for “burnout” the student declined the PHP directors offer of an assessment of his “mental health.” Much to his surprise he was called in the following week by a medical school administrator and told that the PHP was requiring an assessment at one of two out of state “PHP-approved” assessment centers in Lawrence Kansas. He was at first confused at the nonsense he was hearing and then became indignant at the nonsensical and illogical request without rhyme or reason and the betrayal of trust and ethics. “Surely this must be a HIPPA violation.” He obtained an outside consultation from a psychiatrist and contacted the campus physician who confirmed his diagnosis was acute situational depression and bereavement but the PHP disregarded the information. He bartered for a local evaluation but this was refused. He arranged for the 96-hour assessment in Kansas. His mother paid the requisite out-of-pocket up-front $4,500.00 to the facility and she told him not to worry as his life would get back to normal after they confirmed he had no psychological problems. “Dysthymia, Major depressive disorder, severe, in remission and alcohol use disorder” were given as diagnoses. “Alcohol use disorder” was based on a hair test for EtG which was the result of his drinking an occasional beer or two with friends after school and on the weekends. He was told he may be “self-medicating” and playing “Russian roulette” given his history of depression. Recommendations included inpatient treatment followed by a “structured aftercare program” of abstinence and monitoring by for alcohol and drugs of abuse. Forced to sign a contract with the PHP he was understandably upset at the serious and unfounded sequelae that was the result of asking for help.

Another fourth-year student got into a bit of a shoving match with his buddy at the bar on a Saturday night and was reported to his PHP anonymously. He is awaiting evaluation.

This brings up another potential problem–sham peer review. As PHPs accept anonymous referrals what is in place to prevent inappropriate referrals based on removing a competitor and improving your academic standing.

A legitimately prescribed stimulant for ADHD bought a third year student into a PHP contract. He was forced to discontinue the medication prescribed by a psychiatrist specializing in childhood ADHD by a family practitioner in “recovery” from abusing intravenous fentanyl who had been monitored by the PHP himself for ten years then became medical director after getting board certified as an addiction medicine specialist.

This student got 99th percentile across the Board on his MCATs and may one day cure cancer but now faces an uncertain future as he recently got a positive EtG on a urine test and they are currently “sorting this out.”

The most bizarre story was from a student who sought help for sleep troubles after reading about the PHP as a referral source. He subsequently saw a sleep-specialist and was diagnosed with an oversized uvula which was surgically corrected. His sleep troubles improved but his troubles with the PHP remained. A triathlete and excellent student the PHP determined he had a “thought disorder” and discussions of “schizophrenia” were entertained by the PHP and they recommended an out of state evaluation at one of the three gulags used by the FSPHP for “disruptive physician” and behavioral exams–Vanderbilt, Acumen and the Professional Renewal Center. All of these facilities come with a guaranteed diagnosis. Polygraphs and unvalidated neuropsychological instruments designed to detect “character defects” cast a pretty wide net.

Question FSPHP with direct questions to undermine a “culture of professionalism.

It is important that medical school administrators refuse to engage in blind deference to the authority of the state PHP. Authority must always be questioned and to not do so is irresponsible. Unquestioning allegiance to an authority does not comport with the history of the medical profession or science. Faith in institutions demands mass adherence to faith in that authority and direct challenges to the status quo are needed to undermine that faith. They have bamboozled the medical boards into implementing bad policy, approving bad science and making bad decisions. They have duped state legal authorities into deference to their expertise and integrity under the notion that questioning these attributes undermines a culture of professionalism. Fact of the matter is they have no expertise, no integrity and no professionalism.

PHPs have been contaminated with an outside influence and support an agenda that has nothing to do with protecting the public or helping medical students. They are an illegitimate authority that has become an irrational authority and their recommendations mandate direct answers and justification.

If the PHP has concerns about a student then the first step should be to obtain an independent second opinion. PHPs discourage second these second opinions and disregard all outside expert opinion no matter how well qualified and experienced that expert is. Anyone outside this brood of addiction addicts is scoffed at as biased or unenlightened to the simplistic belief system with which they have contaminated the medical profession. Look into the assessment centers to which they are mandating referral. Ask what qualitative factors and quantitative measurements were used to approve that facility and why no one in Massachusetts has the ability come to a competent diagnosis. The yarn that doctors and medical student have an ability to dissemble and appear normal while harboring a “potentially impairing condition” is one of the medical urban legends they started. Ask to see the evidence base. There is none and it defies common sense, logic and science.

An increasingly bright light is being shed towards the malfunctions and corrupt practices of this unaccountable confederacy of “authorities” and at some point soon their jig will inevitably be up. In the interim, if you are referred to a PHP it would be a good idea obtain independent lab tests and two second opinions. Although the PHP will disregard this documentation it would be wise to obtain it to prove both your normality and the discrepancy between your independent evaluation results and the cherry-picked pulled out of a hat multiple diagnoses confabulated and misrepresented by the PHP.

Hughes PH, Brandenburg N, Baldwin DC, Jr., et al. Prevalence of substance use among US physicians. JAMA : the journal of the American Medical Association. May 6 1992;267(17):2333-2339.
Flaherty JA, Richman JA. Substance use and addiction among medical students, residents, and physicians. The Psychiatric clinics of North America. Mar 1993;16(1):189-197.

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Medical school drug testing is a moral and scientific failure
ANONYMOUS | EDUCATION | MAY 11, 2014

Before the 1980s, drug testing was uncommon. It was widely viewed as an invasion of privacy and an infringement on fourth amendment rights. Today, a medical student is likely to be drug tested before entering medical school, before clinical rotations, and/or before residency. If preventing drug use among medical students is the goal of these tests, they have failed miserably. Urinalysis drug tests are ineffective. But more importantly, they are immoral.

Drug tests are ineffective for two reasons. First, they basically just test for marijuana. A 10 panel urinalysis technically tests for 10 different drugs, but marijuana is one of the only drugs that can be detected for more than 30 days. Cocaine can be detected for 4 days. Amphetamine, methamphetamine, ecstasy, heroin, and codeine all can be detected in urine for only 2 days. This means that a user of drugs far more dangerous than marijuana needs to abstain for just a couple of days. Psilocybin mushrooms, as well as several other mind-altering drugs, are not tested for at all.

For a marijuana user, a drug test might seem like a nightmare. But here we arrive at the second reason why drug tests are ineffective, they are easily beaten. A marijuana user may choose to drink a lot of water before his drug test to dilute his urine. Alternatively, he may choose to use a friend’s urine who he knows does not use marijuana. Either one of these options might work. But fortunately for such a marijuana user, there is another option that is essentially risk free, synthetic urine. There are several companies that make synthetic urine capable of beating drug tests. The word on the Internet is that Quick Fix is a safe bet. I personally know some people who would agree. At just $30 for a bottle, it looks like the drug test is no match for the free market.

Do not just take my word for it though. In 2003, the University of Michigan conducted a study on the effectiveness of drug testing students. From nearly 900 schools, the study found that drug testing, whether routine, random, or based on suspicion, had no measurable effect on drug use among students. Put simply, drug testing accomplishes nothing.

The most important concern I have about drug testing medical students is a moral one. Regardless of their effectiveness, or ineffectiveness, the endgame of drug testing is to prevent drug users from becoming doctors. Users, not addicts; and there is a big difference. A marijuana user might use on weekends or at night to relax, much like an alcohol user. A marijuana addict, although rare, is the type of person who might show up to important occasions intoxicated. The statistics on marijuana addiction vary. They usually show that less than 10% of users become addicts, but they always show that alcohol users have higher rates of addiction. A urinalysis detects alcohol for no more than 12 hours after use. This means that medical students who use alcohol are more likely to be addicted, and they face basically no risk of failing a drug test.

Should we be worried about medical students being drunk in clinical settings? Of course. And we should also be worried about medical students being high in clinical settings. Intoxication could be disastrous and it needs to be prevented. The good news is that this is done naturally. It is highly unlikely to find medical students who are addicts of marijuana, alcohol, or any mind-altering drug. I believe it is safe to say that the rigor of medical school itself prevents drug addicts from becoming doctors. There are, however, drug users who will make it into medical school or other rigorous scientific careers. Actually, many of them thrive. Richard Feynman, Kary Mullis, and Francis Crick used marijuana and LSD, Carl Sagan used marijuana, and Oliver Sacks used several illicit drugs. When drug tests are required for every medical student, the casual drug user, no matter how much potential he has, is bullied for no reason. The potentially dangerous drug addict has already been weeded out long ago.

Medical school is supposed to be based on science. The science shows that drug testing does not work. If it did work, then many great scientists would have been removed from their professions. These facts alone should be enough to settle the issue, but it is important to look at two more moral objections we should all have.

First, drug tests are not free. Before entering medical school, I paid about $30 for one. This does not sound like much. But charging students even one penny is unacceptable, for there is not even a fraction of a penny in benefit from these tests. The nearest drug testing facility for me was a 20 minute drive from my house. I could have driven anywhere for 20 minutes and just handed $30 to any random person. Surely, that $30 would bring more value to society than $30 wasted on a drug test. Imagine if a police officer searched a person’s car for drugs against his will, found none, and then charged this person $30. That is the reality of drug testing.

Second, drug tests are an invasion of privacy. Medical students should not be forced to prove their innocence. This creates a guilty until proven innocent environment. It immediately creates resentment among students, and rightfully so. Furthermore, what about people with paruresis? The International Paruresis Association estimates that 7% of people suffer from this condition, also known as shy bladder. Type “paruresis drug test” into a search engine and spend some time reading through the horror stories that are shared. These people suffer from a medical condition, and of all places, their medical school is completely inconsiderate.

Drug testing is a moral and scientific failure. Medical schools should be too embarrassed to take part in such nonsense.

The author is an anonymous medical student who blogs at unchainedmedical.
TAGGED AS: MEDICAL SCHOOL

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice

April 17, 2015April 18, 2015mllangan1 12 Comments

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice.

I can think of nothing more institutionally unjust than an unregulated zero-tolerance monitoring program with no oversight using unregulated drug and alcohol testing of unknown validity. But that is what is occurring. Some of us are trying to expose this corrupt system but barriers exist. As with the Laboratory Developed Tests (LDTs), those involved have intentionally taken steps to remove both answerability and accountability. Both the tests and the body of individuals administering these tests are notable for their lack of transparency, oversight and regulation. This renders them a power unto themselves.

Doctors (and others coerced into Professional Health Programs) across the country have reported going to law enforcement and state agencies only to be turned away. The Federation of State Physician Health Programs (FSPHP) has convinced these outside agencies that this is a “parochial” issue best handled by the medical profession.. Those reporting crimes are turned back over to the very people committing the crimes.

—There is no place in science for consensus or opinion, only evidence.-Claude Bernard

Dear Senator Warren,

Thank you for your reply regarding laboratory developed tests (LDTs) and the need for regulatory oversight. As you mention, LDTs are developed without FDA approval—a pathway in which is not even necessary to prove validity of a test (that it is actually testing what it claims to be testing for) to bring it to market. With no FDA oversight or regulation a commercial lab can claim any validity they want in marketing these tests. The regulation debate has focused on the reliability and validity of a number of clinical tests marketed with unverified claims of accuracy such as prenatal screening and Lyme disease and this lack of oversight is a direct threat to patient safety.

I am sure you would agree with me that the importance of tests diagnostic accuracy is directly proportional to its potential to cause patient harm if reported inaccurately. Sensitivity and specificity are important components of any diagnostic test as there are consequences associated with both false-positive and false negative results.

A test falsely indicating the absence of a condition in someone who truly has it can delay or prevent needed treatment wile a test falsely indicating the presence of a condition in someone who does not truly have it can result in unnecessary testing and treatment.

Incorrect treatment and false labeling of patients can also occur. Therefore diagnostic accuracy is paramount if a test is being used as the basis for further tests and treatment. Any test being used as a basis for further tests or treatment needs to be accurate. It needs to be reliable and valid. Moreover, if the consequences of a test can result in significant patient harm (such as unneeded chemotherapy) it needs to be either 100% accurate or be combined with other tests to confirm the true diagnosis.

“Forensic” vs. “Clinical” Laboratory Testing

“Forensic” testing differs from “clinical” testing because of the consequences and the process is tightly controlled because false-positive results are unacceptable as the consequences can be grave, far-reaching and even permanent.

Forensic testing demands special handling and safeguards to protect the donor such as validated tests, certified labs, strict chain-of-custody procedures and MRO (Medical Review Officer) review. These safeguards of quality control assure the validity and integrity of the specimen. The LDT pathway was not designed for forensic tests.

Forensic Laboratory Developed Tests (LDTs)

Paradoxically, laboratory developed tests with the potential to cause life-changing and possibly irreparable harm have been absent from the regulatory debate; LDT drug and alcohol tests used for “forensic” monitoring purposes.

A panoply of tests using urine, blood, hair, fingernails breath and saliva have been developed and brought to market since 2003 when the first one was introduced by Gregory Skipper, then Medical Director of the Alabama Physicians Health Program, who “convinced the initial lab in the USA, NMS near Philadelphia to start performing EtG testing.” 1

Developed as an LDT, Skipper and NMS then claimed the alcohol biomarker (which was discovered in the 1950s) “appeared to be 100 percent specific” in detecting covert use of alcohol based on a study he coauthored that involved a mere 35 forensic psychiatric inpatients in Germany, all male. 2 With this “evidence-base” and a not yet published paper in the pipeline,3 Skipper then pitched the test to the Federation of State Medical Boards (FSMB) as an accurate and reliable tool detect covert alcohol use in health care professionals.

Policy Entrepreneurship

In “Agendas, Alternatives, and Public Policies,”4 John W. Kingdon describes the problem, policy and political streams involved in public policy making. When these three streams come together a specific problem becomes important on the agenda, policies matching the problem get attention, and then policy change becomes possible.

Kingdon also describes “policy entrepreneurs’ who use their knowledge of the process to further their own policy ends. They ‘lie in wait… with their solutions at hand, waiting for problems to float by to which they can attach their solutions, waiting for a development in the political stream they can use to their advantage.”4

And due to a perfect confluence of streams ( Institute of Medicine report that 44,000 people die each year due to medical error,5 media reports of “impaired physicians,” the the war-on-drugs, etc.) the FSMB was swayed into accepting not just the validity but the necessity of using an alcohol biomarker of unknown reliability and validity on doctors referred to or monitored by state Physician Health Programs (PHPs) .

As the national organization that gives guidance to state medical boards through public policy development and recommendations, the individual state medical boards adopted use of the test without critical appraisal and no meaningful opposition.

Shortly after its founding in 1912, the FSMB began publishing a journal called the Quarterly of the Federation of State Boards of the United States. Now known as the Journal of Medical Regulation, the publication has archived all issues with full articles dating back to 1967 and, as the official journal of the national organization involved in medical licensing and regulation this facilitates an unskewed and impartial examination of how and when specific issues and problems were presented and who presented them and, in doing so, the “policy entrepreneurship” Kingdon describes can be seen quite clearly. For example a 1995 issue containing articles written by the program directors of PHPs in 8 different states contains an FSMB editorial acknowledging the reported 90% success rate claimed of these programs (in part attributed to the 90-day inpatient treatment programs) that concludes:

“Cooperation and communication between the medical boards and the physician health programs must occur in an effort to protect the public while assisting impaired physicians in their recovery.” 6

No one bothered to examine the methodology of these reports to discern the validity of the claims and it is this acceptance of faith without objective assessment that has allowed the passage of flawed public policy in medical regulation.

Nowhere is “policy entrepreneurship” more glaringly displayed as it is in a 2004 issue promoting the use of EtG in monitoring doctors as under the same cover is an article identifying both the need7 for such a test and an article providing the solution.8

“Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs,” a survey of state Physician Health Programs (PHPs) concludes that “surreptitious alcohol use” is a significant concern” for PHPs, there is no current “best method” for detection, but a promising new test with “exceptional specificity (100 percent) and sensitivity” in detecting small amounts of alcohol for up to 18 hours has recently become available.7

This same issue contains an article authored by Skipper about a new marker “not detectable unless alcohol has been consumed” recently introduced in the United States and now commercially available.”8

Notably absent from both of these articles is Skipper’s role in the commercial availability of the test. This conflict-of-interest is nowhere mentioned in this display of “creating a market then filling it.”

This “regulatory sanctification” of the test implied its tacit approval by the medical profession (i.e. “if they are using it on doctors it must be valid”) and facilitated its marketing to other monitoring agencies (nurses, airline pilots) as well as Courts and Probation Departments where those doing the monitoring had absolute power while those being monitored had no voice.

Bent Science

In Bending Science: How Special Interests Corrupt Public Health Research9, Thomas McGarity and Wendy Wagner describe how special interest groups scheme to advance their own economic or ideological goals by using carefully crafted distorted or “bent” science to influence legal, regulatory and public health policy. The authors describe how those making these decisions often assume the information that reaches them has been sufficiently vetted by the scientific community as it flows through a pipeline of rigorous peer-review and professional oversight and that the final product that exits the pipeline is unbiased and produced in accordance with the norms and procedures of science.

McGarity and Wagner note the serious and sometimes horrific consequences of bent science and provide examples involving Tobacco and Big Pharma . The authors call for:

“..immediate action to reduce the role that bent science plays in regulatory and judicial decision making” and the need for the scientific community to be involved in “designing and implementing reform.”

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

In the case of EtG this shedding of light is not very hard as no “carefully crafted” studies bending science were used to sway opinion. None existed. The only items in the pipeline were directly related to Skipper. If anyone dare to look, the Emperor has no clothes.

Lack of Answerability and Accountability

There are difficulties in challenging bent science including a general lack of recognition of the problem and an absence of counter-studies to oppose deliberately manufactured ends-oriented research. This has proven true with the myriad LDTs introduced into the marketplace as no counter-forces or competing economic interests producing counter-studies exist.

Multiple lawsuits, including a class-action, have been decided in favor of the labs who have taken a stand-your-ground approach supported by a body of industry-related “research” they or their affiliates produced to support the validity and reliability of the tests.

Those affected by these tests either have no power or have had their power removed. Most do not have the resources to mount a defense let alone produce counter-studies questioning the reliability and validity of the tests.

Most employee drug testing follows Department of Health and Human Services (DHHS) guidelines using FDA-approved tests that have specific cutoff levels defining a positive-result in an effort to eliminate false-positive results.10 Procedural safeguards are in place in these programs to protect the donor. Forensic testing programs using LDTs provide no such safeguards as the testing is unregulated and there is no oversight from outside actors.

Unlike clinical LDTs “forensic” LDTs are even exempt from CLIA oversight. The only avenue for complaint is through the College of American Pathologists (CAP) and, as an accrediting agency, they can only address problems by ensuring compliance with CAP guidelines. If an investigation concludes lab error or misconduct CAP can mandate the lab correct the test result and come into compliance with their guidelines under threat of loss of accreditation but no other consequences exist. Accountability has been removed yet the consequences to those harmed by these are significant and without remedy.

State Physician Health Programs

As is the case with the LDTs they introduced, Physician Health Programs have no oversight or regulation. A 2013 Audit of the North Carolina PHP 11 prompted by complaints from doctors and performed by State Auditor Beth Woods found absolutely no oversight of the program by either the state medical board or medical society and that “abuse could occur without being detected.”

The Audit also found that doctors were predominantly referred to the same “PHP-approved” out-of-state facilities to which they in part attribute their high success rates in treatment. Interestingly the PHP could not identify what quality indicators or quantitative measurements were used by the PHP to “approve” the “PHP-approved” facilities.

In January of 2015 a Federal class action lawsuit was filed in the Eastern District of Michigan against the state PHP program and found health care providers were subject to the same referral system using these out-of-state facilities. The suit alleges constitutional violations related to the forced medical treatment of health care professionals and the “callous and reckless termination of professional licenses without due process.” 12

As with North Carolina, the Michigan PHP will be unable to provide what quality indicators and quantitative measurements are being used to “qualify” and “approve these facilities. None exist. The sole indicators for approving these assessment centers are ideological and economic. In fact, the medical directors of most, if not all, of these facilities can be seen on this list of “like-minded docs.”

Institutional Injustice

You once said “People feel like the system is rigged against them. And here’s the painful part: they’re right. The system is rigged.”

So too is this system.

As the Michigan lawsuit notes: “Unfortunately, a once well-meaning program has turned into a highly punitive and involuntary program where health professionals are forced into extensive and unnecessary substance abuse/dependence treatment under the threat of the arbitrary application of pre-hearing deprivations.”

This has become the rule not the exception. The Federation of State Physician Health Programs (FSPHP), the same group to which Dr. Skipper belongs, has systematically taken over these programs state by state by removing competent and caring doctors not agreeing with the groupthink and silenced them under threat of litigation if they violate their confidentiality agreements and “peer review” statutes.

The same system of coercion, control and abuse exists in Massachusetts. In the past week alone I have heard from a medical student, a resident and two doctors who complained of misconduct misconduct involving fraudulent testing and falsified diagnoses.

In “Ethical and Managerial Considerations Regarding State Physician Health Programs,” published in the Journal of Addiction Medicine in 2012, Drs. John Knight, M.D. and J. Wesley Boyd, M.D., PhD who collectively have more than 20 years experience with the Massachusetts Physician Health Program (PHP) state that:

“Because PHP practices are unknown to most physicians before becoming a client of the PHP, many PHPs operate out- side the scrutiny of the medical community at large. Physicians referred to PHPs are often compromised to some degree, have very little power, and are, therefore, not in a position to voice what might be legitimate objections to a PHP’s practices.”13

Noting that “for most physicians, participation in a PHP evaluation is coercive, and once a PHP recommends monitoring, physicians have little choice but to cooperate with any and all recommendations if they wish to continue practicing medicine,” Knight and Boyd raise serious ethical and managerial questions about current PHP policies and practice including conflicts of interest in referrals for evaluation and treatment, lack of adherence to standards of care for forensic testing of substances of abuse, violations of ethical guidelines in PHP research, and conflicts of interest with state licensing boards.

Knight and Boyd recommend “the broader medical community begin to reassess PHP’s as a whole” and that “consideration be given toward the implementation of independent ethical oversight and establish and appeals process for PHP clients who feel they are being treated unfairly.” 13

They recommend the relationship between PHP’s and the evaluation and treatment centers and licensing boards be transparent and that national standards be developed “that can be debated by all physicians, not just those who work within PHPs.”13

Accountability, or answerability, is necessary to prevent corruption. This requires both the provision of information and justification for actions. What was done and why? Accountability also requires that consequences be imposed on those who engage in misconduct.

In discussing the financial conflicts-of-interest between PHPs and “PHP-approved” assessment centers Knight and Boyd state:

“..if a PHP highlights a physician as particularly problematic, the evaluation center might–whether consciously or otherwise–tailor its diagnosis and recommendations in a way that will support the PHP’s impression of that physician.”

To “consciously tailor a diagnosis” is fraud. It is political abuse of psychiatry. And it is not only the assessment and treatment centers willing to “tailor” a diagnosis; so too are the labs involved.

Physician Suicide

The Massachusetts Medical Society and Massachusetts DPH claim no oversight of the Massachusetts PHP, PHS.inc. The Massachusetts Board of Registration in Medicine (BORM) will not address ethical or even criminal complaints about the doctors involved in the PHP and there is good evidence that some members of the BORM are in fact complicit in unethical and even criminal behavior. As the Massachusetts AGO represents the BORM they defer issues back to them and dig no deeper.

Drs. Knight and Boyd have suggested State Audits and we are hoping that MA State Auditor Suzanne Bump will investigate the MA PHP and the Board of Registration in Medicine’s Physician Health and Compliance Unit shortly.

One major problem is that barriers have been put in place to prevent information from getting to the right people.

The majority of people at medical societies, boards, departments of public health and other organizations are individuals of integrity and honesty but the system has been erected so that valid complaints are deflected, delayed, dismissed or otherwise tabled by sympathizers, apologists and those complicity. The criminal activity the Massachusetts PHP is engaging in is undeniable and indefensible but who is going to hold them to account?

It is going to take a while to reform this system of institutional abuse and it has to be done state by state. Please take a look at the facts and documentary evidence and help me hold them accountable. This needs to be exposed, acknowledged and addressed. Doctors are dying from this system of institutional abuse. It is a public health emergency no one is talking about. Yet those behind the PHP programs are claiming this system of coercion, abuse and control is the “gold standard” of addiction treatment and, using another loophole, they want to expand this system to mainstream healthcare.

Sincerely,

Michael L. Langan, M.D.

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.
Wurst FM, Vogel R, Jachau K, et al. Ethyl glucuronide discloses recent covert alcohol use not detected by standard testing in forensic psychiatric inpatients. Alcoholism, clinical and experimental research. Mar 2003;27(3):471-476.
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.
Kingdon JW. Agendas, alternatives, and public policies. Updated 2nd ed. Boston: Longman; 2011.
Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA : the journal of the American Medical Association. Jul 5 2000;284(1):95-97.
Schneidman B. The Philosophy of Rehabilitation for Impaired Physicians. The Federal Bulletin: The Journal of Medical Licensure and Discipline. 1995;82(3):125-127.
Jansen M, Bell LB, Sucher MA, Stoehr JD. Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs. Journal of Medical Licensure and Discipline. 2004;90(2):8-13
Skipper G, Weinmann W, Wurst F. Ethylglucuronide (EtG): A New Marker to Detect Alcohol Use in Recovering Physicians. Journal of Medical Licensure and Discipline. 2004;90(2):14-17.
McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
US Department of Health and Human Services. Mandatory guidelines and proposed revisions to mandatory guidelines for federal workplace drug testing programs: notices.Federal Register. April 13, 2004;69(71):19659-19660.
Wood B. State of North Carolina Performance Audit North Carolina Physicians Health Program. . http://www.ncauditor.net/EPSWeb/Reports/Performance/PER-2013-8141.pdf. Accessed March 17, 2015.
U.S. District Court Eastern District of Michigan, Case No: 2:15-cv-10337-AJT-RSW (2015). Carole Lucas, R.N., Tara Vialpandno, R.N., Scott Sanders, R.N., Kelly Schultz, P.A., and all other similarly situated health professionals v. Michigan Department of Licensing and Regulatory Affairs, Carole Engel, J.D.Former Director of Michigan Bureau of Health Professions, Ulliance, Inc. (State Contractor), Carolyn Batchelor (HPRP Contract Administrator), Stephen Batchelor (HPRP Contract Administrator), and Nikki Jones, LMSW. Filed January 30, 2015.
Boyd JW, Knight JR. Ethical and managerial considerations regarding state physician health programs. Journal of addiction medicine. Dec 2012;6(4):243-246.

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Institutional Justice and Quality Disparity in Drug and Alcohol Monitoring–The Contrast Between MBTA Operators and Massachusetts Doctors is Shocking

April 10, 2015April 10, 2015mllangan1 3 Comments

Safety-Sensitive Occupations

Safety-sensitive jobs are those in which impaired performance, for whatever reason, could result in a significant incident affecting the health or safety of others. Doctors and bus drivers are both safety-sensitive occupations. Impaired doctors can harm patients and impaired bus drivers can harm passengers and others on the road.

The MBTA or “T” operates commuter railways, buses, rapid transit trains, and trackless trolleys. It operates every day of the year and provides ridership to about 700.000 people per day. With the safety of the riding public and the MBTA’s own employees a concern, the MBTA Medical Clinic exists to promote and monitor the fitness of its employees in “safety-sensitive” positions such as bus drivers and train conductors.

Physician Health Services, inc. is a non-profit corporation founded by the Massachusetts Medical Society that provides confidential consultation and support to physicians, residents, and medical students. PHS provides monitoring contracts for referred doctors.

Drug-Testing and Employee Assistance Programs

After Ronald Reagan signed Executive Order 12564, the Drug Free Federal workplace Act in 1986 implementing drug testing in safety sensitive Federal Employees, other private sector companies soon became interested in implementing their own workplace drug testing. As these programs developed, EAPs began to oversee testing at the workplace and also determine protocol for what treatment was needed for employees who developed problems with substance abuse and what requirements were needed for return to work.

Employee Assistance Programs address impairment issues by overseeing drug and alcohol monitoring which may be random, post-accident or for suspected impairment. If an employee has a positive toxicology screen or is self-referred or referred by others to the EAP it is their responsibility to meet with and refer for outside treatment and recommendations. The EAP also determines the requirements for returning to work and monitors compliance with treatment recommendations, work performance and other reports, meeting with, referring for outside assessments, and monitoring compliance. If the referral is related to alcohol or drugs then the EAP oversees the process.

Physician Health Programs are essentially EAPs for doctors and have the same responsibilities to monitor compliance with recommendations and test for substances of abuse.

Doctors and bus drivers are in safety sensitive positions in which impairment can compromise safety. Which is more safety-sensitive? I would say those operating vehicles carrying passengers as they are unsupervised and in a safety-sensitive state (in a moving vehicle) for long periods of time in which they must remain vigilant. Doctors, for the most part are usually interacting with patients, colleagues and nurses and therefore observable for signs of impairment. With the exception of those doing procedures and surgeons during an operation the amount of time spent in a safety-sensitive state is intermittent.

The drug and alcohol impairment testing for bus drivers and doctors is not the same, however.

MBTA Medical Clinic

In 1996 as a medical fellow I took a part time job moonlighting at the MBTA Medical Clinic. The job required seeing MBTA employees in “safety-sensitive” positions for occupational medicine matters such as annual physical exams, return to work check-ups, and post-accident evaluations.

The MBTA had implemented random drug testing (combined with explicit disciplinary consequences in the event of a positive test) in 1991 to deter use of illicit drugs by safety-sensitive employees and thereby reduce the probability of accidents. Dr. Amnon Wachman served as the MBTA’s “Medical Review Officer” (MRO), something I knew very little about. On my first day he gave me a copy of the MBTAs Policy and Procedure Manual on drug testing as well as a copy of the “MRO Handbook” and requested that I read both thoroughly.

MBTA policy mandates all drug testing be done by a laboratory certified by the National Institute on Drug Abuse and the strict procedure and protocol involved. I learned that the initial screening assay tests were based on the ability of antibodies to recognize drugs in biological fluids. If the test is positive, then a confirmatory test is done using Gas Chromatography/Mass Spectrometry (“GC/MS”). because it is the most accurate and reliable test technique available. The designated laboratory must have procedures to ensure that the chain of custody of specimens is secure and well- documented and that the process controls are thorough and reliable.

The “MRO Review Manual” discusses the Medical Review Officers responsibilities in reviewing the results of drug tests from the laboratory, verifying the documentation in laboratory reports, and the necessity that each and every step of the drug-testing process must be recorded completely and accurately. “If it is not,” he said, “then it is as if the test was never even done.”

In the event of a positive report, Dr. Wachman would bring the employee in to the clinic and review their medications, medical history and try to obtain any other information that could interfere with testing. During the interview, the employee was afforded the opportunity to discuss the test results and to offer any additional or clarifying information that could explain the positive result. If there were none then the test was deemed a “true” positive Some tests were explained through prescribed medications and occasionally a positive test would be invalidated based on the interview–one such case I remember vividly was that of an Subway operator one month from retirement who tested positive for PCP (phencyclidine)—we both concurred that it was an obvious mistake after a lengthy interview with him.

Dr. Wachman and his successor, Dr. Mathew Weintraub, M.D. understood the important role an MRO plays in testing for drugs of abuse. professionally, procedurally and ethically they represent the highest standards. Each and every person who tested positive was treated with courtesy, respect and understanding in reviewing the findings and discussing what needed to be done next. Keeping up to date on the relevant literature, Conscientious and thorough review of all the data was standard operating procedure. So too was strict adherence to the Federal Workplace Drug Testing Guidelines and the reasons or this were understood. Concepts of Cutoff-levels, chain-of-custody, the accreditation of testing labs were understood, respected and strictly followed. Understanding that the consequences of positive tests can be grave and far reaching the duties of the MRO were performed conscientiously and carefully.

Federal Workplace drug testing is fair, evidence-based, and provides accountability that protects both those doing the testing and those being tested

Federal agencies conducting drug testing must follow standardized procedures established by the Substance Abuse and Mental Health Services Administration (SAMHSA), part of the U.S. Department of Health and Human Services. These Mandatory Guidelines for Federal Workplace Drug Testing include, among other safeguards, the use of certified laboratories and FDA approved tests, chain-of-custody procedures and utilization of a Medical Review Officer (MRO) review of all tests prior to reporting them. The United States Department of Transportation (DOT) regulated employees (truck-drivers, subway operators, ship captains, locomotive engineers, bus drivers, etc) drug and alcohol testing program follows strict procedure and protocol.

The Office of Drug and Alcohol Policy and Compliance publishes regulations on drug and alcohol testing, how to conduct tests, and the evaluation and treatment procedures “necessary for returning employees to duty after testing violations.” The Division of Workplace Programs (DWP) provides oversight of the Federal Drug-Free Workplace Programs. The National Laboratory Certification Program certifies laboratories to conduct forensic drug testing for the federal agencies and some federally regulated industries. ,It is for these reasons that Federal drug and alcohol testing programs promote transparency, oversight and accountability as represented in the overview of DOT Drug Testing below:

Physician Health Program Drug and Alcohol Testing

“When a critical event occurs in most high-risk industries (such as airlines, nuclear power or railways)” a 2013 article published in JAMA proposing drug testing of doctors begins, a “detailed investigation” examines both systemic and individual factors “that caused or contributed to the event. Directly involved individuals are commonly tested for alcohol and other drugs.” Sounds like a reasonable proposal. If other “safety-sensitive” occupations use drug and alcohol testing to help determine what caused a critical event why shouldn’t doctors? I’ll tell you why!

The article was co-authored by Dr. Gregory Skipper who introduced the EtG and other questionable laboratory tests into the forensic marketplace via the non-FDA approved laboratory developed test (LDT) loophole. He again declares no conflicts-of-interest. His reference to the nuclear power, airline and railway industry is erroneous as these three agencies follow strict Federal Workplace Drug Testing Guidelines, and use only certified labs and FDA approved tests. Given Skippers history it is inevitable that any monitoring system will include LDTs.

Unlike Federal Workplace Drug testing which follows strict guideline and regulations administered sequentially from collection to analysis to protect the donor, PHP drug and alcohol testing does not provide these safeguards. PHPs have put barriers in place to block the procedural protection and rights of the donor.. They have removed both answerability and justification for actions. They have effectively blocked the timely provision of information but even if information was provided documenting mistakes, errors or even misconduct no outside agencies exist to confirm it let alone hold them accountable.

Part of this lack of accountability is due to the tests they are using for substances of abuse. While SASMHSA/DOT require the use of certified labs and FDA approved tests, PHPs use commercial for profit labs and non-FDA approved Laboratory developed tests (LDTs) of unknown validity. In addition many conflicts of interest exist as Greg Skipper and Robert Dupont introduced a lot of these tests and did “research” on unknowing PHP participants. Testing for LDTs in a zero-tolerance abstinence based program is like playing Russian Roulette without the gun.

Overview of PHP drug and alcohol testing

Bypassing the FDA approval process, the LDT pathway was designed to improve patient care and improve public health. It was not designed for “forensic” tests. Nevertheless, since 2004 a panoply of “forensic” LDTs have been introduced into the marketplace by doctors associated with the American Society of Addiction Medicine (ASAM) and the Federation of State Physician Health Programs (FSPHP). As discussed here and here, the implementation of laboratory developed tests (LDTs) for substances of abuse is a loophole that removes accountability of the testing agency and testing labs to outside actors. Moreover, to introduce an LDT to the marketplace it is not even necessary to prove the test is actually testing what it is purporting to be testing for (validity).

Moreover, PHPs have removed answerability. While SAMHSA’/DOT testing promotes timely and transparent provision of information and provides accountability, PHPs have put barriers in place to prevent and delay the provision of laboratory records. PHPs have additionally used tactics to discourage and dissuade those being tested from doing so.

SAMHSA/DOT drug and alcohol testing guarantees the donor certain rights such as chain-of-custody and MRO review. Some even give the right to challenge a positive test by using a split sample in the collection process. If the test is questioned by the donor it can be retested at an independent lab. What rights do those being monitored by PHPs have? Essentially none. Someone being monitored by a PHP who gets a positive test and questions the validity of it has essentially two choices as seen below—they can either 1. Do nothing and do everything the PHP tells them to do (which includes an out-of-stater evaluation at an out of state “PHP-approved” assessment center, or 2. Demand provision of the information and risk losing professional licensure by being reported as noncompliant to the regulatory agency.

Most take the former route believing they will get a fair and balanced assessment. Drug and alcohol tests that are the result of legitimately prescribed medications are being reported as positive.

Levels of substances well below the cutoff level for positivity are being reported as positive. A classic example of this is Morphine and Codeine which can be the result of poppy seed ingestion. Poppy seeds do contain small amounts of opium, and eating foods with poppy seeds may cause a sample to screen positive for opiates at the 300 ng/mL cutoff level. This post-marketing surveillance resulted in a revision of the cutoff level from 300 ng/ml to 2000 ng/ml to eliminate the possibility of false positive results from poppy seeds. In this case the cutoff level was adjusted as the result of new research and evidence. The PHPs apparently did not get the memo on this revision as the standard operating procedure is to report any level as positive. One physician I know was reported to the medical board for a morphine level of 150 ng/ml (half the level of the prior cutoff before the revision in the year 2000. Unfortunately many of the doctors involved n running PHP programs see the world as rife with false-dichotomies and this includes drug testing. I have heard many times “it’s either their or it’s not” in justifying reporting a test on someone as positive. As these individuals are holding the lives and livelihoods of those being monitored in their hands urgent reform is necessary. Someone who does not understand the concept of cutoff levels and how and why they are established should not be making decisions about drug-testing.

Forensic testing utilizing LDTs is antithetical to Federal workplace guidelines. Forensic testing demands tightening and strengthening procedural protocol and accountability not loosening and erasing it. The LDT pathway bypasses the FDA approval process and circumvents regulation and oversight by the FDA as well as other agencies. There is, in fact, no outside regulation of either those administering or performing these tests.

In Backfire Step 1: Expose the Injustice–Forensic Fraud being committed by PHPs in Collusion with Corrupt Labs, I used documentary evidence from my own case to show how the PHPs and labs are engaging in undeniable and indefensible forensic fraud. The documents speak for themselves and it does not take a toxicologist or Medical Review Officer to understand that “Updating” a “chain-of-custody”and adding a new ID # to an already positive test breaches all procedural and professional guidelines, medical and societal ethics and state and federal law. It exemplifies how PHPs are blocking the “provision of information” required by most substance of abuse testing programs. Whereas most substance of abuse testing guidelines require not only answerability but “timely” answerability, PHPs use tactics that block and delay such information. These tactics include both refusing to provide the information and dissuading those monitored from requesting it.

In my case it took 5 months to obtain the “litigation packet” (a documentary record generated on any and all “forensic” drug and alcohol testing that records the “chain-of-custody” from initial collection to final analysis. The litigation packet I received in December of 2011 from a test collected by Quest Diagnostics can be seen here: USDTL Litigation Packet.

If you take a look at it you will see that no documentation exists regarding the specimen from when it was collected July 1st, 2011 to when it was reported as positive on July 19th, 2011 by Dr. Luis Sanchez, Medical Director of the Massachusetts PHP, Physician Health services, inc. (PHS). There is, in fact, absolutely no external chain of custody documenting the collection, handling and transport of the specimen. This in itself, according to each and every guideline ever published in the history of forensic testing invalidates the test.

But more importantly, the litigation packet revealed evidence that the reported positive test was not the result of oversight or accident but deliberate and intentional–forensic fraud by fax. Although this laboratory misconduct and fraud is undeniable and indefensible PHPs have no oversight or regulation. Neither do the labs.

Most individuals being tested for substances of abuse by employee assistance programs have a union or some other organization protecting their best interests. In the case of a suspected fraudulent or mishandled test these groups facilitate accountability by helping to obtain the information and requesting justification of actions. No such agencies exist for those being monitored by PHPs. No avenue of complaint against PHPs exist. In addition to no FDA oversight, “forensic” LDTs (unlike clinical LDTs) are exempt from Clinical Laboratory Improvement Amendments of 1988 (CLIA). The only avenue of complaint against a lab utilizing forensic LDTs is through the College of American Pathologists (CAP). As an accreditation agency, however, they are limited in what they can do as a result of an investigation. Whether the complaint involves accidental lab error or intentional fraud the only action CAP can take at the conclusion of an investigation is to threaten the lab with loss of accreditation if the lab does not come into compliance with their “Forensic Drug Testing Checklist.” They can also force the lab to “correct” these tests under threat of loss of accreditation. This is what CAP did in my case which brings us to Backfire Step 3: Reframe: emphasize the injustice, counter reinterpretation.

Drug testing that follows mandated guidelines provides procedural safeguards that protect the donor. .Accountability demands both the provision of information (answerability) and justification for ones actions. both those administering the tests and those performing the tests are held accountable by outside agencies. The system is transparent and when the validity or integrity of a test is questioned the employer and lab must provide the records and documentation.

Why are doctors allowing PHPs to use drug and alcohol testing of unknown validity? We require evidence-base and adherence to professional protocol and ethical guidelines in every other arena but this one. Using the fallacious appeal to authority, however, the impaired physicians movement doctors (FSPHP) convinced regulatory boards that these tests were valid, reliable and necessary. In fact the sensitivity and specificity is unknown so the false-positive rate is unknown. In addition, with no regulation or oversight, positive tests can be the result of deliberate misconduct and, with no agency to sanction those engaging in the misconduct, it can continue unchecked.

It is time we demand better care for our fellow doctors. It is time we debunk the mythology surrounding the required length of stay in rehabilitation facilities that is three-times longer than anyone else. There is nothing unique about being a doctor that warrants this. No evidence base exists. PHPs need to be reformed and rebuilt as programs of institutional justice. The current state of affairs is one of coercion, control and abuse.

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice

March 31, 2015April 1, 2015mllangan1 6 Comments

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice.

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

March 23, 2015April 7, 2015mllangan1 11 Comments

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.

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.

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 .

Backfire Basics: http://www.bmartin.cc/pubs/bf/bfbasics.pdf
More materials on Backfire: http://www.bmartin.cc/pubs/backfire.html

EtG–The Rosie Ruiz of Bent Science and Bad Medicine

March 20, 2015March 20, 2015mllangan1 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 PM On 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.”

They 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”

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, mouthwash^18,19, 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

Sauerkraut 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.

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:

EtG measurements increase with alcohol ingestion.
The window of detection is shorter than what is commonly proposed (80 hours).
Individual values are variable both within and between subjects.
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.

Kamil A, Smith JN, Williams RT. A New Aspect of Ethanol Metabolism: Isolation of ethylglucuronide. Biochemical Journal. 1952;51:32-33.
Kamil IA, Smith JN, Williams RT. Studies in detoxication. L. The isolation of methyl and ethyl glucuronides from the urine of rabbits receiving methanol and ethanol. The Biochemical journal. Jun 1953;54(3):390-392.
Schmitt G, Aderjan R, Keller T, Wu M. Ethyl glucuronide: an unusual ethanol metabolite in humans. Synthesis, analytical data, and determination in serum and urine. Journal of analytical toxicology. Mar-Apr 1995;19(2):91-94.
Schmitt G, Droenner P, Skopp G, Aderjan R. Ethyl glucuronide concentration in serum of human volunteers, teetotalers, and suspected drinking drivers. Journal of forensic sciences. Nov 1997;42(6):1099-1102.
Aderjan RE. Ethyl glucuronide. A non-volatile ethanol metabolite in hair. 1995.
Wurst FM, Seidl S, Alt A, Metzger J. [Direct ethanol metabolite ethyl glucuronide. Its value as alcohol intake and recurrence marker, methods of detection and prospects]. Psychiatrische Praxis. Nov 2000;27(8):367-371.
Wurst FM, Seidl S, Ladewig D, Muller-Spahn F, Alt A. Ethyl glucuronide: on the time course of excretion in urine during detoxification. Addiction biology. Oct 2002;7(4):427-434.
Martin DM, G.E. S, Costantino A. Alcohol Use Can Now be Detected for Days Rather than Hours Using a New Test, Ethyl Glucuronide. 2003; http://www3.firstlab.com/media/16032/EtGFirstLabReport.pdf.
Skipper G. “Urine Luck” Overview of New Drug Testing Technologies and Conundrums. http://gregskippermd.weebly.com/uploads/7/4/7/5/74751/skipper.urine_luck_2014_aaap_meeting.pdf. Accessed March 17, 2015.

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.
Jansen M, Bell LB, Sucher MA, Stoehr JD. Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs. Journal of Medical Licensure and Discipline. 2004;90(2):8-13

Skipper G, Weinmann W, Wurst F. Ethylglucuronide (EtG): A New Marker to Detect Alcohol Use in Recovering Physicians. Journal of Medical Licensure and Discipline. 2004;90(2):14-17.
McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
US Department of Health and Human Services. Mandatory guidelines and proposed revisions to mandatory guidelines for federal workplace drug testing programs: notices. Federal Register. April 13, 2004;69(71):19659-19660.
Clark HW. The role of physicians as medical review officers in workplace drug testing programs. In pursuit of the last nanogram. West J Med. May 1990;152(5):514-524.
Resnick RB, Volavka J, Freedman AM, Thomas M. Studies of EN-1639A (naltrexone): a new narcotic antagonist. Am J Psychiatry. Jun 1974;131(6):646-650.
Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science. JAMA : the journal of the American Medical Association. Jan 5 2015.
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.
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.
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.
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.
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.
Jatlow P, O’Malley SS. Clinical (nonforensic) application of ethyl glucuronide measurement: are we ready? Alcohol Clin Exp Res. Jun 2010;34(6):968-975.
Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
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.
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.
Thierauf A, Wohlfarth A, Auwarter V, Perdekamp MG, Wurst FM, Weinmann W. Urine tested positive for ethyl glucuronide and ethyl sulfate after the consumption of yeast and sugar. Forensic Sci Int. Oct 10 2010;202(1-3):e45-47.
Helander A, Olsson I, Dahl H. Postcollection synthesis of ethyl glucuronide by bacteria in urine may cause false identification of alcohol consumption. Clinical chemistry. Oct 2007;53(10):1855-1857.
Helander A, Hagelberg CA, Beck O, Petrini B. Unreliable alcohol testing in a shipping safety programme. Forensic science international. Aug 10 2009;189(1-3):e45-47.
Sarkola T, Dahl H, Eriksson CJ, Helander A. Urinary ethyl glucuronide and 5-hydroxytryptophol levels during repeated ethanol ingestion in healthy human subjects. Alcohol and alcoholism. Jul-Aug 2003;38(4):347-351.
Hoiseth G, Bernard JP, Stephanson N, et al. Comparison between the urinary alcohol markers EtG, EtS, and GTOL/5-HIAA in a controlled drinking experiment. Alcohol and alcoholism. Mar-Apr 2008;43(2):187-191.
Wojcik MH, Hawthorne JS. Sensitivity of commercial ethyl glucuronide (ETG) testing in screening for alcohol abstinence. Alcohol and alcoholism. Jul-Aug 2007;42(4):317-320.

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An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice

March 17, 2015December 5, 2016mllangan1 10 Comments

—There is no place in science for consensus or opinion, only evidence.-Claude Bernard

Dear Senator Warren,

I am sure you would agree with me that the importance of tests diagnostic accuracy is directly proportional to that tests potential to cause patient harm if reported inaccurately.

Sensitivity and specificity are important components of any diagnostic test because there are consequences associated with both false-positive and false negative results.

“Forensic” vs. “Clinical” Laboratory Testing

Forensic Laboratory Developed Tests (LDTs)

Developed as an LDT, Skipper and NMS then claimed the alcohol biomarker (which was discovered in the 1950s) “appeared to be 100 percent specific” in detecting covert use of alcohol based on a study he coauthored that involved a mere 35 forensic psychiatric inpatients in Germany, all male. ² With this “evidence-base” and a not yet published paper in the pipeline,³ Skipper then pitched the test to the Federation of State Medical Boards (FSMB) as an accurate and reliable tool detect covert alcohol use in health care professionals.

Policy Entrepreneurship

In “Agendas, Alternatives, and Public Policies,”⁴ John W. Kingdon describes the problem, policy and political streams involved in public policy making. When these three streams come together a specific problem becomes important on the agenda, policies matching the problem get attention, and then policy change becomes possible.

And due to a perfect confluence of streams ( Institute of Medicine report that 44,000 people die each year due to medical error,⁵ media reports of “impaired physicians,” the the war-on-drugs, etc.) the FSMB was swayed into accepting not just the validity but the necessity of using an alcohol biomarker of unknown reliability and validity on doctors referred to or monitored by state Physician Health Programs (PHPs) .

“Cooperation and communication between the medical boards and the physician health programs must occur in an effort to protect the public while assisting impaired physicians in their recovery.” ⁶

Nowhere is “policy entrepreneurship” more glaringly displayed as it is in a 2004 issue promoting the use of EtG in monitoring doctors as under the same cover is an article identifying both the need⁷ for such a test and an article providing the solution.⁸

Bent Science

In Bending Science: How Special Interests Corrupt Public Health Research⁹, Thomas McGarity and Wendy Wagner describe how special interest groups scheme to advance their own economic or ideological goals by using carefully crafted distorted or “bent” science to influence legal, regulatory and public health policy. The authors describe how those making these decisions often assume the information that reaches them has been sufficiently vetted by the scientific community as it flows through a pipeline of rigorous peer-review and professional oversight and that the final product that exits the pipeline is unbiased and produced in accordance with the norms and procedures of science.

McGarity and Wagner note the serious and sometimes horrific consequences of bent science and provide examples involving Tobacco and Big Pharma . The authors call for:

Lack of Answerability and Accountability

Most employee drug testing follows Department of Health and Human Services (DHHS) guidelines using FDA-approved tests that have specific cutoff levels defining a positive-result in an effort to eliminate false-positive results.¹⁰ Procedural safeguards are in place in these programs to protect the donor. Forensic testing programs using LDTs provide no such safeguards as the testing is unregulated and there is no oversight from outside actors.

State Physician Health Programs

As is the case with the LDTs they introduced, Physician Health Programs have no oversight or regulation. A 2013 Audit of the North Carolina PHP ¹¹ prompted by complaints from doctors and performed by State Auditor Beth Woods found absolutely no oversight of the program by either the state medical board or medical society and that “abuse could occur without being detected.”

Institutional Injustice

You once said “People feel like the system is rigged against them. And here’s the painful part: they’re right. The system is rigged.”

So too is this system.

In discussing the financial conflicts-of-interest between PHPs and “PHP-approved” assessment centers Knight and Boyd state:

Physician Suicide

One major problem is that barriers have been put in place to prevent information from getting to the right people.

Sincerely,

Michael L. Langan, M.D.

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.
Wurst FM, Vogel R, Jachau K, et al. Ethyl glucuronide discloses recent covert alcohol use not detected by standard testing in forensic psychiatric inpatients. Alcoholism, clinical and experimental research. Mar 2003;27(3):471-476.
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.
Kingdon JW. Agendas, alternatives, and public policies. Updated 2nd ed. Boston: Longman; 2011.
Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA : the journal of the American Medical Association. Jul 5 2000;284(1):95-97.
Schneidman B. The Philosophy of Rehabilitation for Impaired Physicians. The Federal Bulletin: The Journal of Medical Licensure and Discipline. 1995;82(3):125-127.
Jansen M, Bell LB, Sucher MA, Stoehr JD. Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs. Journal of Medical Licensure and Discipline. 2004;90(2):8-13
Skipper G, Weinmann W, Wurst F. Ethylglucuronide (EtG): A New Marker to Detect Alcohol Use in Recovering Physicians. Journal of Medical Licensure and Discipline. 2004;90(2):14-17.
McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
US Department of Health and Human Services. Mandatory guidelines and proposed revisions to mandatory guidelines for federal workplace drug testing programs: notices. Federal Register. April 13, 2004;69(71):19659-19660.
Wood B. State of North Carolina Performance Audit North Carolina Physicians Health Program. . http://www.ncauditor.net/EPSWeb/Reports/Performance/PER-2013-8141.pdf. Accessed March 17, 2015.
U.S. District Court Eastern District of Michigan, Case No: 2:15-cv-10337-AJT-RSW (2015). Carole Lucas, R.N., Tara Vialpandno, R.N., Scott Sanders, R.N., Kelly Schultz, P.A., and all other similarly situated health professionals v. Michigan Department of Licensing and Regulatory Affairs, Carole Engel, J.D.Former Director of Michigan Bureau of Health Professions, Ulliance, Inc. (State Contractor), Carolyn Batchelor (HPRP Contract Administrator), Stephen Batchelor (HPRP Contract Administrator), and Nikki Jones, LMSW. Filed January 30, 2015.
Boyd JW, Knight JR. Ethical and managerial considerations regarding state physician health programs. Journal of addiction medicine. Dec 2012;6(4):243-246.

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Disrupted Physician

The Physician Wellness Movement and Illegitimate Authority: The Need for Revolt and Reconstruction

Laboratory Developed Tests

The importance of reliability, validity and accuracy in all medical and laboratory testing–there are no exceptions

Please donate to DisruptedPhysician.com below

https://www.gofundme.com/PHPReform

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

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

Request Medical School Administrators Question PHP Authority to Prevent Future Medical Profession Brain Drain

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice

Institutional Justice and Quality Disparity in Drug and Alcohol Monitoring–The Contrast Between MBTA Operators and Massachusetts Doctors is Shocking

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice

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

EtG–The Rosie Ruiz of Bent Science and Bad Medicine

An Open Letter to Senator Elizabeth Warren Regarding Laboratory Developed Tests, Physician Health Programs and Institutional Injustice

Please donate to DisruptedPhysician.com below

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