Guest Post: Dr. Daniel Vande Lune, MD discusses how HCQIA provided immunity is misused by hospitals for sham peer-review

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The Ability for Hospitals to Hide behind the Immunity of HCQIA and the Abuse and Coercion by the PHP: my story and caveats.

I have been asked to write a guest blog and whole heartedly agreed. I am not afraid to tell my story and indeed, I feel that physicians need to know my story, so they don’t become yet another victim. This story really isn’t any different that a lot of other physician’s experiences. I want to be certain it is understood that my story is two-fold; violation of due process, breach of contract, and a sham peer review on the hospital’s part and a myriad of violations including roughshod disregard for civil liberties, committed by the North Carolina Physicians’ Health Program. Unfortunately, most physicians have no idea about many of the legal aspects that surround our careers, nor do they have any idea the power a hospital or PHP can wield.

In 1986, HCQIA (Health Care Quality Improvement Act) passed into law. On the outside, this act looked like a good thing because it tried to reign in escalating medical malpractice cases, and to protect people from those physicians. Quite generally, it allows physicians to be reviewed by their peers without the threat of civil litigation by the physician being reviewed. There are many points that have to be met in order for a peer review organization to stand behind HCQIA and earn its immunity. Again, unfortunately, because of this immunity, doctors can become the victim of a Sham Peer Review.

Lawyer, Gregory Piché, who has experience representing not only physicians but also hospitals in these matters, has written an excellent book, Sham Peer Review: The Power of Immunity and Abuse of Trust. While the book duly notes that it is very hard for physicians to fight back against a perceived sham peer review, it is not impossible. There are a multitude of reasons why a doctor might be targeted, for example, professional jealousy or competition. In the second chapter of his book he outlines 12 signs that you may be a victim of a sham peer review. I won’t enumerate those here but, they are eye opening. In my story, I was able to check off 10 of the 12 warning signs.

So enough background for now, let’s get on with my personal example. In November 2013, I was accused of misbehavior at the outpatient surgery center associated with Johnston Medical Center (Smithfield, North Carolina). Four staff members, who were kept anonymous from me, accused me of throwing an instrument and later that same day, striking a patient. Heinous behavior. I didn’t recall anything special from the day in question, I still stand by my side of the events. The instrument I was accused of throwing was a retractor. We were doing an arthroscopic case and thus no retractors were being used. All I can guess is that when we converted to an open procedure, I may have gently tossed the arthroscopic cannula onto the back table. The second accusation, again most heinous, was in a large man who was having hand surgery under a Bier block with sedation. He repeatedly moved and fidgeted, at one point sitting bolt upright on the operating table. I forcibly grabbed his wrist, still attached to a lead hand, and placed it firmly on the operating table, making a thudding sound. I certainly did not strike this patient, that violates my personal rules of honor and integrity. Skipping way ahead for a moment, I eventually had a Fair Hearing through the hospital’s administrative remedies, at which time only one of the accusers showed up. She was not a credible witness and in the end stated that the others hadn’t witnessed anything visually.

Mind you, these events supposedly took place in November of 2013. I was not made aware of it until December and didn’t go before the MEC until January. This is where it is very important to know the bylaws or to review them should you find yourself in a similar position. Under the bylaws I was to have been notified in writing and provided with details concerning the accusastion. Yet, I received only a phone call and then was not told any details of the accusations. Additionally, as a first time report, this should have gone to the head of the surgery department, not directly to the MEC. It should have been handled internally.  This was the first violation of their bylaws. In North Carolina, failure to follow your bylaws is considered a breach of contract.  From this point on they were violating my rights of due process. Because of the violations of their bylaws, due process, and their breach of contract, they have no right to stand behind the immunity of HCQIA. I wish I knew then what I know now. I should have looked at my bylaws and hired counsel before attending a meeting with the MEC. However, I figured that my explanation would ring true with my “peers.” Another mistake. I did ask about having a lawyer present but I was told that would not be allowed, which is probably true under the bylaws, but certainly is another personal violation of representation.

I presented myself to the MEC and gave my side of the story but I was rebuffed.   They investigated and told me they believed my accusers, the same accusers that DID NOT show up to my fair hearing eight months later. I was told that I would be “voluntarily required,” an oxymoron, to go the North Carolina Physicians’ Health Program to be evaluated. The oxymoron was explained as such: if they made it required, they would have to immediately report me to the NPDB. However, it was not voluntary in that my privileges were threatened if I didn’t attend. As I was planning to move out of North Carolina within six months, I agreed simply to keep the peace and move on without issue. I was given assurances by the Vice President of Medical Affairs that the evaluation would be kept confidential and that if anything came of the visit, it would be recommendations only. I, like many others, had never heard of the PHP before.

Due to scheduling issues, I was unable to be evaluated until late February, meanwhile still practicing and working out of this hospital; I was covering their ER, performing consults, and bringing them surgical cases (revenue). I presented for my evaluation, confirmatory email in hand, only to be told that I didn’t have an appointment that day and would need to reschedule. Fine, although I was convinced that was a test of my patience something that has been confirmed by others. Again, due to scheduling issues, (travel for interviews, death of a friend, and on call requirements), I didn’t get seen until early April. I was eventually accused, by the hospital, that I was purposefully delaying my evaluation. Much to my amazement, upon presenting, I was told that I would have to have a urine drug screen and that I would have to pay for it! This was not mentioned ahead of time, although the receptionist who had erred with my initial appointment, commented that I had been told.  I was also told, by the psychiatrist, that there was no doctor-patient relationship and he could report me to any authorities he saw fit. Despite me signing a release, I feel that without a doctor-patient relationship, he never had the authority to see my subsequent test results. Certainly, an argument can me made about a HIPAA violation on his part. To this point I have had my 5th and 14th Amendment rights violated by the hospital. NCPHP is probably guilty of illegal search and seizure as well as invasion of privacy.

We haven’t even started the evaluation. We began our talk. Not more than 15 minutes into the evaluation, he was trying to strong-arm me in to a contract with the PHP which would follow me to any future state where I might work. I refused, as I had been guaranteed that I was there for recommendations only. I answered all questions voluntarily, wanting to present myself as open and willing, not an “angry person.” I never refused a question, answering some of the most intimate questions possible. During this evaluation, I was never asked the 20 Questions of Johns Hopkins nor the CAGE questions. I was simply asked about consumption of alcohol which I didn’t deny. I have never been accused of coming to work impaired nor have I had any legal issues related to the social use of alcohol.

As the evaluation ended, I was escorted to and joined in the restroom by the psychiatrist, who was present as I provided a sample. Humiliating and violating. I then asked what drugs it tested for; I was told 12 drugs and alcohol. I balked as I had told him that I used alcohol socially. The urine was in his possession and I was told “not to worry about it.” Of course, the test came back positive for ethanol metabolites. As my evaluation was on Friday, the test result was communicated to me on Monday. At this point, the NCPHP recommended to the hospital that I undergo an evaluation for anger management as well as substance abuse. Remember, I had never been accused of impairment and this was a single isolated test. The courses were expensive and out-of-state. I refused anything to do with substance abuse evaluation or monitoring – which required the out-of-state evaluation or six months of draconian monitoring. I was especially concerned about travel restrictions under the monitoring contract as my daughter was getting married back in the Midwest. I was told they couldn’t guarantee that I could travel for her wedding. Obviously, that was a deal breaker.

At this point, I appealed to the hospital, offering to attend local anger counseling for which I would pay and I even offered to undergo urine testing at the hospital. The hospital continued to rebuff my concessions and attempts at coming to an amicable middle-of-the-road solution. I finally hired a lawyer who made it plain that signing a contract with the NCPHP was not a good thing. It was roughly at this time that the State Auditor in North Carolina released her report on the NCPHP. With all of the stories I know, it’s hard to believe that they didn’t find more evidence of malfeasance in reviewing 100 charts. They did find conflict of interest issues and recommended that physicians be allowed to seek their own care. Despite this recommendation, I was not afforded that opportunity. I presented this information to the MEC along with position statements from SAMHSA (they are against use of an isolated positive test and don’t believe the EtG test should be used as the sole forensic test especially when dealing the career of a professional), as well as reports condemning the EtG test (it is not approved by the FDA). Again, I was rebuffed.

In early May, after failing to sign the contract, I was summarily suspended from the hospital. Again, the bylaws were violated as I did not meet any of the definitions for a summary suspension. Why after six months was I suspended summarily? If they were so concerned, I should have been suspended the previous November.   After 30 days, by federal mandate, I was reported to the NPDB and subsequently investigated by the NCMB. I was released from my contract at Duke University. Although my license was never suspended, revoked, or restricted, I have been unable to get even a locums job. I have been rejected by at least three hospitals in Iowa. I’m working towards a Texas license but I’m finding that to be quite difficult. The hospital and PHP have continued to hide behind the veil of immunity. The violations of due process and breach of contract cannot be questioned which eliminates that immunity. The bigger concern is violation of civil liberties committed by both institutions.

Interestingly, the NCMB investigated and asked that I seek another evaluation, for anger management, with a counselor. They gave me a short list of providers in Iowa City, where I had relocated with my family. I went to one visit and she found no issues, other than an adjustment disorder stemming from the way I had been treated. I thought one visit rang hollow, so I pretty much begged the counselor to give me some recommendation. She said I could possibly benefit from a course in communication. Again, from a list of their choosing (the NCMB), I completed an at home course that dealt with communication and anger management.

Meanwhile, the hospital continued to hide behind the recommendations of the NCPHP. They would not back down from that. I eventually was given a Fair Hearing. After three nights of testimony in August and September of 2014, I was vindicated. The panel said that there was not enough evidence to have sent me for an evaluation in the first place, making everything following that moot. One of them has called it a witch hunt; a sham peer review. This decision was remanded by the MEC back to the panel who stuck to their initial decision. However, the MEC refused to overturn my suspension, which is allowed according to the bylaws. An appellate review also fell on deaf ears.

I think this story has many take home points. It never hurts to get a lawyer involved, the earlier the better. I firmly believe that had I involved a lawyer in January of 2014, I may never have had to go for an evaluation at the PHP. Know or review your hospital bylaws if you are ever in any situation with a hospital. Although I was given assurances that only recommendations would be made, the hospital hid behind their HCQIA immunity and the PHP, both entities holding my license/privileges over my head. Get everything in writing. Avoid any PHP, unless you feel you truly need their help, voluntarily. Even then, consider an evaluation by a trusted community colleague. The NCPHP is very typical of these organizations throughout the country, its modus operandi is addiction medicine. They base all of their recommendations on the spiritual 12-step program of alcoholics anonymous and the disproven belief that physicians need more intense treatment, junk science as most people call it. Like most of these institutions, they do not treat patients. They evaluate and refer you to an expensive out-of-state course, where you will most likely be entrapped in a prolonged, never ending contract with the PHP. It has been well documented that if you attend a substance abuse evaluation, you will most likely be labeled an abuser, ending up with 90 days of inpatient treatment. Lastly, be aware of the warning signs of a sham peer review, especially if you are just starting in a new position. Physicians are proud and territorial and they are not always “their brother’s keeper.”

I continue to fight for my professional career but the road blocks are enormous. Finding a lawyer to file suit, on a contingency basis, has also been impossible. As physicians, we need to stand up to these inequities. We need to support each other and contemplate the future when we may need to band together in a class action lawsuit. Maybe it’s time the ACLU becomes truly involved and excited about this opportunity.

Daniel Vande Lune, M.D.

 

How False Constructs Come to be Regarded as Irrefutable Truth: The Malleus Maleficarum Mosaic-Let’s See if She Floats!

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“The belief that there are such things as witches is so essential a part of the faith that obstinately to maintain the opposite opinion manifestly savors of heresy.”  

So begins Malleus Maleficarum , a witch hunters manual published in 1486 that  launched a new paradigm for all those concerned with the identification and extirpation of witches.  Used as a judicial case-book the Malleus set forth definitions of witchcraft, rules of evidence, and the canonical procedures by which suspected witches were tortured and put to death.   Written by Inquisitors for Inquisitors, the Malleus construct came to be regarded as irrefutable truth and contributed to the identification and execution of as many as 60,000 “witches”, predominantly women.  The 29th and last edition was published in 1669.

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Although there was a general belief in witches at the time the Malleus was published they were not regarded as evil or life threatening.  Society did not fear them and Church and Political authority  certainly did not feel the need to hunt them down.   There were many scholars who publicly doubted the existence of witches at the time.  That would soon change.

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After being snubbed by secular and ecclesiastical authorities in his witch-hunting pursuits, the  Dominican friar and German Inquisitor Heinrich Kramer told Pope Innocent VIII of a  dangerous outbreak of witches that had occurred in the region.    This diabolical conspiracy hell-bent on destroying humanity needed to be identified and destroyed for the public good, but church authorities were not cooperating.

On December 5th, 1484 Pope Innocent VIII issued the papal bull Summis Desiderantes affectibus giving full authority to proceed with “correcting, imprisoning, punishing, and chastising” such persons “according to their deserts,”  and threatening to sanction or excommunicate those who hindered the pursuit.

images-18From the late 15th century through the early 17th century a confederacy of “authorities” calling themselves demonologists assisted in identifying witches. Shaping ecclesiastical orthodoxy they set the standards that cooperating political authorities could follow in criminalizing, persecuting and punishing heretics.

Behavioral manifestations  included living alone, cultivating strange herb and saying hello to a neighbors cat.Witches were blamed for everything—plague, crop failure, and erectile dysfunction.

Using the nebulous “witch label” anyone with a grudge or suspicion could accuse anyone of witchcraft .

Propaganda, threats, misinformation, guilt assumed from the start.

male31Physician oversight of witch persecution was standard.

During the European witch-hunts the  legal notion of crimen exceptum (an exceptional and most dangerous crime] allowed for the suspension of normal rules of evidence to punish the guilty.

Because of the nature of the enemy the evidentiary bar was lowered and any witness, no matter what his credentials, could testify against the accused.

Belief in the seriousness of the situation rationalized cruelty.

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The Devil’s mark (Stigmata diaboli) was taken as the mark of a witch entailing close inspection.

Professional witch-prickers used  needles, pins and bodkins to poke the skin with lack of bleeding confirming the accusation.   The accused did not bleed due to retractable needles and sleight of hand.   False accusations, if exposed, were excused if they were a result of “zeal for the faith.”

The consequences of being branded a heretic  by questioning the existence of witches essentially silenced any dissenting voices and the notion of crimen exceptum freed the consciences of those involved.

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Sanctimony, feigned piety and  hypocritical devoutness was used as justification.  After all–Torture and torment are a small price to pay when it comes to protecting the public and saving souls.

Through the witch trials clerics, doctors, and lawyers used their expertise as witnesses to increase their prestige.  Witch hunts developed into a means of economic profit.  Some gained a lot of money from the witch trials.  The witch or her relatives paid for the salaries of those who worked the witch trials including judges, court officials, torturers, physicians, clergymen, scribes, guards, attendants. Even the people who made the stakes and scaffolds for executions gained from the conviction and death of each witch.

matthew“Witch hunting,” wrote the historian Rossell Hope Robbins, “was self-sustaining and became a major trade, employing many people, all battening on the savings of the victims.”

The costs of a witch trial were usually paid for by the estate of the accused or their family.

Far from the conventional image of a penniless hag, a significant proportion of accused witches, especially in Germany, were wealthy and male.

Their property was seized to pay the clergymen, judges, physicians, torturers, guards, scribes, and laborers who raked in increasingly large sums of money as well as other reliable assets.

With a single member accused, a moderately wealthy family could be ruined permanently.

In 1592 Father Cornelius Loos wrote:

Wretched creatures are compelled by the severity of the torture to confess things they have never done and so by cruel butchery innocent lives are taken; and by new alchemy, gold and silver are coined from human blood.

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 Context, characters and circumstances may differ but the mechanics do not.

The mosaic remains the same.

The Malleus shows how false constructs come to be regarded as irrefutable and the creation and chains of causation are timeless.

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400 Doctors are Killing Themselves Every Year: The Role of Licensure Complaints in Doctor Suicide

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The “Impaired Physician Movement” Takeover of State Physician Health Programs (PHPs)

Forget what you see
Some things they just change invisibly–Elliott Smith

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Physician Impairment

The Sick Physician: Impairment by Psychiatric Disorders, Including Alcoholism and Drug Dependence, published by the American Medical Association’s (AMA) Council on Mental Health in The Journal of the American Medical Association in 1973,1 recommended that physicians do a better job of helping colleagues impaired by mental illness, alcoholism or drug dependence. The AMA defined an “impaired physician” as “a physician who is unable to practice medicine with reasonable skill and safety to patients because of mental illness or excessive use or abuse of drugs, including alcohol.”

Recognition of physician impairment in the 1970s by both the medical community and the general public led to the development of “impaired physician” programs with the purpose of both helping impaired doctors and protecting the public from them.

IMG_1010The 1975 media coverage of the deaths of Drs. Stewart and Cyril Marcus brought the problem of impaired physicians into the public eye. IMG_0940Leading experts in the field of Infertility Medicine, the twin gynecologists were found dead in their Upper East Side apartment from drug withdrawal that New York Hospital was aware of but did nothing about. Performing surgery with trembling hands and barely able to stand, an investigation revealed that nothing had been done to help the Marcus brothers with their addiction or protect patients. They were 45 –years old.

Top: Twin Gynecologists Stewart and Cyril Marcus Bottom: The Movie

Although the New York State Medical Society had set up its own voluntary program for impaired physicians three years earlier, the Marcus case prompted the state legislature to pass a law that doctors had to report any colleague suspected of misconduct to the state medical board and those who didn’t would face misconduct charges themselves.


Physician Health Programs

Physician health programs (PHPs)  existed in almost every state by 1980. Often staffed by volunteer physicians and funded by State Medical Societies, these programs served the dual purpose of helping sick colleagues and protecting the public. Preferring rehabilitation to probation or license revocation so long as the public was protected from imminent danger, most medical boards accepted the concept with support and referral.

As an alternative to discipline the introduction of PHPs created a perception of medical boards as “enforcers” whose job was to sanction and discipline whereas PHPs were perceived as “rehabilitators” whose job was to help sick physicians recover. One of many false dichotomies this group uses and it is perhaps this perceived benevolence that created an absence of the need to guard.


Employee Assistance Programs for Doctors

Physician Health Programs (PHPs) are the equivalent of Employee Assistance Programs (EAPs) for other occupations. PHPs meet with, assess, and monitor doctors who have been referred to them for substance use or other mental or behavioral health problems.

Most EAPs, however, were developed with the collaboration of workers unions or some other group supporting the rights and best interests of the employees. PHPs were created and evolved without any oversight or regulation.

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The American Society of Addiction Medicine can trace its roots to the 1954 founding of theNew York City Medical Society on Alcoholism (NYCMSA) by Ruth Fox, M.D whose husband died from alcoholism.

The society, numbering about 100 members, established itself as a national organization in1967, the American Medical Society on Alcoholism (AMSA).

By 1970 membership was nearly 500.

In 1973 AMSA became a component of the National Council on Alcoholism (NCA) in a medical advisory capacity until 1983.

But by the mid 1980’s ASAM’s membership became so large that they no longer needed to remain under the NCADD umbrella.

In 1985 ASAM’s first certification exam was announced. According to Dr. Bean-Bayog, chair of the Credentialing Committee, “a lot of people in the alcoholism field have long wanted physicians in the field to have a high level of skills and scientific credibility and for this body of knowledge to be accredited.”2 And in 1986 662 physicians took the first ASAM Certification Exam.

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By 1988 membership was over 2,800 with 1,275 of these physicians “certified” as “having demonstrated knowledge and expertise in alcoholism and other drug dependencies commensurate with the standards set forth by the society.”3 “The formation of State Chapters began with California, Florida, Georgia, and Maryland submitting requests.4

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In 1988 the AMA House of Delegates voted to admit ASAM to the House. According to ASAM News this “legitimizes the society within the halls of organized medicine.”2

By 1993 ASAM had a membership of 3,500 with a total of 2,619IMG_8919certifications in Addiction Medicine. The Membership Campaign Task Force sets a goal to double its membership of 3,500 to 7,000 by the year 2000 to assure “the future of treatment for patients with chemicals. It represents a blueprint for establishing addiction medicine as a viable entity.”5

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Many of these physicians joined state PHPs and over time have taken over under the umbrella of the FSPHP.

Others became medical directors of treatment centers such as Hazelden, Marworth and Talbott.


  1. The sick physician. Impairment by psychiatric disorders, including alcoholism and drug dependence. JAMA : the journal of the American Medical Association. Feb 5 1973;223(6):684-687.
  2. Four Decades of ASAM. ASAM News. March-April 1994, 1994.
  3. . American Medical Society on Alcoholism & Other Drug Dependencies Newsletter. Vol III. New York, NY: AMSAODD; 1988:12.
  4. . AMSAODD News. Vol III. New York, NY: American Medical Society on Alcoholism & Other Drug Dependencies; 1988.
  5. Membership Campaign Update. ASAM News. Vol VIII: American Society of Addiction Medicine; 1993:11.

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Reefer Madness Redux: Is your doctor a marijuana user? Maybe you should ask.

The article below was recently published on “social media’s leading physician voice” KevinMD.com.  A previous piece by the same author attempted to connect marijuana to heroin use.  Interestingly, this type of archaic rigid paternalistic chatter is becoming more and more common in the articles and social media of healthcare.   How, and more importantly why, is this type of tripe and rabble getting past editorial review?   It is 2016 not 1958!  Disappointingly, this absurd and sexist rant has generated a mere 20 comments thus far with the majority being negative.  I do agree with the apt and accurate observations of “FEDUP MD” who states the following:

“The answer is not that cut and dried.

Do I want a surgeon who is clinically impaired from marijuana operating on me at the time, who just smoked a joint before entering the OR? No.

Do I care if a surgeon two weeks ago went to Aspen on vacation, smoked a perfectly legal joint at his hotel, and now is operating on me two weeks later? No.

Both come up the same on a drug test.”

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Is your doctor a marijuana user? Maybe you should ask.

Marijuana use today is not limited to the poor, the marginalized among us; nor is it kept in the inner city, as it pretty much was when I was a kid. Now it is widespread, even legal in some states. One might even make the argument it has become a substantial part of the life of the elite, the affluent of America. And when we think of elite and powerful individuals among us, do we rule out doctors? I think not.

So when I read a reader’s comment to a piece I wrote recently about marijuana and its possible connection to heroin, I was not surprised when one person rejected my ideas 100 percent. He went on to say why, and used the term “weed” once or twice in doing so. I said to myself, “Now here is a person who knows firsthand a bit about marijuana use. ” His use of the term, “weed,” told me this. He no doubt possesses more than a passing interest in the subject. Others who commented seemed to share his opinion — but not all.

My understanding of drugs and their impact on lives comes largely from my lifelong occupation as a social worker. Lots of years of doing social work in many settings including a couple of years working among the Sioux of South Dakota.  In those mid-sixties, years alcohol abuse on the reservation was rampant, and hardly a new story.  Drugs had not yet arrived.  Drugs are there now big time and the situation is horrendous, awful, drugs and alcohol together.  And I believed the conditions could not become worse than what I witnessed.   Well, they could, and they have.

There is another side to my experience, however.  As a much younger person, I dated, while living in Boston, a heavy user of marijuana.  She also took LSD regularly, which tells you how long ago this happened.  I didn’t meet the woman in the conventional way, a bar or some sort of social gathering (no Internet or on-line dating services then).  No, I met the lady at an airport north of Boston: Plum Island Airport, quite near the ocean.  I am a private pilot, and I had landed my two-seater Piper J3, and struck up a conversation with her, and offered her a ride, which she immediately accepted, and thereupon our romance began.  Straightforward enough, I hope you agree.

The J3 is a wonderful airplane, old and slow, but lots of fun to fly.  There is no starter.  You have to get out and spin the prop to start the engine — very old school.  Women seemed to love my J3, except that it wasn’t mine; it was a loaner.

Pilots incidentally are often a fairly conservative lot.  Not a great deal of alcohol or drug abuse among us.  Of course, there are glaring exceptions, but most pilots I know learned quickly that mistakes in aviation can and often are deadly.  There are no dented fenders.  I noticed too that doctors seem drawn to flying in considerable numbers.  They often have the best equipment — I never saw a doctor in a J3 — which I gather they can well afford.  And I should add that I never met a woman pilot/doctor, by the way.

They also were involved in many accidents.  Why?  It is complicated, I suppose, but doctors are busy fellows who might find a couple hours of free time, rush to the airport and were soon airborne.  Not a lot of time to practice, as in practicing takeoffs and landings.  No time for that, but in aviation as in medicine, practice makes perfect, or near perfect.  Also, I think confidence is an issue.  For doctors, at least the ones I was acquainted with, were seldom lacking in confidence, and were, therefore, capable of getting into flight situations they may have been completely unprepared for and untrained to deal with.

So my new friend, Ellen, and I dated.  She was open and very upfront with me about her heavy marijuana use.  She claimed she drove better when she was high, reminding me repeatedly of this as she weaved in and out of traffic on the Mystic River Bridge leading into Boston.  I’d hold my breath, and occasionally recommended she slow down.  She seldom did.   But still, I enjoyed Ellen’s company, and went along for the ride for easily a year or more.  I won’t say her drug use drove us apart, but it did not bring us closer together either, which leads me to this (likely unpopular) observation, and query: How many doctors entering the workplace these days have more than a casual connection to marijuana?  I know the same question can be asked regarding alcohol, but I am not asking that question here, and it is, after all, my essay.

 What if there were an admissions question upon entering medical school, and it went something like this:  How would you describe your use of marijuana?  Often, once in awhile, or never.  Of course, answers to such a query would be totally unreliable, for obvious reasons.  No one would admit to marijuana use when applying to medical school.

My friend and I parted after a time.  She never said as much, but I suspected she found me a bit dull.  She eventually moved back to Virginia, and last I heard, she had wed and had a family.  Good for her.  So no bad ending here.  Maybe that’s what everybody was expecting — what I was leading up to — but you don’t get that.

But I will say this much.  I continue to be a fussy pilot, and when I travel on an airliner, which these days happens less often — I always peek into the cockpit upon entering to see who is sitting in the left-hand seat.  That’s where the pilot in command sits.  I like to see an older man there, a bit stout and maybe balding or gray-haired.  (Please don’t ask me about female pilots.)  I know such a fellow is likely experienced.  He has survived a long time, is my guess.

If I were to find a young Robert Redford-type in that left-hand seat, I would become uneasy and not fully sure of what I was getting myself into.

So the point I am making here is this:  I am clearly discerning as to the skill and condition of an airline pilot, someone I seldom see, so why should I not be really picky when it comes to doctors I select, and whether or not they use marijuana regularly, or even at all?

Raymond Abbott is a social worker.

Image credit: Shutterstock.com 

 

 

 

Diagnostic Testing 101.1: The Importance of Sensitivity, Specificity and Diagnostic Test Accuracy

To have striven, to have made an effort, to have been true to certain ideals — this alone is worth the struggle. We are here to add what we can to, not to get what we can from, life. – William Osler


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Diagnostic Medicine

Diagnostic medicine is the process of identifying the condition or disease that a patient has and  ruling out conditions or diseases the patient does not have through assessment of  the patient’s signs, symptoms, and results of various diagnostic tests.

Diagnostic Test Accuracy

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.

Say we want to develop a new rapid test for detecting strep throat.    Strep throat is caused by the Streptococcus bacteria.   Although more common in children and adolescents it can occur in people of all ages.  Strep throat is one of many possible causes of sore throat and pharyngitis.   It is contagious and can cause complications such as rheumatic and scarlet fever.  Treatment with antibiotics can shorten the course of the disease and reduce the risk of complications.

Pos_strep

A throat culture is obtained by swabbing the patient’s throat with a cotton swab.  The sample is then sent to the lab where it is cultured.  If strep is present it will grow on the culture and look as below.     The bacteria either grows on the culture or it doesn’t.  A throat culture is the “gold standard” for diagnosing strep throat.  The problem is it may take two days to get back.

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Sensitivity and Specificity

The two most important measures of diagnostic test accuracy are sensitivity and specificity.     

The probability that a test will be positive in someone with the condition =  Sensitivity

The Probability that a test will be negative in someone without the condition = Specificity

For diagnosing strep throat we want our test to be as close as possible to the gold standard in terms of both sensitivity and specificity.

Sensitivity and specificity can be illustrated by a table with two rows and two columns.  This simple  Decision Matrix  where the rows summarize the data  according to the true condition status of the patients and the columns summarize the test results.  This table is called a “count table” because it indicates the numbers of patients in various categories.      The total number of patients with and without the condition is, respectively n\ and n0; the total number of patients with the condition who test positive and negative is respectively s\ and s0; and the total number of patients without the condition who test positive and negative is respectively r\ and ro.

The total number of patients in the study group N, is equal to N = si+so+rx+ro, or N = n\ + no·

The true condition status is symbolized by the variable D, where D = 1 if the condition is present and D= 0 if the condition is absent.

Test results indicating the condition is present are called positive; those indicating the condition is absent are called negative.

Test results are symbolized  by the variable T, where T =1 denotes positive test results and T= 0 denotes negative test results.

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The sensitivity (Se) of a test is its ability to detect the condition when it is present.

We write sensitivity as Se = P(T = 1 | D = 1), which is read:

“sensitivity (Se) is the probability (P) that the test result is positive (T = 1), given that the condition is present (D = 1).”

Among the n\ patients with the condition, s\ test positive; thus, Se = s\/n\.

The specificity (Sp) of a test is its ability to exclude the condition in patients without the condition.

We write specificity as Sp — P(T = 0 | D — 0), which is read:

“specificity (Sp) is the probability (P) that the test result is negative (T = 0), given that the condition is absent (D = 0).”

Among no patients without the condition, ro test negative; thus, Sp — TQ/UQ

False Negative and False Positive Tests

There are consequences associated with all test results.

False Negative Tests:   If a test falsely indicates the absence of a condition in someone who truly has it then treatment can be delayed or not provided.

The consequences of a false negative strep test depend on what we do with it.   Serious consequences can arise if we use our new strep test as the sole basis for subsequent decision making.     Putting complete trust in the negative test result would lead to no antibiotic treatment provided to a patient with Strep  and can lead to continued illness,  spread of the disease and complications that would not have occurred if antibiotics were provided.  The patient could potentially get rheumatic or scarlet fever.

If the new test is negative  but a culture was drawn the false results could delay treatment by a couple days or so but treatment is nevertheless provided.  The consequences are likely to be minimal.   It is highly unlikely a patient would get rheumatic or scarlet fever  as, although a little later, they are still  being treated with the proper antibiotics.

False Positive Tests:   If a test falsely indicates the presence of a condition in someone who does not truly have it then unnecessary tests and treatments can occur.  Incorrect treatment and false labeling of patients can also occur.

In the case of a false positive strep test, a patient may undergo a course of antibiotics when they do not need them.     Although the patient may suffer side-effects from the antibiotics the severity and duration of any  of these consequences are minimal.

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The importance of a Diagnostic Accuracy in testing is directly proportional to the tests potential to cause patient consequences and harm.

Diagnostic Medicine uses a patient’s signs, symptoms and the results of various diagnostic tests to arrive at a diagnosis.

In diagnosing strep throat a good clinician will take into account  a number of variables in consideration of a differential diagnosis and base testing and treatment on the preponderance of information supporting or opposing the diagnosis.

For strep throat using the new test in addition to a throat culture, history and careful physical exam and basing the decision to prescribe antibiotics on clinical acumen based on the overall picture is the best approach.     The test can  be considered a piece of the puzzle but does not define it.  Therefore the risk of a false positive or false negative is minimal as it is just one data point.

Diagnostic accuracy is necessary if a test is being used as the  basis for further tests and treatment.  If  a test  is  being used as the sole basis for further tests and treatment it needs to be accurate.   If the results of a test can cause significant patient harm or death then it needs to  be either 100% accurate or combined with other highly accurate tests to confirm the diagnosis.

The specificity of a test is particularly important as a false positive can result in unneeded interventions and treatment.     Stand-alone tests used in diagnosis and treatment need to be both sensitive and specific.    Diagnostic accuracy is a product of consequences of  false-negative and false positive tests.

 Diagnostic Research Methodology

Research to discover the accuracy of a diagnostic test should be straightforward; administer the test to a group of people and see if it works.

The test being tested is the “index test”. Results of the index test are compared with the results of a “gold standard” reference test.

The research question is, “How accurately do index test results predict the (true, gold standard) reference test results?”

Diagnostic test accuracy studies require a sample of subjects  who have been given the test under evaluation,  some form of scoring of the tests findings and a reference or “gold standard” to which the test findings are compared.   Examples include autopsy reports, surgery findings and pathology results from biopsy findings.

The gold standard for a patient’s true disease status may not always be available.    A  brain biopsy could be considered a gold standard for diagnosing Alzheimer’s disease but is neither practical nor humane.

The Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool is a set of fourteen questions that investigate the methodologic quality of scientific studies that quantify diagnostic test performance.

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The questions identify research methodologies known to bias the accuracies research discovers.

Multiple factors need to be considered in  evaluating the diagnostic accuracy of a test including diagnostic validation and  verification.   Is the test testing what it is supposed to be testing for and are we doing it correctly?

Diagnostic accuracy of a test necessitates a reference standard,  The reference standard can be the best available method for establishing the presence or absence of a condition (such as the throat culture for strep throat) or a combination of methods (imaging, neuropsychological testing, clinical exam, etc. in Alzheimer’s disease.

Any test that is going to be used as a basis for decisions that impact other human beings needs to  be validated before it is introduced on the market.  The literature needs to  be reviewed critically and trials must be designed using objective evidence that validates the test is testing for what it purports to be and verifies the correct methodology of the test.  Verification that the test is being collected, handled, stored, transported and processed  correctly is requisite.

Cutoff levels, , cross-reactivity and myriad other issues need to be worked out prior to bringing a diagnostic test to market.

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The reliability, validity and accuracy of drug test results needs to  be known prior to using a test.  Specificity and sensitivity must be known prior to using a test on any population.

This should go without saying as to do anything else would be irresponsible and careless.

References

Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 7: systematic reviews and meta-analyses of diagnostic accuracy studies Pain Physician 2009, 12(6):929-963. PubMed Abstract | Publisher Full Text

Jaeschke R, Guyatt G, Lijmer J: Diagnostic tests. In Users’ guides to the medical literature: a manual for evidence-based clinical practice. Edited by Guyatt G, Rennie D. AMA Press; 2002:121-140.

Lundh A, Gøtzsche PC: Recommendations by Cochrane review groups for assessment of the risk of bias in studies.BMC Med Res Methodol 2008, 8:22.doi:10.1186/1471-2288-8-22 PubMed Abstract | BioMed Central Full Text | PubMed Central Full Text OpenURL

Streiner DL: Diagnosing tests: using and misusing diagnostic and screening tests.J Pers Assess 2003, 81(3):209-219. PubMed Abstract | Publisher Full Text OpenURL

Whiting P, Rutjes AW, Reitsma JB, Bossuyt PM, Kleijnen J: The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003., 3(25)  http://www.biomedcentral.com/1471-2288/3/25 webcite

OpenURL

GCP, good clinical practice; GCLP, good clinical laboratory practice; GLP, good laboratory practice; STARD, standards for reporting of diagnostic accuracy. See Section III, 2.13  From Nature Reviews Microbiology 4,S20–S32(1 December 2006) | doi:10.1038/nrmicro1570

GCP, good clinical practice; GCLP, good clinical laboratory practice; GLP, good laboratory practice; STARD, standards for reporting of diagnostic accuracy. See Section III, 2.13 From Nature Reviews Microbiology 4, S20–S32 (1 December 2006) | doi:10.1038/nrmicro1570

Abuse Hidden Under a Veil of Benevolence: Bill Cosby, Physician Health Programs and Cognitive Dissonance

Under a dictatorship everything else becomes subordinated to the guiding philosophy of the dictatorship. Corresponding doctrine replaces professional guidelines, standards-of-care, and evidence based medicine. And unfortunately in the case of Addiction Medicine the guiding philosophy often trumps autonomy and ethics.

Inherent in the current chronic brain disease model of addiction is the importance of external control over individuals and political correctness and medicalization of addiction is allowing it. Demanding scientific literacy and discriminating good from bad science would prohibit what is occurring and in order to save American Medicine the problem needs to be clearly recognized or we will become a profession that is essentially defined by the impaired physicians movement.

Source: Abuse Hidden Under a Veil of Benevolence: Bill Cosby, Physician Health Programs and Cognitive Dissonance

Happy New Year 2016! -“No matter what people tell you,words and ideas can change the world.”-Robin Williams

“No matter what people tell you,words and ideas can change the world.”-Robin Williams..

“I stand upon my desk to remind myself that we must constantly look at things in a different way.”-John Keating (Robin Williams)

Dead Poets Society

Source: Happy New Year 2016! -“No matter what people tell you,words and ideas can change the world.”-Robin Williams

Happy New Year 2016! -“No matter what people tell you,words and ideas can change the world.”-Robin Williams

Screen Shot 2016-01-01 at 12.39.56 AM

“No matter what people tell you,words and ideas can change the world.”-Robin Williams..

“I stand upon my desk to remind myself that we must constantly look at things in a different way.”

-John Keating (Robin Williams)

Dead Poets Society