Conflicts of Interest in unsuspected places

Patient advocacy organizations — groups such as the American Cancer Society, the American Diabetes Association, the Arthritis Foundation — are non-profit organizations that seek to help patients with a specific disease or disorder by providing services to patients, sponsoring research, influencing government and insurance policy, and promoting and promulgating guidelines that are followed by doctors and patients to diagnose and treat disease. They are sometimes viewed as altruistic voices for powerless patients, providing a necessary counterweight to evil (or at least uncaring) government regulators and policymakers who are only interested in saving healthcare dollars at the expense of helpless sick people.

A study from this week’s JAMA Internal Medicine suggests the picture may not always be so clear. The study authors surveyed a random sample of leaders from 7800 or so patient advocacy organizations. 68% of them reported receiving funding from for-profit industry groups including pharmaceutical, medical device, and biotech companies. About 10% reported receiving more than half of their funding from industry sources, and 8% of respondents “perceived pressure to conform their positions to the interests of corporate donors.”

Patient advocacy organizations are “influential health care stakeholders.” They have accomplished many unarguably beneficial advances for patients. But part of their positive influence is due to the perception that they are not entangled in the financial conflicts of interest which have been so well-documented among physicians, physician specialty societies, and clinical guideline authors. And in my experience, this perception has sometimes led patients to insist on following the recommendations of an organization that knows little of their personal circumstances rather than following the recommendations of their personal physician. For the sake of transparency and good patient care, it is important to ensure that these organizations, which maintain that they speak for patients’ interests, are not beholden to the interests of companies whose aim is to benefit financially from those same patients.

 

 

 

 

 

 

(DISCLAIMER – It is sheer coincidence that a blog post about Conflicts of Interest is appearing on the same day as the Presidential inauguration.)

A novel strategy for suicide prevention

In the Netherlands, a doctor will not be prosecuted for assisting a patient to die either through euthanasia or assisted suicide (EAS) if certain conditions are met, among which are the following: The patient’s request for aid-in-dying must be voluntary and well-informed, without coercion from others, and uninfluenced by psychological illness or drugs; their suffering should be unbearable and hopeless, with no prospect for improvement and without reasonable alternatives; and an independent physician should be consulted, who should concur with the aforementioned conditions. Supporters aver that these guidelines have made physician-assisted death safe and have avoided the “slippery slope” that detractors and fear-mongers fulminate about.

A commentary (preview available here) in last week’s JAMA gives cause to question the rosy picture some paint of the Netherlands experience. The commentary refers to a study that appeared in the April 2016 JAMA Psychiatry. The study describes the practice of EAS for psychiatric disorders in the Netherlands, reviewing 66 patient reports filed by physicians from 2011 to 2014. Surprisingly, only 49 of the 66 patients experienced depression. Thirty-four had at least one prior suicide attempt. Six had substance abuse, two a diagnosis of autism. Thirty-four had personality disorders; 13 had never had a psychiatric hospitalization; 37 described social isolation or loneliness. Thirty-seven of the patients had refused some recommended treatment. In eight cases, the involved psychiatrist believed that the criteria for EAS had not been met. Eighteen cases involved physicians who had not cared for the patients before the EAS request; most had met the patients through mobile euthanasia clinics. (As Paul Appelbaum writes in an accompanying editorial [preview available here], “One might wonder whether a clinic intended to make assisted death more available will have a lower threshold for approving requests.”) In 16 patient cases, three independent physician reviewers could not agree among themselves as to whether the patient was making a competent request, or whether there was treatment that offered some prospect of improvement.

The description of some of the patients is compelling. The study reports that a “woman in her 70s without health problems … and her husband had decided some years before that they would not live without each other. She experienced life without her husband, who had died 1 year earlier, as a ‘living hell’ and ‘meaningless.’ A consultant reported that this woman ‘did not feel depressed at all. She ate, drank, and slept well. She followed the news and undertook activities.’ ” About patients who reported social isolation or loneliness: ” ‘The patient indicated that she had had a life without love and therefore had no right to exist’ . . .  and ‘The patient was an utterly lonely man whose life had been a failure.’ ” A Dutch regional euthanasia review committee found one case that did not meet due care criteria: “. . .a woman … in her 80s with chronic depression who sought help from the End-of-Life Clinic. The clinic physician met with her 2 times (the first time was 3 weeks before her death), and the patient was not alone on both occasions, with family members present. The physician was not a psychiatrist, did not consult psychiatrists, was unaware of the Dutch Psychiatric Association Guidelines, and yet ‘had not a single doubt’ about the patient’s prognosis.”

These stories are tragedies. I do not deny that the patients in this study were truly suffering. But is EAS really an appropriate way to treat the suffering, by killing the sufferer? If someone fails in an “illegal” suicide attempt, can they just go to the doctor and have it done legally? Is EAS to be the new solution for loneliness, social isolation, and grief? Is it not a slippery slope to go from “Doctors must not kill,” to “Doctors can kill in the case of terminal illness,” to “Doctors can kill people who don’t have a terminal illness but just want to be dead”?

Testing, testing: Prenatal genetic screening

The June 2016 issue of Obstetrics and Gynecology includes a study of the conversations between patients and “Health Care Providers” about prenatal genetic screening (PGS). The objective of the study was to “assess how obstetric health care providers counsel patients regarding prenatal genetic screening and how these conversations influence patients’ screening decisions.” PGS refers to blood and ultrasound tests performed early in pregnancy to determine whether a fetus is at high risk for various chromosomal anomalies, especially the anomaly that leads to Down syndrome. Several findings of the study are troubling.

First troubling finding: providers’ counseling of patients about PGS lasts an average of 1.5 minutes.

Second troubling finding: False-positive rates of PGS are discussed so rarely that they could not be reliably analyzed in the study. The false-positive rate refers to how often the screening test is wrong when it suggests that an abnormality is present; when a test says the baby has Down syndrome, but the baby in fact does not have Down syndrome, it is a false-positive. The guidelines of the American College of Obstetricians and Gynecologists suggest that false-positive rates ought to be discussed in counseling about PGS.

But counseling about false-positive rates is itself troubling. The false-positive rate of PGS is somewhere around 5%. Most of us hear this and think, “OK, 95% of the time the test is right when it says that the baby has Down Syndrome.” However, to answer the question, “What percentage of the time is a positive test correct?” you can’t look at the false-positive rate; instead, you have to know something called the Positive Predictive Value. And for PGS, the positive predictive value is only 10%. That means that 90% of the time when PGS says “Down syndrome,” the baby does not have Down syndrome. (Numbers are higher for cell-free fetal DNA testing; however, this test is fraught with its own problems, and the study under consideration here did not include this test.)

Third troubling finding: In 51% of the discussions analyzed, health care providers did not clarify the fact that PGS is not diagnostic. PGS is a screening test, not a diagnostic test. The difference is crucial. Since 90% of abnormal PGS tests are wrong, an abnormal test requires a follow-up procedure to actually make a diagnosis. That follow-up test is usually an invasive test involving a needle into the uterus and a small chance of causing a miscarriage. I have known of several women who didn’t understand the screening nature of the test when they had it performed; when the test came back showing high-risk for a genetic abnormality, they then refused the more definitive diagnostic test. The result was either they spent their entire pregnancy in needless anxiety until the child was born without the anomaly, or they aborted the child on the basis of a false test result.

Why is all of this so troubling? Because medical tests are a big deal. Our understanding — or misunderstanding — of the results of medical tests shape how we see and understand ourselves. And PGS medical tests are a bigger deal than most; because if the results of this study are true, parents are frequently getting cursory explanations (1.5 minutes) from “providers” who give inadequate information about PGS tests. They are then using that (mis)information to make life-or-death decisions for the children they carry. If we’re going to practice eugenics, we should at least make sure that we’re doing so in a fully-informed fashion.

Medical errors and more medical errors

Last week the BMJ reported that annually, there are 251,000 hospital deaths due to preventable medical errors in the US. There’s some debate about the calculations that they used to arrive at that number, and about what exactly constitutes a medical error. However, rather than quibble over the fine points, let’s acknowledge that medical errors are an ethical problem that must be addressed. In this post I would like to widen the conversation beyond the hospital walls. Below is a sample of some deaths due to preventable medical errors that weren’t included in the BMJ calculations (most of these ones happen outside of hospitals); nevertheless, they too affect thousands of people annually. I will also attempt to provide a taxonomy of the relevant errors.

Deaths due to the inability of the patient to obtain medical care because they couldn’t afford the care or the insurance — unknown number. The medical error here is a systemic one, the rationing of health care on the basis of who can pay for it.

Deaths of patients due to their being the subjects of human research — unknown number. This is peculiarly prevalent among embryonic patients (as Jon Holmlund wrote about last week). The medical errors include the failure to extend to embryonic research subjects the protections enumerated in the Declaration of Helsinki. There is also a category error: classifying embryonic patients as something other than human beings.

Deaths of embryonic or fetal patients through elective induced abortion — 977,000 (2014 data). The same category error as previous comes into play here: the failure to recognize the humanity of the unborn human.

Deaths of patients from drugs prescribed by their physician for the purpose of suicide — the numbers data is incomplete. The number is relatively low but projected to grow as more jurisdictions legalize physician-assisted suicide. The errors here include a professionalism lapse (forgetting that the professional status of medicine was established, among other things, on the dictum that doctors do not give deadly drugs, even if asked to do so). There is also the error of hubris: the belief that doctors can decide that someone should be allowed to kill themselves.

Preventable medical errors, all.

“The Enormity of the Moral Mission of Medicine”

As I write, Paul Kalanithi’s book When Breath Becomes Air sits atop the New York Times Bestseller List. I highly recommend it. It is beautiful.

This book was written by a dying man. All books are, I suppose, but this author knew with more certainty than most that his time was short. Paul Kalanithi was finishing a grueling neurosurgery residency and on the cusp of a brilliant career when he discovered he had advanced lung cancer. In this book, written during the last months of his short life, he tells his story, a story of his search for meaning. He initially looked for meaning in the study of words, as he collected degrees in English and history and philosophy. But he discovered that meaning is not just read about, but lived, lived in relationships with others. As he thought about relationships, words, minds, and the brains through which words and minds are expressed, he writes that he “couldn’t let go of the question: Where did biology, morality, literature, and philosophy intersect?” The answer wasn’t to be found, for him, in the classroom: “. . . I found myself increasingly often arguing that direct experience of life-and-death questions was essential to generating substantial moral opinions about them. Words began to feel as weightless as the breath that carried them. . . It was only in practicing medicine that I could pursue a serious biological philosophy. Moral speculation was puny compared to moral action.”

And this illustrates one of the great strengths of the book: the profound understanding that medicine is at its heart a moral practice. Kalanithi writes of “The enormity of the moral mission of medicine . . .” He pursued one of the most technical of specialties, neurosurgery, yet he did not let the technical aspects obscure the moral core of medicine, the patient-physician relationship. As he writes, “When there’s no place for the scalpel, words are the surgeon’s only tool.”

As he explores the moral practice of medicine, Kalanithi writes insightfully of informed consent, not as “a juridical exercise in naming all the risks as quickly as possible . . . but an opportunity to forge a covenant with a suffering compatriot.” As a neurosurgeon he writes of the experience of life and death from the bedside. He learns that “the physician’s duty is not to stave off death or return patients to their old lives, but to take into our arms a patient and family whose lives have disintegrated and work until they can stand back up and face, and make sense of, their own existence.”   Then he receives his own terminal diagnosis, and writes eloquently of his experience of life and impending death from the patient’s bed. The ending of the book, along with his wife’s epilogue, is deeply, deeply moving, but not maudlin.

(Quotes from pp. 32, 43, 44, 87, 88, and 166)

 

The End of Meaningful Use: A Meaningful Opportunity

The Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt said Monday that 2016 would likely see the end of the meaningful use program. Meaningful use is a carrot-and-stick government program designed to get medical providers to use electronic health records (EHRs) and to set standards for using them. The carrot: medical providers who show compliance with meaningful use regulations get incentive payments from the government. The stick: those who do not are assessed financial penalties (257,000 received penalties in 2015).

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The latest Mayo Clinic study on physician burnout shows that in 2014, 54.4% of physicians admitted to at least one symptom of burnout. This is up from 45.5% in 2011. In the non-physician population, the number is about 25%.

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Why the burnout? Lots of reasons, but a major one is that many doctors are spending a lot of time doing things that are not just peripheral to what we went into medicine for, but inimical to it.

When I decided to go into medicine almost thirty years ago, I wanted to do work that didn’t involve sitting in front of a computer all day. My father was a computer systems analyst, and while he brought home cool stuff from the office, I wanted to work with people. So I chose medicine. And somewhere along the way, something changed.

Like many doctors, over the years I found myself spending more and more of my patient care time staring into a computer screen. This in and of itself might not have been so bad, except that it was time taken away from the time I used to spend looking at my patients: looking them in the eye, observing the subtleties of their body language, watching how they breathe or fidget or tremor. And increasingly, the time in the computer was spent doing things that satisfied “Meaningful use” standards, but in no meaningful way improved the care I was providing to the person in the room; in fact, it detracted from care by taking the finite resource of the time I spend with patients and wasting it on irrelevancies. Instead of serving patients, doctoring began to feel like serving the machine, responding to its needs in preference to the needs of patients. Unsurprisingly, a lot of doctors feel this way.

Serving machines instead of people: a good recipe for burnout. The CMS may finally be figuring that out.

Meaningful use was based in part on the blind faith that technology is good, so more must be better. That’s why, in Andy Slavitt’s words, it “reward[ed] doctors for the use of technology.” Think about that: a program that rewards doctors not for improving patient care, or fostering better patient-physician relationships, or making contributions to medicine, but for . . . using technology. Might as well pay us for using smart phones.

Current EHRs have been designed (from all appearances, without knowledge of what physicians actually do in the office) to facilitate increased billing  and to meet meaningful use. Getting rid of meaningful use is an opportunity to completely redesign EHRs — using what physicians actually do as a guide — to make them a useful adjunct to the practice of medicine, rather than a burnout-promoting waster of colossal amounts of time; to enhance (or, at the very least, not detract from) the patient-physician relationship; and to put the patient rather than the technology back at the center of what physicians do.

This may require hefty changes, the complete rethinking and redesigning (maybe scrapping) of current EHR systems. This could be disruptive; but sometimes, when you make a mistake, the best thing to do it to go back and erase it and start over. And if change resulted in doctors getting back to being doctors, I think most of us would welcome it. As Slavitt said on Monday, “We have to get the hearts and minds of physicians back. I think we’ve lost them.” Using this opportunity to completely rethink and overhaul EHR systems is a good way to see that happen.

 

 

 

OB Potpourri

This month’s issue of the medical journal Obstetrics & Gynecology (O&G) has a review of the four best ethics articles that appeared in their journal in the last year. Here are my comments (in italics) on their review (in quotes).

Article title: “Clinical, Ethical, and Legal Considerations in Pregnant Women With Opioid Abuse.” O&G‘s bottom line: “Opioid abuse is a chronic medical illness, not a moral failing. Obstetricians should advocate for pregnant women’s access to opioid maintenance therapy and social services that support healthy outcomes for these women and their fetuses.” Some will quibble about whether the slavery that is opioid addiction should be defined as a chronic medical illness (and remember that some opioid addiction comes courtesy of us physicians who misprescribe opioid medications). However, whether you believe that these women are unable to stop their substance abuse (illness model) or somehow unwilling (moral failure model), from a medical standpoint, treating these women as criminals isn’t helpful for either them or their babies to achieve the best outcomes. We’re doctors, not the police, so acting judgmentally has no role; we should be helping these patients and their babies in any ethical way possible.

Article title: “Evaluation of Ethics Education in Obstetrics and Gynecology Residency Programs.” In this study, 57% of OB residencies had 0-5 hours of ethics training, and 64% of residency directors said their graduates are unprepared or only somewhat prepared to handle ethically challenging situations. O&G‘s bottom line: “Obstetrics and gynecology residencies are behind in creating and evaluating formal ethics education programs. Additional resources and support, including a standardized formal curriculum, are needed to provide all obstetrics and gynecology residents with an adequate baseline ethics education.” In a specialty that regularly comes up against some of the most ethically problematic issues in medicine, it is extraordinary that over half of residencies have a hard time finding even five hours for ethics education during the course of a four-year residency. I could write a lot more about forming professionals vs. training technicians, but space doesn’t permit.

Article title: “The Ethics of Access: Who Is Offered a Cesarean Delivery and Why?” O&G‘s bottom line: “The ethical principles of justice and respect for autonomy require obstetricians who provide cesarean deliveries on maternal request when medically appropriate to discuss this delivery option with all appropriate patients and not just with those patients who request the procedure.” Since I don’t think it’s good medical practice to offer a pregnant woman a cesarean section if there is no medical indication to do one, this article seems to me to be a futile exercise, giving advice on how to perform an unethical act ethically.

Article title: “Prenatal Consultation for Extremely Preterm Neonates: Ethical Pitfalls and Proposed Solutions.” This article addresses the situation of the patient who is at high risk for the imminent delivery of an extremely preterm infant, one whose survivability is doubtful. Often a newborn specialist is called in, who quotes statistics and asks the parents to make an immediate decision regarding whether or not to treat the newborn. The article advocates a more fluid, ongoing process that takes into account the evolving situation. O&G‘s bottom line: “The prenatal consultation process should be viewed as an ongoing, long-term, shared decision-making process that provides desired information, emotional support, and compassion to parents.” As I’ve argued before, the autonomy-trumps-all approach of the physician asking “Do you want us to let your loved one die?” is an abrogation of professional physician responsibility for actions and decisions. This article takes a welcome step away from inappropriately placing the entire burden of decision-making on highly-stressed parents who may not be in a position to make such a decision.

From Marianne Burda, “What is New in Ethical Issues in Obstetrics? Best Articles From the Past Year.” Obstet Gynecol 2016;127:157–8

Seeing the Horror

A video released by The Center for Medical Progress (CMP)  about Planned Parenthood included these words: “Some viewers may find this content disturbing.” It was to warn the viewer about the images of piled fetal body parts dumped from a bag by an abortion clinic worker.

What might be most disturbing…and chilling…is not the body parts, but the casual and glib attitudes of the Planned Parenthood staff toward them.

A subsequent post  in the Bioethics Forum of The Hastings Center attempted to explain away this indifference:

…most of us also don’t want to see graphic photos of any other type of surgery either. But our desire to look away isn’t inconsistent with thankfulness for the life-saving and health-preserving results of any type of medical procedure. It just means we don’t want to watch their gory accomplishment. But physicians don’t have the privilege we have of enjoying medical results without seeing the unpleasant in-between.

I suspect that the author hasn’t watched all the videos. And I’m not sure what purpose bioethics institutes will serve for our society if they harbor notions that fetal vivisection is comparable to “enjoyable” medical results that are “life-saving and health preserving.”

Yes, as a physician, I can see body parts…and worse…without passing out. But every physician must recognize the moral significance of the connection to the human, or else the profession of medicine is not a moral endeavor. In contrast to attitudes of the abortion clinic workers, in the CMP’s videos, the former StemExpress employee Holly O’Donnell expresses a depth of moral insight to recognize that each of these aborted fetuses was more than just a “tissue opportunity.”

It had a face…I remember picking him up…he was big…I remember holding that fetus in my hands when everyone else was busy…It’s really hard knowing that you’re the only person who is ever going to hold that baby…I would think about things like that…I wonder at age 3 if she would like a color…or I wonder what it would look like, her mom or her dad…

Planned Parenthood’s brutality is the logical consequence of Dr. Alan Guttmacher’s (former president of Planned Parenthood) belief, subsequently effectively written into law by the Supreme Court, that “…no baby receives its full birthright unless it is born gleefully wanted by its parents.” Yes, Planned Parenthood and its supporters are being purely logical. But pure rationality in the face of human dismemberment is no virtue. Watching Planned Parenthood staff speak of selling fetal body parts, I am reminded of G. K. Chesterton’s words in Orthodoxy: “The madman is not the man who has lost his reason. The madman is the man who has lost everything except his reason.

The Physician’s Imprimatur

In a previous blog response about physician-assisted suicide (PAS), Mark McQuain asked, “Why involve physicians at all?” That question gets too little attention.

There are some easily discernible (and perhaps expressed) reasons why physicians are chosen to be the agents of assisting suicide. First, they have access to pain- or consciousness-relieving pharmacologic measures that also have the (in this case) desirable effect of stopping breathing when given in high enough doses. Second, by their professional ethic, physicians should approach patients with compassion, which, as mentioned previously, is the catchword that is quite deliberately attached to the act of assisting suicide by those who promote it.

But as Dr. McQuain suggests, access to painless methods for killing need not be restricted by to physicians, just as compassion is not; there is no law of physics that prevents others from assuming this role. To limit the methods and the responsibility to physicians is a willful act by society.

This leaves one main reason for committing the responsibility of assisting suicide to physicians: involvement of physicians gives it a much-desired moral certification, or imprimatur. Here is the logic, unspoken as it is:

  • Physicians have moral standing;
  • If physicians are involved,
  • Then the act has moral basis

But this gets it backwards. Physicians have moral standing based on what they do and what they refrain from doing. Edmund Pellegrino wrote often of the “intrinsic morality” of medicine which depended on the nature of the physician-patient relationship. Such morality stems as much from what is not done as from what is done.

We need not agree upon any particular bioethical issue to realize the significance of the tactic, in how it can could be used by proponents of various acts to enlist, and yes, even pressure or legally mandate, the involvement of physicians. Or, for that matter, the involvement other people whose life work is viewed by society as having moral standing.

If PAS were to be legal across the US, would physicians buy into the idea that it is consistent with the underlying ethic, or intrinsic morality, or their practice? I predict that most would not. Recall the vision of abortion (when first made legal by judicial decree) being done by the patient’s family physician, which presumed a longstanding benevolent and wise relationship. This of course failed to happen, and abortions have since become centered in facilities where patient and doctor remain, by no accident, strangers. Most physicians do not want to be associated with abortions ( and none of the many family physicians I’ve met) because they know that there is a quality to the act that impacts them; it would not be benign simply because they did it. And it is not consistent with the underlying moral and ethical basis for their medical practice.

So it will be with physician-assisted suicide. The strategic involvement of physicians will most certainly mean that some will be involved. But most who could be involved will decline, knowing, or at least sensing, the inverted logic behind how physicians got pulled into the affair to begin with.

How Far Can We Fall If There is No Bottom?

A May 26th post in the Bioethics Forum of The Hastings Center asks “Are we reaching a tipping point in the debate over physician aid in dying?” The author cited the case of a Cornell psychologist who opted to commit suicide with physician assistance before Alzheimer’s caused her to lose “all quality of life” and “meaning.”

Cases such as these are compelling, because aging, infirmity, and dying are so. Each instance causes distress, and to remove distress seems to be the ultimate humanitarian act.

We must ask, however, why Hippocrates thought it necessary so long ago to include in the physician’s oath the injunction against assisting suicide. What was it he saw that made it necessary to draw this bright line? Certainly suffering was at least as common then, as physicians did not have nearly as many tools to alleviate it. For Hippocrates to draw this line in the face of suffering, he would have had to see how far physicians could go in willfully causing their patients’ deaths, and the consequences of such actions on the profession, the community, and the relationship between them. We don’t see such problems today, as we are still living off the fruit of that ethical standard.

In ethics we ought to consider the importance and value of clear lines such as those written into the Hippocratic Oath. They do not guarantee that nothing undesirable will happen. They do, however, serve as a floor, guaranteeing that professional conduct will only fall so far. If removed, what then becomes the insurance that we will not step lower and lower?

Many years ago I spoke with the head of a large shelter for the homeless. He had an impressive background, retiring from the Army where he had served in the Rangers. Driven by the imperative of his Christian faith to aid his fellow man in need, he had become a nurse and eventually in charge of this shelter in a Georgia city. I asked him what was it that he saw that worried him the most. He said, “Youth today have no bottom.” After I asked him to explain, he said that many youth so lacked any moral foundation that there was no depths of depravity to which they couldn’t fall. A few months later was Colombine.

We could debate in detail each of the author’s premises, such as claims as to what is “quality of life,” or “meaning,” or the role of physicians. One thing we must recognize, however, is that line drawn so long ago by Hippocrates has served as a “bottom,” preventing physicians from plumbing the depths of increasingly abhorrent acts. In discussions of PAS, proponents of it extract the positive feelings and leave the scene before the unpleasant consequences emerge. Hippocrates must have known those full well, and with that knowledge wrote his oath. I fear that we will soon regain that knowledge…the hard way.