Care Dis-integration

The May 3rd edition of the New England Journal of Medicine brings us a powerful story. It is a tale of a patient, named Kenneth, written by his physician brother.

Central to the story is a delay in diagnosis, brought on by unfamiliarity with the patient as a whole person, biases against those with mental illness, presumptions and other errors familiar to those of us with an inside view of what can go wrong. The healthcare system allows these to occur through its “dis-integration.” From the story:

Rosenbaum highlights the larger problem: “Care integration is an attitude.” But this “attitude problem” affects countless U.S. patients, not just those with mental illness (or severe physical disabilities, like quadriplegia).Whose attitude, then, needs adjustment? Many doctors and nurses seethe about the profit-driven dis-integration of our health care “market” yet insist they can’t fix this mess themselves. Kenneth, no stranger to cognitive dissonance, said, Well, if they can’t fix it, who the hell can? This question becomes more urgent as our health care system’s balkanization becomes increasingly “normalized.”

I have just seen this up close. A friend of mine has a terminal illness. While he has long been well-served by his family physician, the onset of the illness brought specialty care, extensive and repeated imaging, hospitalizations, a rehabilitation facility, and no more contact with his physician. It also brought delayed diagnoses which seemed avoidable had he been seen regularly by someone who knew his story and his usual condition.

Wasn’t such familiarity what we always had hoped would come from the “specialty” of family medicine? And that years of familiarity would lead to an understanding no stranger could have? Such an understanding would give us what we longed for in medicine, such as more efficiency, avoidance of excessive and intrusive testing, smoother transitions of care, more acute perception of changes (and quicker diagnoses), and better advice.

Increasingly, however, the family physician of today can no longer fulfill the promise of the profession from decades past. Financial constraints keep him in the clinic exam room, efficiently churning through patients within a narrowing scope of practice— no longer on the wards, or in the nursing home, or performing obstetrics, or even seeing children under two. Unable to venture out because time (equals money) would be lost, he is no longer involved in the care of his patients when they need something beyond his clinic. And it is in those intense moments that he is needed the most.

I would like to have a simple answer. Kenneth’s question stings: “Well, if they can’t fix it, who the hell can?” The financial pressures are enormous, however. Costs are up for countless reasons, and to keep the money flowing, a physician becomes the engine that must keep running… inside the engine room that is the modern day clinic.

Perhaps nothing short of a major disassembling of our medical system will change that. Such change may only come from catastrophe; even then any rebuilding would take a level of insight and courage…and preparation…that are unlikely to appear in future leadership under modern pressures. If we’re ever to move toward a dream of “care integration,” however, we’ll have to start somewhere– with understanding where we are, how we got here, and where we ought to go.

A pause for doctor-assisted suicide in California

Readers of this blog probably saw this week’s news that a California judge blocked the state’s End of Life Options Act, the one that legalized doctor-assisted suicide in California.  The law passed after apparent failure in a regular California Legislature session, when its sponsors brought it up again in a special session that was supposed to be about Medicaid funding.  The judge said that inserting the assisted suicide law into that session violated the California state constitution.  So doctor-aided suicide is on hold in the state, for the moment.

Sort of a technicality, and celebration of the decision by folks (like me) who are staunch opponents of assisted suicide is likely to be short-lived.  Supporters will certainly challenge the ruling on appeal, perhaps win, perhaps also bring up the law anew in the Legislature, with (re)passage all but certain.

Legal assisted suicide is still bad policy, and assisting another’s suicide is still unethical.  But efforts against it have to address the attitudes and perspectives of our fellow citizens.  Allowing doctors and others to aid suicide poisons the central calling of medicine to protect life and to address human suffering accordingly.  It risks undermining proper palliative care.  It creates a “duty to kill” that someone has to step up to fill—or to be conscripted to fill, against moral objections that will be rejected as “inconsistent with standards of medical practice.”  It cannot logically be limited to the terminally ill (see Steve Phillips’s May 9 post on this blog) and cannot be reliably limited to those who freely and willingly choose death.  And it opens the idea of “rights” to misuse by those who desire death and to misappropriation by those who have reason to think that someone else should desire death.

Opposing assisted suicide is a longer undertaking, more than one vote or even series of votes, more than a court case with appeals.  It requires the cultivation of moral virtue by ourselves and our posterity.  It requires humble compassion subject to valuing the sanctity of human life.  It requires changed hearts.

One Man’s Trash is Another Man’s DNA Treasure

Last month, investigators used big data analysis, public DNA genealogy websites and “Discarded DNA” to identify the Golden State Killer (WSJ subscription needed), an individual believed responsible for over 12 murders, greater than 50 rapes and over 100 burglaries in California between 1974 through 1986. While justice may be served if the legal case remains solid, there are some interesting bioethical issues that warrant discussion.

This blog has previously discussed the ethics of searching reportedly anonymized databases and the ability of algorithms to “unanonymize” the data (see HERE and HERE). The current technique used in the Golden State Killer case takes this one step further. Using a public genealogy database site, where individuals looking for distant relatives voluntarily share their personal DNA samples, investigators looked into these databases for partial DNA matches. A partial DNA match means that the investigators were looking for any relatives of the original suspect hoping to gain any identifying information of the relative, leading back to the original suspect. Then, using this narrower group of DNA relatives, investigators literally collected DNA samples this group of people unwittingly left behind, such as skin cells on a paper cup in the trash, so called discarded or abandoned DNA.

One man’s trash is another man’s DNA treasure.

Presently, neither the method of partial DNA search of public voluntary genealogy databases nor the collection of discarded DNA samples violates the 4th Amendment regarding unreasonable search and seizure. Neither the Health Insurance Portability and Accountability Act of 1996 (HIPAA) nor the Genetic Information Nondiscrimination Act of 2008 (GINA) provide protection as none of the data relates to health care records or employment, respectively.

Shouldn’t some law or regulation prevent my personal DNA code from becoming public, particularly if I have not taken steps to publicize it on one of the many public voluntary genealogy sites?

Since your DNA is the ultimate physical marker of personal identity, how much control do you or should you have over it? While you may wish to live a life of anonymity, your extroverted cousin who voluntarily provides her DNA to a public DNA database has just unwittingly publicized some portion of your family DNA as well as traceable personal family data that may allow others to know more about you than you desire. An energetic sleuth dumpster-diving your trash can retrieve your actual DNA. I shred my mail to avoid my social security number or other personal financial information from being obtained and used for identity theft. How do I “shred my DNA” to prevent it from being similarly recovered from my trash?

What may someone do with my DNA information obtained using these techniques. What should someone be able to do?

You could not have convinced me back in 2001 that anyone would spend money to build cars with 360 video equipment and figure out optimal routes that would eventually become what is now Google Street View. Might not someone do the same thing with trash-sourced DNA samples, perhaps Google DNA View?

We already have figured out the garbage truck routes.

Choosing to die

When people present an argument for the moral permissibility of euthanasia they commonly start with a case in which a person is suffering from a terminal illness and has uncontrolled pain. They say that we should have no moral reason to say that it is wrong to assist those in such a condition who choose to end their life as a means of ending their suffering. This is a combination of two arguments. One is the argument from compassion that says that we have a moral obligation to minimize suffering and that euthanasia should be used if it is the most effective way to eliminate a person’s suffering. The other is the argument from respect for autonomy that says that people should be able to make decisions about their own lives, which should include the decision to end their lives, and that their physicians should respect those decisions. It has been pointed out by many who take the position that euthanasia is wrong that if these are good arguments for the permissibility of euthanasia they should be able to stand on their own. If we take these arguments individually, they lead places we should not want to go.

A couple of weeks ago I wrote about the concerns that many who live with disabilities have regarding the argument from compassion. It says that it can be the right thing to do to end a person’s life when that life is no longer worth living. They are concerned that if they become unable to make their own decisions someone will decide their lives are not worth living and they will be euthanized nonvoluntarily.

A recent case of joint euthanasia by a married couple in their mid-nineties in Canada reported in the Globe and Mail shows what can happen when the argument from respect for autonomy is taken by itself. George and Shirley Brickenden, who had been married for nearly 73 years, choose to die together. They died by lethal injection while lying on their bed holding hands in the presence of their children and clergyman. There was question about whether they both met the criteria of the Canadian law, which requires that the person receiving assisted death be suffering intolerably from a grievous and irremediable condition and that death is reasonably foreseeable. Even though Shirley suffered from long-standing rheumatoid arthritis and heart problems and George had recently begun having fainting spells from a heart rhythm problem, the primary reason for choosing euthanasia was that they did not want one of them to die and leave the other behind.

If the argument from compassion is a reason to accept euthanasia then we must accept nonvoluntary euthanasia in spite of the concerns of those with disabilities. If the argument from respect for autonomy is a reason to accept euthanasia then we must accept euthanasia for any reason given by a rational person including the desire of a married couple not to have one spouse survive longer than the other.

Rather than going to these extremes it seems reasonable to accept that there are limits to the things we ought to do to diminish suffering and there are limits to how far we should go in respecting a person’s autonomy. The intentional killing of an innocent person lies outside those limits.

My Day at the Florida Bioethics Network Conference–2018

For the past several years, it has been my privilege to attend the annual conference of the Florida Bioethics Network.  As in prior years, this year’s conference showed the great range of topics that fall under the umbrella of bioethics.   Topics included the so-called “Tattoo DNR,” a discussion of medical marijuana, the potential promise of an electronic and interactive informed consent document, and even a discussion of the role of clergy on ethics committees.  Each of these topics could merit a blog post, but the one that grabbed my attention the most was the discussion of “Public Health” by Celeste Philip, Florida’s Surgeon General and Jeffrey Brosco, the Deputy Secretary of Children’s Medical Services for the Florida Department of Health.

In an increasingly divided country, the concept of public health seems more remote than ever before, yet the presenters made it clear that it is a goal worth pursuing.  After all, “Your zip code is a better predictor of your health than your genetic code,” they argued.  With the prevalence of the 23 & Me-style genetic testing, their statement took me by surprise. After giving it some thought, their point was clear.  Addressing public health is an important function of government, they stated, and if the disparities between zip codes continue to grow, our health care system will be facing even more serious challenges than ever imagined. They claimed that the greater the inequality there is in income in a community, the greater the mortality – for everyone.

Both Drs. Philip and Brosco used the ethical concept of justice (which they used alongside “accessibility”) to underscore their case for a robust public health system.  Understanding that there is an ongoing tension between community protection and individual autonomy, they made a case that “Public health ethics requires both identifying the values that underlie policy as well as optimizing the language we use to convey available options.” (If you haven’t seen this already, in 2010 The Robert Wood Johnson Foundation published an article entitled, “A New Way to Talk about the Social Determinants of Health.”

I found the presentation to be both thoughtful and thought-provoking, going beyond many of the typical bioethics conversations that I encounter on a day-to-day basis. Those committed to a Christian worldview would do well to engage in this discussion.



More on genetic medicine

The third and final installment from The Code, a series of 3 short documentaries on the internet about the origins of genetic medicine, is entitled “Selling the Code.”  This is about genetic testing to try to predict risks of diseases, among other things.  Doctors use some of this testing in clinical care and a burgeoning amount of research.  A number of companies, such as 23andMe, will, for a (not-too-high) price, sequence your genes, or at least some of them, from a cheek swab sample you send, and then give you a report of what the results are and what they might mean.  In cases where there is a simple connection between a genetic abnormality and a disease—if you have the gene, you get the disease—the approach can be very helpful.  But it’s rarely simple.  Even for known cancer-propensity genes like BRCA1 and BRCA2, there are many variants, and what they mean clinically is far from fully known.  In fact, for most of the common disease we care about, like heart disease, diabetes, and most cancers, the story is complicated indeed.  So what to do with the information is often far from obvious, and careful genetic counseling by a physician who specializes in genetic medicine is a must.

23andMe ran afoul of FDA a couple of years ago, leading to a long process that resulted in FDA acceptance of a more limited menu of testing by the company.

And some companies will sell you “genetic information” for more trivial concerns—presuming to tell you something meaningful about what fitness regimen you should pursue, or what wine you’ll like.  Caveat emptor, I suppose, although the risks are low for some of this.

AND—companies like 23andMe keep anonymized data bases of the genetic information they get for and from their customers, and sell that information to drug companies to support the latters’ research.  An individual can’t be identified in the process (at least, not readily, see my January 2013 post about “DNA research and (non)anonymity”) but the data in the aggregate is valuable to the genetic sequencing company.

These kinds of concerns—particularly what to do with an individual’s information, but also the usefulness of having genetic data on a large group of people to understand disease and help discover new treatments—are germane to an ongoing project of the Hastings Center to assess the implications of genetic testing of the whole genomes of large numbers of babies, to screen for any of several dozen genetic diseases.   Again, most of the babies will be perfectly healthy, and the yield from screening for rare conditions is low.  But people arguably have a right to know about themselves, and parents to know about their newborns.  Yet still, to what end will we use information that we don’t fully understand?  Read a good Los Angeles Times article, that overlaps some of the points in The Code’s video, and provides other useful information in quick-and-easy form, here.

Finally, I was gratified to read that a project to synthesize an entire human genome in the laboratory is being scaled back, at least for now.  Apparently, they can’t raise enough money.  I bet would-be investors aren’t convinced they could own the results and guarantee a return on their money.  I fretted about this in May of 2016 and again in July of the same year.  I encourage readers to click through and read those, as well as the concerns raised by Drew Endy of Stanford and Laurie Zoloth of Northwestern, who criticized both the effort in concept and the closed-door, invitation-only meeting at Harvard to plan it.

That was two full years ago.  A lot is going on under our noses.

Deep Brain Stimulation: the New Mood Modifier?

A patient of mine recently had a deep brain stimulator (DBS) placed to reduce her severe tremors. The stimulator has worked very well to almost eliminate her tremor but has resulted in a side effect that causes her personality to be more impulsive. Her husband notices this more than the patient. Both agree that the reduction in the tremor outweigh the change in her personality though her husband has indicated that her personality change has been more than he imagined when they were initially considering the surgery. He has commented that if her new impulsivity were any stronger, he might be inclined to reverse the process. As one might imagine, the patient sees no problem with the impulsivity and remains extremely pleased with her newfound lack of tremor.

I share the preceding clinical vignette as backdrop to a recent article in Nature describing research funded by the US military’s research agency, The Defense Advance Research Projects Agency (DARPA – the same group that sponsored the early development of the Internet), where they are looking into modifying neural activity with the goal to alter mood, and eventually cure mental health disorders. Using patients that already have DBS stimulators in place for treatment of epilepsy or movement disorders such as Parkinson’s Disease, scientists are developing algorithms that “decode” a person’s changing mood. Edward Chang, a neuroscientist at the University of California, San Francisco (UCSF) believe they have a preliminary “mood map” and further believe that they can use the DBS stimulators to stimulate the brain and modify the local brain activity to alter the patient’s mood. The UCSF group describes this as a “closed-loop” (using the stimulator to both receive and then stimulate the brain). Chang further admits that they have already “tested some closed-loop stimulation in people, but declined to provide details because the work is preliminary.”

If scientists are on the verge of changing your mood, might they not also be on the verge of creating your urges? Professor Laura Cabrera, a neuroethicist, and Professor Jennifer Carter-Johnson, a lawyer, both at Michigan State University, argue we need to begin worrying about that possibility and further that we need to begin considering who is responsible for those new urges, particularly if those urges result in actions that cause harm against other people. The article does a masterful job of the ethical-legal ramifications of just what happens when your DBS causes you to swerve your car into a crowd of people – Is it your fault or did your DBS make you do it?

Returning to my patient, the alteration in her behavior is an unwanted but not a completely surprising result of her DBS to treat her movement disorder. Despite the informed consent, her husband was not prepared for the change in her personality. The treatment to correct my patient’s movement disorder (a good thing) has altered my patient’s personality (a not-so-good thing). My patient’s husband might even argue that his wife is almost a different person post DBS.

When we modify the brain in these experiments, we are intentionally modifying behavior but also risk modifying the person’s actual identity – the “who we are”. As the DARPA experiments proceed and cascade into spin-off research arms, we need to be very clear with patient-subjects in current and future informed consents that the patient who signs the consent may end up very different from the patient who completes the experiment. How much difference in behavior or urges should we tolerate? Could the changes be significant enough that they are considered a new person by their family and friends?

And if that is true, who should consent to the experiment?

Euthanasia and those who live with disabilities

This week the students in the medical ethics class that I teach are looking at the issue of euthanasia and physician assisted suicide. An article in The Catholic Register reminded me of the important role that people with disabilities have played in the public discussion of euthanasia. The article discusses the concerns that Taylor Hyatt, policy analyst and outreach coordinator for the disability rights group Not Dead Yet, has expressed about assisted suicide in Canada. She is concerned about proposals being considered to expand the Canadian Medical Aid in Dying (MAiD) law “to include mature minors, allow advanced directives for those with a dementia diagnosis, and allow MAiD for those with psychological suffering without the necessity of death being reasonably foreseeable.” She also expressed concern that under the present law no one is looking to see if those seeking assisted death have unmet accessibility needs that are pressuring them to end their lives.

From the earliest discussions about legalizing physician assisted suicide in the US, disability rights groups have played a significant role. They recognize that with any form of euthanasia the physician who chooses to assist in causing another person’s death must agree that the person’s life is not worth living. If we say that it is ever permissible for one person to say that another person’s life is not worth living, then it opens the door to people thinking that a the life of a person with disability is not worth living and that it would be best if that person’s life would be ended. Thus, even fully voluntary euthanasia puts those who are disabled at risk for nonvoluntary euthanasia. Actually many more than those with disabilities are at risk, but the marginalization that they experience makes them more sensitive to the risk.

We should listen to them.

Raiding the CRISPR

The second installment from The Code, a series of 3 short documentaries on the internet about the origins of genetic medicine, addresses gene editing.  The current approach to this exploits “CRISPR,” or “Clustered Regularly Interspersed Short Palindromic Repeats,” DNA sequences initially discovered as a sort of bacterial immune system but very efficient at editing out undesirable genetic features, such as disease susceptibility mutations in plants or, for that matter, people.

For medicine, the CRISPR approach is one of the latest ways of approaching gene therapy.  For example, sickle cell anemia is caused by a single misplaced “letter” in the 3-billion-letter human genetic code.  (It’s actually 6 billion because there are two copies of each gene, only one of which is “read” to produce what the gene codes for.)  It’s a blood disease, one in which the red blood cells are defective, and to treat it definitively requires replacing an affected person’s blood cells with good, normal ones.  Sickle cell is inherited, and it shows up in kids, and, trust me, if you’ve ever taken care of someone with it, as I did 30-some-odd years ago in my medical training, you’d welcome a world in which people didn’t have to suffer from this.

The problem: where to get the good cells.  Answer: from a suitable donor, or perhaps by taking out some of the sick person’s bone marrow cells, editing the abnormal hemoglobin gene with genetic “scissors,” and infusing them back into the person’s vein, to take up residence in the bone marrow and flourish, normally, replacing the sick cells.  CRISPR is the genetic “scissors.”  The approach is still experimental, but promising.

Technical and safety concern: how can we be sure the scissors don’t go “snicker-snak,” as my old genetics professor used to say, in the wrong places, and change other genes?  They appear to be pretty accurate so far, but just how sure are we?

Bigger ethical concern: might we—should we—edit a human embryo—say, one diagnosed after IVF but before implantation—to nip the genetic disease in the bud, with the prospect of preventing future generations from getting the abnormal gene, and hence the disease, at all?

Hmmm…to cure—perchance to control?—that’s the rub.  Where would be draw the line?  Could we?  Why would we?  Why not try to edit as many diseases out of existence—and as many desirable traits into existence or predominance—as we could, technically?  Well, apart from the small problem that the genetic bases of most diseases are more complex than we yet understand (see last week’s video release from The Code), or the other small problem that editing multiple genes at once is, as of now, still a future prospect for genetic engineering and the field known as “synthetic biology,” is the concern that people making the decisions about what to edit become, as it were, the “actors,” or “conditioners,” to borrow C.S. Lewis’ term from The Abolition of Man, while those acted upon, and their progeny, are subjects—perhaps (unavoidably) unknowingly.  If this is in the context of doctor/patient relationships and specific diseases and informed consent (to the degree that is possible), and the like, that may be fine, but broader use raises concerns that should be obvious.

CRISPR-based gene editing is the most recent approach to gene therapy.  The bulk of the video is about other approaches.  It reviews past history, including efforts not to edit genes, but add good genes to replace missing or bad function of bad genes.  It also reviews the history of people dying from gene therapy research that was, in retrospect, charging ahead perhaps faster than it should have been.  And it mentions recent successes.  Still relatively scattered, but promising, and, if pursued under proper human subject research ethics, generally ethical.  It’s the prospect of heritable editing that gets worrisome.  And we should remember that, even for the ethical stuff, we humans can envision medical advances faster than we can make them reality.

These videos are good viewing for the general public.  Check them out.

New Moral Anesthesia for Abortion

“Is it possible, once again, to hold in tension seemingly opposite ideas about abortion?” This is the main question asked by Dr. Lisa Harris in the lead editorial in the April 12, 2018 NEJM. Her concern is that in her view, since the creation in January of the new Conscience and Religious Freedom division at HHS, subsequent comments by HHS leaders “suggest that they are uninterested in discrimination against health care providers whose consciences compel them to provide care, and uninterested in injuries to patients caused by care refusals.” (emphasis hers) She wants us to return to the time of the 1973 Church Amendment when she argues that lawmakers reached common ground protecting conscious rights of healthcare workers, then holding what she describes as a tension “between abortion as a new fundamental right for U.S. women and the reality that some healthcare providers could not in good conscience participate in it.” Our inability to maintain that tension, she believes, will continue to result in our present extreme divisiveness on the abortion issue. So, specifically, per Dr. Harris: “Can we understand abortion as both something that ‘stops a beating heart’ and a fundamental right, rather than insisting it’s only one or the other?”

Trying to understand abortion as both is the problem. Cognitive dissonance is the word Dr. Harris was looking for, and she is correct that something was needed immediately after Roe v. Wade to ease that dissonance.

With Roe v. Wade in early 1973, the Supreme Court determined that the Constitution prohibits the government from stopping one individual from ending the life of a second individual who was not actively ending the life of the first individual. No one was honestly claiming that we needed Roe v. Wade to allow physicians to perform an abortion to save the life of the mother if the baby/pregnancy was immediately threatening the life of that mother. The Church Amendment, which passed shortly after Roe v. Wade became law, essentially said that no one will be forced to perform an abortion or be discriminated against if they did so – effectively permitting an individual to follow one’s own religious beliefs or moral convictions on the matter. Abortion became just a personal religious or private moral thing.

I believe that the Church Amendment was the necessary moral anesthesia that allowed the Supreme Court to surgically join the opposite ideas that an abortion is both a fundamental right and an act that “stops a beating heart”, the amendment effectively numbing our ethical faculties to what Roe v. Wade would now permit.

Had pro-choice supporters simply adhered to the Church Amendment, there would not have been growing broad demand by pro-life groups for the proposed Conscience Protection Act of 2017 (H.R. 644). I suspect most pro-life supporters hope the creation of the new HHS division will correct the concerns addressed in the failed bill.

I worry the new HHS division will be the new moral anesthesia to lull us into contentment with securing arguably necessary conscience protections at the cost of leaving Roe v. Wade intact.

In his recent blog post, The Child I Want, Neil Skjoldal nicely articulated the dehumanization that results when we create a fundamental right to “stop a beating heart.” But we have known that this would happen since that right was first established. Almost identical concepts were discussed during oral arguments of Roe v. Wade, such as the following exchange between Justice Potter Stewart and attorney Sarah Weddington, who represented Roe. (see LINK for transcript or audio of the second reargument Oct 11, 1972, approximately one-third of the way through):

Potter Stewart: Well, if it were established that an unborn fetus is a person within the protection of the Fourteenth Amendment, you would have almost an impossible case here, would you not?

Sarah R. Weddington: I would have a very difficult case. [Laughter]

Potter Stewart: You certainly would because you’d have the same kind of thing you’d have to say that this would be the equivalent to after the child was born.

Sarah R. Weddington That’s right.

Potter Stewart: If the mother thought that it bothered her health having the child around, she could have it killed. Isn’t that correct?

Sarah R. Weddington: That’s correct.

So, to answer Dr. Harris: “Can we understand abortion as both something that ‘stops a beating heart’ and a fundamental right, rather than insisting it’s only one or the other?” — I certainly hope not.