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?

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.

Belgian Euthanasia: Volunteers No Longer Necessary?

A recent resignation letter by one member of Belgium’s Euthanasia Commission suggests the slippery slope of who meets the criteria for legal euthanasia is becoming even more slippery. Dr. Ledo Vanopdenbosch sent his resignation letter to members of the Belgian Parliament who oversee the commission. His concern was with one of the main requirements of the law, which demands that the individual patient formally request euthanasia. Vanopdenbosch claims euthanasia occurred on a psychiatric patient without his or her request. His resignation has generated substantial concern not only because Vanopdenbosch is a committee member but also because he is considered a strong advocate of euthanasia. Here is the AP article in Voice of America with the details.

One of the main tasks of the Belgium Euthanasia Commission is to review every euthanasia case to make sure each case meets the legal criteria necessary for euthanasia. Any case in doubt is referred to the public prosecutor’s office. It is perhaps telling that in the last 15 years since legalization of euthanasia in Belgium, over 10,000 individuals have been euthanized but only one case has been referred to prosecutors by the commission with the concern that it may have been performed illegally. Vanopdenbosch argues that the commission is acting in place of the courts, a potential conflict of interest given that those on the commission are generally considered strong supporters of euthanasia. In addition to the slippery slope metaphor used earlier, one might also add that the foxes are guarding the henhouse.

An internal review of this particular case resulted in the committee claiming that what really happened was an accidental death related to palliative care rather than actual involuntary or non-voluntary euthanasia, as is claimed by Vanopdenbosch. The general population will never know, as commission protocol and privacy concerns prevent the details of the case from ever reaching the light of day. In absence of further details, one wonders whether the alleged palliative care for the unknown psychiatric condition was formally requested by an otherwise competent patient or just provided absent his or her formal consent but “in his or her best interest” by the patient’s physician or caregivers.

It is presently unknown whether or not Dr. Vanopdenbosch’s resignation will result in any changes in the structure, function or transparancy of Belgium’s Euthanasia Committee. At the very least, one would expect to see an increase in referrals to the public prosecutor’s office for legal oversight. It is simply unbelievable that the committee has only encountered one case out of 10,000 cases that they found sufficiently suspect to refer to prosecutors for legal review. Perhaps more importantly, I want to believe that even those supporting euthanasia would be against all forms of non-voluntary euthanasia, particularly involuntary euthanasia. Sadly, I am naive. In our post-modern world, how can any death be a “good death” unless, at the very least, the competent patient in question so stipulates?

(For an excellent recent YouTube interview containing a brief history of euthanasia, please see this link of an interview with Dr. Richard Weikart, Professor of History at California State University, Stanislaus. Some highlights: at 10:40 where he touches on Belgium and psychiatric euthanasia, at 19:00 where he discusses the slippery slope argument, and at 21:30 regarding non-voluntary euthanasia)

Psychiatric advance directives

Even though I teach bioethics and teach about advance directives, I was not aware that there was such a thing as a psychiatric advance directive until I read this article in the online magazine STAT, which I found while browsing the articles listed on Bioethics.com.

The concept of a psychiatric advance directive makes so much sense that I am amazed that I hadn’t thought about it or read about it before now. Psychiatric advance directives allow people with a psychiatric illness that causes them at times to be incapable of making decisions about medical care to make and record decisions about treatment during times in which their disease is under control and they have capacity to make those decisions. This allows them to consent in advance to much needed treatment which they might refuse during times of incapacity and give direction on what treatments they would not consent to during those times of incapacity. It allows people with psychiatric illness to have control over their own lives that they commonly lose when the illness takes away their decision-making capacity. It can also help assure that they receive treatment from those that they know and trust.

This is something that many of us who are not psychiatrists need to be aware of so that we can encourage patients to take control of their own care in a positive way. When I investigated this, I discovered that my own state, Indiana, has a law regarding psychiatric advanced directives that makes them legally recognized and outlines the proper way to make such a directive. The National Resource Center on Psychiatric Advance Directives is an excellent resource on this issue.

This is something people need to know about.

Reviewing the ethics of paying human research subjects

Sometimes it is both necessary and proper to pay a person to participate in a clinical trial, of a drug or some other medical intervention, or a data-collection study, or something else that involves people.  An article in this week’s New England Journal of Medicine reviews many of the relevant ethical issues.

A link to the article is here.  Correction to initial post:  subscription or purchase does appear required.

Why pay somebody to be in a trial?  The main reasons are to reimburse them for unavoidable expenses, to compensate them for time that would not otherwise be required in the course of standard medical care or normal life, and, indeed, to get them to participate in the first place.  In cancer medicine, where I’ve worked, the subjects are cancer patients who are generally not paid to participate; they usually are willing to do so in the hope of possible benefit, plus, often, a sense of altruism.  But most drugs have their first human testing in healthy volunteers, to begin to identify potential safety concerns and understand how, and how rapidly, the drug is eliminated from the body.  In those cases, the research subjects are almost always paid, sometimes substantially.

Such payments are not necessarily unethical, as long as they are not too big.  If they are, then they could create an undue influence to participate.  That would upset the balance of benefits and risks and compromise true informed consent.  By well-accepted ethical standards for research on human subjects—many of which are codified in regulation—the risks to human subjects must not be excessive, must be avoided or mitigated to the extent reasonably possible and commensurate with the goals of the research, and must not exceed the foreseeable benefits of the research, either to the individual subject or to society overall (e.g., in the form of important medical knowledge), or both.

Payment to a subject is not considered a benefit in and of itself, but should be “neutral” to the benefit/risk assessment.

There’s no hard and fast rule about paying subjects—no single standard “fee schedule,” so to speak.  Rather, each ethics board reviewing a study must also review and approve the amount and timing of payments to subjects.  Again, such payments should be high enough to respect the subject’s contribution to the research, but not too high so as to give them incentive to participate when maybe they should not.  Also, it’s a general principle that payment should be in installments; generally, no more than 10-15% of the total should be held back to the very end of the study.  Why this last point?  Because it’s also a principle that subjects can opt out of a study at any time, but if they think “I have to stay in to the bitter end to get paid,” that could pressure them too much.

Note, BTW, that such pressure is not the same as coercion, which by definition involves a threat, and does not apply to this payment question.

Also, payments must be appropriate so that subjects don’t get a wrong idea about the potential value or efficacy of an experimental drug, or that they might be induced to try to be in more than one study at once.  You might be surprised how significant that last risk is.  In my past IRB work, we just to worry about “professional subjects” who make some level of living by going from one research study to another.  More than one at once means getting two or more drugs at once that probably ought not to be combined, willy-nilly.

And of course, the potential for economic exploitation of low-income individuals must also be considered and respected.

The NEJM article really doesn’t break new ground but is a helpful review for those interested in essential research ethics.  The FDA has also provided guidance, which can be reviewed here.

DIY CRISPR Kits – Gene Editing for the Rest of Us

One might think with the amazing advance of technology and easy access to nearly infinite data via the Internet that we, as a society, would see a reduction in false claims of benefit for novel medical procedures and untested medications. Sadly, it seems to be just the opposite. I seem to be spending gradually more time with my patients reviewing the results of their internet research for new solutions for their chronic back pain. Their efforts are laudable even though the “hoped for” benefits claimed in their researched solutions are woefully lacking. Unfortunately, often this exercise in reviewing the outside data takes valuable time away from the remainder of the office visit.

Reviewing false or confusing information is one thing but preventing patients from self-experimentation with untested medications or unproven treatments is another. Enter the biohacker and companies offering do-it-yourself (DIY) kits claiming to allow anyone to experiment with CRISPR (a method of genetic editing) for self-administration. Emily Mullin covers biohacking and DIY CRISPR very nicely in her recent article in the December Technology Review. To me, this has the feel of the 1980s when a curious kid with some basic programming knowledge, an inexpensive computer and a modem can access previously forbidden government systems, potentially unleashing havoc on the rest of us (WarGames, anyone?) After all, now that we know the human genetic code, all we need is for someone to just provide the instructions and tools for editing that code, then anyone could tweak their own DNA. Easy peasy lemon squeezy, right?

Recently, the FDA has been busy trying to prevent medical clinics from administering untested stem cell treatments (see Neil Skjoldal’s recent November blog entry on (Stem Cell Clinics & the FDA). Imagine the significant increase in the scope of the regulatory problem if individuals can order a DIY CRISPR kit off the Internet!

While we might chagrin at the naiveté required to believe the street-side pitch of the Old West Carter’s Little Liver Pill salesman, that same pitch via a modern tech savvy YouTube video (complete with separate internet links) somehow offers a new level of legitimacy. The Technology Review article speculated that one of the featured companies was preparing not a vaccine but a treatment for herpes. In less than 8 weeks from the article’s publication, Aaron Traywick, CEO of Ascendance Biomedical, publically self-injected himself with his firm’s untested and non-FDA approved “treatment” for herpes. The linked article by Reegan Von Wildenradt in the popular magazine Men’sHealth offered an excellent counter as to why this type of “science” might be suspect, including quotes from ethicist Arthur L. Caplan at NYU in support of the standard FDA process for screening medical treatments.

We often lament in this blog that technology is advancing so rapidly that we fail to have a fair public hearing and discussion of the ethics involved in a particular biomedical advance. Now it seems our time may be better spent speaking out first about the basic risks of the new technology and doing our best to support the FDA in their massive task of policing the Internet to prevent a DIY CRISPR kit from falling into the wrong hands – ours.

P.S. – I’m accepting names for the title of the future Hollywood blockbuster where the son of Matthew Broderick and Ally Sheedy injects himself with his own DIY CRISPR-modified DNA and …

Citizenship, Surrogacy and the Power of ART

A recent LA Times article by Alene Tchekmedyian explores a complicated case involving birthright citizenship, surrogacy and same-sex marriage. Briefly, a California man, Andrew Banks, married an Israeli man, Elad Dvash, in 2010. At the time, same-sex marriage was not legal in the US leaving Elad unable to acquire a green card for residency (via the marriage) so the couple moved to Canada where Andrew has dual citizenship. While in Canada, the couple conceived twin boys, Aiden and Ethan, using assisted reproduction technology (ART) whereby eggs from an anonymous donor were fertilized by sperm from Elad and Andrew and then implanted within the womb of a female surrogate and carried to term. When the US Supreme Court struck down the federal law that denied benefits to legally married gay couples in 2013, Elad applied for and was granted his greed card. The present controversy occurred when Andrew and Elad applied for US passports for the twins. US State Department officials required detailed explanation of the boys’ conception, eventually requiring DNA tests which confirmed Aiden to be the biological son of Andrew and Ethan to be the biological son of Elad. Aiden was granted a US passport while Ethan was denied. The family has since traveled to the US (Elad with his green card and Ethan with his Canadian passport and temporary 6 month visa) where they are now suing the State Department for Ethan’s US birthright citizenship. They are arguing that the current applicable statute places them wrongly in the category of children born out of wedlock rather than recognizing their marriage, thus discriminating against them as a binational LGBTQ couple.

Birthright citizenship is a complicated legal arena and I am no lawyer. The US is even more complicated because we allow birthright citizenship to be conferred jus soli (right of the soil) in addition to jus sanguinis (right of blood). The twins were not born in the US so establishing “bloodline” is needed. The law specifies conditions where one parent is a US citizen and one is not a US citizen, and there is further differentiation depending on whether the children of the US citizen were born in or out of wedlock. They also vary depending on whether the US citizen is male or female, with the law more lenient (easier to acquire citizenship) for the child of a woman than of a man.

While the legal challenge here will almost certainly involve potential issues of discrimination of LGBTQ binational couples, the problem is really with the current legal definitions of parent as it relates to surrogacy in general. The State Department actually has a website dedicated answering questions related to foreign surrogacy and citizenship. The real issue is that the State Department relies upon genetic proof of parentage for foreign surrogacy births. In the present case, the surrogacy occurred outside the US, Elad is the genetic father of Ethan and Elad is not a US citizen; therefore Ethan is not a US citizen. While I’m deep in the weeds here, technically, Aiden and Ethan are not fraternal twins in the usual sense but rather half siblings (and this assumes that the donor eggs are from the same woman; otherwise the boys would be unrelated despite sharing the same pregnant womb through the magic of ART). Had Ethan been physically born via surrogacy in the US, he would have acquired his citizenship via jus soli (see US map for surrogacy friendly states near you).

This problem is just as confounding for heterosexual couples using foreign surrogates, and the problem is global. A more detailed technical legal discussion may be found here. A heterosexual couple using donor eggs and donor sperm and using a foreign third party surrogate would have exactly the same problem establishing US citizenship for “their” child. A similar problem would exist for an adopted embryo gestated in a foreign country by a foreign surrogate. If either the egg or the sperm of the US citizen is used for the surrogate birth, the child would be granted birthright citizenship.

The main difference for homosexual couples is that only one spouse can presently be the biological parent. I say “presently” because with ART it is theoretically possible (and may become actually possible in the future) to convert a human somatic cell into either a male sperm or a female egg. At that point, both spouses within a same-sex marriage could be the biological parents of their child. The present legal issue is not the result of a cultural prejudice against anyone’s sexuality but with the biological prejudice of sex itself. ART has the potential ability to blur the categories of sex as culture is now blurring the categories of gender. Should we consider this a good thing?

Given the present technological limits of ART, the simple issue of US citizenship could be resolved in all these cases if the US citizen parent simply adopted the child. Elad correctly points out that while adoption of Ethan by Andrew would grant Ethan US citizenship, it would not grant Ethan birthright citizenship, a necessary requirement for Ethan to someday run for US president. ART may be forcing us to look at changing our definition of parent but should it change our definition of biology? Ethan is the biological son of Elad. He is able to be the legally adopted son of Andrew and enjoy the benefits of US citizenship as currently does his half brother Aiden. He is not able to become the biological son of Andrew and enjoy the additional benefit of birthright citizenship via jus sanguinis.

Should we change the definition of birthright citizenship because ART is changing our definition of parent?

Fertility with frozen eggs: not a sure thing

In case you didn’t see it, the Washington Post has this story about how more women are trying to improve their overall chances of having a baby—particularly in the later reproductive years of their 30’s and 40’s—but success is far from certain.  Human oocytes (eggs) are fragile things, and it was not until recent years that freezing techniques developed to a point that would allow the eggs to survive being frozen and, some time later, thawed (the “freeze-thaw” cycle).  Then, they would be fertilized in the lab, by in vitro fertilization, and implanted into the womb of the would-be mother.

As the article points out, women are born with their entire endowment of eggs, which become less likely to be successfully fertilized and develop into a healthy baby as they, and the woman, age.  Hence a woman’s inexorably declining fertility, particularly from their mid-30’s on.  Freezing eggs for later use is increasingly popular, if one can afford it, or if employers offer it as a perk, as some do, to their female employees.

It’s still expensive, and success appears to depend on the age of the woman (and eggs) at their harvest, and the number harvested and kept in frozen storage.  One must use the qualifier “appears,” because, as the article also points out, reliable statistics are not being kept.  The not-so-subtle implication is that the fertility “industry” wants to sell the process but would rather not know that the ultimate success rate could be as low as, or lower than, the 50-60% rate quoted by New York University.

Clear implications: better data and more transparency are to be desired, and there appear to be at least some remaining biologic limits, strong if not absolute, to reproductive freedom.  Beyond that, as I opined in May of 2013 (fairly bluntly, I do confess) are the radical implications for our concepts of parenthood and begetting children, and for turning said procreation into just plain old, quality-controlled, fully artificial creation.  Things haven’t gotten quite so absolute, yet.  But better quality control of egg freezing and the outcomes, if possible, would be a move in the direction of more artificial reproduction.

It’s a good article from the Post.  Too much to try to do justice to here.  Read the whole thing.

What’s really happening with doctor-assisted suicide?

Recently, Wesley Smith posted on the National Review’s “Corner” blog new concerns that Oregon’s “Death With Dignity” law may not be as tightly regulated as advertised.  Specifically, a Swedish fellow named Fabian Stahle, who evidently is troubled by the prospect that his country might embrace doctor-assisted suicide, claims to have carried out an e-mail exchange with someone in the Oregon Health Authority to ask how the law is interpreted in that state.  The responses included a statement that, to qualify for assisted suicide, a patient must have a “terminal illness” but said illness could include a potentially treatable condition which, if allowed to take its course without treatment, would be expected to cause death within 6 months.  That suggests that assisted suicide might be legally employed in Oregon in cases in which the patient refused treatment or the patient’s insurance company refused to pay for effective treatment.  The Oregon official cited by Mr. Stahle is quoted by him as having written that “the law is best seen as a permissive law…[that] does not compel patients to have exhausted all treatment options first, or to continue current treatment.”

You can read Mr. Stahle’s entire account here.

I must say that, while I mention this for this blog, I have not attempted to confirm these assertions by contacting the Oregon officials myself, and my first reaction is skepticism that what Mr. Stahle reports is in fact the correct interpretation of the Oregon law.  Even I, a staunch opponent of assisted suicide, must allow that the intent of such laws seems to be that assisted suicide is intended for cases for which potentially effective treatment options HAVE been exhausted.  But I suppose that further investigation is in order.

While at it, Wesley Smith also cited a 2005 British House of Lords inquiry into the Oregon law, from which a group apparently opposed to assisted suicide posted some comments here.  The entire House of Lords transcript, BTW—all 744 pages of it!—is available here for interested parties.  I must confess I have not had time to read the whole thing.

The most recent data summary from the state of Oregon that I am aware of is for 2016.  It reports 133 deaths from taking drugs from 204 lethal prescriptions filled in the state in 2016.  These numbers were slightly down from 135 and 214 in 2015.  The 2016 “death with dignity” rate is cited as 37.2 per 10,000 deaths in Oregon.  Of the 133 people who died with medical assistance in Oregon in 2016, 96% were white, about 80% had cancer, nearly all had some form of insurance, and about 85% were age 65 or older.  The two most commonly-stated reasons for seeking assisted suicide were loss of autonomy and loss of enjoyment of life—about 90% in each case.  Inadequate pain control was listed for about one-third of the cases.  The median time the patient had been seeing his or her prescribing doctor was 18 weeks, and the prescribing doctor was present for 13 of the 133 deaths.

Of course, all of this assumes the reporting is complete and accurate.  I have no information that would lead me to believe otherwise.  I state the facts in the preceding paragraph without commentary or, in some cases, without the irony I feel in reading them.

I can’t conclude from the Oregon report that patients who availed themselves of assisted suicide there were foregoing potentially effective treatment for their disease, much less that an insurance company refused to pay for it.  Of course, there is the one famous case of a person there getting a “suggestive” note about PAS from his insurer, some years ago—I can’t locate it at the moment.

In general, I’d say that the concerns raised through the above-mentioned posts are ones we must keep in mind, but that the slope may not yet have gotten that slippery.

Finally: the National Academies of Science, Engineering, and Medicine will hold a conference in Washington DC on Monday and Tuesday, February 12 and 13.  Looks like a webcast is available.  You can find information about it, and sign up to attend in person or by the web, here.  I’m going to try to at least watch some of it. From the information at that site:

This workshop will include discussions, and background materials, that address:

  • What is known empirically about the access to and practice of physician-assisted death in the U.S. and in other countries?
  • What are potential approaches for physicians, including those practicing in states where it is legal, those who receive a request for access when the practice is legal in nearby states but not in the state of practice, and those who practice in a state where it is legal but are personally opposed to physician-assisted death.
  • What is known about how palliative care and hospice services have incorporated the practice of physician-assisted death in states where it is legal?

Will Medical Compliance Ever Become Non-Voluntary?

A recent article by Dr. Lisa Rosenbaum in the New England Journal of Medicine explored both the benefits and drawbacks of Digital Adherence Monitoring. The focus was on the FDA’s recent approval of Abilify MyCite, a medicine technology that combines the medication aripiprazole, used to treat various psychiatric diseases such as schizophrenia, certain features of bipolar disorder and depression, with a digital ingestion tracking system. This voluntary digital health feedback system (DHFS) works by having the patient wear a skin patch that is triggered when the pill contacts the acid in the stomach. This event is then recorded and tracked on the patient’s smartphone. The patient can then permit their caregivers and/or physicians to access the data via a web portal. The company responsible for the DHFS, Proteus, has shown improvement in patient’s systolic blood pressure using DHFS compared with standard care. The article primarily focuses on using the technology to help doctors work with their patients to determine the reasons for non-compliance.

While this presently voluntary technology obviously can track pill ingestion and this data can certainly help doctors and patients improve medication treatment adherence, I wondered about non-voluntary uses of the technology. This particular DHFS confirms that the prescribed pill was actually ingested regardless of what the patient or their caregiver may claim. Would an insurance company be permitted to have access to this data in exchange for payment for a particularly expensive medication? Could a government agency require such a system in exchange for providing coverage for a patient for a procedure whose subsequent outcome is improved with the use a given medication?

Dr. Rosenbaum offered in her article that she thought it unethical to withhold coronary artery bypass from one of her patients with whom she was fairly certain would not subsequently take the dual antiplatelet therapy post revascularization. Using a DHFS eliminates mere suspicion. Prematurely discontinuing of thienopyridine therapy (antiplatelet drugs such as Effient, Ticlid, or Plavix) after a similar cardiac stent placement has been shown to increase the risk of both re-hospitalization and death within the subsequent 12-month period. Given the success of the Proteus DHFS in reducing systemic high blood pressure, mandating this DHFS to monitor antiplatelet therapy immediately post cardiac stent placement should reduce both patient morbidity and mortality during the following 12-month period.

A consequentialist in charge of public health care expenditures might disagree with Dr. Rosenbaum regarding the ethics of providing a revascularization procedure in an individual who is poorly compliant with beneficial post-procedure medication compliance. Bluntly, why spend the money if the patient (for whatever reason) is going to act in a manner to reduce the benefit of her procedure? Thankfully, money is not the only healthcare utility worth measuring and economists are not yet fully in charge of healthcare delivery, though they appear to have an ever increasingly important seat at the table.

So, I think DHFS technologies such as Abilify MyCite will slowly become non-voluntary.