Sign up to be a research subject

A special issue of IRB: Ethics & Human Research (March-April 2018) is all about “Listening to the Voices of Research Participants.”  The main argument for making participants into something more like true “partners,” is that experienced research subjects have a lot to teach researchers.  Rebecca Dresser points out that many developments in political science and philosophy emphasize the importance of personal experience as “a valuable source of knowledge.”  Experienced research subjects can help researchers and IRBs spot problems that can raise ethical issues, or interfere with enrolment and retention.  “Ethical and policy deliberations should include people who know what it is like to participate in research.”  Stephanie Solomon Cargill follows Dresser with a discussion of how to get from the “why” to the “how.”   Two more articles round out the special issue. None of them suggests one obvious piece of the puzzle: researchers themselves, and bioethicists who serve on IRBs and make research decisions, should raise our hands and sign up to be research subjects.

 

When I speak at bioethics conferences, I often ask my audience who has volunteered to be a research subject, and I am astonished at how few people respond.   Jumping through the looking glass is a fascinating experience.  I have been a volunteer for the REVEAL study, where I was told my APOE status and some approximation of my genetic risk for Alzheimer’s.  I recently ended a five year stint in the VITAL study, where I took some combination of vitamin supplements and placebos daily.  (I would not have believed how sick I got of doing that, nor how annoying those little round pills were when they rolled off the counter and dropped onto the floor.  Only the tremendous esprit de corps generated by the newsletters and thank you notes and little holiday gifts—thanks, guys, for the keychain flashlight—kept me going.)  I tried to volunteer for another Alzheimer’s study; I didn’t survive the initial screening, but I still learned a lot.   Some of that learning made its way into my writing, some of it has helped me enormously as I sit on various IRBs.

 

Granted, this doesn’t solve the problem by a long shot.  Few of us are likely to be of low income, or have an eighth grade education.  Nonetheless, we can learn a lot from being “participant observers.”  Look at the huge amount of wisdom that we have accrued from illness narratives of doctors who were forced to become patients.  Why shouldn’t we enjoy at least some modicum of that wisdom from having ethicists volunteer to be subjects?

 

I would also argue that bioethicists, at least those of us who have been relatively unburdened by illness, have an obligation to participate in research. Actually, I believe everyone has a prima facie obligation to participate in research, because we are the beneficiaries of that research.  But as bioethicists we are doubly beneficiaries: not only do we owe our good health to medical research, but many of us make a pretty good living writing about it.  Don’t we have a duty to give back?

 

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Being Poor is a Full-time Job

A new article in The Hastings Center Report, by Nir Eyal, Paul Romain, and Christopher Robertson, asks whether it is ethical to ration healthcare by inconvenience and red tape?  In other words, given that all societies must ration health care in one way or another, is it ever ethical to push people away from an unpreferred healthcare option by making it more inconvenient?  For example, what if physicians had to go through a very long process to prescribe a nongeneric drug, or if ERs had really onerous check-in procedures for patients without medical emergencies? This came at an interesting time for me, because I was recently asked to provide informal support for a low-income woman I will call Millie, who was moving from her home in New York State to my community in Pennsylvania.  Despite my fairly extensive reading on what it means to be poor in America today, I was blown away by the sheer inconvenience of Millie’s daily existence (and awed by the way she navigated bureaucracies that would have reduced me to gibbering idiocy).

Millie is in her 50s, dependent on public assistance, and with a number of health problems (e.g., diabetes, hepatitis C). She had spent her last dollars to hire the truck to move her possessions to her new home; she had moved to live with distant relatives who had been persistent in inviting her, but turned out to be interested only in her disability paycheck.  The household was chaotic and unsafe, and everyone smoked.  Millie’s immediate problems were to find new Section 8 housing and a way to move her stuff; to get her many medical prescriptions transferred to her new state; to find new doctors and get her medical care back on track.  She had to do this with no car, no credit card, and no checking account.

In addition to the hours that Millie spent dealing with those problems, her daily life presented its own inconveniences. Living miles from a decent grocery store, she tended to shop at the local bodega, whose meager offerings were not ideal from the standpoint of her diabetes.   Without a car, or the money to call an Uber, shopping by public transport would have eaten up a big chunk of her day.  Picking up prescriptions presented parallel problems.

In short, what I learned from Millie was how time-consuming and inconvenient it is to be poor.  Being poor is virtually a full-time job.  Being poor with chronic illness is two full-time jobs.

This is especially concerning because of a theory, promulgated by Schilbach, Schofield and Mullainathan at the Wharton School of Business, that poor people are often so preoccupied with the challenges of daily living that they have less “bandwidth” with which to make good choices.   Of course, the authors of the Hastings Center article do not ignore this question.  They are concerned that any rationing process not be regressive, that is, that it not disadvantage those who are poor.  But they believe that rationing through inconvenience is less regressive than, e.g., rationing through cost-sharing.   “[All] people have twenty-four hours in a day, a limited attention span, and a body that can be in only one place at a time.”  The authors do acknowledge that rationing through inconvenience must be used thoughtfully, but some of their solutions seem merely to generate more onerous paperwork:  “In some instances, a hardship waiver would be feasible and appropriate.”  Can you imagine how long it would take to fill out the application for that waiver?  Rationing through money can more easily be made less regressive by exempting people who have already done the paperwork to be eligible for Medicaid, SSI, and so on, and already have the card to prove it.

Eyal, Romain and Robertson are not targeting only patients in their paper; they hypothesize “negative nudges” that operate on all players in the healthcare system.  But because poor people already get poor healthcare, and live in less healthy environments, and because their lives are already burdened by inconvenience, we need to be very sure not to increase that inequality.

 

Longer life with dementia? No thanks!

An article this week, from The European Heart Journal, reports that cholinesterase inhibitors, commonly used to treat some of the symptoms of Alzheimer’s, also lower the rate of heart attacks and other causes of death.   As the researchers explained, “for every 100,000 people with Alzheimer’s disease, there would be 180 fewer heart attacks – 295 as opposed to 475 – and 1125 fewer deaths from all causes – 2000 versus 3125 – every year among those taking ChEIs compared to those not using them.”  As reported in the relentlessly upbeat Alzheimer’s & Dementia Weekly, there is no suggestion that this might not necessarily be a good thing.

Note to self: Just in case I do not manage to end my life before getting dementia, make clear to my health care proxy now that under no circumstances do I want any drugs that might risk prolonging my life.

Could we be marsupials?

Four scientists have just announced, in Nature Communications, that they have successfully created an artificial womb in which “extremely premature” lambs were nurtured for four weeks, enough to make them ready to meet the world.  The goal is to advance this technology until it is available for very premature (23-26 week) human infants.  At present, very premature infants have extremely poor prognoses: likely death, or severe disabilities.  4-5 weeks would be enough to allow a “very premature infant” to become merely a “premature infant,” with a good prognosis.

If successful, this could be a terrific technology.  At present, we put preemies into Neonatal Intensive Care Units, which are super stressful for the babies and their families, and the things we do to try to support them very often cause serious damage if the baby does survive.  Fetuses, for example, are meant to breathe liquid while in the womb, but if they are born prematurely, all we can do is to force air into their little lungs, often causing permanent lung damage.  A calm, soothing environment that mimicked the human uterus would be a wonderful thing.

But it does make me wonder—would this make humans somewhat like marsupials?  At present, one is either born or not.  A fetus just a day away from delivery is still just a very late-term fetus.  And a very premature infant, once it is born and draws breath, is now an infant, legally and ethically a human person.  Would this technology create a new, intermediate stage?  What are the ethical and legal implications?

 

Neil Gorsuch, Aid in Dying, and Roe v. Wade

In the absence of any “paper trail” that would give clues to Supreme Court nominee Neil Gorsuch’s views on abortion, many commentators have turned to his book, The Future of Assisted Suicide and Euthanasia, based on his doctoral dissertation at Oxford, where he worked with natural law theorist John Finnis.  Ronald M. Green notes with alarm that Gorsuch relies on an inviolability-of-life principle that would likely lead him to vote to overturn Roe v. Wade.  Furthermore, Green writes that Gorsuch’s conservative preference for allowing states to make their own decisions, would lead to a return to the pre-Roe reality in which women would have to travel long distances for abortions in those states that allowed it.  (https://ronaldmgreen.com/2017/02/17/how-will-neil-gorsuch-vote-on-roe-v-wade/)

However, there are more dire possibilities to consider. In a long and fascinating essay in Vox (March 20, 2017), J. Paul Kelleher argues that Gorsuch is not an originalist in the Scalia mold, but actually a natural law adherent like his mentor Finnis.  Natural law theorists believe that there is an over-arching moral law that judges can and must rely on when existing laws are unclear, or manifestly unjust.  The recognition of human life as a “fundamental good” that can never be intentionally harmed, is an example of such a moral law, and one that Gorsuch relies on in his condemnation of assisted suicide.

It’s important to see that Gorsuch is not merely agreeing with the current legal status of assisted suicide in our country.   In Washington v. Glucksberg, in 1997, the Court declined to follow the logic of the “privacy” cases stretching from contraception through abortion and find a constitutional right to assistance in ending one’s life.  Glucksberg leaves the country, with respect to assisted suicide, in the same position in which we would left with respect to abortion if Roe were overturned: at the mercy of the legislative wisdom of the individual states.   Gorsuch goes further in arguing that the equal protection clause of the 14th amendment forbids treating the lives of terminally ill people differently from those of the healthy, by allowing the “killing” of the first but not the second. (Philosopher Felicia Nimue Ackerman has often made a similar point from an ethics perspective.)  In other words, Gorsuch would presumably view favorably an appeal to the Court to strike down existing “death with dignity” laws in Oregon and elsewhere.

As Corey Brettschneider writes in the New York Times (March 21, 2017), all of our abortion jurisprudence rests on the assumption that embryos and fetuses are not “constitutional persons” under the 14th amendment.   Anti-abortion activists have made occasional gestures toward a constitutional amendment declaring embryos to be constitutional persons from the moment of conception, but constitutional amendments are very hard to pass, as proponents of the Equal Rights Amendment will recall.  Relying on natural law theory, John Finnis has written that fetuses deserve to be considered constitutional persons.  Thus, an equal protection argument claiming that the 14th amendment requires embryos and fetuses to be treated the same as born children, might acquire some traction with Gorsuch on the Court.   The result would be much worse for abortion rights than simply overturning Roe; it would criminalize abortion across the country.

This is a GREAT day to have a cardiac arrest!!!

I thought that headline would get your attention.  Okay, so actually, yesterday would have been an even better time to have a cardiac event, but today’s still good.  March 17-19, the American College of Cardiology was meeting in Washington, DC.  Lots of top cardiologists were away from their hospitals and not seeing patients.  Today I assume they are mostly in the air, on their way home.

Now, you might think, this is a terrible time to need cardiac care, because there are fewer specialists available.  You would predict that on average, people needing cardiac care would do worse during these big national conventions.  In fact, the opposite turns out to be true.  An article published in JAMA shows that patients admitted to teaching hospitals with high-risk heart failure or cardiac arrest, did significantly better when cardiologists were away at these conventions.[i]   The benchmark chosen by the researchers was 30-day mortality.  Of high-risk patients admitted with heart failure during meeting dates, 17.0% died within 30 days compared with 24.8% admitted on nonmeeting dates.  Similarly, 59.0% of patients admitted to teaching hospitals with cardiac arrest during meeting dates died within 30 days compared with 68.6% on nonmeeting dates.

When Anupam Jena, the lead author, was interviewed on NPR’s Freakonomics, he explained the magnitude of the results. “The mainstays of treatment for heart disease are beta blockers, statins, aspirin for some individuals, a blood thinner like Plavix. If you were to combine all those therapies together, we’re probably talking about reducing your mortality by about 2 to 3 percentage points.”  Whereas just going to the hospital when the cardiologists are at a meeting reduces your mortality by 8 and 10 percentage points. WOW!

So what might explain this result?  We can’t know for sure, but Aaron Carroll of my favorite blog, The Incidental Economist, has some ideas.[ii]  Maybe the best cardiologists stayed home. Maybe fewer invasive procedures were done, leading to better outcomes.  Maybe the hospital triaged patients, told the low-risk ones to stay home, and concentrated on the high-risk patients, leading to better care.  But as Carroll says, “Whatever is different during the meetings, it’s associated with lower intensity care and better outcomes.”

In other words, as is so often the case in medicine, less is more.

 

[i] Anapum B. Jena, Vinay Prassad, Dana P. Goldman, et al. Mortality and Treatment Patterns among Patients Hospitalized with Acute Cardiovascular Conditions During Dates of National Cardiology Meetings.  JAMA Intern Med. 2015;175(2):237-244.

[ii] http://theincidentaleconomist.com/wordpress/patients-do-better-when-cardiologists-are-away-at-academic-meetings/

“Docs v. Glocks”: Gag rule lifted

The American Academy of Pediatrics, the AMA, and the American Academy of Family Physicians all encourage their members to ask parents about firearms, in the same spirit as they ask about automobile restraints, swimming pools, and other factors that relate to the health of their patients.  If parents report that there are firearms in the home, the pediatricians advise them on gun safety.  Among homes with children and firearms, more than 40% have at least one unlocked firearm.  A trial in 2008 showed encouraging results when pediatricians counseled parents on strategies for safe gun storage and handed out cable locks, reporting a 21.4% increase in families who stored their firearms locked.

In 2011 the State of Florida passed a law (Firearm Owners’ Privacy Act, or FOPA) that forbade doctors from asking patients whether there were firearms in the home.   The law carried some harsh penalties, including a $10,000 fine and loss of medical license.  FOPA was overturned by the Florida Supreme Court on free speech grounds, but was reinstated by a three judge panel of the 11th Circuit.    Florida managed to convince the panel that: 1) this was not impingement of free speech, but merely a regulation of professional activity; 2) the law was necessary to protect the Second Amendment rights of parents.  A number of physicians and organizations appealed, and on February 17, 2017, a full panel of the 11th Circuit once again overturned most of the elements of FOPA.

The court was unanimous and blessedly crisp on the merits of the case.  On the question of free speech, the court opined that “[C]ertain First Amendment principles can be applied with reasonable consistency, and one of them is that, subject to limited exceptions, content-based regulations [of speech] are presumptively invalid.”  Rejecting the State’s claim that the law regulated speech only incidentally to its primary goal of regulating professional conduct, the court said, “Saying that restrictions on writing and speaking are merely incidental to speech is like saying that limitations on walking and running are merely incidental to ambulation.”

The court also rejected the truly ludicrous claim that FOPA was necessary to protect gun owners’ Second Amendment rights, pointing out that “there was no evidence whatsoever before the Florida Legislature that any doctors or medical professionals have taken away patients’ firearms or otherwise infringed on patients’ Second Amendment rights. This evidentiary void is not surprising because doctors and medical professionals, as private actors, do not have any authority (legal or otherwise) to restrict the ownership or possession of firearms by patients (or by anyone else for that matter).”

It will be interesting to see if Florida appeals to the Supreme Court, and if the Court agrees to hear the case.

FOPA is just one of many laws that either gag health professionals from speaking to their patients on certain subjects, or require them to give patients certain information (some of it false, as in purported associations of abortion with subsequent depression), or force them to coerce patients into actions such as listening to a fetal heartbeat before going ahead with an abortion.   Eric Kodish and I wrote an article about how physicians ought to respond to such constraints on their abilities to practice good medicine.  If you’re interested, you can find it here:hcr-laws-that-conflict-with-the-practice-of-medicine

Dena S. Davis and Eric Kodish, “Laws that Conflict with the Ethics of Medicine: What Should Doctors Do?,” Hastings Center Report 44, no. 6 (2014).