Bioethics at Yale, Encyclopedic Edition

I just got my copy of the hefty new six-volume edition of the Encyclopedia of Bioethics. The Editor-in-Chief, Bruce Jennings, and two of the six Associate Editors (me, Mark Mercurio) teach at Yale. One of the two Consulting Editors (Joe Fins) is visiting at Yale this term. Another of the Associate Editors (Greg Kaebnick) is at The Hastings Center, with which Yale has a research alliance and a joint visiting-scholar program. Just sayin'.

Out of the Frame and Into the Gutter: Graphic Novels and Health Justice

A while ago I shared with you this wonderful cartoon from Comic Nurse, alias MK Czerwiec. Now let me share with you this symposium, Out of the Frame and Into the Gutter, brought to you in part by Comic Nurse. Thanks, Comic Nurse! If you're near Columbia on the afternoon of April 4, learn what graphic novels can do for health and social justice!

No Aid in Dying In CT This Year

The Public Health Committee of the Connecticut Legislature has no plans to bring an Oregon-style bill for Aid-in-Dying (aka physician-assisted suicide) to the floor of the legislature for a vote, in spite of 61% public support for the bill. Serious opposition by religious groups and by disability activists have kept legislators from moving the bill forward. But, the failure of the Aid-in-Dying bill seems to have resulted in some substitute enthusiasm for a Medical Orders for Life-Sustaining Treatment (MOLST) bill for Connecticut. (Some states call MOLST "POLST," for Physician Order for Life-Sustaining Treatment. It's the same thing.) Under MOLST, terminally-ill patients and their physicians can frame orders to be entered onto the patients chart, from "do everything" to orders restricting intubation, antibiotics, resuscitation, ventilation or artificial feeding; such orders would be legally binding on all caregivers. It's like an advance directive on steroids, because it's both an expression of the patient's desires and a physician's medical order in the patient's chart.

End-of-Life Planning, Roz Chast Edition

Please, please go read this wonderful and moving and honest cartoon about, among other things, why we don't do end-of-life planning, by longtime and beloved New Yorker cartoonist Roz Chast. Really, go read it. 

Criminalization of Drinking While Pregnant in UK?

A council on northwest England plans to bring legal action to establish liability for criminal damages by women who drink while pregnant, with resultant damage to their newborns. A tribunal in 2011 had ruled that a child had sustained personal injury "directly attributable to a crime of violence," and so was eligible for a payment from its mother. The holding came in spite of the fact that the mother had never been criminally convicted. The court simply held that, regardless of the lack of prosecution or conviction in her case, she had in fact committed the crime of maliciously administering poison so as to inflict grievous bodily harm, a crime under section 23 of the Offences Against the Person Act 1861. The upper tribunal of the Administrative Appeals Chamber reversed the holding, however. (The opinion can be downloaded here.) The Appeals Chamber agreed that there had been “administration of a poison or other destructive or noxious thing, so as thereby to inflict grievous bodily harm,” but found that the fetus who was damaged by the mother's drinking was not a "person" in legal terms at the time of her injury. The case now goes to the Court of Appeal.

It's important to recognize that the case at bar would set precedent for cases quite unlike it in the future. In the case at bar, adoptive parents of a child damaged by fetal alcohol syndrome are seeking payments from the child's biological mother--payments due them pursuant to criminal law. But if drinking-while-pregnant is criminal, the ordinary case of prosecution in the future may look rather different. It will involve not payment of damages by a biological mother to a third-party adoptive parent, but imprisonment of a new mother shortly after her child's birth.

Criminalization of drinking-while-pregnant seems like a terrible idea. It is obviously true that drinking while pregnant can damage one's fetus. It is also obviously true that the majority of women who drink while pregnant do not thereby damage their fetuses. The relevant studies seem to show no genuinely "safe" level of drinking during pregnancy, but also show that significant drinking during pregnancy often results in no harm to the fetus. In these circumstances--and given the addictive nature of alcohol--can it really be true that criminalization of drinking-while-pregnant is really the best, or even a reasonably good, method of reducing harm to fetuses from maternal drinking?

Criminalization will make it difficult for pregnant women to speak to their physicians or nurses about their drinking habits. Threat of criminal prosecution for drinking could be used as a lever against pregnant women by abusive men. Criminalization will subject visibly-pregnant women not only to prosecution, but also to public abuse and accusations from strangers, even though the actual danger to fetuses from moderate later-term drinking is minimal.

Women should be informed of the dangers to their fetuses of drinking. Alcoholic pregnant women should be offered help. The state's money is better spent on public service announcements and counseling sessions than on prosecutions and jail-cells. I'm guessing that no one who knows that drinking during pregnancy might damage her child, but who drinks anyway, does so with malicious intent, or does so without regard to the dangers to her child. People who don't know the damage they may be causing, or who simply cannot stop their drinking due to addiction, need help rather than punishment.

Friday Frivolity, Throatie Edition

State Vaccination Exemption Policy Makes A Difference

Mother Jones has just run a very nice analysis of recent years' research on state laws governing non-medical exemption from childhood vaccines. It turns out that if a state makes it very easy for parents to exempt their children from recommended school vaccinations for non-medical reasons, lots of parents will exempt their children. This causes loss of herd immunity, and children die of childhood diseases that haven't been common for decades. And when one state (Washington) tightened up its rules by requiring a doctor's signature for exempting children from vaccination, exemption rates fell by 40%.

Meanwhile, cases of measles are on the rise in California--more than half of them involving children who were intentionally not vaccinated.

Ventilating the Dead: Jahi McMath Update

Nailah Winkfield, the mother of Jahi McMath, the girl who was declared brain dead on December 11 of last year but who is being kept on ventilation and artificial feeding in an undisclosed location, has authored a letter to the general public about her daughter's condition. In the letter, she says that her daugher is "much better" physically and that she sees changes in her condition "that give me hope." She also hopes that Jahi's story will change the way the world thinks about brain death.

I'm very sorry for Ms. Winkfield, and cannot imagine the anguish she suffered when her 13-year-old died as a result of what was meant to be a routine tonsillectomy. Nonetheless, I sincerely hope that Jahi's tragedy does *not* change the world's mind about brain death. Brain death is a useful and important criterion for determining death in the modern hospital setting where machinery can prevent the cessation of breathing and heart activity. The permanent, irreversible lack of upper and lower-brain activity also seems to me to be the very essence of death, since it signals the deceased's complete and permanent lack of experience in and relation to the world. The fact that a dead person can be kept oxygenated is indeed useful for organ harvesting and transplant; but to keep a person oxygenated after the complete cessation not only of mental life but also even of brain-stem-coordinated automatic activity seems to me at best a very sad exercise in false hope. Harsh as it seems, I think it's also a waste of valuable resources. And most importantly, it mistakes a person for her body. Persons are bodies, to be sure; but they are more than that, fundamentally more. I'll admit to struggling with line-drawing here; my father remained father to me even after he was demented and in many ways no longer the person he once was. And certainly he remained a human being with preferences and experiences. He wouldn't have wanted to live in that state, but my mother (for example) did want him alive, even in that state. But brain-death is a more thorough kind of absence, a more complete dissolution, than mere dementia. I reduces a person to a collection of living and interdependent but non-coordinated and gradually dis-integrating cells and systems. Ms. McMath's life is over; and the end of her story has already been written, even if it takes months to arrive. I wish Ms. Winkfield her peace, but I remained convinced that she has been driven by love and hope and faith into making a terrible, though terribly human, mistake.

Your Short-Order Stem Cells May Not Have Arrived After All!

A few weeks ago I blogged about a Japanese researcher's piece in Nature, in which she claimed to have induced pluripotency in mouse blood cells simply by immersing the cells in an acid bath for a half-hour.  It now emerges that the researcher, Haruko Obokata, may not have done this after all. The RIKEN center in Kobe announced on Friday that it is investigating "alleged irregularities" in her work. Questions have been raised about the use of duplicate images across several of her papers, and about numerous unsuccessful attempts to duplicate her results. Obokata is not answering press inquiries. The jury is very much still out: the failures to duplicate her results may simply be due to the complexity of her protocol and the character of the particular cells she used. The business about duplicate images may simply have been a mistake. Read the latest from Nature on the matter, and stay tuned.

Bioethics Poetry, Another Dannie Abse Edition

A DOCTOR’S REGISTER

And yet God has not said a word!

“Porphyria’s Lover,” R. Browning

Half asleep, you recalled a fading list

of girls’ sweet names. Now to old women

these names belong—some whom you tumbled and

     kissed

in summer’s twilit lanes or hidden by heather.

You were a youth who never stayed long

for Gwen or for Joyce, for Rita or Ruth,

and there were others too, on a lower register.

Then, suddenly, a robust, scolding voice

changed your dream’s direction and the weather.

“That much morphia, doctor? Wrong, wrong.”

Surprised to discover your eyes still shut

you wondered which dead patient or what

(whose accusing son and when?) as any

trusted doctor would who did not murder

any pleading one with sovereign impunity.

“I found a thing to do,” said the lover

of Porphyria. Porphyria? Awake you add

the other pretty names too: Anuria,

Filaria, Leukaemia, Melanoma,

Sarcoma, Euthanasia, amen.

Dannie Abse

Bioethics Music, Military Bearing Edition

Lyrics are here.

Health Insurance Execs Watch Patient Battle Cancer

This story from The Onion, which is a parodic source of "news," is really funny.


What makes it especially funny is that it's so far-removed from the truth. Really. Far-removed. Really. I swear. Hardly true at all.

Wolves and Rivers

This is amazing.

US IVF Conceptions at All-time High

1.5% of babies born in the US in 2012 were conceived via IVF, according to data just released by the Society for Assisted Reproductive Technologies. Transfers of multiple embryos were down compared to previous years, but the average number of embryos transferred was still 1.9 for women under 35, and higher for older women. An old piece of mine at the Hastings Center Forum on the relationship of US insurance law to multiple-embryo transfers is still available here; it dates back to the Octo-mom story, but its point is still relevant. The rough punchline is, if you don't insure people for assisted reproduction, folks who can only afford one expensive try at having children will opt for multiple-embryo transfers, both in order to enhance their chances at successful implantation and in order to achieve a whole family at one go. This, naturally, results in multiple births--which are considerably more risky both for mom and for kids than are singleton births.   

Euthanasia in Quebec?

Quebec legislators are reportedly within days of passing a law that would permit euthanasia for competent adult patients with incurable disease which causes constant and unbearable physical or mental suffering. The euthanasia-related portion of Bill 52 (an English-language copy of which can be download here) seem modeled on euthanasia laws in Europe, in that it requires a diagnosis of incurability rather than of terminality, and explicitly ties access to euthanasia to suffering. A person is eligible to receive a physician's aid in dying only if he or she "suffer[s] from an advanced state of irreversible decline in capability; and suffer[s] from constant and unbearable physical or psychological pain which cannot be relieved in a manner the person deems tolerable." The term "aid in dying" is not actually defined in the bill, presumably in order to leave methodology in the hands of physicians.

Euthanasia is illegal according to Canadian national law, and it's not clear that the Quebec provincial law's alternative reference to "aid in dying" will skirt that national prohibition. Parti Quebecois officials are reportedly thinking of simply asking Crown officials not to prosecute euthanasia within Quebec after the law passes.

The bill covers a great deal of ground in addition to the euthanasia innovation. It creates a provincial commission to gather information on end-of-life care, establishes a regime for the creation and registration of advance directives, and addresses the provision of hospice and palliative care.

The bill has attracted a fair bit of high-profile opposition from groups of physicians, from the Catholic Church, and from some bioethicists. Here's a piece on the slippery-slope argument ("Soon we'll be killing children and the demented, just like in Belgium") being advanced by prominent conservative Canadian bioethicist Margaret Somerville.

New Lungs from Scrap Lungs

Researchers at the University of Texas Medical Branch have announced that they've successfully grown fresh human lungs from tissue borrowed from damaged lungs. Researchers took lungs that were too damaged to be used in transplant, and stripped all cellular material from them, leaving a sort of "lung scaffolding." They then took live lung tissue from another non-transplantable lung and put it on the scaffolding, and "fed" the cells with a bath of nutrients that "looks alot like Kool-aid" in an aquarium purchased from a local pet-shop. The cells from the second lung "colonized" the scaffolding, and generated a complete lung in only three days. The hope is that this technology will greatly decrease the shortage of organs for transplantation. But actual transplantation is 5 to 10 years in the future. The lungs need to be tested (probably in pigs) for function, ability to grow, robustness, and so on.

Bioethics Poetry, Dannie Abse Edition

In the Theatre

(A true incident)
‘Only a local anaesthetic was given because of the blood pressure problem. The patient, thus, was fully awake throughout the operation. But in those days—in 1938, in Cardiff, when I was Lambert Rogers’ dresser—they could not locate a brain tumour with precision. Too much normal brain tissue was destroyed as the surgeon searched for it, before he felt the resistance of it … all somewhat hit and miss. One operation I shall never forget … ’  (Dr. Wilfred Abse)

Sister saying—‘Soon you’ll be back in the ward,’
sister thinking—‘Only two more on the list,’
the patient saying—‘Thank you, I feel fine’;
small voices, small lies, nothing untoward,
though, soon, he would blink again and again
because of the fingers of Lambert Rogers,
rash as a blind man’s, inside his soft brain.

If items of horror can make a man laugh
then laugh at this: one hour later, the growth
still undiscovered, ticking its own wild time;
more brain mashed because of the probe’s braille path;
Lambert Rogers desperate, fingering still;
his dresser thinking, ‘Christ! Two more on the list,
a cisternal puncture and a neural cyst.’

Then, suddenly, the cracked record in the brain,
a ventriloquist voice that cried, ‘You sod,
leave my soul alone, leave my soul alone,’—
the patient’s dummy lips moving to that refrain,
the patient’s eyes too wide. And, shocked,
Lambert Rogers drawing out the probe
with nurses, students, sister, petrified.


‘Leave my soul alone, leave my soul alone,’
that voice so arctic and that cry so odd
had nowhere else to go—till the antique
gramophone wound down and the words began
to blur and slow, ‘ … leave … my … soul … alone … ’
to cease at last when something other died.
And silence matched the silence under snow.

Dannie Abse

Caution on the Mammography News

By now, you've likely heard about this study in BMJ, which found that, in a population of 90,000 women tracked for 25 years, cancer mortality was the same among women who'd received mammograms annually as it was among women in the control arm, who hadn't. This has led to headlines like, "Vast Study Casts Doubts on Value of Mammograms," or "Study Shows Mammograms Don't Save Lives." Those headlines (and the associated articles) aren't inaccurate, but it's important to note that the women in the mammogram arm of the study and the women in the control arm were all receiving annual breast breast exams. That is, the study shows that adding mammography to a regime of regular breast examination doesn't do more than merely having regular breast examination. Women should not stop mammography without ensuring that they get, or continue to get, ordinary annual breast exams.

Friday Frivolity, Totally Predictable Edition

Bad Argument Linking Belgian Euthanasia With US Death Penalty

Eugene Kontorovich (Northwestern Law) has penned an egregious argument over at the Volokh Conspiracy. Go read it, if you're entertained by egregious arguments. In sum, it goes like this:

In Roper v. Simmons (2005) the Supreme Court found unconstitutional the execution of persons who had committed their crimes while under 18. In doing so, they "caved in to pressure" from Europeans who opposed the death penalty. Indeed, the court "cited the European position as support for its conclusion." Part of the court's reasoning was that juveniles were "too immature to understand the consequences of their decisions, or the meaning of life and death." But now Belgium is permitting juveniles to decide to have themselves euthanized. This proves that Roper misread the European's belief system. It wasn't one of "paternalistic concern for youth."

"Rather [Kontorovich continues], a system that permits the euthanasia of innocent 12 year-olds but not the punishment of guilty 17-year-olds is one that exalts autonomy without culpability....So it comes out that the juveniles cannot really make accountable decisions when it comes to killing people, unless it is themselves. Or to put it differently, Belgium will not hold children responsible when they hurt others, but gives them free license to hurt themselves."

All of which goes to show you that the US Supreme Court shouldn't pay attention to what other countries do, because they're different from us. And because the Supreme Court misunderstood what other countries stand for, Roper should be overruled.

I feel a bit unclean picking up this rotting fish of an argument, so I'll summarize its major faults quickly:

1)   Roper mentioned, but was not based on, the broad consensus of other countries that juveniles shouldn't be executed. "The opinion of the world community," wrote the court, "while not controlling our outcome, does provide respected and significant confirmation for our own conclusions."
2)  The Roper majority did not get the idea that juveniles were immature from Europe, but from developments in the Supreme Court's own death penalty jurisprudence and that of many states, which were in turn based on ample expert psychological testimony about juvenile judgment. Read the opinion and see. 
3)  A system that lacks capital punishment for juveniles is not, on that account, a system that does not permit "the punishment of guilty 17-year-olds." It is not actually constitutive of the idea of "holding someone responsible when they hurt others" that you must kill them.
3) The Belgian law doesn't "permit the euthanasia of innocent 12-year-olds" unless they are terminally ill and in untreatable pain, and unless they are deemed competent to make the decision by a physician. And their parents have to agree! So Belgium does not give children "free license to hurt themselves."

Sorry, Eugene. The fact that Belgians now approve euthanasia for terminally-ill, competent, suffering children who request it (and who get their parents' permission) doesn't actually give Americans a reason to execute juvenile offenders. I'm baffled that anyone thought that it did.

Belgium Passes Law Permitting Voluntary Euthanasia for Children

Belgium has become the first country to permit euthanasia for children. Amendments to the country's 2002 euthanasia statute will now permit competent terminally-ill children in a "medically hopeless condition of constant and unbearable physical suffering" to request euthanasia. For the request to be honored, a medical professional must deem the child mature enough to understand the meaning of the request. The child's parents or guardians must also approve. A Google-translation of the text of the amendment is here.

In January, the Parliamentary Assembly of the Council of Europe voted to condemn the Belgian Senate's approval of the measure. The measure also attracted the opposition of a substantial number of Belgian pediatricians, 170 of whom signed a petition urging delay of passage of the law. But the Chamber of Representatives has now approved the measure (86 to 44 with 12 abstaining), and King Philippe is expected to sign it.

Ventilating the Dead: Canada Update

Robyn Benson, who has been brain-dead--which is to say, dead--for the last six weeks, was disconnected from ventilation after giving birth, via c-section, to a premature but reportedly healthy son. Her husband was understandably overwhelmed at the prospect of burying his wife just as his new son arrives. It's as hard a thing as I can imagine.

The article I linked is headlined, "Brain Dead B.C. Woman Dies After Giving Birth to Son," but in fact she died weeks before giving birth to her son. It ends by saying that she was "kept alive for six weeks so the couple's child would have a better chance of survival...." But in fact her dead body was kept ventilated and connected to various medications for that reason. This kind of confused use of language is rampant in the coverage.

My previous post on the case is here.  

Lancet/Oslo Commission on Global Governance for Health: Preliminary Response

Consider, if you will, the The Lancet–University of Oslo Commission on Global
Governance for Health report entitled "The political origins of health inequity: prospects for change." Really, consider it. It's extremely interesting. Roughly speaking, the Commission wishes that the world's attention were focused on health as a "precondition, outcome and indicator" of sustainable society. It's not satisfied to wish for improvements in "global health governance"--the functioning of the network of folks already focused on health. Instead, it aims for the establishment of "global governance for health," under which "health equity should be an objective for all sectors"--governments, NGOs, firms, individuals, alliances, and so on. In other words, it argues for the establishment of a global regime for which health is an important goal, and which therefore attends closely to all of the social determinants of health. A central assumption of the report is that the health of populations is not primarily to be achieved through the healthcare sector.

The report stresses the powerful role of inequality in establishing and reinforcing global health inequities. It criticizes global regimes for trusting too much in unregulated global markets; criticizes global over-reliance on biomedical approaches to health, rather than social-determinants approaches; and promotes the human-rights approach to health promotion. It offers various examples of failures of global governance to advance health: the austerity regime imposed on Greece by the EU; the international intellectual property regime's affects on drug availability in the developing world; the impact of investment treaties on health equity; the impact of agricultural and food policy on health; the impact of transnational corporate pollution; the impact of armed violence; of immigration; and more.

On the whole, the report's recommendations strike me as an unrealistic wish-list for ideal global governance, entirely divorced from consideration of the political and legal constraints under which real countries and international associations operate. (The cure for this sort of irrealism is to be found in John Coggon's wonderful book, What Makes Health Public?, which makes admirable and fair use of political and legal reality to test theory in this area.) Unrealistic though it may be, however, the report also makes a number of important observations and recommendations which, I hope, might eventually inform the debate in the real world.

I will not, at this moment, run through the arguments of the report. I will instead--hopeless academic that I am--make note of one feature of the document that disappoints me profoundly. That is: the citations. Here is a report on the need to attend to social determinants of health worldwide, and on the ways in which structural wealth differences and global political inequality perpetuate health disparity. How can it make no mention of Thomas Pogge? of Norman Daniels? of Amarty Sen and Martha Nussbaum? of Madison Powers and Ruth Faden? The report laments the lack of global policy standards relating to health, and promotes the human rights arguments for global health, but makes no mention of the academic and global-policy work of, to take one example, Larry Gostin.

The authors of the report, had they looked, would have found a large number of highly-respected and very sympathetic authors doing politically and legally well-informed work which both anticipates and supports the goals articulated in their report. This is work by people who identify themselves, variously, as bioethicists, philosophers and lawyers. These people (and their work) are already well-known in academic circles having to do with health law and policy, both national and international. I fear the authors of the Lancet report just didn't look for these supporters, not because of any disagreement on their part with the various authors I've mentioned, but simply because they didn't know these authors existed; and because they didn't think to search for support from academics in non-medical fields. And this leads me to despair that academics is hopelessly divided.  An alternative thesis is that the report's authors feared that citing the authors I've mentioned would alienate their primarily medical audience; I hope that's not the explanation, but I also believe it's not.

Ah well, more later.

Ventilating the Dead, More Updates

The following message was posted on the Facebook website, Keep Jahi McMath on Life Support, less than an hour ago (boldface added):

Thank you for all your prayers, thoughts and good wishes for Jahi, her family and others helping them. Jahi is Gods own child, she is being properly taken care of and loved by many. She is stable and she is much better in the new facility. Keep the love and prayers going. When there's any eventful information on her continuous healing, you will be updated. Please continue to be respectful of Jahi, her family and each other, have a blessed weekend and let us keep praying for Jahi. Matthew 18:20, "For where two or more are gathered together in My name, there I am in the midst of them". Thank you and God Bless.

McMath was declared brain dead by the state of California on December 11, and her parents have been keeping her body on ventilation and artificial nutrition/hydration at an undisclosed location ever since. It is very unlikely that she is "much better," or that she is undergoing "continuous healing." The power of the loving eye to see evidence for hope is strong indeed.

Meanwhile, Salon is reporting that the family of Marlise Munoz, the brain-dead Texas pregnant woman who was kept on ventilation against her family's and her own previously-expressed wishes, may be faced with $300,000 of medical bills. Alternatively, the taxpayers of Tarrant County may end up footing the bill for their county hospital's actions. The hospital spent the money because of its view (rejected last week by a Texas judge) that a Texas law prohibiting the removal of "life-support" from any pregnant "patient" applied to the dead pregnant woman.

My previous coverage of the McMath case is here and here. Previous posts on Munoz are here (initial news), here (update), here (family's intention to sue), here (court proceedings), and here (removal from ventilation). A contrast of the Munoz case to a similar case in Canada is here.

Use of Animals in UK Research

The UK's coalition government made reduction of the number of animals used in research a plank in its platform early on. Today, a report released jointly by the Home Office, the Department for Business Innovation & Skills, and the Department of Health purports to lay out a plan for that reduction. Indeed, the document is called, "Working to Reduce the Use of Animals in Scientific Research." The report has been greeted warmly by scientists and decried as as whitewash by animal-rights activists. This is in part because the report clarifies the government's platform position in this way:

[In] 2010, the Government made a commitment to work to reduce the use of animals in scientific research. This commitment is not focused on baseline numbers which are influenced by a range of extraneous factors. Instead, it encompasses replacement, reduction and refinement (the 3Rs) more broadly, putting them at the heart of a science-led approach.

In other words, the report contains no promises and no target numbers for animal-use reduction, but instead relies upon the 3Rs, as developed by the National Centre for the Replacement, Refinement and Reduction of Animals Used in Research (NC3Rs). The government has promised to increase NC3Rs' funding. The report contemplates a more active role for inspectors in recommending "3Rs" steps to the facilities they inspect. It also introduces a new initiative to limit use of animals by other countries via education and outreach; it mentions as an example a plan to use education to reduce the use by China of animals in cosmetic testing. Such use has been banned in the UK for 15 years; one strange result of this ban is that UK cosmetic products (such as those sold by the Body Shop) cannot be imported into China, precisely because they have not been tested on animals. The government hopes that by persuading China to alter its animal-testing standards, it can benefit animals--and also open an enormous cosmetics market to British manufacturers.

The report shows a dramatic increase in the number of procedures done on animals in recent years.

(For a Yale Bioethics/Hastings Center joint project on the use of animals in medical research, look here.)

Friday Frivolity: Much Nicer Than Yours Edition

Drug Trials in India: The Pendulum Swings?

In India, 2013 began with allegations that an American NGO (Programme for Appropriate Technology, or PATH) had conducted illegal trials of cervical cancer vaccines on tribal girls. A subsequent Supreme Court filing named major firms including GlaxoSmithKline and MSD pharmaceuticals in the scandal. In September, that court gave the government a month to come up with regulations to curb industry practices which one judge said were "heaven for clinical trials" but were "proving hell for India." Meanwhile, the court banned all new trials. Pharmaceutical firms immediately threatened to leave India. The central government's response was the Drugs and Cosmetic (Amendment) Bill 2013, which included (on and after page 11 in the linked document) much sharper governmental regulation of drug trials, including sponsor liability for all harms caused to subjects by trials, including not only necessary medical care but also damage awards. The new rules required videotaping of subjects' consent, and required that agreements between subjects and companies be filed with India's Drugs Controller-General.  

Now, with industry having dropped the number of trials going on in India by more than half, many are wondering whether the government is regretting its fairly hard-line stance of last year. Speaking after the inauguration of a new Baxter global research center in Syngene, Union Health Minister Ghulam Nabi Azad said,

“The industry has complained that the regulations are too stringent, but there have also been complaints by parliamentarians, NGOs and others that they are too lax, which the Supreme Court had taken note of....We are happy with the current balance between the different interests, but industry also needs to be happy....

Pointing out the decline in the number of trials, he added: "While we are interested in the matter of patient safety, we also want to make sure that innovation is not hampered.”

Many in the press seem to be taking this as a sign that the law will be relaxed. Stay tuned!

Bioethics Poetry, William Carlos Williams Edition

The Last Words of My English Grandmother

There were some dirty plates
and a glass of milk
beside her on a small table
near the rank, disheveled bed--

Wrinkled and nearly blind
she lay and snored
rousing with anger in her tones
to cry for food,

Gimme something to eat--
They're starving me--
I'm all right--I won't go
to the hospital.No, no, no

Give me something to eat!
Let me take you
to the hospital, I said
and after you are well

you can do as you please.
She smiled, Yes
you do what you please first
then I can do what I please--

Oh, oh, oh! she cried
as the ambulance men lifted
her to the stretcher--
Is this what you call

making me comfortable?
By now her mind was clear--
Oh you think you're smart
you young people,

she said, but I'll tell you
you don't know anything.
Then we started.
On the way

we passed a long row
of elms. She looked at them
awhile out of
the ambulance window and said,

What are all those
fuzzy looking things out there?
Trees? Well, I'm tired
of them and rolled her head away. 

William Carlos Williams

Bioethics Music, Philip Seymour Hoffman Memorial Edition

Order Up Those Lab Results!

A new regulation from the US Department of Health and Human Services permits patients or their designees to receive laboratory reports directly from labs, rather than through their physicians. The federal regulation preempts a number of state laws that previously permitted patients to receive laboratory results only through their doctors, or with their doctors' permission. The regulations also amend rules under the Health Insurance Portability and Accountability Act (HIPAA) to require labs to provide copies of individual health information to any patient who requests it, within 30 days of the request. Labs were previously exempt from that HIPAA requirement. Under the new rule, labs will be able to charge a reasonable copying fee for the information they provide.

The goal of the new regulations is to increase patients' control over their own medical information. It will permit patients to build, either on their own or with the help of firms, their own comprehensive medical records. The regulations may improve patient safety, given findings that over 7% of physicians fail to report abnormal test results to their patients. The American Medical Association and the American Academy of Family Physicians are reported as having raised concerns that patients would not be able to understand laboratory results without their physicians' help, but neither group opposed the regulation.

Ventilating The Dead: Canadian Case, McMath Update

Dylan Benson of British Columbia, Canada, is keeping the pregnant body of his brain-dead wife Robyn ventilated in order that their son might develop inside her and be born. Robyn was 22 weeks pregnant when she was struck dead by a brain hemorhage. Benson is using donated funds to pay for Robyn's ventilation; when his son is delivered by C-section, he will then bury his wife.

This case is strikingly parallel, of course, to last month's Marlise Munoz case in Texas, but there are also some striking differences. In the Benson case, the husband and the hospital agree on the aim of saving the developing fetus, and the husband believes his late wife would have wanted the child saved. In the Munoz case, both husband and parents wanted ventilation removed, and husband believed that his wife, an EMT, would not have wanted to be kept hooked up to machinery. Benson was 22 weeks pregnant when she died; Munoz only 14. Munoz's fetus went without oxygen for the same period of time that Munoz herself did; the lack of oxygen that killed her brain left her developing fetus devastated. But Benson was still breathing, though unresponsive, when her husband found her and rushed her to the hospital; it is possible that her fetus was unaffected by her brain hemorrhage.

Meanwhile, last week, a video was posted on the Keep Jahi McMath On Life Support Facebook page, purporting to show the feet of Jahi McMath, the brain-dead 13-year-old whose parents are keeping her on ventilation and artificial nutrition and hydration, responding to cold stimulus. The video has since been pulled, but remains widely available on the web. A female voice on the video says, "I don't understand how a brain-dead person could do this." But spinally-mediated movement by brain-dead persons has been documented for a long time.

US Abortion Rates Lowest Since 1973

This report from the Alan Guttmacher institute shows that in 2011, there were only 16.9 abortions per 1000 women aged 15-44. That's the lowest rate since 1973, and represents an annual drop of 4-5% since 2008, for a 13% drop overall. Guttmacher attributes the drop to the increased uptake of contraception, particularly among younger women, and to a shift toward use of long-acting reversible forms of contraception such as the IUD, injections and sub-dermal implants. These are much more effective than shorter-term chemical contraceptive methods such as the pill, patches or vaginal rings.  

The most controversial part of the report has been its assertion that it could attribute little of the decline to the recent spate of anti-abortion laws passed by various states. This is partly because many of the laws passed too recently to have taken effect by the 2011 year they were measuring. Some of the laws simply added more information to already-existing counseling requirements; these seemed to have had no effect. Some limited or banned late-term abortions, but these would do little to reduce abortion numbers, because only 1.2% of abortions occur after week 20 of gestation. Guttmacher does concede that some state laws (like those requiring abortion facilities to meet requirements similar to surgical centers, or requiring all abortion providers to have hospital admitting privileges) may have interrupted the availability of abortion services, reducing the number of abortions; and that other laws (e.g., law requiring an additional in-person counseling session 24 hours in advance of the abortion) might have made it more difficult for women to seek abortion. Louisiana passed restrictions on clinics and experienced a 19% decline; Missouri imposed the extra counseling visit and experienced a 21% decline. But it's hard to tell how much of the impact was due to legal restriction. While the new restrictive laws were concentrated in the Midwest and the South, the number of clinics actually only fell in the Northeast and the West. And there is little overall correlation of laws to abortion-rate decline. Rates fell most dramatically in the Midwest (17%), but below the national rate-of-decline in the South (12%). The West experienced a 15% decline and the Northeast a modest 9%. Pro-choice states California, New Jersey and New York experienced 16%, 12% and 9% declines respectively, in the complete absence of new restrictive laws.

IVF and Non-Identity, Continued

Iain Brassington, over at the Journal of Medical Ethics blog, has posted a nice response to my post, IVF Babies at Enhanced Risk. But Why, and So What? In that post I raised the question (based on Derek Parfit's non-identity problem) whether an IVF baby born with a disability has any right to complain, since that baby would not exist if it weren't for the IVF which resulted in the disability. This argument seems logical to me, but it also troubles me, because it often seems capable of proving too much. I gave the example of the slave, to whom (in the right circumstances) one might plausibly argue, "You have no right to complain of being a slave, since without the institution of slavery you would never have been born." Another similarly-structured argument might be addressed to animals being bred in awful conditions by agri-business: "You have no right to complain, little piggy, because if it weren't for this horrific factory farm, you wouldn't exist at all." (Of courses, both the slave and the animal would have grounds for complaint if their lives were so wretched as not to be worth living--but that's a high (or a low) bar.

Iain suggests a couple of ways to think about the problem. One involves the idea that the non-identity argument is weakened if it's at least possible that the very same person could have been born without the complained-of injury. The very same person might have been born not a slave. But I think that's fiddling with the hypo. If we're talking about the person who owes his existence to the institution of slavery because, for example, his mother met his father only because they were sold to the same plantation, I don't see what leverage is gained by arguing that it's at least metaphysically possible that the same person could have been born outside the peculiar institution.

More promising, to me, is Iain's suggestion that an IVF baby might have been harmed, but not wronged, by being born, just as the slave of a benevolent master would still be wronged by the institution of slavery, even if she has not been harmed by it. This leaves us with the question, when we debate about the existence of a complaint "from a particular person's point of view," are we talking about complaints of wrongdoing, of harm, or (as in tort) only of harmful wrongdoing?

Finally Iain tries to distinguish the case of the disabled IVF baby from the case of a baby harmed in utero (as when mom drinks, or ingests Thalidomide). The second sort of baby, Iain argues, would clearly have a complaint about the harmful behavior, because the very same baby might have been born unharmed.

But as I said briefly in my comment to Iain's post, I'm not so sure that personal identity is genetic at root. I don't think it's too much to argue that the disabled baby is a different person from the genetically-identical baby that would have been born but for mom's behavior. So the non-identity problem is not solved by reference to continuity of genetic makeup, or even by reference to bodily continuity with the same blastocyst.

     

Johnson and Johnson To Share Raw Drug/Device Data Through Yale

A Johnson & Johnson subsidiary has entered into an agreement with Yale School of Medicine's Open Data Access (YODA) Project permitting YODA to review requests from investigators and physicians seeking access to anonymized clinical trials data relating to J&J pharmaceutical products. Aggregate and granular data are included, right down to anonymized individual patient and study-subject medical records. YODA will have authority to make final decisions regarding data sharing. J&J is also committed, in the future, to sharing its data on consumer products and medical devices. J&J's press release on the new initiative is here. 

This is a big deal. Independent researchers will be able to scour and re-crunch all the J&J data, looking for side-effects or sub-population effects of drugs, comparing previously unpublished data to data from outside sources, and so on. 

What's particularly novel here is that J&J has given up control of its data to the Yale group. Yale can decide to release data to researchers even if they anticipate findings that are negative for J&J. In contrast, GlaxoSmithKline has a limited data-sharing plan controlled by the firm. Requests that they deny are sent to arbitration. The J&J/YODA deal--struck between Harvard med-school classmates Harlan Krumholz of YODA and J&J chief medical officer Joanne Waldstreicher--is considerably more open. 

If You're Healthy, Don't Take Vitamins

Just don't, okay?

Your Short-Order Stem Cells Have Arrived!

A Japanese research team has discovered a way to render somatic cells (in this case, blood cells) pluripotent, simply by bathing them in acid for under a half-hour. The pluripotent cells were generated in a mouse model, and when injected into a mouse embryo, contributed to all three of the developing embryo's tissue-types. They also exhibited stem-cell like growth capacity when cultivated with growth factors. The team are calling their creation STAP stem-cells, for "stimulus-triggered acquisition of pluripotency." The new method involved no nuclear transfer and no introduction of transcription factors.

If the method works in humans, it could be the key to practical regenerative medicine. A person in need of replacement pancreatic cells, for example, might be able to give blood or other tissue to scientists who could then, very quickly, create pluripotent cells from them, and then develop these into replacement tissue which would not be rejected by the recipients body.

This story in the New Scientist has a lot of excellent detail, but includes a side allegation that an unnamed collaborator of the researchers permitted some STAP cells to grow into "spherical clusters" and then implanted one of these into a mouse uterus. According to the story, a researcher's "understanding" was that the collaborator's experiment resulted in the creation of an embryo. The unnamed collaborator hasn't commented. This would be a big deal, as it would indicate that STAP stem-cells were actually STAT stem cells (totipotent, not just pluripotent), and it would constitute an embryonic cloning without nuclear transfer.

Bioethics Music, Cotton Eyed Joe Edition

A Well-Regulated Militia Being Necessary...

Okay, so we knew that almost 3500 youths under 21 were killed by gunshots annually, and that gunshot wounds accounted for 21,000 emergency room visits each year. What we didn't know was that, quite apart from deaths, 20 American kids were hospitalized each day from gunshot wounds.Sure, guns guarantee our liberty, to some extent. But is our right to defend ourselves with firearms against the fully-mobilized Army of a futuristic dictatorial US, or against the black helicopters of the new One World Government, really so important that we can't risk some regulation  (background checks, limits on use of guns by mentally ill people, lock boxes) to try to save the 3500 deaths and 7300 hospitalizations of youth we're experiencing each year now?

Silencing Hospital Alarms

There's a great story on NPR today about a Boston hospital's success in reducing random alarm noise. In major part by giving nurses authority to adjust devices alarm settings based on what they knew of patients' conditions, a single hospital unit was able to reduce alarm noise from 90,000 beeps per week to only 10,000.

Why is that good? First, the incessant beeping of monitoring and other devices is very annoying to patients and staff alike. Second, too much beeping--about 350 beeps per patient-bed per day!--can induce alarm fatigue, causing staff to miss the really important signals when they occur. The Boston Globe attributed about 200 deaths over 5 years to alarm fatigue; the Joint Commission has reported 98 alarm-related sentinel events in a 3.5 year timespan, resulting in 80 deaths and over a dozen instances of permanent disability. The Joint Commission has therefore recently published new standards relating to alarm safety. It turns out that a lot of that beeping is really unnecessary; the Joint Commission has cited industry estimates that between 85 and 99 percent of hospital alarms aren't clinically actionable.

A paper on the Boston's hospital's alarm experience is here. A special alarm-safety issue of Horizons magazine (published by the Association for the Advancement of Medical Instrumentation) is here.

Infertility Funding in the UK

The UK's National Infertility Awareness Campaign has published the results of its recent audit of infertility-treatment provision in the UK. The UK's own National Institute for Health and Care Excellence (NICE) recommends providing 3 full cycles to IVF to women under 40 who have not conceived after two years of unprotected intercourse or 12 cycles of artificial insemination. But the Awareness Campaign's audit shows that, for funding reasons, 73% of Clinical Consulting Groups in the UK do not offer treatment up to the NICE guideline standard. Of the 198 Clinical Consulting Groups that do offer some funding for IVF, 49% offered only one cycle and another 24% only two. Only 24% of the CCGs that fund IVF actually offer all three recommended cycles.

Swedish Womb Transplant Update

One of the nine women who received uterus transplants in Sweden earlier this year has now had a fertilized embryo transferred into her body. The embryo is from the woman's own egg, so if it implants and if she can carry to term, the resultant baby would be her genetic child. The woman suffered from MRKH syndrome, which prevents proper uterine development but does not affect ovaries or eggs. The donated uterus came from the woman's own mother, so if the procedure works, she would not only be the first woman to bear a live child with a donor uterus, but also the first woman to bear a child with the uterus from which she, herself, earlier emerged.

Brain-Dead Texas Woman Removed From Ventilator

At 11:30 this morning, the dead body of Marlise Munoz was disconnected from mechanical ventilation. Munoz, who has been brain dead for weeks, was being kept ventilated by a Texas hospital, over her family's objections and against her own previously-stated wishes, on grounds that she was pregnant. On Friday a court found that the Texas Advance Directives Act, which prohibits removal of "life support" from any pregnant "patient," did not apply to a dead person; the judge gave the hospital until Monday at 5 to appeal or to remove the mechanical supports from Munoz's body. As of the close of business yesterday, hospital officials were still saying they weren't decided; but apparently the decision was made this morning, much to the relief of the Munoz family.

My coverage of the court decision, with greater legal detail and links to court documents, here. Earlier coverage here, here and here.

Pass Me That Kidney! Indian Edition

The Hindu is reporting the successful completion of India's largest ever "domino" kidney transplant: a chain of transplants in which A's relative donates a kidney to B, B's relative donates one to C, C's to D, and so on, until (in this case) F's relative completes the chain by donating a kidney to A. 12 patients (6 donor-recipient pairs) were operated on. Doctors at Johns Hopkins did a similar set of procedures in 2009. Physicians in Mumbai completed a 5-family domino donation last year; an earlier attempt at a 5-family donation failed when one of the 5 prospective recipients died. In 2012, doctors in 11 different American states completed the largest domino donation chain ever, involving 30 donor-recipient pairs.

Court Orders Vent Removed From Brain-Dead Pregnant Woman

A Texas judge has ordered a hospital to remove Marlise Munoz, a brain-dead pregnant woman, from mechanical ventilation. Munoz was being kept ventilated against her husband's, her parents' and her own previously-expressed wishes because the hospital believed it was legally obligated to provide life-support to her fetus under the Texas Advance Directives Act. The Act prohibits removal of "life support" from any pregnant "patient." The court found that the Act did not apply to persons who are legally dead. The court's order is here. The parties' stipulation of facts, including that Munoz is brain dead and that her fetus is not currently viable, is here.  Munoz's husband filed an affidavit with the court, describing his wife as rigid-limbed, smelling of death, and having a soulless look in her eyes. His attorneys had earlier described the fetus as developing abnormally, and today in court accused the hospital of using Marlise Munoz as "a science experiment" and as a "dysfunctional incubator."

The hospital, which has until Monday at 5pm to comply with the order or file an appeal, is considering its options.

Earlier posts on the Munoz matter are here, here and here.

Bioethics Poetry: Peter Everwine Edition

At the Playground, Singing for Psychiatric Outpatients

The bright-faced children have gone home,

trailing the sun to supper.

                   Tonight,

these others have come,

almost sweetly shy, starched

for their monthly party.

Nurse herds them into metal chairs.

I've come to sing, Nurse tells them,

and they fold their hands

--these lately mad who failed behind a door

or slipped under in a jammed street,

whose eyes blossomed like silver

fists in mirrors, in plate-glass windows.

Nurse is waiting for me.

So I sing for them,

                    for the boy

in the front row, groping

the stiff corners of his pockets;

for the ugly one in pink anklets

--her legs have never felt a razor,

though her wrist has; for him

whose fingers are eaten by ants; for her

whose face sags like a torn sack.

They do not like my songs,

but infinitely polite, they turn

their smiles up into the dark

as if a smile should fall softly, 

obliquely, like rain.

"Home on the Range," Nurse calls out,

her sure fingers on the pulse of America.

I start in faltering voice,

half-forgetting those dead words

sung at campfires in the past.

One joins, and then another:

Home, home on the range. . .

Where the deer. . .

And the skies are. . .

The voices crack and lurch, we

are singing--the boy, the ugly one--

singing like crows in the empty

prairie of a children's playground 

where if there are distances that shine 

they shine like the eyes of pain.

Peter Everwine

Friday Frivolity: Nursing Realism Edition

Ventilating the Dead, Continued

Though she is brain-dead, Marlise Munoz is being kept ventilated against her husband's, her parents', and her own previously-expressed wishes. The Texas hospital where she is being kept argues that this course of action may be required by the Texas Advance Directives Act, which makes it illegal to disconnect any "patient" from "life-support"--if that patient is pregnant. Munoz was 14 weeks pregnant when she died; her fetus is now 22 weeks old. A hearing tomorrow should determine whether ventilation of the dead counts as "life support" under the Act, and whether a dead person is a "patient." Meanwhile, her husband's attorneys point out that the fetus suffered from the same lack of oxygen that destroyed Munoz's brain:

"According to the medical records we have been provided, the fetus is distinctly abnormal," the attorneys said. "Even at this early stage, the lower extremities are deformed to the extent that the gender cannot be determined." The attorneys said the fetus also has fluid building up inside the skull and possibly has a heart problem.

"Quite sadly, this information is not surprising due to the fact that the fetus, after being deprived of oxygen for an indeterminate length of time, is gestating within a dead and deteriorating body, as a horrified family looks on in absolute anguish, distress and sadness," the attorneys said.

 Previous posts on Munoz here and here.

 

Attention: Your $1000 Genome Has Arrived

With the unveiling by Illumina of its Hi Seq X combination of machines yesterday, we've now got the technology to sequence a human genome for $1000. The $1000 genome has been an industry goal for some years now, and seemed tantalizingly close last year. But now, it seems, it's arrived. Sequencing at that price level (the current level is $10,000) will, of course, make sequencing much more common. Goodbye, genetic privacy. Hello, debates about data control and access. Everyone better go read the Presidential Commission for the Study of Bioethical Issues's new report on incidental findings. We're going to have quite a few.

India Eradicates Polio

Monday marked India's third year without any new polio cases, so the country will soon be WHO-certified as having eradicated the disease. Meanwhile, in neighboring Pakistan, where the disease is still rampant, Taliban are executing vaccinators as possible spies. This is apparently because the US used a fake vaccination program as cover for its search for Osama bin Laden. Aagh!

Ventilating the Dead: Update

The Fort Worth Star Telegram is reporting that the family of Marlise Munoz, the pregnant brain-dead woman who is being kept ventilated against the wishes of her family, will sue the John Peter Smith hospital to get her removed from the machinery.  The hospital has kept Ms. Munoz on the machinery for weeks, citing the Texas Advance Directives Act, which states that no one can withdraw or withhold "life sustaining treatment" from a pregnant patient. The crucial legal question is whether the statutory restriction can properly be applied to treatment which is not "life-sustaining," because the patient in question is dead. (Family members have said that they've been told Ms. Munoz is brain-dead, but the hospital has made no official statement confirming this.) A hospital spokesman said the hospital was "encouraged" by the lawsuit "because the courts are the appropriate venue to provide clarity, direction and resolution in this matter." That sounds to me as if the hospital's position may be wholly liability-driven, and they're just looking for the safety of a court ruling to justify stopping the mechanical intervention. On the other hand, the hospital's outside council is reportedly one Neal Adams, who led a drive to end abortions at the hospital in 1988 and serves on the advisory board of the Northeast Tarrant Right-to-Life Educational Association, so perhaps more than liability is driving the hospital's position.

Earlier post on this case and on the Jahi McMath case in California here.

Read more here: http://www.star-telegram.com/2014/01/09/5473242/family-of-pregnant-brain-dead.html?rh=1#storylink=cpy

Read more here: http://www.star-telegram.com/2014/01/09/5473242/family-of-pregnant-brain-dead.html?rh=1#storylink=cpy

New Mexico Judge Finds State Constitutional Right to Aid-in-Dying

A judge in the New Mexico Second Judicial District Court (County of Bernalillo) has found that "the liberty, safety and happiness interest of a competent, terminally ill patient to choose aid in dying is a fundamental right under [the Due Process clause of the] New Mexico Constitution." District Judge Nan G. Nash therefore found that the state's criminal law against assisting in suicide is unconstitutional insofar as it is applied to aid-in-dying for competent, terminally-ill patients. The court's order enjoins prosecution of physicians for aiding competent terminally-ill patients in dying. From the opinion:

This Court cannot envision a right more fundamental, more private or more integral to the liberty, safety and happiness of a New Mexican than the right of a competent, terminally ill patient to choose aid in dying. If decisions made in the shadow of one’s imminent death regarding how they and their loved ones will face that death are not fundamental and at the core of these constitutional guarantees, than what decisions are? As recognized by the United States Supreme Court in Cruzan “[t]he choice between life and death is a deeply personal decision of obvious and overwhelming finality.” Cruzan, 497 U.S. at 281.

The opinion in Morris v. New Mexico only affects prosecutions within Bernalillo County; it will not apply to the whole state unless it is affirmed on appeal by the state's Supreme Court.

The court explicitly declined to distinguish aid-in-dying from suicide: "Through the practice of aid in dying a physician deliberately aids the terminally ill patient in taking of his own life, bringing the practice of aid in dying within the definition of assisting suicide contained in [the criminal law]." But the court went on to find a constitutionally-protected right to suicide for competent, terminally-ill patients, and therefore invalidated the criminal law against assisted suicide insofar as it is applied to doctors assisting in the suicides of such patients.

The case was brought by the ACLU of New Mexico and Compassion & Choices on behalf of two physicians and a terminal cancer patient.