Wednesday, November 30, 2011

I'm Not Lovin' It

So, San Francisco last year prohibited the inclusion of free toys in kids' meals that fail to meet nutritional standards. The so-called "Happy Meal Ban" goes into effect on December 1. So what are San Francisco McDonald's restaurants doing? Charging ten cents for the toy.

Update: Burger King, too.

Tuesday, November 29, 2011

Laptop Connected to Internet Can Damage Sperm

Bad news for road warriors who are also aspiring dads: a recent article in Fertility and Sterility indicates that sperm is severely damaged by exposure to electromagnetic forces associated with wireless communication. Four hours of exposure to laptop WiFi left 25 percent of sperm dead, as opposed to only 14 percent kept at the same temperature away from WiFi; and 9 per cent of sperm showed DNA damage--more than three times as much damage as comparison samples.

HIV (Lack of) Awareness

This CDC report says that of 1.2 million Americans with HIV, 240,000 don't know they're infected. Of every 100 people with HIV, 80 know they have it, 62 are linked to HIV care, 41 stay in care, 36 get antiretroviral therapy, and 28 have their viral loads well controlled. We're used to saying, glibly, that in the US HIV used to be a death sentence, but now it's only a chronic illness. But the fact is that we need to do a lot better on testing and treatment. 16,000 per year are still dying of AIDS--not a large number, as causes of death go (AIDS has been outside the top 15 causes of death since 1997); but AIDS is still a leading cause of death in certain sub-populations, e.g., among younger women and African-Americans. We can do better.

2011: Tenth-hottest Year Ever

The World Meteorological Organization is reporting that 2011 is looking to be the 10th warmest year on record, and the warmest-ever La Nina year. (La Nina years are typically cooler than the years before and after them.) The decade from 2002-2011 is tied with 2001-10 for having the highest average temperatures on record. 13 of the hottest 15 years on record have occurred within the last 15 years. Arctic sea ice extent was at its second smallest level ever, the smallest having been recorded in 2007; and sea-ice volume hit a record low.

Paralyzed Man Seeks Right to Be Killed

Tony Nicklinson, a British man who is paralyzed from the neck down as a result of a stroke, is going to court in order to challenge the law against murder. He is asking that he be permitted to have a physician euthanize him at his request. Last year's guidelines from the Director of Public Prosecutions on prosecution for assisted suicide made it clear that, while some sorts of assistance in patient suicide would not be prosecuted, "[i]t is murder or manslaughter for a person to do an act that ends the life of another, even if he or she does so on the basis that he or she is simply complying with the wishes of the other person." Mr. Nicklinson's case against the Ministry of Justice seems to be an effort to carve out a medical exception to the manslaughter/murder law. I don't expect it will succeed.

New Jersey Nurses Sue to Avoid Abortion Care

The University of Medicine & Dentistry of New Jersey recently and abruptly changed its conscientious objection policy to require nurses to provide care to hospital patients before and after they undergo abortion procedures. Previously, the University had permitted nurses to avoid caring for abortion patients at all, if they objected morally to abortion; but the new policy requires them to deliver pre- and post-operative care. Nurses are still free to decline to participate in, or to be present in the room during, the abortion procedure itself. A dozen nurses have sued to stop the implementation of the policy, and in November a judge granted a restraining order barring the hospital's training of nurses in pre- and post-operative abortion care until after its December 5 hearing on the case. Conscientious objection laws for healthcare providers are problematic, particularly if they reduce access to necessary medical services; but here there seems to be no question of the availability of the procedure. It seems to me that being required to take care of a pregnant mother just prior to her abortion, and then again just after it, is seriously offensive to a nurse who's morally opposed to abortion. If the nurses who feel strongly about this issue are a small minority of available nursing staff (which they seem to be), then I think the University ought to return to its previous, more sensitive, conscientious objection policy.

Obese Child Seized by State

Ohio officials have taken an eight-year-old child away from his mother and placed him into foster care because they believe his mother has been unable to help the child control his weight. (The boy weighs 200 pounds, while normal weight for an 8-year-old is 60.) State authorities had been working with the mother to reduce the boy's weight for 20 months. The boy has been diagnosed with sleep apnea. In this interview, Art Caplan offers several reasons why the state's move was wrong: the removal from his mother will cause emotional turmoil; there's no proof that foster care will help control the boy's weight; the foster-care system is already overwhelmed and there are too many morbidly obese kids to make this a viable policy; the boy will eventually return home, where bad habits and social conditions may not have changed during his absence; and, finally, while the boy's weight places him at high risk for future disease, his obesity does not put him in the kind of imminent danger normally needed to justify removal from the home. On this last point, bioethicist Norm Fost disagrees; he's quoted in the first article linked above as saying that the boy's sleep apnea could be placing him in imminent danger.

Removing the child from home can't be the right approach. It may be true that his mother is incapable of taking basic steps to control his weight. But even on that assumption, his obesity is likely to have social, emotional and physical origins that even very fine foster care will be ill-equipped to address. Perhaps he'll lose weight when he's away from his home--or perhaps the emotional turmoil will make it harder for him to lose weight. In any case, he'll eventually return home, and what will happen then? Meantime, his mother is surely learning the wrong lesson about the benevolence of state interventions on her son's behalf.

Monday, November 28, 2011

Heart Patients: Quantity Please, Not Quality!

MSNBC Health is reporting on the findings of this paper from the European Heart Journal. Faced with various heart-disease-related symptoms (shortness of breath, fatigue, weakness, swelling of the legs and feet), three-quarters of elderly Swiss heart patients surveyed said they wouldn't prefer a one-year symptom-free life to two years with symptoms--and the severity of their symptoms was not a good predictor of who'd pick quality over quantity. Most wanted CPR if they coded--and, stunningly, researchers found that patients' preferences for resuscitation varied from what was actually entered on their charts about one-third of the time.

The finding that most of these subjects actually preferred two years of symptom-burdened life to one year symptom-free is, I'm guessing, likely to be counterintuitive to a number of bioethicists--particularly to the young, healthy ones who haven't yet had to make any concessions to their failing bodies.

Bioethicsy Stuff at Yale

Our Animal Ethics group will hear Charles C. Camosy (Theology, Fordham) on the topic of Ethics and Other Animals: Common Ground Amidst Difference, on December 1 at 1pm.

Our Jerome Medalie End-of-Life Issues group will host Helen Stanton Chapple, PhD, RN, MA, CCRN, MT (Center for Health Policy and Ethics, Creighton) on December 6 at 5:30.

Our Technology and Ethics group will hear Aimee Vanwynsberghe (PhD Candidate in Philosophy, University of Twente) on A Framework for Integrating Ethics in the Design of Care Robots on December 7 at 4:15.

Locations and other details on all of these events are here.

Vaccine Exemptions

This AP story gives a lot of interesting detail on the current parental flight from childhood vaccination. In eight of the US states, over 5% of kids don't get the required vaccinations before kindergarten; their parents exercise the right to exempt them from some or all vaccinations, instead. The exemption rate is up in more than half of all states, but highest in Western and Upper Midwestern states.

Part of the trouble is that some states make it quite simple to exempt a child from vaccination--a note from home alleging a personal opposition to immunization does the trick in Colorado, for example. Some kids need to be exempt for medical reasons, of course, and some accommodation must be made for religious opposition to vaccination; but the response to mere personal or philosophical opposition to immunization should be education, at least in the first instance, rather than surrender. Parents who exempt their children are endangering them and other people as well.

Bioethics Web Resource of the Week

This week I'll call your attention to the developing Bio-Ethics Bites page at the Oxford Centre for Neuroethics. The first seven of ten planned podcasts are up, and feature Tim Lewens on selling organs, Jonathan Wolff on political bioethics, Onora O'Neill on trust, Nick Bostrom on status-quo bias, Jeff McMahan on moral status, Peter Singer on life and death, and Julian Savulescu on designer babies.

Saturday, November 26, 2011

OECD Health Data on US System

This report on health data from OECD countries has some distressing, though not entirely new, news for US citizens. The US spent 17.9% of GDP on healthcare in 2009; OECD average was 9.6%. The US spent two-and-a-half times more per person than the OECD average. For that pricetag, we ended up ranked 28th out of 34 for life-expectancy (78.2 years, just behind Chile, compared to the OECD average of 79.5). We're fourth from the bottom on premature death, have more than twice as many avoidable asthma hospital admissions than the OECD average, see our doctors less often, and pay more for our drugs. On the plus side, the colorectal cancer survival rate is excellent, and our breast-cancer survival rate is best in the OECD. We're good at the pricey stuff, and terrible at the inexpensive basics.

Physician Brain Drain from Africa

According to this piece in BMJ, Australia has saved $621m, Canada $384m, the UK $2.7bn, and the US $846m in medical education costs by recruiting and licensing African physicians whose training was paid for at home. Ethiopia, Kenya, Malawi, Nigeria, South Africa, Uganda, Tanzania, Zambia, and Zimbabwe have lost more than $2bn from training doctors who then migrated to one of those four countries.

Global Health Fund Suspending New Grants

The Global Health Fund to Fight AIDS, Tuberculosis and Malaria, which pays for about half of all AIDS treatment in developing countries, is in financial crisis and will not make any new grants for the next two years. This is a serious blow to global health. Details here and here.

Friday, November 25, 2011

Criteria for Personhood?

Here is a lovely paper by Tim Chappell, staking out a generally more conservative position than my own on the question of whether it's legitimate to decide who's a moral "person" on the basis of psychological or other mental criteria. Nothing better for the brain than to read a smart person who's standing somewhere else....

Friday Frivolity, Sharing Bad News Edition

Bioethics Poetry, James Tate edition

The Lost Pilot
By James Tate

for my father, 1922-1944

Your face did not rot
like the others—the co-pilot,
for example, I saw him

yesterday. His face is corn-
mush: his wife and daughter,
the poor ignorant people, stare

as if he will compose soon.
He was more wronged than Job.
But your face did not rot

like the others—it grew dark,
and hard like ebony;
the features progressed in their

distinction. If I could cajole
you to come back for an evening,
down from your compulsive

orbiting, I would touch you,
read your face as Dallas,
your hoodlum gunner, now,

with the blistered eyes, reads
his braille editions. I would
touch your face as a disinterested

scholar touches an original page.
However frightening, I would
discover you, and I would not

turn you in; I would not make
you face your wife, or Dallas,
or the co-pilot, Jim. You

could return to your crazy
orbiting, and I would not try
to fully understand what

it means to you. All I know
is this: when I see you,
as I have seen you at least

once every year of my life,
spin across the wilds of the sky
like a tiny, African god,

I feel dead. I feel as if I were
the residue of a stranger’s life,
that I should pursue you.

My head cocked toward the sky,
I cannot get off the ground,
and, you, passing over again,

fast, perfect, and unwilling
to tell me that you are doing
well, or that it was mistake

that placed you in that world,
and me in this; or that misfortune
placed these worlds in us.

C-Section on Maternal Request, Cont.

BMJ has a "Head to head" feature on whether women should be given the chance to request c-sections if they aren't medically indicated. Have a look, pro here, con here. My own view is that maternal request for c-section is sometimes reasonable, particularly with regard to the woman's desires to avoid sequelae that are more associated with one form of birth than the other; but that I'm also worried that "maternal request" can be manipulated by physicians who are concerned with scheduling, cost, or other variables, and can manipulate women into requesting the surgery.

Sperm Donor Anonymity

Have a look at this video, courtesy of BioEdge, on the children of anonymous sperm donors. As I've said before, this issue is one of the top bioethics stories of the year. Is there good reason to keep sperm donors anonymous? Several countries have abolished anonymity, and sperm donations haven't dried up....

Thursday, November 24, 2011

Light Blogging, Thanksgiving Edition

I'll try to post a bit in the next day or two, but I'm traveling for the Thanksgiving holiday, so the posting is apt to be light. Happy Thanksgiving!

Monday, November 21, 2011

Bioethics Poetry, Sylvia Plath Edition

The Stones

This is the city where men are mended.
I lie on a great anvil.
The flat blue sky-circle

Flew off like the hat of a doll
When I fell out of the light. I entered
The stomach of indifference, the wordless cupboard.

The mother of pestles diminished me.
I became a still pebble.
The stones of the belly were peaceable,

The head-stone quiet, jostled by nothing.
Only the mouth-hole piped out,
Importunate cricket

In a quarry of silences.
The people of the city heard it.
They hunted the stones, taciturn and separate,

The mouth-hole crying their locations.
Drunk as a foetus
I suck at the paps of darkness.

The food tubes embrace me. Sponges kiss my lichens away.
The jewelmaster drives his chisel to pry
Open one stone eye.

This is the after-hell: I see the light.
A wind unstoppers the chamber
Of the ear, old worrier.

Water mollifies the flint lip,
And daylight lays its sameness on the wall.
The grafters are cheerful,

Heating the pincers, hoisting the delicate hammers.
A current agitates the wires
Volt upon volt. Catgut stitches my fissures.

A workman walks by carrying a pink torso.
The storerooms are full of hearts.
This is the city of spare parts.

My swaddled legs and arms smell sweet as rubber.
Here they can doctor heads, or any limb.
On Fridays the little children come

To trade their hooks for hands.
Dead men leave eyes for others.
Love is the uniform of my bald nurse.

Love is the bone and sinew of my curse.
The vase, reconstructed, houses
The elusive rose.

Ten fingers shape a bowl for shadows.
My mendings itch. There is nothing to do.
I shall be good as new.

Sylvia Plath

Must Aussies Drug Their Kids?

There's a kerfuffle in Australia regarding these Attention Deficit Hyperactivity Disorder (ADHD) guidelines from the National Health and Medical Research Council. Family support groups are upset because the guidelines include this language: "As with any medical intervention, the inability of parents to implement strategies may raise child protection concerns." Critics are interpreting this to mean that parents will be forced to medicate their hyperactive kids, or risk losing custody of them. I think the criticism is overblown. First, it's just true that failing to help treat your child's mental health problems can indeed amount to child abuse, and can merit state intervention. Moreover, the language doesn't apply only to drug interventions, but to the full scope of ADHD interventions (psychosocial, educational, drug, and combination) which the guidelines contemplate. In fact, the real story here seems to be that these guidelines are not pushing Ritalin as a one-stop approach to ADHD symptom control, but are instead taking a nuanced approach to ADHD's situation within the child's broader mental health status. In this way they differ from previous draft NHMRC guidelines--guidelines which were ditched last year because they relied heavily on the work of a professor (Harvard Med’s Joseph Biederman) who was sanctioned for failing to declare conflicts of interest.

The Meaning of Geron's Stem-Cell Decision

Michael Cook at BioEdge says the decision by Geron to end its human embryonic stem cell spinal-therapy research is a huge blow to those who believe in the therapeutic potential of hES cells. I have to disagree. It's true that the tissue-generating potential of hES cells was overblown in the battle to secure funding for hESC research. But I don't think Geron's move stands for anything greater than what it was: the decision of a single firm that its cancer research was more profitable than its stem-cell research. University-based work with hESCs and induced-pluripotent cells have shown real progress toward the tissue-generation goal; and, additionally, researchers are using stem cells as tools for drug-testing and for the analysis of diseased cells--work which is quite apt to have short-term therapeutic payoff.

Note, too, that while Geron had secured funding from the California Institute for Regenerative Medicine for its trial, it has given the money back with full interest, so there's no story here of wasting public funds.

Stem Cell Politics

No real surprises in this piece in NEJM summarizing public-opinion polling results on support for human embryonic stem cell research. 62% of Americans think hESC research is morally acceptable, while only 30% think it's wrong; 55% favor federal funding and 41% oppose it. But only 52% of Republicans favor hESC research, compared to 67% of Democrats; and a 58% majority of Republicans oppose federal funding, which 70% of Democrats favor.

Of 34 European countries, majorities favored prohibition of hESC research only in Luxembourg, Slovenia, Austria and Greece.

Friday, November 18, 2011

Microbial Resistance

Here's the newly-unveiled European Commission action plan to address the threat of increasing antimicrobial resistance. The plan calls for better control of antibiotic use in both human and animal medicine, for exploration of alternatives to antibiotics, for international surveillance of the resistance problem, and for public/private support for the development of new antibiotics. That's the key issue. It's difficult to get industry interested in developing the new drugs because, as the action plan pithily puts it:

"Developing new, effective and safe antibiotics is more and more scientifically difficult and costly. Restrictions on the use of antibiotics deter investment. Pricing structure does not reward utility. The majority of antibiotics are administered for short periods. Generics take an increasing share of the antibiotic market."

In the US, Senators Blumenthal and Corker have introduced their bipartisan Generating Antibiotic Incentives Now ("GAIN") act. The plan is to reward manufacturers of new antibiotics with longer time on-patent. This approach has the political advantage of not costing the government much up front, but it may miss the mark. The difficulty is that the responsible plan for using any effective new antibiotic will likely involve not using it, so that it retains its potency and is taken off the shelf only to defeat multiply-resistant superbugs. That means the new product will not be flying off the shelves, so it's not clear how valuable a lengthier patent exclusivity period will be to the drug developer. Governments may have to make more direct payments to industry to encourage antibiotic development; or they may have to do the R&D themselves.

Friday Frivolity, Credulous Git Edition

Thursday, November 17, 2011

Challenge to Canada's Assisted Suicide Law

The Royal Society report I blogged on earlier today may end up having an impact on an important case which has just begun in British Columbia. It's a new challenge to the constitutionality of Canada's law criminalizing assisted suicide. The case aims to overturn the 1993 Rodriguez case, in which a 5-4 split Supreme Court upheld the criminal law by affirming that it did not interfere with the rights to liberty and security of the person affirmed by the Canadian Charter. The Royal Society report includes extensive discussion of contemporary Canadian attitudes toward euthanasia and assisted suicide--attitudes which have changed substantially since 1993. Such changes in national climate--plus a number of intervening cases interpreting "security of the person"--may leave Rodriguez vulnerable to reversal.

Supreme Court to Rule on Health Reform

I'm a few days late with this, but here's the irreplaceable Timothy Jost's take on the US Supreme Court's grant of certiorari on a number of legal and constitutional issues related to Obama's health-insurance reform law.

Geron Halts Stem-Cell Trial

Here's a report on Geron's decision to halt its human embryonic stem cell spinal-cord therapy trial--the first ever in-human stem-cell trial approved in the US. The decision seems not to have been driven by the trial's progress, but by economics: the trial was costing a lot and not attracting investment, whereas Geron's other work on cancer has drawn the interest of big Pharma investors. Only four people had been enrolled in the trial; all had reportedly tolerated GRNOPC1, a Geron product containing hESC-derived progenitor cells, well and without side effects.

Royal Society of Canada: Assisted Death

Have a look at this report from the Royal Society of Canada on end-of-life care. It's headline-grabbing recommendation is that both assisted suicide and voluntary euthanasia should be legally available; but the full report, with its overview of current Canadian public opinion and law on end-of-life options, is well worth reading.

Friday, November 11, 2011

Health Costs of Climate Change

The current issue of Health Affairs includes this article, which is trying to quantify the health-related costs of US environmental events related to climate change. This is a tricky problem, since no single environmental event can properly be attributed to climate change. The authors have instead named six categories of events tied in the literature to climate change (ozone pollution, heat waves, hurricanes, infectious disease outbreaks like West Nile, river flooding, and wildfires), and done a health-cost estimate for one example of each such event. It's an interesting approach to getting a handle on health costs of environmental problems. They find $14 billion of health costs related to the six events, most of it due to premature loss of life; and $740 million in health-system costs incurred during 760,000 encounters with the health-care system.

Sick Americans Have More Trouble Paying

A new report from the Commonwealth Fund shows that sicker, high-cost US patients are much more likely than those in other high-income countries to forgo needed care because of costs, and to struggle with medical debt. The study surveyed patients from the US, Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland and the UK. In all of those countries, patients with a "medical home"--a primary care practice that knows the patient's history and coordinates care--had fewer medical errors, better coordination of care, and greater satisfaction.

27% of the US patients had serious problems paying medical bills in the last year; the next-highest rate was 14% in the Netherlands. 42% of American patients reported having forgone care, missed doctor visits or left prescriptions unfilled for reasons of cost. This was over twice the rate for every other country except Australia (30%), New Zealand (26%) and Germany (22%).

A nice summary set of charts on the findings is available here.

Friday Frivolity, Homeopathic Edition

Thursday, November 10, 2011

Cheap Way to Detect Consciousness

This report in the Lancet shows that ordinary hospital EEG equipment can be inexpensively adapted and used to detect consciousness in patients who appear vegetative. In the study, 3 of 16 superficially unresponsive patients were able to generate EEG-detectable brain activity in response to simple requests, e.g., to imagine moving a toe--indicating a previously undetected level of consciousness. The existence of this technology, which involves sticking electrodes to the patient's head, could have a profound effect on diagnosis of and care for brain-injured patients, many of whom can't be examined even using more expensive fMRI technology because of the presence of metal screws or plates in their brains, or because they are unable to keep still. People on all sides of the end-of-life debate should welcome an inexpensive way to avoid misdiagnosis of PVS.

Misuse of Aid Funds in Nigeria?

Oh dear. This article reports allegations that a half-dozen different Nigerian organizations which received aid from The Global Fund to Fight AIDS, Tuberculosis and Malaria either misused, stole or lost track of millions of aid dollars. The news article seems to be based on a leaked audit report from the Fund's own Office of Inspector General. Officials from the various accused organizations are crying foul, claiming that the Fund's accounting rules have changed, making some of the Fund's demands for retrospective accounting on early grants impossible to fulfill; and that the Fund's audit is an exercise in overreaching and is actually an opening play in a negotiation rather than a conclusive finding. The report adds that some of the audited organizations have already returned some or all of the un-accounted-for money. The opacity of the report, and perhaps of the underlying grantmaking/audit process, makes it difficult to determine which of the reported problems are serious and which aren't; but it all amounts to an object-lesson in the difficulty of managing global health aid.

DC Circuit on Health Reform

Can't have a bioethics blog in America without at least noting this very important appellate opinion upholding the constitutionality of the Obama's health reform. It comes on the eve of the Supreme Court's decision whether to grant cert and hear appeals from earlier-decided cases on the same issue. For unbeatable analysis, see Tim Jost's post here.

Bioethicsy Stuff at Yale

November 15: Our Jerome Medalie End-of-Life Issues group and our Yale-Med sister institution the Program for Biomedical Ethics will co-host Richard Gunderman, MD, PhD, speaking on "Professional Lessons from the Bedside of My Dying Father." Details here.

November 16, 2011: Our own Robert Levine will continue his seminar series on the ethics of research on human subjects, concentrating this time on privacy and confidentiality, and on epidemiology, social and behavioral research. Details here.

November 17: Our Biotechnology in Agriculture group will hear the USDA's Mark Lipson speak on "Policy Frameworks for 'Coexistence' of Transgenic, Conventional and Organic Systems." Details here.

November 18, in San Francisco: Our sister institution the Yale Forum on Religion and Ecology will have a luncheon before the American Academy of Religion meetings. That evening, the Forum will sponsor a showing of Journey of the Universe, followed by a discussion led by several of the filmmakers, including our own Mary Evelyn Tucker and John Grim. Details here.

November 19: The next meeting of our Perspectives in Aging group. Details here.

November 29: The next meeting of the Students' Medical Ethics Seminar Series (open to all Yale Nursing, PA and Med students). Details here.

Tuesday, November 8, 2011

Conflict of Interest on NIH Guideline Panels

Here's a New York Times story from last week, reporting a very high prevalence of financial ties to industry among experts on NIH panels drafting guidelines on hypertension, obesity and cholesterol. (As the article notes, the panels were seated in 2008, before the current more rigorous guidelines on COI were put into place.) 20 members of the three panels, including some co-chairs, have been told they ought to recuse themselves from voting on crucial issues. 8 of 19 obesity panel members have ties to industry, as do 7 of 16 cholesterol panel members. Worryingly, 5 of 17 hypertension panel members have taken industry money since the panel was seated.

And government panels are among the least worrying on the COI issue. This piece from BMJ last month finds that, among 7 panels working on diabetes and 7 on hyperlipidaemia guidelines between 2000 and 2010, most panel members and half of all panel chairs had COI, and that the COI prevalence was lowest on government sponsored panels. It was highest on panels sponsored by specialty societies. It's time for a hard look, not only at standards but at remedies. Mere disclosure and self-recusal from voting doesn't help much, if the panelist has had the chance to frame the discussion. One panelist in the Times story is quoted as saying he severed his ties with industry in order to serve--but if he had the ties before, and will be free to have them again afterwards, what does the current severing really do to secure his independence? The best solution is probably the one used by NICE in the UK: no one who's received industry money in the last year is permitted to serve.

Monday, November 7, 2011

More On Undead Donors

Ugh. Here is Wesley Smith claiming that "they" "still" "really want" to "kill" people to get their organs for transplantation. What he's reporting on is the recent paper, which I briefly mentioned here, advocating the abolition of the dead donor rule, fundamentally because it relies on two definitions of death ("total" brain death and "irreversible" cardiac death) which only occur problematically, if ever. Smith claims that he "still believe[s]" that "properly diagnosed and with proper protocols, the current system is ethical." What this means is that he thinks there's a clear line at which we can stop, beyond which we're killing people for organs, and before which we're not. But the current system doesn't actually supply a clear line--which is the paper's point. What the paper says (and what some similar papers by Dr. Robert Truog have said) is that hardly anyone who is pronounced "brain dead" actually meets the legal criterion for brain death, which is total cessation of upper-brain and brain-stem activity; and that those who meet the "irreversible cardiac death" definition often only meet it because someone actively decides not to try to reverse their cardiac death. In other words, under the current system, we're not really using a clear "dead donor" rule. We're using a small, constrained element of judgment to determine who counts as dead enough to be a donor.

Is that a problem? I think not, because I believe that physicians declare people brain-dead, or cardiac-dead, only in situations when those people are irreversibly and severely compromised, beyond recovery, and bound shortly to die. But Smith (who imagines a world full of "utilitarian bioethicists" who actively want to kill people if they can't fence, ace a calculus exam, and sing an aria from Aida) doesn't trust judgment, because judgment leads to slippery slopes. Give them an inch, and "they" will "really want" to "kill" people for organs. What he's missing is: they already have their inch. The current system gives them the inch. Eliminating the dead donor rule, according to these papers, is no erosion--it's just honesty.

Deadish Donors

BioEdge is reporting on a proposal made this summer in AJOB, and repeated this year at the ASBH meeting, to do away with the dead donor rule. The basic argument is that 1) the legal definition of "brain death"--total cessation of all upper-brain and brain-stem function--seldom applies to people we term "brain dead," because there's typically a little bit of residual functioning left; and the cardiac-death criteria depend, often, upon a decision being made not to revive someone who, in other circumstances, might be considered revivable (e.g., someone whose heart stopped 90 seconds ago). So, given that we're already harvesting organs from people who are only problematically "dead" according to our current, flawed, definitions, why not just tell the truth, do away with the dead donor rule, and substitute a regime of honesty about the complexity of death, and informed consent? The difficulty, of course, is with the politics and public understanding of the rule. No matter what kind of public education you attempt to do, if you were to announce the end of the dead-donor rule, a certain segment of the population would flee from being organ donors because of fear that they'd be "killed" for their organs.

Note: Harvard's Bob Truog has been making very similar arguments against the dead donor rule for years.

Friday Frivolity, Health Reform Implementation Edition

Evidently this healthcare executive hasn't been reading his Health Affairs. Or his JAMA. Or his NEJM....

Wednesday, November 2, 2011

More on NHS and C-Sections

Over at BMJ Journal of Medical Ethics Blog, Iain Brassington wonders why, in my earlier post on the new NHS policy permitting c-section on maternal request, I said I was worried about the policy opening the door to c-sections being scheduled for reasons other than maternal request. "It's a heck of a leap from 'maternally requested' to 'requested by someone else," he says.

Well, maybe not such a leap. Allow me to quote myself (and co-author Errol Norwitz) (notes omitted):

"There is extensive support for the idea that some cesareans are performed at the instigation of physicians for reasons unrelated to medical indication. A by-now venerable body of published data demonstrates that the overall cesarean rate is responsive to method of reimbursement, to physician time demands, and to physicians’ fear of medical malpractice lawsuits. This medical literature is supported by the results of a 2006 survey of recent mothers. The survey showed that mothers with primary cesareans indicated that not they, but their physicians, were the predominant decision-makers in choosing the cesarean procedure. A total of 26% of women with primary cesareans reported having felt pressured by their providers to get the procedure. In contrast, only 1 of 252 survey respondents with primary cesareans reported making the choice to schedule a cesarean in advance for no medical reason. Two others who reported having had cesareans for no medical reason reported that the decision to have the cesarean was made by their provider and not by themselves. These data are similar to findings in Brazil, which has a cesarean rate of 36%. Repeated studies there have shown that a majority of primiparous women in Brazil want to delivery vaginally, but end up delivering surgically, particularly in private hospital settings.Their decisions to undergo surgery emerge only after discussions with their physicians; yet the public rhetoric around cesarean section in Brazil is that women are “demanding” the procedure. Finally, consider the striking results of a 2004 paper on intrapartum elective cesarean delivery. Researchers surveyed obstetricians after all intrapartum cesarean deliveries in their facility, asking whether cesarean delivery was offered by the obstetrician or requested by the patient before being medically indicated. Of a sample of 422 cases, cesarean was offered in 13% of cases before any clear medical indication emerged, and requested in only 8.8%. Thus, among intrapartum cesareans without medical indication, more were offered by physicians than were “requested” or “demanded” by patients. Physician characteristics, and not patient characteristics, were a significant factor in determining whether elective cesareans were offered."

In sum: in the US and in Brazil, a lot of what gets talked about as c-section on maternal request is physician-driven. Will the new NHS policy open the door to this phenomenon?

Finally, I don't think I said anything inaccurate about the new NHS policy, as Iain gently suggests. I gave a summary account of the steps to be taken under the policy by the physician before the woman's request for c-section is agreed to, and Iain helpfully spells those out. But in the end, if the requesting persists, the c-section is given, even if that requires transfer to another physician's care. My concern is that the initiation of requests, and their persistence, is subject to influence by physicians. At least in the States (where, admittedly, the financial incentives are different), the occasional doc has been known to prefer higher reimbursement to lower, Friday afternoon c-sections to vaginal births on Saturday at 2am, and so on.

Bioethics Web Resource of the Week

This week's Bioethics Web Resource is the Hastings Center's Bioethics Briefing Book, freely available online here. The book features politically-neutral articles by top experts on a very broad range of bioethics topics. It's designed to supply sophisticated background to journalists and members of the general public. One look at the table of contents and I bet you'll click through to something or other. Previous BWRW's are here and here.

Red-carded for Bad DNA?

ESPN reported two weeks ago that an unnamed Premier League soccer club has done DNA testing on its players to determine whether any of them are genetically prone to injury. From the story:

"Professor Marios Kambouris, assistant professor at Yale University School of Medicine, carried out the ground-breaking work following research into tendons and common football injuries by a group of British scientists. The study profiled more than 100 genetic mutations linked to an increased chance of injuries such as ruptured tendons. Professor Kambouris said: 'I have no idea which players they were but there were good genes in there, things which would positively affect their performance, such as their ability to have better aerobic respiration, which would give them more stamina on the pitch.'"

Obviously there's the potential here for testing to help clubs prevent some of their stars from incurring injuries; for clubs to use testing to recruit players with "good genes;" and for clubs to decline to recruit even excellent players with high genetic risk for injury. And there's the potential for testing, as it becomes cheaper, to trickle down to the amateur and collegiate levels of play. "Sorry kid, you've got the heart and the moves, but you just don't have the genes."

Hat tip to Yale's excellent Molecular Anthropology Blog

Tuesday, November 1, 2011

Anthrax Vaccine Testing in Kids?

It's a post-modern world. Here's the Washington Post's headline on a Friday story: "No testing of anthrax vaccine on children _ for now _ federal advisory board tells regulators." The next day, the San Francisco Chronicle's headline on a story written by a Washington Post reporter reads, "Panel endorses anthrax vaccine test on children." Global Security Newswire's headline? "Panel Urges Ethics Study of Testing Anthrax Vaccine on Minors." And yes, you guessed it, all these articles are about the same report. In fact, the "final draft report" of the National Biodefense Science Board actually recommends the following:

"HHS should develop a plan for and conduct a pre-event study of AVA in children, to include a research IND. HHS should submit the study protocol to one or more IRBs, and comply with the 21 CFR 50.54 / 45 CFR 46.407 federal review process. This recommendation should be revisited if new anthrax vaccines or other therapeutic countermeasures become available."

Translation: do the Anthrax vaccine study in kids after IRB review.

The NBSB report gave considerable attention to the ethics of testing Anthrax vaccine in kids, but it didn't end up "urging an ethics study" or saying "no testing for now." The report takes the position that it's important to understand how the vaccine works in kids before it's used in an emergency--important enough for kids to incur the risks of the trial, given the informed consent of their parents. The recommended trial would begin with older kids and work its way down to lower ages as results come in.

Note that the intended use of the vaccine is not as a routine population-wide prophylactic, since Anthrax isn't infectious. Rather, it would be given to selected people (including children) after they'd been exposed to Anthrax spores, to prevent disease development. Here's the second sentence of the executive summary of the report: "In this emergency scenario, [anthrax vaccine] would be used in conjunction with antibiotics to prevent the development of infection and illness following exposure to anthrax spores, a form of therapy termed “post-exposure prophylaxis." That's why Steven Salzberg's righteous indignation in this Forbes article seems to me to be misplaced; he seems to think that NBSB is contemplating huge and wasteful population-wide vaccination, but it's not.

UPDATE: Here's a nice piece by Art Caplan predicting that the study on kids won't happen. Basically Art is arguing that the likelihood of an anthrax attack is so small, the risks of the vaccine so uncertain, and the likelihood of vaccination being used as a response to an attack so uncertain, that no IRB will ever think the vaccine test has a good enough risk/benefit profile to permit it. Highly recommended!