Saturday, December 24, 2011

'Tis the Season

I'll be blogging very little in the next few days, as I'll be celebrating the season with family--and grading! Pace will kick up again near the end of the month.

Wednesday, December 21, 2011

EU Bans Export of Death Penalty Drugs

The European Commission has moved to limit the export of barbiturates to countries which, like the United States, use the drugs in lethal-injection death-penalty executions. Some individual countries and some pharmaceutical firms have already restricted export to death-penalty states, resulting in a serious shortage; this move by the EU will restrict supplies still further. Sadly, I imagine that resourceful death-penalty states will simply move to using other drugs; but perhaps the need to reconsider their methods of execution will lead some states to reconsider the death penalty entirely.

Tuesday, December 20, 2011

Bioethics Poetry, Donald Hall Edition


To grow old is to lose everything.
Aging, everybody knows it.
Even when we are young,
we glimpse it sometimes, and nod our heads
when a grandfather dies.
Then we row for years on the midsummer
pond, ignorant and content. But a marriage,
that began without harm, scatters
into debris on the shore,
and a friend from school drops
cold on a rocky strand.
If a new love carries us
past middle age, our wife will die
at her strongest and most beautiful.
New women come and go. All go.
The pretty lover who announces
that she is temporary
is temporary. The bold woman,
middle-aged against our old age,
sinks under an anxiety she cannot withstand.
Another friend of decades estranges himself
in words that pollute thirty years.
Let us stifle under mud at the pond's edge
and affirm that it is fitting
and delicious to lose everything.

Donald Hall

Two Tales of Conjoined Twin Separation

In one story, two once-conjoined toddler girls are heading back to the Dominican Republic, having been successfully separated by a day-long surgery that divided their liver, pancreas and other shared organ systems and reconstructed their abdominal walls. Virginia Commonwealth University had a farewell party for them. In the other story, one of two girls separated at Santiago, Chile's Calvo Mackenna Hospital has died, and her sister is said to be in stable but critical condition. The two, who had had a shared intestine and liver, had been struggling since their 18-hour separation surgery in early November.

The decision to attempt to separate conjoined twins is an ethically challenging one. First, there are the medical risks. Sometimes separation is simply out of the question; sometimes it is medically required if one or both of the twins are to survive infancy. Often, though, separation is surgically possible, but risky. The question then arises, "What risks should parents submit their children to for the sake of bodily normalcy?" An additional problem arises if the medical risks of separation are not be shared equally between the twins: May one twin be put at risk, or even sacrificed, for the sake of the other's attaining a more "normal" life?

There are also some very complicated questions about the motivations of the parties seeking separation. After all, many twins have lived happy lives without separation, and a certain amount of desire for separation may be driven by social pressure for bodily normalcy and biases against disability. (Parents and medical personnel can, of course, share those social attitudes.) More troubling is the possibility that the separation surgery is being pressed by physicians or hospitals for the sake of publicity or reputation-enhancement.

To be clear: I cannot tell from the media coverage which of the above questions or ethical problems were in play in either of the two stories I cited above. It's just that the simultaneous stories, with their very different outcomes, put me in mind of this set of issues.

Canadian AIDS Researchers Oppose HIV-Exposure Prosecutions

The current CMAJ includes this letter from three researchers at the British Columbia Centre for Excellence in HIV/AIDS, arguing for an end to Canada's criminal prosecution of people who allegedly expose sexual partners to HIV. The letter points out that the actual risks of transmission to sexual partners are quite low for well-controlled HIV; that prosecutions have never been shown to reduce rates of infection: and that they may in fact discourage or interfere with HIV testing and treatment. In this interview, one of the co-authors also notes that while Canadian rates of prosecution for HIV exposure have been on the rise, there is no similar policy of prosecuting those who expose partners to other potentially serious viruses like HPV.

About Comments

I welcome comments on my posts, and will try to respond to substantive points. But I will (continue to) delete any comment that 1) is obscene or offensive or 2) links to a commercial site.

Republicans De-fund Needle Exchanges

House Republicans have restored the ban on US federal funding of needle-exchange programs--programs which have been proven effective, time and again, at reducing HIV and hepatitis transmission, and which therefore also reduce the costs of medical care. Art Caplan has more here.

Insurance Reform Successes

This report from the Centers for Disease Control shows that provisions of the Obama health insurance reform law which went into effect in 2010 have resulted in an additional 2.5 million young adults (19- to 25-year-olds) having insurance coverage. And while we're talking about provisions of the health reform law that are already helping people, let's not forget the reduced Medicare Part C premiums and the Medicare "doughnut-hold" drug rebates for the over-65 set; the no-copay, no-deductible preventative care; the low-rate "pre-existing condition" insurance pools that have allowed some seriously-ill people to find coverage; the tax credits for small businesses who insure their workers; the restrictions on insurance-company limits on what they'll spend on the seriously-ill; and the limits on health plans' ability to spend premium dollars on marketing and administration. All of these benefits are already flowing from Obamacare. If people knew what was in it, they might be less anxious to ask judges to strike it down.

Freelance Sperm Donor

Here's an interesting story: a San Francisco bay-area engineer is being told by the FDA that he has to stop giving away his sperm to infertile couples. The FDA objects to the fact that the donor is not getting a blood test prior to each donation, as required by federal regulations. The donor, who promotes his free service on the web, decided to donate to couples on his own rather than through a clinic because he wasn't interested in payment for donation, wanted to give away his sperm for free, and didn't want the donor anonymity offered by clinics. He's interested in the possibility of playing a role in the lives of his children--which may keep him busy in the future, given that he's fathered 14 since 2007.

Thursday, December 15, 2011

More on Chimps in Research

Now Francis Collins says NIH will abide by the IOM consensus committee's guidelines about use of chimps in biomedical and behavioral research. That was fast!

GMC Will Draft Guidance on Assisted Suicide

According to this report in The Guardian, the UK's General Medical Council is planning to issue new guidance for investigation of physicians who've allegedly assisted a patient in suicide. The problem is in part with uncertainty over what sorts of actions by doctors really count as assisting in suicide. Is a sympathetic conversation enough to count as "assisting"? How about a factual assertion about the availability of assisted suicide in Switzerland? Some physicians' words or actions may not lead to criminal charges, but may nonetheless lead to complaints about their fitness to practice; a handful of investigations of this sort have already been conducted.

GMC plans to publish the guidelines for public comment next month.

Shocking US Rape Statistics

This CDC report of the results of the National Intimate Partner and Sexual Violence Survey finds that 1 in 5 American women, and 1 in 71 men, are raped in their lifetimes. The vast majority of female rape victims are raped before age 25, mostly by intimate partners. Over a quarter of male victims are raped before age 10.

Presidential Commission Report on Protection of Human Subjects

The Presidential Commission for the Study of Bioethical Issues has released its report on protection of human subjects. This is the follow-up to September's report on the unethical studies done by the US Public Health Service in Guatemala in the 1940s. Major recommendations in the new report seem to be for better data collection and transparency by funding agencies, and for provisions guaranteeing that subjects injured in research are compensated for their research-related medical care.

Institute of Medicine Approves Limited Use of Chimps in Research

The much-awaited Institute of Medicine consensus report on the use of chimpanzees in biomedical and behavioral research is here. Bottom line: chimps may be used in biomedical research if no other models are available, if it would be unethical to conduct the research in humans, and if failing to do the research would significantly slow progress toward control, prevention or cure of a debilitating or fatal disease. The panel split on whether chimps could be used in hepatitis research. Comparative genomic and behavioral research should be permitted, the report says, only if it would yield otherwise unattainable insights into behavior, genomics or mental health; and may only be conducted on acquiescent animals using minimally invasive techniques that minimize pain and distress.

The report is bound to upset animal-rights activists; but it also appears to be full of arguments for much sharper limits on, and better oversight of, chimpanzee use in research.

Update: I neglected to note that the report says, in no uncertain terms, that most current chimp research is unnecessary, and fails to meet the guidelines I mentioned above.

Wednesday, December 14, 2011

Doctor's Conflict of Interest

This is a wonderful, and subtle, discussion of what it was like for an MS patient to discover that her treating physician had long been on the payroll of the pharmaceutical firm which made the drugs he'd been asking her to take.

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

Tuesday, December 13, 2011

America's Health Rankings

It appears that I live in the third-healthiest of these fifty United States. Vermont's the best, Mississippi the worst. This site from United Health Foundation actually has a wealth of health data on each of the states: obesity rates, smoking rates, infant mortality, infectious disease. Enjoy!

More on Abortion and Mental Health

Michael Cook at BioEdge is making the mistake I blogged about briefly last week!

Here's the issue: This review study from the National Collaborating Centre for Mental Health (NCCMH) finds that while unwanted pregnancies have a negative effect on women's mental health, the mental health of women with unwanted pregnancies was no different whether they had an abortion or gave birth.

Now, 98% of all UK abortions are performed to preserve the physical or mental health of the mother; of those, 99.96% involve mental health. Should we infer, with BioEdge and with the Christian Medical Fellowship, that those abortions are inappropriate, because the NCCMH study proves that abortion doesn't preserve mental health after all?

We should not. NCCMH looked at rates of mental health problems among women who had had unintended pregnancies, some of whom had chosen to terminate them with abortion, and some of whom had given birth. It found similar rates of mental health in those two populations. But the women in those populations were in them by choice. The study does show that women who choose abortion have no better or worse mental health than those who do not. But it certainly doesn't show that their mental health would have been the same if the option to abort had been denied them, and they had been forced to give birth. The study, in other words, leaves open the question whether abortions are good for the mental health of the women who choose them.

Too Much Spending on Healthcare, Not Enough on Social Services

Here's a remarkable op-ed by my colleagues Betsy Bradley and Lauren Taylor. (Among many other things, Betsy runs Yale's Global Health Leadership Institute and Lauren is an alum of our Bioethics Summer Program.) Their piece summarizes data from a study that ran in BMJ Quality and Safety earlier this year.

The US famously spends very much more on healthcare than other countries. But the study looked at social spending more broadly, counting expenditures not only on health, but also on social services such as rent subsidies, employment-training programs, unemployment benefits, old-age pensions, family support, and so on. When those expenditures are added up, the US comes in 10th in world spending. And we're one of only three industrialized countries which spends more on health care than on those other social services. This failure to spend on social services, the op-ed claims, explains why our huge expenditures on health care don't give us good health outcomes. We'd get more health for our dollars if we offered people more social support.

A striking example from the op-ed: 119 chronically homeless people in Boston logged 18,884 emergency room visits in just five years, at a cost of $12.7 million. Perhaps if those people had had better social services, we wouldn't have had to pay for so many costly ER visits.

"Postcode Lottery" for Healthcare

The 2011 NHS Atlas of Variation is out! And sure enough, it shows dramatic variation in healthcare utilization and in GP practice patterns around the UK. North Lancashire doctors, for example, prescribe 25 times as many pills for dementia as those in Kent. Only 3 of every 100,000 people in Devon and Cornwall are admitted to NHS care homes, while in Northumberland that number is 190. Peterborough has an angioplasty rate treble that of County Durham. Coverage here and here.

The US has regional practice variation which is just as dramatic; it's been documented for decades by the Dartmouth Atlas of Healthcare, whose creator, Jack Wennberg, is the father of regional-variation research.

NHS has a webpage collecting different countries' medical-variation atlases here.

Friday, December 9, 2011

Abortion Doesn't Affect Mental Health

A new study from the Academy of Medical Royal Colleges' National Collaborating Centre for Mental Health (NCCMH) finds that, while unwanted pregnancies place women at risk for mental health problems including depression, the rates of mental health problems among women with unwanted pregnancies remain the same whether they have abortions or give birth. The finding certainly undercuts anti-abortion arguments about the prevalence of "abortion regret" and the supposed negative mental-health consequences of abortion. An important question is whether it also de-legitimates the idea of "abortion for the sake of the mental health of the woman." (A Christian Medical Fellowship spokesperson is quoted making that argument near the bottom of this article.) But that's a misreading of the findings. The women in the studies that NCCMH reviewed weren't, after all, randomly sorted into "abortion" and "birth" groups. Each chose her own best all-things-considered option given the fact of the unwanted pregnancy, her own moral views, her doctor's advice, pressure she was receiving from partners or relatives, and so on. The fact that the "abortion" and "birth" groups had similar mental-health outcomes therefore certainly doesn't imply that the outcome would have remained similar if all the women who chose to have abortions had instead been denied them.

Friday Frivolity, Genetic Determinism Edition

Thursday, December 8, 2011

Tobacco Warnings and the First Amendment

This piece by Kevin Outterson in the New England Journal of Medicine is an excellent overview of the tobacco industry's ongoing attempts to get the cigarette-packet warning provisions of the Tobacco Control Act declared unconstitutional.

Bioethics Poetry, Dylan Thomas Edition

Do Not Go Gentle Into That Good Night

Do not go gentle into that good night,
Old age should burn and rave at close of day;
Rage, rage against the dying of the light.

Though wise men at their end know dark is right,
Because their words had forked no lightning they
Do not go gentle into that good night.

Good men, the last wave by, crying how bright
Their frail deeds might have danced in a green bay,
Rage, rage against the dying of the light.

Wild men who caught and sang the sun in flight,
And learn, too late, they grieved it on its way,
Do not go gentle into that good night.

Grave men, near death, who see with blinding sight
Blind eyes could blaze like meteors and be gay,
Rage, rage against the dying of the light.

And you, my father, there on that sad height,
Curse, bless, me now with your fierce tears, I pray.
Do not go gentle into that good night.
Rage, rage against the dying of the light.

Dylan Thomas

Morning-After Pill: Contrasting News

President Obama defended HHS Secretary Sebelius's decision yesterday to override the FDA's recommendation that morning-after contraceptive pills like Plan B be made available over-the-counter to women and girls of any age. Critics were accusing Obama of having directed the override in order to avoid controversy during the upcoming election. Obama today said that he wasn't in on the decision, but that he approved of it, "as the father of two daughters." As a result of the override, the drug will remain behind pharmacy counters, available without a prescription only to women over 17 years of age. Proponents of the FDA's plan saw its main advantage in putting the drug out on the pharmacy floor, where sexually active women could easily locate it, rather than in making it available to young girls; one expert observed that "not many 11-year-old girls" go into drugstores to buy anything, let alone single pills that cost $50.

Meanwhile in the UK the British Pregnancy Advisory Service is offering to make morning-after pills available free to women over 17 via post, after a preliminary telephone interview with a nurse ensures that they understand the pill's use. The charitable organization, which is the UK's largest abortion provider, is urging women to stock up in advance of the holidays, when unwanted pregnancies occur with higher-than-average frequency. The pills are sold online and in pharmacies to girls and women over 16, and are widely available, free of charge, in doctors' offices and NHS clinics.

Medical Journalism!

Presidents live longer! Nuns should use contraceptives! Smoking can make your nipples fall off! Eating cake makes you hairy! Yawning is a compliment!

Wednesday, December 7, 2011

Physician Assisted Suicide in Massachusetts?

This weekend the delegates at the annual meeting of the Massachusetts Medical Society affirmed their longstanding opposition to physician-assisted suicide. Lynda Young, M.D., president of the Society, described physician-assisted suicide as "inconsistent with the physician’s role as healer and health care provider."

Meanwhile it appears that Dignity 2012 will succeed in its efforts to get a "Massachusetts Death With Dignity Act" on the next state ballot. The Act, if approved by voters, would establish an Oregon-style assisted suicide regime in the state.

Patient Access to Medical Records

I blogged briefly the other day about the new plan to give all NHS patients access to their own medical records online. A few more thoughts:

In the short run, making medical records available to patients will give rise to a great deal of GP/patient friction. Patients won't understand what they read, and will ask for explanation. Some patients will be shocked and offended at the way physicians have characterized them (as frightened, as uncomprehending, as unwilling to discuss certain topics, as obese, and so on). Patients may not understand why a doctor hasn't written down their whole story, or accepted their version of events. A certain number of hours will inevitably be given over to discussion of what patients find in their medical records when they are first made available. (Of course, some of this might be quite healthy--patients, for example, may well discover and correct various errors or omissions in their medical histories.) In the longer run, the availability to patients of medical records will cause doctors to write and to use them differently. Gone will be the comments on patients themselves, and the notes-to-self about options to think about trying. Medical records will become cleaner, clearer, public documents; and at the same time will become a bit less useful for doctors. For that reason, I predict, doctors will come up with other ways--perhaps even extra-legal ways, but in any case ways outside the four corners of the medical record--to note their informal impressions about patients and their families.

NSW, Australia Considers Eliminating Organ Donor Family Veto

A new discussion paper from the New South Wales (Australia) Ministry of Health raises the possibility of eliminating the veto-power over organ donation that families of potential organ donors currently hold. NSW has the largest donor registry in Oz, but that hasn't translated into high transplantation numbers, largely because 45% of families choose to veto the harvesting of organs from their loved ones who'd signed up to be organ donors. This article summarizes some responses to the proposal. Transplant Australia, Kidney Health Australia and the Australian Medical Association all line up in favor of the change, but, interestingly, a spokesman for transplant lobby group ShareLife opposed the move, arguing that it could undermine people's willingness to sign up to be donors, and pointing out that the countries with the most successful transplant programs (Spain, Portugal, Croatia) all respect the wishes of the family. What matters isn't the legal regime, but the quality of communication with the families.

The discussion paper also raises the possibility of moving from the current opt-in system to a "presumed consent" system where patients would have to opt out of donation, but it does so only formally, noting (correctly) there's little international evidence in favor of making that move. Finally the paper suggests scrapping the NSW Roads and Maritime Services donor register and transferring its content to Medicare's national register.

Plan B Availability Blocked by Sebelius

FDA Commissioner Margaret Hamburg has just released a statement on the FDA's plan to allow the emergency contraceptive Plan B to be sold over-the-counter to women and girls of all ages. FDA found the drug safe and effective for emergency contraceptive use, over-the-counter, for all women and girls of child-bearing potential. But then--this morning--came the politics. From Hamburg's press release:

"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."

Tuesday, December 6, 2011

All Men Are Mortal, Hard Drive Edition

MIT's Sebastian Seung has some bad news for transhumanists: there are some serious obstacles to your ever uploading your brain to a computer.

Patient Access to Medical Information

A group of health-related federal agencies have proposed a new regulation which would permit clinical laboratories to release test-results to patients who request them. (Currently 39 states either have no state law explicitly permitting such release to patients, or have laws mandating release only to physicians or other healthcare providers.) The current JAMA has a thoughtful analysis of some the questions raised by the new rule. The regulation is supposed to decrease physician workload, reduce the number of patients who never receive test results, and improve follow-up rates. But there are a lot of questions: will patients understand their test-results? will they experience needless anxiety over results that are abnormal but inconsequential? is it useful for patients to receive test results on their own, without medical interpretation or counseling?

Meantime, in the UK, Her Majesty's Treasury has announced in its Autumn Statement (p. 40) that all NHS patients will have online access to their own medical records by the end of this parliament (that is, by 2015). This raises a lot of questions about security and privacy, of course; but also about whether patients may be pressured into supplying their records to third parties.

Monday, December 5, 2011

Obese Child Seized by State, UK Edition

I blogged last week about the 200-pound eight-year-old who was removed from his mom in Cleveland and sent into foster care. Seems that it's not only in the US that public health officials are removing children from families who let them become too overweight. Here's an article about a five-year-old from Tameside, Greater Manchester, UK, removed from home for similar reasons; this child appears to be the youngest, but is by no means the first, to be seized from parents by UK health officials by reason of obesity.

Art Caplan has of course commented, and I have to agree: "You don't take someone out of the house and away from their parents unless they have an immediate risk of death."

Is foster care really a less expensive and more effective option than offering counseling and assistance to the child's parents?

Clone Me A Mammoth!

A team of Russian and Japanese scientists plan to use bone marrow from a recently-recovered woolly mammoth thigh bone to clone a living wooly mammoth--within five years! The team plans to create a mammoth embryo via Dolly-the-sheep style nuclear-transfer cloning, and transfer it to a "surrogate" elephant mother for gestation and birth. No word yet on the price-per-skein of mammoth yarn.

NHS to Share Patient Data With Industry?

Prime Minister David Cameron will give a speech today in which he'll announce plans for NHS to share its wealth of patient data with private industry, in order to boost the health sciences industry and speed up drug development. The government has assured critics that patient data will be properly anonymized, but there are already protests to the effect that privacy protections won't be adequate, firms will be able to re-identify private health information, and so on. In the same speech, Cameron will announce increased support for and use of tele-medical patient monitoring, and a program to give cancer patients and other seriously-ill patients early access to as-yet-unlicensed drugs.

Friday, December 2, 2011

NHS: Disclosing "Death Pathway" Use

The NHS's "Liverpool Care Pathway"--known to some in the press as the "death pathway"--is a palliative care pathway designed to reduce burdensome end-of-life medical interventions including, controversially, artificial nutrition and hydration. Tens of thousands of patients annually are put onto the pathway in the last days of their lives. But a new report claims that in a quarter of hospital trusts, one in three families are never informed that their loved one has been placed on the Liverpool Care Pathway. In one trust, fully half of families weren't informed. The good news is that doctors do discuss the issue with families in 94% of cases overall--a sharp improvement over the 2008-09 audit figure of 75%, even though twice as many patients are put on the protocol now than then.

Hershey School Rejects HIV+ Student

The AIDS Law Project of Pennsylvania has filed a lawsuit against the Milton Hershey School for disadvantaged students on grounds that the school violated the Americans with Disabilities Act when it rejected an applicant explicitly on grounds of his being HIV+. A statement from the residential pre-K to 12 school said: "In order to protect our children in this unique environment, we cannot accommodate the needs of students with chronic communicable diseases that pose a direct threat to the health and safety of others." "We are serving children," a spokesman for the school said, "and no child can be assumed to always make responsible decisions that protect the well being of others." This seems like a pretty clear ADA violation to me.

Friday Frivolity, What Patients Hear Edition

Thursday, December 1, 2011

Ninth Circuit Approves Bone Marrow Payment

The US Ninth Circuit Court of Appeals has determined that the federal ban on selling organs does not apply to bone-marrow donors who use modern marrow-donation technology. The once-painful procedure has now been replaced by a procedure resembling blood donation. Instead of removing actual marrow from the donor's bone, physicians now remove marrow precursor cells from the donor's blood--and the National Organ Transplant Act does not restrict payments for blood donation. The holding permits MoreMarrowDonors, a California nonprofit, to move forward with a program to offer $3000 scholarships, housing allowances or charitable donations as inducements to bone marrow donors.

Argentina: Toward "Dignified Death"?

Argentina's Lower House has passed, by a wide margin, a "dignified death" bill. The bill, which is still to be debated in the Senate, would permit patients with irreversible conditions or terminal illness to make informed refusal of lifesaving or life-sustaining medical interventions, including nutrition and hydration. Incompetent patients' wishes could be expressed by a defined set of eligible proxy decision makers (family members and partners). The bill would also relieve medical professionals of liability for following patients' wishes.

Bioethcs Poetry, Galway Kinnell Edition

Parkinson's Disease

by Galway Kinnell

While spoon-feeding him with one hand
she holds his hand with her other hand,
or rather lets it rest on top of his,
which is permanently clenched shut.
When he turns his head away, she reaches
around and puts in the spoonful blind.
He will not accept the next morsel
until he has completely chewed this one.
His bright squint tells her he finds
the shrimp she has just put in delicious.
Next to the voice and touch of those we love,
food may be our last pleasure on earth—
a man on death row takes his T-bone
in small bites and swishes each sip
of the jug wine around in his mouth,
tomorrow will be too late for them to jolt
this supper out of him. She strokes
his head very slowly, as if to cheer up
each separate discomfited hair sticking up
from its root in his stricken brain.
Standing behind him, she presses
her check to his, kisses his jowl,
and his eyes seem to stop seeing
and do nothing but emit light.
Could heaven be a time, after we are dead,
of remembering the knowledge
flesh had from flesh? The flesh
of his face is hard, perhaps
from years spent facing down others
until they fell back, and harder
from years of being himself faced down
and falling back in his turn, and harder still
from all the while frowning
and beaming and worrying and shouting
and probably letting go in rages.
His face softens into a kind
of quizzical wince, as if one
of the other animals were working at
getting the knack of the human smile.
When picking up a cookie he uses
both thumbtips to grip it
and push it against an index finger
to secure it so that he can lift it.
She takes him then to the bathroom,
where she lowers his pants and removes
the wet diaper and holds the spout of the bottle
to his old penis until he pisses all he can,
then puts on the fresh diaper and pulls up his pants.
When they come out, she is facing him,
walking backwards in front of him
and holding his hands, pulling him
when he stops, reminding him to step
when he forgets and starts to pitch forward.
She is leading her old father into the future
as far as they can go, and she is walking
him back into her childhood, where she stood
in bare feet on the toes of his shoes
and they foxtrotted on this same rug.
I watch them closely: she could be teaching him
the last steps that one day she may teach me.
At this moment, he glints and shines,
as if it will be only a small dislocation
for him to pass from this paradise into the next.

Globe and Mail on End-of-life Care

I'm grateful to Thaddeus Pope for drawing my attention to the Globe and Mail's amazing current series on end-of-life care.

There are two current important cases on end-of-life care pending in Canada. I blogged earlier about Gloria Taylor's case rising from British Columbia, which is challenging, for the first time since the Rodriguez case in 1993, the constitutionality of Canada's law against assisted suicide. The second case is that of Hassan Rasouli, a patient in a permanent vegetative state in Toronto. Rasouli's medical team wants to discontinue aggressive care and begin palliative care, but the patient's family disagrees. Lower courts held for the family, but the doctors have now appealed to the Supreme Court.

Garden Sheds, Men's Health, Weeds

So it turns out, according to NHS, that the recent claims in articles in the Daily Mail and the Sun to the effect that garden sheds are good for men's health are based on, well, a slight misinterpretation of an article in BMJ which actually dealt with "men's sheds," an "Australian skills and wellbeing programme that provides a place for male-focused activities outside work, not just a small building at the end of the garden."

Nonetheless, this song by John Williamson may reveal a different connection between shed's and men's health. Something to do with medical marijuana, I think.

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!

Monday, October 31, 2011

One-fifth of Major Journal Articles Have Misattributed Authorship

Here's a sobering article from BMJ. The authors (all senior editors from JAMA) surveyed in 2009 hundreds of corresponding authors on pieces that had published in high-impact medical journals in 2008. (The journals were Annals of Internal Medicine, JAMA, Lancet, Nature Medicine, New England Journal of Medicine, and PLoS Medicine). The surveyed authors self-reported 21% rates of ghost authorship and/or honorary authorship! ("Honorary" authors are listed authors whose actual contribution to the paper should not merit authorship under the International Committee of Medical Journal Editors criteria. "Ghost" authors are those who meet the criteria and aren't listed, or whom the corresponding author mentioned as participating in writing the article, but who remained unnamed.) Overall incidence of honorary authorship was largely unchanged since a similar survey was conducted in 1996, though ghost authorship was down to 7.9% from 11.5%. Fully a quarter of all original research articles in these top-notch journals had honorary authors--as did 15% of reviews and 11.2% of editorials. 11.9% of research articles, 6% of reviews and 5.3% of editorials had ghost authors. Of course, these numbers may overlap, because a ghost-written article can be signed by an honorary author.

This looks terrible, especially since one might expect under-reporting of bad behavior in surveys of this kind. Of course, we needn't think that all of the honorary authorships were the extreme case of people signing onto something they didn't work on; most probably fell into the category of people who contributed a lot to the piece but not enough to merit full authorship--they were made authors, in other words, when they should merely have been mentioned in an acknowledgement footnote. Still: a fifth of all articles, and a quarter of original research articles, gave the wrong kind of credit to the wrong people, and 8% failed to acknowledge the right people. And people wonder why NIH is requiring Responsible Conduct of Research training....

Brief Technical Post


Sunday, October 30, 2011

NHS Permits "Caesarian on Maternal Demand"

An update of a new guidance document being developed by the UK's National Institute for Health and Clinical Excellenct ("NICE") would permit caesarian section on maternal request, even when there are no medical indications for the procedure. In the US context, I'm skeptical even of the language of "maternal request" or "maternal demand," since I believe that there is significant evidence that physician preferences and reimbursement drive our sky-high c-section rates here in the US, and elsewhere (such as Brazil); and also that physician preferences and conversations can end up driving what is later called "maternal demand". The new guidelines make me worry that the official availability of c-section on maternal request in the UK will lead to some non-medically-indicated c-sections being performed for reasons other than "maternal request," like physician scheduling convenience. But it may work differently in the NHS; and anyway, the NICE guidelines include a number of steps to be taken before acquiescing in mom's request for CS, like counseling on fear of childbirth, and proper discussion of the comparative risks of CS and vaginal birth. Let's see what happens to the overall CS rate, and how many maternal requests for CS crop up, after the new guidelines are finalized.

Bioethics Hall of Fame, Henry K. Beecher Edition

My second nomination to the notional Bioethics Hall of Fame is Henry K. Beecher. Beecher, an distinguished anaesthesiologist, wrote a highly influential 1955 paper on the placebo effect; wrote a then-controversial 1966 paper which served as the single most important goad to regulation of research on human subjects; was one of the cast of all-star contributors to the American Academy of Arts and Sciences influential 1969 book, "Experimentation with Human Subjects" (Paul Freund, ed.); and chaired the Harvard Medical School ad hoc committee whose report supplied the first generally accepted criteria for brain death. Less well-known is Beecher's post-war work on LSD and mind-control, some of which was done on unconsenting subjects. Indeed, it may have been this military and CIA-sponsored work which led him, shortly thereafter, to embrace the necessity of informed consent.

Friday, October 28, 2011

Friday Frivolity, Side Effects of Big Pharma Edition

Ah, an oldie but a goodie! Enjoy!

Black Market Kidney Conviction in US

A man pled guilty yesterday to multiple counts of illegal trafficking in human kidneys. This is the first conviction under federal law banning the sale of human organs. The defendant took payments of $120,000 or more for each of three kidneys which he purchased from donors in Israel for $10,000 each. He was caught in a government sting operation, attempting to sell an organ to a federal agent. His attorneys argued that the resultant transplants worked, relieving the American buyers from the burdens of kidney disease and dialysis; that the organ recipients had sought him out and not vice-versa; that the donors in each case were aware of what they were doing; and that the surgeries were conducted by reputable and skilled transplant surgeons in well-known (but unnamed) American hospitals. The money, they argued, was used for "expenses associated with the procedures"--though it's not clear from the coverage what that's supposed to mean. Federal prosecutors were rightly unimpressed, noting that black-market organ sales pose a public health danger, and are also unfair, since they result in preferential allocation of organs to the rich (and corrupt).