A Blog on Bioethics

Informed Consent: Cool PEG tube video edition

2013-05-15T19:13:00.002-04:00

Here's a great Youtube video on PEG tube placement; it seems to be up as a marketing move by the company that made it. Is there any reason why patients and their families shouldn't always watch something like this in connection with informed consent for any procedure? BTW, I have no connection to Nucleus Medical Art, I just think it's a great video. Of course, it's not the whole of informed consent--someone contemplating PEG placement for a loved one with advanced dementia, for example, ought to be given data about whether PEG feeding actually increases lifespan. But videos like this are a great way to tell patients about procedures.

Somatic Cell Nuclear Transfer Used to Create Human Embryonic Stem Cells

2013-05-15T18:31:00.000-04:00

A international team including scientists from Oregon Health & Science University and the Oregon National Primate Research Center have just announced in Cell that they have successfully used somatic cell nuclear transfer (SCNT) to develop human embryonic stem-cell lines. As I understand the paper, the team removed genetic material from the core of multiple oocytes from two different human donors, and replaced it with nuclear material taken from the skin cells of an embryo. Some portion of the eggs from each donor then proceeded to develop to the blastocyst stage, at which point their cells were plated and tested for pluripotency. Pluripotency was proven when the cells, injected into immuno-deficient mice, formed tumors containing tissue- and cell-types representing all three germ layers.This paper, then, is the most powerful proof of principle to date that we may one day be able to combine SCNT and embryonic stem-cell technologies to generate made-to-order, genetically-compatible replacement tissue for humans with diseases such as diabetes or Parkinson's.

It's important to note that the blastocysts were imperfect in various ways, and could not have successfully been implanted into a woman to make a child. (Members of the same team have not yet been able to create a cloned monkey embryo capable of implantation.) This has created some verbal problems that will no doubt be fodder for the culture wars. Strangely, the mostly-liberal National Public Radio is reporting that the scientists created and destroyed human embryos, while the mostly-conservative Wall Street Journal is saying that the team's achievement "is a long way from creating a human embryo."

Here's how I think of it: while the team used cloning technology to create human embryonic stem cells, they didn't exactly create and destroy a human embryo along the way; they created what they knew to be a faulty approximation of a human embryo, but one close enough to the real thing to generate pluripotent human embryonic stem-cell lines. (Think of the fact that human embryonic stem-cell lines can also be generated from parthenotes which are completely incapable of developing into embryos.)

Nonetheless, I'm pretty sure these scientists would have no problem with creating a perfect, and in principle perfectly implantable, human blastocyst--though they have no intention of implanting one, and no research oversight body anywhere would permit them to, even if they did. They want to generate tissue, and if perfecting human embryo cloning helps them do that, they will. Even if you agree with me that the toughest ethics questions aren't quite yet raised by this work, this work certainly implies that they'll be raised sooner or later.

Vermont Legislature Passes Physician-Assisted Suicide Law

2013-05-15T17:29:00.001-04:00

The Vermont legislature has passed a new physician-assisted suicide law and is sending it to Governor Shumlin, who supports it and is expected to sign. The Oregon-style legislation will be the third such state law in the country and the first adopted by a legislature, as opposed to via popular referendum. The strange feature of this law, though, is that while it begins by mandating (in section 5283) a number of Oregon-like anti-abuse measures to make sure that the program doesn't help the wrong people to die by mistake (two different oral requests, 15 days apart; a written request for self-administered lethal medication signed by two disinterested witnesses; findings of terminality and capacity entered into the chart; and so on), most of these requirements sunset in 2016 in favor of the much shorter section 5289, which says only:

"A physician with a bona fide physician–patient relationship with a patient with a terminal condition shall not be considered to have engaged in unprofessional conduct under 26 V.S.A. § 1354 if:
(1) the physician determines that the patient is capable and does not have impaired judgment;
(2) the physician informs the patient of all feasible end-of-life services, including palliative care, comfort care, hospice care, and pain control;
(3) the physician prescribes a dose of medication that may be lethal to the patient;
(4) the physician advises the patient of all foreseeable risks related to the prescription; and
(5) the patient makes an independent decision to self-administer a lethal dose of the medication."

A subsequent section immunizes any physician from civil or criminal liability for any actions performed in good faith compliance with the law.

The legislators's assumption, according to press coverage, is that physicians will have developed adequate professional standards for physician-assisted suicide by 2016. I wonder whether the law's repeal of safeguards will really last, or whether the Vermont legislature will re-think the matter in the next year....

And I know, I'm supposed to say aid-in-dying, not physician-assisted suicide. But I'm an academic, not an advocate, and even though the term "suicide" scares some folks, and others argue that it's not really suicide if you're dying of a disease you didn't choose, my own view is that if you give a terminally ill person some pills with which she can kill herself faster than her underlying disease would have, you're assisting in her suicide. (Wow! On that one verbal point, I actually agree with Wesley Smith! Though, unlike him, I approve of physician-assisted suicide with appropriate safeguards, and think that the Oregon safeguards are appropriate. And I'm not a fan of slippery-slope arguments.)

Friday Not-So-Frivolity: Sherlock Holmes Alzheimer's edition

2013-05-03T22:26:00.000-04:00

This is in fact a lovely sketch, funny at the start and then just plain moving. It's the final bit with which Mitchell & Webb closed their last show.

Friday Frivolity: Not Intolerant to Wheat Edition

2013-05-03T22:21:00.002-04:00

Our Voting Public: Uninsured revolt against the Anti-Christ behind the climate hoax edition

2013-05-02T11:49:00.003-04:00

An April survey from Kaiser Family Foundation found that four in ten Americans (42%) are unaware that "Obamacare" is actually the law of the land. 12% thought the health reform measure had been repealed by Congress, 7% thought it had been overturned by the Supreme Court (which actually upheld the law in June of 2012), and 23% didn't know enough to say whether the law was in force or not. Overall, 49% of Americans didn't know enough to say whether the law will impact their own families--but, depressingly, the percentage of people lacking that knowledge was highest in the two groups the law is likely to benefit most: the uninsured (of whom 58% said they didn't know how the law would affect them) and the poor (56%).

Another poll--from PublicMind at Farleigh Dickinson University--shows that 29% of all Americans (18% of Democrats, 27% of Independents, and a whopping 44% of Republicans) believe that an armed revolution might be necessary in the next few years, in order to protect our liberties. An armed revolution. In the next few years. Another 5% of Americans aren't sure about that. Well, that's good, I guess; one doesn't want to decide these things too precipitously.

And in other polling news from what appears to be this planet, Public Policy Polling (a well-respected polling firm known for asking the occasional oddball or controversial question) has found (among many other amusing and/or scary things) that 58% of Republicans think global warming is a hoax, while 77% of Democrats disagree; and that 20% of Americans think vaccines cause autism, while 34% aren't sure.

And 20% of Republicans believe that President Obama is the Anti-Christ. Well, I guess we know why they think armed revolution might be necessary. Hope your health insurance covers gunshot wounds.

Ways for Republicans Not To Attract Women's Votes

2013-02-11T21:48:00.001-05:00

Require a transvaginal ultrasound before an abortion! Limit abortion availability by giving legal rights to fetuses and requiring abortionists to have local hospital admitting privileges that they don't use! Oppose gun control that women overwhelmingly support!

Medical Causes of the Sexual Revolution

2013-01-28T22:16:00.000-05:00

Prof. Andrew Francis, an economist at Emory, is claiming that penicillin, rather than The (Birth Control) Pill, was the drug that gave us the sexual revolution of the 1960s. The idea is that the post-war availability of penicillin reduced the cost (to both partners) of intimate contact, by substantially reducing the risk (to both partners) of contracting an STD--especially syphilis. This effectively lowered the cost of sexual activity, inducing more people to engage in it (the benefits remaining more or less constant). An easily-accessible version of the story appears on the CBS news site, here.

Let us not lose sight, however, of the vital importance of The Pill. I have spoken personally with women of the 60s generation who were admitted to medical school (imagine this!) only after they'd told an interviewing dean--an actual Dean--that they were on The Pill, and that they didn't intend to let a pregnancy interfere with their progress through medical school, or with their entry into medical practice. "A medical school education, after all," the argument went, "is expensive not only to the student, but also to the faculty and to the government which (at least in the US) has substantially subsidized it for decades; why should we offer it to someone who will quit (and waste the investment) the moment she has a child? We're rather more inclined to enroll you if you can guarantee that you won't have a child--that is, if you tell us you're on The Pill, or will have an abortion if The Pill fails." The assumption, of course, was that if a woman were to have a child, it would be she, rather than her partner, who would give up on her profession and waste the investment made by others in her career. The idea of the working mother--though it was a reality for many working-class Americans--wasn't yet acceptable to Americans of the professional class.

Like access to birth-control, the abortion right announced in Roe v. Wade made it easier for professional schools to admit women. It meant that women could legally prevent themselves from having children whose rearing would interfere with their professional careers. They could control their reproduction even if their efforts at birth control had failed. (Remember, please, that men were *never* asked whether their having children--whether in or out of wedlock--would interfere with their taking full advantage of their educations.)

Punchline: Yes, Professor Francis, it may well be that penicillin did more than The Pill to facilitate the Sexual Revolution--by which we might mean, the widespread acceptance of pre-marital sexual relations. But it was for The Pill (and the abortion right) to translate that newfound sexual freedom into sexual equality.

Friday Frovolity, Cancerous Obese Vegetarian Edition

2013-01-25T14:07:00.000-05:00

Comedy Central Stand-Up
Get More: Jokes,Joke of the Day,Funny Jokes

Harvard Prof Isn't Recruiting Neanderthal Moms

2013-01-22T23:00:00.000-05:00

Oh, good. This story isn't true. There isn't actually a Harvard professor who wants to recruit a woman to bear a Neanderthal child from an embryo constructed, using stem-cell and cloning technology, from Neanderthal bone DNA. Turns out there was some translation error in the account of his interview with a German magazine. And the professor is upset. He's not actually proposing to clone a Neanderthal baby; he only thinks the issue should be up for discussion. For several years.
Oh, good.

Quick, Effective Public Health Measures

2013-01-22T22:36:00.000-05:00

I'm freshly back from the annual meeting of the Public Health Law Research program, sponsored by Robert Wood Johnson.

At most academic meetings, I prefer schmoozing in the halls to listening to the talks. That's part personal vice, and part stage-of-career: at this point, it matters more who I talk to than whose paper I hear. This conference was different, though--perhaps because I'm new to it. A very large percentage of the papers (and posters!) repaid close attention.

But the best session of the conference, to my mind, was the "Critical Opportunities" session. The session, which is apparently an annual affair, is presented as a competition: a handful of public health law scholars are invited to present their best ideas for high-impact, evidence-based public health interventions that have a chance at actual enactment. The audience votes on which one they think is (to put it roughly) most worth peddling to health-policy folk under the banner, "Do it now!"

This year's choices: a proposal for corn masa flour fortification for the prevention of neural tube defects, made by the CDC's Erica Reott, MPH, LCDR S. Kinzie Lee, MPH, and Amy Cordero, MPA; a proposal for legal reforms to prevent opioid overdose from Corey Davis of UNC Chapel Hill; a proposal from Adam Finkel, Sc.D., of UPenn Law, to make "smart disclosure" rules, like nutritional content labels, more complete and accurate; a proposal to put decals on the cars of teens subject to "novice drive" license restrictions, from Allison Curry, PhD, MPH, of Children’s Hospital of Philadelphia; a proposal for better (and better supported) local governance of public health institutions from Scott Hays & Janine Toth of the University of Illinois at Urbana-Champaign; and a set of proposals for gun-control laws from Marvin Swartz, MD, of the Duke University School of Medicine.

All of the proposals were terrific and important, but I want to take a bit of time to mention a few that might surprise my blogging audience, as they surprised me. I leave aside the Hays/Toth proposals about public health governance, though they were completely sensible and apt to have immense impact over time; and I leave aside the gun control measures, as you're all apt to be reading a great deal about them these days; and, finally, I leave aside the superb presentation on labeling and "smart disclosure" rules, as I have the sense--perhaps wrongly--that we are all aware that many disclosures, mandated as a substitute for regulation on the grounds that people can decide for themselves when adequately informed, do not in fact inform adequately.

I shall instead mention the three options that, for different reasons, gobsmacked me. In each case, I'm relying entirely on data from the presenter's own slides, which I've obtained from the PHLR folks (Thanks, Bethany!)

I present, first, corn masa flour fortification. (This ended up being the crowd's favorite.) Neural tube defects like anencephaly and spina bifida affect about 3000 pregnancies per year. NTD's affect the Hispanic population more profoundly than the rest of the population. This is likely because flour is enriched with folic acid, which helps prevent NTD's, but corn masa flour (widely used in the Hispanic community) is not fortified. Flour fortification has reduced NTD rates by more than a third. A similar rate among Hispanics would prevent 40 NTD's a year. Given the high cost of NTD medical treatment, the public health intervention saves $100 for each $1 spent. And here's the kicker: there is but one major manufacturer of corn masa flour in the US, and this firm has in fact joined public health groups in petitioning the FDA for permission to fortify.

Second, legal reforms to prevent opioid overdose. Did I know that prescription pain-killer overdoses had passed automobile crashes and gun accidents as the number one accidental cause of death in America? No, I did not. 100 a day die from prescription painkiller overdoses--more than die from heroin overdoses and cocaine overdoses combined. There's a drug called Naloxone, which, if administered nasally to someone who's OD'd, will actually interfere with a prescription opioid's effects on the body, and prevent the OD from being fatal. Ambulances and first-responders carry it, but physicians are reluctant to co-prescribe it to people to whom they prescribe pain-killers. This is mainly because the Naloxone is apt to be administered to their patient by someone with whom they don't have a doctor-patient relationship (a relative, or bystander). Docs worry about liability for prescribing a drug to X which is mainly to be administered by not-X. But of course, isn't that how epi-pens are used? Maybe law could be used to create a standard of care that involves co-prescribing the emergency cure with the problematic pain-killers. Next, bystanders often fail to call 911 because they fear arrest. The solution here is a relatively simple, narrow, legal grant of immunity to people who telephone first-responders from the scenes of drug overdoses. Turns out that police--who, after all, have a lot of depressing experience in finding the dead bodies of prescription drug overdosers--don't even mind granting that limited sort of immunity. They'd rather let a few druggies get away than pick up another body. Me, too.

And third, putting decals on cars whose teenaged drivers are subject to various license restrictions, such as not having any non-family members in the car. As the father of a 15 year old, I like this idea. Yes, it makes your car into a police target. That's, um, the idea. Your kid knows s/he's a police target, and caution (or at least obedience to the license-restriction regulations) ensues. Some folks worry that predators will use the decals to make their search for vulnerable teens easier, but really, how hard is it for a predator to look at the driver? And predators, unlike cops enforcing license-restriction rules, aren't picky about the driver's exact age. Here's the main punchline, though: New Jersey put the decals on, and 1600 crashes per year were prevented. Driving is apt to be the most dangerous thing one's teen will ever do, and the decal law helps cops clamp down on teens who evade the sensible rules. In New Jersey, graduated driver's license enforcement rose by 14% after the decals went on. That means, teens who were breaking the rules by driving with their friends in the car were cited, and teens who were driving after dark were cited. As a dad, I'm all in favor.

So: fortify that corn flour! Co-prescribe that antidote! Label those teens! And save lives.

Nuffield on "Public Ethics"

2012-12-28T22:15:00.000-05:00

I always enjoy and benefit from reading the reports of the Nuffield Council on Bioethics. Its latest on Emerging Biotechnologies is no exception. I hope to have more to say about the substance of this report in future posts, but for now I want to single out one of its features for questioning. The report makes a great point of the importance of thinking about emerging biotechnologies from what it calls a "public ethics" perspective. The public, the Council urges, has various important interests at stake in the regulation of emerging biotechnologies: the impact they'll have "on a public scale;" the public resources invested in them; the "significance attached to living things;" and their potential to change our lives, and to benefit some at the expense of others. We need to hold these public interests in mind when doing our ethical analyses. We can't leave private or scientific interests in charge. The Council articulates three "values" of public ethics (equity, solidarity and sustainability) and five "procedural virtues" of public ethics (Openness and inclusion,Accountability, Public reasoning, Candour, Enablement, and Caution).

When I first saw this, I thought immediately of Rawls's "Idea of Public Reason." But it turns out there's nothing so subtle or interesting here. Where Rawls was thinking about the kinds of reasons that could properly be mobilized in a public debate (general principles of equity, for example, rather than private religious convictions), the Council's talk of "public ethics" seems to be asserting the claims of public and collective interests against those of private interests. Their insistence on public ethics is not an insistence on a way to conduct ethical debate in public, but rather an insistence that ethical debate should be dominated by public rather than private interests. Normally, regulation is bargained for by those with focused interests in that regulation's structure. Those who would benefit or be burdened by a proposed regulation organize themselves politically in order to shape it. Folks tend not to mobilize and organize to shape regulations that will benefit them or burden them only in a diffuse, small way. (That's why the US Clean Air Act poses a classic mystery for Poli Sci. Its burdens--costs of compliance--were concentrated on a highly-motivated few, while its benefits--slightly cleaner air--were diffuse and uncertain. Yet it passed.) The Council here seems to be arguing, "Don't let the focused interests of industry run away with nanotech or synthetic biology; regulatory framing should instead be dominated by consideration of the admittedly diffuse and disorganized interests of the general public--because, diffuse as they may be, they weigh more in the end than the focused and organized interests of the small numbers of people concerned with developing new biotech."

On this reading, the Nuffield Council's promotion of "public ethics" is a quiet sort of attack on the normative Interest Group Theory of Politics.

Friday Frivolity: Hair of the Lime that Bit You Edition

2012-12-28T21:03:00.000-05:00

The Liverpool Care Pathway Kerfuffle

2012-12-12T22:45:00.002-05:00

The British press has been hurling around various accusations about the use and misuse of the Liverpool Care Pathway for the Dying Patient ("LCP") for a couple of years now. The LCP is a UK care pathway covering palliative care and nursing options for patients at the end of life. It includes prompts for management of a wide range of end-of-life symptoms; crucially for the debate, it provides for cessation of artificial nutrition and hydration for some patients. The latest round of adverse coverage is largely based on findings of an audit undertaken by the LCP's developer; the audit found that in 44% percent of cases in which a decision was made to place a patient on the LCP, there was no record of a discussion with the patient about that decision; and that one-third of patients' families were never given an informational leaflet describing the LCP. Additionally, there are accusations that hospitals are putting people on the LCP who shouldn't be, perhaps in order to secure financial rewards that flow to facilities that reach targets for LCP use. These allegations, combined with earlier alarmist claims that the LCP was being used to "euthanize" scores of thousands of patients who weren't dying, resulted last month in the government's announcing the launch of an independent investigation into the use of the LCP.

Since that announcement, though, an additional accusation has been leveled in the Daily Mail (which has been pressing the LCP issue all along). Citing this anonymous article from BMJ about withdrawing feeding from newborns, the Daily Mail claimed that babies were being put on the LCP. The trouble is, the BMJ article was written by a physician not based in the UK, and not using the LCP. Of course, that didn't prevent the Daily Mail piece from being picked up here in the states by, for example, Wesley Smith, whose sensitive treatment of the subject, entitled "Dehydrating Disabled Babies in UK Hospitals" ran in the National Review Online. "This is what happens when a country allows bureaucrats to control healthcare," he intoned--and then drew the "parallel" to Obamacare. Similar discussion could be found on numerous right-wing websites. Will any of those sites revise their comments now that their foundation in the Daily Mail piece has been exposed as fact-free? I'm not holding my breath.

At this point, I hope the independent investigation is thorough and that it makes serious recommendations for addressing all of these concerns. A tough review with real suggestions for training and reform might well save the LCP, and the LCP is well worth saving. The protocol has won plaudits in palliative care journals, was well reviewed in the Royal College of Physicians original National Care of the Dying audit, has garnered the support of palliative care nurses, and undoubtedly eases the deaths of many tens of thousands annually. But there seems also to be little doubt that it has sometimes been carelessly implemented, or implemented with insufficient discussion and explanation.

One suggestion--indeed, a plea--for anyone who wants to comment on the issue, though: Read the actual pathway. That will have the salutary effect of enabling you to distinguish problems that result from following it from those that result from not following it.

Medicare coverage litigation--Jimmo v. Sebelius

2012-11-04T22:49:00.000-05:00

I'm a few days late covering this vitally important settlement of litigation between patient groups and Medicare, but I thought I'd give a small taste of what it's really about.

My mother-in-law passed away in January of ALS (Lou Gherig's disease). That disease, among other things, gradually eliminates your ability to control your limbs, while leaving you with full sensation. In other words (to take an easily understood example), you can be lying in your bed, wishing you could roll over because your arm is in an uncomfortable position, but not be able to roll yourself over. All night.

Physical therapy, you can easily imagine, was a great relief to my mother-in-law. It's a huge benefit to have your body moved around by someone else, in the ways you'd like to move it yourself, if you could: stretching, twisting, opening up. Even just 20 minutes of externally-supplied mobility each day goes a long way toward making up for the immobility the ALS patient faces the other 23 hours and 40 minutes of each day.

But the Massachusetts entity that holds the contract to administer Medicare (along with very many other state contract-holders) decided that Medicare should not pay for my mother-in-law's physical therapy, because it did not stand any chance of curing her.

At some level, of course, one can understand a cost-controlling rule that says, "We're not paying for things that don't work." It was such a rule that Massachusetts's and other states's intermediaries were attempting to follow. But it's simply false to think that anything that doesn't cure you doesn't "work." Think of physical therapy, or nursing attention, for example: many who are chronically or terminally ill can benefit from those kinds of interventions, even if they hold out no prospect for cure.

And that's what the government agreed to in its settlement of Jimmo v. Sebelius. Manuals that guide the decision-making of contractors who administer Medicare at the state level will no longer permit denials of payment to therapies simply on grounds that they don't cure. They'll now explicitly permit payments for treatments that help maintain the patient's current condition or that prevent further deterioration. Mind you, the holding isn't as generous as a rule that might permit payment for every treatment that keeps a patient comfortable, or that reduces a patient's suffering; but it's a big improvement over the "we only pay for cures" position that a number of Medicare intermediaries had been taking.

My mother-in-law offered testimony in this case. Luckily, during the pendency of the case, my father-in-law had sufficient private funds to pay for the therapy she needed to keep herself comfortable during the months of her ALS decline. But she always knew that the Massachusetts Medicare intermediary's position just wasn't right; that it couldn't be the case that national health insurance wouldn't pay for care that met people's basic human needs, even if it wouldn't cure them.

So now, after this settlement, Medicare will pay for those needs. That will certainly drive up the cost of Medicare. But I don't mind. I don't mind paying the extra taxes necessary to ensure that patients, like my mother-in-law, who are paralyzed with ALS, will be able to get their legs manipulated, or their arms massaged, if that's what will bring them comfort.

Mary would be very pleased that her lawsuit was settled favorably to patients. She and her husband didn't need the money; to them, it was a question of principle. But this settlement brings real relief to thousands of people who have no other means of paying for the care they need.

It's a big deal. I offer now a toast, to our now-departed litigant, Mary: You won. You're gone, and can't enjoy the victory, but that doesn't matter. You weren't fundamentally fighting this battle for yourself. And many thousands will benefit from the lawsuit you supported.

The Lyric and the Narrative

2012-10-16T20:51:00.000-04:00

If you are interested in medical humanities, please go read Cat Belling's lovely piece in BMJ Medical Humanties. She argues that medical humanities has been too closely equated with narrative, and that medical humanists would do well to attend to the non-narrative elements of literature, and to their value for understanding medicine.

Friday Frivolity: Altruism at the Deathbed Edition

2012-10-12T11:54:00.003-04:00

M46BJ776CBCB

Note: Viewer discretion advised! This video contains strong language! Or at least, strong language being mouthed very clearly, though silently.

Presidential Commission Report on Genomic Privacy

2012-10-12T11:39:00.000-04:00

The Presidential Commission for the Study of Bioethical Issues has released its report, "Privacy and Progress in Whole Genome Sequencing." The full text of the report, along with the accompanying press release, is available here. A Google-roundup of news coverage of the release is here.

I looked through the report last night, and am left with the general view that it's a necessary and useful prod to action. The report points out huge gaps in our legal preparedness for the $1000 genome. For example, federal law prohibits health insurers and employers from discriminating against insureds on the basis of genetic information, but life insurers and long-term care insurers aren't covered. Another: only about half of the states have laws in place prohibiting genetic sequencing of persons without their consent.

The report calls for states to adopt "robust" consent standards, though it is skeptical about the workability of rigorous re-consenting of subjects for new research done on their previously-obtained genetic information. It calls for uniform rules governing access to genetic data, and for policies requiring researchers to make clear to subjects whether and in what circumstances incidental findings will be disclosed to them. And it calls for strong standards not only of privacy-protection, but of data-security protection.

It's hard to blame the Commission for remaining at a fairly high level of generality in their recommendations. They were looking at genetic screening by public and private bodies, of persons and of tissue samples, for clinical and research purposes. When you have to talk about everything, it's hard to say much of anything. On the whole, the Commission is to be applauded for bringing policy-makers' attention to, and offering sensible discussions and analysis of, problems associated with genome sequencing for which we are legally unprepared.

More when I've had more time for reading!

Science Humor, Chocolate-Faced Nobel Winners Edition

2012-10-12T11:24:00.000-04:00

This article from New England Journal of Medicine conclusively proves, sorta, that countries that consume more chocolate per capita produce more Nobel Prize winners. Enjoy!

Shaking the Family Tree, Neanderthal Edition

2012-10-12T11:20:00.000-04:00

The revelations from genetics about the past of our species continue to amaze me. This study from PLOS Genetics, for example, reveals evidence that supports the hypothesis that the subset of humans who left Africa may have continued to mate with Neanderthals until as recently as 47,000 years ago. There's more detail about related studies in this article from Science News--including mention of the fact that Neanderthal DNA is even more prevalent in Asian and South American populations than in European.

Massachusetts and Physician-Assisted Suicide

2012-10-08T21:28:00.000-04:00

Having recently emerged from a multi-month blogging hiatus, I feel guilty for not having addressed the pending Massachusetts physician-assisted suicide initiative.

This November, Massachusetts citizens will vote on an initiative to establish an Oregon-like regime of physician assisted suicide. The full text of the initiative is here; the Oregon Death With Dignity Act, on which the Massachusetts initiative is very closely modeled, is here. The proposed law would permit competent, terminally ill patients to receive from their physicians a prescribed lethal dose of medicine with which to end their own lives.

I was against physician-assisted suicide (PAS) before I was for it. I feared that PAS would be offered to poor people, poorly-educated people, and minorities, in lieu of more difficult- and expensive-to-provide high-quality end-of-life care. Others (not I) worried about a slippery slope from assisted suicide (where the patient kills herself) to euthanasia (where the doctor gives, for example, an injection to a patient who wants it), and thence to involuntary euthanasia (where a doctor gives an injection to a patient who doesn't want it, or whose desire to die is not well-documented). Others worried that the availability of PAS would undermine incentives to improve end-of-life care and palliative medicine. And still others (again not I) worried about an assisted-suicide regime giving rise to a "duty to die;" that is, a sense among elders that they really ought to commit suicide rather than inconvenience their children, or cost them too much money.

What I feared would happen has not happened. If you look at Oregon's annual reports about who uses their assisted suicide program, what you find is that most are white, well-educated urban dwellers, already in home hospice care. Minorities are barely involved with the program, let alone being disproportionately its "victims." As I say to my students, it appears that assisted suicide is for control-freaks. No case of euthanasia, voluntary or involuntary, has been established in either Oregon or Washington, so that slope seems not to be so slippery. And Oregonian hospice care and palliative care has not suffered after the introduction of PAS; indeed, it has prospered. It remains a vexed question, though, whether end-of-life care in Oregon is good because of pressure exerted by the existence of the assisted suicide option, or whether, alternatively, assisted suicide performs well in Oregon because its end-of-life care is so unusually good; or, indeed, or whether both things are true.

Have we slipped down the slope toward a duty to die? I see no evidence.

My own position on physician-assisted suicide is completely open to revision in light of empirical data. Can someone show that people who don't want to die are being pushed into assisted suicide? I'll count that as important evidence against PAS. Can someone show that PAS programs enhance the quality of end-of-life care? That'll count in its favor. Can someone show that medicine is completely able--not just in ideal circumstances, but on the ground in real clinical settings--to control the suffering of patients at the end of life? Then I'd drop my support for physician-assisted suicide altogether.

One thing I won't do, though, is stop calling Physician Assisted Suicide by that name. Many who lobby in favor of PAS want to jettison the negative associations of the word "suicide," and point out that we are, at least for the moment, talking about people who are dying anyway, and who would, in many cases, prefer not to. The word "suicide," they argue, doesn't fit the cases they're talking about. But to my perhaps-overly-legal mind, the word "suicide" simply applies to people who are killing themselves, even if they're killing themselves because they're dying. Other phrases (Aid in Dying, for example) are inexact, in that they cover not only PAS but also voluntary active euthanasia. Words mean what they mean, usually; the battle, in my view, should not be about claiming that the terminally ill aren't really committing suicide, but rather about the deeper point that some suicides are morally, even religiously, permissible. Think about the harm of death: the suffering attending the dying process, the loss of integrity and control, the loss of a future you'd like to live to experience. The person who rationally elects PAS avoids the suffering, maintains and even establishes integrity and control, and has no desirable future to lose.

If I were a Massachusetts resident, I'd vote in favor of the initiative.

The Presidential Candidates on Bioethics

2012-10-06T21:50:00.000-04:00

Thank you, Hastings Center, for putting up this very valuable site, highlighting the two candidates' and their parties' positions on various bioethics issues.

Canada and the Crime of HIV Exposure

2012-10-06T21:30:00.001-04:00

The Supreme Court of Canada has just issued two rulings, one on an appeal from Quebec and the other on an appeal from Manitoba, which together clarify and restructure the circumstances under which criminal sanctions can be applied to an HIV+ person who has sex without disclosing that HIV status to his or her sexual partner.

Since 1998, Canadian law has held that those who fail to disclose their HIV status can be charged with sexual assault or aggravated sexual assault if their sexual relations pose "a significant risk of bodily harm" to their partners. Lower court holdings over the years have held that there was no significant risk of bodily harm where the accused used a condom, or where the accused had a low viral load due to medication. The new Supreme Court holdings agree that there is no significant risk, and no legal duty to disclose HIV status, where the accused's viral load is low due to medication, and a condom is used. But the Supreme Court upheld the convictions of defendants who did not use condoms, even if their viral loads were low.

The decisions have drawn immediate criticism from opposite sides. Advocates for persons with HIV/AIDS accuse the court of reinforcing irrational and unscientific fears of HIV transmission, of stigmatizing those who are infected, and of creating a world in which even responsible condom use offers no surefire protection from prosecution for those who do not disclose their HIV status. The threat of criminal prosecution for an act of consensual sex, they argue, doesn't protect people from HIV transmission. Conservative critics of the opinions lament the Court's having given legal permission for people not to disclose their HIV+ status to their sexual partners in some circumstances.

The Court also said that the "significant risk" necessary to underwrite criminal prosecution would vary with the sex-act in question, and could also change with medical progress.

Mouse Eggs from Stem and iPS Cells

2012-10-06T20:41:00.001-04:00

Okay, this is a big deal. A research team from Kyoto University has successfully used both murine stem cells and murine induced pluripotent stem cells to generate functioning oocytes. For those of you who do not excel in Latin, that means they took mouse embryonic stem cells and some ordinary mouse cells, and developed each into eggs. Those eggs were then used to create healthy mouse offspring.

This team and others have created both sperm and eggs from stem cells before, but haven't been able to produce healthy offspring from them. This time the researchers used proteins and other factors to induce the stem cells and iPS cells into becoming "primordial germ cell-like cells," or PGCLCs. The PGCLCs were then combined with cells from mouse ovaries to make artificial ovaries. These were then transplanted into female mice. After a month, the mice were found to be carrying immature eggs. The eggs were matured in vitro and then fertilized; the resultant embryos were transferred into female mice, who then gave birth. The happy mothers later became grandmothers, without need for further laboratory intervention.

Making oocytes out of stem cells would be impressive enough, but making them out of iPS cells is huge. This lab took an ordinary cell from a mouse, tweaked it and coaxed it into becoming an oocyte, and then made a baby mouse out of it. We're that much closer to being able to do that same trick for humans.

So, any tissue sample from any person, dead or alive, could in theory be used to make that person's baby. Did I say this was a big deal? Obviously it opens up some amazing possibilities for infertility treatment; but obviously, also, it poses huge challenges for control over the future uses of tissue in research and in the clinic.

Bioethics-y Things at Yale

2012-10-05T16:44:00.000-04:00

Our Technology and Ethics group will be hosting Danah Boyd, Senior Researcher at Microsoft Research, on Wednesday, October 10 at 4:15 PM at 77 Prospect St. (ISPS), room A002. Ms. Boyd will speak about "Privacy and Ethics in Big Data Research."

There are several great Yale-based exhibits on bioethics issues right now. The Sterling Memorial Library has a show called "The Fortunoff Video Archive for Holocaust Testimonies: Achievements and Challenges 1982-2012." The Cushing/Whitney Medical Library has its display, "Medicine at Work: A Selection of Instruments and Materials from the Medical Historical Library;" you can glimpse the collection here. The Yale Peabody Museum has an exhibit called "Big Food: Health, Culture and Evolution of Eating."

And then there's Ain't Gonna Make It: A Rockabilly Exploration of Death at the Yale Cabaret.

Enjoy!