Friday, December 28, 2012

Nuffield on "Public Ethics"

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

Wednesday, December 12, 2012

The Liverpool Care Pathway Kerfuffle

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.

Sunday, November 4, 2012

Medicare coverage litigation--Jimmo v. Sebelius

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.

Tuesday, October 16, 2012

The Lyric and the Narrative

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, October 12, 2012

Friday Frivolity: Altruism at the Deathbed Edition


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

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

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

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.

Monday, October 8, 2012

Massachusetts and Physician-Assisted Suicide

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.

Saturday, October 6, 2012

The Presidential Candidates on Bioethics

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

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

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.

Friday, October 5, 2012

Bioethics-y Things at Yale

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.


Friday Frivolity, Administrative Waste Edition

They Blinded Me With Science, Climate Change Edition

One day a group of friends were talking about climate change in the cafeteria. Ralph said, “There is growing concern and evidence that scientific data, from which global warming theories emerged, has been manipulated, enhanced or deleted.” Larry nodded and responded, “The data does not support the premise that carbon dioxide emissions are playing a significant role in the world temperature variations. The temperature of the Earth has been changing over centuries with warmer and colder periods throughout history.” Dana agreed, saying,“I do not believe that CO2 is a cause of global warming.”

Chip was more emphatic. “One word,” he said, “Bunk. It's built off of corrupt data and a corrupt NASA program. It's bunk. It's fallacy. There is absolutely no substantial evidence to prove that there is global warming.” And Dan agreed: “I think it’s all baloney. It’s all baloney. I think it’s just some scheme….I just don’t believe it, I just don’t believe it. You know, I’m a scientist, I’m a surgeon, I’ve done scientific research papers, there’s a lot of skepticism.”

From his seat at the next table, Chuck muttered, “I think we ought to take Al Gore, put him on an iceberg, and put him way out there.”

Randy took a sip of his drink, and started to wax philosophical. “The greatest impact on our climate clearly is the sun,” he said, “and we have very little impact on the sun and how much energy and temperature the sun is sending to the earth. We have seen clearly over thousands of years that at different times more energy has come through and different times less energy has come through, and that variation has impacted climate change. Over the thousands of years that’s been recorded we’ve had both colder times and warmer times. It happens to be that we’ve recently come out of a warmer time and now actually we’re headed in to a little bit of a colder time. The impact of the sun is much different than impact that we could have had.” Ben nodded and offered his terse agreement, saying, “Our planet has warmed and cooled from the beginning of time.”

Paul spoke up: “Scientists all over this world say that the idea of human induced global climate change is one of the greatest hoaxes perpetrated out of the scientific community. It is a hoax. There is no scientific consensus.” And he had a lot more to say about science: “All that stuff I was taught about evolution and embryology and the Big Bang Theory, all that is lies straight from the pit of Hell. And it’s lies to try to keep me and all the folks who were taught that from understanding that they need a savior…You see, there are a lot of scientific data that I’ve found out as a scientist that actually show that this is really a young Earth. I don’t believe that the Earth’s but about 9,000 years old. I believe it was created in six days as we know them. That’s what the Bible says.”

Jim shifted the conversation back. “I think that the science is inconclusive on this,” he said. “What the science says is that temperatures peaked out globally in 1998. So we’ve gone for 10 plus years where the temperatures have gone down….I personally believe that the solar flares are more responsible for climatic cycles than anything that human beings do and our lunar, our rovers on Mars have indicated that there has been a slight warming in the atmosphere of Mars and that certainly was not caused by the internal combustion engine.”

Sandy wanted to know, “Does the so-called danger posed to the economy by not acting to reduce what some may call man-made effects on climate change outweigh the economic costs to the country?”

Finally Todd concluded for the group, saying, “This whole thing strikes me if it weren’t so serious as being a comedy you know. I mean, we just went from winter to spring. In Missouri when we go from winter to spring, that’s a good climate change. I don’t want to stop that climate change you know. Who in the world want to put politicians in charge of the weather anyways? What a dumb idea….Some of the models said that we’re going to have surf at the front steps of the Capitol pretty soon. I was really looking forward to that.…”

Then the whole gang got up to attend their next meeting of the US House of Representatives Committee on Science, Space and Technology.

Tuesday, October 2, 2012

Three Genetic Parents?

The UK's Human Fertilization and Embryology Authority is conducting a public consultation on the question of whether they ought to permit the creation of children with three genetic parents. The question is about a new assisted reproductive technology that could prevent children from suffering from diseases carried in mitochondrial DNA. In essence, the fertility clinic would fertilize an egg, and then remove the genetic material from that egg and pop it into a de-nucleated egg from a donor. The result would be an embryo with Mom and Dad's nuclear DNA, but with mitochondrial DNA from Donor--free from any mitochondrial diseases of which Mom is a carrier.

I'm not actually bothered by this. While having three genetic parents is something new, surrogacy has given us many children with three biological parents (egg Mom, sperm Dad, and surrogate Mom--who, make no mistake, makes some serious contributions to the basic makeup and future health of the child, via hormonal and epigenetic influences, diet, gestational environment, and so on). And after all, what will we call the child of this high-tech intervention, with her three different pro-genitors?


Food Stamps and Sugary Drinks

Back in 2010, New York's Mayor Bloomberg (he of the new big-soda ban) and then-Governor Paterson proposed limiting the ability of food-stamp recipients to spend their aid-money on sugary sodas. They hoped to show that limiting spending on sugary drinks would reduce obesity. This was viewed as paternalistic intervention into the lives of the poor, and the federal government blocked the proposal. Now colleagues at Yale's Rudd Center for Food Policy and Obesity have demonstrated that "[d]espite all the evidence on health risks linked to their consumption, sugar-sweetened beverages account for almost 60% of beverage purchases among SNAP [Supplemental Nutritional Assistance Program] households and about one half of beverages purchased by WIC-only [Supplemental Nutrition Program for Women, Infants and Children] households." In all, around $2 billion dollars of SNAP money is spent annually on refreshment beverages "with no nutritional value." Perhaps it's time to put additional limits--not all-out bans, but limits--on the freedom of nutrition-subsidy recipients to spend their aid dollars on sugar-water.

Friday, September 21, 2012

Bioethics Poetry, Charles Lamb Edition

On an Infant Dying as Soon as Born

I saw where in the shroud did lurk
A curious frame of Nature's work.
A flow'ret crushed in the bud,
A nameless piece of Babyhood,
Was in a cradle-coffin lying;
Extinct, with scarce the sense of dying;
So soon to exchange the imprisoning womb
For darker closets of the tomb!
She did but ope an eye, and put
A clear beam forth, then strait up shut
For the long dark: ne'er more to see
Through glasses of mortality.
Riddle of destiny, who can show
What thy short visit meant, or know
What thy errand here below?

The poem continues here.

Thursday, September 20, 2012

Friday Frivolity, Another Breaking Bad News Edition

In case you missed one, all the past Friday Frivolity's are here.

Bad News on Vaccinations

This letter to the New England Journal of Medicine reports an increase in the rate of non-medical exemptions from the childhood vaccinations generally required by state law. (Non-medical exemptions are permitted in 48 of the 50 United States.) States that allow "philosophical," as opposed to only "religious," exemptions to mandated childhood vaccinations, had higher rates of exemption, as did states with "easier" opt-out provisions. Easy opt-out states allow parents to opt out of the vaccination requirement by filling out a standardized form supplied by the school; harder opt-out provisions require an original and/or notarized letter from the parent, or a form obtainable only from the state health department.

For whatever reason--but certainly including unscientific vaccine/autism fear-mongering--there has been a dramatic decline in US parents' willingness to vaccinate their children. The result has been the return of deadly childhood diseases including pertussis, whooping cough and measles. Vaccination is among the most effective public health measures. Certainly, states should make it harder for parents to opt out of vaccination programs for non-medical reasons. But rates of opt-out are on the rise even in "difficult" opt-out states, and there is some evidence that when states make it hard to opt out of vaccination for non-medical reasons, parents respond by pressuring doctors to write them bogus "medical" excuses.

The root of the problem seems to be that vaccines are victims of their own success. Most people haven't seen the effects of the awful childhood diseases that vaccines have been so effective at eradicating. But they've heard about vaccine reactions, and have heard all the unsubstantiated--or downright fraudulent--claims about vaccines and autism. How many kids will have to suffer or die with whooping cough or measles or pertussis before the public can be persuaded to trust in some of the most reliable science in all of public health?

Physician Interpretation of Industry Funding

According to this article in the current New England Journal of Medicine, physicians are more apt to prescribe drugs supported by studies they perceive as rigorous, than those supported by studies perceived as less rigorous. More interestingly, though, physicians downgrade their perception of the rigor of a study, their confidence in its results, and their willingness to prescribe the studied drug, when the study discloses that it was industry-sponsored. Physicians surveyed were twice as willing to prescribe a drug supported by an NIH study than one supported by an industry-sponsored study.

In general I greet this as good news. Industry sponsorship injects bias into the literature in many ways: via unconscious biasing of sponsored researchers, via careful selection of the kinds of studies sponsored (e.g., avoidance of head-to-head drug comparisons that have any chance of turning out badly), and even (in a few documented cases) via the burial or abandonment of sponsored studies that don't work out. So it's fine if physicians greet industry-sponsored trials with some skepticism.

Two worries, though: first, there can be too much of a good thing. After all, if a company develops a drug that really works, it will want to sponsor studies to prove that fact; and too much skepticism of positive results could end up hurting patients. Second, if industry sponsorship gives rise to skepticism, then there's an incentive to bury the fact of industry sponsorship via ghost authorship or other means.

Study registers, publication of negative results, rigorous authorship standards, rules for disclosure of funding sources and of conflicting interests, public funding for independent research: these can all help.

But the facts are 1) that we rely on private, profit-motivated research to find our new drugs; 2) that such research has historically done an excellent job in discovering and publicizing useful new drugs; and 3) that the very same motives that drive the industry to do a good job in discovering and publicizing useful new drugs are those that drive it to pollute and bias the literature. So there will be no easy answers.

Tuesday, September 18, 2012

Tom Koch on Bioethics, Oily-faced Edition

Okay, so Tom Koch thinks that, as a bioethicist, I'm an "oily-faced official worthy" who pretends to a care I don't deliver. Really, he does. Wait--does my face look shiny to you? Should I be worried?

Hmm. Maybe not. After all, Tom Koch also thinks that when we bioethicists argue that we're needed because the old ethics of medicine won't serve in the new world of advancing medical science and technology, we call that the "Georgetown Mantra." But when I google "Georgetown Mantra," I find people discussing somethng completely different!

And Tom Koch also thinks that bioethicists' "primary training is in philosophy, not biology, genetics, or medicine." He thinks this in spite of that fact that there are more physicians than philosophers on the current ASBH board, and more physicians than philosophers among the 200 or so Hastings Center Fellows. Maybe Tom Koch's beliefs are not all correct.

It's hard to tell, exactly, but Tom Koch seems also to think that bioethics has its roots in the "Regan" (sic) administration and its "postmodernist economics." I guess Tom Koch must think of the Hastings Center as a real field leader, being founded under Nixon and all.

And look! Tom Koch also thinks that "[b]ioethicists rarely work with patients," in spite of the fact that 100% of all US hospitals with over 400 beds, and 81% of all US hospitals regardless of size, have some kind of clinical ethics consultation service. It must be that Tom Koch thinks those clinical ethics consultants aren't bioethicists....

Wow! Tom Koch also thinks "some and perhaps many" bioethicists promote "a eugenic present and future, pruning the human tree, as "rational" by which is meant cost efficient." Some? Perhaps. Many?

Tom Koch also thinks that bioethics as a field has promoted a reductive consumerism in medicine, and has cast patients as consumers whose care ought to depend on their resources. I don't think we know the same people. Or read the same books. Or journals.

No, I'm not going to worry after all. Tom Koch doesn't seem to know much about bioethics, or about my skin--except how to get under it.

Bioethics-y Things at Yale: Killer Kitty edition

On Thursday, September 27 at 4:15 PM, our Animal Ethics Forum will host its first-ever public lecture. Clare Palmer (Philosophy, Texas A&M) will speak on "Ethics, Conservation, and Animal Welfare: Wildlife and Outdoor Cats." Outdoor cats, you say? Well, yes, actually. Our little purring murderers are estimated to kill 4 billion animals a year in the US alone. We humans are having a huge environmental impact via our cats. Clare's talk will raise a number of tough issues: the tensions among animal lovers and environmentalists, the limits of our personal responsibility, the meaning of animal suffering.

The event is co-sponsored by the Yale Interdisciplinary Center for Bioethics and the Yale Divinity School.

So Good to Be So Young!

Ah, what a relief: according to this survey, I'm not yet middle-aged!

Thinking About Fracking at Yale

This afternoon at 4, Yale School of Forestry and Environmental Studies will host what looks like an excellent panel entitled "Hydraulic Fracturing: Bridge to a Clean Energy Future?" The panel will feature John Hofmeister, a former Shell Oil executive and CEO of Citizens for Affordable Energy; Bill McKibben, an environmental journalist and founder of the grassroots climate campaign; Sheila Olmstead, a fellow at the nonpartisan think tank Resources for the Future; and James Saiers, F&ES professor of hydrology and a water chemistry expert. These people will not agree with one another.

Brad Gentry, director of the Center for Business and the Environment at Yale and a member of the F&ES faculty, will be the moderator.

The event will be held in the Burke Auditorium of the Forestry School's Kroon Hall. Details are here. If you can't make it to New Haven in time, don't worry: you can watch the event via live-streaming video here.

This isn't a Yale Interdisciplinary Center for Bioethics event, but given the unusual breadth with which our Center reads the "bio" in bioethics, it's exactly our kind of issue. Hope you'll join me in watching!

Friday, February 3, 2012

Bioethics Poetry, Katy Giebenhain edition

Glucose Self-Monitoring

A stabbing in miniature, it is,
a tiny crime,
my own blood parceled
drop by drop and set
on the flickering tongue
of this machine.

It is the spout-punching of trees
for syrup new and smooth
and sweeter
than nature ever intended.
It is Sleeping Beauty's curse
and fascination.
It is the dipstick measuring of oil
from the Buick's throat,
the necessary maintenance.

It is every vampire movie ever made.

Hand, my martyr without lips,
my quiet cow.
I'll milk your fingertips
for all they're worth.
For what they're worth.

Something like a harvest, it is,
a tiny crime.

Katy Giebenhain

(This poem first appeared in Prairie Schooner; used by permission of the author)

Komen Re-funds Planned Parenthood, Sorta

The Susan G. Komen for the Cure folks have reversed themselves on the question of funding Planned Parenthood's breast-cancer screening and mammography referral services. A statement released today said the foundation was revising its no-funding-for-people-under-investigation policy so as not to include political, as opposed to criminal, investigations. (As I blogged earlier, there's an ongoing congressional investigation into the question whether Planned Parenthood uses any federal funds for abortions, and Komen originally pointed to the existence of that investigation as a reason for discontinuing funding.) The statement said nothing about another reason Komen has given for the de-funding of Planned Parenthood, namely, that they don't provide mammography services directly, but only make referrals for them. The statement says funding for Planned Parenthood will continue to flow under existing agreements, and that Planned Parenthood will remain eligible to apply for more funding in the future. It remains to be seen whether Planned Parenthood's angered constituency will revise its views on Komen as quickly as Komen has revised its grantmaking policy.

UPDATE: This piece has persuaded me that there's less of a reversal here than meets the eye. Komen never intended to renege on existing commitments to Planned Parenthood, so saying they're going to continue funding them isn't any change. Saying Planned Parenthood is eligible to apply for further funding is, in fact, a reversal of their "no money to folks being investigated" policy, but isn't a guarantee that funding will flow. We'll see how many grants are actually made to Planned Parenthood in the future....

ANOTHER UPDATE: Further evidence that there's less to this "reversal" than meets the eye is here. And here, too.

Friday Frivolity, Dental Competence Edition

Thursday, February 2, 2012

Romney on Stem Cells

I blogged recently about Newt Gingrich's recent attacks on human embryonic stem cell research, and his intention to investigate and regulate the practices of IVF clinics which create excess human embryos. The news item led me to wonder what Mitt Romney's stem-cell position is. Not surprisingly, it's bounced around a bit.

In his gubernatorial race of 2002, Romney was a supporter of embryonic stem-cell research, and even promised to lobby President Bush for increased research funding in the area. But after a conversation with some Harvard researchers who, Romney often claims, had no moral qualms about destroying two-week-old embryos, he changed his position. Indeed, he credits the stem-cell debate with pushing him toward his current pro-life abortion position. In the run-up to the 2008 presidential election, Romney formulated his current position, namely, that it isn't unethical to use "excess" embryos from IVF clinics for embryonic stem-cell research, but that he opposes government funding for such research, and opposes any laboratory creation of embryos (by cloning or otherwise) for research purposes. This page gathers a number of quotations from Romney on the issue over the years.

He has spoken in favor of shifting research from human embryonic stem cells to induced pluripotent stem cells, since the latter research involves no embryonic destruction. He has also made mention several times of "altered nuclear transfer," the purported "scientific solution" to the ethical problem of embryonic stem-cell research promoted by William Hurlbut, a Stanford professor and member of President Bush's bioethics committee. Altered nuclear transfer essentially produces a severely disabled embryo which cannot develop into a human baby; Hurlbut argued that using ANT embryos thus avoided the problem of killing a viable embryo. Pro-life organizations briefly endorsed, and then pulled away from, the Hurlbut proposal. (There's a website touting ANT here; and brief discussion halfway down this page of the political reception by pro-life groups of Hurlbut's proposal.)

This recent item from Fox News takes Romney to task for continuing to invest in Novo Nordisk, a Danish pharmaceutical firm which uses some stem cells in its research, up until 2010--in spite of having taken a position against embryonic stem-cell research in 2007. But I think that's just a mistake. Romney, as far as I've been able to find, has never taken a comprehensive position opposing all human embryonic stem-cell research. He isn't opposed to privately-funded research on leftover IVF embryos. He opposes laboratory embryo creation, and he opposes the public funding of any embryonic stem-cell research.

Wednesday, February 1, 2012

Komen Defunds Planned Parenthood

By now anyone who spends any time on the net is aware that the leading breast-cancer charity, Susan G. Komen for the Cure, has decided to pull all funding for breast cancer screening from Planned Parenthood. Planned Parenthood is saying that the move is a cave-in by Komen to pro-life political pressure. Komen has responded that the move isn't political; it's just that they have a new policy of not funding organizations that are under investigation, and Planned Parenthood is under a (highly political) investigation by Congress about whether they're violating the Hyde Amendment by using federal funds for abortions.

A few of the more interesting tidbits from the web:

A number of pieces, including this one, and this rather less mild one, about how the decision was influenced by Komen's new senior VP, Karen Handel--a pro-life former Republican candidate for the Georgia governorship, endorsed by Sarah Palin; pieces like this one, claiming that the immediate outcry from Planned Parenthood supporters has already resulted in PP recouping much of the money it won't get from Komen, and may deliver a real long-term blow to Komen; pieces like this one, showing enthusiasm for Komen's move among some religious and pro-life groups; articles like this one, and this, detailing past Komen-related controversies, like suing other charities for using "cure" and pink ribbons at their events, and lending their support to unhealthy products like KFC ("because nothing says that you care about women's health like a big vat of fried chicken"); this meta-coverage of the Internet/Social Media response to the news; and this story about a dissenting Komen affiliate group in Connecticut.

I'm guessing, along with many others, that Komen will emerge a loser here, and that Planned Parenthood will benefit significantly from the anger stirred up in its pro-choice base--and from the sense in the broader women's health community that Komen's political move threatens access of the poorest women to preventative breast-cancer screening.

Top 5 Regrets of the Dying

This piece from the Guardian lists the top 5 regrets of dying patients, as recorded over the years by an Australian palliative care nurse named Bronnie Ware. The five most-frequently heard regrets were these:

1. I wish I'd had the courage to live a life true to myself, not the life others expected of me.

2. I wish I hadn't worked so hard.

3. I wish I'd had the courage to express my feelings.

4. I wish I had stayed in touch with my friends.

5. I wish that I had let myself be happier.

Look at the article for a bit more detail, or read Bronnie Ware's book. More importantly: be true to yourself, don't work so hard, say what you're feeling, look up those old friends, and smile.

Tuesday, January 31, 2012

Emanuel on Accountable Care Organizations

Zeke Emanuel and Jeffrey Liebman are predicting that health insurance companies will vanish by 2020, to be replaced by the Accountable Care Organizations (ACOs) being called into being by President Obama's Affordable Care Act. ACOs, they predict, will practice more efficient medicine than the current fee-for-service system can generate, and will also replace insurance companies' risk-spreading function by pooling the risks of their higher- and lower-cost patients.

I can't share their optimism. Data from the five-year Medicare Physician Group Practice demonstration project casts doubt on the ability of ACOs to extract major savings from care-coordination. This Health Affairs Health Policy Brief on ACOs raises that question, and others as well: will ACOs form only in wealthier regions of the country, thus worsening already-existing health disparities? Could alliances among healthcare providers result in higher prices? Will ACOs run afoul of antitrust laws?

Of course we should do a better job of coordinating care; of course we should incentivize our doctors and hospitals to work on keeping people well rather than on intervening with expensive procedures after they're sick; of course we should use our better information technology to cut costs without cutting quality. Can ACOs do all of that? I sincerely hope so. But I'm not willing to bet that they'll be so successful as to make private health insurance obsolete in the next eight years.

Friday Frivolity, Vegetative Teens Edition

Yeah, I know, it's only Tuesday. But this is just too good to wait for.

Brain-Dead Teen, Only Capable Of Rolling Eyes And Texting, To Be Euthanized

Affordable Malaria Medicine in Nigeria

Here's a heartening article about a coalition that has just completed negotiations which will permit antimalarial medication to be sold in five Nigerian states (together containing about one-fifth of the population) for as little as N60.00 per dose (that's about 27 cents). Previously, Artemisinin-based Combination Therapies had sold for anywhere between N800.00 and N2000.00. The Partnership for Transforming Health Systems, PATHS2, is a program of the United Kingdom Department for International Development. The initiative is a collaboration of PATHS2 with the Clinton Health Access Initiative, Nigeria's Federal Ministry of Health, and some pharmaceutical manufacturing firms, working through the Affordable Medicines Facility for malaria (AMFm) initiative. More details on the funding mechanism are here. Malaria accounts for 70% of all disease incidence in Nigeria; in 2008 there were 57,506,430 reported cases, of which 225,424 were fatal.

Monday, January 30, 2012

Council of Europe on Euthanasia

The Parliamentary Assembly of the Council of Europe ("PACE") has issued a non-binding declaration (mainly aimed at getting member states to beef up their laws governing living wills and advance directives) in which it opines that "[e]uthanasia, in the sense of the intentional killing by act or omission of a dependent human being for his or her alleged benefit, must always be prohibited."

A number of different publications are mistakenly alleging that PACE has called for a permanent ban on assisted suicide. The resolution explicitly says that it "is not intended to deal with the issues of euthanasia or assisted suicide," and while it goes on to condemn euthanasia, it says nothing additional about assisted suicide.

The PACE declaration may indeed have some political effect on movements within Europe toward legalization of euthanasia. But it's a mistake to report it as a condemnation of assisted suicide, or to anticipate that it will have strong effect on pending cases involving assisted suicide. The European Court of Human Rights, for example, has repeatedly recognized the distinction between assisted suicide and euthanasia, and has held that Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms protects the individual's choice to avoid a painful and undignified death.

No Fetuses in Food!

Oklahoma Senate Bill 1418, introduced by State Sen. Ralph Shortey, would prevent anyone from manufacturing or selling food "which contains aborted human fetuses in the ingredients or which used aborted human fetuses in the research or development of any of the ingredients." The concern behind the bill, apparently, is with food companies which are in fact using tissue derived from aborted fetuses in research on the development of new product flavorings. (This is of course different from saying that such cells are being used as ingredients in food!)

The Onion, America's finest news source, has gathered some informed opinions on the issue.

Gingrich Would Ban Stem Cell Research, Regulate IVF

Newt Gingrich is telling conservative audiences in Florida that, if elected, he will ban all human embryonic stem-cell research, including research done on excess embryos from fertility clinics. He regards embryonic stem-cell research as "the use of science to desensitize society over the killing of babies." This is a reversal of positions he took in two different interviews in 2001, in which he expressed support for federally funding research on leftover fertility-clinic embryos which would otherwise be discarded. Over this weekend Gingrich also indicated that he would create a commission to look into the ethics of IVF: “I believe life begins at conception, and the question I was raising was what happens to embryos in fertility clinics, and I would favor a commission to look seriously at the ethics of how we manage fertility clinics....If you have in vitro fertilization, you are creating life; therefore, we should look seriously at what the rules should be for clinics that are doing that, because they are creating life.”

The roughly $125 million saved by cutting all of NIH's human embryonic stem-cell research funding could presumably be used to help offset some of the billions and billions of dollars required to create the new moon-base Gingrich says he wants by the end of his second term.

Friday, January 13, 2012

Bioethics Poetry, Sylvia Plath Edition

Morning Song

Love set you going like a fat gold watch.
The midwife slapped your footsoles, and your bald cry
Took its place among the elements.

Our voices echo, magnifying your arrival. New statue.
In a drafty museum, your nakedness
Shadows our safety. We stand round blankly as walls.

I'm no more your mother
Than the cloud that distills a mirror to reflect its own slow
Effacement at the wind's hand.

All night your moth-breath
Flickers among the flat pink roses. I wake to listen:
A far sea moves in my ear.

One cry, and I stumble from bed, cow-heavy and floral
In my Victorian nightgown.
Your mouth opens clean as a cat's. The window square

Whitens and swallows its dull stars. And now you try
Your handful of notes;
The clear vowels rise like balloons.

Sylvia Plath

Research Misconduct and Red Wine

Dipak Das of the University of Connecticut has been found by a special review board to have committed 145 separate counts of data falsification and fabrication in his studies of the effects on the heart of red-wine consumption (and specifically of the compound resveratrol, found in red wine). A summary the board's findings is here. The research misconduct is said to affect 26 articles in as many as 11 journals. Retraction Watch is following the case, and has printed some responses from Das, who is alleging ethnic bias, conspiracy and mistreatment by UConn.

Harvard's David Sinclair (a booster of resveratrol) was quoted in the New York Times as saying that there will be little fallout for the general field of resveratrol study around the world. "Today I had to look up who he is. His papers are mostly in specialty journals,” he said. Ouch! But Science 2.0 (which is skeptical about resveratrol) notes an earlier connection between Sinclair and Das, and a sort-of retraction by Sinclair of his NYT comment. Curioser and curioser!

Friday Frivolity, Machine That Goes "Ping!" Edition

Pharma and Phraud

Here's a report from Public Citizen summarizing the recent trend in payments by the pharmaceutical industry of civil and criminal monetary penalties. It seems that pharma has now eclipsed the defense industry as the leading defrauder of the US government under the False Claims Act. Some of the report's findings:

In the last twenty years, pharma firms have made 165 settlements for $19.8 billion in penalties. Three-quarters of these (both in terms of numbers of settlements and in terms of fines paid) have occurred in the last five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted, together, for more than half of the twenty years' penalties. Illegal off-label promotion of drugs has triggered the largest number of federal fines. Overcharging state Medicaid programs triggered the largest state-level fines. Actions initiated by industry whistleblowers gave rise to 67 percent of payouts over the last decade.

The report concludes that fines are probably not sufficient motivation to get high-profit-margin firms to behave. It recommends the application of the "Park Doctrine" to pharma executives--a doctrine under which individual executives can be convicted of criminal misdemeanors based on corporate misbehavior, even if they weren't personally aware of the problem. The doctrine is designed to motivate executives to become pro-active in preventing their firms from engaging in criminal misconduct.

The report's call for the FDA to revive the long-neglected Park Doctrine in fact follows recent signals from the FDA that it intends to do just that. The law firm of Hyman, Phelps and McNamara has an informative powerpoint presentation on the FDA's past and future use of the Park doctrine, here. The clear message from the FDA has been, "Expect some prosecutions of pharma executives soon!"

Tuesday, January 10, 2012

Lesbian Couple's Parental Rights

A lesbian couple in Florida had a child. One of the couple was the child's birth-mother and the other its genetic (egg-providing) mother. (The genetic father was a sperm donor, not involved in the case.) After years of jointly rearing the child, the two mothers split up. Genetic mom sought parental rights to the child, and birth-mom resisted, claiming that 1) Florida common law recognizes only birth-mothers as mothers; 2) since Florida doesn't permit adoption by gay couples, it has prohibited lesbian couples from sharing custody of children; 3) the genetic mother was an "egg donor," required under Florida gamete-donation law to relinquish parental rights; and 4) the biological mother had relinquished her parental rights contractually, in the text of her agreement with the fertility clinic which helped the couple create the child. In this opinion, the Fifth District of Florida finds 1) that Florida in fact has no common law recognizing exclusive parental rights in birth mothers--particularly in a case like this, where the birth mother is not the genetic mother; 2) that if Florida law prevents gay couples from sharing parental responsibility for a jointly-conceived child for whom they cared as mothers for years, then that law is unconstitutional under both the US and the Florida constitutions; 3) that a biological mother who provided her lesbian partner with an egg for purposes of fertilizing and implanting it in her partner and then raising the resultant child together, is not an "egg donor" under Florida law; and 4) that the provisions of the standard pre-printed form used by the fertility clinic did not apply to the facts in the case and could not operate to vitiate the genetic mother's parental rights. This is big news, because it appears to establish a fundamental, constitutionally-protected right to procreate--even for gay couples who, under current Florida law, can neither marry nor adopt.

ABC reports that birth-mom intends to appeal the case to the Florida Supreme Court.

Addiction, Philosophy--and Science

A number of bioethics twitterers were calling attention to this piece on addiction and philosophy from the New York Times's online Opinionator page. I enjoyed it, but thought that at its core it was more the application of a metaphor drawn from philosophy to the problem of addiction, rather than a philosophical treatment of the problem of addiction. So I googled around for a philosophical treatment of addiction and found this piece by Piers Benn. It is a genuinely philosophical treatment of the issue, but one which fails for lack of familiarity with contemporary addiction science.

In the piece, Benn asks whether addiction is properly termed a disease. (He speaks mostly about alcohol addiction, and so shall I.) Benn entertains and rejects four reasons why we might consider it a disease. The first is people sometimes argue that it would be more humane for us to talk about it that way, and thus to relieve addicts from blame and stigma. But Benn rejects that argument, favoring a "tough love" approach. (In another portion of the essay, he rejects the idea that addicts can't control themselves, essentially by pointing to the fact that some addicts can and do.) The second reason he considers for the disease model is that "the disease model seemingly gains support from genetics;" on this point, he cites a study from 1973 that showed that children of alcoholics, raised by non-alcoholic parents, are more likely to become alcoholic. Benn rejects this on grounds that genetic predispositions to drink don't actually force anyone to drink, and don't keep everyone from quitting. The third justification for the disease model is that addicts often talk about their own experience of powerlessness--inability to quit their habit even though they want to; Benn rejects this as self-deception. Addicts, he implies, aren't powerless, they just think they are. The fourth reason is that ordinary language often describes addiction in terms of irresistible forces and compulsions; Benn recommends that we simply think about addiction differently, as involving powerful forces, but not irresistible ones.

The underlying theme seems to be that addiction can only be a disease if it implies complete lack of control and therefore supplies addicts with a moral excuse for their conduct. If some addicts can control their behavior, then addiction doesn't imply complete lack of control, and therefore isn't a disease, and therefore supplies no moral excuse.

This won't do. First, it implicitly regards "addiction" as uniform, such that the ability of one person to kick an addiction is proof that all others could have done so as well, but for their weakness of will. Second, as Benn comes close to admitting at the close of the essay, the whole essay maps the idea of disease onto an idea of powerlessness which doesn't make sense. Some Type II diabetics can bring their insulin and blood-glucose under control with diet and exercise. Does this imply that the others aren't really sick?

Most unfortunate, though, is the fact that the whole article proceeds without any investigation into the current science of addiction. Scores of studies since 1973 have confirmed genetic predispositions to addiction, not only in humans but also in rats and monkeys. And contemporary brain-scan science has firmly established that the brain's reward-triggers are physically altered by substance use among addicts, in a way that they are not among mere "social users" of the same substances. (These results, too, have been duplicated in other species.) Recent brain-imaging studies have show that addicted alcoholics, unlike social drinkers, drink less for pleasure than for stress-relief; and that alcohol abuse among those with the correct genetic predisposition sensitizes the brains to stressors. This sensitization lasts well after detoxification, both in humans and in other species, and may help explain high rates of relapse. And finally, it's been shown that judgment centers of the brain (in the prefrontal cortex) are physically inhibited by alcohol intake, so that when (as Benn puts it) the tenth drink seems "highly alluring" to the alcoholic, that is not because (as Benn argues) the alcoholic is being akratic, and lacks the resolution to act on his better judgment, but because the portion of the brain which might normally supply better judgment has literally been shut down.

Someone, somewhere, might mount a philosophical argument against the disease model of addiction. But such an argument cannot be based only on armchair reflections about how we use language, about the Greek view of weakness of will, or about whether medicalization of addiction would or would not be kind. It must, also, deal with the science of the last four decades.

Monday, January 9, 2012

Chimeric Monkeys, Mice and Stem Cells

Shoukhrat Mitalipov of the Oregon National Primate Research Center has created chimeric rhesus monkeys, each of whose bodies combines tissues with up to six different genetic identities. The chimera creation was part of research which showed that--unlike in the case of mice--chimeras cannot be formed by injecting rhesus embryonic stem cells into blastocysts. Chimera formation was instead achieved by aggregating several four-cell embryos (a result never achieved in mice). The research hints at some important limitations of using mouse embryonic stem cell models to predict experience in primates, including humans.

The Onion has gathered some on-the-street comments on the research, including from Mr. Bobo.

Online Advance Directives

Virginia has recently decided to create an advance directives registry which, when it goes live sometime this spring, will permit patients to upload their own living wills. The plan is eventually to integrate the advance directives information into the state's health information exchange, so that physicians will be able to access their patients' documents without needing to know their login information. The hope is that physicians will then be able to act on their patients' previously-expressed wishes without having to locate and contact surrogate decision makers.

Saturday, January 7, 2012

Bioethics Poetry, Emily Dickinson Edition

Death is a Dialogue between

Death is a Dialogue between
The Spirit and the Dust.
"Dissolve" says Death -- The Spirit "Sir
I have another Trust" --

Death doubts it -- Argues from the Ground --
The Spirit turns away
Just laying off for evidence
An Overcoat of Clay.

Emily Dickinson

(Mary M. Scott Morton, RIP)

86% of Medical Error Goes Unreported

Hospital incident reporting systems were informed of only 14% of errors that harmed Medicare patients, according to this report on a recent survey undertaken by the Department of Health and Human Services Office of Inspector General. Hospital staff didn't perceive 61% of adverse events as reportable. Another 25% were classified as of a type commonly reported, but somehow not reported this time.

Remember what the Institute of Medicine told us, back in 1999, about how we ought to be dealing with medical errors? We're supposed to report them all, in a blame-free atmosphere, in order to gather information that will help us change the systems which give rise to them. The idea was that we'd make more progress by reporting error in this blame-neutral way than by either a) covering the error up or b) blaming error on particular human beings. The basic assumption was that most medical error resulted from flawed systems (training systems, oversight systems, information systems, and so on) which put hospital staff at predictable and preventable risk of making mistakes.

Some progress has been made. But this latest report shows how very far we have to go. A 14% reporting rate is absolutely dreadful, particularly because this is the report-rate for events that actually harmed Medicare patients. The IOM's goal was that not only harmful errors, but also "near-misses"--events that could have harmed patients, but luckily didn't--should be reported.

The Inspector General recommends that the government establish a list of reportable events, so that there's clarity about what needs to be reported and what doesn't; and that CMS (the Medicare agency) cooperate with accrediting bodies like the Joint Commission to establish review of hospital reporting procedures. Accrediting bodies currently tend to concentrate on what's done with reported information, rather than on the accuracy and breadth of the reporting process itself. That clearly needs to change.

Friday, January 6, 2012

Regulation, War, and Face Transplants

These proposed regulations from the US Department of Health and Human Services would subject vascularized composite allographs (VCA) to the rules currently governing solid organ procurement and transplantation. VCA involves transplanting multiple tissue-types as a single functional unit. The highest-profile VCA procedures are face and hand transplants, but VCA procedures around the world have included limb transplants, abdominal wall transplants, finger transplants, and transplants of penises and uteruses. What the procedures have in common is the need for re-vascularization via surgical connection of blood vessels to the transplanted tissue. Bringing these procedures under the existing organ procurement and transplantation rules will rationalize the supply and distribution of transplantable tissue, and permit medical teams to find better matches for their patients.

Recent successes in face-transplantation have captured a great deal of media attention. But another reason for this move is the medical aftermath of the US military presence in Iraq and Afghanistan. More than 1,000 military personnel have lost an arm or a leg in these conflicts; one fifth of those have lost two or more limbs. In the summer of 2010 there were an estimated 200 soldiers who might be eligible for partial or full face transplant, and an additional 50 who could use hand or forearm transplants. The US Departments of Defense and of Veterans Affairs have been leading funders of research on limb and face transplantation. The proposed regulation of VCA is in part aimed at permitting more veterans to get the procedures they need, with the best available material.

Friday Frivolity, Annoyingly Chipper Edition

NB: some strong language

FDA Approves Depressant Drug For The Annoyingly Cheerful

Thursday, January 5, 2012

Hepatitis C Vaccine Success and Chimpanzees

This article from Science Translational Medicine shows excellent results in a phase-1 trial of a new hepatitis C vaccine. This is a huge deal: hepatitis C infects 170 million globally, and causes a great deal of the world's liver damage. It kills more people in the US annually than HIV/AIDS.

The new vaccine was developed using chimpanzees as research subjects. I submit that this is exactly the sort of research for which the IOM's recent report on use of chimps in research left room. But I submit, also, that there aren't many more examples of this sort.

Wakefield Sues BMJ Editor for Defamation

Wow. Author of the a now-discredited Lancet article which started a vaccine scare by falsely linking MMR vaccination to autism onset, Andrew Wakefield is suing BMJ's editor, Fiona Godlee, and British investigative journalist Brian Deer, for defamation of his character. The complaint, filed in Travis County, Texas, is here. It focuses fairly narrowly on statements by Godlee and Deer to the effect that Wakefield manipulated or falsified data in the study.

The UK's General Medical Council, after the longest hearing in its history, found Wakefield guilty of serious professional misconduct in connection with the conduct of the research underlying the article, and erased him from its rolls. But they didn't specifically find that he altered data in the study; their main complaint about the article itself was that it mischaracterized the children under study--especially the means by which, and purpose for which, they were recruited. The GMC's findings spoke mainly to other forms of research and clinical misconduct. To review, the GMC found that Wakefield violated the limits of his appointment as an Honorary Consultant in a "breach of trust of patients and employers alike," and mismanaged funds, and failed to disclose "matters which could legitimately give rise to a perception of a conflict of interest," and conducted research on vulnerable children without required ethics review, and concealed that fact, and repeatedly breached "fundamental principles of research medicine," and acted contrary to the clinical interests of 9 of the 12 children mentioned in the article, and violated his duties as a senior author, and failed to correct his mistakes when given the chance, and made "dishonest and irresponsible" statements to the GMC board itself.

Of course, the fact that Wakefield was unprofessional in a bunch of different ways doesn't mean that he was unprofessional in all of the ways that Godlee or Deer have, at one time or another, alleged. It's just possible that one or the other of them has said something factually wrong by accusing Wakefield of some specific kind of scumbaggery that he didn't actually engage in. If so, may the damages found be very, very small.

Because the damage caused by Wakefield hasn't been small. The publicity around his unethical research likely caused children to die of completely preventable childhood diseases, and is certainly still causing misguided parents to fail to vaccinate their children. It is depressing to note that here, the Autism Action Network is already trumpeting Wakefield's suit against Deer and a woman whom they call "Fiona Godley." Their view is that Wakefield and his co-author John Walker-Smith "had their medical licenses suspended for their refusal to recant their hypothesis." They don't mention the actual GMC findings against Wakefield, nor those against Walker-Smith (which you can read here), nor the fact that in 2004, six years before the GMC acted, Walker-Smith and nine of Wakefield's other co-authors specifically retracted the portion of the paper that posited a link of MMR with autism.

Egg Donors and Stem Cell Research

This piece from the Atlantic (summarizing this article from Fertility and Sterility) says that most fertility clinics which accept donor eggs for fertility treatments, and which donate at least some "excess" embryos for research, fail to inform egg donors of the possibility that their eggs might be used in stem-cell research. Most of the surveyed clinics told donors that they would not have control over the future uses of their eggs or the embryos made from them, and 30% mentioned the possibility of research use, but very few mentioned stem-cell research by name. This ought to be remedied. I doubt that most women who are willing to donate eggs for fertility treatment have serious opposition to the use of their eggs in fertility research or in stem-cell research, but a few might. They should be given the information.

Commission Report on Assisted Dying in UK

Here is the final report of the UK's Commission on Assisted Dying. The private commission was funded by author-turned-end-of-life activist Terry Pratchett, who suffers from Alzheimer's disease and founded the UK's Dignity in Dying organization. It was led by Lord Falconer, a vocal proponent of liberalization of laws prohibiting assisted suicide. No one expected the Commission to come out with anything other than a pro-assisted-suicide view, Falconer's protestations of independence and neutrality notwithstanding. The Church of England has condemned the report, as have many (sometimes predictable) others.

But it is perhaps interesting to notice what the Commission actually ends up recommending: a relatively modest assisted suicide program rather similar to those in place in the US states of Oregon and Washington. The proposed program would help only competent adults with terminal diagnoses verified by two physicians. ("Terminal" means under a year to live, as opposed to the 6-month requirement in place in Oregon and Washington.) The patient's decision would have to be voluntary, not subject to undue influence, and not the result of a treatable mental condition such as depression. All requesting patients would be told about available social services and about other end-of-life treatment options such as palliative care. And the program would be open only to patients who are physically capable of taking the lethal medication themselves.

The report doesn't advocate euthanasia, though Falconer is often condemned by the other side as "pro-euthanasia." The program it recommends won't help Mr. Pratchett, whose Alzheimer's will likely render him incompetent before he has the report's recommended 12-month terminal diagnosis. Nor, as the Guardian points out, would the recommended program help Debbie Purdy, whose litigation forced prosecutorial authorities in England and Wales to issue guidelines backing away from criminal prosecution of those who assist their loved ones to die. Purdy has MS--a chronic, rather than a terminal, illness, and one that will likely make it impossible for her to take her own lethal medication within a year of her forecast death.

Drug Research on Non-Representative Populations

A while back I had my eyes opened by this review by Alex John London of Adriana Petryna's wonderful book, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. One of Petryna's important points is that when drug-trials are conducted in the developing world, the populations on whom drugs are tested are not very similar to the populations to whom the drug companies expect, eventually, to sell most of their drugs. Not only that, but the drug companies know this, and can work to choose populations with particular characteristics favorable to good trial results. Of course, they can do that at home, too, using inclusion and exclusion criteria for drug trials. A letter in last week's JAMA drives the point home: hardly any drug studies in high-impact journals include patients with multiple chronic conditions--this, in spite of the fact that 28% of Americans, and 2 of 3 three seniors, have multiple chronic conditions; and treatment of multiple chronic conditions accounts for 66% of overall US healthcare expenditure, and 95% of Medicare expenditure. The letter's sobering conclusion: "Given the possible drug-to-drug, drug-to-disease, and disease-to-disease interactions that remain unexamined, most of the evidence gathered to date by [clinical trials] is of limited value to guide decisions about medication use by patients with multiple chronic diseases."

Mouse Sperm Grown in Culture, Press Overreacts

This article from the Asian Journal of Andrology reveals that a German/Israeli team of researchers has been able to grow murine testicular cells in a soft agar culture system, and differentiate them to the point where they appear like morphologically normal spermatozoa. That is: they can take pre-sperm cells from mouse testes and grow them until they look like real, functional sperm cells. This is amazing news, but not as amazing as some journalists have made it seem. The Daily Mirror and the Telegraph said this could lead to in-lab production of human sperm "soon." Well, okay--depending on what you mean by "soon." JotZoom went with the present tense: "The latest news reports reveal more details about sperm grown in laboratory as a real scientific breakthrough. Infertile men are no longer deprived of the unique experience of becoming the father of a child using their own sperms." And the Times of India headlined the story, "Way to beat male infertility found." CBS used the Telegraph's reporting to do a more careful story, here. NHS splashes some appropriate cold water here.

US Restricts Antibiotics in Animals

From the "it's about time" department: the New York Times reports that the FDA is restricting the use of cephalosporins in livestock feed, in order to slow down the development of antibiotic-resistant bacteria. (Recent studies have shown that such resistant bacteria are indeed passed from feed animals to human beings.) Cephalosporins are a class of antibiotic widely used to treat strep, pneumonia, UTIs, skin infections and childhood bacterial infections. Europe banned the use of several antibiotics important in human medicine in 1998; banned the use of all antibiotics for growth-enhancement of livestock in 2006; and has recently moved to ban all prophylactic use of antibiotics in feed animals.

Bioethicsy Stuff at Yale

Here are a few upcoming bioethical events at Yale, all of which are open to the public:

Our Jerome Medalie End-of-Life Issues group will hear Kenneth Goodman, PhD, FACMI, Bioethics Program Director and Co-Director University of Miami Ethics Programs, on January 10 at 5:30. Details here.

Our sister institution, Yale Med's Program for Biomedical Ethics, will hear Carl Elliott, M.D., Ph.D., Professor, Center for Bioethics, University of Minnesota, on "Fear and Loathing in Medical Research: How to Exploit the Poor," on January 10 at 5p.m. Details here.

Our Biotechnology in Agriculture group will hear Scott Deeter, President and CEO of Ventria Bioscience, on "Global Human Health Innovations From Plant Biotechnology" on January 12 at 4pm. Details here.

Our Perspectives on Aging group will hear Dr. Marianthe Grammas, Clinical Fellow, Internal Medicine/Geriatrics, Yale School of Medicine on January 12 at 9 a.m. Details here.

Blogging Hiatus Ends

Just goes to show you: I take a seasonal holiday from the blog (any my own daily blog-reading) and miss the one day when Andrew Sullivan's The Dish sends hundreds of page-views my way.

Anyway, holiday's over. Time to make the donuts. Andrew, Patrick, Chris, Zoe, Maisie, Zack: come back anytime, and bring your readers!