January 2006

The President. A Bioethicist?

Cornell University has announced that it has hired a bioethicist as its new President. Well, sort of.

David Skorton, the current President of the University of Iowa, has been officially confirmed as the new President of Cornell. A physician and expert on congenital heart disease, he holds appointments at iowa in the Departments of Internal Medicine, Electrical and Computer Engineering, and Biomedical Engineering. But in addition he has a long history of interest in human subjects protections. As his bio at Iowa states:

"A national leader in research ethics, President Skorton is charter past-president of the Association for the Accreditation of Human Research Protection Programs, Inc., the first entity organized specifically to accredit human research protection programs."

Skorton is also a jazz musician, playing saxophone and flute. He even hosts a program on the University of Iowa's radio station calle "As Night Falls - Latin Jazz."

Just the kind of bioethicist we'd like to know.
- Paul Root Wolpe

Editorial Retraction

The following notice regarding the article by Jung, K. W., and I. Hyun, "Oocyte and somatic cell procurement for stem cell research: The South Korean experience," published in The American Journal of Bioethics 6(1): W19-W22, was released Tuesday January 31st at bioethics.net and will appear in AJOB 6(1):W33.:
The January/February 2006 issue of The American Journal of Bioethics contains a report from Drs. Insoo Hyun and Kyu Won Jung describing in detail the oocyte and somatic cell donation consent procedures developed for the stem cell research program of Seoul National University (Hyun and Jung 2006). Drs. Hyun and Jung report that they were led to believe that these consent procedures were used by Dr. Woo-Suk Hwang and his colleagues to enroll all of the oocyte and somatic cell donors who provided the research materials reportedly utilized in the derivation of eleven patient-specific embryonic stem cell lines (Hwang et al. 2005).

Following the acceptance and online publication of that manuscript, allegations about the veracity of the research performed by Dr. Hwang’s team surfaced. On January 10, 2006, the committee empowered by Seoul National University to look into these allegations concluded that the data published by Dr. Hwang and his colleagues were fabricated (Investigation Committee Report 2006). A similar report, issued by Korea’s National Board of Bioethics (KNBB) following their investigation of the Hwang lab’s oocyte donation procedures, raised additional concerns about the consent process. For example, Dr. Hwang was found to have used a far greater number of oocytes than originally claimed in the Science article. The KNBB committee also found that a number of egg donors suffered side effects from the oocyte donation process, and concluded that the oocyte donors were neither given sufficient information about the risks of donation nor were they asked to sign the consent forms approved by the Institutional Review Board.

It now appears likely that the oocyte and somatic cell donation consent procedures described by Hyun and Jung, which, they report, were developed through what they described as close collaboration with Dr. Hwang and his team, were not used for donor screening and enrollment in the research that gave rise to the now discredited Science paper (Hwang et al. 2005). Neither Dr. Hyun nor Dr. Jung have been accused of any misconduct with respect to the contents of this paper, but the Editors of The American Journal of Bioethics nevertheless believe that a retraction of their manuscript is warranted. Both authors have agreed to a retraction.

Glenn McGee PhD

Editor-in-Chief

References

Investigation Committee Report, Seoul National University, 10 January 2006.

Korean National Board of Bioethics, 30 December 2006. Hwang, W. S., S. I. Roh, B. C. Lee, et al. 2005. Patient-specific embryonic stem cells derived from human SCNT blastocysts. Science 308: 1777-1783.

Jung, K. W., and I. Hyun. 2006. Oocyte and somatic cell procurement for stem cell research: The South Korean experience. American Journal of Bioethics 6(1): W19-W22.

"Nanoethics": The ELSI of 21st Century Bioethics?

Fabrice Jotterand of East Carolina's Brody School of Medicine, gave a great talk about the state of biologically-focused nanotechnology this past week at AMBI. He happened to show a slide that indicated how much money is spent each year on ethical, legal and social research in nanotechnology by the US federal government.

$42.6 million.

In one year.

The Age of the Code of Codes

Let's put that in perspective. Altogether - all included - the whole kit and caboodle - of ethical, legal, and social research dollars spent by the NHGRI (national human genome research institute) of NIH from the beginning of the ELSI program until 2003 totaled $125 million. This was famously described by Art Caplan as the "full employment act for bioethics," because it resulted in the hiring of dozens of new people to work in bioethics in institutions around the country: philosophers, doctors, lawyers, social and natural scientists, public health people, religion faculty ... lots and lots of people who otherwise might have had little time or access to work on ethical, legal or social issues surrounding what at the time seemed like the most important new frontier in science and medicine.

There are plenty of critics of ELSI. I'm not one of them. I frankly think that the ELSI group has done an extraordinary job of accommodating new methodologies - who would ever have funded a philosopher to study genetics prior to the genome project? - as well as taking some important risks on studies that could very well have reflected poorly on efforts of the genome project itself: mapping of the genes of indigenous peoples, the impact of gene banking on members of disadvantaged groups, investigation of genes for "criminal tendencies." ELSI put bioethics to work and if it had not come into existence, bioethics as we know it today would probably not exist. We would still be reading about how "medicine saved the life of ethics."

...nobody ever got rich off of ELSI grants...but their existence built great bioethics programs in the 1990s ...

Some folks who hate ELSI argue that it has made mercenaries out of philosophers and social scientists, that people followed the money. Others argue that research that might otherwise have been subtle or methodologically slower (more ethnographic studies published in books) was suddenly and woefully altered by the lure of filthy lucre.

But seriously, nobody ever got rich from ELSI money. And, of course, that isn't the way paradigm shifts work. Young investigators had to beg and plead dissertation directors to let them "bet their careers" on dissertations in genetics and society. Trust me.

The real story is more subtle. People whose interests were compatible with ELSI funding were able to do the sort of work they wanted to do by participating in endeavors that ELSI could reasonably fund - or merely by finding a way to work in places that were able to get ELSI funding from the genome project. University bioethics centers, in many places, became plausible targets for money even beyond the ELSI grants because a viable argument could be made that indirect costs from ELSI grants would sustain the efforts not only of ELSI grantees but of ethics committee chairs, research ethics people, a real faculty to teach medical ethics, etc. And indirect costs - half again the amount of the NIH ethics grant - paid for lights and coffee and air conditioning.

The Age of Bioethics 'Hub Cities'


But the genome project's agenda for ELSI has changed. First, there was the odd effort to do most ELSI research "internally" through groups run out of the ELSI program offices themselves. It was creative, but many wrote and argued that this was not a great success, and it angered just about everyone who had already said that the ELSI study sections were becoming inbred. Then, Francis Collins, as early as 2003, began to give interviews in which he would lay out the roadmap for a "new" ELSI:

"We clearly need to continue this in the most vigorous way," Collins told [one interviewer]. But NHGRI will be more assertive in steering ELSI grantees toward specific subjects, he said. "We're going to shift our emphasis more in the direction of topics that we know we need people to work on. We're also considering funding centers for ELSI research, as opposed to individual investigators." The point is to develop institutions with a critical mass of different disciplines.

Correct me if I am wrong, but my review of the 2004 and 2005 budgets for ELSI suggest the almost total aggregation of ELSI dollars by a set of Centers for Excellence in ELSI Research, sort of "hubs" for ELSI research, which receive huge hunks of money to accomplish lots of different projects. I participated in a working group at which the creation of these centers was discussed, and they have easily exceeded expectations. They are all great, and each is led by a researcher with a long track record of good ELSI research and other service to NHGRI and to science itself.

The Case Western site has projects in family studies, community, enhancement, commercialization, etc. The Stanford site studies "new models of deliberative, interactive processes that integrate ELSI considerations into the design and conduct of genetic research," and features projects on genetics and autism, a documentary film program, benchside ethics etc. The Duke program focuses on intellectual property, and ethics in society. The University of Washington site aims at: assessing the clinical utility of genomics, looking at the uptake for and impact on underserved communities, training, etc.

Get the picture? NIH has basically created four huge think tanks in genomics.

In other words, Collins has I think it is fair to say grown somewhat tired of ELSI as a free-for-all with hundreds of investigators competing willy-nilly for grants of all kinds. And there are reasons why that is problematic. It means that even though there is some significant research funding available for ethics and genetics, it is perhaps a third of the amount available for nanotechnology and society, and the amount of the NHGRI ELSI money that is left to build the investigators spread across the field of bioethics is miniscule once you pay for the CEER centers. And like other core grants of their kind, the CEER centers are expected to help their junior investigators write their own grants - the "R01 pump" model in which the big centers are responsible for - and at huge advantage for - helping the junior scholars in their program to suck up still more ELSI money in order to do still more research to make each CEER center still better at the objectives laid out in the roadmap. So if you are competing for the remaining ELSI money after the CEER checks are paid, you are probably going to be competing with someone amazing from a CEER center, and with zillions of other folks.

Funding in ELSI Genomics Can No Longer Save the Life of Bioethics

It is fair to say that for up and coming researchers in bioethics, ELSI money from NHGRI is no longer a viable support structure for a career, unless there is reason to believe that one can work in a CEER center. Having recently served as the U.S. reviewer for the equivalent of the CEER centers in the UK, funded by the ESRC there, centers that receive double or triple the amount of support, I can tell you that those who are training in ethics and genetics in the U.S. better start looking for jobs at Cardiff, Exeter, Lancaster or Edinburgh than trying to persuade an American university that there is ELSI money sufficient to support a funded trajectory through tenure track.

Now Comes the Age of Small

Every year, $42.6 million in funding for ELSI in nanotechnology [although I am now told that much of this is for "education"]. That's roughly the amount spent by the US genome project on ELSI in a decade.

What sort of funding is available, and what would pursuing it entail? What kind of person would build a career around nanotechnology and bioethics? Would it look anything like the bioethics scholarship that has grown up around genetics? Let's "follow the money:" just about everyone knows about the big programs in nanotechnology at the National Science Foundation, each of which requires some ELSI work by those who are funded with the big science grants. But there are other sources of funding: EPA: ORD: NCER offer funding, for example.

And there are journals coming, books, and of course new groups. Just last week this group was announced, comprised of those who have worked in some way or other on ethical legal and social issues in this, um, field. Ray Kurzweil. James Hughes. Vivian Weil. And there are places that work hard on this stuff, like Davis Baird's group at South Carolina funded with $2.8 million to study all sorts of stuff.

I have big big nanotechnology in my backyard - and the world's only college devoted to the stuff - and I have spent enough time there to get it that this is an interesting area of work with implications for public health and for enhancement.

But, oddly, the purveyors of scholarship about ethical issues in nanotechnology have been ultraskeptical about the idea of "nanoethics," and have in fact done a fair share of "ELSI bashing," even before Congress. Langdon Winner of the STS program at Rensselaer Polytechnic Insitute, e.g., testified to the House Committee on Science that:

Studies of this kind could be launched in a number of ways, including
funding truly cross-disciplinary programs in universities to scope out key
issues and policy alternatives. But I would not advise you to pass a
Nanoethicist Full Employment Act
[emphasis mine], sponsoring the creation of a new
profession. Although the new academic research in this area would be of
some value, there is also a tendency for those who conduct research about
the ethical dimensions of emerging technology to gravitate toward the more
comfortable, even trivial questions involved, avoiding issues that might
become a focus of conflict. The professional field of bioethics, for
example, (which might become, alas, a model for nanoethics) has a great
deal to say about many fascinating things, but people in this profession
rarely say "no."

Ouch. And Baird, we noted, himself says that nanotechnology folks should avoid calling on ethicists "to patch things up as best as they can after the fact," preferring instead "humanists" and social scientists. Commentator and original guru of the Department of Defense's Energy's ELSI program Michael Yesley - don't ask why there was a DOD ELSI program in genetics; ask Michael if you are curious - disagrees, saying that bioethics is still in the mix for these guys. But he's wrong. The new nano ELSI people seem to be steering as clear of "bioethics" as they can.

Baird is smart, funny and nobody's tool but it is notable that to get at the nanotechnology issues he is aided considerably by the USC Nanocenter on his campus. Just like ELSI for genomics, the pride of place comes from proximity and funding; the "nSTS" group is nested right within the nanotechnology group itself. Nobody's arguing this is a bad thing, but it is hard to see how it counts as a move beyond cultivation of institutions in which "bioethicists can't say no," at least not on its surface. How long do you thing nSTS would be funded if they began to argue that USC nanotechnology is horrific? I just do not know. But neither does Baird.

Or maybe that isn't right. It is hard to tell. The program at USC is the paradigm case. It has tons and tons of projects - educational, scholarly, artistic. It answers to NSF, who have discussed their efforts in detail here.

Is There a There There?

I'm still quite clueless about what it is exactly that nanotechnology means, or to be clearer the sufficient conditions are for a thing to be correctly classed as the product of nanotechnology in as much as that moniker is opposed to something else. I have begun to read voraciously in the nanoethics literature, yet I do not understand the necessary or sufficient conditions for an activity to be nanotechnology.

I am not sure what it means for a scholar to have the special set of skills and knowledge to study social, ethical and legal issues in nanotechnology; are there "special" issues in nanotechnology that require the analog to the medical knowledge that a clinical ethics consultant must have in order to understand what it is that doctors are fighing about at the bedside?

But it is clear from reading just the 10% or so of the dozens of blogs and hundreds of articles that cross my desk in this area that there are interesting social issues here, and that they deserve serious consideration, whether they are special or not. They are there and even if the money devoted to "nanoethics" becomes much like that devoted to ELSI in its formative years at NHGRI, it is easy to see that careers built around the early study of the very small could yield very big scholarship, and new ways of communicating with the public. Even if at the end of the day the work these people do isn't primarily about nanotechnology.

And it seems clear too that the crowd who do nanoscience are just at the beginning of the curve when it comes to understanding the risks associated with making utopian projections for the future of bionanotechnology - projections whose analog in gene therapy resulted in huge misconceptions among research subjects. Just look to South Korea to see what happens when people believe that technology is earth shaking long before it can even shake the building.

New York Times Discovers Informed Consent

It's an "eh..." article but hey have at it: [Link; hat tip to Tim Halkowski]

The Holocaust and Research Ethics

Penn Center for Bioethics is starting a new program on the holocaust and its impact for contemporary research ethics. Sponsored by the Bronstein Foundation it will provide major funding for research in that area.

Put Your Money Where Your Ethics Are

In a sea of scandals in all walks of American life here is a bit of hope! - Art Caplan

No More Free Lunch

Washington Post covers the JAMA piece just out by Brennan et al. calling for academic medical centers to take the lead in purging inappropriate gifts by pharmaceutical companies to physicians. The JAMA piece is pretty short but here are the highlights:
A physicians group called for new steps to sever ties between manufacturers and practitioners at academic medical centers. • Ban gifts to physicians from drug and device makers, including meals and payment for travel and continuing education.
• Bar direct distribution of drug samples to physicians. Replace them with vouchers for low-income patients.
• Exclude physicians with financial relationships to manufacturers from committees overseeing preferrred drug lists.
• Ban physicians from speaking at manufacturers' events or publishing articles ghost-written by industry employees.
• Post consulting and research contracts on a publicly available Web site.

New England Journal Sounds Off on Paying Egg Donors

New England Journal discusses the issues associated with egg donation in light of the lovely situation with recruiting egg donors in Korea. AMBI's own Bonnie Steinbock has the right answer:
Some bioethicists argue that egg donors should be compensated — on the basis of the time and discomfort associated with the process, not the number and quality of the eggs that are produced. According to Bonnie Steinbock, a professor of philosophy at the State University of New York at Albany who has studied egg donation, in the absence of a consensus that no egg donor should be compensated, payment for donations for research is ethically acceptable.5 In an interview, Steinbock explained: "Any time that we ask people to do things that impose significant burdens and some degree of risk, fairness may require that they be adequately compensated. At the same time, there's a general consensus that it would be improper to offer enormous sums of money to egg donors that could sway their judgment."

Yes We Love Quarantine. Please Don't Do It.

Health Affairs published today a report by Blendon et al. of the opinions of those around the world toward quarnantines for public health emergency.
Most Americans favor the use of quarantine as a weapon against contagious diseases like SARS and avian flu, but that support dries up quickly when the talk turns to strictly enforcing and monitoring the quarantines. This message is contained in a new study, “Attitudes toward the Use of Quarantine in a Public Health Emergency in Four Countries,” that will be published 24 January on the Health Affairs Web site. While 76 percent of Americans surveyed said they favor quarantining those potentially exposed to serious contagious diseases, only 42 percent supported a compulsory quarantine under which those who refused to comply could be arrested.

Among residents of Hong Kong, Singapore, and Taiwan, the threat of arrest also reduced support for quarantine, according to Robert Blendon of the Harvard School of Public Health and his coauthors, John Benson and Catherine DesRoches of Harvard and Martin Cetron, Theodore Meinhardt, and William Pollard of the U.S. Centers for Disease Control and Prevention (CDC). However, in these Asian nations, which recently experienced quarantines and other public health measures in connection with the SARS epidemic, the use of quarantine retained majority support even when the arrest sanction was included.

In the U.S., the threat of arrest reduced support for quarantine especially among African Americans. In phone interviews conducted between 18 November and 16 December 2004, 90 percent of blacks said that they supported the use of quarantine, compared with 76 percent of whites. But when told that quarantine violators could be arrested, only 33 percent of blacks stood by the use of quarantine, versus 46 percent of whites.


This is at the conceptual level vacuous; proof of the obvious. I have a hard time imagining the execution of this study ... zzz ... yup ... same as you guessed before you funded us. But at another level it is important - even fascinating - because it suggests the actual dimension that the police will face, and the specific pressures on politicians that will arise particularly in the U.S.. How will the U.S. government in particular, given the abject failure with Katrina, deal with the clear threat of insurgency when a quarantine becomes necessary, given what the study reveals to be a very large group likely to rebel. Print this one off and send it to your public health commissioner.
[thanks Jim Fossett]

Toronto/Gates Bioethics Initiative

The University of Toronto has launched a new effort in the developing world, the product of their continuing effort to expand bioethics - considerably - in terms of its focus on the world's health at large. The program is funded by the Bill and Melinda Gates foundation and others for $10 million. Toronto has become the leading program in the world in executing large-scale initiatives in bioethics and this is another great example.

Oath Lite

Cornell Medical School has rewritten the Hippocratic Oath. The Dean says Hippocrates would have done it himself had he been alive. The effort was led by Joe Fins.

Essentially it is the same, except for a few tiny modifications: that little bit about abortion and physician-assisted suicide? Out. The Greek Gods? God? Out. It's an oath. It's unoffensive. It's actually pretty good, and the new docs love it. But it is a far cry from the Hippocratic corpus:

Of the Cornell version, he said: "I think it's a wonderful oath, but it's not the Hippocratic oath."

He said about 80% or 90% of medical school administer some version of the original. He said the Cornell oath is so different he would not consider it a version of the classic.

Donation After Cardiac Death Increases

It's happening in Colorado, Wyoming and across the country: DCD donation. Denver Post is situated in the middle of America and in a state that has had some awful transplant cases in the past year. Including a scandal involving these guys. So Denver is really thinking hard about a big increase in DCD:
Organ donations from partially brain-dead patients - a controversial source - jumped tenfold in Colorado and Wyoming last year, the group that coordinates donations said.

This group of donor patients rose to 20 last year from two in 2004. Those 20 donors, each of whom is considered one donation, provided 36 organs - primarily kidneys and livers, according to Sue Dunn, chief operating officer of Donor Alliance, which oversees donations in the two states.

Pain Control, Abortion and the States

The Washington Post declares that things will get better in terms of legal protection for physicians who prescribe unusually but in their view appropriately large doses of pain control, as a result of the recent court decision. The decision in the Oregon case has several effects, among them the affirmation of the priority of the states. The Post quotes all sorts of people who hold that this is a positive thing for clinicians. Maybe so. Certainly in Oregon. Probably not though in South Dakota.

The same goes for abortion.

The War on Boys

Now that the holidays have (thankfully) passed, the Jewish/Muslim/Buddhist/Atheist/Democrat “War on Christmas” is but a memory. The holy armies of commercialism have won once again. All praise Visa.

Until we get closer to the 2006 election, the gay “Assault on Marriage” will remain on the back burner. Nothing gets elderly conservatives to the election booths like a fictitious attack on the bastion that is traditional marriage, but let’s not get them riled up too soon or their collective apoplexy may decimate the GOP voting rolls. Can’t let those minions of Satan (sorry, liberals) infringe upon the rights of Brittney Spears to have as many quickie Vegas weddings as she wants.

So then, what’s a good conservative to do? For social critics like John Tierney and Kate O’Bierne, the way to keep their acolytes happy is to complain about the “War on Boys” – the observation that the traditionally male-dominated fortress of higher education is becoming increasingly dominated by the fairer sex. Perhaps David Horowitz can add gender parity to his “Academic Bill of Rights”.

I’m so glad that they brought this onslaught on us Y-chromosomes to my attention, otherwise my victimhood might have failed to register in my pitiful little testosterone-addled brain. After all, I’ve been too caught up reading horrific stories about gender inequality in other areas of the world, such as the recent Lancet study that (conservatively) estimates that 500,000 female fetuses are aborted every year in India because boys are “more economically beneficial” to the family. This selective termination of fetuses on the basis of sex isn’t limited solely to India, or even so-called non-Western cultures. Nor will stricter enforcement of existing pre-natal screening restrictions by Indian and other authories resolve this problem. Just consider the fact that 95% of all children in Chinese orphanages are girls, a result of China’s one-child policy coupled with a cultural preference for male heirs. Heck, we don’t even have a good idea of how severe the problem of gender equality is. Hopefully some future, brainy, and most likely female academic will have the intelligence and wherewithal to address these problems.

And to all those individuals worrying about the “War on Boys”, let me give you a sage piece of advice that the coach of my boyhood soccer team once gave – suck it up and deal. Of course, my coach was a woman …
- Sean Philpott

But the Vatican. That Must Be the Product of Intelligent Design!

New York Times reports on the clear, unequivocal response by the Vatican to the nonsense of intelligent design:
The official Vatican newspaper published an article this week labeling as "correct" the recent decision by a judge in Pennsylvania that intelligent design should not be taught as a scientific alternative to evolution.

Medicare Drug Plan Looks Like a Big Scam - Los Angeles Times

The new prescription drug coverage that the administration has touted as its major social policy achievement for seniors is nothing short of a debacle. The plan might as well have been written by big pharma and the administration's faith in consumer choice is proving to be a fiasco when it comes to older Americans confronted with the gobbledygook that clothes this handout to the pharmaceutical industry. - Art Caplan; [Link]

State Based Bioethics

In our bioethics Institute in Albany the big focus right now is on the effect of the increasing presence of state government in bioethics-related areas, from the move to state-by-state stem cell funding decisions to the diversity of newborn screening programs to the coming wave of state-by-state assessment of physician assisted suicide. Our program in the area is being developed by both Alden March Bioethics Institute and our partners in the Nelson Rockefeller Institute of Government. It is my favorite project by far and I truly believe that work by bioethicists in state government and on state policy will come to be much more influential and important than that at the federal level. Long ago and far, far away I built a bioethics concentration at Penn around a course that required students to examine a problem in bioethics by thinking about and then authoring a proposed policy at the state level.

The catch was that to make an "A" in the course you had to get the bill formally introduced into the state legislature of your choosing. It was a weird experiment that drew the attention of the Times at a time when I believe I might have been the only liberal out there who wanted to see states take the initiative on stem cell research. Lots of fascinating people helped teach the students about health policy and lobbying. A number of the bills from "A" students were actually passed, including several that are now actually law in the area of genetic discrimination and even cloning.

I don't teach that course anymore, but I have been more than persuaded that the motivation was right on the money: students and policymakers alike are clueless about the relationship between scholarly bioethics and state policy. And when it came time for big powerful states like California to deal with the matter of funding something on the scope of stem cell research, it showed.

Now comes Josh Braun, who gets it. In "The New Federalism" just out in Seed, he asks these questions of several other folks - what happens when science and bioethics goes to the states?

Your Blood's No Good Here

Last week, the Gay and Lesbian Alliance of South Africa staged an unusual protest. Some of its male members donated blood, violating the blood donation criteria of the South African National Blood Service (or SANBS), which forbids donations from men ‘who have had sex with other men in the last five years.’ The Alliance claims the SANBS donation criteria is discriminatory, because the blood of young women between the ages of 18-24 -- the group with the highest HIV prevalence in the country – can be accepted. Furthermore, the SANBS has high-tech equipment that detects HIV in donated blood before it is used, and this constitutes another layer of protection. While such equipment cannot detect HIV in the blood of newly infected persons, this is in itself no reason to reject ‘gay’ blood and accept the blood of young women. For its part, the SANBS argues that it is merely following international guidelines to protect the safety of the blood supply.

The issue of the ‘gay blood ban’ extends far beyond Africa’s borders. A few years ago, protests were staged in Hong Kong. In Australia, a gay man has recently filed charges against the Australian Red Cross. The ban has been the object of student protests from Ireland to Montreal. In the United States, while the scientific basis of the ban has been questioned a number of times, a proposal to relax the ban was narrowly rejected by a Food and Drug Adminstration committee back in 2000.

The FDA rules on blood donation are really the heart of the matter, because they form the basis of the donation criteria for the American Red Cross and the Red Cross in most (if not all) other countries. In 1985, the FDA proposed the rule that a man could not donate blood if he had sex with another man – even once – since 1977. The rule obviously harks to a time when HIV/AIDS was considered a ‘gay disease’.

But how should this rule be considered in areas of the world, such as sub-Saharan Africa, where HIV/AIDS is largely transmitted heterosexually? The WHO states that blood donations should come from groups with low risk of TTIs (transfusion transmissible infections) but seems to acknowledge that high risk groups may be different in different regions of the world. Should blood donation criteria be determined by the most current epidemiological data on HIV prevalence among social groups, or should one forget social groups altogether, and concentrate on the risk behavior of individuals who wish to donate their blood? In either case, it seems irrational -- if not unethical -- to exclude people from donating blood on the basis of their sexual orientation alone.
- Stuart Rennie, Our Man in Holland

You're Hooked. Face It.

CBS reports that:
The world's first face transplant recipient is using her new lips to take up smoking again, which doctors fear could interfere with her healing and raise the risk of tissue rejection.

"It is a problem," Dr. Jean-Michel Dubernard, who led the team that performed the pioneering transplant in France on Nov. 27, acknowledged on Wednesday.

The woman's French surgeons made their first scientific presentation on the partial face transplant at a medical conference in Tucson this week, the 6th International Symposium on Composite Tissue Allotransplantation.

Crow Is Served

Richard M. Doerflinger and Wesley Smith have made much ado about an error in a column in the Albany Times Union that Glenn McGee and I wrote. They were incensed that we misidentified the Korean scientist involved in the experiments, which purported to show that adult stem cell research had proven therapeutic - indeed Miraculous - by helping paralyzed patient Hwang Mi-sun walk. They argued that somehow in making the mistake McGee and I were obscuring the fact that paralyzed people were allowed to walk again as a result of adult stem cell therapy.

Glenn and I got the name wrong. But we were not wrong about the fact that hyping adult stem cell research in the way that Smith and Doerflinger and many other critics of embryonic stem cell research have done is often rooted in research that has no more substance than that conducted by Professor Hwang with respect to cloning. Now comes the news--hardly surprising--that the crackpot Korean experiments so eagerly embraced and touted by Smith and Doerflinger - are complete and utter failures. Worse they actually have harmed most of those involved.

McGee and I await the prompt admission from those who touted this work that it is just as false, just as hyped and just as 'devastating' to the case that adult stem cell research is a proven alternative to embryonic stem cell research. Those who have paid for people from this group to show up and testify about the power of their 'cures' to legislators should make public their guilt by association with this immoral research.

As the critics know both of us have long counseled caution about 'breakthroughs' in embryonic stem cell research including Hwang's now discredited announcements. The critics now have some explaining to do about their hyping of Korean research that is just as immoral as that engaged in by Hwang. - Art Caplan

Where No Stone Has Gone Before

William Shatner sold his kidney stone for $25,000. Do we really need to say anything else?
[thanks Alta for the title]

Dying British

The cover story in the Guardian today reports data from a new study on euthanasia rates in the UK. Extrapolation from the study data would indicate that of 170,000 terminally ill patients last year, over 30% died after withhold/withdrawal decisions were made. 936 patients (.16%) patients received (illegal) voluntary euthanasia--a lower rate than in other European countries, Australia or New Zealand. 1930 patients (.33%) received (illegal) "non-voluntary euthanasia"--that is, euthanasia they hadn't "explicitly requested." There were no cases of physician assisted suicide reported.
- Stephen Latham JD, PhD

Somebody Call Jon Stewart:
Hwang to Work with UFO Cult?

Dr. Hwang needs some help. And who better than space aliens. Enter the Raelians (not to be confused with the RAE). The funky UFO cult, which calls itself ever so appropriately "the intelligent designers," (CLICK HERE for a helpful video!) worship some French sports journalist/race car driver's vision of heaven-through-cloning.

Although they claim otherwise, they are also the utter and total sponsors of a lunatic fringe cloning group called Clonaid, a Bahamas-based group that claims to have cloned "baby Eve. Clonaid is run by Raelian Brigitte Boisselier, the brainpower behind their decade-old quest to clone somebody, anybody. If you follow or work in bioethics you will recall that the Raelians kept everyone with any scholarly work in the area of reproductive genetics completely transfixed and horrified for the better part of three years until they failed to produce the baby Eve, and at last people started to realize that they were nutty.

Anyway they are hoping to recruit Dr. Hwang to join in their efforts. Please, someone send this story to Jon Stewart.
[thanks Art Caplan]

Embryonic Stem Cell Research in California

This editorial in the LA Times today by an advocate of the research does a nice job of outlining the incredible problems with the machinery set up by Proposition 71 to get the research accomplished.

"A History of Broken Rules"

Attorney Alan Milstein made history in research ethics with his landmark and recently settled lawsuit against James Wilson and University of Pennsylvania in the matter of the death of Jesse Gelsinger, an 18 year-old participant in a gene transfer research trial at Penn.

He has now served as counsel in many more legal actions involving medical research, and shared with us his recent chronology of research misconduct through his eyes: [PDF download].

The Best of the Best of the Best, Sir

Thanks to a last-minute rally by dead Chicagoans, no doubt victims of physician assisted suicide, who seem not only to be able to vote for mayor of that city but also to have a love of bioethics and a broadband connection faithful readers, we somehow won the 2005 Medical Weblog Award for "best health policy/ethics" blog. The self-effacing, self-proclaimed underdog among the nominees, an excellent blog called Hospital Impact almost routed us, as they note with a great big chart, but the help of a veritable army of Raelians faithful readers seems to have resulted in an eBay-style last minute win. So, now, the sparkling trophy will annoy you from the top of our page for a while.

Oregon Assisted Suicide Law Upheld by Supreme Court

Finally some bioethics news that has nothing whatsoever to do with Hwang Woo-suk. New York Times' coverage of the decision by the US Supreme Court gives some sense of what was at stake in the decision, a rebuke to Ashcroft's absurd reaching in attempting to trump states' rights by employing a DEA anti-drug strategy to invalidate the Oregon measure. A more focused explanation is given by Kennedy himself, focused almost entirely on smiting the preposterous excess Ashcroft used in going after the Oregon measure.

The scope immediate impact for this decision is not obvious apart of course from the effect on Oregon. Nor is it clear how this decision interacts with SCOTUS' reversal several years ago of decisions involving physician-assisted suicide issued by the 2nd and 9th Circuit Courts of Appeals. We'll have to dredge up some lawyer to blog about that. Certainly there are plenty of bioethics experts ready to talk about the decision.

No surprise, the strategy of conservatives is beginning to gel, a shift to calls for concerted federal action by the experts on persistent vegetative state who rule the House of Representatives. The blue states meanwhile are likely to move toward more Oregonian positions on PAS.

[update: Womens' Bioethics Blog discusses this stuff today]

Caplan & McGee:
Rest in Pieces

From today's Albany Times-Union


When it comes to the body, they say you can't take it with you when you die. But they didn't say it should be sold from the back of a truck. Or that you should not have the right to give a fully informed consent for whatever it is that medical science wants to do with your remains.


Recently it was revealed that a group of criminals was stealing bones from bodies at crematoriums in New York. monty python dead They were then sold to for-profit tissue banks in New Jersey and Florida. Among the victims was the late host of PBS television's Masterpiece Theater, British broadcaster and journalist Alistair Cooke. His bones were removed without his or his family's permission or even knowledge, and then sold for thousands of dollars. What happened to Cooke has happened to others.


Investigations across the United States have revealed a gruesome market in body parts made possible by a motley collection of grim reapers who sometimes secretly and illegally and with dubious consent harvest the skin, bones, tendons, organs, and even brains of those in funeral homes, burial sites and morgues. From Maine to California to Louisiana, unscrupulous brokers are removing tissues and selling them to tissue banks which then sell them to medical schools, hospitals, research institutes and testing facilities. The trade in tissues is a half-billion dollar industry and that is enough to get some who have access to body parts to put their ethics on the shelf.


There is a long and ignoble history of pseudo-medical mutilation of bodies: William Burke and William Hare in the 19th century murdered and robbed graves to supply bodies for examination to the school of medicine in Edinburgh. A pathologist present at the Princeton, N.J., hospital where Albert Einstein died, removed Einstein's eyes and his brain, despite his specific instructions that he be cremated. The brain went off to Philadelphia, was divided into dozens of slices and preserved; it then spent the next 40 years being lugged around ...

Read the rest of the column...

Glowing Pigs. No Comment Required.

Hwang in a Nutshell Take 5,982

Peppered with anecdotes not previously printed, this is the best short analysis of the Korean implications of the Hwang Woo-suk matter.

And this is an equally clever take on Gerald Schatten of Pitt by Philadelphia Inquirer.

But perhaps the best piece about Hwang this week isn't about him at all. It comes from Scientific American who discuss all the little lapses that add up to more damage than the big ethical lapses ever could. Anyone who has ever made a little mistake in publishing and research - and seriously who hasn't - should read this piece about nipping and buds.

And easily the worst is this nonsense from Nigel Cameron slamming Peter Singer through the most oddball comparison to Hwang ever construed.

Columbo to Woo-suk Hwang: Don't Leave Town

AP reports that South Korean prosecutors have stopped Woo-suk Hwang's collaborators from fleeing leaving the country. It is starting to look like CSI:
Prosecutors raided eight more offices of Hwang's former associates, a day after they searched Hwang's home in southern Seoul, said Hong Man-pyo, the prosecutor in charge of the criminal investigation.
Dr. Hwang though is the picture of class, making sure to put the blame right where it belongs: on his junior scientists (kind of like the ones the ones he coerced into donating eggs?)
Disgraced researcher Hwang Woo Suk asked forgiveness Thursday from fellow South Koreans for his fraudulent claims of human stem cell breakthroughs, but blamed the scandal on junior researchers who he said deceived him.

The Coolest Bioethics Job Ever

Duke University Institute for Genome Sciences and Policy Center for Genome Ethics Law and Policy (seriously, was there nobody available at the branding company that day?? 'GELP'?) is hiring what we think is the first full-time "benchside bioethics" faculty member ever. It is a great idea, one in fact we're trying ourselves, but Duke - funded by truckloads of money from NIH NHGRI ELSI (yet again, branding people out to lunch...) and led by Robert Cook-Deegan, a versatile, well-published and affable scholar Duke recruited from RWJ/IOM (if you think we're going to mock the IOM, think again) has the idea down to a science:
Associate Director for Research Ethics Consultation

... (GELP) seeks to hire an Associate Director for Research Ethics Consultation. The Associate Director will work with research teams at Duke on large or complex research projects to ensure that ethical and policy issues are considered from the start of the research conception and study design, and throughout the course of research; his or her focus will be broader than issues related to IRB approval. The Associate Director will also link to other national bioethics centers developing a capacity for “bench to bedside” research ethics advice, and conduct independent scholarly research of his or her own, related to the themes of science, ethics, research and society

Start Spreading the News

Introduced recently (ask me if I can figure out the NY legislative process...), say hello to the "big" stem cell bill for New York, which has passed the NY Assembly, been delivered to the Senate and now "REFERRED TO HEALTH." It includes $300 million through June 2007. The summary language for the bill is straightforward:
Ordinarily, American`s rely on the federal government to fund biomedical research. With regard to stem cell research however, the federal govern- ment, for reasons other than the value of the science, has withdrawn its support. In response to the withdrawal of federal support for stem cell research, a number of States have initiated their own stem cell funding efforts. California, Illinois, Wisconsin, Massachusetts and New Jersey have all passed or proposed significant funding support for stem cell research. New York State is world-renowned for the excellence of its academic and medical institutions and the scientists who work there. Should New York not keep pace with the commitment that other States have made in support of stem cell research, we risk losing our competitive advantage. Additionally, biotechnology is an important element of our economy, and by encouraging and supporting growth in these industries, New York State could gain thousands of new jobs.

Sloooow Down in Blogdom

Well things are going to slow down a bit. McGee is shuttling from one place to another for some pretty interesting meetings but they are meetings nonetheless and enough people know about the blog that he cannot cheat and write posts, although when nobody was looking he did send those of us who are helping this week this picture of the amazing one Skip Nelson ran in Bethesda on emergency research in children. Between three of these in a row and interviews for this position and this one in Albany things will slow down in blogdom for one full week from today.

And a reminder that the polls are open at the Medical Blog Awards for best health policy and ethics blog; insert voter suppression here please don't vote if you hate us.

President Clinton's Plan for AIDS

World Bank Group reports that:
Former US President Bill Clinton plans to announce today that his foundation has negotiated lower prices on AIDS tests and on two important AIDS drugs, reports The New York Times.

Four companies, from the United States, India and China, will offer rapid HIV tests for 49 cents to 65 cents, which will reduce the typical cost of a test in poor countries by half, Clinton said in a written statement.

Watch Out for Falling Bioethics:
Maryland Drop-Kicks Wal-Mart

Maryland is not kidding about Wal-Mart and its incredible cuts to health benefits. The legislature has overridden the veto of its Governor Robert Ehrlick Wal-Mart is threatening to drop plans to build still more Wal-Mart stuff in the state, but it is a sign of desperation. The business model that has allowed Wal-Mart to colonize the nation depends on state and local government wanting it there, and handing over big tax breaks in exchange. When Wal-Mart says to the same state: "here, you pay the health care costs of these cheap laborers we employ as we suck the revenue out of your state" (ok a paraphrase), go figure that the state legislature is fed up.

Rabbit-Human Embryos

Eh, what's up Doc? Scientists continue to push for the creation of chimeras without any guidelines, regulations or public dialogue. Can anyone spell trouble??
-Art Caplan

Learning the Lessons of Hwang? Nope.

Zach Hall the president of the California Institute for Regenerative Medicine says that peer review is the key to prevent fraud in stem cell research. Not a new kind of peer review, or a better review of peer review, or more peer review, just peer review. In the San Fran Chronicle, he is asked what will prevent Hwang-style fraud and other bioethics problems in California. His answer?
"Scientists," responded Zach Hall, president of the California Institute for Regenerative Medicine, the funding entity created by Prop. 71. Warning that every industry has the potential for an Enron, Hall touted the American system of peer review as the best way to expose rogue scientists and bad science and to keep research-funding decisions apart from undue political, religious or geographic influences. "What will not stop this from happening is government oversight," he said.
Not regulations. This from the guy who is giving out the money. Oversight is the key to giving the money out responsibly. It is one of the reasons why we should give government funding in the first place. California has become the standard-bearer for state-based biotechnology research funding. That could I have argued be ok. But not if the standard-bearer claims that fraud is best prevented by peer review.

Please, Please Take This One to the Supreme Court

A Phoenix judge has ruled that:
Fetuses do not count as passengers when it comes to determining who may drive in the carpool lane, a judge ruled.

Candace Dickinson was fined $367 for improper use of a carpool lane, but contended the fetus inside her womb allowed her to use the lane. Motorists who use the lanes normally must carry at least one passenger during weekday rush hours.

Municipal Judge Dennis Freeman rejected Dickinson’s argument Tuesday, applying a “common sense” definition in which an individual is someone who occupies a “separate and distinct” space in a vehicle.

-Art Caplan

Resetting the Clock on Stem Cells from Nuclear Transfer

David Magnus puts it well in Forbes:
Research is being reset to "where we were before, where using somatic cell nuclear transfer to derive stem cells is only a theoretical possibility," added David Magnus, director of the Stanford Center for Biomedical Ethics. "We're hopeful, but whether it's possible and how long it's going to take is something that is now a complete unknown. This really is a setback in a lot of ways."

Nevertheless, stem cell research with the potential for real breakthroughs continues. According to The New York Times, two labs at Harvard have been seeking approval for more than a year to clone human cells. Two institutions in England are moving down the same road, as are some private companies.

In a prepared statement, Dr. Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, said his university intends to use dollars from California's Proposition 71 -- which earmarks state funds for embryonic stem cell research -- "to recruit scientists who will find ways to do nuclear transfer research, first in animal models and then with human cells."

Like a Virgin, Tested for the Very First Time

South Africa is a land of contrasts. One of the contrasts is between its post-Apartheid constitution – said to be one of the most liberal ever made – and South Africa’s patchwork of African ethnic traditions. Same-sex marriage was recently approved on constitutional grounds, a decision met by hostility and disbelief among South Africans of different races and classes. And last month, the Children’s Bill was adopted, which among other things bans virginity testing and male circumcision under the age of 16. This verdict was also greeted with a great deal of resentment. Traditional leaders don’t like it. Many Africans writing into blogs don’t like it. Some virgins don’t like it. (Warning: images of bare breasted virgins.)

Virginity testing? Yes, virginity testing. Whereas some American teenagers make virginity pledges and self-report their own virtue, South African girls go a step further by submitting to a pelvic examination aimed at ‘proving’ their chastity. Especially among Zulus, it has long been thought important that girls keep themselves pure for their future husbands; a young woman who has pre-marital sexual relations is thought to show intemperance and brings shame on her family. This is why a confirmation of virginity is accompanied by celebration, while failing to pass the test can lead to stigma and social exclusion. In Uganda, girls can even get a scholarship for remaining virgins, i.e. if they manage to scrape through years of poverty without exchanging sex for money and security from predatory older men.

The devastating HIV/AIDS epidemic has increased the popularity of virginity testing throughout Africa. It has given traditional leaders a modern, medical justification for an ancient practice. If girls are encouraged to pass the test, the thought goes, they will not have sex and will not acquire or transmit HIV. On the other hand, a hymen may be torn by means other than intercourse, and the pelvic examinations are performed in conditions where the hygiene leaves a lot to be desired. As the US example suggests, young people committed to virginity may have sex in alternative ways (i.e. anal and oral) that leaves them open to HIV and sexually transmitted diseases. The practice also feeds into a powerful and tragic myth in South Africa: that a man with AIDS can be ‘cured’ by having sex with a virgin. And of course, there is the detail that the practice of virginity testing is widely condemned by human rights groups as gender discrimination. If there was a reliable biomarker for male virginity, involving an invasive and possibly contaminating procedure, would that be as popular? It is hard to imagine.

Condemning the practice of virginity testing outright, however, may be unwise. One of the biggest mistakes of HIV prevention in the past is the failure (or unwillingness) to understand and take seriously the sexual culture of Africans, and the place of that culture in a network of related social practices. Here’s yet another job for African bioethicists: to help negotiate an acceptable path here between HIV prevention, gender rights and cultural traditions.
- Stuart Rennie

Hwang Woo-suk Fabrication:
The Full Text of the Seoul National U. Report

Direct from Al Jazeera, where we get most of our ethics articles, a full text version of the conclusions that were reached about Hwang Woo suk. None are surprising but some are new.

The 2004 Science article is a tissue of lies:

The claim in 2004 article that the DNA fingerprinting pattern of NT-1 and that of the donor A match perfectly was a clear false report. Given that none of the alleged NT-1 derived cells or tissues match the donor A, the committee concluded that NT-1 ES cell line reported in Science in 2004 is not an ES cell line derived from a cloned blastocyst. In addition, claims that photographs of cells in 2004 Science article are those of MizMedi ES cells have also been confirmed to be true. Therefore, the committee concluded that results described in 2004 Science article including DNA fingerprinting analyses and photographs of cells have also been fabricated.
The dog is really a clone.

Egg donation ethics? Try this on:

Professor Hwang accompanied the student [who donating eggs, about which Hwang earlier claimed he had no idea] to the hospital himself. In May of 2003, Professor Hwang's research team circulated a form asking consent for voluntary egg donation and collected signature from female technicians. This is based on information provided by eight current and former lab members.
The committee takes it upon itself to proclaim that thanks to Hwang, "when it comes to animal cloning, with the added consideration for the successful cloning of a dog, Korea seems to be internationally competitive."

And there is the simple, clear statement by the committee as to the total nature of the fabrication, i.e., almost everything was utterly made up:

According to the records of Professor Hwang's research team regarding the stage of cell line establishment, the scientific bases for claiming any success are wholly lacking. The establishment of ES cell lines must meet the criteria of being able to differentiate through embryoid body formation or to form teratoma, for example. However, Professor Hwang's team regarded the initial formation of cell colony as the successful establishment of ES cell line, and no record of further confirmatory experiments could be found.

Taken together, Professor Hwang's research team possesses neither the patient-specific ES cell line described in 2005 publication nor the NT-1 ES cell line, the forerunner cloned cell line described in 2004 publication. The data in 2004 publication are also fabricated as can be seen by the non-match between the donor A and NT-1. Such act is none other than deceiving the scientific community and the public at large. Even the scenario based on switching cell lines cannot explain the parthenogenetically derived cell line and cannot undo the fabrication of DNA fingerprinting data.

And with that, hopefully, the Hwang matter will cease to be a font of unending insanity and become a cautionary tale about frontier science and its regulation.

Wanted: Bioethicist to Congress (Sort of)

Congressional Research Service Employment Home Page has listed two great new positions. Royal Shipp the head of the CRS tells me that these come out of a previous position that was essentially "bioethicist to think about aging issues" that was provided for in a grant on aging in 2004. It went so well that these have now been announced. I can tell you they have a great view of the Capital Building.
The ANALYST IN GENETICS (Vacancy #050319) provides analysis of research, medical, and policy issues in the field of genetics, especially as they relate to an aging population. Key issues include the ethical, social, biologic, and legal issues involved in the application of genetic science to the development and regulation of gene therapies and pharmaceuticals; and the relation of this work to medical care, public health, biodefense, and associated public and private financing. The ANALYST IN GERONTOLOGY (Vacancy #050320) provides analysis of issues in the field of aging. Key issues include: 1) changes in the demographic and disability status of the aging population; 2) an understanding of the complexity of aging issues and the effects of aging policy on society; 3) the continuum of care needs of this population; 4) innovative strategies for integrating services the elderly need; 5) options for financing these services; and 6) the role of Federal and state governments and the private sector in the delivery, quality assurance, and financing of these services.

Positions are being offered at the GS-13 level ($77,353-$100,554); promotion potential is to the GS-15 level ($107,521-$139,774). To apply online (preferred), visit http://www.loc.gov/crsinfo or call (202) 707-5627 to request an applicant job kit. Please refer to the appropriate vacancy number in all correspondence. Applications must be received by January 31, 2005. CRS is the public policy research arm of the U.S. Congress and is fully committed to workforce diversity.

Disability Studies:
Please, Please Start Making Sense!

The University Illinois at Chicago’s Lennard J. Davis takes just about everybody to task in his article "Life, Death, and Biocultural Literacy," published Friday in the Chronicle of Higher Education. In this must-read piece, Davis argues the left, the right, bioethicists, philosophers, and disabilities studies folks are all short sighted and hypocritical in their positions on life, death, and abortion because of a lack of bioculture literacy (a deep understanding of "issues concerning the body, identity, history, and culture").

Davis makes several valid points – particularly in his critique of the disability movement’s position physician assisted suicide. He correctly points out that the movement’s sweeping arguments against choice in dying conflate dying with disability in a way that is both illogical and inconsistent with a movement dedicated to promoting independent living and free choice for its constituents. He writes:

Many disability advocates . . . claim that all people who are dying are, in fact, disabled, and that their identity as disabled individuals trumps their identity as autonomous beings. The faulty syllogism goes that dying people are disabled, and in an ableist society they naturally will be pressured to kill themselves; ergo disabled people are being put to death through physician-assisted suicide. …

There are at least two flaws in that argument. First, it is hard to shoehorn someone dying of cancer, for example, into the category of chronic disability. The aim of making it possible for disabled people to live full lives with their impairments and of ensuring a free and accessible society has little to do with someone who will be dead in six months (the requirement for receiving physician-assisted suicide in Oregon). Why should people have to accept disability status when they will be dead within a few months? Second, according to statistics provided by Oregon, most people seeking physician-assisted suicide are end-stage cancer patients who, by and large, are educated, middle class, and informed. While it is true that many seek physician-assisted suicide because they fear losing their abilities and their autonomy, they no doubt have the independent judgment to make that decision.

It seems illogical for some disability advocates to try to prevent dying people from choosing a humane way of ending their lives (as opposed to shooting themselves or wrapping a plastic bag around their heads) because those advocates see suicide as a critique of the disability perspective.

Davis concludes that a more nuanced approach, a biocultural one, would make distinctions between physician assisted suicide, euthanasia, and abortion – something the disabilities folks fail to do.

Yet some of Davis’s assertions themselves lack nuance. For example, he claims that the "left's" position (by left he seems to mean anyone who supported removal of Theresa Schiavo’s feeding tube) on Schiavo is "actually saying that we should assume that people who are disabled enough to be unconscious no longer have identities. According to that view, those people paradoxically no longer have the ability to have chosen to stay alive." Davis’s characterization of the position is simply wrong. The principal argument supporting removal a feeding tube in the Schiavo case was that Schiavo’s then-present identity (that of a person in a PVS) included and incorporated her identity as asserted before the onset of the PVS. That whole person, past and present, deserved respect. Had that person expressed a preference to stay alive, the so called left would have supported that preference.
- Alicia Ouellette

Polls Open for "Best Health Policies/Ethics Blog"

A blog called medGadget holds an annual online poll open to anybody to select the best medical blogs. There is a Health Policy/Ethics category. You can check out the nominees and you, anyone who has donated an egg to Hwang Woo-suk, the Dover PA school board, all the human cloning afficionados in Nebraska, anyone publishing any kind of book by anyone in the Schindler or Schiavo family, anyone who is selling a kidney in our comment pages, anyone selling their old pacemaker on eBay, the people who stole Alastair Cooke's bones, the Euthanizers of Katrina, anyone who would name a dog 'Snuppy', all of those who build Respirator Timers of Death in Israel, and anyone whose dog has eaten their face can vote on the medGadget site.

Weiss: "Stem Cell Legislation Is at Risk

A part of me just does not care that yet again the ridiculous theory advanced by the only man more dangerous to stem cell research than Hwang Woo-suk, William Hurlbut, has become again part of the national debate about the funding of stem cell research.

It didn't bug me when Jeb Bush backed Hurlbut's nonsense.

It didn't bug me when Hurlbut used his mind-numbingly stupid theory to defend Tom Delay.

I was not surprised that having been castigated for the theory's stupidity by real scientists on the Hill and in New England Journal, and by basically every serious stem cell researcher in, um, the world, Hurlbut remained unfazed.

I admit to being a tiny bit annoyed that Slate's William Saletan not only dignified Hurlbut's idea but belittled Laurie Zoloth for questioning Hurlbut's science.

But anyone who has not figured out by now that Hurlbut's poorly thought out plan to make handicapped embryos is both disingenuous claptrap and utterly political in nature is probably not going to be persuaded by any sort of arguments to emerge in the upcoming battle on the hill about federal funding for embryonic stem cell research.

So why not be grumpy about a statement from Senator Frist - whose support of embryonic stem cell research was the key break against President Bush just months ago - in which he essentially switches sides using the Hurlbut copout:

"The new science that may involve embryo research but not require destruction of an embryo is tremendously exciting," Senate Majority Leader Bill Frist (R-Tenn.) said recently. "It would get you outside of the boundaries of the ethical constraints."
Simple. Because it does not matter.

The stem cell debate in Washington is over. Whatever pittance that might be won were Democrats and reasonable Republicans to prevail in their push for additional US government spending would pale by comparison to what will be spent in the states.

It would be wonderful to see the US government spend additional dollars on stem cell research. For the price of a day's military activities in Iraq, the US could be at the lead of the most important medical research in the history of the world.

But instead, it seems clear now that cutting edge regenerative medicine is going to happen offshore and in a few enclaves in the US. What Korea didn't kill, those who published these silly "alternative" theories in Nature - none of whom want to use them - and their conceptual Godfather William Hurlbut - may have.

Stolen Bones and Skin Books

A hospital in North Carolina tells the story of sending letters to its patients - 16 of them - who received bone implants that had come from "illegal sources" over the past three years. Stolen from bone banks? Robbed from another hospital? Purchased on eBay? No, stolen from funeral homes. Lovely.

And our David Magnus makes the really disgusting point: "“It would be an awful shame if, in addition to the utter contempt and disrespect shown to the deceased, the patients at the receiving end become very sick,” said David Magnus, director of the Stanford Center for Biomedical Ethics."

But if you are worried about what's in your bones, afraid that you are infected by another, touched without permission ... don't go to Brown University to look up answers about body parts or how to think about death. See, the anatomy book there - and if you get really ambitious, the 19th century edition of Dance of Death, are literally bound in human skin.
[thanks Art Caplan]

Informed Consent for Scientology?

Razor describes a kind of consent form and contract that is signed he claims by some if not all who join the Church of Scientology:
In September 2003, one of these Scientology release forms surfaced on the Internet. The form, which describes itself as a "contract," states that the signer opposes psychiatric treatment for anyone, particularly him or herself. Should some mental illness befall them, they authorize the Church of Scientology to "extricate" them from the clutches of psychiatrists who might seek to treat them. In lieu of psychiatric care, the contract says they agree to be placed on the "Introspection Rundown," a Scientology therapy invented by the Church's late founder, L. Ron Hubbard.

The release form reads: "I understand that the Introspection Rundown... includes being isolated from all sources of potential spiritual upset, including, but not limited to family members, friends or others with whom I might normally interact. As part of the Introspection Rundown, I specifically consent to Church members being with me 24 hours a day at the direction of my Case Supervisor." In addition, "...the Case Supervisor will determine the time period in which I will remain isolated..." And later in the same paragraph: "...such duration will be completely at the discretion of the Case Supervisor." The form ends with: "I further understand that by signing below, I am forever giving up my right to sue the Church... for any injury or damage suffered in any way connected with Scientology religious services or spiritual assistance."


It is however permitted, Mr. Cruise, to buy and place ultrasonography equipment in your home for cosmetic ultrasound.

And People Pick Scandanavian Sperm?

This is the sperm donor you've always wanted. He has a 153 IQ. He was a cute child. He makes fresh donations. And he will come to you.

And if one day your child wants to find his biological father, "knowndonor" has made it easy:

Since this is a permanent website, I know I'll be easy to locate if there are any questions that only I could answer (e.g. medical history). That's one advantage of using a non-anonymous donor, even if future contact with the child is highly unlikely.
How proud the child will be.
[thanks Alta Charo]

It is Very Hard, However, to Get Informed Consent

Chicago Sun-Times looks at the increasing use of dead bodies in research - not just dead bodies, as in cadavers. "Dead people," as Jim Ritter puts it. His point is that the research that is possible using the newly dead - those whose bodies are still in one way or another functioning despite whole brain death - is expanding and appears to be a sort of new frontier for the testing of more and more devices.
Life-support equipment can keep a cadaver's heart and other organs functioning until a research procedure is completed. Unlike clinical trials on living patients, there's no danger of harming a person with a risky experimental treatment.

For example, researchers could induce an irregular heartbeat in a brain-dead patient and see whether an experimental drug helped restore a normal beat. They also could test new ways to do joint replacement surgery or place breathing tubes.

"There are enormous potential benefits," said Mark Wicclair of the University of Pittsburgh's Center for Bioethics and Health Law and West Virginia University philosophy department. "We're probably at a point where it's going to be done more frequently."

Research on the newly dead requires new attention to the sense in which life and the respect for life fade away, rather than dropping off alongside the EEG. So there are guidelines:
The guidelines, written by 15 researchers, ethicists, doctors and patient and religious advocates, were published recently in the journal Nature Medicine.

"Respect for persons, a pivotal principle in research ethics, should be extended to the recently dead," the guidelines state.

There's more in the article - description of studies, detail on odd cases in which patients aren't really dead, new modalities that are under such testing.

Quick Update on Stem Cells in the States

MSNBC runs through the states that are actively engaged in the stem cell debate.

Who's Sorry Now?

Indiana is thinking about enacting legislation that would allow doctors to offer written apologies to patients from being used in court against doctors in civil cases:
Under a bill being considered in the House Judiciary Committee, defendants in lawsuits could not be punished for apologizing to plaintiffs before a trial. Other statements of sympathy, such as those expressing condolences or support, also would be blocked from liability...Current Indiana law allows communications of sympathy to be used as evidence in most instances.
- Art Caplan [by the way the pic is from here. Not sure they trust apologies. - Ed.]

Large Scale Review of Abortion Data

I trust none of this data until it is examined by the Gutmacher Institute, but today a Sydney newspaper considers what is billed as the largest scale review of the effect of abortion on patients.

Tiny Ethics

Among those who have put energy and careful scrutiny into ethical issues in nanotechnology the group at the University of South Carolina really stands out as not only the most rigorous but the most productive. The group of 20 is run by philosopher Davis Baird, and is the subject of this article in SmallTimes. Baird's group, though, has assiduously avoided using the moniker "bioethics" and in fact has advanced a fairly unusual claim: better to use humanists up front than ethicists at the back end. He testified to the Senate this way:
We have a real opportunity here. Instead of calling on ethicists to patch things up as best as they can after the fact, if we start now, bringing social scientists and humanists to the table, our understanding of the social and ethical dimensions of nanotechnology can co-evolve with the technology itself. This will make for better, more socially responsive work in nanotechnology, and for fewer problems to patch up later. Nanotechnology can avoid the fate most recently of genetically modified organisms.

Delaware Goes Where Nebraska Dares Not

America's first and smallest state is pushing stem cell research rules and funding, as reported in delawareonline. The state has a great biotech park and of course a leading children's hospital.

So Much for an Unbiased Examination of Hwang Woo-suk

The "presidential panel" (National Bioethics Committee) that has been conducting the investigation of Hwang was supposedly going to be the first "real effort" to identify what went wrong in the Hwang matter. Today everyone in the world is looking to this board to release continuing analysis of ethics issues that have cropped up in the scandal. The other mechanisms have failed: the IRB missed every problem in the study, and the school's ethics committee was made up entirely of people nominated by the Hwang group.

So now, the head of the National Bioethics Committee has offered to resign. His law firm - and he - gave advice to Hwang to apply for an injunction that might prevent the broadcast of the first big television program aired by MBC that would bring Hwang down. Then after it aired, he helped Hwang think about his options. What a great guy to have in charge of the primary panel whom we are all listening to for final word on the investigation of Hwang Woo-suk.

At this point South Korea must call for an international investigation, lock up its current records, and await help in the matter. Anything further they do in the investigation will only make matters worse.

Risk vs. Risk: Obesity, Gastric Bypass and Other Methods

Doctors are debating different methods for fighting obesity, many far more imaginative than the "stomach stapling" surgery that has been around a while - giving us good information about its risks. In Australia, they just put a rubber band around the offending organ. More physicians are considering just cutting away part of the stomach. Big parts, little parts, etc. And there's the best one of all - a balloon sent down through the mouth that gets inflated so that you feel full all day. The cost and risk of these procedures is not insignificant - but how do they weigh against the cost of obesity?

Another Study Contradicts FDA Advisory Concerning Newer Antidepressants

James Coyne offers this guest blog:
Yet another large scale study has contradicted the March 2004 FDA public health advisory warning that newer antidepressants are associated with worsening depression and suicidality. This new study of over 65,000 patients who were enrolled in the Group Health Cooperative and receiving antidepressants found no increased risk of suicide associated with prescription of newer antidepressants, including, notably, the selective serotonin reuptake inhibitors (SSRIs) [Link]. Results of this study are consistent with results of a recent of study of 146, 095 patients receiving antidepressants in primary care in the United Kingdom [Link], as well as two meta-analyses of the results of clinical trials data.

Even at the time of its warning, the FDA conceded that available evidence did not indicate any increased risk of suicide associated with these drugs. [Link]. At the hearings leading to the FDA public health advisory, first personal accounts from the family members of victims of suicide and vocal representatives of groups who had never encountered a psychotropic medication they liked were favored over research data. The FDA's handling of the issue of risks associated with antidepressants gives a new dimension to concerns about how the agency makes decisions.

Controversies about how the efficacy and safety of antidepressants are promoted have played a defining role in the discussions of conflict of interest in the bioethics literature, even if there is little attention to whether the best evidence actually indicates a risk for suicidality. However, more than has been acknowledged in this literature, debates about the safety of antidepressants have been clashes of conflicting financial interests. No doubt the drug companies producing the new antidepressants want us to believe that these drugs are absolutely safe and as dramatically effective as seen in the television commercials. They will spend enormous amounts of money to get their message across, including by enlisting key opinion leaders in psychiatry. Yet, there is big money behind the other side as well, though often undisclosed. For instance, take David Healy, whose "Normal Volunteers Study" of employees at his hospital given antidepressants has become the primary source for claims that even nondepressed persons became suicidal when they take SSRIs. He has widely been portrayed as a "self-effacing" hero fearlessly challenging the drug companies for the public good [Link]. Yet, at the time of his study, he was actually receiving substantial financial support, from Pharmacia a drug company attempting to capture a share of the SSRI market with a nonSSRI antidepressant [Link]. And the results of his study had immediate application in Healy's work as an expert witness in civil litigation, from which he has been making hundreds of thousands of dollars.

Healy had made his own contribution to the meta analysis of data concerning the safety of SSRIs, claiming to find that SSRIs were over 7 times more likely than other antidepressants to be associated with a fatal suicide attempt [Link]. This figure is comfortably over the odds ratio of 2.0 arbitrarily needed in the post-Daubert era to establish general causation in product liability. Unfortunately, readers showed that Healy's claims were contradicted by the data in his own article, and a correction was issued that acknowledged a lack of any differences between SSRIs and older antidepressants in terms of rates of fatal suicide attempts [Link]. Maybe financial interests sometimes do lead to distorted presentations of data.

Now that research data are available concerning SSRIs and suicidality, it might be time to revisit some of what has been said in the bioethics literature concerning the controversy in terms of conflict of interest and bias. A re-examination of the literature could lead to a more nuanced and sophisticated discussion of COI than has occurred so far.


James Coyne is Professor of Psychology and Co-director of the Health Research and Behavioral Sciences Program of the Abramson Cancer Research Institute of University of Pennsylvania

The Worst

Still more developments in what is turning out to be one of the most egregious clinical research scandals ever, involving SFBC International and noted at Bloomberg. [thanks Art Caplan]
UPDATE: Al Yarinsky reminds me that this piece at Bloomburg really casts a pall over SFBC.

How Google is Changing Medicine

Everyone should read this editorial in BMJ, which might as well be titled, "why we love Google." It is a great review of what is happening in medical scholarship and information and why Google is in charge of it. Their motto is "don't be evil" so their takeover of the entire universe is a peaceful and happy one.

Design, More Intelligent Every Day

This is my first monthly column for The Scientist, and first podcast, whatever that is. Excerpt:
Thanks to a recent court decision, children in Kansas will learn that the fossil record of our planet holds evidence of "irreducibly complex" traits, biological wonders that seem too sophisticated to be products of natural selection. Advocates of intelligent design argue that such complexity of biological life reveals evidence of a designer.

... A different sort of designer is working in the nascent filed of synthetic biology. These scientists generate novel biological functions through the design and construction of living systems (see "Is This Life", p.30). Synthetic biologists manipulate the most complex biological interactions using the tools of engineering and computer science. It has borne fruit in the design of genomes, proteins, devices, integrated biological systems, and even cell-circuit hybrids. Synthetic biologists use evolution as a method. That seems pretty intelligent.

Art Caplan on MSNBC on Hwang:
The End of Stem Cell Research? Hardly

Art writes on MSNBC that stem cell research can survive and learn lessons from this encounter with the bizzare in South Korea. He details the fraud and then argues that:
At the end of the day the system worked. Hwang was outed. Cloning was shown to be as tough a strategy for obtaining stem cells as most experts had thought it was. Still, Hwang almost pulled off his great charade.

Science like all other human endeavors such as the professoriate, the priesthood or the military is only as strong as its weakest links. And that will be true long after the critics and the proponents of embryonic stem cell research find out whether it really can do anyone any good.

[UPDATE: William Saletan's version of "what went wrong" is up today as well.]

Woman Forced By Hwang to Donate Eggs?
2004 Paper a Fraud?
Time to Move to Nebraska

The Korea Herald reports that researcher Park Eul-soon, the researcher who went into utter seclusion in Pittsburgh in November, has re-emerged on MBC television - a network so dedicated to exposing the corruption of Hwang Woo-suk at the peak of his popularity that a month ago its reporters were scared to tell cab drivers to take them to the studio.

This expose is by far the most serious in the short but ignoble history of Hwang's fraud:

An investigative program is set to air today and is expected to report that one of his junior researchers was coerced into donating her eggs.

The researcher, Park Eul-soon, wrote in an e-mail that she was forced to contribute her eggs after mistakenly spilling ova used for experiments in 2003.

"I regret that I did not stand up to Dr. Hwang," MBC television station quoted her as saying in the e-mail.


Park had already said that she spilled ova, but in her prior account published elsewhere she had said she merely felt guilty. It is not clear that either MBC or the Korea Herald know that she had already said this, but ultimately the new claim is that she was point-blank pressured to give eggs.

We have followed Park's odd history for some time - she was by all accounts instrumental in the research, and was hanging out in the Schatten lab when the scandal broke - with Schatten announcing that he suspected that there were issues with egg donation (which anyone from planet Duh might surmise he learned from Park).

And then, you'll recall, she failed to show up at the airport in Seoul to meet the other South Koreans who were all forced to leave Pittsburgh immediately for South Korea, in a rush, immediately after the Schatten announcement and just hours before Seoul National University released a statement implying that Schatten was merely retaliating against Hwang because Schatten SNU would not let him have power, position and money. So SNU and some sketchy government people showed up - apparently, we later learned, bearing a cash bribe as well - to "check on her," with one newspaper in Korea actually stating that they were trying to make sure she didn't steal away with intellectual property from the project

She has still not resurfaced and is no doubt setting up an illegal cloning operation in Nebraska.

In other reports, the 2004 paper, which every reporter with an IQ above 100 has been describing as "now in doubt," is still under investigation. But guess what. It really doesn't matter anymore. See,

Hwang's team claimed to have used 242 and 273 eggs, respectively in its research in 2004 and 2005 to clone human embryos derived from ova and somatic cells.

However ... the number of human eggs "far exceeded" the number presented in the paper - possibly about 2,000.

And what that means is that even if the 2004 paper in fact holds up - and Hwang can produce cell lines from nuclear transfer - the 2005 fraud demonstrates that it takes an order of magnitude more eggs to do so than previously thought, and that sets the idea of routinizing the use of nuclear transfer-derived stem cells back considerably. World Stem Cell Bank? Better put the word "Disney's" in front of it, and have little trains that pass by all the places where the fraud took place. Only the UK has anything remotely like the Korean endeavor, but it has different goals and much more intense oversight.

At any rate, the Hwang implosion is huge for Newcastle, which appears to have moved as far as Hwang, and with every bit as much care - publishing their accomplishment by press release rather than peer review.

The next step in damage control for nuclear transfer-based stem cell research has nothing to do with Hwang. It's the good guys in the field. My cloning ethics collaborator and pal Ian Wilmut is doing great things, but he and Robert Lanza in particular have gone on somewhat poorly timed media campaigns, to discuss in Wilmut's case how important it is to hurry up and get into clinical trials, and in Lanza's case to suggest that Hwang will slow things down enough to kill thousands.

If part of the problem here is overheated rhetoric about stem cell research, the answer is not only slightly less overheated rhetoric about stem cell research. Let's turn our attention to the question of funding all of stem cell research and use that opportunity to fiat some rock solid rules that any researcher who wants to work or sell products in the US will have to follow.

And from the "awakened from deep slumber" department, the President of Seoul National opened his New Year's address to the campus by promising that he will take "serious disciplinary action against the university’s disgraced cloning expert Prof. Hwang Woo-suk over findings by an SNU panel that the veterinary professor fabricated groundbreaking research." Given recent events one might ask whether or not he means it - after all, shortly after Hwang resigned from the world stem cell bank - as popular opinion swelled in his favor - he was essentially offered the chance to pull his resignation. But in this case, Hwang already quit. How do you discipline someone who has already quit? It is time for severe disciplinary action at SNU, but the President is optimistic if he thinks he will be the one doling it out.

Becker and Posner Agitate for Organ Sale

The Becker-Posner Blog features Becker advocating for markets in organs, and Posner piles on but suggests fundamental issues Becker did not identify.
[thanks Dave Undis of Lifesharers, whose "members promise to donate upon their death, and they give fellow members first access to their organs."]

The World Waits Breathless as Nebraska Considers Banning Cloning

It is puzzling to me that developing nations and, in the US, states with the smallest concentration of biotechnology industry have put such a high priority on bans for stem cell research and cloning. So when I read that Nebraska's legislature, with all the issues in the world to discuss, will be focusing on cloning in its legislative session, the only thing I could think to say was who cares? why?

Akin to South Dakota, Nebraska is despite its excellent university in Lincoln and medical school hardly a place likely to attract scientists who want to work on nuclear transfer. Before you flame us, yes we get that they do research. But the bit of stem cell research underway there is on "Bush approved cells" and is not funded by the NIH. And the other pieces that would have to be in place to do major embryonic research are just not likely to come to Nebraska, ever. So why is a very, very red state debating a ban on stem cell research?

Wait ... did anyone check to see whether Dr. Hwang has left the country? Perhaps the legislators in Nebraska know something about where the South Korean stem cell team is going. Anyway, where the matter of rogue cloning is concerned you can never be too careful.

The Scientist Becomes Something Different

Over at The Scientist they have made a dramatic transition to a new format both on paper and online. Their new Editor, Richard Gallagher was Publisher of Nature from 2000 (and senior editor at Science from 1992-1999) until leaving to take the helm at The Scientist. His debut in that role is this week's launch, and he has some interesting things to say about his philosophy for a science magazine.

Our own Glenn McGee will be writing a bioethics column in every issue beginning in the first issue with a column called "Design Gets More Intelligent Every Day" about synthetic biology and what it proves about intelligent design.

Infected with Intelligent Design

Dominic Sisti hammers on the Intelligent Design crowd in Pennsylvania - in their newspaper. His claim? ID kills:
the case of H5N1 is a perfect example for why students, the public, and our politicians need to be taught clearly - without obfuscation by creationists - that evolution is a scientific fact. Evolution through natural selection is not simply a slow process creating over eons the wonderful biodiversity seen on the planet and the extinctions found in the fossil record. Evolutionary processes also constantly propel some microorganisms to become more virulent and dangerous.

In the long run, denying students the facts about evolution will put the public health at risk because it is the foundation of biomedical research. The search for cures, vaccines and prevention methods is solidly built upon the principles of evolution and their corollaries in the fields of genetics and microbiology. Denying evolution happens not only stifles the scientific thinking of students but also sets them back as would-be researchers in the biological sciences and public health.

Dr. Hwang Enters the Twilight Zone

Happy new year. Unless you are Hwang Woo-suk. Ulcers and mixed up cell lines are nothing compared to the January he is about to have. Korea Times has the most damning report yet about his research, posted Saturday, which reads as follows:
Prof. Hwang Woo-suk plagiarized his subordinate’s work on the first-ever cloned human embryonic stem cells that was featured in the U.S. journal Science in early 2004, some scientists argued Friday.

The scientists contend a stem cell photo featured in the 2004 paper partially overlaps that of an article in another journal Stem Cells that was authored in 2003 by Kim Son-jong, a member of Hwang’s team.

This means the 2004 paper may also have been fabricated and Hwang’s team has no original technologies in therapeutic cloning, a process that opens the possibility of curing currently incurable diseases.

In fact, some scientists both at home and abroad have already raised questions about the 2004 paper, contending the DNA fingerprint traces documented in the article were fabricated.

And as we discussed earlier the role of the Korean government in what amounts to a coverup on behalf of Hwang began early and reached a fever pitch just last week, with an agency pushing Seoul National University to suppress information about the ongoing investigation.


I am interviewed at length for a wire service piece on the importance of the collusion in this case, though I am misquoted bigtime: "The Korean investigators were able to work in this complicated field where there's no federal money only because they could persuade venture capitalists that their investments were safe with them." Uh, no. The point I actually made was that American researchers who have no access to federal dollars and are thus funded by VC are at new risk because the VC people will see the Korean matter as evidence that this is an even riskier investment than was otherwise obvious. But otherwise it is a decent piece about the real issues here - not simply telling the truth but setting up a system in which mistakes can be more easily averted.

UMDNJ Under Fire

In a devastating development UMDNJ became the first medical school in the nation to be put in receivership ceding control of its operations to a federal monitor. [Link]
- Art Caplan

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