blog.bioethics.net

Hooray! Utilitarianism is back!

Richard Layard makes a compelling argument for the return of utilitarianism in the magazine, Prospect: " I am talking of the perennial philosophy which enables us to find the positive force in ourselves, and to see the positive side in others. Such compassion, to ourselves and others, can be learned...Every city should have a policy for promoting a healthier philosophy of life in its youngsters and for helping them to distinguish between a hedonistic addiction to superficial pleasures and real happiness." - Linda Glenn

When Private Health Care is Administered with TLC (Toxic Lethal Care)...

An article in the New York Times today issues a scathing indictment of private health care hired by prison officials in New York, Georgia, Maine, Pennsylvania and numerous other states. The horror stories led Frederick C. Lamy, chairman of a NY medical review board, to denounce Prison Health Services (P.H.S. as it widely known), as "reckless and unprincipled in its corporate pursuits, irrespective of patient care."

And despite such horror stories, this current administration wants to take aim at malpractice laws and lawyers, undercutting the ability of those victimized to recover compensation, and doing nothing to reduce medical errors. In fact, I suspect that this administration would be quite happy to deny any form of health care to prisoners at all, viewing it as a privilege rather than as a basic human right. Geez, and I thought the "compassionate conservatives" were supposed to protect the vulnerable populations...
-- Linda Glenn

Incredible Journey: the Nanotechnology Edition

The thing is narrated by a Peter Sellars faux Frenchman, so I kept waiting for this shockwave file to get to a punchline, but it never does. Instead, this 6 minute animation, forwarded to me by Jean Jacques Caplán, does a good job of describing the relationship between nanotechnology, neuroscience, computing and human nature. It might be great to show your bored grandmother anyone who is new to 'the vision' of neuro/nanotech - there certainly isn't anything better on the subject that is three minutes or less.

Unethical Bioethicists? Take a Look to the Right

There has been a lot of handwringing over the past few years about conflicts of interest on the part of bioethicists. Nearly all attention has focused on the role of private companies especially pharmaceutical companies in funding either bioethics centers, bioethics research or bioethicists acting as consultants. What has garnered very little attention is the role of explicitly political foundations in supporting bioethics work. The most obvious example is the Ethics and Public Policy Center in Washington which has been aggressively expanding its bioethics activities and is closely allied to some of the members of the President's Council on Bioethics.

Is it a conflict of interest to claim to speak as a bioethicist or to conduct research under the auspices of explicitly political funding sources? Should these funding sources be disclosed in all public presentations? What about in offering opinions to the media? Does receipt of funding from these sources in the form of awards, grants, salaries or other renumeration constitute grounds for dismissal from public commissions and organizations?

Here is the breakdown on EPPC:

According to Media Transparency, most of EPPC's funding comes from the so-called "four sisters" of the
conservative foundation world: the Olin, Bradley, Smith Richardson, and Sarah Scaife foundations. The center is also supported by the Castle Rock and Earhart foundations.

So if you are planning to attend the big "ethics of bioethics" meeting in Albany in about a month, take a look at the biggest non-governmental investment in bioethics: conservative advocacy foundations. - Art Caplan

The Ethics of Funding Therapy for Erectile Dysfunction

New York Times examined this week the debate about whether Medicare should cover erectile dysfunction medications; Kaiser summarizes the bioethicists' views in that piece and elsewhere:

Daniel Callahan, co-founder of the Hastings Center bioethics research institute, said that a "possible compromise solution" might be to "set specific medical criteria allowing Medicare coverage for [the] drugs when erectile dysfunction can be traced to some identifiable medical condition other than age." Robert George, a professor at Princeton University and a member of the President's Council on Bioethics, said, "If impotence occurs in the normal course of a human life, as a consequence of aging, these drugs should not be covered. But if there is a real health problem, I am inclined to say the drugs should be covered." William Gee, chair of the health policy council of the American Urological Association, said, "For a 70-year-old man with hardening of the arteries caused by smoking, for a man with diabetes or multiple sclerosis or a man who has had pelvic surgery for cancer, there are clear medical indications for these drugs." Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the issue has forced policy makers to ask, "What emphasis will we give to quality of life as a goal for pharmacological intervention?"

Not Guilty

Today's San Francisco Chronicle:

Most of the 100 or so National Institutes of Health researchers who the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical and biotechnology companies have been cleared by NIH investigators, according to agency officials.

Umbilical Cord Blood Banks Do Not Pay Interest

Finally someone has done it: confronted the preposterous fees charged for umbilical cord blood banking at birth. Researchers Nick Fisk and Irene Roberts of Imperial College London have identified the problem: the procedure is overpriced, not anywhere near as useful as is claimed by companies who sell the procedure, and poorly studied:

They said it was unlikely the blood would ever be used and all the applications for non-blood diseases, such as the regeneration of heart muscle, were speculative.

Future Health Technologies, a private bank in Nottingham, estimates that the chances of using the blood over a typical storage period of 20 years are four in 10,000.

Prof Fisk said; "The probability of needing an autologous transplant is less than one in 20,000, although commercial providers quote higher figures." He said the European Group on Ethics in Science (EGE), had reported serious ethical concerns about commercial banks and questioned their legitimacy for selling a service of "no real use".

Oregon Assisted Suicide Law:
Are the Days Numbered?

Christian Science Monitor reviews the case in great detail. Ashcroft Ashcroft II is going after the Oregon law with vigor.

The Bush administration and key members of Congress argue that prescribing a lethal drug for purposes of suicide violates the federal Controlled Substances Act, and that this trumps state law and the long-held position that medical practices are to be regulated by the states.

A federal judge and then the Ninth US Circuit Court of Appeals rejected that position. To do so, the appeals court ruled, "interferes with the democratic debate about physician-assisted suicide."

The Pet Cloning Debate Really Can Get More Ridiculous

Wonkette put us on to this press release from DefendPetCloning.org, put up by some smarmy PR jerk the thoughtful people at Genetic Savings & Clone, who clearly believe that someone out there wants to read brochureware arguments in favor of pet cloning. And not to be outdone, the people who do not get out enough fearless opponents of pet cloning have mustered up their own array of new PR.

I can't figure these folks out. The market for this service is, what, thirty oil barons and their kitties a year, and yet both sides of this awfully silly debate seem dead-set on beating it to death. California has actually introduced a bill to ban pet cloning, reports Rick Weiss of the Washington Post, who also should have better things to do, and the the anti-vivisection folks are so happy that they too have created a web site, called, you guessed it, nopetcloning.org.

But seriously, who is the bright guy who wasted a legislative aide's time putting this bill into the mix? And where do the pro-kitty folks get these ethicists who speak on behalf of and against pet cloning? A blog. In fact there is quite a little feud brewing on the kitty cloning front between Stanford's David Magnus and Penn's Autumn Fiester, both of whom are being waved about like mascots by the disputants. Frankly the only thing more amusing than a battle over the cloning of pets is a battle of wits between these two pals - of ours and of each other. And yes, they also have better things to do.

FDA Oversight Panel: What Big Reforms Committees You Have!

Not many are impressed with the new FDA plans for an "oversight board" to monitor drug safety.

But FDA critics weren't impressed. "It's really a cosmetic way of dealing with a much more serious problem," said Dr. Sidney Wolfe, director of the nonprofit Public Citizen Health Research Group in Washington, D.C. "In the absence of any fundamental change, it's a cruel hoax."

The composition of the new board drew immediate fire. While the board will consult with outside medical experts and patient and consumer groups, its members will be drawn only from the FDA and other government agencies.

Particularly unhappy about it is Tom Murray, who is quoted everywhere about it to this effect:

"I'm a little surprised that the description of the board doesn't include outside advisory committees empowered to ask the hardest questions," said Thomas Murray, president of The Hastings Center, a medical think tank in Garrison, N.Y.

I'm not sure it would matter much who was on the panel, given the preposterous challenges such a board will face, but outsiders certainly seem like a good idea.

Ranking the Governors on Biotechnology

USATODAY.com has done just that - offered a spiffy "quick look" at where the various state governors stand on biotechnology issues, and you can draw a few inferences about how that relates to the relative standing of the different states. Next: state stem cell trading cards. "I will trade you five Mitt Romneys for one Arnold."

As I Suffer So Must Ye All

AP/NY Times reports that

Vatican officials on Thursday held out Pope John Paul II's stoic suffering with Parkinson's disease as an antidote to the mentality that modern medicine must cure all, calling this a ``religion of health'' that is taking hold in affluent countries.

``While millions of people in the world struggle to survive hunger and disease, lacking even minimal health care, in rich countries the concept of health as well-being figures in creating unrealistic expectations about the possibility of medicine to respond to all needs and desires,'' said the Rev. Maurizio Faggioni, a theologian and morality expert on the Vatican's Pontifical Academy for Life.

I doubt the idea that stoic suffering is the morally desirable way to cope with illness will catch on outside the inner circle of the current Pope! - Art Caplan

Million Dollar Provocation

Jeffrey Weiss of the Dallas Morning News reports that "Clint Eastwood's boxing film Million Dollar Baby is taking pre-Oscar body shots from commentators and activists who say the movie is pro-euthanasia or anti-disabled...

Start with the medical ethics problem: The quadriplegic is a prisoner of the medical center's care – desperately wanting to die and being forced to live. But U.S. law says that no patient should be trapped that way ... What we have is a case of perpetuated ignorance," said Jeff Shannon, who may be the only quadriplegic in the country reviewing movies for a major newspaper. He freelances for The Seattle Times. (His injury was lower on the spine than the movie character and he lives a mostly independent life.)

He's given the film a good review but is troubled by the way it handles some of the details of disability and medical care.

"Basically, the third act of the movie is utter fantasy," he said. And he doesn't mean that as a compliment.

-Art Caplan

Meet Stuart Rennie

We like Stuart Rennie. He flogged the blog for concentrating on America too much. So, as with all people who complain, he earned a new assignment - writing some posts about all those places outside the Last Superpower. Here's the lowdown on Stuart:

Stuart Rennie PhD (Philosophy, University of Leuven, Belgium) is Research Assistant Professor at University of North Carolina-Chapel Hill. He is program manager of an NIH-Fogarty sponsored project to enhance bioethics capacity in the Democratic Republic of Congo and Francophone Africa in collaboration with the University of Louvain (Belgium) and the School of Public Health in Kinshasa, Democratic Republic of Congo. He also works as ethics consultant for the UNC-Global AIDS Program (GAP) activities in Kinshasa.

The U.N. Legal Committee Votes
to Prohibit All Forms of Human Cloning

This just in from MSNBC:

REUTERS: UNITED NATIONS - A deeply divided U.N. General Assembly committee adopted Friday a nonbinding declaration calling on governments to prohibit all forms of human cloning including techniques used in research on human stem cells.

The assembly’s legal committee voted 71 to 35 with 43 abstentions to adopt the nonbinding proposal put forward by Honduras and backed by the Bush administration but opposed by advocates of stem cell studies.

The measure now goes to the full 191-nation assembly.

Before adopting the text, the assembly’s legal committee rejected a series of amendments by Belgium that would have softened the declaration to make it more acceptable to stem cell research supporters."

[thanks Art Caplan]

The Gilead Saga

From our UNC-Chapel Hill bureau, Stuart Rennie blogs:

Those attending the International AIDS Conference in Bangkok last July may fondly recall the destruction of the Gilead kiosk by members of the Asian Pacific Network of Sex Workers and ACT-UP Paris. Gilead posters were sprayed with fake blood, while passersby were playfully pelted by flying spoonfuls of symbolically red strawberry jam. The colorful and sticky protest was occasioned by Gilead Inc.’s testing of its antiretroviral drug Viread as an HIV prevention method for sex workers in Cambodia, Ghana, Nigeria and Cameroon. Since last summer, the Gilead trials has become one of the hottest items in international research ethics.

Viread, or tenofovir, an FDA-approved drug, has been shown to boost immune responses and reduce viral loads in HIV-positive persons. The NIH, CDC and the Bill and Melinda Gates foundation are funding separate trials of Viread on human subjects to determine if the drug is safe and efficient for its use as a ‘prevention pill’ to block acquisition of the HIV virus. The value of such a pill should be obvious: HIV transmission continues apace, particularly in developing countries, and there is no effective HIV vaccine in sight. Oral HIV prophylaxis would also benefit women, who often have difficulty negotiating condom use. A prevention trial of this nature, however, requires recruitment of study participants who are HIV-negative but at high risk of acquiring the virus. The CDC has funded ($3.5 million) trials in Atlanta and San Francisco among 400 men who have sex with men, scheduled to start this spring. The CDC is also running trials in the high HIV prevalence country of Botswana, and among HIV-negative injection drug users in Thailand. The Gates Foundation is supporting ($6.5. million) randomized, placebo-controlled trials of Viread with 2000 HIV-negative volunteers in Cambodia, Ghana, Cameroon, Nigeria and Malawi. The NIH awarded a $2.1 million grant to the University of California-San Francisco to test Viread on HIV-negative Cambodian women, mostly sex workers. Around the world, at risk HIV-negative persons (gay men, drug users, sex workers, Botswanans) are being recruited into HIV prevention studies on a drug marketed by a major pharmaceutical company and backed by powerful US donors and research institutions.

You don’t need a PhD in bioethics from Case Western Reserve University to know an ethical minefield when you see one.

All ethical hands on deck: do the trial participants really know they are not being guaranteed immunity from getting HIV? Are participants given sufficient resources and education about the use of condoms and other preventative means? Are the women, even if educated about prevention, really in a position to negotiate condom use? And what will be provided to those who become HIV-infected during the trial? If weaving an acceptable path through these issues is not difficult enough, keep in mind that the participants are often from non-Western cultures where the understanding of biomedical research may be less than ideal. And note that from a strictly scientific point of view, it is in the researcher’s interest that (at least some) participants fail to take the recommended precautions and expose themselves to HIV transmission. The study design is an ethical tinderbox waiting for a flame.

Cambodia was the first to combust. Last August, the Cambodian trial of Viread was halted by the Minister of Health, citing ‘safety concerns’ about the drug. But this was after pressure from the groups such as the Asian Pacific Network of Sex Workers, who were more concerned about compensation for sex workers becoming HIV-positive during the trial. And here is where the gloves came off.

In this corner, the sex workers union demanding 30 to 40 years of medical care for sex workers in the study who acquire HIV. In that corner, Mary Fanning, associate director of clinical research at NIAID, countering that offering such compensation would be tantamount to undue inducement, would invalidate voluntary informed consent, and hence would be, um, unethical. In this corner, ACT-UP Paris claiming that the $3 offered to prospective participants already constitutes unethical inducement, and calling for the immediate termination of Viread trials worldwide until participants were assured of effective HIV prevention education and resources, and received access to adequate treatment and care in event of HIV infection. In that corner, Ward Cates of Family Health International (the North Carolina-based non-profit health organization overseeing the Cambodia and Cameroon trials) arguing that the human rights of study participants were respected, because the care being offered to them was well above the standard of care in Cambodia. Any reasonable sex worker, it seems, would be better off joining the trial than plying her trade outside it (but isn’t that, um, undue inducement?). However, opponents point out that we are talking about a country where the government spends $2 per person per year on health care (Asian Development Bank, 2004) and 23% of HIV-positive persons in need of antiretroviral treatment have access to it (WHO, 2005). Exceeding low standards, they argue, is nothing to write home about.

And now there is Cameroon . Anyone on a listserv about AIDS and Africa has been hearing fearful murmurings of unethical goings-on with the Viread trial in Douala, Cameroon for the past months. There was talk of consent forms in French and English for participants who knew neither; participants being told that they were all getting a sure prevention against HIV; no provisions whatsoever being made for those who became HIV positive. The subject line of one memorable post read: Scandal humanitaire au Cameroon!!! TEST FRAUDULENT DE SIDA CONTAMINATION AGGRAVEE, PAUVRES DE NOUS! On the 20th of January, members of ACT-UP Paris demonstrated in front of the Cameroon embassy in Paris, demanding the trial be stopped for reasons similar to those used against the Cambodian study. By the 4th of February, the Ministry of Public Health in Cameroon suspended the study. On state radio, Health Minister Urbain Olanguena Awono stated that his Ministry’s audit revealed ‘dysfunctions’ and certain measures need to be taken the by research team. He did not detail the dysfunctions, or list the measures, a move unlikely to slow down the rumor mills.

A preventive pill against HIV infection would be a powerful weapon in the fight against the AIDS pandemic, but the ethical challenges of designing and implementing a study proving its safety and effectiveness are daunting. But the quest for such a pill is not over. Look out for new installments of the Gilead saga in 2005. [Stuart Rennie - guest post]

notinourhospitalyoudont.com

Tampa's Tribune reports today on the plight of Alex Crionas, who is being refused a direct donation from a willing donor (a friend of his) because, two years ago, Alex set up a website, http://www.SelflessAct.net to ask for someone to donate to him. Alex says that his friend - the prospective donor - was not recruited through the web site. But it isn't selling:

Because Crionas had set up a Web site that was deemed to be in violation of its ethics policy, LifeLink, a Tampa- based organ transplant center, has refused to perform the living donor transplant that Crionas hoped would occur by March.

In early February, the center abruptly stopped an evaluation process to determine if 23-year-old Patrick Garrity would be a good match for Crionas.

What isn't clear in the story is why the web site matters if the donor does not come from that venue. The letter to Crionas reads like a disciplinary action from a high school principal:

His case had been reviewed, the letter said. ``In addition, we have reviewed your personal Web site.''

The American Society of Transplant Surgeons and LifeLink are ``strongly opposed to the solicitation of organs or organ donors by recipients or their agents through Web sites,'' the letter continued.

``After careful deliberation, we will not consider any living donor for you.''

If it is in fact the case that the two didn't meet through the web site, it is really, really hard to figure out how a transplant program could arrive at the conclusion that the existence of the web site is enough to exclude any possible directed donor. In fact the decision seems pretty peculiar all the way around because the letter doesn't specify the degree to which the web site played a role in the decision. But on the other hand, this situation does raise the question of how a transplant program can disentangle claims about donor motivations when something like this web site is in evidence...

Clearly Crionas should go to Denver, where at least one hospital seems ready to consider even donors found through a web site, in that case matchingdonors.com. And maybe these guys should use their new found celebrity to form a rock group - they have the pose down.
[thanks Dave Undis]

Update: Alex writes in to the blog:

Who can say that there is more of a risk of financial compensation if the pair meets online as opposed to meeting somewhere else? The internet is simply a way to reach a larger audience, to expand one's circle of friends, among whom a donor may be found. It may be abused just as any other piece of technology that has developed faster than its regulations. That potential for abuse still does not justify denying the patient the benefit of the doubt, as it is virtually impossible to ascertain with complete assurance whether or not the donation is purely altruistic. This is why affidavits are signed. In my case, however, we did not even get to the point where we were offered that option. Thanks for the suggestion, by the way. I think we'll call the band, "The Rolling Kidney Stones".

I'd give him a kidney just to see the band.

Martian Bioethics (Updated)

Evidence Work from the X-Files by Ames researchers show that life might exist on Mars after all -- which raises an interesting question. If, as the researchers claim, life exists in pockets of water and in caves on the red planet, do we have any moral obligations to such (undoubtedly microbial) life? Does the Star-Trekian Prime Directive not to alter the life on other planets have a moral hold on us? Believe it or not, there is an office at NASA that thinks about these things, headed by the person with the coolest title of any living human: "Chief of Plantary Protections." ("What do you do, Daddy?" "I protect planets, honey." "Wow!") But as we venture forth into the great beyond, there will be attendant moral problems about how we treat other planets. Considering how we have treated this one, the problems will not be trivial.

On the other hand, there may be no life on Mars at all ... NASA released this today:

NASA STATEMENT ON FALSE CLAIM OF EVIDENCE OF LIFE ON MARS

News reports on February 16, 2005, that NASA scientists from Ames Research Center, Moffett Field, Calif., have found strong evidence that life may exist on Mars are incorrect. NASA does not have any observational data from any current Mars missions that supports this claim. The work by the scientists mentioned in the reports cannot be used to directly infer anything about life on Mars, but may help formulate the strategy for how to search for martian life. Their research concerns extreme environments on Earth as analogs of possible environments on Mars. No research paper has been submitted by them to any scientific journal asserting martian life.

Hmm. We have a call in to Area 51. - Paul Root Wolpe/GM

More on Million Dollar Baby

Writing for MSNBC.com, Art Caplan highlights the glaring flaw of the new Eastwood flick. It might not be what you think it is. [Link] --Dominic Sisti

Massachusetts Democrats Draw a Line in the Sand

After weeks of disappointing news about Mitt Romney's "openness" to stem cell research - essentially a bunch of jibberish about funding the research backed up by little willingness to act - finally some news that Massachusetts democrats are going to try to hobble his efforts to ban therapeutic cloning. The New York Times reports, in a mixed-up piece that equates therapeutic cloning with the creation of any embyros through any means, that

... the governor, whose wife, Ann, has multiple sclerosis, a disease that might be helped by stem cell research, said he opposed creating embryos specifically to be used in research, a process known as therapeutic cloning. "For Ann and me, that's a line that we concurred we could not cross," he said after sending a letter to Mr. Travaglini that outlined his position.

Proponents of therapeutic cloning said the governor was being logically inconsistent by drawing his ethical lines to exclude the most promising type of embryonic stem cell research.

"To think that this very important work would be criminalized," said Dr. George Q. Daley, a colleague of Dr. Zon's.

And at last an honest appraisal of what is at stake in Massachusetts:

Some Democrats and scientists contend that the law sought by Mr. Romney would drive from Massachusetts talented researchers and biotechnology companies. Mr. Romney said that one of the 280 biotech companies in the state was conducting embryonic stem cell research and that it had plans to leave the state.

Abortion opponents and Roman Catholic groups flocked to Mr. Romney's corner.

What Scientists Will Not Touch?

From Science this week, Jon Merz's group (lead author, Joanna Kempner) publishes a great study about scientists' sense that they have been targeted for public criticism based on their controversial studies - and how that can affect their choices about what to study. It is one of those studies that makes you wonder why someone didn't already ask this question empirically - and makes you hope that this sort of study will become part of regular scientific self-appraisal. The findings are interesting:

The paper's findings are based on 10 pilot interviews and 41 in-depth interviews with researchers from prestigious U.S. academic departments in seven fields - neuroscience, sociology, molecular and cellular biology, genetics, industrial psychology, drug and alcohol abuse, and computer science.

Some 42 percent described how their work had been targeted for public censure in one form or another, the paper said.

But the authors were surprised to find that scientists were most affected by so-called "informal constraints," such as the fear of breaching an unspoken rule against inquiry in a particular area.

[updated]

Children of the Clones: The Kids are Taking Over Bioethics

Hear me now and believe me later: the kids are taking over bioethics. Mega conferences in bioethics hosted by undergraduates are a bit like those hosted by law students, which most of us are more familiar with: they tend to be a bit overhyped, which is fine, but they also tend to stress only the most cutting edge issue and then to invite only the most visible speakers - to do their least substantial presentations. Far too often these super-important next wave conferences, which attract tons of students and lay people alike, end up reinforcing stereotypes of what bioethics "does" among those who are critical of the discipline. But now there is a chance for that trend to reverse itself - three super big new conferences by undergrads are coming up soon: Arizona State's offering, and Toronto's conference, and of course the whompum bad daddy of them all at Penn. For starters, all of these folks are honest about the fact that it is a student-oriented conference. Looks like good stuff. Prepare to be replaced. [updated]

No More Drugs from Canada?

You had to see this coming.

Stanford to Put Mice in Men

Stanford's special ethics committee convened to make a decision about putting mouse-harbored human stem cells into humans, a committee led by Hank Greely, has decided that the experiments should go ahead. Mercury-News is high on Stanford's accomplishment in studying the problem before moving ahead - which is really a major achievement, particularly since this committee did not attempt to gloss over the issues, as have, arguably, a number of comparable corporate ethics committees on stem cell research:

... Stanford asked where it should draw the line. It is the first university in the nation to tackle the philosophical question: When does a chimera stop being an animal and start becoming a person, suggesting that research should end? The report foreshadows the release of guidelines on stem-cell research, including chimeras, by the National Academy of Sciences this spring.

The committee has asked Stem Cells, Inc. (the company that is in collaboration with Stanford on the research) to

kill the mice as they develop to see if their brains are developing in human ways.

``If there is anything that might suggest some risk that there is anything that might remotely be viewed as `humanness' being transferred to a mouse, we've asked him to stop,'' Greely said.

``It's a little creepy,'' he conceded. ``But it's not going to get up and say, `Hi, I'm Mickey.' Our brains are far more complicated.''

Baptists Love Embryos

This may be news to you if you live under a rock. But what is significant about this story is that for the first time in my recent experience at least you see a Baptist bioethicist engaging in the kind of dissemblage that is usually reserved for the Conference of Catholic Bishops and the National Catholic Bioethics organization - that is, arguments in favor of a moral position on embryonic status that neither admit that there is scientific ambiguity nor acknowledge the impact of the decision on the practice of religious life. It is particularly interesting, in fact, because if this argument is representative of the fundamentalist Baptist bioethics lobby's plan of attack on embryonic status - which it probably is, given Mitchell's standing in that community - you can bet that it spells bit debate among Baptists concerning IVF, which has not been a big issue among Baptist congregations, since this ruling really would spell the end of IVF. From the article:

LIFE DIGEST: Judge rules embryo a human being; pro-lifer leaves DNC race; Oregon teen wins breast cancer suit - (BP): "That ruling “is only stating the obvious,” said Ben Mitchell, associate professor of bioethics at Trinity Evangelical Divinity School in suburban Chicago. “Law should conform to facts. The fact is, the human embryo is as fully human and as fully a person as a newborn baby. Every human being has a right not to be unnecessarily harmed. The law must recognize this fact, not deny it for the sake of social engineering.

“Geography should not dictate our view of the immorality of homicide,” said Mitchell, a consultant with the Southern Baptist Ethics & Religious Liberty Commission."

They Came Around...to Giving a Contract to Georgetown's Kennedy Institute

Not the minimally conscious people who are all over the headlines this past week - no, the big news about awakenings is from the people at the National Library of Medicine, who have finally agreed to carry their weight on the project of building the Kennedy Institute's famous National Reference Center for Bioethics Literature. The NLM has just bestowed an $8 million contract on KI, whose library - the product in part of the field's brilliant bibliographer, Christian ethicist LeRoy Walters - has defined bioethics literature since the genesis of the field. Anyone who knows anything about the field is on a first name basis with Doris Goldstein, M.L.S., M.A., and her large and brilliant staff at the NRCBL - they stalk you at the ASBH meeting to confirm the citation for your weirdest articles so that everything that is written in bioethics is in the library. And they then help anyone find anything in bioethics. And they are all as resourceful as they have to be to keep track of a field this strange.

So anyway this big cash infusion means we have at least another decade of 1-800-MED-ETHX to look forward to - and hopefully that KI and the NRCBL will be in a position to do even more amazing things!

Pet Cloning Scares Cheeseheads

The Capital Times of Madison reports on the small lab of pet cloning pioneer Genetic Savings and Clone, which has set up shop in Madison for its primary scientific operations. Columnist Doug Moe declares that the lab will make Madison "ground zero" for the pet cloning debate. Doug, is that really the metaphor you wanted? ... This might be the stupidest bioethics debate ever but it certainly is getting more amusing by the second: according to Moe, GS&C is planning to open a veterinary ER next door to its cloning shop. I cannot wait to see its slogan.

Of Mice and Men and those in between...

In a similar vein to the previous post, Rick Weiss of the Washington Post reports that that US Patent and Trademark Office has officially denied a patent for a "humanzee" - a half chimpanzee, half human hybrid. In April 1998, scientists Jeremy Rifkin and Stuart Newman, who are both opposed to genetically modified organisms, applied for a patent for a “humanzee,” to fuel debate and to draw attention to potential abuses in transgenic/genetic engineering experimentation. In the posting below, I suggest that Homo sapiens may need move over to make space for others who are worthy of moral respect and legal status...

--- Linda Glenn

Move over, Homo sapiens...

Traditionally, Western philosophy has assumed that humanity (i.e., a member of the sub-species Homo sapiens sapiens) is a necessary precondition to personhood. But a recent archeological discovery reported in Nature adds a new cousin to our family tree, dubbed Homo floresiensis. Described as "hobbit-like", the discovery has spawned speculation that similar species may still exist somewhere in the unexplored tropical forests of Indonesia.

Interestingly enough, the US Supreme Court does not require humanity for someone to be recognized as a "person" -- the Court has recognized corporations or even ships to be "person(s)." Which, when you think about it, maybe isn't such a bad thing -- we need to be prepared when technology (through transgenics and/or the melding of computers and bodies) creates other species, sapiens, homo, or otherwise, that are worthy of moral and legal status to expand our traditional notions of personhood.

The real question is, though, can we humbly acknowledge that granting other species moral respect and legal status does not necessarily diminish our place on this earth? Must we cling to our cherished belief that Homo sapiens sapiens is the perfect end result of evolution, or can we concede that our species can survive best as stewards of the earth and all of its species and as an integrated element of a global ecosystem? Move over, Homo sapiens sapiens... make room for new, and maybe-not-so-new-but-as-yet-undiscovered, kids on the block.

-- Linda Glenn

Million Dollar Baby: Bioethicist Susan Wolf Clears Up the Confusion

If you haven't seen the movie yet, you might want to stop reading now. If you have seen it, and would like to read a careful commentary on some of the bioethical dimensions presented therein, read on...

--Dominic Sisti

Guidelines for Full Body CT Scans?

With the convenience and popularity of full body CT scans increasing as a simple solution to detect the ever growing number of maladies cropping up in aging bodies Menlo Park's Almanac reports that some doctors warn of the risks inherent to the technology. Advertisements for body scans espouse the procedure’s ability to identify heart disease, lung disease and cancer and other ailments, but do not mention the plausible health side effects of the scan itself. In addition to this, the FDA provides no regulatory standards for the scanning industry. When considering the potential dangers of false positives and radiation exposure, is it right to steer people who show no symptoms of problems toward a treatment that could damage an otherwise healthy body? Should there be professional standards or guidelines for when it is (and is not) appropriate for someone to receive a body scan? Or should this aspect of medicine remain Caveat Emptor--and hope that "informed consent" will wash away any problems?

A Hippocratic Oath for Biologists?

Oliver Morton says yes, and that in fact it is long overdue. [thanks Wayne Shelton]

Must Subjects be Given Access to Experimental Interventions Even if they Do Not Work?

New York Times reports that Amgen has refused to allow subjects in a trial of an experimental drup to resume taking the drug for their Parkinson's disease after the company decided that the drug is ineffective and possibly dangerous.

The company said it would not make the drug available to the four dozen patients who had participated in its clinical trials, even though the Food and Drug Administration had left the door open for it to do so. Company executives said that besides exposing the patients to unnecessary risks, to let them continue treatment would only generate false hopes. It might also ultimately hinder development of improved versions of the drug, Amgen said.

- Art Caplan

Awakened from ... Something ... She Speaks

Chicago Tribune and everyone else is reporting this morning on a "miraculous case of waking up from a long-term coma," which apparently included an eyes open state for some significant amount of time. This is the AP account:

HUTCHINSON, Kan. -- Sarah Scantlin was an 18-year-old college freshman on Sept. 22, 1984, when she was hit by a drunken driver as she walked to her car after celebrating with friends at a teen club.

Since then she has been mostly oblivious to the world around her, able only to blink her eyes to respond to questions no one knew for sure she understood.

But a week ago, her parents got a call from Jennifer Trammell, a licensed nurse at the Golden Plains Healthcare Center. Trammell asked Betsy Scantlin if she was sitting down, told her someone wanted to talk to her and switched the phone to speaker mode:

"Hi, Mom."

"Sarah, is that you?" her mother asked.

"Yes," came the throaty reply.

"How are you doing?"

"Fine."

It is unclear what sort of state Scantlin was in. Was it a coma? Was she merely unable to talk? Was she "locked in"? There are no clinical comments beyond a speech therapist in the story so far, but you can bet this story will lead everyone's news for the next several days.

What becomes of the brokenhearted...

A study published just in time for Valentine’s Day, reports how the loss of a love, intense grieving, or similar emotional trauma can cause classic heart attack-like symptoms, including chest pain and shortness of breath; doctors have dubbed it the "broken heart syndrome". This might seem like a little bit of "duh!"; for centuries, poets and philosophers have written of this phenomena and common wisdom has been that emotional shocks can trigger heart attacks and sudden deaths. However, the study also shows that for some unknown reason, postmenopausal women seem to be more prone to this syndrome. The good news is that study will lead more ER and heart doctors to consider the syndrome when examining patients with chest pain, especially those who are grieving.

-- Linda Glenn

Penn Reaches Settlement in Gelsinger Affair

The University of Pennsylvania reached a settlement on Wednesday with U.S. Department of Justice to the tune of just over a half million dollars. Injunctions were handed down, limiting research by Jim Wilson, Steven Rapar, and Mark Batshaw.

[Philadelphia Inquirer]
[The Daily Pennsylvanian]
[Kansas City Star]

--Dominic Sisti

Mooney Essay: Cell Out?

Blogger Chris Mooney of American Prospect and ChrisCMooney.com surveying the Bush policy on stem cell research concludes stagnation and silence are the benchmarks. [CBSNews.com Opinion] --Dominic Sisti

Ok, Maybe We Were Wrong About that Whole "Vegetative" Thing

In what could be a complicating factor in the Schiavo case, a report in The New York Times today, called "Signs of Awareness Seen in Brain-Injured Patients," claims that brain imaging suggests that some patients with severe brain injuries still have some awareness of their surroundings. They seem to respond differently to familiar stimuli. The open questions are, first, whether such information might predict the potential for some additional recovery, and second, whether minimal awareness is enough to suggest that such patients be kept alive. -- Paul Root Wolpe

Your Nurse Has Been Tuhminated

Jon Carroll really loves Arnold Schwartzenegger's thoughtful campaign against nursing in California:

Ahnold boasted of his victory over the nursing profession by calling nurses 'special interests' and announcing that he had 'kicked their butts.' That is such a useful way to refer to nurses, because everyone I know is really angry about nurses and all the care they give and the extra hours they work and sick people they comfort. Nothing gets the public on your side quicker than nurse-bashing.

Amazingly, though, there has been limited public outcry. Do we think that nurses make too much money? Do we think they whine too much about understaffing and compulsory overtime and standing helplessly by while cost- saving procedures compromise the level of care? Do we resent their yachts and their skiing trips to Davos?

Triage at Abu Ghraib

That little newspaper they hand out on airplanes, the International Herald Tribune, has taken the NY Times piece from bioethicist Marks and Bloche's work, this segment being about the use of leashes on prisoners in Abu Ghraib who were purportedly psychotic. Yes, those leashes ... the ones you saw in the pictures being used for decidedly different ends. And as a result of this story's wider global dissemination, apparently the question has arisen as to how triage should be conducted in a harsh military prison.

Major David Auch told us that some of the prisoners at Abu Ghraib were psychotic and out of control. One, he said, would repeatedly strip off his clothes and smash his head against the wall. After handcuffs and a helmet failed to stop him and with straitjackets unavailable, some soldiers suggested the leash. Auch granted their request. "My concern was whatever it took to keep him from getting hurt," he said.

It is easy to criticize Auch for allowing military police officers to use a leash, but it is difficult to say what he should have done instead. He had antipsychotic drugs on hand but no psychiatrists to prescribe them, and he lacked the experience to give these powerful drugs himself.

So the leashed detainee went untreated, as did hundreds of others with mental disorders. The lone psychologist who accompanied Auch, Lieutenant Joseph Wehrman, was troubled by what he found on their weekly visits. Up to 5 percent of the detainee population (which averaged 2,000 in late 2003 and early 2004) was mentally ill, Wehrman told us, but to his knowledge, none of the prisoners received medication.

The atmosphere at Abu Ghraib hardly promoted sanity. Mortar shells landed almost daily, according to military personnel we interviewed, and prisoners often rioted, sometimes using smuggled weapons, with deadly effect. In late 2003, Auch's unit set up a field hospital, bringing a full-time medical presence to the prison for the first time. For the dozen or so clinicians assigned to the hospital, the daily routine was surreal.

Move Over Oil for Food, it's ...
Cigarettes for Stem Cell Research

LifeNews.com, an anti-abortion web site, often gets news stories first, as in the case of the state of Washington's plans for a big stem cell program. Somebody up there in Olympia looked south and got jealous. Anyway LifeNews is apoplectic about the fact that the Governor of Washington is planning to put some or all of its $350 million tobacco money into stem cell research. It's a smart idea, one that several other states are considering but that Washington looks poised to push forward. Next: a tax on slot machines for ADD research, and after that look for a tax on prostitution to fund erectile dysfunction research.

The 5% Solution

AllAfrica and scidev.net London report on Peter Singer's (of Toronto) comments last week to the effect that the world's wealthiest countries should "allocate five per cent of their total spending on research and development to [fund scientific] projects that are directly related to the needs of developing countries." The context is the amazing study his research group in Toronto published in Nature Biotech in December, in which Singer and colleagues found that research in the developing world is burgeoning and needs only resources in order to grow dramatically.

Could this actually work? Would countries that spend a lot on research give their research dollars to fund competing efforts in tiny nations?

Canada, he says, has already taken up the charge:

Canada's prime minister, Paul Martin, keen to re-establish his country's reputation as a generous source of support for the developing world, has already taken up such a suggestion, and has recommended that his country should adopt the figure of five per cent as an official target.

He expects - amazingly - that Britain and indeed the entire G8 may adopt something like this guideline. And on a related note the EU has begun funding of an Africa research ethics group. Good stuff.

Now if only California could give 5% of Proposition 71 to stem cell research programs in developing nations...

Update on Brain Stealing in Maine

Maine's Portland Press-Herald updates its long series on the relatively large number of brains taken from deceased persons by medical examiners in Maine. Surprisingly, people don't like it when brains are removed from their dead relatives without consent!

"I think the medical culture historically has been one that says, 'We don't have to tell patients everything that we're doing. We're doing things to benefit parents and families, and they don't need to know everything,' " said Karen Maschke of Hastings Center ... The (new) notion is really informed decision-making, and people may decide to say 'no.' "

A Broad Bush Bioethics Agenda is Coming

Jon Moreno pointed us to this Reuters piece that cites a "senior administration official," who said yesterday that: "Bush plans to lay out a detailed, broader bioethics agenda in the near future." The agenda will apparently include the pursuit of "limits on other research conducted by what she called 'rogue scientists.'" But the big news here is that

President Bush plans to press for even stricter limits on human embryo research and has no intention of softening restrictions on stem cell research, a senior administration official said on Thursday.

Maybe we could put barcodes on the brains.

There is no NIH Reputation Problem Bad Enough to Make Me Sell My Stock

NIH employees are furious with Elias Zerhouni over his "'drastic' restrictions on stock ownership and other forms of outside income, which take effect today for all agency employees," writes Rick Weiss in the Washington Post this morning.

In a meeting yesterday, Dr. Zerhouni met the critics of his new policy:

"What I'm asking you to do is hold your fire until you hear the details," [Zerhouni] told the crowd assembled in an auditorium on the agency's Bethesda campus.

They held.

And when he was done, they let him have it.

One after another, scientists, doctors and other agency staffers stepped up to the microphones and raged against the new rules, made public Tuesday. By the time it was over, 90 minutes later, nary a positive word had been uttered about the new policy and there was more vented spleen around than a busy medical center like the NIH might normally see in a year.

Clearly, Zerhouni made his best case. And he has one thing going for him: he is clearly right when he argues that aggressive rules on conflict of interest may be the key to "save the venerable agency's reputation, which had become badly sullied after 14 months of embarrassing revelations about conflicts of interest among NIH scientists."

But he's asking for unmitigated selflessness on the part of every single NIH employee at the expense of people's college savings and nest eggs. And not all of these people in the NIH are susceptible to conflict of interest in the first place. Like Zeke Emanuel's secretary.

"Even my secretary is going to have to sell her stock. How much sense does that make?" fumed Ezekiel Emanuel, chairman of the agency's department of clinical bioethics.

But seriously, does Zeke's secretary own more than $15,000 in drug, biotech and medical stocks? Because if she does, maybe she is conflicted given that she works for the ethics department at the NIH. Don't you wonder just a little bit how anybody can own more than $15,000 in pharma and biotech and medical stocks and be utterly immune to the power that being in the world's brain center for medicine brings?

But there were other concerns from scientists at NIH that flat out make sense. Rick writes them up brilliantly:

"Does this apply to the Department of Energy? To the Department of Agriculture? To the Defense Department?" asked Elaine Jaffe, a pathologist who is chief of blood diseases at the National Cancer Institute, to cheers and applause.

"If we really want to reassure the public," Emanuel added, "why don't we apply these to everyone who gets an NIH grant?"

Again applause.

Another attendee noted that NIH employees are subject to periodic outside evaluations and reviews by nongovernmental scientists who are not subject to the same ethics restrictions -- a bizarre situation, the employee said, in which people with real conflicts of interest will be sitting in judgment of those with none.

Moreover, the NIH calls upon hundreds of outside scientists from academia and industry to judge grant proposals every year -- people who have far more power over purse strings than most employees but who will not be covered by the new rules.

That speaker was among several who refused to identify themselves to reporters because of fears of punishment by superiors at the Department of Health and Human Services. One told a reporter that employees were being "muzzled." Another said "there have been retributions." Neither would elaborate.

Still others complained that the stock restrictions will apply not only to themselves but to their spouses, as well.

"How can the U.S. government in 2005" define spouses as dependents? asked Abner Notkins, chief of experimental medicine in the National Institute of Dental and Craniofacial Research. "Spouses are independent people." He added that his wife has already contacted the American Civil Liberties Union to discuss the issue.

It will be interesting - and scary - to see how Congress - and by extension HHS and the White House - who dole out $28 billion to NIH annually, react to the concerns of scientists and others at the NIH.

Sound Off

It's Friday uh, Thursday. You know you want to kill some time. We know you do too because our traffic is through the roof today. Can you please help us out. It has been almost an eternity six months since this blog went up. What do you think/want/hate? Sound off blog addict.

Benching T.O. -- An Ethical Obligation?

Various opinions on the eternal problem of the non-compliant patient; this time with the Super Bowl and a stellar career in the balance:

"Philadelphia Eagles wide receiver Terrell Owens could suffer a career-ending injury should he play in Sunday's Super Bowl, and the team is ethically obligated to prevent him from taking such a risk, according to local medical specialists." [More from the Boston Globe]

-- Dominic Sisti

Sorry, Dr. Fishbein, We Meant to Say "We Love You!"

Jonathan Fishbein has been through the ringer, as we noted, and we also noted that he applied for 'whistleblower' protection. The Department of Health and Human Services has opposed him at every turn. But, you may have noticed that NIH is suddenly the 'market leader' on conflicts of interest, and seems to be pushing hard on other internal ethics initiatives. So, while the Washington Post is stunned to read about a change in position on Fishbein's status, we're not. It is just too bad that Fishbein has been through the ringer while waiting for this change of heart.

Religious Rites and Physical Injury

CNN.com is reporting the death of a baby boy who was one of three infants to contract herpes after a rabbi circumcised them.

Ten days after Rabbi Yitzhok Fischer performed religious circumcisions on twins last October, one died of herpes and the other tested positive for the virus, according to complaint filed by the health department in Manhattan Supreme Court.

RangelMD on Autonomy, the Family and the Law

We love RangelMD.com, and he's got a really poignant case this week on autonomy and family wishes.

The Most Important Ethics Article Ever Written

Is about the Eagles and the Superbowl. - Art Caplan

Zerhouni Means Business at NIH

NIH Announces Sweeping Ethics Reform, reads a major press release today from Bethesda, where LA Times reports that "all staff scientists at the National Institutes of Health will be banned from accepting any consulting fees or other income from drug companies, and the employees must also divest industry stock holdings."

I'm not sure why anybody ever thought that the old requirements, which really put the greatest emphasis on self-reporting and made some awfully charitable assumptions when it comes to enforcement, would keep researchers at NIH clear of major conflicts of interest - I keep thinking of the very poignant claim by Beecher all those years ago that the only way to really fix issues in research ethics is to teach researchers in a vastly less technocratic way than was (and is) the norm.

The focus is still on spankings for bad actions, rather than prophylactic ethics, though: LA Times is going to town with the idea that its exposes have resulted in a culture shift at NIH - but the report it gives of that culture doesn't sound so easy to ameliorate:

... scientists worked for drug companies that directly benefited from their recommendations to doctors. In other cases, scientists appeared at public forums and commented upon or endorsed treatments or drugs without revealing that they were on the payroll of companies making the products.

While the full list of new rules is not out yet, the Times reports that

All NIH scientists will be prohibited from accepting consulting fees, speaking fees and any other form of income from all biomedical companies, professional societies and other outside entities. The scientists must sell or otherwise dispose of any stock or stock options they hold in individual pharmaceutical or biotechnology firms.

And folks that there's serious teeth. Maybe, while we wait for folks to figure out that there will need to be major reform in how scientists are trained, these "new sheriff in town" rules will help keep things under control in the world's most important scientific institution. It is definitely big progress and sets a precedent for universities and foundations.

Bush's Bioethicists Under Fire Again for Political Role

This time it isn't Leon Kass stumping for President Bush's stem cell policies in the final months of the election cycle. This time it is President's Council on Bioethics member and Washington Post columnist Charles Krauthammer, for two things. First, heaping praise on President Bush's inauguration speech in his editorial writing - when he himself advised the president on the content of that speech. Second, and more important, he is accused of playing a somewhat inappropriate role for a journalist in that he was advising a president on a speech - particularly of this magnitude. It is actually a sort of strange charge, I think, but the Post is hammering away at it.

Krauthammer was invited to the 90-minute session by Peter Wehner, director of the White House Office of Strategic Initiatives. Presidential speechwriter Michael Gerson was also there, along with counselor Dan Bartlett, senior adviser Karl Rove and more than a half-dozen other administration officials.

Wehner's invitation said: "What should this administration do/say more of -- and what should it do/say less of? What are the key, achievable goals we should aim for during the next four years?" In a follow-up note, Wehner asked Krauthammer to lead off the discussion on "spreading liberty to the Middle East."

Now seriously, what possible purpose other than providing political advice can there be for a meeting with Rove and company? I'll wager that no member of the National Bioethics Advisory Commission ever met with James Carville, even just to tell jokes. But, then again, Harold Shapiro, its chair, didn't campaign for the connection between Clinton and NBAC recommendations during an election year either.

But I'm having trouble with the claim that Krauthammer is behaving any differently in terms of advising President Bush than are dozens of other journalists on the right who have well known positions. But then I am not a journalist. To wit: Fred Hiatt, while speaking in defense of Krauthammer's integrity, concedes that "Post editorial board members are not permitted to offer politicians private advice, but 'obviously I have less ability to set rules for people who don't work for me.'"

I guess I think it is much more problematic that the members of the President's Council are selling the product of their deliberations for profit through a commercial press. But that's just me.

Persistent Vegetative State Stories

Orlando Sentinel is just the latest Florida paper to tell the stories of PVS, a condition that with the Schiavo case has become a lightning rod for Florida politics. Everyone has a strong opinion - and notions of compassion riddle the stories no matter which side is telling. The PVS patient is very much alive in the Florida narratives. Alive both in the eyes of parents and loved ones and in a new kind of story - the story of what it "is like to be in PVS." It seems a little bit odd to me, almost macabre. This story focuses in particular on how the lives of PVS patients are animated by the incredible hopes of their families, who hope against all factual evidence that their children will snap out of a condition from which there is literally no chance of recovery:

MIAMI GARDENS, Fla. - (KRT) - Today is a lavender day. Edwarda O'Bara's nightgown, the ribbons in her braided hair, the sheets on her bed, are all matching hues of lilac.

For 35 years, she has lain in the same bed, locked in the same void, but her surroundings are cheerful, a palette of pastels, an oasis of warmth. Other than her prone figure and the pill bottles nearby, there is very little in the room to suggest "hospital."

Her mother won't have it. If nurses show up in white, Kaye O'Bara hands them a colored smock. The retired teacher has banished negativity from her house, just as she has banished the words her daughter's doctor uses to describe Edwarda's condition: vegetative state.

And she'll have fun, fun, fun till her daddy takes the T-Bird away...

A Washington Post article reports on an NIH study that the measures brain activity of adolescents and young adults when driving. The study suggests that the brains of young adults and adolescents do not mature sufficiently to adequately appreciate risky behavior when driving, and may not mature sufficiently until the age of 25. Partly as a result of this study, at least one state has passed a law banning the use of cell phones by drivers younger than 18.

This is yet another example of how strides in neuroimaging and neuroscience and our understanding of how our brain functions could have an impact on laws and policies.

-- Linda Glenn