blog.bioethics.net

Prisoner Organs from China Confirmed by BBC

BBC NEWS reports in this hidden camera story from China that organ sales are thriving there.

The BBC's Rupert Wingfield-Hayes visited No 1 Central Hospital in Tianjin, ostensibly seeking a liver for his sick father...

Officials there told him that a matching liver could be available in three weeks.

One official said that the prisoners volunteered to give their organs as a "present to society"...

Officials there told him that a matching liver could be available in three weeks.

One official said that the prisoners volunteered to give their organs as a "present to society"...

The American Journal of Bioethics
September/October 2006

Our new issue is out, featuring a number of interesting pieces, including, In Focus, Jessica Berg and Nicholas King on bioethics and disaster planning, Ricki Lewis on the Advanced Cell debacle, and Jonathan Moreno and Sam Berger on taking stem cells seriously. Jonathan Kahn takes on the issue of BiDil marketing - the "black drug" that didn't quite make it, Haavi Morreim, Baruch Brody, David Cassarett, Stan Goodman, Harvey Gordon, Robert Krouse, John Lantos, Barry Morenz, Ken Rosenfeld, Jim Sabin and George Webb, the ethics group for Abiocor Artificial Heart, report on the entire experience, in what is certain to be a timeless article on the experiences and debates the group both provoked and dealt with. And Charlotte McDaniel and colleagues study ethical environments in terms of healthcare work and patient outcomes.

This issue's target articles focus on two areas. First, bioethics and health disparities, a new area of emphasis for the journal, in the form in this issue of Mary Ellen Wojtasslewicz's article "Damage Compounded: Disparities, Distrust and Disparate Impact in End of Life Conflict Resolution Policies." Commenting on the piece are Mark Kuczewski, Robert Truog, Martin Smith, Mary Ann Bailey, Greg Loeben and others.

Also as a target, Christian Simon, Michelle Eder, Eric Kodish and Laura Siminoff author "Altruistic Discourse in the Infomed Consent Process for Childhood Cancer Trials." Commentators include Liva Jacoby, Katherine Wasson, Micah Hester and Chris Hackler among others.

Reviewed this month: a double review of the two Terri Schiavo exploitathons, Mary and Robert Schindler, Suzanne Schindler Vitadamo, and Bobby Schindler's A Life That Matters: The Legacy of Terri Schiavo–A Lesson For Us All; and Michael Schiavo and Michael Hirsh's Terri: The Truth. Kathy Cerminara authors that review. Also reviewed, Behind the Scenes: Chinese Voices on Abortion and Readings in the Philosophy of Technology

And among the correspondence this month a defense of the PolyHeme clinical trial, recently concluded and brought into the national spotlight by AJOB and the Wall Street Journal; Anne Hamilton Dougherty authors that letter.

Enjoy.

Will Bioethics Take the Life of Philosophy?

From the Editorial in the September/October issue of The American Journal of Bioethics:

Stephen Toulmin asked whether the challenges of medicine present either a special case for the utility of philosophical methods in professional practice or an essential test of whether the role of the philosopher could return to an earlier, central place in the discourse of literate society. His oft-cited essay “How Medicine Saved the Life of Ethics” was one part of a broad but short-lived emphasis in the literature of philosophical ethics to craft a special institutionalized activity, largely in philosophy departments, that aimed at returning ethics as a theoretical pursuit to the American social agenda.

There exist a few clever exceptions, such as the presence of perhaps a dozen fully credentialed, “practicing” philosophers, e.g., Ph.D.s working as sheriff’s deputies, therapists, or elected officials, but one can point to a general failure of the discipline of philosophy to adjust its modes of training or scholarship in response to the experiences of or opportunities for philosophers who are “applying ethics” to modify social institutions. We do not teach philosophers to or solve the ethical problems of individuals in any way that places the philosopher in a direct, Socratic interaction, apart from classroom teaching.

One need not point to the fact that the young philosopher who writes popular books or articles in non-philosophical journals, or who pursues a non-standard research agenda clearly marginalizes him or herself. This would have been viewed with incredulity only a century or so ago by, e.g., the Harvard philosophy department of William James’ era, and indeed by philosophy across much of the history of western philosophy. Utilitarianism was published first in a womens' magazine in Britain.

Today, if you want tenure as a philosopher, the wrong path is public engagement.

One need not point to the almost mandatory hyperspecialization of the most successful graduate students in philosophy, programmed into the arcane style of philosophical dissertations or the general resistance of faculty in the most prominent philosophical institutions to mentor their students in bridging the gap between philosophical rigor and the idiom of the general public and its media. Just no- tice where philosophers are not. In bookstores, “self-help” replaced philosophy by 1985. Philosophy courses are no longer mandatory in most universities. Philosophers comprise only a tiny and shrinking number of columnists and essayists in mainstream literature. And where philosophers are present they are often selling something: the validation of the current mode of teaching the discipline.

So it is not surprising that philosophers both seem, often, to be the most qualified to make a valuable, timely and historically informed contribution to public debate and education yet least likely to make it.

I will not pause, as have some historians of philosophy, to amplify the observation made by Toulmin himself that the rarification of contemporary philosophy has lessened the possibility that a philosopher trained at, e.g., New York University, Princeton or Harvard might ever play the kind of social role of Socrates, Aristotle or even Nietzsche, not even while holding a post in a philosophy department that ranks among the top “applied ethics” departments in Brian Leiter’s “Philosophical Gourmet Report,” a now oft-cited ranking of the key departments in the field.

Instead I want to identify why disciplinary philosophy’s attempts to create a new area of specialization, training and publication, which Toulmin believed could save the discipline from the irrelevance that Dewey predicted would otherwise come for philosophy in American political and moral discourse, have failed.

Only the briefest review of applied ethics’ most successful inroads over that past twenty years is required to see the scope of this failure and its significance.

In the application of philosophical work to medicine, Stephen Toulmin, Al Jonsen, Arthur Caplan, Tom Beauchamp and James Childress, Norman Daniels, Donald Light, William Winslade, Mark Siegler, among others [and not all of whom are philosophers], have authored canonical textbooks that attempted in part to make philosophical material more accessible by reducing complex moral problems to formulae and/or principles that can be applied in the course of ordinary medical practice in a coherent way. These writers and others stress those elements of moral philosophy that are most compat- ible with allopathic medicine. Each principle seems chosen, or at least translated, for the purpose of maintaining its relative ubiquity, for its relevance to the law, policy, and practice of such diverse medical endeavors as trans- plantation, genetic engineering and euthanasia, and for its simplicity.

This spread of “cook books” in bioethics has been, of course, much criticized and viciously by philosophers, and today books of this sort are almost never reviewed in philosophical journals, but neither have they been considered.

Toulmin suggested that if philosophers were not able to solve such problems as were encountered in professional clinical practice of the early 1980s, they “might as well close up shop.” ...

[read an uncorrected [sorry] galley of the rest of the Editorial]

The Juice of Humanness

Richard Dawkins' blog discusses embryonic stem cell research, and while he hs nothing particularly earth-shattering to say, and repeats without coming anywhere close to citing an argument that has been made (um, by us, with an extensive response by Gil Meilaender in the Hastings Center Report, a response in which he basically calls us Nazis), he does make some pretty Dawkins-like comments about moral standing of embryos relative others, so if you are anything like the rest of my Dawkins-loving friends, you'll find it interesting that he refers to objections to embryonic stem cell research as "fundamentally un-evolutionary:"

...partly a mystical reverence for humanness, as though all cells of Homo sapiens are suffused with a divine essence, some sort of sacred juice called Homsap, which no other species possesses.* Such a notion is fundamentally un-evolutionary. At what point in the line of descent from the common ancestor we share with chimpanzees, was the divine essence first injected? If you set aside what it will eventually grow into, there is no important difference between a human blastocyst and that of any other mammal. So we are left with the fact that human blastocysts, which can feel nothing now, have the future potential eventually to develop into beings that are capable of human suffering, human loves, hates and fears, human consciousness. It seems to me an inadequate basis for an ethical decision. Even if you disagree, you should surely at least consider the relative moral status of an Iraqi or Lebanese whose capacity to suffer is not just potential in the future, but here and now in the present.

If you ask me whether I care more about the destruction of a blastocyst, which theoretically has the potential to develop into a conscious human being, or the painful killing of an adult cow in an abattoir which has already reached its full potential, my answer is not in doubt. If I see a terrified cow about to have its throat cut by a Jewish or Muslim slaughterman who insists, purely for religious reasons, that it must be fully conscious when the knife hits, I want to intervene on its behalf. If I see a human blastocyst the size of a pinhead about to be flushed down the drain, do I want to intervene on its behalf? Oh come on, get real."

[hat tip: Rob Baird]

Life is Spinach. Mmm.

We have all been aware of the recent contamination of spinach with e. coli. Certainly, the concern is justified. But why, asks Thomas Rooney of Insituform Technologies, a sewer and water repair company, is no one talking about the increasing contamination of our waterways and beaches?

Rivers and streams such as the Flambeau River in Wisconsin, St. Mary's in Michigan, the Delaware in Pennsylvania, and a number of others in the US and Canada have been found with high e. coli levels in just the past month. Beaches periodically close in Florida as well as Calilfornia because of outbreaks of bacterial infestation.

According to the CDC, e. coli bacteria infect approximately 73,000 people a year in the US, causing an average of 61 deaths annually. Coincidentally, Mr. Rooney reports that last year, there were 73,000 sewer spills in the US, and the aging of our sewer systems only promises to make things worse. Sickness from e. coli is one of our most preventable public health problems, and it is spreading.

Let's hope the CDC sees the spinach outbreak not as an aberration, but as the canary in the mine. We have come from discovering that cholera was spread through a central water source to testing water to parts per billion in a short time. It would be a shame if our unwillingness to invest in our infrastructure set us back again.

(And by the way, Mr Rooney reports that the stories about alligators in the sewers are true -- along with racoons, shopping carts, and just about anything else you can think of. And if you don't belive him, he has videos).
-Paul Root Wolpe

Egg Donor Protection Law is Up

The California Stem Cell Report blog, the best source of up to the minute stuff about the gazillion shifts in California's sands where stem cell money and research are concerned, reports that the Ortiz bill has been signed, which essentially means there will be real and significant limits on compensation of women with regard to egg donation. It's driven me nuts forever, this preposterous reluctance of IVF and research groups to put a lid on the payments to donors. But it is what it is. Except, now, in Cali.

Oregon Reproductive Case

There are enough goof-ups, mistakes and twists and turns in this case to take up an entire course on ethics and reproductive technologies.
- Art Caplan

Routine HIV Testing for Everyone. A Good Idea If You Can Sell It

The CDC finally has issued its recommendations that all adults and teenagers in the United States be offered routine HIV testing as part of their annual physical – assuming they get an annual physical. Of course, we’ve been discussing the ethics of routine HIV testing in the bioethics and public health community for decades, focusing on issues of privacy, stigma and discrimination – fiddling, some argue, while cities like New York and San Francisco burn. The grim fact is that the number of new HIV infections has hovered around 40,000 newly infected individuals per year since 1990, regardless of whatever new prevention strategies and messages public health officials and advocacy groups have dreamed up. Maybe the CDC’s recommendations can help. A surprising number of HIV-infected individuals in the United States are completely unaware of their serostatus. They’ve never been tested, either because they do not believe that they are at risk or because they won’t ask their doctor for testing out of embarrassment or fear of revealing that they are gay, a drug user, or the sexually active teenage daughter of the local evangelical minister.

Even before the likely recommendations of the CDC task force first became known in May of this year, several states, districts and municipalities hardest hit by the HIV epidemic had already begun to explore new ways of increasing awareness and testing. Consider, for example, the District of Columbia’s campaign this past summer urging every resident between the ages of 14 and 84 to be tested for HIV.

So what happens now that we have federal guidelines for routine testing? Now comes the fun part, as individual states consider whether or not to adopt the CDC recommendations, if they even can under existing state laws. Thomas Frieden, the New York City health commissioner, already is on record as saying he agrees with the new recommendations and reportedly has been actively lobbying the New York State Legislature to incorporate them into the state’s Public Health Law. But here in my adopted state of New York we also have some of the nation’s strictest privacy protections, with the law requiring HIV counseling and voluntary informed written consent prior to testing (unless, of course, you’re a pregnant woman – we also are one of only two states with mandatory HIV screening of newborns, and detection of HIV antibodies in the infant’s blood automatically reveals the mother’s positive serostatus). Contrast these laws with those of my home state, California. California does not require separate written consent for an HIV test, and the San Francisco Department of Public Health recently amended city policy to eliminate the need for written consent there.

From my own experience as an HIV researcher in New York, I can tell you that HIV counselors in the state are already overwhelmed; there are too few counselors, too many patients, and not enough money in already tight public health and hospital budgets to train and hire more. So do we weaken these privacy protections, as Dr. Frieden would seem to advocate? New York City officials proposed this last summer, holding a series of meetings in which they proposed changes to New York’s HIV testing laws, including abolishing the requirement for separate written consent for an HIV test. Needless to say, those meeting didn’t go so well. Representatives of civil liberties groups and organizations that serve people with AIDS were outraged.

There still are a number of unanswered questions about routine HIV testing. For example, do the benefits of universal screening outweigh the costs and risks, given the wide disparity in HIV infection rates between the various states? Who will pay for expanded screening, particularly as Medicare is not allowed to pay for routine screening tests unless specifically authorized by Congress?

The feds have weighed in. It’s now up to the laboratory of the states to find the answers.

Sean Philpott, Executive Editor

Dr. Frankenstein at work in Slovenia on ESCR

Don't know if faithful readers of this blog saw the announcement which was lost amidst the hullabaloo about the creation of stem cells from dead embryos but a team of researchers in Slovenia recently announced that they had cloned stem cells from embryos that had been transported back in time. Lead scientists Slobodan Putoneoveronski announced at a press conference amidst the ruins of a medieval monastery in Kranj, where it is believed a prototypical university once stood, that as a result of Slovenia's open policy toward embryonic stem cell research he and his unified Korean team of North and South Korean scientists had, with the support of a generous grant from the Committee to Annihilate Poor and Extraneous Research (CAPER) located in the Kamnik Alp town of Raduha, had successfully beamed a set of eight embryos back from the 22nd century. "We don't know exactly who or whom may have been the source of these embryos or even if they are embryos but we have every reason to believe that they were intact, potent and fully functional upon arrival in Kranj. Each embryo was capable, when subjected to enormous physical pressure when placed gently upon a growth medium of potica and struklji of producing a small pedicle which they belived to be a fully totipotent stem cell" one of the North Koreans said. Putoneoveronski immediately announced that he and his team intended to conduct experiments that might be published some day in a peer-reviewed journal to verify these insights.

Not everyone was thrilled with this pathbreaking work to find new sources of embryonic stem cells.

Hugo Chavez, Noam Chomsky, Madonna and Athanasius, Bishop of Alexandria, issued a joint press conference condemning embryonic stem cell research, time travel and the poor status of tourism in the Kamnik Alps. Each promised to find other irritating things to say about topics they were unfamiliar with in the weeks to come.
-Art Caplan

Attention Poor People: If You Want Medicine, You Must Become a Research Subject

Andrew Rosenthal pointed out this piece from August JAMA that we missed, the claim by Miller and Emanuel that it is not problematic for Medicare to:

allow certain services and treatments to be covered if patients participate in clinical trials. According to the authors, the policy has been used in many high-profile decisions, but critics say the policy is coercive and unfair. The authors say that the policy is not unethical because patients are not automatically entitled to new treatments that would be covered under Medicare. The authors also discuss the cost concerns associated with determining which treatments will be covered through the policy; the policy's importance in making coverage decisions; and whether the policy can play a role in balancing the needs for better effectiveness with the needs and desires of patients for access to new treatments.

Yup, no coercion there. Right.

Whole Lot of Sex Selection Going On

Could it be that IVF, faced with a drop in the number of adults who want children as the baby boomer generation ages, is about to try and transform itself into a treatment that makes parents 'happy' about the traits of their kids?
[MSNBC coverage] - Art Caplan

Blastomere Blasphemy: Advanced Cell Technology, the Media and the Lost Opportunity in Stem Cell Research

In the current issue of The American Journal of Bioethics our new regular contributor and amazing essayist Ricki Lewis writes about what she calls Blastomere Blasphemy:<

Sometimes a few words make a huge difference. In the late-summer saga of obtaining human embryonic stem (hES) cells from single blastomeres of eight-cell-stage embryos, the damning words were “while leaving the embryos intact”. The ensuing angst exemplified how oversimplification in science reporting can widen the divide between scientists and the public.

Algebra 101 and Biology 101

The first news release sent to reporters by Nature magazine heralding work at Advanced Cell Technology (ACT) of Worcester, MA, and referring to an online pre-print-publication (Klimanskaya et al. 2006) stated, “By plucking single cells from human embryos, Robert Lanza and his colleagues have been able to generate new lines of cultured human embryonic stem (ES) cells while leaving the embryos intact.” The problem: while the technique could, theoretically, have left the six or seven-celled remainders able to complete development, or at least survive until the blastocyst stage at which hES candidates are usually isolated, that had not yet been accomplished. One must infer from numerical data in the online report that the biopsied embryos had not gone on to become babies. And here is where the linguistic disconnect occurs. The data in the report are indeed plain as day that the embryos were destroyed – but only to biologists. Let me explain.

The information that the embryos did not survive is conveyed in language akin to an algebra problem. The first paragraph of the online report states that 16 embryos were thawed and had cells removed. 53 of the removed cells divided, and these 53 represented 58% of the total number of cells removed. Got that? Solve (0.58)X = 53 for “X” and you get 91 blastomeres. Next leap: 91 blastomeres from 16 embryos means more than two from each, which spells “destroyed”. Short feature articles in the print editions of Nature and Science, dated August 24 and 25, respectively, present the 91-from-16 critical information, albeit with lots of qualifying “cans” and “coulds” (Pearson 2006; Vogel 2006). Only the Nature feature spelled out that the embryos had been dismantled.

Now switch to basic biology. The reason that an eight-cell human embryo can spare one or two cells and still develop is one of the characteristics that includes us among the deuterostome animals, along with other chordates and the echinoderms. If such an experiment were performed on a protostome, such as a boll weevil or an octopus, the sampled embryo would be kaput.

The initial Nature news release, sent to reporters all over the world, catalyzed a series of events that not only detracted from the significance of the ACT research, but also fueled public distrust of stem cell researchers. Was this to be another chapter in the saga started by Seoul National University stem cell researcher Hwang Woo-suk? The fuss also drew media attention from other stem cell research announced at about the same time that was, in my opinion, equally compelling – nurturing adult human neural progenitor cells from medical waste.

Correction and Spin Breed Suspicion

After a few media reports based on Nature’s initial news release prompted inquiries as to what actually befell the 16 embryos, the journal issued a “corrected” news release. It omitted the key five words, and added that the ACT embryos were biopsied more than once apiece. The embryos’ demise could perhaps have been inferred by someone familiar with the aforementioned deuterostome/protostome distinction. Reporters who had relied on the news release from ACT issued August 23 rather than the original Nature release might have had a heads-up on the oversimplification that to some smelled of deception. The company’s more guarded announcement stated: “ACT today reported that company scientists have successfully generated human embryonic stem cells (hES cells) using an approach that does not harm embryos” (ACT 2006).

True enough. The approach used was similar to preimplantation genetic diagnosis (PGD). The decade-old technique offers quality-control type testing of the 8-celled, indeed just what ACT would have done had they taken only one or two cells per embryo. But they didn’t, at least not in the experiments covered in the online report. The reasoning again seems vaguely algebraic: “removing one or two cells for PGD does no harm. We can take away more than two cells and generate hES cells. Therefore, taking away one cell can preserve the embryo and also generate hES cells.” If a=b and b=c, then a=c may work in logic, but it leaves a gap in research. However, the experiments that “retrieve” only one or two cells have indeed been done, successfully, and are included as an Author’s Note in the print version of the Nature paper (R. Lanza, personal communication).

Coverage in The New York Times (Wade 2006a) accurately echoed the Nature news releases, focusing more on the potential of the approach to avoid harming embryos than on what had been accomplished technically. An impressive group of commentators put the work in perspective, all assuming that ACT had indeed nurtured the cells from embryos that survived. Other reports spread the story.

On August 30, the New York Daily News published an essay by the father of two children who began their existence as PGD-probed embryos, celebrating the ACT success (Skenazy 2006). Unfortunately the headline, “Anti-stem cell zealots are all out of ammo”, proved premature. Government-speak was hastily rewritten to express fear of harming embryos, rather than killing them. Many critics seemed oblivious to the long and successful history of PGD, and Lanza’s statements that cells used in the ACT technique would come from embryos slated for PGD anyway.

By September 2, the corrected news release itself had become the story. The New York Times reported that both the Nature article and the corrected news release from the journal had “made clear” that the embryos had been destroyed (Wade 2006b). The Washington Post used similar language. Since I could not find the word “destroyed” in the news releases in relation to what ACT had done, I wondered what, exactly, “made clear” meant. Had any reporters actually read the online report that Nature provided along with the news releases? So I read the online report for the third time. Still, all I could find was the algebra exercise and an inferred step that might have gone somewhere between disrupting the zona pellucida and separating the selected blastomeres. I finally contacted Dr. Lanza himself, who confirmed that the only reference to the fate of the embryos was in the numbers. This is what the media collectively deemed a “very clear” explanation. Game of telephone, anyone?

With all the confusion, it wasn’t surprising that Arlen Specter (R-Pa) and Tom Harkin (D-Iowa) berated Dr. Lanza before the Senate Appropriations Labor, Health and Human Services subcommittee for confusing the theoretically possible with what was actually done in the reported experiments -- even though stem cell research at ACT is privately supported, the researchers had followed the protocol and language of any other technical paper about deriving hES cells, and Lanza et al had in fact done the key experiments but had not yet published them.

But this is a tale distinctly lacking in logic. The fact is, research reports on hES cells are subject to greater scrutiny than others, at least in the U.S. Senate subcommittees hardly convene to probe the manner of death of rodents when a new knockout mouse debuts, nor do researchers routinely spell out how various model organisms meet their ends – it isn’t relevant. But using human embryos for research is another story. So I don’t think it was necessary for the ACT team to have spelled out what was obvious to its intended audience of scientists, but it might have been prudent to have done so – or at least for them to have reviewed the first Nature news release before it was sent to reporters, which Dr. Lanza claims they didn’t have the opportunity to do.

It’s a shame that little attention was paid to the results, which were spectacular. The hES cells indeed gave rise to specialized cells representing all three primary germ layers, differentiating into such potentially clinically useful cell types as endothelium, retinal pigment and other epithilia, hematopoietic cells, and neural progenitors. The effort that went into characterizing these cells was simply astonishing – and that was very clear, if underreported.

The brouhaha over the ACT work all but overshadowed a report from the University of Florida’s McKnight Brain Institute, published online August 16 in the journal Development (Walton et al. 2006). Coverage was turned down by at least one large newspaper that jumped at the ACT release a week later. In science as well as in everything else, apparently timing is everything.

Stem Cells From the Brain

The McKnight Brain Institute investigators cultured gray matter from the brains of people who had undergone surgery to treat intractable temporal lobe epilepsy. The cells came from various brain regions, including the subventricular zone (a known incubator of endogenous neural progenitor and stem cells) and also areas not known for harboring stem cells. The cells sampled from material otherwise destined for the trashbin were cultured, allowed to divide, seeded onto culture flask interiors, fed cocktails promoting stemness, given various labels, and analyzed several ways. One way was to transplant the cells into the lateral ventricles of nude mice, a nurturing niche for stem and progenitor cells. Slices of the mouse brains later revealed adult human neural progenitor (AHNPs) cells complete with migrating axons – and not only in the parts of the brain that are normally stem cell repositories.

As with any scientific research, the McKnight work raises further questions. Did the protocol select pre-existing, albeit rare, AHNPs and create conditions that favored them, or stimulate neurons or glia to actually reverse their specialization and enter a progenitor-like state? Ongoing experiments will distinguish these two possibilities – either of which has intriguing implications – or reveal that perhaps both occur. If implants are ever devised from endogenous cells, how will their growth be controlled? Although the AHNPs were restricted in their potential compared to ES cells, the researchers predict that a single one could potentially divide to yield 40 million or more cells. That’s a lot of potential brainpower.

While comedians and cartoonists had a field day a few years back with the idea of customizing stem cells from liposuction leftovers, the possibility of nurturing progenitor or stem cells from medical waste is, I think, tremendously exciting. It means that the seeds of treatment for the millions of people with neurodegenerative diseases are sitting right there in their heads, ripe for the picking, so to speak. Perhaps ES cells are more newsworthy because of the controversy. Many developmental biologists do consider them to be more promising in an overall sense for regenerative medicine. But if neurons are the goal, then harvesting AHNPs from a patient’s own brain, rather than going the somatic cell nuclear transfer route, seems a win-win situation. At least this strategy should be free of the political agenda that is strangling even privately-funded hES cell research in the U.S.

Lessons Learned

What can we learn from the game-of-telephone that ensued with the announcement that ACT researchers had found a way to culture hES cells without harming embryos? That depends on who you are.

If you are a reporter, go to the primary source! If you want to know whether ACT researchers let their plucked embryos cease developing or put baby bonnets on them, read their papers! Ask them what they did! A news release is a teaser, not the whole story.

If you are a researcher in the U.S. working with hES cells, and you publish the work, spell out what was done in plain English, even using the “d” word (destroy). It is better to be blunt and state the obvious than to risk the taint of perceived deception because reporters or the lay public cannot effectively read between the lines.

If you are neither reporter nor researcher, but John or Jane Q. Public, put technical reports on hES cells in context with the raw facts:
Embryos are routinely discarded in fertility clinics at the donors’ request.
Abortion is legal. It happens.
PGD is an established procedure, not an experimental technique with unknown risks.
Millions of people who have already been born suffer from illnesses that can potentially be treated with stem or progenitor-cell based therapies.
The true crime is the stifling of hES cell research.

Welcome Ricki!

Are Cancer Docs Conflicted About the Drugs they Prescribe?

gThat's the question asked by Brian Williams of ethicists.
-Art Caplan

[Insert Chess Joke Here] Castle Ready for Another Suicide Run on Stem Cells

CAMR reports:

Rep. Michael N. Castle (R-Del.) Sept. 14 reaffirmed his intent to introduce next year vetoed legislation to expand federal funding for embryonic stem cell research, but said that the Bush administration will continue to be the biggest obstacle in moving the bill forward.

Castle was the author and primary Republican House sponsor of H.R. 810,
a bill that would have allowed discarded embryos from in vitro
fertilization clinics to be used in federally funded research, lifting a
White House restriction on funding for study of embryos created after
the policy was announced in 2001. The bill passed both the House and
Senate, but President Bush vetoed H.R. 810 within days after it reached
his desk, the only veto of his presidency so far (5 MRLR 513, 8/2/06 ).

"I guess you could entitle this talk, 'The Making of
Legislation--Almost,' " Castle said to a group of federal employees and
corporate executives at an event sponsored by the Brookings Institution.
"It's the story of incredible success in terms of passing legislation
that was not wanted by the majority ... Obviously I'm not happy because
we didn't get it made into law."

Uh. Hello STOP Not going to happen STOP Put energy into states STOP EOM

[Insert Penis Here]

Naturally Bill Saletan has the most interesting take on the transplant of a penis in China, where naturally getting penises transplanted should be a top public health priority. His links are great but here's the stub [ok that's a technical term in Wiki so don't get all stiff on me]:

Chinese doctors performed the world's first documented penis transplant. An unexplained accident left the patient with a "small stump," unable to urinate properly or have sex. Doctors gave him the penis of a brain-dead man whose parents agreed to donate it. Good news: After 10 days, he could "urinate smoothly" and showed no signs of tissue rejection. Bad news: After two weeks, "because of the wife's psychological rejection as well as the swollen shape of the transplanted penis," the organ "regretfully had to be cut off." Upbeat conclusion: We're figuring out the human body. Skeptical conclusion: We still have no clue about the human mind. (For updates on the world's first two face transplants, click here, here, and here. For Human Nature's take on genital mutilation, click here.)

And no, we will not have a special issue on this. Faces was where we stopped. We quickly learned that we were in fact driving the increased publicity for the face transplant debate, which led to a movie deal and horrific and stupid conversation about what could and should have been the sort of issue that was discussed in our issue, but which got covered because every reporter on the planet saw the pretty cover and press release from us and suddenly the obscure little IRB protocol in Cleveland was big news. Oops. We all went limp over that.

Genetics for Evil and for Good

The average age of holocaust survivors is now 82, and there is precious little time to link them to whatever lost family members might still be alive or to let them know the fate of loved ones they lost track of in those terrible times. So kudos to Syd Mandelbaum, Gene Codes, Michael Hammer, and James Watson, who are collaborating on the DNA Shoah Project. Bones from victims of Nazi terror are being discovered all around Germany and other European countries, and until now there has been no way to identify them or link them to survivors. Due to the need to identify remains in the aftermath of 9-11, Gene Codes developed its Mass Fatality Identification System which is being used to identify the bone fragments that still exist from the Holocaust.

The irony should not be lost here; a set of genetic tools is being used to help the victims of a regime who based its killing on a distorted vision of genetic purity. There is a kind of poetic justice in that.
Paul Root Wolpe

The Dumbest Stem Cell Propaganda Ever

The Dream Team. Not.

Perfect.

WiCell, a subsidiary of the Wisconsin Alumni Research Foundation (WARF) is famous for attempting to claim incredibly broad patents in the area of stem cell research (I half-expect them to start billing all pregnant women for creating new embryonic stem cells). Advanced Cell Technology is earning a growing reputation for hyping and misleading the public whenever they need an infusion of cash. What could be better than for these two institutions to get together and create an agreement to jointly distribute new cell lines?

As soon as Bush recognizes that the new ACT method solves all of the ethical and political objections raised by stem cell opponents and allows funding of the new ACT procedure, then WiCell would distribute them.

By the way, there is no confirmation to the rumor that ACT is attempting to develop a method of abortion that foes of abortion will find morally acceptable.
- David Magnus

Stanford: No More Small Gifts

New York Times reports on the dramatic embrace by Stanford of the principles at the heart of the AMA report recommending against acceptance of even small gifts from pharmaceutical companies. AJOB's own David Magnus helped his institution create the policy, which has teeth:

''Gift giving creates a reciprocal obligation that is a powerful force, and pharmaceutical companies know this very well,'' said David Magnus, director of the Stanford Center for Biomedical Ethics who helped write the new policy. ''So we're discouraging it from happening anywhere at the medical center.''

No free samples. No ghost authorship of articles. No coffee mugs, drug reps dropping in without appointments, not even any pens. It's all over for pharma trinkets, folks. The old line, nicely delivered in the AP piece, just doesn't fly anymore:

...if I was concerned that my doctor was influenced by a pen or a slice of pizza, I would find another doctor.

Pens do influence physicians. The key study proving that small gifts have a big effect was published in The American Journal of Bioethics in 2003, and though you may be thinking "but obviously small gifts work, or drug companies wouldn't spend tens of millions on them, or more, every year," the data confirming that fact somehow remained a matter of advertising research, and then of bioethics conversation, until the JAMA report - and even then nothing really changed until a few schools picked up the mantle.

But Stanford, which is per capita (with its tiny but hyperproductive faculty) easily the most engaged in relationships that transfer research into technology, well, when Stanford locks out the drug companies it is a sea change.

Six Degrees of Scientific Misconduct

Stanley Milgram one of the 'giants' of social science seems to have misrepresented the findings in one of his classic studies. Maybe we are not as interconnected as we think we are! And what sayeth those social scientists who continue to insist that there is no need to hold their feet to the same regulatory fire as pertains to medical research? - Art Caplan

Paging Dr. Hwang?

Wired Bodyhack, who have shifted into Full Reverse after their initial skepticism about our initial skepticism about the ACT experiments, notes that the problems with the ACT Nature experiment go far beyond killing the embryos in the experiment:

What they [also] apparently didn't report in Nature is that they soaked those individual cells in the same dish as the "parent" embryo for a while, so the single cells received important signals from the solution that it needed to survive."

Robert Lanza is visibly shaken meanwhile, though photographs of him disappearing into stress camp have not yet emerged.

Guest Post:
The Hidden Cost of our Stem Cell Policy

The President’s stem cell policy not only hurts federal research, but also wastes state and private money. In a report entitled “Too Much to Ask”, the Center for American Progress found that states have spent 86% of their funding on building infrastructure, training scientists and attracting researchers to the state, not on actual research.

The restrictive federal policy means researchers cannot use facilities or equipment purchased with federal funds to conduct research on stem cell lines that are ineligible for federal funding. This has forced states and private funders to spend large sums of money on redundant equipment and laboratories, as well as create expensive bureaucracies to track which costs can be paid with federal funds.

New Jersey is spending 75% of its money for stem cell research on new equipment and a stem cell research institute. The University of California-San Francisco is spending $6 million to remake a lab for stem cell research. As Dr. Dave Scadden, Co-Director of the Harvard Stem Cell Institute, said, “It really is something that has a very real impact and I can tell you, at our own center we have people using methods of analysis that we haven’t used in 10 years simply because the instruments that we usually use are ones that have federal money associated with them.”

While a higher percentage of future state funding will go to actual research projects, federal inaction is increasing the burden on state governments, taxpayers and private investors, and slowing down stem cell research too.
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Sam Berger, Research Assistant at the Progressive Bioethics Initiative at the Center for American Progress

The Kevorkianization of Stem Cell Research

Believe it or not I was working on a column about the dangers of well-intentioned but hype-seeking stem cell researchers - finished it actually - before the Advanced Cell Technology people decided that the correct way to please the right to life crowd was to take IVF embryos (all together now, chant with the predictable pro-life response: "IVF=murder") that have been put through genetic diagnosis ("PGD=eugenics") and grow their cells in a way that might or might not yield good stem cell colonies but likely would produce at least a few totipotent cells as a byproduct ("cloning is evil").

To make sure the experiment aimed at pleasing pro-life would actually work, they tried it on 16 embryos first, then killed them all (Inside the mind of Richard Doerflinger: "please, please let these guys stay in the paper just one more day...") and justified the fact that none of the people who were supposed to love their experiment actually did by calling them (Lanza's words) "irrational" ("scientist=athiest or anti-catholic").

If there is a school to teach scientists how to screw up the pursuit of PR, ACT has the professors on retainer.

What is so puzzling is that the piece that reported this great innovation [well, great in the mind of William Hurlbut, though not particularly interesting to anybody who doesn't buy the science or ethics of these continuing, idiotic schemes to make "part embryos" in order to get Bush money] in Nature was interesting - at the level of a piece that merits publication in Nature - only because it was supposed to solve the ethics problem by appeasing those who seek embryonic cells created without an embryo. Hence there was no PR officer, just the ethicist, since the whole business amounts to an "ethics experiment."

So here is the ethicist and Lanza, the former constantly (and inaccurately) referred to as "unpaid" as though he spoke from a distance, defensively spinning this experiment rather than bothering to even consider the objections raised by those whom the experiment was supposed to please. It was like reading that "ask the ethicist" nonsense in The New York Times: as recently as yesterday Green was actually quoted as saying that if it weren't for all this controversy, there might be tons of new stem cell lines very soon [without any destruction of embryos] (which the experiment didn't prove), and that - my favorite - the controversy about the experiment just proves that there is lots of interest in this work.

Go team. Except, not.

The controversy proves unambiguously that ACT can cause half of the U.S., including the intended audience to be appeased, to believe that the people with whom they disagree are not so much trying to respect their beliefs as to create monstrous half-embryo things using technologies that only Frankenstein could love - and then to duck and cover when things go badly. And to sell it all with the ethicist who is "unpaid" doing PR. ACT has been through four or five cycles of scandal, depending on who is counting, each time repeating the same cycle of misbehavior. It's time to stop blessing these guys with ethics PR. Please, Ron, give it up before ACT becomes the undoing of embryonic stem cell research.

I've already read five commentaries by major conservatives comparing ACT to Hwang. It is awful and irresponsible but you guys are asking for it. Can't we just be honest and say that we favor embryonic stem cell research, at least for now, since that's what happens at ACT (and since it is true), even though the research destroys embryos? Can't we just say that the Bush policy is idiotic and that the new "alternatives fund" is worse yet? Must you pander to the neocons?

I continue to be amazed at the degree to which this company manages to do more harm to the battle to get embryonic stem cell research funded than could any concerted right wing campaign against the research. ACT is the Kevorkian of stem cell research.

Of course, having written this piece before ACT lept out into the sun, I used my friend Ian Wilmut's recent experiences in the same vein to make the point. The enemy of my enemy, in the case of stem cell research, is not necessarily my friend. Jack Kevorkian didn't do much for end of life care or the battle to provide hospice care. And the mantle of Kevorkian has been handed over to ACT, or at least that is what I claim in the September issue of The Scientist:

Since the cloning of Dolly the sheep, research involving nuclear transfer-derived cells - and intelligent debate about that research - has been plagued by a phenomenon you might call "kevorkianization." Whatever your view of physician-assisted suicide, the now-legendary convicted felon Jack Kevorkian was the last person on earth who should have been the public advocate for the procedure. Dropping off cadavers in a rusty Volkswagen van on the way to press conferences, he turned euthanasia into reality TV, extolling wisdom about the wishes and conditions of his "patients" and promoting a chain of euthanasia shops.

Kevorkian's untimely decision to make theater out of coping with suffering at the end of life resulted in the total collapse of public discussion about the national need to improve hospice care, nursing homes, and Medicare. To this day, far more attention has been focused on assisted suicide in Oregon than on the drug needs of elderly citizens.

And so it is with the manipulation and engineering of cells. In February 1997, Ian Wilmut kevorkianized nuclear transfer. First, he elected to label the most revolutionary and complex exercise of human procreative control in history as "cloning," conjuring up inaccurate images of a Xerox machine that would yield two, say, Kate Beckinsales. Worse, the first "clone" was named after Dolly Parton, the well-endowed country music singer, because the embryo was engineered in part from adult sheep mammary cells. Wilmut gave his first press conferences unprepared to face questions about why anyone would birth a mammal using nuclear transfer without first holding, at a minimum, an ethical discussion about the implications for humans and agriculture. He was clearly horrified by the subsequent misuse of the word cloning by the media, and was the first to embrace the harried explanations by bioethicists that a cloned human wouldn't be an actual copy.

But the sheep had already been labeled. The world went nuts in a mad rush to ban everything remotely related to nuclear transfer. Efforts to keep discourse civil in the wake of the naming of "clones" were made even more difficult by the parade of lunatics who wanted to make one: Remember the UFO cult, the Raelians, and physicist Richard Seed? Later, that was quieted by the steady flow of information about the agricultural and medical benefits of cloning.

Scientists such as Wilmut were leaders once it became clear how to lead. He was quick to say that human cloning would be wrong, and he and I actually coauthored an approach to regulating human cloning to help in that effort. But have other high-profile members of the scientific community learned from early mistakes with euthanasia and cloning that the wrong way to approach scientific innovation of great public import is to throw it like a pie into the face of the unprepared public? I'm not so sure.

During the unraveling of Hwang Woo Suk in South Korea, even Wilmut decided that he would seize the moment to make a very public start of making cloned human embryos, and publishing a book in which he reverses himself on his previous moral objections by embracing reproductive cloning. The timing is doubly bad for the public's perception of cloning, because Wilmut found himself fending off likely unwarranted charges that he had essentially no right to claim authorship in the key scientific paper about Dolly. The anti-abortion, anti-stem cell research crowd could not have designed a more effective PR perfect storm...

[Read the rest of the article here]

Anybody Want an Artificial Heart from These Guys? Step Right Up.

This is truly a 'long and windy road'. One would not be well advised to serve as the first subject in this series given the history of this device in earlier trials. - Art Caplan

Another Cure for AIDS Bites the Dust

As a recent issue of Newsweek points out, the AIDS epidemic has been with us now for 25 years, and has resulted in at least 25 million deaths. Given the magnitude of the suffering, the desire for a cure is strong. So it is not surprising that people come forward from time to time with the claim of a cure for AIDS. Probably the most interesting is the cure for AIDS attributed to Luigi Scrosoppi, an Italian priest, who died back in 1884. Peter Changu Shitima, a young catechist in Zambia, was in the terminal stages of AIDS in 1996. The local parish prayed to the Blessed Luigi, and Scrosoppi appeared in a dream to Shitma, who was miraculously returned to health. Scrosoppi was canonized in 2001 for this feat. Unfortunately, this is not the sort of cure that can be generalized for whole populations. But neither can mopane worms, for that matter. And as for Dr Abalaka in Nigeria, always willing to inject himself with blood from HIV positive patients to prove the efficacy of his homebrewed HIV vaccine, not much news of late.

Last week, the Iranian Elahi Allahgholi was arrested for making and peddling his own AIDS cure, which goes by the evocative name of Khomeini. An 11-member team established by the Ugandan Ministry of Health determined that Khomeini is composed of olive oil, honey, and minerals, and while it could be an excellent base for making baklava, it will not cure AIDS.

In sub-Saharan Africa, only approximately 11% of those in need of AIDS treatment have access to anti-retrovirals, and anti-retrovirals have sometimes terrible side-effects and are made by powerful pharmaceutical companies that tend to care more about the bottom line than the interests of individuals. So it is tempting to think that an indigenous, herbal cure will come out of Africa, and defy all the well-funded attempts of Western medicine to control the virus. The scenario is delightful enough, but at the moment it is still too good to be true.

-Stuart Rennie

Will Single Payer Healthcare in California be Tuhminated?

The papers are going wild about the proposal but Ahnold is likely to kill it dead. Celebrate the moment when we almost have universal healthcare in the nation's most populous state:

On Monday, August 28th, Senate Bill 840, authored by State Senator Sheila Kuehl (D-23), passed out of the California State Assembly on a preliminary vote of 43-30 (final vote expected to be 44-31). SB 840 provides a concrete plan for covering every California resident with comprehensive health insurance, saves the state of California, businesses and working families nearly $8 billion in the first year, and guarantees our right to choose our own doctor. The bill will now return to the State Senate for concurrence and is expected to reach the Governor’s desk by September 1st.

SB 840 provides comprehensive medical, dental, vision, hospitalization and prescription drug coverage to every California resident. This broad coverage is made possible through a streamlined claims and reimbursement system that is projected to save billions of dollars in administrative costs. SB 840 allows California to use its purchasing power to negotiate bulk rates for prescription drugs and durable medical equipment, such as wheelchairs, thus realizing an additional $2 billion in savings, SB 840 preserves the status of healthcare providers, hospitals and pharmacies as private, competitive businesses.

The plan is funded by drawing in current public spending and replacing all premiums, co-pays and deductibles paid to insurance companies with premiums paid to the system. As amended, the bill creates a blue ribbon panel of health, finance and technical experts to lay out the mechanics for an affordable premium structure using information gathered in available funding studies.

“The growing cost of health insurance is bankrupting our businesses and working families. Our health care system is being decimated to pay for insurance company waste”, says State Senator Kuehl. “SB 840 is the right solution for California’s broken health care system. It covers everyone, it contains costs and it improves quality ­ most important, it guarantees your right to choose your own doctor.”

“This plan provides security and savings to every California family, helps businesses by reducing their health insurance costs, and saves the state almost a billion dollars”, said Speaker Fabian Nunez. “The Governor should sign this historic bill.”

“Right now we have a broken system that leaves too many Californians in medical or financial jeopardy and a system that hinders economic growth”, said President Pro Tem Senator Don Perata. “SB 840 is responsible, it’s achievable and it’s what we need to do to fix the health care system in California.”