blog.bioethics.net

Partial Face Transplant

AP reports that the first partial face transplant has happened in France, of course, leaving the good people of Cleveland and Louisville to compete for the first whole-face (is that even a coherent term?) transplant. We've followed this since the whole business started, including the first major collection about the ethical issues for it. Worth checking out just for the dopey puns. Anyway here's the scoop:

The hospitals’ statement said the woman was in “excellent” condition, and the transplanted organs looked “normal.” She wants to remain anonymous, the statement added.

The woman was disfigured by a dog bite in May, and the injury made it difficult for her to speak and chew, the statement said. Such injuries are “extremely difficult, if not impossible” to repair using normal surgical techniques, it added.

The organs were taken from a donor who was brain dead, with the family’s consent, the statement said.

Experts say the mouth and nose are the most difficult parts of the face to transplant.

8 Million Doses Against Pandemic Influenza to be Stocked Up

They don't give you the address to get some of this vaccine, which 'they' say would in the worst case scenario vaccinate only 4 million, but if you start working in public service you might get some. Washington Post reports that it may be possible to stretch the stuff out to cover 33% of the population. Are you one of those free market folks worried about rationing? Fear socialized medicine? Well get ready, then, because it's nightmare time.

We Interrupt Normal Life for Continuing Coverage of the Meltdown

There is no time to ramble about all of these stories. Not so many, so fast. So as you let yet another hypnotic green-tinted image of stem cell research (above) wash over you, satisfy yourself with some bite-size nuggets:

The Korean matter is not going to cause a backlash against stem cell research [wait, or, maybe it already has?]. And in fact South Korea may very well keep Hwang Woo-suk on as head of the effort, but not until the crack bioethics team reviews the scandal. No matter how Hwang's own situation works out, scientists now get it that they'd better start defending the integrity of this work and are, um, lining up to defend the integrity of this work.

Thank goodness Harvard is opening up what by my count is their fourth applied ethics program (someone needs to tell these people that once the school starts a program with Dan Brock at the helm the need for other clone programs decreases...).

Anyway back to the nutty world of pluripotency: the ongoing battle to keep state-based stem cell money from being raised and disbursed continues. Apparently not in Connecticut, where $100 million will be given out over ten years. But in California, as we've noted, where the courts have locked up disbursement for the immediate future. And even in Arizona, where stem cell opponents the Alliance Defense Fund have argued that the proposed ballot for raising stem cell money there is not good enough because it doesn't say "CLONE" in bright flashing letters. And if the money comes through, there is still no guarantee anybody will move their labs to get it, at least not to Illinois, although bad law is certainly keeping some scientists out of states like Missouri.

But this stuff is still extremely interesting to do and has created whole new kinds of careers in science.

New Wrinkle in the Korea Saga

At the time that things were about to unravel with revelations by Gerald Schatten that Hwang Woo-suk's labs had paid donors for eggs and perhaps taken eggs from subordinate scientists, it is now alleged that Schatten - who 'blew the whistle' on the whole matter - was negotiating for a share in at least one patent related to the work of Hwang's lab. Digital Chosunilbo (English Edition), which is now part of my perverse Korean reading obsession, reports this morning that the matter involves as well a request by Schatten to serve as chair of the world stem cell bank. Text of the story:

Prof. Gerald Schatten of the University of Pittsburgh demanded to share a patent for stem cell cloning technology developed by geneticist Hwang Woo-suk and his team, press reports said Monday. Hwang and his team deny the report. Schatten recently ended his collaboration with Hwang citing ethical flaws in occyte procurement for an earlier project.

The U.S edition of the JoongAng Ilbo reported Monday that Schatten demanded 50 percent of the patent for technology cloning tailored stem cells for terminally ill patients early last month. He also asked Hwang to give him the chairmanship of the World Stem Cell Foundation and to allow several U.S scientists to sit on the foundation’s board. The paper said Hwang rejected the request, saying the stem cell research was a national asset and he was not in a position to give out stakes in the patent.

However, Prof. Lee Byung-choen, a member of Hwang’s team, said he heard of no such demand and Hwang did not mention it. Government officials involved in the research also said they had no knowledge of it. Prior to this week’s Cabinet meeting Tuesday, Science and Technology Minister Oh Myung told reporters he had not been briefed about the demand and Prof. Hwang did not discuss the issue with the government. Health and Welfare Minister Kim Geun-tae and presidential policy aide Kim Byung-jun also denied knowledge of the demand.

Wang Sang-ha of Seogang University, Seoul National University Hospital’s legal adviser, said Schatten made the demand while discussing the establishment of a stem cell hub network in the U.S. with Hwang. He confirmed Lee had no knowledge of the U.S professor’s request.

Another member of Hwang’s team said Schatten did not make the demand officially. “We intend to maintain good relations with Prof. Schatten for international joint stem cell research,” he said. “We are embarrassed by the report since it gives the impression we took issue with Prof. Schatten’s demand to put the blame on him.”

The most likely interpretation is that Schatten did informally ask for a share of the patent but Hwang did not officially discuss the issue with his team and the government. Schatten has not commented on the allegation.

Throwing tar at the whistleblower? The whistleblower has no clothes? This all reinforces the point we've made particularly in the Times-Union column that international regulation must begin with unambiguous rules concerning the conduct of scientists in stem cell research, and the U.S. simply must lead in that effort, given that our nation controls most of the intellectual property and houses most of the leading scientists in the world and is home to the key regulatory agency that will set the standards that define access for any of these therapies to the all-important US market. Otherwise we will watch in awe as one crazy scandal like this after another unfolds on international television. And the answer to this is not for the World Stem Cell Bank to hire bioethicists - it is for the NAS group and others to step up to the plate right now to propose that international standards for scientific integrity and clinical research be adopted voluntarily by the leaders of all major stem cell programs - and indeed insist that enrollment in such coalition be requisite to any relationship that entails funding from state based stem cell funding programs.

Abortion Politics Twist Facts in Fetal Pain Laws

Art Caplan's MSNBC column today addresses the fetal pain legislation:

As it so often does in America, the drive to restrict abortion produces bad legislation. The Unborn Child Pain Awareness Act is no exception.

This fall the Wisconsin state Senate passed the Unborn Child Pain Awareness Act. The bill has passed the key committee in the Wisconsin House and it seems likely to pass there before the end of the year as well.

Wisconsin is not alone. The states of Arkansas and Minnesota have passed versions of this law. And Congress is taking a hard look at the same legislation as well. The House of Representatives recently completed a committee hearing on the law.

The proposed law requires doctors to read a script to women who are considering having abortions telling them that Congress has determined that an unborn child feels pain by 20 weeks of age. The express purpose of the bill is to diminish the suffering that a fetus must endure as part of a post-20-week abortion. But, the real purpose of the bill is to discourage woman from choosing an abortion by stressing that a 20-week-old fetus feels pain.

The script that doctors are supposed to read tells every woman that Congress has determined that “…at least 20 weeks after fertilization, every unborn child has the physical structures necessary to experience pain.” The woman would also have to be told that there is substantial evidence that the abortion methods most commonly used 20 weeks after fertilization cause substantial pain to an unborn child.

Those in the House who favor the bill, and there are many, want to be sure that women considering an abortion have the option of choosing to have anesthesia or other pain-reducing drugs administered directly to the “pain-capable unborn child.” The purpose of administering such drug or drugs would be to reduce or eliminate the capacity of the unborn child to experience pain during the abortion procedure.

The law warns that, “in some cases, there may be some additional risk to you associated with administering such a drug.”

Why is this such bad legislation? There are a lot of reasons. None of them are getting much attention because of abortion politics.

The bill insists on calling a fetus an unborn child, something medicine would never do. The bill goes far beyond what medical science believes to be true about when a fetus feels pain. The bill treats every fetus as the same in terms of capabilities if they reach 20 weeks of age or more, which they are not. And, most troubling, it reduces the process of informed consent to the reading of a fixed script created and mandated by politicians not doctors.

If, as this bill purports, Congress is concerned about what medicine believes to be true about the capacity to feel pain felt by a human fetus then why does it consistently refer to a fetus as an unborn child — a phrase never used in any medical textbook or medical school lecture?

The answer is simple — abortion politics.

Do doctors agree that fetuses have the ability to feel pain at 20 weeks in utero? Some doctors do. But, some do not. A quick search of the medical literature reveals no consensus at all among physicians and scientists about when a fetus can feel pain. Estimates range from 16 weeks to 28 weeks. How is it then that Congress can legislate a 20-week line in the sand as the date when a fetus can feel pain despite a lack of consensus on the part of actual doctors and scientists?

The answer is simple — abortion politics.

The proposed law says that doctors can administer anesthesia or pain relieving drugs to the "pain-capable unborn child." It also says this sort of treatment may result in “some additional risk to you” meaning the mother.

How does Congress or a state legislator know whether doctors can truly relieve pain by in utero anesthesia? And how can an obviously inadequate disclosure of risk to a mother considering an abortion — "some additional risk to you" — pass legislative muster.

The answer is simple — abortion politics.

And how is it possible that Congress or a state legislature could decide that a one-size-fits-all script constitutes an acceptable way to achieve informed consent when they would never accept such oversimplified, rhetoric-laden boilerplate as adequate from their own doctors?

The answer is simple — abortion politics.

Abortion politics continues to rip at the social fabric of America. That is a fact. When abortion politics are permitted to twist, obscure and ignore the facts about fetal development, fetal pain and the nature of informed consent in medicine that is a fact that those who are pro-life and pro-choice should not tolerate.

What Went Wrong in South Korea and What Should We Learn from It?

There are many accusations that have been flying about, but there have been as many misses as hits in the criticisms of Hwang and his colleagues. So what exactly did they do that was wrong? What should we learn from their mistakes as we go forward?

Some of the accusations have centered on the issue of the payment of the egg donors. Our own Glenn McGee has claimed that this is the major ethical problem in the research. This seems to miss the mark. The question of whether it is appropriate to pay donors (and if so, how much) is a controversial issue with many ethicists on each side of the debate. In the absence of agreement, and no laws or guidelines to the contrary, it would be a mistake to condemn Hwang or his colleagues for paying donors at the time that the payments were made. Going forward, the NAS has recommended that donors should not be paid, and possibly more importantly, Prop. 71 in California forbids such payment. Thus, the major argument at this point is the value of consistency—it will be difficult for the field if cell lines that are acceptable in some states are not acceptable in others—so it will be best if everyone accords with the same standards (even if there is still some question about what the right thing to do is).

McGee has raised an additional (but separate) concern—viz. that the women who donated were not adequately informed of the risks. This concern has been raised several times (including by myself and my colleague Mildred Cho). The mere fact that some women reported that they did not know of the risks of egg donation is not sufficient to establish that consent was not obtained or that full disclosure did not take place. The standards for disclosure are fairly clear—and time will tell whether they were met in this research (it seems as if a good faith effort to do so took place in all of their later work).

The more serious objection is that the donors included subordinate women who worked in Hwang’s lab. Even if Hwang was truly unaware of the donation, this would clearly represent an institutional ethics breach and merits condemnation. No one in the ethics community is defending this practice—the only question is over precisely where within the institution blame lies.

While it is generally not a good thing to lie and doing so to journalists is never a good strategy, a more serious ethical breach may have occurred if Hwang lied to the editors of Science in response to the queries that they would likely have made. This would be an egregious breach of behavior. From the early roots of science (see Shapin's Social History of Truth or Shapin and Schaeffer's Leviathan and the Air-pump) publication has been about virtual witnessing. For science to work, the testimony of its practitioners must be beyond reproach. Otherwise, we would not believe the reports of experiments. This is one of the reasons why there is so much hand-wringing over fabrication, falsification and plagiarism (is spite of their low frequency) in research ethics.

What should we learn going forward? Above all, the contrast between the ethical conduct of their later research and their earlier work (where all of the allegations have centered) highlights what happens when researchers who are enthusiastically pursuing valuable research, run in to obstacles in the form of ethical or legal requirements. The temptation to cut corners in the name of the higher good of the research is a powerful and familiar story—one thinks of the Gelsinger case and many other examples of similar corner cutting. And it means that we must be particularly vigilant precisely when these standards are most likely to be most painful. It is easy to hold the bar high when it is effortless to do so. This also means that we must take care to make sure that the obstacles to research that are imposed are minimized as much as possible so that this important research can go forward.
-David Magnus

Sex and Drugs:
'You Will Never Meet an Ugly Drug Rep'

Jon Moreno saw this New York Times piece in which the key skill for drug representatives has finally been identified: cheerleading skills!

Wholesome, sexy and animated, they are now being recruited directly from the cheerleading programs:

T. Lynn Williamson, Ms. Napier's cheering adviser at Kentucky, says he regularly gets calls from recruiters looking for talent, mainly from pharmaceutical companies. "They watch to see who's graduating," he said.

"They don't ask what the major is," Mr. Williamson said. Proven cheerleading skills suffice. "Exaggerated motions, exaggerated smiles, exaggerated enthusiasm - they learn those things, and they can get people to do what they want." ...

"There's a lot of sizzle in it," said Mr. Webb. "I've had people who are going right out, maybe they've been out of school for a year, and get a car and make up to $50,000, $60,000 with bonuses, if they do well." Compensation sometimes goes well into six figures.

And the effect of very attractive salespeople making very unusual sales pitches in what quickly become somewhat flirtatious relationships is obvious:

Still, women have an advantage with male doctors, according to Jamie Reidy, a drug representative who was fired by Eli Lilly this year after writing a book lampooning the industry...

In an interview, Mr. Reidy remembered a sales call with the "all-time most attractive, coolest woman in the history of drug repdom." At first, he said, the doctor "gave ten reasons not to use one of our drugs." But, Mr. Reidy added: "She gave a little hair toss and a tug on his sleeve and said, 'Come on, doctor, I need the scrips.' He said, 'O.K., how do I dose that thing?' I could never reach out and touch a female physician that way."

Stories abound about doctors who mistook a sales pitch as an invitation to more. A doctor in Washington pleaded guilty to assault last year and gave up his license after forcibly kissing a saleswoman on the lips.

One informal survey, conducted by a urologist in Pittsburgh, Dr. James J. McCague, found that 12 of 13 medical saleswomen said they had been sexually harassed by physicians. Dr. McCague published his findings in the trade magazine Medical Economics under the title "Why Was That Doctor Naked in His Office?"

Korea Round Up

The Chronicle of Higher Education put out this piece today in which the matter of fallout from the Korea discussion is matched to commentary by a couple of unknown ethics people who discuss what is essentially Robertson's view (below) on paying donors and recruiting young colleagues.

And the drums are beating in Korean mass media for immediate continuation of the efforts in the labs there. More images of somber support for Hwang are genuinely moving - although they are disturbing in some ways as well, given what the supporters are actually saying about their fervent hope for immediate cures. Donga quotes Financial Times' editorial that minimizes the issue.

Korean People

Digital Chosunilbo (English Edition) reports that the World Stem Cell Hub is hoping it will be able to use bioethics to help it get on top of its wicked PR problem.

The World Stem Cell Hub is setting up an emergency management team following the resignation of cloning pioneer Prof. Hwang Woo-suk as its president last week over an ethics scandal ... A spokesman at the center said the position of president would remain vacant for the time being. Experts on bioethics will be part of the emergency team.

Can't wait to see the ad for that job: "show dogs wanted."

And Reuters reports that "Several advertisers have pulled commercials from a South Korean TV prime-time slot because of public anger over the network's broadcast of a damning report on ethical lapses by a pioneering stem cell scientist." The anger is so profound that:

South Korean President Roh Moo-hyun expressed concern that public sentiment had gone beyond acceptable public debate. "I was also annoyed by MBC's reporting," he said in a message released by his office on Sunday, adding he himself questioned whether MBC needed to be so unrelenting if the purpose had been to raise awareness of an ethical dilemma in scientific research.

"But when commercials get cancelled it has gone too far. What we have now is social terror that doesn't accept objections." Over 2,000 messages charging MBC of everything from treason to sensationalism were posted on the network's Web site on Sunday. "The public is enraged because (MBC) has cast Dr. Hwang as an inhumane criminal," wrote one viewer, Kim Eun-hee. Local media reports said journalists who worked on the programme had received threats to them and their families. The anger has led all but one of 12 advertisers -- including Kookmin Bank and GS Holdings Corp -- to pull commercials from the documentary programme's weekly Tuesday night slot or consider such a move.

And Sify news service of India reports from Korea that there is lots at stake for Korea's soon-to-be-booming medical tourism business. Booming stem cell medical tourism business, that is. The very first stem cell medical tourist hotel, located on a resort island and run by a group that is currently charging hundreds of thousands of dollars for unproven "therapies" that have yet to be tested or published. This has to be read to be believed:

Although some western doctors are sceptical over the proven benefits of [stem cell] treatment, the firm [Histogen] is hoping to build a hospital in South Korea's tourist island of Jeju, off the country's southern coast, in the next few years.

Han Hoon, the doctor who heads Histostem, said the hospital would be the first in the world offering only stem-cell therapy.

Since May 2003, Han and his team have been using umbilical cord blood stem-cell therapy to treat patients with medical conditions that other treatments have failed to help such as liver cirrhosis, Buerger's disease, diabetes, chronic renal failure and a dozen other diseases.

The team's first patient from the United States is expected to arrive before the end of the year.

Michelle Farrar, 36, from Virginia, was paralysed in a car accident two years ago. She is paying around $100,000 for the treatment without a guarantee of success...

He and his researchers have carried out more than 250 umbilical cord blood stem cell treatments since July 2003, including cases of spinal cord injuries. Han has recently added Alzheimer's Disease to his list for treatments and is excited about the potential. He has treated two Alzheimer patients in the past six months and the results were "quite impressive," he said.

A 79-year-old woman who received two injections of stem cells 16 days earlier has been making progress, her son Back Jae-Seoung said.

"Before the injections, she didn't even recognise me and just stared blankly at TV," he said. "Now she keeps up her own running commentary on TV drama and knows who I am," said the 55-year-old businessman.

However, critics say that although Han's therapy is based on genuine science and may have potential, its benefits remain unproven.

"Medical tests must be backed by scientific papers submitted to authoritative journals for experts' scrutiny. If you just say 'Hey, I tried this and it worked well', you would become a laughing stock," said Kong Il-Keun, a bio engineering expert of the Suncheon National University.

[file all of this under "only Alta could find this stuff"]

Nice Work if You Can Get It

Royal Gazette notes the very important bioethics session in Bermuda on ethical issues in living wills. It is wicked cold in Nova Scotia, so hold no grudge against Dr. Jeff Kirby and Dr. Christy Simpson of Dalhousie University bioethics department. Nor I suppose the Carribean's first bioethicist down in Jamaica. Well, maybe a little bit of a grudge against the last guy. What do you write in a living will in Bermuda, anyway?

Korean Researchers and Ethics in Science

I was actually very surprised when I saw this survey that Alta Charo unearthed on the Dong-A Ilbo (donga.com) business pages. According to the relative large poll of Korean "biotechnology researchers" conducted yesterday by a science survey group commissioned by Dong-A Ilbo, a Korean daily paper,

About 46 percent of respondents (440 people) said they did not know about the Helsinki Declaration, while 39 percent (374 people) answered that they have heard about the declaration but did not know what it is.

Approximately 42 percent (402 people) said they are not aware of the Institutional Review Board which investigated into possible ethical problems of Hwang Woo-seok뭩 team at the College of Veterinary Medicine of Seoul National University.

Ethical Mountain or Ethical Molehill?
John Robertson on the Matter of Korea

Guest blogger John Robertson offers this:

The attention slathered on Dr. Hwang Woo Suk’s belated admission that two lab workers donated eggs to his nuclear transfer work suggests the greatest ethical lapses since Ricardo Asch stole embryos at UC-Irvine. But some bioethicists are making a mountain out of a molehill. The road to nuclear transfer research needs speed bumps but not barriers. The science is tough enough.

Yes, we need clear rules for how eggs and somatic cells are derived, and yes, we have to reassure the international public that everything is on the up and up in the bright new world of embryonic stem cell research. Granted, too, that lab workers should not be egg donors, and erring researchers should ‘fess up immediately to wrong.

But crucifying Hwang and canonizing Gerald Schatten for his prescient resignation is a bit much. From my e-view of these happenings, Hwang may have lacked culpability about the underlying question of lab worker involvement. He might have run imposed tighter controls on egg sources but appears not to have directly induced or even been aware of two contributions from lab workers. He certainly did err in not coming clean up-front. Now that he has done his public mea culpa I say the time is to forgive him and let him get back to plying his considerable craft.

The same for the shrieks of horror at the news that some of the eggs came from paid donors. It appears that Hwang’s source of eggs actually paid twenty women for their time and effort but was not straight with Hwang about it. But with rules unclear and no legal barrier neither he nor Hwang should be pariahs for paying women for the time and effort expended in providing eggs.

The idea that it is wrong to pay egg donors for their contribution is much less tenable than the bar on using lab workers. A system of paid donation for infertility has developed in the United States that works reasonably well, e.g., few accounts of injured or misled donors or exploitation of the underclasses. With some tweaking (nothing is perfect) it could easily be extended to paying egg donors ESC research when the need for eggs to create new ESC lines or tailor them to particular genomes arises.

Indeed, the National Academy of Sciences never made a principled argument for their judgment that egg donors should receive no money for undergoing hormonal stimulation, close monitoring, and surgical retrieval. In opting for prudence over expediency, they clearly made a political choice to get the field moving, not an ethical one grounded in sound analysis.

We do not treat women as objects with no interests or rights when we compensate them for the time, effort, and discomfort of being egg donors. Nor do we coerce them to be donors when we pay them. Yes, financial need will be part of the motivation, but so will be a willingness to help others, just as it motivates egg donors for infertile couples. As Ezekiel Emmanuel has reminded us about “unfair inducements” in research rules, there is no “there” there. Let’s pay attention to the consent process, make sure that the egg retrievers are qualified, and that medical treatment will be provided for any injuries, but there should be no barrier to payment as such. Let’s also agree never willingly to use the term ”commodification”until someone shows that it clarifies rather than confuses discussion of an issue.

The ethical purity sought in barring payments would also cast doubt on most likely source of unpaid volunteers—patient families and relatives. Surely helping a loved one or their disease group will be as strong an incentive in many cases as the fees that egg donors for infertility typically receive ($3000-$5000 in many locales). But good reasons for doing unpleasant things always exert some pressure in life, and we make our choices accordingly.

Here David Magnus and Mildred Cho, despite their handwringing, may have a point. Yes, donating eggs for research is a new role of sorts so let’s focus on treating donors with respect while allowing important research to go on. Extra monitoring of the consent process might also work. But the rush to regulation has its costs. Researchers who need eggs for new ESC lines or disease models should not have to deal with egg shortages that financial payments would alleviate.

John holds the Vinson & Elkins Chair at The University of Texas School of Law at Austin.

Snuppy, the Top Invention of 2005

Time Magazine has selected Snuppy the cloned dog - yes yet another South Korean reference - as the most amazing invention of 2005. Yes that went to press before this morning. Their top pick for "what people are saying" about Snuppy is a guest posting on this blog written by Penn's Autumn Fiester, which to our knowledge is the first of our posts to go directly from blog to textbook - it is being published next year in that form.

Hwang Woo-suk Resigns

IF YOU WERE DIRECTED HERE, this is no longer the main Hwang Woo-suk Page;

This is the page you are looking for.

The American Journal of Bioethics' blog front pageis even more updated.

The most recent analysis from the Editor's blog is a our rant on the "bad apple" theory of misconduct currently being proffered by many bioethics scholars.

Forbes led with this on the 23rd of November:

SEOUL (AFX) - South Korean cloning pioneer Hwang Woo-Suk has resigned after admitting that two junior researchers in his team had donated eggs and that other women had received money for eggs used in his landmark research on human embryos.

'I feel so sorry to speak about such shameful and miserable things to you people,' he said in his first public comments on a scandal that has been brewing for months concerning the origin of ova used in his research.

'I again sincerely apologize for having caused concern at home and abroad.'

Hwang said that he was resigning all his official posts including the chairmanship of a new research body, the World Stem Cell Hub, established last month to produce stem cell lines here.

'As of today I am resigning from the chairmanship of the World Stem Cell Hub and all other official responsibilities I held at government and social organizations,' he said, according to Agence France-Presse.

'This is my way of seeking repentance.'

The South Korean government said earlier that Hwang had done no wrong despite receiving ova from junior researchers and other women who received payments.

'There were no breaches of legal or ethical standards in the course of obtaining human eggs for the research,' a spokesman for the Ministry of Health and Welfare said.

[update: MSNBC/AP coverage]

Caplan & McGee: The Way to Control International Problems in Stem Cell Research is to Fund it in America

The latest installment of Caplan & McGee deals with the Korean egg problem and what it says about American stem cell policy:

Because there is no real federal funding for embryonic stem cell research, other nations have begun to take the lead. But the real concern isn't that the other guys are winning, it is what happens when they bend the rules to do so.

Hwang Woo-suk is South Korea's first superstar scientist. His team was the first to successfully make stem cells using cloned human embryos -- a process often referred to as therapeutic cloning. He has been busy since his initial breakthrough.

Since creating the first cloned human embryos, he created a technique to derive stem cells five times more efficiently using far fewer donated eggs. Last April his colleague at SNU and others held a news conference at which a patient who had been treated with umbilical cord blood-based stem cells walked after having been bedridden for 19 years. Hwang is also the scientific father to the world's second-most famous cloned animal, Snuppy the dog.

South Korea took notice of his work. The grateful Asian nation of 48 million has lavished praise, titles and money on Hwang, declaring him their first "supreme scientist." His labs receive more support than the U.S. government has invested in all of our nation's stem cell labs put together.

It should be no surprise then that a leading American stem cell scientist, Gerald Schatten, wanted to work with Hwang. Finding a partner overseas was a matter of survival for Schatten's University of Pittsburgh team, because embryonic stem cell research is a third-degree felony in Pennsylvania.

An impressive work ethic prevails in South Korea. Hwang's labs do not close -- ever. He has said that all of his scientists work every day of the week. Their devotion and his success, he jokes, derives from the "chopstick theory of scientific supremacy," by which he means that because Korean chopsticks are metal and somewhat slippery, one has to learn early to be precise. While Dr. Hwang's work ethics may be impressive, his research ethics may be less so.

One key requirement for success in therapeutic cloning to create stem cells is raw material. Cloners need eggs. To make Snuppy the dog, Korean scientists used more than 1,000 dog eggs to create embryos which they transferred into 123 dogs to create one Snuppy.

Hwang and Schatten's work in making human embryonic cells required an unprecedented amount of human eggs. Since the odds against any single cloned embryo working are enormous, they needed a lot of eggs to make a lot of embryos. That means that many women would need to be willing to consent to the risks of taking hormones so they would create a lot of eggs and then having them removed surgically from their ovaries. And that is where things went wrong.

Schatten announced recently that he would no longer be collaborating with Hwang. He cited new information that led him to believe that Hwang's group had accepted eggs from a young woman who is a junior scientist in the lab. He also said he had evidence that the woman may have been paid for her eggs.

Taking eggs from an employee smacks of coercion. Paying for them smacks of bad judgment.

If Hwang's lab knowingly violated the rights of egg donors in a rush to advance stem cell research, and then when asked about such behavior, covered it up, a lot of people will start asking whether or not stem cell researchers are a rogue lot, not to be trusted. What is the answer? Get the United States government involved in paying for and regulating embryonic stem cell research.

A clear majority of Americans favor embryonic stem cell research. Yet there are no meaningful federal funds for such research. And the administration has been growling about cloning for research ever since it took office.

As a result, our best stem cell researchers, like Professor Schatten, are going offshore to avoid prosecution or to find research funds.

This means that ethics can get forgotten as other nations and private companies race to fill the void left by the President's reluctance to fund stem cell research.

Only a properly funded U.S. stem cell research program will guarantee oversight and the protection of all involved. Professor Hwang has gotten too powerful and the Korean government too dazzled with his work to allow him to be a sole man in Seoul.

CDC Asks for Law to Allow Tracking of Travelers

Kansas City Star carried the story. It could cost airlines hundreds of millions of dollars but would link every aspect of the airline industry directly to the CDC to identify and respond to outbreaks.

The Ultimate Sex Drug

Alta Charo turned us on to the best news ever in enhancement technology. The media will search high and low and find not a credible soul who will oppose it. It is the sex inhaler, the smell Pepe le Pew always thought that he emitted. It is the love drug. For real. New York Magazine's Julian Dibbell reports:

Now entering Phase 3 clinical trials: the first real, honest-to-God, horny-making, body-shaking, equal-opportunity aphrodisiac. Horn of rhinoceros. Penis of tiger. Root of sea holly. Husk of the emerald-green blister beetle known as the Spanish fly. So colorful and exotic is the list of substances that have been claimed to heighten sexual appetite that it’s hard not to feel a twinge of disappointment on first beholding the latest entry—a small white plastic nasal inhaler containing an odorless, colorless synthetic chemical called PT-141. Plain as it is, however, there is one thing that distinguishes PT-141 from the 4,000 years’ worth of recorded medicinal aphrodisiacs that precede it: It actually works.

And it’s coming to a medicine cabinet near you. The drug will soon enter Phase 3 clinical trials, the final round of testing before it goes to the Food and Drug Administration for review, and with the FDA’s approval it could reach the market in as soon as three years. The full range of possible risks and side effects has yet to be determined, but already this much is known: Putting that inhaler up your nose and popping off a dose of PT-141 results, in most cases, in a stirring in the loins in as few as fifteen minutes. Women, according to one set of results, feel “genital warmth, tingling and throbbing,” not to mention “a strong desire to have sex.” Among men, who’ve been tested with the drug more extensively, the data set is, shall we say, richer... [details omitted, read them at the site if you must, I blushed]

The precise mechanisms by which PT-141 does its job remain unclear, but the rough idea is this: Where Viagra acts on the circulatory system, helping blood flow into the penis, PT-141 goes straight to the brain itself. And there it goes to work, switching on the same neural circuitry that lights up when a person actually, you know, wants to.

“It’s not merely allowing a sexual response to take place more easily,” explains Michael A. Perelman, co-director of the Human Sexuality Program at New York Presbyterian Hospital and a sexual-medicine adviser on the PT-141 trials. Though he cautions against jumping to conclusions, he’s hopeful that the drug represents a breakthrough. “It may be having an effect, literally, on how we think and feel.”

I see a lot of couples in my practice—lawyer couples, banker couples—who don’t know how to relax,” says Leonore Tiefer, a professor of psychiatry at New York University School of Medicine. “That’s fine—it’s a big asset to them in their corporate lifestyle, where they can work 80 hours a week—but then I have to shut off two BlackBerrys in my office in order to keep the noise down. They’re trained to multitask. Well, it doesn’t seem that that is really doable when it comes to sex. And they’re angry about that: It should be doable. And they need it to be doable because they only have five minutes.”

The five-minute meaningful sexual encounter: If ever there was a holy grail for the age of the tight-wired global economy—with its time-strapped labor force and its glut of bright, shiny distractions—that is it...

Happy Thanksgiving, indeed.

Abortion Pill Deaths

Gardiner Harris reports in the NY Times today that "all four women in this country who died after taking an abortion pill suffered from a rare and highly lethal bacterial infection, a finding that is leading to new scrutiny of the drug's safety." The deaths all occured in California, but not, apparently, because of a bad lot of pills. The driving hypothesis at this point is that the pills might somehow make women "vulnerable to an infection with Clostridium sordellii, the lethal bacteria. If so, they will explore how such an infection 'could be more easily diagnosed and even prevented,' one official said."

Gardiner quotes a conservative womens' group leader:

Wendy Wright, executive vice president of Concerned Women for America ... said that the latest news about deaths involving Mifeprex proved that the drug was unsafe. Ms. Wright also speculated that more women were dying after using the drug but that their deaths were going unreported.

"I'm pleased that the F.D.A. is taking a serious look at this," she said, "and hope that they will no longer allow this drug to be available to cause the deaths of more women."

"I Love Hwang Woo-suk"

JoongAng Daily reports today that the presidential bioethics review committee in South Korea has asked that there be new laws there about donation of eggs. But more interesting is the close of the article:

Internet sites here have been flooded with messages of support for Dr. Hwang as Koreans rally around their high-tech favorite son. At one Internet site called "I Love Hwang Woo-suk," about 30 women had pledged to donate eggs by yesterday afternoon.

I am trying to find this site, anybody want to help?

The Business Ethics Blog

Blogspawn alert. Chris MacDonald is a thoughtful guy and philosopher who works on a variety of intersections between biotechnology and business. Now he has a blog, and he's no better at naming it than we were at this one, calling it The Business Ethics Blog. Check it out, it is great so far!

Semantic Misconception:
The American Journal of Bioethics Special Issue

The new issue of The American Journal of Bioethics is out, and it includes a number of articles that take aim at the question of whether or not ethical issues in stem cell research can be "avoided." The issue is called Semantic Cell Transplantation [thanks Dr. Sally Temple], and in it are:

InFocus articles by Kyu Won Jung and Insoo Hyun - which are up now but will appear in the January Febuary issue - who created the Korean stem cell research team's egg procurement protocols, which they say are the lynchpin of an ethical program at Hwang Woo-suk's labs; together with a reply from (our own) David Magnus and Mildred Cho who discuss the Jung/Hyun guidelines and argue that ironically we may now realize in the wake of the Korean egg debacle that the Hwang team has the best procedure of all.

Led by an editorial by our Sean Philpott "Eggs, Lies and Compromise," two Target Articles go right to the heart of the relationship between stem cell research, politics and ethics. S. Matthew Liao argues for a method that might avoid the debate, with Open Peer Commentaries from Søren Holm, John Robertson and others. And Lawrence Nelson and Michael Meyer contend that the President's Council on Bioethics made deep mistakes in its report on ethical issues in stem cell and embryo research. There too there are Open Peer Commentaries from a number of key scholars with access to the debates involving the PCB.

Matt Wynia writes the second installment of our new Bioethics & Public Health section, on public health research. And there are a number of other articles and reviews.

Korean Scientist Did Pay Women for Eggs

The other shoe has dropped. Eggs were purchased in Korea, although it is not entirely clear from whom or by whom. The scientist involved insists that he kept the information from Woo-suk Hwang. From the International Herald:

"It was difficult to obtain enough eggs for our research. It was inevitable to offer some compensation in return for egg donations," Roh said.

The doctor said he paid 1.5 million won, or $1,440, per woman.

"I made a difficult decision hoping that it would help pave the way for a breakthrough in fulfilling one of humankind's biggest dreams, which is to find remedies for hard-to-cure diseases," Roh said, fighting back tears. "I did not discuss my decision with Dr. Hwang because I thought I should take all responsibility myself." ...

MBC ... said Monday that some of the eggs Hwang's team had used were acquired from women who were in debt and sold their eggs for money..."

MBC also quoted a woman as saying that she did not know whether her eggs would be used in stem cell research - an allegation Roh vehemently denied Monday...

The story here is not about whether paying for eggs or taking eggs from colleagues is a problem (although that is certainly an issue), because Hwang's team addressed that issue in its outstanding guidelines for egg procurement out today in AJOB. The issue is whether they followed the guidelines that they set and if not why not and why there has been such delay in full disclosure.

Saletan the Magnificent: On Zoloth on Hurlbut on Stem Cells

In a piece that is just a bit too clever, William Saletan accuses Laurie Zoloth of being a bit too clever. He reviews a dialog between Zoloth and William Hurlbut that took place at a typical forum about stem cell research. The impression he takes from the encounter can be summarized very briefly, although the nuanced "I was there-ness" that Saletan's pieces have taken on will be lost in my summary. Which is not, you will see if you read his new piece, an altogether bad thing.

Saletan points out that Hurlbut's dopey idea (altered nuclear transfer, which we have written about so much in this blog that I won't bother to put the links here anymore) unraveled under Zoloth's retorts, leaving Hurlbut livid and incoherent. If you read this blog you will find the latter fact easy to believe. Hurlbut, I have argued, has devolved into a charlatan selling a snake oil science-based solution to the stem cell debate. But he does a fabulous impression of a sincere and devoted scientist who only means well. And, equally, Saletan performs: his act is "the liberal who feels bad for neoconservatives," and when he is in character he writes with a voice that can be quite annoying.

In what seem like a dozen columns for Slate it goes like this: he begins his commentary by telling us that he is 'sitting in the audience' at events in which the neoconservatives participate, and the message he brings back each time is that although he himself is liberal, the problem with liberals is that they are too cavalier, too loosy-goosy with the facts, and not ... Second ... here it comes ... serious enough.

So the account he gives of this event is all-too-familiar to me as a loyal reader of his new and fairly comprehensive writing about bioethics issues. It amounts to the claim that Zoloth wins the debate but cheats, and not because she is intending to cheat but instead because the overconfidence of liberals leads them to fail to question facts.

The problem with this argument is simple. It is wrong. Zoloth, he claims, had her facts wrong. His example is the question of whether ANT will reliably produce an embryo that will not implant. He says that he trusted Zoloth - her authority on the matter as a disputant - until she got them wrong:

At lunch, Zoloth said the idea behind ANT—knocking out a gene called Cdx2 to prevent development of an implantable embryo—wouldn't reliably succeed because gene knockouts produce a range of outcomes. I asked for her evidence that a range of implantation outcomes would occur with Cdx2 deletion. That's how it works, she assured me. But as I write this, I'm looking at the published report on the ANT experiment. It says "none of the Cdx2[-deleted] nuclear transfer blastocysts formed visible implantation sites (0 out of 40)." There goes my faith.

Well, that is a clever claim to make but all Saletan had to do was look deeper and he would see that while this is the report made in the Nature piece, it does not in any way exhaust the claim Zoloth is making. Her point is not that the group who conducted this single experiment should have found "implantatability" but that work on Cdx2 deletion has shown that there are a wide variety of effects on the developing cells that would include some embryos having the potential to be implantable, and that from a pro-life point of view if that potential exists at all, we're killing someone. Her point is subtle and frankly that is what makes me furious. And not with some sort of simple "liberal indignation" of the sort Saletan has begun to assert that liberal bioethicists hold.

So there's the rub. Saletan misses the fact that Hurlbut is at bottom disingenuous, he has heard countless times from many disputants including many of the top biologists in several related fields that his purported solution is voodoo and a political tactic at best. Hurlbut is clearly thrilled that the bad science that undergirds the attempts to avoid the stem cell debate has advanced as far as it has, so far in fact that perfectly respectable stem cell researchers are publishing wacky science in Nature in order to keep the dogs at bay. Hurlbut, it should be restated in this regard, apparently has no training in ethics, and is not a stem cell researcher. He is the one playing fast and loose, and Saletan should perhaps have taken just a few minutes to identify the multiple claims to that effect in the voluminous literature on such 'solutions'.

So why, when Laurie presents cogent arguments that position stem cells in relation to complex social and political phenomena and scientific issues, is Saletan hammering her for that sin?

Simple. He likes the seriousness, the monasticism of the Kass crowd. It is appealing because it feels academic, sincere, earnest. When Hurlbut pleads for us to take things more seriously, to not be "rude," it is because that political - and strictly political - tactic works for him. But when Hurlbut leaves the cathedral, he is flying all over the country on an entrepreneurial mission to kill stem cell research, shows up everywhere he can and courts profile articles like nobody in the history of bioethics, never once confessing to be an amateur in a field where most folks believe you should actually be a scholar of ethics before professing to be an ethicist.

Saletan is taken in by the claim that moral seriousness is a phenotype, a thing you can see and smell on people when they talk. It isn't. Real moral seriousness comes from thinking and writing carefully, and that is precisely what Hurlbut does not do. In fact with the exception of the one piece in which he argues for cheating the stem cell debate through the theoretical use of ANT, Hurlbut does not as best I can tell write in the field at all. Either field, in fact, stem cells or bioethics. How can you be a morally serious tutor of bioethics if you don't write in the field? This the problem Saletan misses. It isn't about trust, it's about scholarship. I am quite sure that the folks who trust Saletan enough to have lunch and discuss the issues would prefer he start there, no matter how exciting the performances of bioethics may be.
[updated 11/20 and pushed to the top]

China to Create Bioethics Rules

Shanghai Daily reports on the plans that were unveiled at a conference today.

Kentucky Fried Flu

Peter Singer of Princeton opines that factory farming, born in the USA, is at bottom responsible for the threat of virulent avian flu viruses. The answer? Taxes on chicken.:

That won’t be easy to do, but we could make a start by imposing a tax on factory-farm products until enough revenue is raised to pay for the precautions that governments now have to take against avian influenza. Then we might finally see that chicken from the factory farm really isn’t so cheap after all.

Free Association

I had no idea until Josh Braun, who blogs at Seed Magazine's new 'scienceg8', pointed out to me that two other big science outlets have Editors' Blogs. Check out Free Association, the blog of the editors of Nature Genetics, which is excellent and often updated, and SCIAM Observations, a blog from Scientific American that is very imaginative and sweeping. I was interviewed last week for a forthcoming piece in Nature on blogs and science that will I am sure catch the existence of these as well.

Aging, Logic and Bioethics

It’s been said before, but worth repeating: the bioethical priorities and concerns between developed and developing nations are sometimes poles apart, revealing differences in mentality, values and power. A case in point is a recent article in The Journal of Medical Ethics, entitled “Life extension, human rights, and the rational refinement of repugnance”. In it, the author -- a self-described biogerontologist – claims that aging is “humanity’s foremost remaining scourge”, that we are “within striking distance” of curing aging, and that those of us who are wary of the idea of radical life-extension via biotechnology are simply backward and irrational. All of this may sound strange to those living in countries with scourges more pressing than aging, or rather, where many people die of preventable diseases before getting much of a chance to age.

Then again, the notion of ‘curing aging’ probably sounds strange no matter where you are. Aging to most people is as natural as being born; it is what people do, or what at least their bodies do, between being born and being dead. Most people don’t like it much, but it is accepted as part of the picture of what life is like, and what we have in common with other creatures as well as what we share with environmental cycles of growth, decay, death and regeneration. This is probably why it is unsettling to hear aging turned from a feature of the human condition into an affliction – like gonorrhea – that we might get rid of with injections and pills.

The author of the piece (A.D.N.J. de Gray) contends that we should all embrace radical life extension in so far as we embrace logic and human rights. We all – except perhaps death penalty advocates – embrace the right of a healthy human being to go on living, and it is simply a matter of logical consistency to then embrace the related right to cure aging through the use of biotechnology. Our moral intuitions about aging as a human condition will be overcome by rational argument, or at least that is the way things work in Cambridge (England) where de Gray is located.

According to the author, bioethicists have a special role to play in this debate. Being especially logical folks, and being independent of the politics that pervades science (at least in Cambridge), bioethicists are in a position to persuade the masses to give up their irrational attachment to aging. They can demonstrate through rational argument that, despite vulgar appearances, ‘going on living’ indefinitely by means of sophisticated drugs actually accords with our deepest moral values. In other words, bioethics can do humanity a service by doing PR work for the anti-aging enhancement industry.

But who knows, maybe bioethicists can have another, less slavish role. They could namely critically reflect on what living 150 years might mean for ordinary persons -- its impacts on human relationships, family life, and work – and offer a nuanced opinion that neither glorifies nor condemns the possibility of extending lifespans. All this, while affirming something that every poor Malawian villager knows: that death, even in Cambridge, waits for us all.
- Stuart Rennie

Actually, I Was Just Campaigning

Sometimes Wonkette says it best.

Korea Has Therapeutic Misconception and Egg Donor Consent Issues? Big Problems in Stem Cell Politics? Time for India to Declare It is Curing People.

Alta shared this article from I-do-not-know-who-in-the-world-this-is news source Rediff , who describe the claim that a private clinic in India reports that is has been using embryonic stem cells in treatment and that the 'therapy' "ha[s] improved medical condition of 100 patients suffering from Alzheimer, paralysis and Parkinson's disease using the technique but government was cautious saying it would set up more operational guidelines for the area." The piece continues:

Dr Geeta Shroff, director of Nu tech Mediworld, said research in the use of embryonic stem cells at the centre began in 2000 and 100 cases had been completed in five years.

"While these clinical case studies comprise a variety of disorders, incurable and terminal in nature, the most dramatic results have been achieved in paralysis, spinal injuries, genetic and autoimmune disorders," she said.

She claimed that all existing government guidelines were being followed in the use of stem cell therapy.

"We have been in touch with ICMR and submitted our protocol to ICMR. Details of all cases are sent to them before the therapy is started," she said. Currently, stem cell research falls under the purview of ICMR guidelines on bio-medical research and Department of Biotechnology's guidelines on stem cell research.

Has anyone else noticed that a few reckless stem cell researchers turn out to be the worst enemies of embryonic stem cell research?

Judge Alito: Let the Borking Begin

The Raw Story has reprinted the text of the speech that Senate Minority Leader Harry Reid of Nevada will give this morning on the floor of the Senate. It is worth a read but here are some pertinent parts:

We don’t have to guess whether Judge Alito’s description of himself in that memo would predict what kind of judge he would be. For the past fifteen years, Judge Alito has been one of the most conservative federal judges in the country... For example, in civil rights cases he has often dissented to argue for higher barriers to recovery for people with claims of discrimination. In Bray v. Marriott Hotels, his colleagues said Title VII of the Civil Right Act “would be eviscerated” if Judge Alito’s approach were followed. In Nathanson v. Medical College of Pennsylvania, he dissented in a disability rights case where the majority said: “few if any Rehabilitation Act cases would survive” if Judge Alito’s view were the law. And in Sheridan v. DuPont, he was the only one of 11 judges on the court who would apply a higher standard of proof in a sex discrimination case.

In another area of the law, Judge Alito has been quick to limit the authority of Congress, when it is working to help people with real problems.. In Chittester v. Department of Community Development he held that the Constitution did not allow a state employee to enforce the Family and Medical Leave Act. The Supreme Court effectively repudiated that view three years later in the Hibbs case from my own State of Nevada.

Note that there is no mention of Roe in the comments. I could offer conjecture about why that is, but having been lectured on my ridiculous assessment of the political maneuvering that led to the withdrawal of Harriet Myers, I won't. You do that.

The UK Leads in Addressing the Korean Stem Cell Fallout

The Register reports, just as we had hoped, that in the wake of this unfolding international debacle about who knew what about whatver actually happened in Korea, scientists are beginning to consider self-regulation aimed at ensuring as a matter of "peer pressure" that stem cell researchers work on the development and pressure for enforcement of research ethics guidelines in stem cell research but in particular "the sourcing of human eggs for use in research." In the piece, entitled "Stem cell researchers want watchdogs for human tests," none of the UK scientists involved are quoted but I can tell you that yesterday morning we held a conference call with three scientists in UK labs that work with stem cells to discuss a call to the international stem cell organization for leadership on the matter.

Note on What is Coming Up on the Korean Matter in the Pages of AJOB and at bioethics.net:

Upcoming in The American Journal of Bioethics is a special article by the leaders who worked with the Hwang group on the development of ethics guidelines for egg procurement, who defends their efforts, and alongside will be a commentary on the article by Mildred Cho and David Magnus of Stanford. Those will be released early next week under embargo and by the end of next week as free-to-the-public In Focus Articles. The former piece is also part of a special issue on international issues in bioethics sponsored by Case Western Reserve University's Department of Bioethics and edited by Mark Aulisio.

I'm on the way to the UK so while I am going to try to keep up I can guarantee it will be slow blogging until Monday. So maybe it might be fun if you have a minute to check out some of the links on the right - several new blogs listed and we have updated our journals links as well. -gm

African Americans Urged to Donate Organs

From the AP:

TRENTON, N.J. -- Worshippers at black churches in 20 states will be urged this weekend to consider organ donation.

The program, Linkages to Life, is aimed at raising awareness about organ donation among blacks, who suffer higher rates of diseases that damage the liver and kidneys.

The fourth annual effort will take place over the weekend at nearly 60 churches. Instead of just asking churchgoers to sign organ donor cards, as in the past, speakers from the pulpit will urge audience members to go home and talk about the issue in detail with family, said Victoria Dent, national chairwoman for Linkages.

Blacks comprise 18 percent of U.S. organ recipients, while whites comprise 63 percent, according to the United Network for Organ Sharing. Only 12 percent of organ donors are black, according to Linkages.

Minorities are three times more likely than whites to have kidney failure and account for over half of the 56,500 Americans waiting for kidney transplants. But they are less likely than whites to find a good genetic match and spend more time on the waiting list.

Nearly 25 percent of those who died waiting for an organ transplant last year were black.

Patient Richard Adams, a longtime deacon at Delaware Valley Baptist Church in Willingboro, received a kidney transplant in 2004 after his kidney failed due to damage from high blood pressure and diabetes.

He plans to describe his plight at a church service Saturday.

"I just want to encourage them," Adams said Wednesday. "Coming from a black environment, we don't like to give up our organs."

Drug Regulation for Women, Rove Style

New York Times has the best description of the GAO report out Monday in which it is made clear at least to me that the FDA killed morning after contraception in a political charade

The Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report released Monday that the Food and Drug Administration's May 2004 rejection of the morning-after pill, or emergency contraceptive, application was unusual in several respects.

Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded...

The report suggested that it quickly became apparent that the agency was not going to follow its usual path when it came to the pill. "For example," it said, "F.D.A. review staff told us that they were told early in the review process that the decision would be made by high-level management."

Alito In His Own Words

New York Times reports:

[Alito] said he had been honored to serve as assistant to the solicitor general "and to help to advance legal positions in which I personally believe very strongly ... [including the position] that the Consitution does not protect a right to an abortion."

HIV Drugs Do Not Protect the Brain

Los Angeles Times reports that the drug cocktails that have worked so well to prolong the lives of those who are infected with HIV may not do much to protect the brain:

A study published by the National Academy of Sciences last month used 3-D brain scans to see how much tissue was damaged. In vivid, color-coded images, researchers found up to 15% tissue loss in the centers that regulate movement and coordination, as well as a thinning of the language and reasoning centers.

"As people are living longer, the major risk of HIV is not the immune system anymore, but the brain," said Dr. Paul Thompson, professor of neurology at the UCLA School of Medicine and author of the brain scan study. "People who are doing well with HIV, living with it for over 10 years, have this progressive damage going on in the brain, well before symptoms are obvious."

[update - Matt Wynia explains that "Just to be clear on this. Highly active anti-retroviral therapy does a HUGE amoung to protect the brain. Patient with AIDS and previously incurable brain diseases are now often cured by starting HAART. Cerebral Toxoplasmosis, which used to be a common killer, is now rare, as is Cryptococcal meningitis. What is being seen now is that HIV continues to live in CNS tissue (which we have long known, since the drugs don't penetrate the CNS all that well) and apparently, this has some local effects. That's not good, but it is not the same as saying the drugs don't do anything to protect the brain. They clearly protect the brain by preventing life-threatening CNS infections."]

Is the Korean Stem Cell Revolution Imploding? Gerry Schatten Thinks So

Rick Weiss reports this morning that Gerald P. Schatten, who has taken the lead in American collaboration with Korea's leader in stem cell research, has pulled out of that collaboration because of what he referred to as ethical breaches and lies.

Now folks, this is a big deal.

The allegation - which has in the last week become a huge scandal in Korea - involves the way that Hwang and his colleagues obtained the eggs that they used in making the embryos from which they harvested stem cells:

For many months after Hwang's 2004 publication, rumors had spread in scientific circles that the eggs Hwang used to achieve that landmark result had been taken from a junior scientist in his lab. That situation, if true, would be in violation of widely held ethics principles that preclude people in positions of authority from accepting egg donations from underlings. The rules are meant to prevent subtle -- or not-so-subtle -- acts of coercion.

Questions have also circulated as to whether the woman received illegal payments for her role.

Schatten said that Hwang had repeatedly denied the rumor and that he had believed Hwang until yesterday. "I now have information that leads me to believe he had misled me," Schatten said. "My trust has been shaken. I am sick at heart. I am not going to be able to collaborate with Woo Suk."

So what, you might say, if one Korean researcher makes a mistake and it leads to the discontinuation of one partnership between a group in Seoul and a guy from Pittsburgh. Well it is much bigger than that.

The impact of the continuing catastrophe with the Hwang lab is not, of course, because he used cloning to create Snuppy the dog.

Hwang's work has been revolutionary in the scientific quest to do 'therapeutic cloning' - to use nuclear transfer in order to make embryonic stem cell lines, and to do it more efficiently and faster than anyone thought possible. He has made them in strange ways, to be sure, such as deriving the somatic cells from six-year olds.

And Hwang is a symbol - big time. We pointed in October to the unmitigated praise for his 'Korean work ethic', which many have cited as the reason for his incredible success. And we noted that he alone has made progress with the Catholic church on how to proceed with the research. Anyone who was paying attention to that moment would have to note the stark contrast between Hwang's careful approach and that of those in the United States who have instead decided to play semantic games or do bizzare science in order to avoid the debate.

He alone received more money from the Korean government than the U.S. government has given out everyone put together for research using the President's approved stem cell lines.

But most - including Schatten - believed that the bulk of his research involved derivation of stem cell lines from materials that had been properly donated under careful scrutiny. What do I mean by 'most'? Well, to put it in a nutshell, Woo Suk's effort has just last month culminated in the announcement that his team plans to create hundreds of stem cell lines every year. Many of us in bioethics, though, quietly took notice that while the Schatten group - who had been working with Hwang for a while - linked up early and consistently with Hwang, other major stem cell researchers were cautious. And when the big explosion happened in Korea last week, it became clear that the Pitt agreement with Hwang was doomed.

I would have said - and in fact most major news and technology magazines have written - that Hwang's team has become the one to beat in the 'stem cell race', and that his efforts to think about ethics of stem cell research were unmatched even among the California scientists who must now create and follow highly complex regulations about egg donation.

But if Hwang has misled Schatten, the Korean government, the Catholic church - who really went the distance in listening to and trusting him, and the people in his lab, it will be tragic in a way that vastly exceeds the simple violations of research ethics.

Hwang, I fear, could firmly establish in the public mind the view that stem cell researchers as a group cannot be trusted, not only because they are in a hurry and miss things along the way, but because they may be willing to deceive their own peers and the public about their devotion to ethics. Stem cell researchers do good work, and many of them are very thoughtful about the controversy that attends it. But the bar is higher. Embryonic stem cell research, research that involves the donation of eggs, and particularly research that involves therapeutic cloning simply demands that scientists show the utmost respect to everyone involved and the utmost trustworthiness about how they proceed.

November hasn't been a good month for embryonic stem cell research. First the all-too-clever Nature article about how to dodge the stem cell debate, then the appearance of profound misconduct at the core of the work of the key scientist involved in producing new stem cell lines. If this doesn't prove that there needs to be an Ethical, Legal and Social Issues program for stem cell research, I cannot imagine what would. And in the meantime, it is going to be a rough few months for the Korean stem cell research effort. - Glenn McGee
[thanks Art Caplan]
[update: a comment below "from Seoul" doubts the sincerity of Hwang's efforts in that regard and points out that there has been skepticism from bioethicists in Korea about "his integrity" for some time; I also heard this from Seon Kui Erica Lee this weekend at this conference at McGill where I was speaking. None of this changes the point, though.]

[update: Hwang responds through a spokesperson in the Korea Times; he says all will be revealed soon, that he has been back bitten before, and that the pullout of Schatten will not affect their work because other Americans will be happy to collaborate.]

The Bioweapon is In the Mail

New Scientist synthesizes the elements of the problem posed by the combination of gene synthesis and the mapping of genes that comprise deadly viruses. The emphasis in the piece is on the technology involved in moving the information through the internet. It is a great article:

Such a check would have spotted one suspicious order, sent from a Hotmail address to BaseClear of Leiden, the Netherlands. This was for a modified sequence from a hepatitis-like virus. BaseClear itself rejected the order after the would-be customer failed to respond to requests for more information, says Gerben Zondag, the firm's scientific director.

But email addresses are notoriously easy to fake. And even orders from legitimate institutions may not be what they seem. Alfred Lasher, who manages Picoscript in Houston, Texas, says that he turned down one order placed by an individual at a US biotech firm, after Picoscript's enquiries revealed the gene was being ordered on behalf of a friend in another country.

Experts are concerned that the checks currently employed by some companies aren't sufficient to exclude orders placed by terrorists. "We're taking this very seriously," says Endy. Together with the J. Craig Venter Institute in Rockville, Maryland, and the Center for Strategic and International Studies in Washington DC, Endy's research group at MIT has launched a study into the risks and benefits of synthetic genomics, and aims to produce a set of policy recommendations by late 2006. The US National Science Advisory Board for Biosecurity, set up last year to advise the US government on which advances in biology could be exploited by terrorists, is also considering the issue.

The Giant Sucking Sound Ross Perot Didn't Predict

Health care costs too much, obviously, in the United States. And our recalcitrant refusal to be creative about ways to provide more than just emergency rooms for the 45 million uninsured has created a preposterous system in which the resulting costs (along with the cost of HMO red tape and ridiculous premium prices for patented drugs) are passed on to employers and employees. God bless America.

Or not. In California, there is a solution to the problem, or at least an effort afoot to make it less burdensome for corporations with a large number of insured, blue collar employees. No, it isn't to get drugs from Canada. It is to send patients to Mexico. No kidding:

The [profiled family in this WaPo article the] Gonzaleses are members of a Blue Shield of California HMO that provides all of the family's nonemergency care in Mexico. They are among 20,000 California workers and their dependents in health plans that cost 40 to 50 percent less than comparable care in the United States because the doctor's visits are outsourced south of the border.

With health care costs in the United States continuing to rise, many employers in Southern California are turning to insurance plans that send their workers to Mexico for routine care, plans that are growing by nearly 3,000 people a year...Lower-priced labor, malpractice insurance and overhead in Mexico mean both basic and sophisticated medical procedures can be performed at a small fraction of the cost. A hysterectomy that averages $2,025 in the United States costs $810 in Mexico, said Mary Eadson, director of legal compliance for the Western Growers Association, an agricultural organization that provides health insurance for California workers in Mexico.

Don't Hand Me No Lines, and Keep Your Sperm to Yourself

London Guardian reports that:

Ending anonymity for sperm donors has contributed to a huge drop in the number of applicants, according to a study published in the journal Human Reproduction yesterday. The study centred on Newcastle Fertility Centre, where applications fell from 175 in 1994 to around 25 in 2003, with the sharpest fall from 2000 when the possibility of ending anonymity was first debated. The change in the anonymity rules introduced this year gives children conceived as a result of using donor sperm or eggs the right to know the donor's identity when they are 18.

If this surprises you then you live under a rock. Donor are basically identifiable already - good luck keeping records secret when a "recipient" comes calling to find dad.
[thanks Alta Charo]

Conservative Bioethics Thoroughly Exposed

A number of news reports today about a report by Kathryn Hinsch's Women's Bioethics Project [PDF download]. In it, in a very unconventional way, she aggregates and presents information about how conservative bioethics is developing as a set of institutions. The download is useful and whatever your view on the politics of bioethics this is must-reading if you want to understand the debate. I think it is great.

I haven't yet seen anything like this kind of thorough indictment of what amounts to exploitation of the academic standing and role of bioethics by a political movement (and even by a Presidential administration), although I have argued in an editorial , in Nature and elsewhere that the Kass leadership of the Presidential bioethics group is incredibly problematic, and of course this blog published his "manifesto" for bioethics, which I would link to were I not using bad internet in an Allentown Pennsylvania hotel and late to go give a talk.

And like Karen Kathryn (and with her) we have been all over the problems with the PCB since it first began to play presidential politics, and to pretend to offer scientific solutions to the embryo research problem (most recently in the form of David Magnus' excellent argument "Bad Science + Bad Ethics = Nature Publication?"

Women's Bioethics Project has made exposing the hijacking of bioethics by conservatives a top priority. Hinsch is the principle author and a good writer and speaker who has a neat take on what bioethics from a women's perspective might mean. For example she gave this excellent speech at the UN Plaza.
[thanks Jon Moreno]

The Great Brain Robbery

In the October 27th issue of New England Journal of Medicine, Fitzhugh Mullen’s article “The metrics of the physician brain drain” offers some fresh measurements of the extent of physician migration from less-developed to more developed nations. One of the more striking figures is the percentage of ‘international medical graduates’ from low-income countries estimated to be in the United States medical workforce: of the 25% of working physicians who have graduated abroad, 60% of them come from low-income countries.

The United States is not alone in luring foreign physicians to its shores: of the 28.3% of physicians in the United Kingdom who have graduated from medical school ‘elsewhere’, 75.2% come from resource-poor nations. Canada and Australia are also significant importers. In absolute numbers, India is the greatest exporter nation of medical professionals, while sub-Saharan Africa sees the largest percentage of its medical workforce leave for greener (or at least other) pastures.

This development has its benefits: overseas physicians wire much needed remittances to extended families in their home countries, and the move abroad opens opportunities for them as individuals. But the social burdens outweigh these benefits: the exodus of physicians have significantly weakened the ability of low-income countries to face the great health challenges posed by HIV/AIDS, malaria, tuberculosis and other serious conditions faced by low-income nations. And the exodus is not slowing down: Canada is adding residency positions to allow for more medical professions from overseas and is busy streamlining immigration and training requirements to insert them into medical practice. Australia and the United States have their own plans to make medical work in their countries more attractive to foreign-trained practitioners.

The British Medical Association has at least recognized that the brain drain phenomena is largely the responsibility of developed countries and that they therefore have an obligation to do something about it. In May of this year, BMA issued a ‘call to action’ on the healthcare skills drain that elaborated four key points:

1) All countries must strive to attain self-sufficiency in their healthcare workforce without generating adverse consequences for other countries.

2) Developed countries must assist developing countries to expand their capacity to train and retain physicians and nurses, to enable them to become self-sufficient.

3) All countries must ensure that their healthcare workers are educated, funded and supported to meet the healthcare needs of their populations.

4) Action to combat the skills drain in this area must balance the right to health of populations and other individual human rights.

Fine sentiments, but it remains to be seen whether the individuals and nations who profit from the skills drain are willing to do the ethically right thing. And what is the ethically right thing anyway? If it would be wrong to forbid physician immigration, what other means would be appropriate to stop the brain drain?

- Stuart Rennie

Antidepressants Are Highly Correlated with Suicide Among Adolescents? Maybe Not

The article "Emergent Suicidality in a Clinical Psychotherapy Trial for Adolescent Depression," abstracted below, just appeared in American Journal of Psychiatry (162:2173-2175) in an article by J Bridge et al.:

The authors' goal was to examine the incidence and predictors of emergent suicidality that occurred during a clinical trial of psychotherapy for adolescent depression. METHOD: The rates and predictors of emergent suicidality in 88 medication-free depressed adolescent outpatients who reported no current suicidality during an intake interview were assessed over 12 to 16 weeks of psychotherapy treatment. RESULTS: The incidence of emergent suicidality was 12.5% (11 of 88 subjects). Self-reported suicidal thoughts at intake were a significant predictor of emergent suicidality, even when suicidality was denied at intake interview. CONCLUSIONS: Emergent suicidality is a common occurrence in psychosocial treatment of adolescent depression, with rates similar to those reported recently in antidepressant trials. To evaluate accurately the role of treatment in emergent suicidality, it is important to assess self-reported suicidality at intake and to balance treatment groups on this key predictor of emergent suicidality.

[thanks J Coyne]

Frontline Tonight: The Last Abortion Clinic

From the PBS site:

Today, the headlines are filled with speculation about changes in the U.S. Supreme Court and what those changes might mean for abortion -- an issue that has divided the country for over 30 years. Heated rhetoric from both sides continues to be heard in courtrooms and on the campaign trail. But while attention is often focused on the arguments, there is another story playing out in local communities. Pro-life advocates have waged a successful campaign to reduce abortions in many places throughout the country. By using state laws to regulate and limit abortion and by creating their own clinics to offer alternatives to women, they have changed the facts on the ground. On Nov. 8, FRONTLINE investigates the steady decline in the number of physicians and clinics performing abortions and focuses on local political battles in states like Mississippi, where only a single clinic performs the controversial

When They Start Rationing Tamiflu, Have a Glass of Grape Juice and Shut Up

Jason Schwartz at Penn pointed us to Welch's web site, where there is a Newspeak advertisement for, well, read it yourself:

While we are aware of recent research on resveratrol and the inhibition of influenza viruses, no research has studied the effects of drinking Welch’s 100% Grape Juice made from Concord grapes on the avian flu. Because of this limited information, we cannot recommend the use of our product in this area. We do know, however, that Welch’s 100% Grape Juice is abundant in a number of natural antioxidant compounds, of which resveratrol is just one, that may contribute to good health in many ways. Decisions on how to manage conditions like the avian flu should be made in consultation with a physician.

Circumcise Me

In an earlier post, I mentioned some of the preliminary and partial results of a randomized controlled trial of the use of male circumcision to reduce risk of HIV infection in South Africa (the ANRS 1265 trial). Those results were presented at the International AIDS Society in Rio last July, and an article further detailing the study methods and findings have just appeared in the November issue of PLoS Medicine. In an unusual move, the editors of PLoS Medicine have seen fit to write an editorial to explain why it choose to publish the trial results – after having them combed over by six reviewers -- and the issue also includes a commentary by the head of one of the IRBs that originally approved the protocol. It is safe to say that the study is regarded as ethically hot, and its publication is unlikely to cool it down.

ANRS 1265 was a randomized controlled trial with one intervention arm (1640 men who received circumcisions after recruitment) and one control arm (1654 uncircumcised men). During the course of the study, initially planned to take 21 months, 20 men in the intervention arm became HIV positive as opposed to 49 in the control arm. This translates into a 60% protection rate – a rate comparable to an efficacious vaccine and achieved by means of a relatively simple surgical intervention. For decades, there have been observational studies and meta-analyzes suggesting the protective qualities of circumcision against female-to-male HIV transmission, but this study seems to finally offer experimental proof. The importance of the findings is unquestionable.

But where are the ethical flashpoints? There seem to be at least two related ones. First, while it would seem to be logical to limit the participants to HIV negative men, the researchers choose not to use a positive HIV test as an exclusion criterion, reasoning that such a criterion would risk subjecting prospective participants to stigmatization. Thus the presence of some HIV positive men in the trial was virtually guaranteed. Second, while the researchers drew blood to test for syphilis and HIV, interviewed participants in detail about their sexual activities, offered HIV counseling, and encouraged the men to be HIV tested at local clinics, they did not inform participants of their HIV status if they did not wish to be informed. The study design, in fact, called for researchers to be blinded as to the HIV status of the participants. So on the one hand, the trial presupposed that some of these at-risk men (both circumcised and uncircumcised) would be or become HIV positive during the trial, but on the other hand the trial left no room for a ‘duty to warn’ those who were or became HIV positive, even if the participant revealed in interviews that he was engaging in unsafe sex. As the article puts it:

They [the investigators] considered it unethical to inform participants of their HIV status without their permission, even if they thought that participants should be aware of their HIV status.

Some might say that in the name of avoiding stigmatization and respecting autonomy, the researchers were studying (at least in some cases) HIV positive persons engaging in harmful practices without protecting third parties. And why did the investigators need to be blinded in regard to the HIV status of the men in the first place? Couldn’t the same results be generated by an ethically less controversial trial design?

Readers are invited to read the PLoS article and draw their own ethical conclusions.
-Stuart Rennie

South Korea Cracks Down on Illegal Egg Sale

South Korean bioethics has teeth, as noted by Reuters:

South Korean police have made their first arrest under a new bioethics law, capturing a man they suspect illegally sold human eggs to infertile couples in South Korea and Japan, a police spokesman said on Monday.

Police raided four Seoul area hospitals on Sunday following the arrest on Saturday of a 28-year-old man identified by his family name Kim, who tried to entice women to sell their ova to help them pay off debts such as massive credit card bills, the spokesman said.

The Pain of the Unborn: the US House Feels It and You Better Too

From Washington Update via Alta Charo:

On November 1, the House Judiciary Subcommittee on the Constitution held a hearing entitled "Pain of the Unborn" to discuss the merits of the "Unborn Child Pain Awareness Act." The legislation would require physicians performing abortions to tell women at 22 weeks or more gestation that "The Congress of the United States has determined that at this stage of development, an unborn child has the physical structures necessary to experience pain." The bill would also require a physician to offer women the option of anesthesia for the fetus. (An article published in the August issue of the Journal of the American Medical Association (JAMA) found that the fetus likely does not have the capacity for conscious perception of pain until well into the third trimester, if at all, and that administering anesthesia as suggested by the legislation may be harmful to the woman.) Witnesses supporting the legislation argued that the script for physicians is necessary to guarantee a woman’s informed consent prior to having the procedure. Arthur Caplan, director of the Center for Bioethics and chair of the Department of Medical Ethics at the University of Pennsylvania, asserted that Congress should not interfere with the doctor-patient relationship and that a mandated script does not conform to standards of medical ethics. Even Kanwaljeet Singh "Sunny" Anand, a proponent of the legislation from Arkansas Children’s Hospital who disputed the findings of the JAMA article, stated that a federally mandated script is "counterproductive" to good medical practice.

Leon Kass Focuses on the Family

Hilde Lindemann of Michigan State drew my attention to the fact that Dr. Leon Kass is writing providing columns for James Dobson's Focus on the Family website. Here are three: link, link, link. Anyone who wants to argue that there ought to be less 'politics' in bioethics, or that we need to be more "Fair and Balanced, Really" might want to take a look at the Focus on the Family site.
- Art Caplan

The New Tuskegee:
The Poor Exploited in Clinical Trials

In one among a series of exposes (they appear somewhere every year or so) of the clinical trials industry, Bloomberg news service reveals (yet again) something that drives me crazy. Quoting astonished ethicists - including Ken Goodman of University of Miami, whom the reporter brought to a clinical trials site - the reporters identify one of many clinical trials sites engaged in truly ugly exploition of research subjects. The setting is laid out like a script for a play (and indeed several plays have focused on clinical research abuses):

Oscar Cabanerio has been waiting in an experimental drug testing center in Miami since 7:30 a.m. The 41-year-old undocumented immigrant says he is desperate for cash to send his wife and four children in Venezuela.

More than 70 people have crowded into reception rooms furnished with rows of attached blue plastic seats. Cabanerio is one of many regulars who gather at SFBC International Inc.'s test center, which, with 675 beds, is the largest for-profit drug testing center in North America.

Most of the people lining up at SFBC to rent their bodies to medical researchers are poor immigrants from Latin America, drawn to this five-story test center in a converted Holiday Inn motel.

Inside, the brown paint and linoleum is gouged and scuffed. A bathroom with chipped white tiles reeks of urine; its floor is covered with muddy footprints and used paper towels. The volunteers, who are supposed to be healthy, wait for the chance to get paid for ingesting chemicals that might make them sick.

They are testing the compounds that the world's largest pharmaceutical companies hope to develop into best-selling medicines.

Cabanerio, who has a mechanical drafting degree from a technical school, says he left Venezuela because he lost his job as a union administrator. For him, the visit to SFBC is a last resort. "I'm in a bind," Cabanerio said in Spanish. "I need the money."

Zeke Emanuel writes about coercion in research in the current American Journal of Bioethics, and the current issue of Hastings Center Report is dedicated to research ethics more generally.

But the real chronicles - and most of the discussion - of abuses and frankly systematic neglect in the clinical trials industry has been published in newspapers, with quotes from astonished ethicists, and it is notable that the Bloomburg piece - like an equally amazing one in 1996 in the Wall Street Journal - have been greeted with the same kind of deafening silence that accompanied early newspaper accounts of the Tuskegee experiment. The piece has been published in at last count three newspapers.

The regulations as the piece points our are "porous," enough so that some medical centers have had non-physicians conduct clinical trials for years with bogus credentials - faking a medical degree for example. The solutions proposed in bioethics to date have been less than imaginative, and nobody is stepping up to the plate from policy or pharma either.

In fact the single most apparent change in clinical trials has been the divestment of pharma in the clinical trials industry: one large phamaceutical company after another has decided that the best idea is to outsource them for lower cost - and to eliminate liability.

I cannot believe I am saying this, given my skepticism about national commissions in bioethics and their utter lack of effectiveness in recent years, but it is time for a national commission on clinical trials that focuses on these issues. Or better yet it would be great if a senator took up the challenge, as happened (to terrible effect, granted) in 1993 concerning emergency research. The commission should be - minimally - sponsored by the IOM and ASBH.

The poor, who are most vulnerable are being offered cash and promises of therapeutic efficacy ("depressed? got no money for psychotherapy? we will give you free evaluations and study medications...") to serve as faceless guinea pigs in multiple and poorly policed experiments in labs that boggle the mind. Troy Duster famously referred to "credit card eugenics," a new form of genetic selection dominated by a market rather than the state. I submit that clinical trials in the United States have become a "welfare Tuskegee."

Not only African Americans, and not only a small town, and not with the deliberate and systematic involvement of public health authorities, there is nonetheless a broad and even systematic campaign that is ongoing to design clinical trials - the ads, the facilities, the trials themselves and the cash payments - in such a way as to deceive and endanger specific and well understood socioeconomic groups in society.

It is a new version of an old problem and we need to go from being astonished to being furious. Even if that means fighting your own university's psychiatry department, or developing new roles that feel more like "ethics police" than like researchers. And I am skeptical enough to suspect that it is fear of our own institutions - most of whom benefit mightily from clinical trials - that plays a big role in preventing many of us in bioethics from studying or protesting research ethics abuses in our own institutions. The most prominent case of resisting that kind of pressure was that of Mary Faith Marshall (now of University of Minnesota), who famously fought against State sanctioned abuse of pregnant women in South Carolina and paid a significant penalty as a result.

Bioethics has been asleep at this switch for too long, teaching responsible research courses that hang on the Tuskegee experiment as though we have come so far in fifty years. Come so far? Tell that to Oscar Cabanerio. India, one of the worst offenders in research ethics for years, has done more to reform clinical trials than the US.

deCODE CEO Attacks Icelandic Medical Journal for Publishing Yet Another Expose

IcelandReview reports that Kári Stefánsson, CEO of deCODE genetics ...

plans to file charges against the board of directors of the Icelandic Medical Association and the Medical Association of Reykjavík for not removing an article that criticizes Kári from the Icelandic Medical Journal's website ... [the article] criticizes the fact that during Kári's five day stint of relieving at Neurology Department, Kári suddenly "ran away" to open the NASDAQ Market in New York. "How can something like this happen at Iceland's most eminent medical institution? Is this a theater?" asks [the author of the article]...

Known for being outspoken, Kári recently told Bio IT World.com that you had to be "somewhat twisted" to be concerned about privacy and it was "ugly and predatory behavior" not to participate in biomedical research. When interviewed shortly after opening NASDAQ this summer, Kári referred to the Icelandic Stock Market as a "small and muddy puddle". [He demanded an apology for the publication of the article, but] no apologies have been reported.

Gazzaniga Finds Sunshine

Neuroscientist Michael Gazzaniga has been recruited to UC Santa Barbara, away from his endowed chair at Dartmouth (where he has also served as Dean), to lead a new interdisciplinary research center focused on interdisciplinary examination of the mind. The Center has been endowed by a $3.5 million gift from SAGE publications. Gazzaniga, who has recently focused almost exclusively on bioethics and specifically neuroethics - he authored the first book on the subject, The Ethical Brain - is a member of the President's Council on Bioethics.

On the Other Hand, Condemnation of Physician Involvement in Torture is Beginning

Steve Miles, who has done more to discuss ethics in Abu Ghraib and Guantanamo Bay than anyone, notes on MCW-Bioethics that the American Psychiatric Association, the American Psychological Association, and the American College of Physicians have spoken out forcefully on the McCain amendment concerning among other things the involvement of US health professionals in inappropriate roles in interrogations. He writes though that the AMA has not gone to the mat on this issue, and points for contrast to the AMA 2005 strategic plan to build its brand identity and promote professionalism which is here.
[update] Matt Wynia at AMA, who is nobody's apologist and tells it like it is, replies that the AMA did in fact send letters to the US congress and put together releases on the matter. Miles contends though that the AMA did not push to make the public aware of those efforts. If you are dying to read more of that exchange, which just began, email aderse@post.its.mcw.edu to be added to the MCW-bioethics list serve, sit back, and let the emails begin.

Mens' Rights in Procreation: Goose Meets Gander

New York Times today on the juxtaposition of two roles for men in contemporary reproductive practices:

Case study one: a pregnant woman wants an abortion. Her husband doesn't. Should he have a say?

Case study two: a woman wants to become pregnant with frozen embryos. Her ex-husband opposes the decision. Should he have a say?

The answer, legally, is no in the abortion case, and in the case of frozen embryos, almost always yes.

[thanks Jeffrey Spike]

Rationing Tamiflu

U.S. pandemic flu plan includes rationing of medicines, according to a review of the document by San Francisco Chronicle.

A Window into the Future of Donor Gametes: You Cannot Hide from Your (Sperm-ish) Offspring

New Scientist News uncovered a story about a boy who found the sperm donor who is his "father." It is the future of gamete donation, no matter what you hear to the contrary - and despite the supposed standing of contracts preventing such contact:

LATE last year, a 15-year-old boy rubbed a swab along the inside of his cheek, popped it into a vial and sent it off to an online genealogy DNA-testing service. But unlike most people who contact the service, he was not interested in sketching the far reaches of his family tree. His mother had conceived using donor sperm and he wanted to track down his genetic father.

Trudo Lemmens is quoted as saying ethicists have not thought about these issues, but I am obsessed with this issue and have long argued even more expansively against the practicality of promises of anonymity. The problem is finally getting some anecdotal attention in the media. But it isn't just a practical problem; even if it were practical to keep secrets on behalf of donors or parents, children have a right to know whatever they want to know about their biological origins.

Very Very Small Health Risks?

Woodrow Wilson International Center for Scholars released its strategies for assessing the toxicity of nanomaterials.

The report stresses that cellular, also called in vitro, tests will play an important role in evaluating nanomaterials, Warheit said.

For example, in vitro tests can be used to determine whether a nanoparticle might cross through the lungs and enter the blood and immune system, Warheit said, adding the ability of some nanoparticles to move through or "translocate" biological barriers is one reason they must be carefully studied...

In vitro tests also can be used to determine whether a nanoparticle might pass through the skin, the report said.

A table in the report illustrates how in vitro tests could be used to determine ways a nanoparticle might get into the body.

Another table describes in vitro tests that could be used to help figure out whether a nanoparticle might harm various organs.

Thank You for Your Rejection

Philadelphia Inquirer reports that

The Bush administration's opposition to emergency contraception seems to be doing wonders for awareness and use of the method...

Annual prescriptions for Barr Laboratories' brand, Plan B, have doubled to 1.6 million during the two years that Food and Drug Administration leaders have refused to approve nonprescription sales of the product. FDA advisers and staff, as well as major medical organizations, have endorsed over-the-counter sales.

Home DNA Testing Kits in Your Pharmacy Now

Denver Post reports on the quick development of a test kit by a Colorado company, and its mystical powers:

The tests, called Cellf Genetic Assessments, are produced by another Boulder company, Sciona Inc. The tests allow customers to collect their own DNA with a swab and mail it to a laboratory that tests the sample and returns detailed health and diet recommendations based on genetic analysis.

'This is the future of self-care,' said Don Summerfield, vice president of integrative medicine for Pharmaca, a company that combines traditional prescriptions in a drugstore concept with homeopathic and natural medicines. 'It provides a blueprint of what is specific to you.'

While Pharmaca and Sciona officials pitch the test as an opportunity for customers to tailor their diet and exercise regimes to their specific health risks, some experts are skeptical. They caution that the science may not be far enough along to support retail sales, and customers might not be equipped to deal with the information without a doctor's guidance.

The Cellf Assessments testing packages so far available are not, um, the product of what one might describe as 'top shelf' genetic research. Genetics and Public Health blog actually conversed with these Sciona folks, which is somewhat interesting to read but frankly these particular tests don't seem to me to be going anywhere. But their availability in drug stores - and the marketing that led to it - opens the door to a wave of home genetic tests that at this point would still be essentially unregulated.