blog.bioethics.net

Now Comes the Age of the Hamburger

What if Zocor went off of patent and cost $2 a pill or less and was covered by Medicaid everywhere? Large fries. Greasy pizza. And in Philadelphia, scrapple and cheesesteaks. A bright future beckons.

A Report Card for a Decade of Biotech Crops

Reuters discusses the state of biotechnology in a pretty nice overview of how folks feel about the political and gastronomic impact of a decade of GMOs.

I'm Sorry Dave Grandpa, I'm Afraid I Can't Do That

Two interesting articles in The Japan Times Online today on the plans to incorporate new robotic technology in caring for the aging:

Taking advantage of this nation's advanced robot technology, the public and the private sectors are developing new types of robots to support the aged.

One example is Toshiba Corp.'s ApriAttenda, a 90-cm-tall robot that can keep an eye on those elderly people who easily get lost.

ApriAttenda, with image processing algorithm functions and stereo vision technology, identifies the first person it sees as its master and analyzes his or her clothing patterns. It follows its master, and emits sounds to draw its master's attention when it loses sight of him or her.

Good luck with that.

Why is it So Hard to Pay Malpractice Insurance: Because the Market Will Bear It

Washington Post reports on a very important study by the consumer advocacy group Foundation for Taxpayer and Consumer Rights, in which it is estimated that malpractice insurers overstated their losses by 31% from 1986 to 1994.

How to Avoid Learning the Lessons of Schiavo

It would seem that despite losing both the battle for popular opinion and all legal and legislative skirmishes as well those who wish to believe what they wish to believe continue to insist that Terri Schiavo was 'euthanized'!

While Ex-Husband Enters Politics, Terri Schiavo's Family Helps Disabled Clearwater, FL (LifeNews.com)
While her former husband enters the world of politics, Terri Schiavo's parents and family are working to help disabled patients like Terri have their right to live protected by law. Michael Schiavo recently announced the creation of a political action committee to target pro-life lawmakers who sided with Terri and her family to allow her to stay live and get medical help. However, Bob and Mary Schindler, Terri's parents, and her brother and sister are working to promote a foundation to help others. Terri's brother Bobby resigned from his position as a teacher at a Catholic high school in Tampa to work with the foundation full time. "I think this foundation and at least trying to help others and staying involved in this fight is therapeutic and helpful, and it's something that Terri would be very happy we're doing," he said recently. "Our family said from the beginning that we just wanted to bring Terri home and care for her," Bobby Schindler said. He wants to help other families in similar situations be able to care for their loved ones. The Schindler family is working on a book that will be released in March. Michael also has a book release planned for around the same time, which will be the one year anniversary of Terri Schiavo's euthanasia death.

- Art Caplan

Fraud Busters or the Politics of Convenience?

Frankly speaking the outrage from those opposed to all forms of embryonic stem cell research (as well as IVF) is to put it mildly beyond hypocritical. They say they are horrified by the occurance of fraud in South Korean. Well is it really fraud that is horrifying them or simply the opportunity to take a cheap shot at all stem cell research? I suspect that latter.

Richard Scrushy of the good old USA has caused incalculable harm to real people, stolen tens of millions of dollars for personal gain, and brought a company upon which millions of Americans depend for their health care to its knees by means of --FRAUD! Yet his actions have elicited no comment in the pages of the National Review, the neo-con blogs, or the Weekly Standard. Could it be that corporate tycoon Scrushy's firm embrace of evangelical Christianity makes him a less appealing target for moral approbation than a South Korean veterinarian?

The politics of stem cell research remains as ever incredible to observe!
- Art Caplan

Shout Out to 2005 Sponsors

If you've read any from among a dozen virtually identical screeds in the past year, you know that bioethics is now an unethical, wholly-owned subsidiary of the pharmaceutical industry, and bioethicists now a troupe of touring show dogs in the guise of watchdogs. Your editors, moreover, are apparently beholden to pharma and biotech and in need of a twelve-step program. And we're rank sinners too.

So naturally we want to close out the blog this year by giving props to those who returned the Ring to Smeagol ("Gollum, Gollum") made financial contributions to the blog this year. Thanks go to PBS, to WGBH Boston, to MSNBC Keith Olbermann, to Basic Books as publisher of The Republican War on Science, to Scholargy publishing as publisher of Explaining Postmodernism, to the 48er bookstore, to GoToMeeting, to MyCustomTailor.com - because when the evil pharma money people reporters show up to film your comments about Hwang Woo-suk, you don't want to be caught in an off the rack suit. And finally to these guys and their odd-looking book about religion. All told, blogads generated just under $500 in support in 2005 all of which we plowed right back into coffee support for the students who help the editorial staff at Alden March Bioethics Institute, subject to the institute's policies and procedures.

We do have one sponsor who actually invested real money in this thing. In the immortal words of Click and Clack, the Tappet brothers of Car Talk, "though they probably wince every time we say it," the blog was built with a major grant from The Greenwall Foundation, whose programs in research and education have supported bioethics for almost 15 years.

Another Cloning "Breakthrough": The World's First Phony Stem Cells

Wesley Smith is the first to make the argument that I had expected to hear 24 hours a day after the Hwang Woo-suk scandal started: that it is nuclear transfer research itself, not scientific misconduct, that is at the core of the bioethics issues in the South Korea fraud. Written for the Weekly Standard, his piece asks a variety of interesting questions about not only how the scandal happened but about what it says about bioethics' "spin." Whether you agree or disagree with Smith about the matter, his piece is as coherent as this argument will withstand, and it needs to be heard and debated.

No AIDS Vaccine Unless the Government Makes It

The head of vaccine research for the US government left the drug industry and vaccine research groups chafing against his comments that without financial incentives, drug makers will not produce an AIDS vaccine.

Good Luck Getting Access to Medicare Prescription Drug Coverage

The Medicare prescription drug benefit is confusing. A typical story illustrates just how much so:

MIAMI BEACH, Fla. (AP) -- Jean Newman is hardly afraid of challenges. The 73-year-old Cuban native came to the United States as a teen, worked for years as a substitute teacher and volunteered in the Israeli army well into her 50s.But when it comes to the new Medicare prescription drug benefit, she is at a loss.''The whole thing is so confusing. It might as well be in Chinese,'' Newman said. Philadelphia senior center counselor Gloria Mack said she herself was confused by the training she received on the program. ''Oh, my God,'' Mack recalled thinking. ''I'm confused, and I'm not a senior.''

-Art Caplan

Hwang Woo-suk Update

Rumor and bits of evidence now dominate the discussion of the Hwang Woo suk matter, and today is no different.

The Korea Times reports that Hwang's lab samples matched somatic cells from donors, indicating Hwang's group "has partially succeeded in creating patient-tailored stem cell lines," which in turn casts in a positive light the original Hwang paper concerning somatic cell nuclear transfer (cloning) derived stem cells.

In the same article it is reported that the SNU panel has officially disclosed now that two scientists in Hwang's group gave a big pile of cash to Kim Sun-jong before and after he gave a really nice interview on behalf of Hwang. They it is suspected were giving a bribe, of $30,000, to Kim Sun-jong and his father, on behalf of Hwang. Marmot identifies a source who says that "the money was supposedly compensation for "mental stress" suffered by Kim thanks to the strong-arm tactics of these mean, mean men from [the Korean television network] MBC." And Marmot writes: "we have an SBS report (via the Chosun Ilbo) claiming that the [Korean] National Intelligence Service (NIS) was involved in the money transfers to Kim. The NIS is denying the report."

You will recall that Hwang accused Kim of swapping cell lines, and that he is implicated in the entire matter of fabrication. In any event, Pauly Walnuts these guys who appeared to be checking on departing scientists at Pitt seem to in fact have been bringing cash to the U.S., and in so doing broke at least the Korean foreign exchange control law. At some point the criminal wrongdoing element of this nonsense will reach a threshold beyond which CNN's Nancy Grace lives.


[Updated 12/28]

The American Journal of Bioethics Letter to the Editor from Authors Concerning Factual Errors in Their Manuscript on Korean Egg Procurement

In a letter published yesterday, Drs. Insoo Hyun and Kyu Won Jung, who authored "Oocyte and Somatic Cell Procurement for Stem Cell Research" in the most recent issue of AJOB, the authors express concern regarding that manuscript. The letter in its entireity follows:

To the Editor, In our article, “Oocyte and Somatic Cell Procurement for Stem Cell Research: The South Korean Experience,” we outlined and defended the informed consent procedures that we reported that Dr. Jung designed for the Hwang team’s 2005 patient-specific stem cell study. In our article, we claimed that the Hwang team followed these rigorous informed consent procedures to procure eggs and somatic cells for their 2005 stem cell research.

However, on December 16, 2005, we began to doubt whether the Hwang team had actually used any of these eggs and somatic cells to generate data for their 2005 Science study. Our doubts were raised by some of Dr. Hwang’s remarks during his press conference that same day and also by the two to three month timeline now widely acknowledged by scientists to be necessary to culture new stem cell lines.

Our first concern was that the timeline for the volunteers’ egg and somatic cell donations did not match the timeline necessary for the Hwang team to produce data for their March 15 article submission to Science. The process we described was not in place prior to January 23, 2005.

Furthermore, Dr. Hwang publicly declared that several patient-specific stem cell lines were contaminated on January 9, 2005, which would suggest that the team performed some of their cloning research well before to the activation of Jung’s informed consent procedures. We reported our concerns immediately to a member of the Hanyang Hospital IRB and the leadership of the International Society for Stem Cell Research (ISSCR) and its bioethics committee.

On December 23, 2005, the SNU investigative body announced not only that the Hwang team had fabricated their data, but that they had also used far more eggs than they had initially reported to Science. These extra eggs most certainly were not procured through our described informed consent procedures. Indeed, we wonder whether any of the eggs and somatic cells donated through our informed consent procedures were ever used for research. If not, then Hwang and colleagues may have allowed egg donors to expose themselves to risk needlessly. So, in addition to the problems of the Hwang team’s scientific integrity, serious ethical charges of informed consent must now be explored.

We are extremely disappointed by the evidence of the Hwang team’s scientific and ethical misconduct. However, we remain steadfast in our belief that the informed consent procedures we describe in our article are ethically rigorous and that they provide a useful starting point for developing tough guidelines for tissue procurement for stem cell research. Unfortunately, we were led to believe that the Hwang team had actually used these procedures to produce the patient-specific stem cell lines they reported to Science.

-Insoo Hyun and Kyu Won Jung

Dispatches from Nigeria on AIDS and Abstinence

Last week, the 14th International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA) took place in Abuja, Nigeria. Despite the disproportionately high burden of these diseases on the African continent, ICASA typically gathers modest media coverage, and a recent, tragic plane crash in southern Nigeria ensured that the event was relatively neglected in the international press. All the more reason to briefly profile two hot themes emerging from this year’s conference: abstinence as HIV prevention strategy and access to second-line AIDS drugs.

Abstinence is obviously a politically heated topic, considering that the ‘just say no’ approach is predictably favored by the Bush Administration, a major funder of HIV prevention programs in Africa, while the actual effectiveness of abstinence promotion is deeply questioned by the scientific community. It is no small irony that Winnie Madizikela-Mandela should appear at the ICASA conference as a vocal proponent of abstinence, given her personal struggles with abstinence when her husband Nelson was languishing on Robben Island, and her issues with old-fashioned fidelity after his release from prison in 1990. Perhaps in this sense she functions as a symbol of the conflict between the allure of purity and the reality of human desire, though I doubt that she (or her followers) see things quite this way.

Access to first-line AIDS drugs in Africa is very limited – according to recent WHO figures, less than 10% of AIDS patients in need of anti-retrovirals in Africa are now on treatment. So it is deeply worrying to learn that a percentage of whatever ‘lucky few’ manage to gain access to first-line drugs will need to switch to more expensive second-line regimes, which pharmaceutical companies are not marketing in Africa (because poor people are poor consumers) and for which no generic equivalents are being produced. According to a presentation at ICASA by Doctors without Borders, standard first-line therapy currently costs $194 per year, while second-line treatment costs approximately 8 times as much ($1661). Toronto’s Globe and Mail are carrying a piece on this issue.

It is discouraging to realize that new efforts to lower prices for second-line AIDS drugs will have to be launched when the vast majority of AIDS sufferers in Africa still cannot get the first-line treatments, and while AIDS patients in developed nations virtually have universal access to treatment -- first-line, second-line and beyond. There is just no way around it: the abiding problems surrounding access to AIDS treatments are unlikely to be overcome without narrowing global inequalities.

-Stuart Rennie

Hands-on Health Care Monitoring, Mozambique Style

Somehow it is hard to imagine this happening outside Africa. Mozambique's Health Minister, Ivo Garrido, has started to make a habit of dropping into local health clinics during the night shift, apparently to see how things are going. And to pitch in. Last Tuesday, he performed minor surgery on a taxi fare collector who was admitted with a throat laceration. After that, he headed over to the ICU, the maternity and the pediatric wards to field complaints and offer guidance. Yes, have no fear, Dr. Garrido is a licenced surgeon.

Mozambique's clinics can use the help. The HIV/AIDS epidemic has hit the country hard, and health care professionals have been severely affected. As Garrido has stated publically himself, some 6000 health care workers are predicted to die from AIDS by 2010, undermining the government's plan to aggressively expand delivery of antiretroviral treatment, and weakening primary care services as a whole. That's not counting the numbers of doctors, nurses and laboratory technicians moving to greener pastures in South Africa, Portugal and the United Kingdom.

In this perspective, Garrido's nocturnal journeys are nothing strange; it is simply what medical ethics demands in dire circumstances.
- Stuart Rennie

Howard Brody MD, PhD Moves to Galveston

Something of a tectonic shift is about to occur in professional bioethics. Howard Brody, a physician and philosopher who is by any estimation one of the very best writers in the field and a precient and thorough scholar, is leaving the Michigan State program, where he has worked since 1980, for University of Texas Medical Branch.

About 50 degrees warmer and several thousand miles away from Detroit, UTMB Galveston played an important role in the founding of bioethics and is a hive of activity in several areas of the field. It is home to a surprising number of superior senior scholars and a long-standing PhD program.

It is a good place but Galveston needed a strong replacement in the director slot for Ron Carson, as it faces a decade of faculty transitions. So UT lured Howard Brody, who as director of the Michigan State program from 1985-2000 did what many describe as an incredible job of program building. It is a significant move for the field.
[thanks btw to Eric Berger at Houston Chronicle; he writes their great science blog]

Hwang Woo-suk Analysis by Marmot's Hole

They say that they are getting tired of blogging about Hwang Woo-suk but the ability of Marmot's Hole to read Korean and understand bench science gives them incredible reach.

In today's installment, they blog an article that quotes members of the SNU committee investigating Hwang as saying that there were no nuclear transfer derived stem cell lines.

A member of the Seoul National University administration team is interviewed in a story that Marmot links to as well - saying that Professor Gerald Schatten demanded a professorial position in the SNU School of Medicine, which doesn't seem like such an odd demand, but they make the point in the context of claiming that Schatten acted inappropriately in his negotiations to "leak" stem cell information to the U.S. The same story indicates that the SNU hospital is "considering legal action against Schatten," although what they could possibly do is beyond me.

Oh and Marmot links to a Japanese web site in which it is claimed that even Hwang's "chopsticks method" in his research was actually published in a Japanese journal in 1991. Of course it was.

And eclexys has some interesting discussion of the university/science climate in Korean science that in their estimation makes all of this more likely.

Dr. Hwang and the Bad Apple Theory of Scientific Misconduct

At last the investigation of stem cell research in South Korea has become a matter for criminal investigation. The Korean equivalent of an indictment is likely, and it may turn out that Hwang Woo-suk will (as Art Caplan describes it) "end up in the DMZ somewhere with a bull's-eye on his lab coat," as detailed in The Korea Times:

Prosecutors are expected to investigate embattled stem cell expert Hwang Woo-suk over his team’s fabricated research...

Investigators are predicted to focus on finding out whether Hwang and his team intentionally forged the research results to receive state funds and donations from a number of private companies.

The Lone Liar Theory

Several of my favorite colleagues, including Laurie Zoloth in the Los Angeles Times, have distilled the ethical implications of the Hwang matter to "telling the truth."

Laurie writes:

The bottom line is this: In a complicated world, the public must trust experts, because how can you know what to do if you cannot know what is real?Tell the truth, always, we teach students, withhold nothing from your data. It is a categorical imperative for science and indeed for all societies. It comes from Immanuel Kant, whose early writings on truth in the new discipline of science shaped what we teach as core questions in bioethics ... Bioethicists cannot reflect on complex moral issues without a truthful narrative. Policymakers cannot regulate without good facts. The public cannot know what to hope for if it cannot know what is real.

The submission of an article for publication in a science journal may well be, as David Magnus points out, a form of testimony. But whose testimony is it? Who must stand to account for the science that seems to have been literally made up in this paper? In this case more than 20 authors. And several institutions. And high-ranking government officials.

To be sure, if the allegations are demonstrated in South Korea, the alleged activities in this case would join Summerlin's painted mice and the Piltdown "missing link" man in the Great Halls of Bogus Discovery. But there is an important difference in this case. In this case a legion of collaborators share the responsibility. The lone-liar theory falls apart:

... the Board of Audit and Investigation has requested the Ministry of Science and Technology submit documents on the state funding it has provided to Hwang’s research team ... The state auditor’s probe into the ministry is expected to focus on the ministry's management of Hwang's research fund and the government’s report channels on the destruction of several stem cells that Hwang reported in January.

In addition, its probe is targeting the Ministry of Health and Welfare for its subsides worth 15 billion won provided for construction of the World Stem Cell Hub ... The inspection agency is also looking into 4.3 billion won in subsidies offered in 2001 to Hwang’s research team by the Ministry of Information and Communication.

This case will turn out to be like peeling an onion.

Hwang's lab was subject to extreme funding mechanisms, insufficient oversight, excessive pressure, a crazy confederation of authors and institutions, confusion about patents, translation of both language and data by international collaborators, pressures from peers (the so-called "chopstick theory of scientific supremacy") and more importantly from the culture, and a grossly irresponsible lack of American leadership in the regulatory and funding arena where in virtue of our intellectual property, our consumer safety rules, and our national interest in getting the science right we have that responsibility.

We in bioethics are part of the problem. We undertake partnership with and are often seen as giving approval to the companies, agencies, industry organizations and individuals that share our ideals, and sometimes the enemy of our enemy is
our friend. This is true whether we heading their ethics committees, as
I once did for an American stem cell company, or working in their
industry organizations. In my own case the company whom I was helping
failed to inform me that it was doing cloning experiments that were
of profound moral significance ... a fact I found out when I was asked to
comment on the experiments for a news organization. In this case Laurie
details with equal regret standing alongside Hwang for an announcement
where validation of the significance and ethics of the experiment
mattered a great deal. And John Robertson wrote persuasively in this blog, in commenting on what he saw as hyperventilation about the egg
donation problem in
Hwang's lab, that, "Now that [Hwang] has done his public mea culpa I say
the time is to forgive him and let him get back to plying his
considerable craft."

No.

Lying is bad. But the tangled web in this matter is not the sort of thing one finds in the history of scientific misconduct. An entirely new kind of deception occurred here, one in which picking out the key player will be like playing Where's Waldo. [updated 12/26]

Seoul National University:
Hwang Fabricated the Stem Cell Data

The committee designated to review ethical and scientific aspects of the landmark 2005 paper by Hwang and co-authors in Science has determined that the material was intentionally fabricated. Specifically, Reuters reports that the panel found that "key findings in their paper on producing tailored embryonic stem cells were fabricated." The investigatory results are preliminary, awaiting confirmation from DNA testing that will also help determine the validity of the two remaining cell colonies.

Bloomberg Asia:

But only two of Hwang's 11 claimed stem-cell lines existed when he submitted his landmark 2005 paper to the journal Science magazine, said Roe Jung Hye, dean of research of affairs at Seoul National University said during a press briefing today. AP:

"Based on these facts, the data in the 2005 Science paper cannot be some error from a simple mistake, [and] cannot be but seen as a deliberate fabrication to make it look like 11 stem-cell lines using results from just two," the university panel said.

Schatten remains silent as does Pitt.

Hwang has resigned as professor at the University. AP quotes him: "I sincerely apologize to the people for creating a shock and disappointment," Hwang told reporters as he was leaving his office at Seoul National University, according to the AP. "As a symbol of apology, I step down as professor of Seoul National University."

"There is sufficient evidence that results were deliberately manipulated, and Professor Hwang accepts this at some level," Roe said. "We don't think that the data in the 2005 Science study were incorrect because of simple mistakes."

It is now clear that there was systematic manipulation and worse yet invention of data in this article. That the SNU panel was able to reach this conclusion so quickly is the precise analog of a quick verdict from a jury in a criminal trial: their comments are to the effect that evidence concerning the cell lines was enough to immediately relay their conclusion - unanimous and to the detriment not only of Hwang but of the University - that Hwang has falsified data. Specifically, Forbes writes that:

At issue are two vital photographs that Hwang used to illustrate his breakthrough claim. They appear identical to photos of stem cells that appeared in 2003 in the journal Molecules and Cells in an article describing a routine experiment.

Marmot's hole is covering all of the Korean papers as they release additional details.

With that in mind, Hwang's response to accusations of misconduct now seems extraordinary. He has slowly relayed one confession after another, each preceded by an all-too-lengthy period of "internal investigation" and abject denials of wrongdoing.

Bloomberg reported on December 16th that Dr. Hwang has "denied local media reports he falsified results of a stem cell study published in the Journal Science in May." China Daily reported that same day, "However, at the televised news conference, the professor admitted some of the cloned embryonic stem cells in his research were contaminated and it was impossible to keep them alive."

And as Rick Weiss tells it,

Roh called his own televised news conference after Hwang's, in which he called Hwang a "liar" looking for a scapegoat. Hwang "tries to beat truth with hypocrisy and cheap tricks," Roh was quoted as saying in the International Herald Tribune. "Dr. Hwang is a narrow-minded man who doesn't have the courage to admit that his paper was made with fabrication."

Hwang's claim in the most recent conference and in subsequent testimony to the committee was as follows:

"The fact remains that our research team was successful in creating stem cells from patients' skin cells. Still, there were mistakes made, human errors, in taking photographs and in the preservation of the stem cells.''

Is this dissembling? Yes. But his description of what he was successful in doing in the 2005 study amounts to nothing more than he reported in his 2004 article.

The more important problem is that he is blaming his peers. AP reports that "Hwang alleged [in the news conference] that five of his stem cell colonies had been replaced with those produced by Mizmedi, and called for law enforcement authorities to investigate how that happened." Rick Weiss and Joohee Cho quote Hwang from the press conference: "I am suspecting that my [personalized] cells may have been replaced by MizMedi's cells," Hwang said. "I am truly concerned as to who did such a thing like this for what purpose." Interesting. I suppose it could be true. In view of the announcement from the SNU panel that seems incredibly unlikely. In which case it would be libelous and perhaps worse.

But even if there is truth in the claim, it is the second such "tit for tat" reply from the Hwang group, offered up in the most inappropriate way possible - first they seeded the story that Schatten had pulled out of the World Stem Cell Bank just moments after he was denied ownership of some intellectual property and directorship over that Korean endeavor, and now they allege criminal wrongdoing by the hospital where the co-author on the article who blew the whistle is based and is chairman of the board - and make the claim only now, as though they would only have noticed these irregularities yesterday.

Here is a summary of the recent events in the Korea matter:

Thursday the 15th opened with a South Korean account that became this Reuters story:

SEOUL (Reuters) - South Korea's most renowned stem cell scientist fabricated key parts of a ground-breaking paper and is seeking to have the work withdrawn, a close collaborator told South Korean media on Thursday.

The daily newspaper Hankyoreh and three South Korean television networks quoted Roh Sung-il as saying that he, stem cell scientist Hwang Woo-suk and another co-author of the landmark 2005 Science paper on tailor-made stem cells had notified the journal that they were withdrawing the paper.

"Professor Hwang admitted to fabrication," Roh said in an appearance on MBC television. Roh, a specialist in fertility studies, was referring to a meeting he had with Hwang earlier in the day.

More detail and more vivid from OhmyNews

According to sources Prof. Hwang's confession verified the fact that actually nine of the 11 stem cells referred to in the paper did not actually exist, and were actually invented by Hwang himself with the knowledge of only three others in his laboratory.

According to reports by the media here, Hwang had ordered one of the junior scientists in his lab team to have three original stem cells and DNA fingerprint samples duplicated and then doctored so as to make it look like there were in fact 11 cells that were a success in their research.

American media is nonplussed by this story, both in terms of its ethical implications and as a CSI-like problem of forensics, which is odd given that it is as animated and preposterous as the disappearance of Natalee Holoway. The nation's best science writers have done their level best in the two weeks before the end of 2005 to bring the story into the public debate but most Americans know virtually nothing about the matter but that Hwang resigned.

The key questions in the public discussion of the Korean matter seem likely to involve a billion versions of: "Will ethical lapses in this lab damage stem cell research elsewhere?"

Answer: yes. And no amount of late-in-the-day standards creation will change that. People are going to ask whether the mechanisms whereby stem cell money is doled out have to be made much more rigorous. And yet again, the U.S. government will be zero help, since our rule for how to fund stem cell research is based on the altogether stupid idea that some tiny collection of embryonic stem cells in Wisconsin are ok in terms of ethics and money, but anything made after August 9, 2001 is evil and not to be funded.

It is a policy that makes our tax code look brilliant by comparison, and it illustrates just how dangerous the present regulatory environment really is.

That things were headed this way was obvious from the moment that the first Chronicle of Higher Education piece came out on the matter, in which Jon Moreno and I both said as much.

How we got here

Either way the outcome of the present debate comes at the end of a long trajectory. A lab assistant had already made the claim that slides were fabricated, introducing that word to the conversation. Dr. Schatten's request to come off of the paper suggested this was likely coming. Nick Wade covered that carefully.

In several posts including this one we have reviewed the overarching issues that recur in this case. As has the great Scientific American blog. . Science posted an utterly comprehensive account of the matter from their perspective. The blogosphere is filled now with interesting characterizations of the situation. See for example The Business of America is Business description.

Our argument: U.S. Support of stem cell research is the only way to prevent this from recurring

We made this argument in the Caplan & McGee column, much to the consternation of our friend Richard Doerflinger, who is so apoplectic about our claim that US intervention through funding is necessary to prevent this kind of meltdown, that he slams our article for getting a name wrong.

But to paraphrase Doerflinger, the facts are the facts: if there was ever a case for the US to get serious about international efforts to participate in the international conversation concerning therapies that will come to the FDA, I have not seen it.

And, for what it is worth, CAMR agrees with our position on the relationship between the US funding situation and our regulatory role. Its president Daniel Perry issued this statement today:

“The validity of a paper, published in the journal Science, that demonstrated the extraction of stem cells from cloned human embryos has now been called into question. We fully support an investigation into these allegations and support the scientific community in calling on the authors to cooperate with them in conducting independent tests of the cell lines.”

“Despite this apparent setback, the field of embryonic stem cell research and therapeutic cloning remains incredibly promising as demonstrated by some of our nation’s leading scientists.”

“This is just another reason that this field of research should be allowed to be conducted in the U.S. under the strict supervision of the National Institutes of Health (NIH) and its stringent peer-review system.”

The position of Science

Bloomberg reports on what Science is doing in terms of asking Hwang what in the world is going on. Previous pieces have pointed to Science's reply to Gerald Schatten's request to be removed from the paper - they essentially say that in asking to be removed from the paper he may very well raise questions about what he himself should have known or did know, questions he now needs to answer alongside the rest of the authors rather than being in a category apart and above. As a Saturday Times piece puts it:

The journal said Friday that it had agreed to the request. "Science's stated policy is that all authors must agree to any retraction," it said in a statement, "and Dr. Hwang has assured us that he is contacting his co-authors. Science editors will honor the authors' request and assist them in preparing a retraction."

But Kennedy said in the Press call on Friday afternoon that Hwang had 'days or weeks and certainly not months' to get all 24 co-authors to agree on the retractions.

If the data is bad, should Science really honor a request from anyone before it decides based on its own investigation that this is the case, and if there is in fact malicious misrepresentation then perhaps the authors - none of them - should have that option. The key though in my mind is maliciousness. If there is fraudulent data here then the real ethics problem is that the researchers will have been proven to be engaged in a cover-up that rises to the level of international, inter-institutional conspiracy and crime - and it may well involve not only fraud and malpractice but also violations of securities rules involving intellectual property.

The effect on South Korea

Bloomberg reports that the government of Korea is thinking about pulling the money - not just the $20 million a year from Hwang's lab but from stem cell research toward other endeavors. South Korea has put nearly $65 million into the Hwang lab since 1998.

This scandal has hit Korea like a bomb, with people in mid-December watching the news in train stations speechlessly waiting to see what could go wrong next.

Some have tired of it though. Korea Times reports that in working class bars in Seoul there is a new drink devoted to the matter:

Dubbed the "Hwang Woo-suk poktanju," it involves creating 11 drinks and numbering them 2 to 12. Of these, all except No. 2 and 3 are made just with beer with an empty shot glass inside ... a parody of Professor Hwang's 11 stem cell lines of which all except for Nos. 2 and 3 are alleged to be faked. The empty shot glass represents the alleged "fakeness."

"While it is fun to engage in such parody, a part of us is in shock and disappointment over the allegations that Hwang's work may be fake," said a 40-year-old man.

The culture of drinking "poktanju" arose out of a desire for people to get drunk quickly and open up to each other away from the reserved atmosphere prevalent in Korean workplaces.

And in the U.S., post-mortem stories on the role of Korean culture in the whole scandal; we link to one of those in our Bad Apples post.

Any way you slice it Korea is losing its first major biomedical science program.
And while it is only barely emerging, one can see now that Korea is turning - angry and betrayed - on Hwang. The first sign of that, I'd say, was the moment on the 16th when Korean newspapers started to preface descriptions of him as "a 53-year old veterinarian," a practice that spread like wildfire through the wire stories that week. A very different description from "leading stem cell researcher," or even Time Magazine's description of his training in their award to him of "person who mattered 2004."

The Government is careening:

The Ministry of Science and Technology, which has strongly supported the embattled Hwang, held an emergency meeting to discuss how to deal with the scandal..."It’s shocking,’’ [government official] Kang Tae-chin, 33, told Yonhap News Agency. "I thought that the stem cells are in researchers’ safekeeping. But they’re not. I can’t believe that."

UPDATE - it now looks like the Ministry as well as others will itself be subjected to investigations for its lack of oversight.

But the Korean government cannot complain about the effect of this controversy. It is shameful that it took so long to for the government shift its focus from intellectual property leaking out of the lab and on backing Hwang's effort prior to initiating either an investigation or pushing Seoul National to do so.

What is Happening Now

The details of the matter continue to emerge. But the general picture is getting clear. There are those who believe as does our David Magnus that "The fact that he lied about the ethical questions was serious," but lying to the journal about the allegations "was an egregious breach." There are those who hold that the key issues here involve the money, lack of regulation, conflicts of interest, and misconceptions held by donors, government and the people of Korea about what this research could do - misconceptions that led to giving one man too much lattitude. And there are those who believe that the evils of detroying embryos could only lead to such an outcome, a 'greater evil'. We've made our argument - whatever the cause and whatever the sin there is only one way for the problem to be fixed and that is US funding of stem cell research with concomitant ethical standards the world is forced to either meet or forgo the US market for its drugs and devices.

Acknowledgements: More than two dozen calls and emails have poured in from scientists, reporters in Korea and the US to help or correct us. Thanks from all of us go to Science, who are stuck in the midst of this whole soap opera of course, for their comments about this blog in the current issue of the journal. It's not every day a blog appears in Science and Nature in the same week, and it isn't like we can quit our day jobs to try to live up to notices like that. And Scientific American, who are doing the lion's share of covering this story (although they are too nice to admit it), have been kind to us about any help we might provide, "... The American Journal of Bioethics' Blog has done an outstanding job in covering not just the facts of this case but also what the ramifications for science might be."

13th Update; 12:05 AM December 27; No more updates to this post; see our main page for regular and hopefully far far shorter updates; among the best Korean blogs and by far the best coverage of the situation from a Korean perspective in the English language is Marmot.

Jack Kevorkian Denied Pardon

Details at CNN.

A Negative Feedback Rating Means You Die

Washington Post reports that people are selling medical devices on EBay. Well now that is great. And these aren't just bearded guys in West Virginia whose girlfriends have finished with their breast pump.

Among the more visible online marketers is ClearMedical Inc. of Bellevue, Wash., one of the five largest reprocessors in the United States. In a three-month experiment last year, the company said, it operated an eBay virtual "storefront," selling reused single-use medical devices that it considers "non-invasive" because they do not enter the bloodstream when used on patients. That includes pulse oximeter sensors, which measure oxygen in the blood, and compression sleeves, which increase circulation. (One bidder offered $450 for a set of compression sleeves; ClearMedical said that was about a 30 percent discount off the original price.)

[thanks Alta Charo]

Dem Bones Dem Bones Dem Dry Bones. Stolen. Masterfully.

Alastair Cooke's bones have been stolen,

days after he died last year at the age of 95, according to reports in New York.

Cooke's bones were removed by a surgeon and then sold for around $7,000 (£4,000) to two companies that provide tissue for transplant operations, said The Daily News.

Paperwork describing the bones, which were cancerous and too old for use in transplants, was reportedly altered to say they came from an 85-year-old man who died of a heart attack.

Masterpiece theater, n'est pas?

Cooke, who presented his Letter from America on BBC Radio for 58 years, died aged 95 at his home in Manhattan last March. He died of lung cancer, which had spread to his bones.

Weeks later, his family fulfilled his dying wish by sprinkling his ashes in Central Park, defying a local bylaw by surreptitiously throwing them from Starbucks cups.

But last week, prosecutors from the Brooklyn District Attorney's office, which is leading a year-long investigation into the illegal sale of body parts and bones from New York funeral homes, called Cooke's family to say that his corpse had been mutilated and sold.

[thanks Art and Stuart Rennie]

Louisiana Attorney General: Euthanasia Allegations in New Orleans Credible

In October, when Steve Latham shared them with us, we broke the news that a tiny newspaper had alleged that there was euthanasia in the waning hours of the post-Katrina rescures. CNN.com reports that allegations connected to Memorial Medical Center are credible.

Snuppy, We Hardly Knew Thee

We wrote previously that the peeling of the onion of the Korean stem cell controversy might result in questions about the second most holy cloned animal. And indeed, Snuppy's credentials are being questioned. It appears that 6 out of 11 of Snuppy's cells were taken forcibly from the dogs of subordinate lab techs working in the Hwang lab, two more were bought off the street by a veterinary hospital, for $1400, from desperate pet honors, each of whom was named as an author for the article but now wants to retract it, and the remaining three cells were made with a Xerox machine somewhere in between Pittsburgh and Seoul. Snuppy's master missed her flight to Korea and has been hiding in a basement in western Pennsylvania.

Nature's statement was that there is "sufficient uncertainty … for us to wish to remove any doubts over the Nature paper."

Nobody Does Enhancement Like Stalin

Yes, it's true, Stalin was no genius. But he thought big thoughts. Like this brilliant idea,

... a secret plan to create hordes of half-man half-ape super-warriors to conquer the rest of world. If successful, the plan would have seen humans and chimpanzees cross-breeding to create a new race of "living war machines", which ignored pain and fear and which thrived on hardship...

Stalin threw scientists and other genetic experts into the program, providing lavish resources and funding in a bid to achieve early results.

"I want a new invincible human being, insensitive to pain, resistant and indifferent about the quality of food they eat," Stalin said, quoted by Moscow newspapers.

His cronies were not slow in supporting him. In 1926 the Politburo in Moscow passed the request to the Academy of Science with the order to build a "living war machine".

The Soviets drafted their top animal-breeding expert into the program. Ilya Ivanov, who previously had set up the world's first centre for the artificial insemination of racehorses, set off for West Africa to conduct his first experiments in inseminating chimpanzees.

Meeting little success, Ivanov turned his efforts around, setting up a facility in Stalin's home republic of Georgia to fertilise human volunteers with monkey and ape sperm. Not surprisingly, the efforts were a total failure...

And the reward for failing Stalin? You guessed it.

For his expensive failure, he was sentenced to five years' jail, later commuted to five years' exile in the Central Asian republic of Kazakhstan.

A year later he died, reportedly after falling sick while standing on a freezing railway platform.

- Art Caplan

Intelligent Design, Bioethics, and the Discovery Institute

Probably the leading institution in the United States in the effort to deprecate the theory of evolution and promote the teaching of intelligent design is the Discovery Institute of Seattle Washington.

This same Institute claims to have a bioethics program, and it is run by Wesley J. Smith a frequent commentator on stem cell research, cloning and assisted suicide.

Pennsylvania Federal court has now ruled in the Dover, PA I.D. trial. The ruling calls into question both the ID movement and those persons and institutions such as the Discovery Institute which are dedicated to promoting ID.

U.S. District Judge John E Jones delivered a blistering rebuke to the effort to place ID into the science curriculum. He states that the effort to promote ID in Dover violates the constitution and is patently a ploy to teach religion. He decried what he termed the "breathtaking inanity" of the attempt to market ID as science and said that board members had lied again and again in trying to conceal their real motive which is to promote Christianity not science.

So the question arises why should anyone credit anything or anyone affiliated with the Discovery Institute when it comes to matters of ethics and science?

The ID movement has now been outed and completely discredited. It is time for those who are truly interested in science and ethics to break any ties with this fraudulent movement.

- Art Caplan

Chris Mooney's Republican War on Science

I'm writing a review of Chris Mooney's excellent new book, but after reading the excellent review by John Horgan, the reply by Mooney, and the great interview of Mooney on Daily Kos, I have no idea what to say. Maybe just: read the book.

Baker's Dozen

Guardian reports that Hwang's new nemisis-apparent and despairing co-author, Roh Sung-il, the chairman of the board at Seoul's Mizmedi hospital, is throwing further fuel on the fire of fraud accusations against Dr. Hwang. You can tell whose side the Guardian is on by the fact that they've jumped on the bandwagon of referring derisively to Hwang as "a trained veterinarian."

It is not at all obvious how to interpret Roh's claim, and it should be noted that Dr. Hwang called for criminal charges to be brought against Roh in a press conference just three days ago, after he and Roh held dueling press conferences to discuss who lied the most in the production and submission and even in the subsequent retraction request for their scientific paper. Roh

said the hospital provided more than 900 eggs from 65 people for a paper Prof Hwang published in the journal Science this year.

The professor, however, claimed in the article that he used just 185 human eggs to create custom-made embryonic stem cells for 11 patients, winning international acclaim for his cloning efficiency.

In a paper published a year ago, Prof Hwang said it took 242 eggs to grow just one batch of stem cells.

"It is not clear how some 700 eggs, besides the 185, were used," Dr Roh was quoted as saying by Yonhap news agency.

Dr Roh has previously claimed that Prof Hwang faked at least nine of the 11 stem cell lines.

Prof Hwang, a trained veterinarian, said last week he had asked Science to withdraw the May article after admitting that at the time of publication his team had only created eight stem cell lines.

Cord Blood Stem Cell Bill Passed; Let Us Rejoice and Be Glad In It

It seems like a good thing all across the board and without reference to politics. Congress passed a Stem Cell Therapeutic and Research Act to fund research using stem cells from cord blood, as well as more funding for the bone marrow transplant organization. Seems like a good thing. No reason to make a political to do. But then again, why not use it as an opportunity to divide the nation even further by confusing people about whether "cord blood cells are better and a moral substitute" for embryonic cells? Consensus? We don't need no stinking consensus.

Hey Thanks for Your Participation in this Research Trial.
Sorry We Gave You Tuberculosis.

If validated this is an incredible violation of research ethics. Too much text to post - we've got rules to follow. Read it at the link.
[From Bloomberg, via Al Yarinsky].

Clinical Trials Going too Slowly? Subjects Want too Much Money? Think India.

Wired News evaluates the newly solidified market for testing drugs on the poor in India. They quote our own Sean Philpott:

The sudden influx of drug companies to India resembles the gold rush frontier, according to Sean Philpott, managing editor of The American Journal of Bioethics.

"Not only are research costs low, but there is a skilled work force to conduct the trials," he said. In the rush to reap profits, Philpott cautions that drug companies may not be sensitive to how poverty can undermine the spirit of informed consent. "Individuals who participate in Indian clinical trials usually won't be educated. Offering $100 may be undue enticement; they may not even realize that they are being coerced," he said.

Hope They Get Paid Well

Chicago Sun Times and others are parading the great news that a vaccine made with live virus from the bird flu will be shot up the noses of volunteers in April to see whether or not we can prevent a virulent form of H5N1 infection, if one springs to life, from causing a pandemic.

The catch is that 30 volunteers have to try the vaccine. Hope the facilities in Baltimore are better than those in Miami.

Smoke Got In Their Eyes

Leonard Glantz at BU passed along his piece in Washington Post this week; he goes to war with the war against smokers in the workplace:

The World Health Organization (WHO), the health branch of the United Nations, has announced that it will no longer hire smokers. Its spokeswoman said, "As a matter of principle, WHO does not want to recruit smokers." The "principle," according to the spokeswoman, is: "WHO tries to encourage people to try and lead a healthy life."

By this action WHO has transformed its war against smoking to a war against smokers. On its new job application, WHO asks applicants if they are smokers. If the applicant answers "yes," the application will be discarded.

With the hanging of the "No Smokers Need Apply" sign on its door, WHO has joined a long line of bigots who would not hire people of color, members of religious minorities, or disabled or gay people because of who they are or what they lawfully do...

Under WHO's policy, if Franklin Roosevelt, Winston Churchill, Albert Einstein and Adolf Hitler applied for a job, only Hitler, the sole nonsmoker in the group (and someone who would not allow anyone to smoke near him), would be eligible for consideration.

You Do Not Want to Pick the Wrong Exit Sign

NewsInferno reports:

...hospitals have denied access to the Swiss voluntary euthanasia group known as Exit.

After almost three years of discussions, however, university hospital officials have determined that permitting the practice on site is proper under the guidelines established by the Swiss Medical Association and the National Committee on Ethics. Both organizations acknowledge that, while assisted suicide should never be viewed as a routine procedure, it should be permitted in exceptional situations in order to respect the independent decision of a competent patient.

This new rule at university hospital will also allow the individual patients wishing to terminate their lives to have access (at the hospital) to a doctor from the outside or a member of Exit.

Of Mice and Men

National Geographic has produced a special examination of the experiments by Fred Gage and others involving the creation of mice with human neuronal stem cells, which begins with this nice piece about the ethical implications.

Previously, New York Times/AP covered the trajectory of the research and the continuing public debate about it, but not particularly well. Rick Weiss describes the implications of the work without laying on the "yuck factor" nonsense about mice turning into Mickey.

Judith Miller Was Not Involved, However

Korea Times opens up the last fissure in the damn on the Korean stem cell scandal involving Hwang Woo-suk and others. The first evidence appeared today that the President of Korea's chief advisor for all of this stuff was very likely aware of at least part of the mess.

It gets messier too as Chosun reports:

Roh Sung-il, the head of MizMedi Hospital, said Schatten knew that nine out of the 11 stem cells died after being contaminated in the lab in January. It was March when the article co-authored by Schatten was submitted to the journal. Since it takes at least three months to cultivate stem cells, a scientist should have raised questions upon hearing that nine stem cells were cultivated in only two months, he said.

There are also accusations that Cheong Wa Dae was told of the accident at the time. If it was, the presidential office will be under intense pressure to say how much it knew and why it kept silent.

Meanwhile, prosecutors are reportedly reviewing statements made by Hwang, Roh and Kim in their press conferences. But they say they will not take action until the scientific inquiry is complete.

[thanks Laurie Zoloth]

Stem Cell Scandal.
Face Transplants with Movie Deals.
Speed Kills

Our Caplan & McGee column in the Times-Union (and elsewhere) is up here and below:

Speed kills. This warning is sage advice. Too bad it's confined to motor vehicle operation. It is badly needed in science.
Consider two recent examples where the desire to race to be first has caused scientists to veer off the road and get into big, big trouble.

Last June, Hwang Woo Suk, a veterinary researcher at Seoul National University in South Korea, reported that he had made embryonic stem cells from human embryos derived from 11 people.

Now allegations are swirling around him that he cut corners in his desire to be the first to make stem cells from cloned human embryos.

Last month it was revealed that Hwang made his embryos from eggs obtained from women working in his lab. That reeks of coercion, since it would be nearly impossible for a young woman in a hierarchical Korean laboratory to say no to a request for her eggs.

Then, on Dec. 10, the news broke that the breakthrough reported in Hwang's initial paper in the journal Science might be fraudulent. Key measurements that would definitely prove that the stem cells Hwang said he made came from his cloned embryos now appear to be too good to be true.

Hwang and his group saw an opening when a lack of government funding in the United States kept the best American embryonic stem cell researchers on the sidelines. They ran to get ahead of the world competition. Now it seems they ran so fast they fell down. A colleague of Hwang said the research was falsified. Hwang stood by his research but asked that the Science article be withdrawn because of errors with accompanying photos.

A similar story can be told about the French team that recently announced the world's first face transplant. Jean-Michel Dubernard of the University of Lyon grafted a nose, chin and mouth taken from a brain-dead donor onto a 38-year-old mother of two from Valenciennes in northern France on Oct. 27. Dubernard and the French were racing against teams in the United States and England that were also planning face transplants. Again speed seems to have gotten a prominent researcher in big trouble.

British newspapers reported that the reason the recipient needed a face transplant is that she had tried to kill herself. London's Sunday Times says the woman acknowledged in a cellphone interview -- though she has denied it elsewhere -- that she took an overdose of sleeping pills during a fit of depression this past spring. As she lay nearly comatose on the floor, her own dog mauled her face.

Physically and emotionally, she may not prove up to the challenge of being the world's first face transplant recipient. But there is more. Three months before the operation she seems to have given a British filmmaker exclusive rights to her story. Who knows what motivated her to decide to go ahead with this risky operation?

Not only did suicide play a role in the life of the recipient, it has now been revealed that the donor used in the operation had committed suicide. So in their haste the French doctors wound up using a donor whose family must have been emotionally devastated when the request came to donate her face.

But the ethical problems did not end there. There is no evidence that the medical team appointed someone to act as the donor family or the recipient family's advocate. When you are asked about whether you want to be involved in the world's first face transplant, it is morally prudent to have advice from someone who does not care whether you say yes or no.
Nor does the science appear to justify trying a face transplant just yet. Results in animals of face transplants have been limited and not particularly impressive. And transplants involving hands and limbs have also turned out poorly.

Certainly a case can be made for face transplants. There are those with oral cancer or burns or injuries for whom no other real option exists. But, in deciding to go first, the French group appears to have given less than adequate thought to who the donor should be, who the recipient should be and what scientific foundation should have been laid down before trying the surgery and more to who should get the movie rights.

These publicized scientific firsts prove more questions need to be asked about how fast researchers have been going when they announce their breakthroughs.

Teaching Scientific Integrity Might Have Prevented the Korean Mess

Art and David opine in the San Jose Mercury News:

The news about the South Korean team involved in announcing the world's first successful generation of stem cells from cloned human embryos has gone from bad to worse to, well, awful.

Last year the South Korean team and its lead researcher, veterinarian Hwang Woo Suk, were at the top of the scientific world. In February they published a paper in the journal Science announcing the world's first human embryo cloning. The South Korean group, working with Gerald Schatten of the University of Pittsburgh, reported cloning 30 human embryos. The paper went on to say that stem cells had been successfully extracted from the cloned embryos that were genetically matched to specific people with various diseases.

Hwang became a huge celebrity in South Korea. The government poured money into his lab. The South Korean government was so excited that the nation had the lead in this promising area of medical research that it announced this past August that it was investing significant funds to create a world stem-cell hub under Hwang's direction that would supply stem cells from cloned embryos to researchers worldwide.

Now Hwang is in a hospital being treated for extreme stress. He has acknowledged lying about where he got the eggs used in his research, both to the public and to the journal that published his work. His key American collaborator wants nothing to do with him. One of Hwang's closest colleagues says key data reported in the Science paper was fraudulent. Hwang is denying these claims, but further investigations into irregularities are under way.

Predictably, opponents of stem-cell research are delighted by Hwang's disgrace. Richard Doerflinger, deputy director of the Secretariat for Pro-Life Activities, United States Conference of Catholic Bishops, burst into print to hyperventilate that ``the fact is that the entire propaganda campaign for research cloning has been filled with misrepresentations, hype and outright lies.''

When the issue is embryos, Doerflinger and other critics of stem-cell research are quick to forget about the merits of the science or the needs of the sick and to use the Korean scandal to impugn what their moral compass unerringly tells them must be abhorrent -- seeking to take stem cells out of human embryos made from a human egg and DNA from a skin cell.

Yelling ethical fire over the Korean fiasco in a world full of people dying of incurable diseases and plagued by cruel disabilities may play in some circles, but is unlikely to fly as a guide to the real lessons to be learned from what happened in South Korea. What should be learned?

Science depends upon trust in the honesty and integrity of its practitioners, perhaps more than any other human endeavor. The peer-review process means that experts review the data and the methods that are reported but, ultimately, scientific articles are a form of testimony. Other scientists then attempt to repeat research results -- so that if something is fabricated it will typically be discovered over time. But oversight committees like human experimentation committees have to trust what their investigators tell them. Journals also must rely on scientists to tell the truth to them. And researchers themselves often have to rely on the honesty of their graduate students and post-doctoral students. When trust breaks down, the very possibility of science is threatened. That is why so much time is spent these days emphasizing to young scientists the importance of integrity.

The mess in South Korea reveals the ethical problems inherent in high-pressure, high-stakes and highly competitive science. Ever since James Watson described in his book ``The Double Helix'' the shenanigans that he and his collaborator Francis Crick engaged in to be the first to discover the structure of DNA it has been very clear that ambition, competitiveness and the desire to be the first can lead the best biomedical researchers to engage in dubious, immoral and even fraudulent behavior.

We do not know yet if Hwang and his colleagues lied about deriving cell lines from cloned embryos, but we know they lied about how they procured the eggs, and that alone is grounds for severe censure.

Honesty and integrity are partly individual traits, but they are also a reflection of institutional culture. If we create a system where there is overwhelming pressure to succeed at all costs, we should not be surprised when corners are cut.

One of the keys to preventing future scandals with respect to stem-cell research will be creating a culture within institutions in which integrity is taught and nurtured and all participants are respected. Adequate mentorship by our scientific leaders will also be critical. Above all, training in ethical standards must be seen as central to the enterprise of science, rather than burdensome make-work.

The real lesson of the scandal in South Korea is not that embryonic stem-cell research cannot be pursued ethically but that it can only be pursued ethically. is the director of the University of Pennsylvania Center for Bioethics. They wrote this article for the Mercury News.

What Say You Now Dan Callahan and Leon Kass? On What Basis do you Continue to Oppose the Search for Immortality?

Death really is an option in Brazil, and in fact it may well get banned.
- Art Caplan

New Jersey Voters Will Get to Vote on $350 Million Stem Cell Program

Newsday explains. This would put the Garden state in second place although at the rate things are going they might well give out cash before California.

You can just hear the stem cell guys in Massachusetts thinking to themselves: "Where to move? Bay Area or Newark. Bay Area or Newark. Hmm."

"FrankenFido"

William Saletan nails it about doggie engineering, whether the outcry concerns snuppy the clone or the announcement that the DNA of canines has been decoded. His wry point is that the story that working on dog genomics will help heal humans by modeling new therapies is

... a heartwarming story, but it's a fraud. The reason we targeted the dog genome for decoding is that it's useful for genetic research. The reason it's useful for genetic research is that dogs are neatly divided into breeds, each of which is plagued by specific diseases. And the reason dogs are divided into diseased breeds is that we made them that way. Dogs are the world's longest self-serving, ecologically reckless genetic experiment, perpetrated by the world's first genetically engineering species: us.

Plus the fur gets in everything. You will never really have black clothing again. Engineer that.

Synthetic Biology

A bit like nanotechnology in that it is bigger than a single term can capture, synthetic biology is here and it is beginning to effect a merge between computer and DNA. It is also, I argue in a column in the January issue of The Scientist, the clearest evidence that evolution is not only evident in our world but now a tool of human engineering at many levels. In other words, to give away my none too clever pun, the real "intelligent design."

Anyway Art sent me this piece from San Diego Union in which the conceptual aspects of synthetic biology are discussed and framed.

It is the best newpaper piece I have ever seen among dozens in terms of explaining the field and laying out what it can do and why it matters how we do it.

In the piece it is made clear that people understand (hopefully) that where synthetic biology is concerned we damn well better have ethical standards before this technology starts spewing biological weapons in someone's basement or producing killer computers:

"Possibly the best protection is promulgation of ethical standards. If people act now, they can stop a hacker culture from the start." Scientists and policy makers have begun discussions, but few existing regulations apply to this new endeavor.

Leaders in the field convened the intercollegiate Genetically Engineered Machine, or iGEM, competition at the Massachusetts Institute of Technology in Cambridge last month. Nine teams fielded by universities and colleges from San Francisco to Zurich presented projects in a prize-less contest.

"We could have made this another 'robot wars' scenario and got the kids all excited about bashing each other's biology," said geneticist George Church, of Harvard University, who helped organize the meeting. "But we specifically discouraged that and instead encouraged a more constructive way of looking at things."

Each team picked a goal, some task for their bacteria to accomplish, then designed a biological circuit to do the job using plug and play components call BioBricks. Each component is a piece of DNA that can do a single simple thing, like make a protein to sense light, relay a signal or fluoresce. The students strung together BioBricks, much like assembling a simple electrical circuit from an electronics kit, and stuck them into cells to see if they would boot up properly. Revisions are always needed.

Schatten: Part of the Hwang Stem Cell Article May be "Fabricated"

Nick Wade at New York Times has assumed the role of narrator in the continuing saga of South Korea's stem cell implosion (with Richard Doerflinger playing the role of Cassandra). Today's chapter - yes it is daily now - involves still worse accusations. If none of this stuff turns out to be true, Dr. Hwang will become the David Baltimore of South Korea.

Dr. Schatten, who had originally been senior co-author on the Science paper demonstrating the creation of stem cell lines through nuclear transfer, had already published a correction in the journal to the effect that his only role was to "analyze data and prepare the paper for publication." But now he has asked Science to remove him as co-author. The journal has refused the request, and cannot retract the article because Hwang and co-authors stand by it.

Today,

Eight leaders in cloning technology, including Dr. Ian Wilmut of Edinburgh University, [Dr.] John Gearhart of Johns Hopkins and Dr. Robert Lanza of Advanced Cell Technology, have written to Science saying that they encouraged Dr. Hwang "to cooperate with us to perform an independent test of his cell lines" to see if they matched the donors.

Dr. Schatten's confidence in Dr. Hwang's results has also been shaken. In his letter to Science, released yesterday by the University of Pittsburgh, he said he wished to retract his co-authorship of the June 17 article because "my careful re-evaluations of published figures and tables, along with new problematic information, now casts substantial doubts about the paper's accuracy."

He also said that over the weekend he had "received allegations from someone involved with the experiments that certain elements of the report may be fabricated."

The individual was not named, and Dr. Schatten was unavailable for comment yesterday, but Korean press accounts have quoted Kim Sun Jong, a member of Dr. Hwang's laboratory who now works at the University of Pittsburgh, as saying in an interview with MBC-TV in South Korea on the program "PD Diary" that he was told by Dr. Hwang to make 11 or so cell lines out of the two or three he had in his possession.

Meanwhile, the candlelight vigil for Dr. Hwang continues in South Korea, and he himself is apparently still ill, released from the hospital and at the University to answer questions Monday morning but back that afternoon. He vowed on Monday to continue his work, although on what it is not clear since he had previously said that he would no longer run the world stem cell bank that was to be the core of Hwang's work.

Stamp Out 치료 오해 (Therapeutic Misconception)

If you were trying to design a way to suggest to the people of Korea that embryonic stem cell research has the unmitigated potential to start curing people right now, this is what you would do: make a postage stamp with an embryo alongside a guy getting out of a wheelchair, running, jumping, and getting it on.
[thanks, Tim Murphy; Fritz Allhoff]

Stem Cell Scientist Fear Reprisals ... from the Left??

Here's a twist: Michael Cook inteviews a scientist at MIT name James Sherley, who opposes embryonic stem cell research using nuclear transfer. He meanders around for a while in that normal anti-stem cell research way, then gets to a very strange point:

MercatorNet [the interviewer]: Do you think that most stem cell scientists have an open mind towards adult stem cell research?

Sherley: It’s rather hard to know what most stem cell scientists or cell biologists in general, for that matter, think about these issues. I have asked the leaderships of both the American Society for Cell Biology and the International Society for Stem Cell Research to conduct anonymous on-line polls of their membership regarding their views on human embryo research. Neither has been willing to do so. Many scientists who do not support human embryo research are afraid to speak out because of possible reprisals from powerful scientists who can affect grant success, publication acceptances, tenure promotion, and employment.

Interesting.

posted Dec 14, 2005 | link | comments (3)

Eric Topol Demoted - Retaliation for His Vioxx Testimony?

Cardiologist loses post at medical school , that's the lead in a Cleveland piece about the extraordinary demotion of one of the world's top cardiologists Eric Topol in the wake of his testimony concerning Vioxx. Students at the new Cleveland Clinic medical school, which Topol spearheaded, are complaining very very bitterly. More to come. Search this blog for more on Topol and the history of this conflict.

Yes, It Can Get Worse in Korea.

The Korea Times reports it simply:

Pressian, a Seoul-based online news site, on Sunday reported Hwang may have ordered a subordinate to fabricate photos of nine stem cell batches from just two cell lines that were presented to Science.

Pressian said that it acquired transcripts of an interview with Kim Sun-jong, a member of Hwang's team who is currently at the University of Pittsburgh, made by ``PD Notebook,'' MBC network's investigative news program. MBC delayed the airing of the program containing the interview.

``This April Hwang made me create many pictures with two stem cell lines. It was work that should not have been done. But I was not in a position to disobey the order,'' Kim said in the transcript.

Kim added he had received stem cell lines No. 2 and No. 3 from Hwang and made photos for other stem cell batches, possibly from No. 4 to No. 12.

In response, Hwang's team argued that Kim had made these remarks after coercion by MBC."

Pfizer Publishes Clear Statement of Nature of its Commitment to Ethics in Marketing

In Express Pharma, here, a statement by Anjan Sen, director of their marketing efforts.

Merci, Merci, Merci. Cut.

The face transplant recipient Isabelle Dinoire has signed a movie deal.

I'm speechless, but Jon Moreno and Rosamond Rhodes are not:

"Physicians are supposed to protect their patients who must be emotionally vulnerable in this situation," said Moreno, a professor of biomedical ethics at the University of Virginia. "Her psychological counseling should have included assessing the implications of this offer."

Dinoire was likely acting in her own best interest when she signed the deal, said bioethicist Rosamond Rhodes, a professor of medical education at the Mount Sinai Medical School in New York City.

"Even if her medical expenses are fully covered by the French national health system, it is hard to see how she would have had an income since she was mauled, how she can work during her recovery or how she will find employment in the future," Rhodes said.

Penn Center for Bioethics Vaccine Project

The Center for Bioethics at Penn has announced "an 18 month effort to examine the vaccine field and propose an ethical framework to help guide researchers, pharmaceutical companies, public health agencies, health care providers and citizens regarding vaccines and their safe, effective and ethical use."

What a great idea.

The project has a new weekly summary of happenings in the world of vaccines, and a list of links to key institutions in the field.
[Update:University of Toronto has created an Influenza Pandemic Working Group that will in part take up vaccines as they relate to the broad questions on the table about the potential avian flu pandemic or others yet to come.

Next Up in the Hwang Saga:
Was the Data Cooked?

Nicholas Wade at the New York Times is finally giving this story about stem cell research in Dr. Hwang's lab in South Korea the attention it was bound to receive in American media. And this story is going to change the way that Americans perceive stem cell researchers, who until now have been viewed as unmitigated heroes. Ironic in a way, because American stem cell researchers have almost without exception led the way in calling for regulation and responsible conduct of research.

This scandal is as we argued in our column the paradigm case of what will happen in this field if the U.S. does not step up to the plate to assert clear and concise rules at the level of the NIH and FDA to ensure that irresponsible research practices cannot result in clinical trials or drugs that go to market in this country.

If that sounds imperialist to you, you need to wake up - the U.S. will spend more on the transplants, drugs and devices that come from stem cell research than any other nation, and our capacity to provide standards to make that research responsible is the world's most important piece of leverage against scientific misconduct. The fact that there are strict laws against irresponsible stem cell research in Italy or Cuba or Nigeria just doesn't matter at all.

Anyway here's what happened today, just as Dr. Hwang was apparently having a major operation to deal with his ulcer. It is the most serious charge against Hwang's group yet. If substantiated it would mean the total collapse of the Korean effort.

The newest questions about the paper concern DNA fingerprint tests carried out to prove that the embryonic stem cell colonies were indeed derived from the patient in question. The test, demanded by referees for Science, was necessary because cell colonies often get mixed up or overgrown by other cells in even the best laboratories.

Usually any two DNA fingerprint traces will have peaks of different heights and alignment and different background noise. But in several cases the pairs of traces in the Science article seem identical in all three properties, suggesting that they are the same trace and not, as represented, two independent ones.

If so, there could have been yet another innocent mixing up of data, as seems to have been the case with duplicate photos - an error that came to light earlier this week. But it is also possible that the cell colonies never existed and that a single DNA fingerprint from a patient was falsely represented as two traces, one from the patient and one from the embryonic cell line allegedly derived from him.

Milk Milk Milk Milk
Milk Milk Milk Milk

Dairy Today commissioned a study that found 33% of Americans would never buy milk again if they learned that it could possibly come from cloned cows.

But the survey can be and is spun by the industry magazine as "good news" for big Farma:

“The results also show that people are not automatically rejecting products from cloned animals, and that they are open to learning more about it,” he says. “And the more people learn about it, the more comfortable they are.”

From the point of view of Dairy Today's Jim Dickrell,

“If the FDA does indeed determine that the milk is the same, then I don’t think we would have any further reservations,” says Chris Galen, National Milk Producers Federation spokesperson. “If FDA says something wishy-washy, we’ll have problems because it raises doubts in consumers’ minds.”

[thanks Alta Charo]

Tiiiiny Stem Cells ...

Don Ho is doing much much better now, thanks to a stem cell transplant that sent tiny bubbles of regeneration throughout his body and right to his 75-year-old heart. His medical tourism - an experimental procedure developed in Thailand, using his cells that had been sent to grow in Isreal - led him to Bangkok, where a Pittsburgh heart surgeon went to work.

Ding! Time's Up!

Al Yarinski pointed me to this BMJ piece from tomorrow's issue, entitled "Israeli's turn to timer device to facilitate passive euthanasia." Here's the idea:

A response delayed by a timer attached to a patient's ventilator will solve the Israeli government's wish to introduce passive euthanasia for terminally ill people and to allow them to die with dignity...

The timer, based on the idea of the Sabbath clock, used in religious Jewish homes to turn electrical devices on and off on Saturday, would operate for 24 hours at a time and set off a red light or alarm after 12. The patient or their representative could at any time request an extension. But if the dying person were determined not to have their life extended, the timer would turn off the ventilator at the end of the cycle.

This is clearly an idea that could only have come from a committee, and it did, made up of 58 people from a variety of specializations. The point being of course that it could never have come from research into how people in hospitals - wherever they may be born and however they feel about the Sabbath clock - perceive medical technology. Did anyone try this out on a sample of patients? Isn't there plenty of reason to fear that this somewhat arbitrary "moment" will be perceived as "active" euthanasia - and worse yet euthanasia by robot?

The law also does some useful and long overdue things, including creating statutory hospital ethics committees in Isreal as well as a national database of living wills.

The Price of Motherhood

Slate today describes the new research of Amalia Miller at Virginia on what it costs to be a Mom. Get out your calculator, and egg freezing starts to look pretty appealing:

On average, Miller has found in a new paper, a woman in her 20s will increase her lifetime earnings by 10 percent if she delays the birth of her first child by a year. Part of that is because she'll earn higher wages—about 3 percent higher—for the rest of her life; the rest is because she'll work longer hours. For college-educated women, the effects are even bigger. For professional women, the effects are bigger yet—for these women, the wage hike is not 3 percent, but 4.7 percent.

So, if you have your first child at 24 instead of 25, you're giving up 10 percent of your lifetime earnings. The wage hit comes in two pieces. There's an immediate drop, followed by a slower rate of growth—right up to the day you retire. So, a 34-year-old woman with a 10-year-old child will (again on average) get smaller percentage raises on a smaller base salary than an otherwise identical woman with a 9-year-old. Each year of delayed childbirth compounds these benefits, at least for women in their 20s. Once you're in your 30s, there's far less reward for continued delay. Surprisingly, it appears that none of these effects are mitigated by the passage of family-leave laws.

[thanks Alta Charo]

Cloned Super Soldiers? No Need. Just Give Regular Soldiers a Dose of BZ

Defense Tech's David Hambling writes that BZ is perhaps being used by Iraqi insurgents ... against themselves. What is BZ?

BZ or "Agent Buzz" is the military name for 3-quinuclidinyl benzillate, an extremely powerful hallucinogen. After experimenting with a whole stash of mind-altering substances including cocaine, heroin and LSD, the Pentagon selected BZ for weaponizing. Its major advantages are that it can easily delivered in an aerosol cloud, and it is very safe. With many substances, the effective dose can be dangerously close to the amount needed to kill - ask any anesthetist. With BZ, the tiny effective dose (maybe two milligrams) is around one-thousandth the lethal dose. It is also odorless and invisible, and there is currently no means of detecting it.

Agent Buzz was tested between 1959 to 1975 on some twenty-eight hundred US soldiers at several locations. It proved extremely effective as an incapacitant. The physical effects are increased heart rates, pupil dilation, blurred vision, dry skin and mouth, increased temperature, and flushing of skin – as a med school mnemonic has it “blind as a bat, dry as a bone, hot as Hades, red as a beet.”

But the psychological effects are more important than the physical ones, as the subject is also rendered “mad as a hatter.” ... It also produces uncontrollable aggression, Wouter Basson, the man behind South Africa’s chemical and biological warfare program, notes ... The Serb army manual on their BZ munitions implies a violent react