blog.bioethics.net

But They Did Not Pay for Prostitutes

Two Abbott employees had taken a senior doctor to a lapdancing club, where one of them, a senior manager, borrowed £1,000 for the evening out from the other, a rep. The lapdancing visit took place in January 2004 after a workshop. After dinner, one of Abbott's managers and a rep who had been manning a stand took a hospital doctor out for the evening. The complainant "stated that the manager borrowed £1,000 from the local representative towards the evening, telling him he would be fully reimbursed. However this never materialised and he was still waiting for his money," the ABPI account of the investigation said.

Canadian Public Health System Creaks Slowly Toward Implosion

Pandemic Preparations at the Tower of London

A quick bird-flu update: The Tower of London is bringing its famed ravens indoors.

This quote from Derrick Coyle, the Tower's raven master: "Although we don't like having to bring the Tower ravens inside, we believe it is the safest thing to do for their own protection, given the speed that the virus is moving across Europe."

Legend has it that if the ravens leave the grounds of the White Tower, it will crumble and the Kingdom of England will fall. King Charles II decreed in the Seventeenth Century that there must always be six ravens at the Tower.

Calling all Bloggers

I think thoughtful ethics blogs by people with training in ethics have the potential to be incredibly useful. First, of course, a good blog is a great way for readers “in the business” to keep up with current events and current controversies. Reading the AJOB blog is my primary means of keeping in touch with events in the world of bioethics, now that I’ve shifted most of my research to the world of business ethics.

Secondly, blogs can be useful teaching tools. One friend tells me he’s using my business ethics blog as a source of up-to-the-minute case-studies for discussion in one of his classes. Of course, a blog will never provide the kind of in-depth analysis and historical perspective that a good case book does; but then again, case books tend to be full of examples – the Ford Pinto, the Exxon Valdez – that happened before the current crop of undergrads was even born.

Finally, I think high-quality ethics blogs make a serious contribution to public discourse. A good ethics blog doesn’t just alert people to stories; a good ethics blog should provide at least a little educated insight. So, when a story pops up about the “dangers” of videogames? Here are the basics – a few sentences – of the ethics of product safety. A story about accusations of conflict of interest? Here’s at least a definition of the concept. I find I use my blog the way I use media interviews: not as a chance to give indepth analysis, but as an opportunity to give just enough insight to raise the average educated person’s understanding of a given story one notch, to show that there can be more than knee-jerk moralizing when it comes to ethically contentious issues.

Avian Flu, the African Version

And it is not just in the mainstream media: even academic researchers, public health policy-makers and bioethicists may find themselves locked into the same neo-colonial discourse. A couple years ago, the Danish anthropologist Quentin Gausset wrote in the journal Social Science and Medicine that that when a correlation is found between HIV and a traditional African practice (such as polygamy, circumcision, dry sex, and so on) the practice is regarded as a 'barrier' to be eradicated, whereas if there is a correlation between HIV and modern phenomena (sub-standard health clinics, sex workers, drug use) then talk about 'barriers' and 'eradication' fall away -- we talk instead about those things being made safer. This 'double discourse' seems to assume that African traditional practices are irrational, backward and, with the emergence of HIV, deadly liabilities.

In this light, perhaps we should keep a careful eye on how Avian flu in Africa -- having emerged in Nigeria earlier this month -- is being handed in the international media. So far, it seems to be getting a 'tinderbox' reading: the virus is bound to spread like wildfire on a continent that is already so messed up in so many ways (Of course, unless the cavalry from the North in the form of WHO and USAID step in to save the day.).

Hopefully this way of seeing things will be tempered by African perspectives on the virus. The prospect of a new untreatable, infectious and deadly virus may look different to Africans than it does to those who write for the international media. The majority of patients in Africa do not have access to treatment for AIDS, malaria and tuberculosis right now, so it is understandably difficult to get worked up about a virus that has claimed 200 total deaths worldwide. But complacency would be short-sighted, and there are already calls to mobilize the African media to help local communities protect themselves.
- Stuart Rennie

Do Genes Put You at Risk for Avian Flu?
And if So Could a Vaccine

With four cases confirmed or suspected, her family represents one of the largest clusters of bird flu among humans in the world. It is also notable in sharing a characteristic with nearly all the other family clusters: Those infected by the virus were related to each other by blood and not by marriage. This raises the possibility that genetics play a role in determining who among those exposed contracts the often-lethal disease.

"It's intriguing," said Sonja J. Olsen of the Centers for Disease Control and Prevention in Bangkok, who has studied family clusters of avian influenza. If a biological explanation were ultimately proved, she added, "perhaps we could identify people at genetic risk."

Now, if it is possible to identify those en masse who have such a susceptibility, should they be quarantined first?

And just in case that doesn't confuse things enough - word of a vaccine that might really work.

AlterNet: Big Medicine's Malignant Growth

Massive Outbreak of Bird Flu in China

Meanwhile the French are trying to save their poultry industry after news of an outbreak there. And McDonalds in the UK is taking the most drastic step of all - contingency planning just in case McNuggets go off the menu. Chirac was trés reassuring about the whole business: as long as you cook the chicken, he said in a speech, while grawing on a piece of chicken from the affected area, the virus will die. So cook the chicken!

Only Americans seem somewhat non-plussed about Avian flu; a majority here don't think it is coming anytime soon.

Eenie, Meenie, Meiney, Mo

The Hinxton Group:
A Consensus Statement on Stem Cell Research

: Stem cell and related research holds out immense promise for good. This research has the potential to dramatically increase our understanding of human biology from which may come new treatments for many serious diseases and injuries. The moral reason to conduct stem cell and nuclear reprogramming research thus comes from both the possibility of advancing knowledge and the values of relieving suffering and promoting human welfare. Furthermore, intra- and international scientific collaboration are vital to the success and advancement of science.

While we strive for consensus on a fundamental ethical framework for stem cell research, we acknowledge the reality of cultural diversity and moral disagreement about some elements of stem cell research. Inconsistent and conflicting laws prevent some scientists from engaging in this research and hinder global collaboration. Societies have the authority to regulate science, and scientists have a responsibility to obey the law. However, policy makers should refrain from interfering with the freedom of citizens unless good and sufficient justification can be produced for so doing. As scientists, philosophers, bioethicists, lawyers, clinicians, journal editors and regulators involved in this field, we have reached consensus that if humankind is to have the very best chance of realizing the benefits of stem cell research in an ethically acceptable manner, the following principles should govern the ethical and legal regulation and oversight of stem cell and related research and its clinical applications. This is by no means a comprehensive list of principles, but rather a declaration of those discussed and agreed upon by our group:

1. Stem cell research should seek to minimize harm, and any risk of harm should be commensurate with expected overall benefit. Scientists and clinicians should conduct research according to ethically acceptable norms. For example, research should be conducted so as to protect the well-being, liberty and rights of cell and tissue donors as well as research participants. Research participants and donors of human materials must provide valid informed consent, and conflicts of interest should be appropriately addressed.

2. The law carries great power to facilitate or restrict scientific exploration in the area of stem cell research. Law makers should be circumspect when regulating science. When enacted, laws or regulations governing science nationally and internationally ought to be flexible, so as to accommodate rapid scientific advance.

3. Scientists and clinicians have a responsibility to obey the law. However, they also have the right to know through clear and explicit laws, what is and is not permitted with respect to their research, the jurisdiction of any prohibitions, and related penalties, so that they can regulate their behavior accordingly.

4. In countries with laws that restrict elements of human embryonic stem cell (hESC) research but that do not expressly prohibit international collaborations, research institutions should neither discriminate against nor restrict the freedom of their investigators who want to travel to do work that is undertaken with scientific and ethical integrity.

5. Law makers should be similarly circumspect in restricting citizens’ conduct extraterritorially with regard to stem cell research. So long as scientifically and ethically defensible hESC research is undertaken in a country in which it is legally permissible, scientists should be free to participate in that research without fear of being liable to prosecution, restriction, or discrimination in another jurisdiction.

6. It is essential that scientists and policy makers consult each other and the public in the attempt to develop regulatory regimes for stem cell research that strike the best possible balance between free scientific inquiry and social values.

7. Journal editors should encourage authors to include in manuscripts explicit descriptions of their roles in the published research so as to clarify the appropriateness of their participation, in particular for researchers residing in countries with more restrictive laws and collaborating with researchers residing in countries with more permissive laws.

In addition, we reached consensus on the following forward-looking strategies to foster the scientific and ethical integrity of research in a global context:

8. Insofar as ESC lines are a precious resource and replication and scientific collaboration are vital to scientific advancement, we encourage scientists conducting stem cell research to submit any stem cell lines they derive to national or international depositories that subscribe to internationally accepted standards of quality and make cell lines and data (e.g. DNA fingerprinting and micro satellite data) publicly available.

9. Journal editors should support and promote high standards for scientific peer review. For studies generating new ESC lines described in manuscripts submitted for publication, we encourage journal editors to require that authors submit data verifying the authenticity of the ESC line(s), and an explanation of how the authors have complied with accepted standards of good cell culture practice2. We further urge journal editors to require that the source of the cells used in the research be clearly specified.

10. Journal editors should also support and promote high standards for ethical integrity in stem cell science. Journal editors should require a statement from scientists that their research conforms to local laws and policies, and that, where applicable, it has been approved by all appropriate oversight committees. Authors should provide statements of all conflicts of interest that affect their research. On request from editors, authors should provide protocols approved by ethics review committees, consent forms, information provided to potential human subjects and tissue donors, and other related documents or information that may bear on the ethics of the research.

11. For the purposes of oversight, regulations and applications to ethics review boards and funding agencies, etc., human materials donors in the context of human ESC research ought to be treated as human research subjects.

12. We encourage the creation of a public database for the deposition of statements of ethical conduct and guidance, research protocols, consent forms, information provided to potential human subjects and tissue donors and other related documents that bear on the ethics of stem cell research.

13. As the science evolves, academies of science and relevant professional organizations, in consultation with the public, should continue to develop guidelines for the ethical conduct of stem cell research and clinical trials. Insofar as possible, these guidelines should be applicable to stem cell research internationally and should continue to address the challenges of international collaboration.

14. Funding bodies must take adequate steps to satisfy themselves that those they fund intend to carry out their research ethically and in accordance with relevant national regulations and appropriate international guidance as it emerges.

15. Research institutions and laboratories are encouraged to provide opportunity for researchers to engage in ethical discussion, review, and education.

While we believe we have accomplished much, we believe there is much work to be done. For example:

16. Insofar as donors of human materials are treated as human subjects, many of the ethical issues raised by hESC research can be adequately addressed through existing international codes of ethics and policy documents governing research involving human subjects. However, new ethical challenges in the conduct of stem cell research that are on the horizon cannot be adequately addressed by existing international ethical codes or practices. Examples are gametes derived from hESC, and human-non human chimeras. At least one national effort is currently underway to anticipate such challenges3. However, it is imperative that international efforts to address these new issues be initiated as soon as possible in order to ensure that science proceeds in an ethically acceptable fashion and to reduce the likelihood that diversity in international response will result in obstacles to ethical conduct similar to those raised by existing differences in national policies governing hESC researc h and nuclear transfer.

17. Steps should be taken to develop consensus in ethical standards and practices in hESC research for international collaboration to proceed with confidence and for research from anywhere in the world that adheres to these standards and practices to be accepted as valid and valuable by the scientific community and academic journals.

18. To achieve this goal, it will be necessary to specify what these standards and practices should be through the international efforts of scientists, philosophers, bioethicists, lawyers, clinicians, journal editors and regulators involved in this field, in collaboration and consultation with the public. It is imperative that scientists in particular actively and honestly engage with the public about the promises and limitations of this research.

19. This process of identification of international ethical standards and practices should include concerted efforts to engage people throughout the world in honest and realistic conversations about the science and ethics of stem cell research and its emerging applications.

Hwang Bought Bioethics:
Paid $350,000 for Ethics Research

He later gave her another $100,000 US, to study:

the ethical and industrial impact of bio-organs, as part of a project on producing bio-organs by using transgenic cloning technology and developing transplant technology. Park was appointed presidential aide the following year.

The official said everything was above-board and she published several papers and took part in conferences while producing the ethics guidelines for bio-organs. Academics say it makes no sense to ask a botanist to study the ethics of BSE and cloning research.

Assisting in Executions: No. Period.

``The state has an obligation for the execution to be painless'' and humane, he said. ``On the other hand, it's a violation of pretty core ethical principles to have physicians euthanize patients against their will.''

Doctors played an unusually prominent role in the Morales case because his lawyers argued that California's traditional three-drug lethal injection was cruel and unusual punishment. The initial sedative, they contended, might not make him unconscious before the other two drugs are administered.

Concerned by the suggestions, U.S. District Judge Jeremy Fogel gave the state two options: Hire anesthesiologists to make sure Morales was unconscious, or execute him using the initial drug alone. The first option collapsed late Monday night when the anesthesiologists backed out, citing ethical concerns.

The second broke down Tuesday evening when the state said it could not find a licensed medical professional to give the lethal injection. Previously, prison employees have inserted the intravenous lines, and then the drugs were added by a machine.

Even before the execution was postponed Tuesday evening, the California Medical Association announced it is sponsoring a bill that would prohibit physician involvement in future executions here. On Friday, the state of Georgia went the other way, approving a bill to protect physicians who help administer capital punishment.

It already is a violation of the American Medical Association Code of Ethics for a doctor to participate in an execution, said Dr. Priscilla Ray, a Houston psychiatrist who is chair of the AMA's Council on Ethical and Judicial Affairs.

And while the council has not investigated a doctor in Georgia who announced that he had a contract with the state to monitor executions, ``the AMA president can appoint an investigator to look into that and bring it to us,'' she said.

The chain of events surrounding the postponement of Morales' execution is just another blip in the long history of doctors and executions, one bioethicist said.

During the French Revolution, it was a doctor who proposed the guillotine as a humane method of death for that time, said Dr. Stephen Miles, who teaches at the Center for Bioethics at the University of Minnesota.

``Rich people were being painlessly and swiftly beheaded after slipping money to the executioner to sharpen the blade,'' he said. ``Poor people were being drawn and quartered on the wheel and burned.''

That's when Dr. Joseph-Ignace Guillotin said ``everybody should be executed by decapitation,'' Miles said. ``Another French doctor actually invented the French guillotine.''

Doctors surfaced at the heart of the execution debate in the United States, he said, ``when docs weighed in about new technology called electricity. A committee of doctors developed the technology for the electric chair.''

The next major development with doctors happened during World War II, ``when people were totally disgusted with what Nazi medicine had done,'' he said. ``Then you had the Geneva Convention and the anti-torture movement, which essentially tried to get doctors out of the business of state punishments.''

Benchside Bioethics at Stanford

John Arras honored at University of Virginia

Chinese Kidneys for Japanese Patients

The End of MASH

On learning last week that the very last MASH unit - set up in Pakistan - was to be decommissioned by the Army and given to Pakistan, Steve Gorman at Reuters thought to call Alan Alda for his reaction, which was:

"You had a group of people under a tremendous amount of pressure, and it wasn't just the pressure of a difficult job," he said. "Their lives were being threatened, they were trying to save the lives of other people, they couldn't get out, and they couldn't avoid one another's idiosyncrasies."

Bioethics Story Wins Major Award

Pandemic Planning in New York: Local Emphasis

So, today, the entire New York government has responded by implementing the Caplan & McGee plan, with the New York Times lead Region story as an exceptional description of what is to happen: "Albany's Plan for Flu Epidemic Leaves Big Decisions to Localities."

Already the state department of health is being hammered for their decision. But they are right. The way to cultivate trust and make an effective response to looming pandemic is to build the local institutions that people will depend on. New York is ahead of the curve on this one. But what isn't here - or at least not that I found - is any requirement of town hall meetings - and preferably the mandatory involvement of bioethics in those.

Gilbert the Civil

We noted earlier that Gazzaniga's publishing such a strong position on the claim would have been near heresy had it happened during the Reign of Kass on the President's Commission on Bioethics - a time when two members of the Commission who disagreed with Kass and Bush were quite vividly fired (all rhetoric to the contrary) and replaced by more partisan members - and to cap the incident, Kass went after one of the two members in interviews and even an editorial in Washington Post. Comments on our post about Gazzaniga's recent editorial said, basically, that we had it all wrong; that the Kass folks were just fine with differences among members of the committee. Yeah right. C.f., The National Review. In the National Review piece the opening is that everyone is a member of the big President's Council.

And from there the attack begins, an attack not so much on Gazzaniga's argument as on his way of talking. It is infuriating and I've spent more words fuming about this stupid, patronizing nonsense employed by the neocons on the PCB that I am thinking of writing a little dictionary to help normal people figure out what these guys mean when they say that someone is blithe, less than serious, or when they charge that someone is "opining" or "fails to engage."

So maybe I shouldn't say that the authors of the National Review piece "hammer" Gazzaniga's claims, because it isn't polite to say so. Eh, actually the reason I shouldn't say "hammer" is that the essay by Gil and Robert is not an argument, it is whining.

I will spare you the effort of reading their essay, ever so worthy of its placement in The National Review. Their points are three.

First, Gazzaniga commits the sin of being too blithe - he isn't "serious" about when life begins. No kidding, that is the first argument. It is pro-life on stilts.

The second is that scientists are not working "in a value-free vacuum." By this the authors mean that anyone who is a scientist and disagrees with the authors is a partisan hack afraid to pursue "the truth," whatever that may be. Uh, ok. Actually this argument would be a great and thoughtful one could the authors produce any evidence whatsoever that the arguments made by Gazzaniga or those in the pieces they criticize in NEJM are false in any respect. But, oops, they can't or at least don't. We're to just trust them. After all, they've got the eminent stem cell biologist William Hurlbut working on the details of their own biology.

What they do say though is that scientists who favor SCNT or for that matter any form of ESCR are susceptible to the sins of the anti-life utilitarian - impolite, blithe and unserious. zzzzz.

The third point of the authors is that Gazanniga is mistaken to "deny creativity" in the pursuit of Hurlbut's ridiculous ideas for how to make "moral" embryonic stem cells. They write, "Gazzaniga is far too confident that he knows in advance which paths will turn out to be fruitless. This is the sort of confidence that is produced not by scholarly caution but by political aims." Ok. The sin is his confidence - which comes from reading and working in the scholarly literature of science (unlike, say, Gilbert or Robert, or for that matter Hurlbut, none of whom works on stem cells at all in their labs - or for that matter have labs).

This article is just one more reason to utter a "thank you" to those who have at long last relegated to the margin the prophets of "seriousness" - a term of neocon bioethics that should be entered into the official lexicon of Orwellian Newspeak for its utterly obvious duplicity.

It was never easy to take talk about the importance of sincerity and "seriousness", uh, seriously when it was uttered by those working on a council whose leader handed out leaflets to members of Congress urging them to implement a "second term Bush bioethics agenda" be taken, um, seriously. (Although we do know that those in Congress who called for an investigation of Kass by the Inspector General of DHHS took that very seriously as a matter of, um, uncivility in the extreme). I know of no one in bioethics who is not very happy to see a thoughtful, fair, intellectually responsible leader at the help of the PCB now - at last there will be real and open debate - this little nonsense in the National Review is just the hangover from what seemed like years of oppressive political sophistry.

And You Thought the Cigarettes Were Expensive...

Itty Bitty Notes

Rock Ethics Institute at Penn State's main campus is sponsoring a conference on Islam & Bioethics March 27-28. For more information on bioethics conferences and events near you see the pretty much definitive calendar at bioethics.net.

Justice John Roberts speaks for religious freedom, at least where hallucinogenic tea is concerned.

Most parents would not select their children's sex according to a survey by Jain et al.

According to the French press' report on the Chinese state news agency, births of twins in China are booming as that nation has begun downing fertility pills like candy.

Except in the Muslim west of the nation, where China is cracking down on births.

Korea Times reports at long last that the government is coming for Seoul National University: "The Board of Audit and Inspection (BAI) said Tuesday that it would inspect Seoul National University (SNU) for the first time over the school’s use of research and development (R&D) funds coming from the government."

Alta Charo dug up this interesting summary of the growing concern over pharmaceutical companies broadly in society.

If you aren't sleeping you have noticed that doctors in California have thrown a real wrench in the works of an execution in that state.

Stem cells cause cancer. Like we needed another reason to study them.

Vioxx is good for you. Yup. No liability there.

Fear and Freedom on the Internet

Will the Pope Reconsider Birth Control

Five Questions for Judy Illes

Are You Ready for the Police State?
You Better Be.

The message from scientists and public health agencies the world over is clear: A pandemic of avian flu is going to circle the globe, killing millions, and in an age of air travel there will be little advance notice of its impending arrival. It is a time when Americans must believe that their health and safety is in the hands of those whom they can trust. But they don't.

The world is diverting tens of billions of dollars to every measure one can imagine to fight this nasty bug. Experimental vaccines are being rushed to production. Tamiflu and other anti-influenza drugs are being manufactured and stockpiled in overdrive.

But no matter what we do, we will not have enough vaccine or pills to protect even a quarter of the American population any time soon. Only two things can slow the spread of Avian flu, and they are the scariest things in the armamentarium of medicine: quarantine and rationing.

Quarantine was pioneered in 14th-century Venice, where ships were required to wait offshore for 40 days. During the 2003 SARS outbreak in Toronto, quarantine entered the 21st century: 45,000 people in that area were asked to remain in home quarantine for 10 days, and similar measures were ready to go across that nation.

The U.S. Centers for Disease Control says that 85 percent of those whom they polled are willing to stay home and care for themselves or their families. More than half would be willing to limit contact with others for a month or more. About half even said that they would be willing to wait months for a vaccine so that clinicians and other leaders could be vaccinated first.

But researchers have found people won't do any of this if it is called a "quarantine." That term calls to mind images of police and military enforcing what amounts to martial law to protect the well from the sick and the stigmatized.

The name isn't the only problem with public participation in preventative measures before and during a pandemic. Whether you call it, as some suggest, "community shielding" or neighborhood clustering or, for that matter, just a prolonged slumber party, the public will accept public intervention to prevent disease only if they trust the American health care system as well as their government. And they don't.

Trust requires transparency. When public officials fail to reveal in the most public way the stark truth about the plans of cities, counties and states in a pandemic, it is a prescription for panic. Anyone who has read Richard Preston's best-selling book, "The Hot Zone," or seen the movie "Outbreak" knows what could happen when troops start marching and police in gas masks begin painting the doors of those who have infected family members. A lot of people will be exceedingly unhappy to find themselves in a police state.

Citizens of a country where those in one state have "Live Free or Die" on their license plates will not take kindly to being imprisoned in their homes unless those measures have been presented as part of a comprehensive strategy that takes their sacrifice of liberty into account. They would be much more willing to stay home with their families for a month to prevent the disease's spread if they trust those deputized by the national and state agencies that implement the directives of the Centers for Disease Control and the Department of Homeland Security -- and if they are sure that they will not be left to rot while others receive better care.

For these same Americans, rationing is as terrifying as quarantine: If too few drugs, too few health care workers and terrible medical facilities plague our larger urban areas, imagine what could ensue. Cutting in line will be the least of our problems. Americans must believe that the questions about profit in the development and distribution of vaccines and anti-influenza drugs will fly out the window when the bird flu arrives.

American medical schools and medical associations must reinstill a strong sense of professionalism in medical students and health care workers or they may not be there in the face of danger. The public has taken notice that more and more physicians have refused to work weekends or nights. What makes us think that they will work 24-hour days knee deep in highly contagious patients unless they have a strong sense of professional ethics and duty?

The only answer to these challenges is to build trust. If people understand the rationale for quarantine and why some people must be vaccinated ahead of others, they are more likely to accept hard choices. Building trust means immediate public education, town meetings at which officials listen as well as talk and plans sensitive to local concerns. And it means that all health care workers, though many will arrive ready to serve, will have to be read the riot act about availability in a time of crisis.

Medical ethics has never been tested so dramatically. On the one hand, we had better have a government willing to move fast and err on the side of caution, a better public health sentinel system to prevent avian flu from spreading and a public ready to yield some liberties.

On the other hand, the policies under development are frightening and depend for success on public trust that isn't there. As a pandemic looms, billions spent on surveillance, intervention and quarantine will neither stop avian flu nor those who have it unless the public trusts those who will be kicking the military machinery of quarantine into place.

Got AIDS? Take Two Cloves of Garlic and Call Me in the Morning

Lurking behind this position of neutrality is a longstanding battle between the South African government, health care professionals, biomedical researchers and AIDS activists. The current South African president Thabo Mbeki used to publicly state that HIV does not cause AIDS, few if any people in South Africa die of AIDS, and that anti-retroviral drugs are unsafe and part of a neo-colonial plot on the part of Western pharmaceutical companies. He no longer needs to, because now he has a Health Minister (Manto Tshabalala-Msimanga) who says anti-retroviral drugs are merely an 'option' for AIDS patients, and a healthy diet can be just as effective in controlling the virus. Mbeki has a theory, but Tshabalala-Msimanga translates it into health policy, under the fashionable guises of 'patient choice' and 'respect for indigenous culture.'

This policy of 'neutrality' needs to be evidence-based. The South African Ministry of Health should sponsor an independently monitored clinical trial comparing herbs, micronutrients, garlic, lemon rind (and whatever) against first-line antiretroviral drugs on persons with CD4 count of <200. Nearly everyone in the scientific community would predict a whole lot more death in the 'garlic' arm of the trial, but since the Ministry of Health claims they are equally effective, they at least have clinical equipoise. So they can do it. But they won't.
- Stuart Rennie

Kevlar Vest? Whistleblowers also Need a Good Defense Attorney …

This case again highlights the dangers that whistleblowers face, which results in underreporting of scientific fraud in the United States and other countries. The current atmosphere of overt and covert retaliation against whistleblowers undoubtedly leads many researchers who suspect scientific misconduct to follow the code of conduct favored by Tony Soprano: “Mind your *(#@$ business and keep your mouth shut”. Particularly when money is involved – the commercial rights to pheromonicin have already been licensed to a Chinese biotech company.

But the pehromonicin case is also interesting is other respects. Consider the issue of authorship of the 2003 article in question. Some of the coauthors claim that they were “listed without their knowledge,” but one cannot help but wonder if they would be clamoring to distance themselves from the paper if it wasn’t under investigation. Even more disturbing, one of the corresponding authors, George Wu of the University of Connecticut Medical Center in Farmington, now says he does not even know whether the data presented in the paper are valid or not. According to Science magazine: “[Wu] helped translate the report into English and suggested ways to ‘beef up the experiments with some controls’ and ‘put this together in a presentable way’.” For this level of involvement Dr. Wu deserves corresponding authorship? He didn’t even review the original data.

- Sean Philpott

The Mercy Killings of Katrina Did Occur

reveal chilling details about events at Memorial hospital in the chaotic days following the storm, including hospital administrators who saw a doctor filling syringes with painkillers and heard plans to give patients lethal doses. The witnesses also heard staff discussing the agonizing decision to end patients' lives.

...it was on the seventh floor of the hospital were the situation was most dire. Memorial Medical Center leased the floor to LifeCare Hospitals, a separate long-term patient care facility. Lifecare Hospitals is based in Plano, Texas. LifeCare has facilities in nine states and considers itself an acute specialty hospital capable of treating the most complex of cases.

There, on the seventh floor of Memorial Medical Center, doctors and nurses were faced with few options. Conditions were deteriorating rapidly, evacuations were sporadic and security was compromised. Staff agonized whether to attempt to transport critically ill patients who might not survive the arduous evacuation. It appears another choice was considered: whether to end the lives of those who could not be moved. In the court documents reviewed by NPR, none of four key witnesses say they knew who made the decision to administer lethal doses of painkillers to the patients. But all four heard discussions that a decision had been made to end patients' lives. According to the documents, attorneys for LifeCare self-reported all of this to the Louisiana attorney general's office on Sept. 14, 2005.

How to Eliminate Senate Republicans: Introduce them to Hurlbut

Censorship

The high and mighty editors have made the decision to begin moderating comments to the blog, which can delay the posting of comments from several minutes to several hours. We've always felt free to edit comments - I guess it just comes naturally to editors - but now we've gone too far. We will strike and boldface and emphasize and stuff. It will be terrible. The whole point of the blog will be lost, because as you'd imagine we'll only post comments by people who agree with us or pay us lots of money. It will be typical liberal claptrap from here on out so either accept our newspeak or get lost.

Get Hippa to This, Criminal: We're Taking You Down

Cast Me Not Off in Old Metaphors

Gazzaniga On Bush on Stem Cells

Ironic title, of course, because only after Kass was purged from the leadership of the President's Council on Bioethics would any member of that group ever dare make such as profound statement of opposition to the President or to the High Council Chair. Already a good sign that having a conservative academic of great integrity chair the Council is making a difference!

Black Market Plastic Surgery

Personal Genome Project

Plan to Blow the Whistle on Scientific Misconduct? Better Wear Kevlar

Terri Schiavo Pays Off

Sample the blurbs. From the Schindlers:

Here the people who loved her and knew her best tell the story not only of the fifteen years Terri struggled to stay alive, but of a gentle child who brought happiness to everyone she touched. This is the story of a normal adolescent who blossomed into the beautiful young woman who captured Michael Schiavo's heart. And it is the inside story of their troubled relationship, for the members of Terri's family were witnesses to a growing tension-and were her confidants as she struggled in her marriage with the husband who would later crusade for her premature and unnecessary death.

"A religious zealot offered $250,000 to anyone who would kill me. My two babies were threatened with death. I was condemned by the president, the majority leaders of the House and Senate, the governor of Florida, the pope, and the right-wing media, all because I was doing what Terri -- the woman I loved -- wanted. I didn't respond to their attacks. I didn't confront their lies. Until now."

Rennie: The Ethics of Urgency

In the light of this, the WHO has recently embraced routine HIV testing in areas of high prevalence where AIDS treatment is available. Routine testing basically means informing persons presenting at clinics that they will be tested for HIV, unless they choose not to. Opt-out policies can increase the numbers tested, but also diminishes the ‘voluntary’ component in HIV testing. The WHO believes that since routine testing involves possibility of refusal, the policy balances public health and ethical concerns.

Some commentators, however, worry about the implementation of routine testing policies in low-income countries. What will routine testing for this still-stigmatized disease really involve for individuals, particularly for women? There is also a ‘slippery slope’ concern: if routine testing does not increase the numbers of tested individuals, what more aggressive HIV testing policies will be proposed next? Frankly, I am one of those commentators.

In the most recent issue of Developing World Bioethics, Peter Clark argues that the time for more aggressive HIV testing policies within sub-Saharan Africa has already arrived. Clark argues that mandatory HIV testing of all pregnant women in Botswana – i.e. testing them for HIV whether they consent or not -- is economically, scientifically and ethically justified. Actually, he goes even further: since those who get tested do not sometimes adhere to treatment regimes, Clark is also ready to defend mandatory treatment of Botswanans as well – though he thankfully spares us the gory details of how to implement forced medication of adults and children. Restricting the privacy and autonomy of individuals, he writes, is a lesser evil than the death and social destruction caused by HIV/AIDS.

As far as awareness of the horrors of the epidemic is concerned, Clark’s heart is in the right place. But it is unclear that he put all the potential costs of the policy into his utilitarian calculus. Privacy and autonomy are not the only concerns. There is also stigmatization (and possible harm) of being found HIV positive. There is also the fact that this mandatory testing policy targets pregnant women, not the men they likely received the infection from. How are local communities likely to react to mandatory testing (or treatment)? And what, if this policy did not work, would come next?
-Stuart Rennie

Funding for Stem Cell Research in New York?

After All, Cancer is Awful

Egg Donation for Stem Cell Research in Britain

The proposal includes safeguards to provide mandatory counseling for friends and family of scientists who want to donate and a ban on scientists donating their eggs to their own laboratories.

Collecting Placenta in Oregon: A Case to Watch!

Professor Schatten Did Suggest the Photographer

Dr. Schatten inappropriately took the title of author on the paper published in Nature that reported the creation of the first cloned dog, Snuppy. The report says that:

“we have no reason to doubt Schatten’s statement to us that his major contribution to the paper was a suggestion that a professional photographer be engaged so that Snuppy would appear with greater visual appeal. It is less clear that this contribution fully
justifies co-authorship.”

This is the understatement of the year. Dr. Schatten was not a contributor to that paper and took credit for work he did not do. This means he is also guilty of lying to the journal about his role.

Other problems identified include failing in his duties as the corresponding author who was coordinating the publication (he failed to show final versions of the paper to each of the co-authors which is generally required of all authors and according to the report may have contributed to the fabrication) and took credit for the work by his role as “senior corresponding author” and yet abrogated his responsibilities in that role.

The report says that Schatten took a great deal of money for activities where it was questionable that it was warranted (including $10,000 in cash that he was given right after the press conference for the Science paper) and had a great deal of financial and professional interest in this work being published and well publicized. The report also says that there were problems and logistical issues that should have raised questions for Dr. Schatten about the veracity of the claims being made. Putting these things together, one might conclude that Schatten in fact was bribed to look the other way. However, the report does not explicitly draw that conclusion—it merely points out that his payments were unseemly and points out that he was perhaps negligent in not asking certain questions.

“We feel that he did not exercise a sufficiently critical perspective as a scientist. For example, he did not ask what event in Hwang’s lab prompted the change in the reporting of some data differently in two successive versions of the same table. In another example, he reported that he was told by Dr. Hwang in the middle of January, 2005 that some contamination of the cells had occurred. Dr. Schatten’s reaction was apparently to accept Dr. Hwang’s assurance that this problem was a minor nuisance. Dr. Schatten did not extrapolate to conclude that if new cell lines had to be started in middle or late January there would not have been enough time to grow and analyze them by March 15, the date of the first manuscript submission.”

Even if there is not sufficient evidence to conclude that Schatten is not guilty of fabrication or falsification of data, it is clear that his role in this scandal highlights why it is important not to cut ethical corners. Schatten took credit for work that was not his, lied about his role to journals, equivocated to the investigative committee to avoid blame, failed to do due diligence as a scientist and an author and took money and credit to further his career in a way that made him particularly vulnerable to criticism. He may not have been the one who walked in and robbed the bank. But he was the getaway driver who did not ask why his friends wanted him to drive away when they ran out of the bank.
-David Magnus

The 10th Anniversary of Penn Bioethics

Comments on Schatten

The finding by a University of Pittsburgh panel that reproductive biologist Gerald Schatten made many mistakes but did not commit scientific misconduct in his collaboration with Dr. Hwang Woo-suk struck many observers as fair.

"I think it's obvious that Schatten really was, in many ways, a victim," said Glenn McGee, founding director of the Alden March Bioethics Institute at Albany Medical College.

Though Dr. Schatten may have failed to do everything he could have to uncover problems with the research, he did not participate in the fraud and was taken in by the false reassurances made by the South Korean researcher, the panel said.

Dr. Schatten acted responsibly once he realized that a fraud had been perpetrated, Dr. McGee said, breaking off his collaboration and notifying editors of the journal Science of his suspicions.

He did, however, fail to fulfill his role as an author, as charged by the Pitt panel, and his efforts to remove his name as an author after discovering the fraud were unfortunate.

"When someone steps forward and says, 'I see extremely important problems here and I want to pull out,' that doesn't absolve them," Dr. McGee said.

He also praised Dr. Schatten, not only for blowing the whistle on Dr. Hwang's fabrications, but for "not playing tit for tat with the South Koreans" after the charges became public.

Some Koreans accused Dr. Schatten of criminal behavior and made statements about him that could be slanderous. But Dr. Schatten stayed mum after he announced the break with Dr. Hwang and asked Science to retract the stem cell paper.

Though clearing Dr. Schatten of scientific misconduct, the Pitt panel accused him of "research misbehavior," which caused some consternation. That term is not a recognized distinction from scientific misconduct, Dr. McGee said, though in this case it could be argued it was a reasonable way to describe his limited role in the scandal.

Losing the Battle Against Doping

The Olympics are back. Yes, that time is upon us when you try to figure whether those judging the skating performances are drunk, insane or both, how anyone can really take seriously as athletics any activity involving sweeping with a broom, and which professional hockey player not implicated in a burgeoning betting scandal will be the first to trash his hotel room or wind up taking literally the exhortation to be passionate, which is a part of the philosophical babble that the International Olympic Committee emits every two years.

More familiarly, the return of the Olympics signals a renewed focus on the subject of using drugs and medical science to enhance athletic performance. That's right, doping season is upon us.

The sport that is already in trouble: sledding. The old backyard pastime of tiny tikes in the Northern United States and Canada is in the midst of a moral maelstrom. Who knew letting your kid near a Torpedo Blaster or a Wham-O Snow Luge was the first step in a life of crime? If you have an old Flexible Flyer in your basement, burn it before the kids find it.

In the last Winter Olympics in Salt Lake City, doping scandals beset Nordic skiing and cross-country skiing. Recently, skeleton racer Zach Lund, who is from Salt Lake but apparently was not awake during 2002, has been publicly warned by the United States Anti-Doping Agency for using a drug, finasteride, that is a known masking agent for those taking steroids. The World Anti-Doping Agency may not let Zach launch his apparently pharmacologically bulked up frame downhill on his sled during this year's Olympics, even though the Americans are ready to let him compete.

And it is not just doping. The coach of the U.S. skeleton team — you don’t think this activity would be in the games if it was called sledding do you? — has been put on leave due to charges of sexual harassment. Mamas, don’t let your babies grow up to be skeleton players.

Anyway, the biennial outbreak of doping tests, charges, lies and expulsions leads naturally to the question about the ethics of using drugs to improve performance. My view is that it is wrong to use a drug to improve performance if that drug is dangerous, risky or unsafe. Since most drugs have very real risks, it is hard to justify allowing their use simply to go farther on your skis or get downhill faster on your skeleton.

The problem with my position though is that to enforce it you need to be able to test for performance-enhancing drugs. And while the technology for detecting drugs such as steroids has gotten much better over the years, the ability of the drug cheaters to concoct new and stealthier versions of drugs also gets better year after year.

Scientists continue to brew up new chemical stimulants and muscle builders that those trying to keep drugs out of sport have to find new ways to detect.

This is a race that the good guys cannot win and some bad guys know that.

At the end of the day it is integrity as much as technology that will keep the Olympics drug-free. But if your coach is charged with sexual harassment, your countrymen only see gold medals as making the competition worthwhile, and if you yourself are competing with one eye on the opposition and the other on your endorsement contract, then integrity is in trouble.

Odd as it may be, it is you and I who determine the extent to which drug doping permeates the Olympics. At the end of the day, if we don't want cheating in the Olympics then we cannot behave as if the one and only goal for each and every athlete is winning a gold medal.

If all the honor, money and celebrity accrue only to those who finish first then no matter what testing is done, athletes will cheat. So while testing for drugs is important, the best antidote to doping is not to create a culture in which only those who finish first count. Not to do so guarantees that there will be a few more Zach Lund skeletons in our national closet before the Turin games are through.

Happy Birthday to Charles Darwin

Eric Topol to Leave Cleveland Clinic

For its part, the Clinic is making new statements about a commitment to avoid conflicts of interest.

Case Western Reserve Profiles Insoo Hyun;
Hyun Claims AJOB Editors' View Him as "Guilty by Association"

[Update] Hyun's role in describing the social dynamics of the Korean situation, of late, has been noticeable, not only in his co-authored article in the pages of AJOB but in the media. He repeatedly made reports on "what happened" in Korea, commenting to The Chronicle that, "Hwang and Schatten were referring to each other as brothers." In Nature, Hyun is the sole source for descriptions of Hwang's relationship with Schatten:

Until recently, Hwang and Schatten had been getting on famously. "They seemed as close as they could be," says Hyun, who spent this summer studying the Korean team's ethical practices. "Gerry kept referring to Dr Hwang as his brother, and Dr Hwang's public toast to Gerry at a formal dinner was so effusive, it was almost embarrassing."

One irony of Hwang's resignation is that South Korea's egg donation standards, and those of Hwang's lab, are now stricter than U.S. standards, says bioethicist Insoo Hyun of Case Western Reserve University in Cleveland. The lab requires consent forms and psychological evaluations for donors.

Imagine our surprise then to read Hyun's comments concerning the likely disposition of the Editors of AJOB concerning the retraction of the article by himself and Jung in AJOB to The Chronicle:

In conversations with Mr. McGee, Mr. Hyun says, he proposed publishing a modified version of the paper, one that outlines how to develop an ethical donation system. But Mr. Hyun says he was rebuffed. "I get the sense that there's guilt by association," he says.

Mr. McGee says he welcomes any new submission from Mr. Hyun. But the journal's editors decided that a modified version of the retracted paper did not warrant publication. "It does not make a substantive argument for the process it advocates, rather it reports on the mechanism that is purported, with the support of Dr. Hwang, to have been implemented," says Mr. McGee.

But there is no room in the Chronicle piece for a response from the Editors to Hyun's claim concerning a presumption of his guilt by association. At one level it is easy to respond - and the Editors will of course do so in the appropriate forum - that at no point and in no way was a claim made that Hyun was in any way involved in any misconduct or in particular involved with that of Hwang, in fact the retraction is quite clear on the matter: "Neither Dr. Hyun nor Dr. Jung have been accused of any misconduct with respect to the contents of this paper."

However, the question of guilt by association is really about something else - the question of whether AJOB in some way "imagined" that Hyun and Jung's reports were framed by the two authors in terms of their closeness to the Hwang group. It is a matter that must be addressed in full now that it appears so provocatively in the Chronicle And on this matter there isn't much question: the authors themselves claim not only proximity but the ability to sufficiently judge the implementation of a complex program for egg donation, writing:

These guidelines were closely followed in the Korean research protocol that resulted in the recent derivation of eleven patient-specific pluripotent stem cell lines (Hwang et. al 2005).

After discovering that their procedure was likely not followed, Hyun and Jung first requested that AJOB allow them to retract part of their paper, which the editors declined. The editors offered the possibility of an author-requested retraction of the entire article, or the publication of a letter in which the authors made comment on the events subsequent to the publication of their article. The editors cautioned the authors, however, that should any representations of fact concerning the authors' claims require further amendment, the journal would not publish a series of such corrections. The authors elected to write a letter to AJOB in which they would correct the record.

In the letter submitted, they offered no comments whatever on how the method they used to create and implement their policy might have failed, or more important on what specific representation they based their strong claim about the implementation.

In fact quite the contrary. The authors argued in the strongest possible language that despite the apparent deception, they were certain that the informed consent procedures were put into action in January of 2005. They assured the editors that there was unequivocal proof of this - and specifically that at least 10-15 donors had been put through the procedure - but could not produce that proof, they said, until certain records were unsealed.

The editors refused to publish such language, requiring that any letter include only the representation that, "The process we describe was not in place prior to January 23, 2005." The authors strongly objected to this requirement, several times indicating their certainty that the procedure was in fact followed and that author Jung had conducted several of the interviews for the process himself, but ultimately they acceded.

As we all now know, the procurement of eggs appears never to have been conducted according to the procedure described in the article in AJOB. The documentation that would have proven Hyun's second report of the facts - the modified claim that all donors after January 23rd were put through the procedure - did not in fact exist.

The Chronicle reports that "Mr. Hyun requested that the journal retract the paper, which Mr. McGee did late last month." This is utterly inaccurate. The Editors telephoned the authors to inform them that a retraction would be made by the journal, to which the authors agreed. However, even as the retraction was being authored - in careful consultation with Hyun - Hyun stated alongside that he could confirm based on yet another report - from an officer from the Health and Welfare Ministry - that at least six women in fact passed all three levels of the process and donated oocytes at Hanna Clinic, Hanyang University Hospital. This was the third report as to facts in South Korea. The question at this point was no longer whether or not the authors were deceived, but at what point it would begin to seem inappropriate to the authors to make strong representations as to what happened with their procedure on the basis of ad hoc interviews of those engaged either in the Hwang effort or in the investigation.

What Hyun describes as an implied guilt by association evidenced itself, he says, in AJOB's "rebuffing" a submission of the same paper without any claims as to what actually happened, but with the addition of an ethical argument for the paper. But as noted in the Chronicle piece, the editors actually said to Hyun that parsing their report in the paper concerning what had happened from an ethical argument not yet made but based on the same system just simply made no sense.

Why? Because any argument for a process of the kind reported in the Hyun and Jung article would obviously require something more dramatic than "beefing up the ethics": if the article were merely being modified, the authors would have to defend the claim that a procedure whose purpose was to protect women from unethical procurement of eggs, but that was totally and completely evaded even while observed by one or both authors - who were focused entirely on the process' purported operation - could in fact protect women from violations of ethics.

The claim that an intervention in bioethics has happened and is successful is one that can be verified using a number of methods ranging from interviews to participant observation to recorded interviews of consent sessions. With any such method, investigators can report and be judged on the validity of claims as to what did or did not happen, making clear the limits on their study. In the present case, proximity and observation were claimed as method, and no limits were articulated by the authors on either the method they used or on its deployment. So the report of the success of the method became a matter that peer reviewers and editors had to take on faith.

When the Editors pointed out to Hyun that a modified manuscript would have to explain th abject failure of the authors' methods for observing, interacting with and reporting the conduct of scientists, then defend a system whose only effect to date appears to have been to provide Hwang with the appearance of close collaboration with ethicists and ethics centers while he flagrantly defied their standard.

The effect of such a manuscript would be to throw open the door, we said, to the query: are the technique and the mode in which the process was developed an object lesson not in how to do good bioethics but in what happens when bioethicists are brought so close into the "inner circle" that they make, e.g., representations to the mass media concerning, e.g., the relationships among the principals. It is what Carl Elliot calls the question of the "lap dog."

The question of whether or not the experiment of putting these ethicists in this setting for this purpose was a success or failure seemed to us a question that should not be raised in the same manuscript that made an argument for a "best practice" for egg procurement.

Contrary to the report in the Chronicle, in a conversation with several of the editors, Hyun agreed with this point and said that the two would not submit another version of this manuscript. It was asked yet again whether AJOB might publish another reportorial piece by the authors, instead, in which the historical record would be cleared up on the basis of future investigation of the reports of the various investigative committees. AJOB discouraged such a submission for reasons that are all too obvious, but as reported in the Chronicle, at that point (and earlier, and later) the editors indicated to Hyun that if he wished he was welcome to submit an entirely different manuscript, although the other cautions remained.

The Chronicle piece is in fact riddled with relevant errors of this kind. They suggest for example that the authors came to the editors with a disclosure that they believed that eggs had been improperly procured. This happened, however, long before that time, in fact from the moment that Jung and Hyun's manuscript was submitted, the editors began asking questions about how the authors were able to ascertain several key claims about what had actually happened in the procurement of eggs. The manuscript was in fact delayed for some time while questions about these facts were discussed, and a commentary on the piece authored. The paper was in fact delayed so much that contrary to the claim in the Chronicle that the editor "rushed it into the January/February issue," the paper's review and revision required so much time that the authors expressed concern that the paper be moved along more quickly. That Hyun would report as damning that AJOB moved the paper to press quickly and released a press release on behalf of the paper is extraordinary.

The question of proximity and association is really quite simple. All around Hyun and Jung, who, the Chronicle reports "spent last summer on a Fulbright fellowship in South Korea studying the consent process that Dr. Hwang's team used to obtain eggs and adult cells for its research," and who have made themselves utterly available to the media to discuss the social dynamics of the Hwang lab, the Hwang team was engaged in deception that was massive and about which many if not most involved with egg procurement were aware. The deception also involved other sites obtaining eggs in ways that not only violated the Hyun/Jung standards but did so in a manifest way. Scientists in the lab disclosed their concerns about what would later prove to be violations of ethics in procurement, but not to the ethicists in the lab. The authors, working by their own report very intensively on site and claiming as the great advantage of their report their access to the lab, and at the invitation of Hwang, not only were unable to detect any abnormality prior to the creation of their process, nor later any failing in its implementation.

It is obvious that close association with the Hwang group was at best unhelpful for the authors in terms of describing a procedure that worked - or that could be demonstrated to prevent the sort of unethical behavior that it was designed to prevent. But worse the association clearly put the authors in the position described by the editors in the Chronicle piece as, at best, "duped" - and to the detriment of bioethics - not because of any misconduct by the authors, but because the authors - and by extension AJOB became the symbol Hwang would use to defray criticism that any impropriety had occurred. So the editors declined to publish a revision that treated the matter of how the procedure "worked" as distinct from its defensibility as a procedure for ethical procurement.

The solution? The Chronicle again provides a harsh attribution to Professor Hyun:

Mr. Hyun has had better luck with another bioethics journal, Hastings Center Report. Mr. Hyun had a paper in press with the journal when the scandal broke, and the editor decided to delay publication. Mr. Hyun is now revising the paper and expects it to come out in one of the next issues.

AIDS Drug Treatment Access: Walking the Walk

This year’s international Conference on Retroviruses and Opportunistic Infections (CROI) in Denver is no exception. And it is Gilead Science being taken to task again, not by AIDS activists this time, but by the Nobel Prize-winning humanitarian organization Doctors without Borders, better known outside the United States as Medicins sans Frontieres (MSF). According to MSF-USA, Gilead unveiled its ‘global access program’ for developing countries to great fanfare over three years ago, promising to eventually reduce its prices for tenofovir to 97 countries. They looked like the good guys. But in the meantime, tenofovir has actually only been registered in 6 developing countries: the Bahamas, Gambia, Kenya, Rwanda, Uganda, and Zambia.

According to MSF, the company has not bothered to request marketing clearance or gone through other regulatory procedures to make its drugs available in most developing countries – the typical behavior of a drug company faced with unprofitable markets. (Gilead’s HIV/AIDS products made . $1.39 billion last year, up 47% from 2004, presumably in the better-off regions of the world.) Unfortunately, Gilead is the sole producer of this efficacious, low-side effect antiretroviral drug. No generic equivalent is currently being made. So if MSF’s side of the story is correct, many AIDS patients in low-income countries will just have to wait until Gilead sees a market advantage in registering its product and lowering its prices. Since ‘waiting for treatment access’ in low-income countries is often a polite way of talking about death, this is a serious accusation.

- Stuart Rennie

Turn Your Cellphone *On* In the Hospital

Using mobile telephones in hospitals reduces the error rate in medical care because of more timely communication and rarely causes electronic magnetic interference, Yale School of Medicine researchers report this month...

The senior author, Keith Ruskin, M.D., associate professor in the Departments of Anesthesiology and Neurosurgery, said the electronic interference from mobile telephone was a problem in the past because of older telemetry equipment and analog cell phones.

"The new digital cell phones used much higher power and operate at a different frequency," Ruskin said. "The small risks of electromagnetic interference between mobile telephones and medical devices should be weighed against the potential benefits of improved communication."

Art's Hometown

Saving Obese Children

The Matter of Hwang Woo-suk:
Our Take, in Science and in The Scientist

...In complex, interdisciplinary research, coauthors must often rely on each other to vouch for authenticity. The International Committee of Medical Journal Editors guidelines for authorship implicitly acknowledge this in stating that that "Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content" (9). Adopting the concept of a "contributor" advanced by Rennie et al. (10) would clarify and increase the accountability of individual authors. Rennie et al. also proposed the concept of a "guarantor" of a publication, an individual who takes full responsibility for the integrity of the entire publication. The guarantor model only works, however, in an environment where colleagues (especially junior scientists and staff) are free to probe and challenge results.

This underscores the importance of other facets of individual integrity--collegiality, communication, and sharing of resources. It has been speculated that a large, compartmentalized laboratory structure could have contributed to the ability to falsify data (8). Such structures, while perhaps encouraging efficiency, could inhibit free flow of information and dilute responsibility for the integrity of the work.

The actions of individual researchers do not exist in a vacuum but are affected by institutional factors (11). In South Korea, there was awareness of the need for ethical guidelines for research, as evidenced by the recent passage of laws about stem cell research and human subjects (12). However, the science may have been moving much more quickly than the ethical standards could be absorbed. For example, it was reported that 85% of over 900 biotechnology researchers surveyed in South Korea did not know what the Declaration of Helsinki was, and that 42% did not know about Institutional Review Boards (13). This study was conducted only in Korea, but may be indicative of an international problem. All research institutions need to assess awareness of ethical standards...

And in my piece for The Scientist, "Lies, Damn Lies and Scientific Misconduct," I focus on how scientists and the public each learn and understand scientific integrity:

Merriam Webster reports that in 2005, “integrity” received more hits than any other word in their online dictionary. It’s not clear how many more hits scientific integrity can take: An MIT researcher is fired for fabricating a dozen papers. A pharmaceutical company omits data from key publications about side effects. A South Korean stem cell researcher admits to a stunned nation that, “blinded by work and a drive for achievement,” he submitted a “fake it before you make it” article to Science. It appears that research misconduct has taken its place among the epidemics that scientists need to worry about?

An aphorism attributed to Mark Twain holds that there are three kinds of lies: lies, damn lies, and statistics. At first the public points to a bad apple who paints mice or switches out slides, and fumes if the researcher conspires to hide it. But it takes a village to do big science: authors, collaborators, students, sponsors, regulators; different languages, different countries, disparate goals. A lone scientist can offer mea culpa, but fraud on the scale of South Korea’s almost always involves collusion and conspiracy, hidden in the complexity of the research. It is a nightmare for scientific journals, but more than anything it terrifies the public...

[Link: Read the rest; or hear The Scientist Podcast]

The effect of all our ruminations about Hwang? We seem to be helping him raise money...

News from the Hastings Center

And news as well from their pastoral home along the Hudson: AMBI's Bonnie Steinbock, who has supported Hastings in many ways for many years, has been elected Chair of the Hastings Fellows Council, a long-standing group of academic researchers in the field with affiliation to the Center ... congrats to her.

And Bruce Jennings, a wonderful person, subtle and smart researcher and major force at Hastings since 1980, will be leaving the Center to serve as Director in the Center for Humans and Nature.

Bloomberg to Albany:
If We Won't Do it Here, I'll Fund It Myself in Maryland

The gift, roughly the same amount almost allocated by the entire state government of New York for a year's funding of stem cell research (until it was left to rot on somebody's desk), is an unprecedented embrace of stem cell research by the most prominent major donor one could imagine. Although there have to be some folks at Mount Sinai and Columbia and Rockefeller who wonder whether they should have made Bloomberg an honorary graduate...

The Animal-Human Hybrid President

"Tonight I ask you to pass legislation to prohibit the most egregious abuses of medical research: human cloning in all its forms, creating or implanting embryos for experiments, creating human-animal hybrids, and buying, selling, or patenting human embryos. Human life is a gift from our Creator -- and that gift should never be discarded, devalued or put up for sale."

Turns out the next day one of the most googled terms on the web was animal-human hybrids. Not many people seemed to know what the President was worried about. A few like Jay Leno speculated that he was out to ban werewolves. Is the President positioning himself to mediate conflicts between the Lapiths and the Centaurs having given up on Hamas? Will he be trying to round up and send all Harpies, Mermaids, satrys, and minotaurs to Guantanamo? Where is Peter Singer when we need him?

For those who are not going to take this sort of thing without a fight, take heart that there is help at Boing Boing.
- Art Caplan

Julian Savulescu on "Conscientious Objection" by Physicians

A doctors’ conscience has little place in the delivery of modern medical care, writes Julian Savulescu at the University of Oxford. If people are not prepared to offer legally permitted, efficient, and beneficial care to a patient because it conflicts with their values, they should not be doctors.

Imagine an intensive care doctor refusing to treat people over the age of 70 because he believes such patients have had a fair innings. Or imagine an epidemic of bird flu or other infectious disease that a specialist decided she valued her own life more than her duty to treat her patients. Such a set of values would be incompatible with being a doctor.

The argument in favour of allowing conscientious objection is that to fail to do so harms the doctor and constrains liberty. This is true, says the author, but when conscientious objection compromises the quality, efficiency, or equitable delivery of a service, it should not be tolerated.

He believes that doctors who compromise the delivery of medical services to patients on conscience grounds must be punished through removal of licence to practise and other legal mechanisms.

Values are important parts of our lives. But values and conscience have different roles in public and private life, he writes. They should influence discussion on what kind of health system to deliver. But they should not influence the care an individual doctor offers to his or her patients.

The door to “value-driven medicine” is a door to a Pandora’s box of idiosyncratic, bigoted, discriminatory medicine. Public servants must act in the public interest, not their own, he concludes.

Interactive Bioethics: The Next Level

Saletan and Pollitt Fight About Abortion

The Fall of the House of Hwang:
Reflections of a Stem Cell Enthusiast

With Dr. Hwang’s house of cards now flattened, what lessons are there for those who have seen hope and hype in the embryonic stem cell (ESC) dance.

The Science Lesson. The Hwang debacle, while an embarrassment to science, is also a vindication of science. Fraud gives a temporary advantage but fraud, like murder, will out. Methods that don’t work won’t last. In this case young Korean scientists who suspected fakery pointed out the smoking gun. But if they hadn’t, the inability of other scientists to replicate the feat would have soon outed him. Like all pyramid schemes, short-run success leads to long-run failure.

The Biology Lesson. The lesson about the state of stem cell biology is that learning and then controlling the developmental steps that will turn embryonic progenitor cells into useful therapies will be a long and arduous journey. We knew that, but in the fight against right-to-life attacks, often glossed over it. Well, not the scientists themselves, but the support structure of science on which science itself rests.

The Hwang fraud has also forced us to revise the timetable for nuclear transfer cloning. Proof of principle in humans is still lacking, but excellent labs in the U.K. and the U.S. are on the case. Nuclear transfer cloning, however, is but one part of the puzzle, and one that in the immediate future is not as key as uncovering the gene and protein systems that control differentiation. Nuclear transfer will help obtain disease specific genotypical cells for studying those diseases and targeting treatment to them, but it will be some time before a real clinical need for histocompatible ESCs.

More pressing is the need to uncover the developmental signals that control differentiation. Scientists have turned human ESCs into endoderm pancreatic tissue, a key progenitor for islet cells, but there is much to be learned before clinical applications occur. If we have done the prior work, nuclear transfer cloning may at some point have clinical significance, but that’s further done the road.

The Egg Donation Lesson. The most important ethical lesson in the Hwang debacle is the spotlight now cast on egg donation practices. Human eggs are a precious commodity, and not easily obtained. Women must be willing to provide them. It is imperative that we not abuse or exploit women in the process.

This means that the rights and welfare of egg donors be protected. In the case of women going through IVF for infertility, there should be no alteration in the procedure such as increasing hormone dosages to obtain eggs for research or therapy. It also means getting free and informed consent at the time of donation.

Women who volunteer to undergo ovarian stimulation and retrieval in order to donate eggs need protection and respect. This means fully informing them of the risks, benefits, uses, and other consequences of their participation. It also means using procedures that minimize medical harm, providing treatment in the case of injury, and covering medical and work losses if injuries occur from donation. Until we have more experience, review by an independent review body, such as the ESCROs recommended by the National Academy of Science, is justified.

Dr. Hwang broke every one of these rules. Laboratory workers were pressured to donate. Outsiders were recruited without a full account of the risks and benefits of the science or what they were getting into. There was no independent review. Dr. Hwang’s people also paid egg donors, which many persons think is undesirable or per se wrong.

Money in Hwang’s program payment may have functioned in an unethical way, but even without payment the program would not passed ethical muster. Some would go further and ban compensation beyond expenses, as California and Massachusetts and the United Kingdom have done, but there are strong arguments on the other side, as I noted in an earlier guest posting.

Ah Hubris! Dr. Hwang’s drive for fame and fortune led him to lie and cheat and hurt people along the way. This is an old story, more sad than tragic, an unneeded reminder that pride and greed still work haunt the human heart. Dr. Hwang had the skill to clone a dog and the drive to fool a sophisticated international audience. He is now a monument of the unethical scientist, a negative archetype for the field.

L’affaire Hwang contains a rich lode of lessons for all touched by the ESC endeavor and the temptations it has spawned. A useful corrective for overenthusiastic proponents, it gives opponents only a short leg up. It changes nothing about the basic dynamic of ESCs—societal support within reasonable ethical limits—nor about the steepness of the climb ahead.

On the political front, the Hwang debacle should not produce any permanent set-back. Occurring before the Senate considers whether to enact the Castle-DeGrette bill overriding Bush’s limitations on federal funding of ESC research, there is sufficient time to digest the events and realize that they have no direct bearing on that issue, though no doubt opponents will try to use it to that end. A more important threat comes from the attention being paid to non-embryonic sources for ESCs. While further research in that direction should occur, the mere prospect that such alternatives may exist is not a good reason to keep federal funds from research involving stem cells derived from embryos.

Nor will it affect the battle over stem cells occurring in the several states. It has not undermined the effort to get a constitutional amendment in pro-life Missouri to protect nuclear transfer cloning nor the efforts of Michigan’s governor to repeal the ban on research cloning that Michigan adopted in 1997. The major player here is California, but its rules and funds will not be affected by Hwang’s fall. If anything, it will give added impetus to have a California be the first to successfully clone human ESCs.

[Hwang might have gotten credit as the first one there, and may have patented a technique, but would not have gotten usuable stem cells line.
Some harm to egg donors in his lab or elsewhere. 20 eggs per donor, which suggests much stimulation and thus risks. Plus coercion. Plus recruiting on false grounds of who was being helped, and not a review by an ESCRO to make sure that needed.]

Hwang might have gotten a temporary advantage, but could not have maintained it for long. Maybe could have gotten one as an early founder. Would have drawn more people to him from other programs and led more women to donate than the field was ripe for. But could not have lasted.

We pay women to donate eggs for infertility treatment, and on the whole the practice has been done reasonably well. Donation for ESC research is as important. As long as full information, coverage, etc. are there, there is no reason per se why some financial compensation is not provided. However, some clear procedures or guidelines will be needed. With the National Academy and California taking the lead, the main elements of such a system are coming into focus, and should prove sufficient to guide the field for some time to come.

Corruption is Bad for Your Health

The BBC Health site has some commentary on the report, both on why health care systems are so prone to corruption worldwide, and what can be done about it. Fighting global corruption in health care looks like an uphill battle, however, when it is viewed as stemming from the nature of health care systems within a competitive market context: “What marks the health sector out is that there are large sums of money - often public - washing around in complex systems involving a variety of players from doctors and patients to drug firms and government officials, all of whom have competing interests.” Maybe the plot of The Constant Gardener was not so farfetched after all.

- Stuart Rennie

The Next Biotech Superpower: China

Research Secrecy Revealed

A pair of studies published in the February 2006 issue of Academic Medicine indicates some of the features and the extent of the phenomenon in the United States. The study by Blumenthal et. al. surveyed withholding behaviors on the part of 2893 life scientists at the 100 universities enjoying the most NIH funding in 1998. Respondents were asked if they had avoided disclosure of unpublished scientific information in causal conversations with colleagues, seminars or conferences. They were also asked they had withheld information from research manuscripts in order to protect their scientific edge or the commercial value of the data, including delaying publication of results for more than six months. A good 44% of geneticists reported having withheld scientific information in one form or another. Not surprisingly, those who reported withholding were more likely to have relationships with industry beyond funding of their research, i.e. acting as consultants or owning equity.

Perhaps more depressing is the potential impact of withholding information on education and mentoring of future scientists. Vogeli et. al. have conducted a national survey of 1000 graduate students and postdoctoral fellows in the life sciences, chemical engineering and computer sciences at 50 US universities, and found that 25% of respondents experienced denials for requests for data, information, materials or programming. About half the respondents reported that withholding had a negative effect on their own research or the progress of their lab or group. A third reported negative effects on their education, and a quarter reported negative effects on communication within their research group. Some of those denied data reported having to abandon a line of research, being unable to confirm the results of other scientists, or having their research or a publication delayed.

Neither study attempts to distinguish between forms of ‘withholding behavior’ that may be ethically justified and those that are cause for alarm. But both suggest that the marriage between university research and industry may have serious distorting effects on both scientific progress and education.
- Stuart Rennie