blog.bioethics.net

The Senator Was Too Busy Doing Neurology

Dr. Frist 'sets an example' for all docs. Not only do you not need to see patients to diagnose them--as he did with Terri Schiavo--you don't need to keep up your license to practice! - Art Caplan

IVF Programs Told "She's Too Fat for Me"...

... to quote an old Polka tune. BBC NEWS ran the story. - Art Caplan

Jewish Bioethics in New York 9/10-9/11

ACJB is advertising its upcoming conference:

The Academic Coalition for Jewish Bioethics encourages you to attend its Third Annual Conference "Creation, Procreation, and the New Genetics" to be held in New York City September 10-11, 2006.

The conference will explore Jewish ethical questions in genetics, embryology, stem cell research, cloning, genetic screening, and the use of genetic data. The conference will include invited speakers and peer-reviewed papers, a session on ethics in film, and case-based breakout groups. The Sunday conference sessions will be geared to the general professional in medicine, religion, ethics, law, clinical care, chaplaincy, and other related fields. The Sunday evening and monday morning session will focus on questions of method and theories and decision-making from a Jewish perspective.

Speakers include Harry Oster, Saul Berman, Laurie Zoloth, Hava Tirosh-Samuelson, Rayna Rapp, Robert Pollack, Adrienne Asch, Lester Friedman, Alan Astrow, Avram Reisner, David Teutsch, mark Wshofsky, and Paul Root Wolpe.

The Academic Coalition for Jewish Bioethics was founded to bring a pluralistic perspective to Jewish discourse on bioethics. The Coalition will lead periodic conferences and sponsor important publications about key issues in the field.

Please consider attending this important conference. Brochures and registration can be found at the AJOB-based site for the Coalition

Another Huge Medical Errors Study: Plato Was Right

The Times covered a survey in Archives of Internal Medicine that replicates umpteen other similar quantitative, survey style reviews of attitudes (or experience) regarding disclosure of medical errors. The authors find, unsurprisingly, that those who believe they are likely to be called out for making a mistake are more likely to reveal the error than those whose mistake is less obvious:

The hypothetical errors were all mistakes that would cause some degree of serious injury. Some were apparent — like leaving a sponge in a surgical patient — and some were less so, like misreading chart data.

When the error was obvious, like an improperly written prescription that led to an overdose, 81 percent of doctors said they would definitely disclose the error to a patient.

But when presented with an error less apparent, only 50 percent thought it was worth mentioning. One example was a blood chemistry reading that had been overlooked. If it had been noticed, a serious complication would have been prevented.

The less sophisticated these studies get, the more dangerous they are. Previous qualitative studies, beginning of course with the landmark work of Charles Bosk, Forgive and Remember, aim at understanding how the dynamics of iatrogenesis, of error's identification, and disclosure evolve within a social context. The lead author of the present study, Thomas Gallagher, an exceptionally accomplished assistant professor at UDub with a Greenwall Scholar award and an RWJ fellowship with Bernie Lo, understands - develops curriculum even - to deal with the subtleties of disclosure of conflicts and errors. But the methods here are just silly and scary, and the effect is nil. We know no more than we did about how apology affects patients and families - or more important about what Gallagher is really in a position to study, namely how the different ways in which one might actually disclose something would affect patients. Oddly, go figure, an apology from an insensitive physician might be worse than no apology at all. Hmm.

At any rate the data set is huge and it will certainly scare even more people half to death.

The Republican War on Science, but Flaccid

The word on the street is that the Pope is about to go from casual affection to an outright embrace of intelligent design.

Shortly thereafter, if ID follows the stem cell pattern these days, a group of defunded paleontologists will form a company and write an article in Nature in which they defend really intelligent evolution, hoping to please the pope.

The Republican War on Science by Chris Mooney is the answer to these problems, of course, and Art Caplan reminded me that a new, paperback version with some new material is just out. As if the stem cell boneheads weren't going to sell enough of Chris' books.

People's Medical Society: It's Just One Guy

The policy think tank on healthcare in Pennsylvania "People's Medical Society" is just one guy.

From a policy point of view the greatest force present in any bioethical debate are patient advocacy and consumer groups. It is pretty clear that the drive to shift Federal policy on the funding of embryonic stem cell research was fueled mainly by patient advocacy groups and those involved in lobbying for research funds and treatments for various diseases. It is common for academic bioethics to call for more contact with and even alliances to be formed with patient advocacy organizations and once in awhile, as at the recent conference in Albany, a group calls on academic bioethicists to do the same (Not Dead Yet).

As this article makes clear, not all patient advocacy and consumer groups are created equal! In navigating these waters it becomes very important to know exactly who you are dealing with, what their sources of funding are and most importantly who does the group represent!

- Art Caplan

Could Nanotechnology Become a Problem for the Developing World?

Our Tim Halkowski brought this piece to our attention, which summarizes all of the reasons to suspect that given the increasing obvious potential for harm from inhalation or other ingestion of nanoparticles, the research on them and manufacturing utilizing them might become a problem in the developing world unless much more rigorous standards are created and implemented.

Solomon's Wisdom

Art Caplan claims in MSNBC that the Virginia courts' ruling on the case of Abraham Cherrix is a good one:

Very good news emerged from a Virginia courtroom this morning. Starchild Abraham Cherrix, who has been through more hell than any 16-year-old ever ought to have to face, will be spared from the chemotherapy he dreads but still receive cancer care that could save his life.

gThe tall and articulate young man, who lives with his four younger brothers and sisters in rural Chincoteague, Va., was diagnosed with cancer last year. Doctors at the Children’s Hospital of the King’s Daughters in Norfolk recommended chemotherapy to treat his Hodgkin’s disease. The treatment left him bald, feverish, nauseated and so weak he could not walk. After two months the cancer came back.

His doctors said he needed to go through the treatment again. This time, he said no. The state of Virginia took him and his family to court with the idea of forcing chemotherapy on him.

Instead of chemo, the teen, who goes by Abraham, and his parents wanted to pursue an alternative treatment method that they learned of in a clinic in Tijuana, Mexico. Abraham's dad stews up a brew of herbs including licorice and red clover, which he gives to his son four times a day. The parents offer up spiritual prayers while their son drinks the potion.

The case for the Virginia courts to leave Abraham and his parents alone was very strong. At 16, Abraham is smart and thoughtful. He has already been through a round of treatment which did not work and left him sick as a dog. His parents, who obviously love him, agree with him and support him in his decision to pursue alternative medicine. So why should the state have insisted on a trial?

The answer became clear this morning. Standard medical treatment for the kind of cancer he has usually works. And Abraham, for all his apparent sophistication and thoughtfulness, is still a kid.

Cancer doctors at my medical school, the University of Pennsylvania, tell me that, supplemented with radiation, the cure rate for Abraham’s cancer is between 85 and 90 percent after three rounds of chemo. This is one of the most curable of cancers.

True, the young man has been through a round of treatment and hated it. He and his parents have talked themselves into believing that a screwball regimen from a Tijuana clinic is just as likely to save his life. It isn’t.

Still, how can you really force a 16-year-old to take a tough treatment that he does not want? The answer is to find a doctor who believes in standard medical therapy, who has a good rapport with the boy and his family and is open to working with them to allow them to pursue their ideas about healing, in conjunction with standard medical treatment for cancer.

That is exactly what happened today in the courtroom. Judge Glen Tyler announced that the state and the family had reached an agreement to let Abraham be treated by an oncologist who will work with them and be as flexible as possible about Abraham’s care. The regimen won't include chemotherapy, but might involve radiation. The court will keep an eye on Abraham to make sure that his treatment is reasonable and within the standard of care that young people with Hodgkin’s ought to receive.

That is absolutely the right resolution for this difficult case.

Keep in mind that none of this would have happened if the state had not intervened and demanded that Abraham and his parents go to court. There would have been no settlement.

Instead, Abraham would have only been pursuing a treatment that is nothing short of quackery. By intervening, social services and the courts of Virginia forced an accommodation that respects the family’s values but also ensures that standard, proven medical care will be used as well.

While it is hard for some who say the only thing to do is to leave families alone when it comes to medical care decisions, sometimes a bit of a push from government officials and courts can help doctors do the right thing.

PostIt on Desk of President of UC Irvine: "Hire Bioethicist Quick, Also Consider Reading Internal Investigation Reports. Also, Look for New Job?"

On and on and on it goes in scandal-ridden UC Irvine, where the latest troubles concern the brain:

TV news personality Jane Pauley had a message to deliver in April when she spoke at a fundraiser for UC Irvine's Brain Imaging Center.

She told the 140 guests at the Island Hotel in Newport Beach about her battle with mental illness and spoke in support of the research being done by the center's director -- and Pauley's brother-in-law -- UCI psychiatry professor Steven G. Potkin.

Potkin is one of UCI's biggest stars. The 60-year-old psychiatrist is among the university's most prolific researchers. He brings in lucrative contracts from some of the world's biggest drug companies and has presided over as many as a dozen clinical trials at a time.

Recently, his investigation into nicotine's effects on the brain received national attention. And in March, the university proudly trumpeted his role in heading a $24-million National Institutes of Health project that will be headquartered at UCI.

But at the same time Potkin has attracted funding and recognition for UCI, he has also been investigated three times by the university for alleged ethical or financial breaches, according to more than 300 pages of documents obtained by The Times. And although Potkin says he was not disciplined as a result the investigations, each raised serious questions about his practices and how UCI dealt with the issues.

Most recently, administrators found in 2004 that the professor had skirted the school's patient safety review board to test a drug for a pharmaceutical company without the required university approval. When UCI learned of the research, it ordered Potkin to immediately halt the study.

Seven years earlier, administrators looked into why Potkin had directed drug companies to pay more than $2 million in research funds to a firm his family owned. The payments were related to studies he was performing at UCI. The university concluded that the company may have been set up to avoid UCI overhead fees, and it prohibited Potkin from using the company in future research projects.

At least they don't use prisoners.
- hat tip to Art Caplan

NPR : A Bioethicist Takes a Peek at 'Body Worlds'

I dont agree with her completely but Ruth Guyer's commentaries on the current fashion in plastinated bodies that is sweeping through science museums around the country and in europe are worth pondering.
- Art Caplan

After All, Look How Well it Worked Out for Retin-A

Who doesn't want to enroll more inmates in drug trials? The record is great. Safety, risk analysis, compassion:

Until the early 1970’s, about 90 percent of all pharmaceutical products were tested on prison inmates, federal officials say. But such research diminished sharply in 1974 after revelations of abuse at prisons like Holmesburg here, where inmates were paid hundreds of dollars a month to test items as varied as dandruff treatments and dioxin, and where they were exposed to radioactive, hallucinogenic and carcinogenic chemicals.

In addition to addressing the abuses at Holmesburg, the regulations were a reaction to revelations in 1972 surrounding what the government called the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930’s and lasted 40 years. In it, several hundred mostly illiterate men with syphilis in rural Alabama were left untreated, even after a cure was discovered, so that researchers could study the disease.

It will be interesting to hear more from Larry Gostin, who chaired the panel:

The report also expressed worry about the absence of regulation over experiments that do not receive federal money. Lawrence O. Gostin, the chairman of the panel that conducted the study and a professor of law and public health at Georgetown University, said he hoped to change that.

Even with current regulations, oversight of such research has been difficult. In 2000, several universities were reprimanded for using federal money and conducting several hundred projects on prisoners without fully reporting the projects to the appropriate authorities.

Professor Gostin said the report called for tightening some existing regulations by advising that all research involving prisoners be subject to uniform federal oversight, even if no federal funds are involved. The report also said protections should extend not just to prisoners behind bars but also to those on parole or on probation.

Agent Orange Depleted Uranium

I was on the Presidential advisory committee that examined Gulf War Syndrome at the end of the Gulf War. I did not believe that the kind of monitoring and surveillance of our soldiers and civilian contractors in that war was adequate to detecting much less explaining the syndrome that some exhibited. Not much has been done to rectify the inadequate epidemiology and health monitoring present in that conflict in the current Iraqi conflict. That is what makes this inevitable report from Iraq so very disturbing.
- Art Caplan

Bones of Contention

Well no problem with here. missing links. The latest move of the Intellegent Design crowd is not to haggle about the evidence for evolution. it is simply to hide it!
- Art Caplan

Lobbyists for the Schindlers Got Paid for their Work on the Schiavo Effort

Could this be more pathetic? Paid consultants to plan 'media' strategies. I always suspected that those 'advising' the Schindlers were there for the money. And they were. What a crock. That this guy would even consider running for office is a joke. He is a spin-meister for hire.
- Art Caplan

A Poignant Account of Assisted Suicide

The Guardian calls it "an act of love:":

I wasn't there when she told our children what she was going to do, and gradually I began to realise that they understood her intentions rather differently than I did; that our daughter, particularly, was more aligned with Elizabeth's views than I was. So I wrote her a long letter, arguing that I was in favour, but only when it became necessary; only when Elizabeth's quality of life had declined so much it had become intolerable. It seemed to me that she was jumping the gun, talking about doing it fairly quickly, perhaps not even reaching her birthday, which I thought was crazy.

- hat tip to Art Caplan

Stephen Latham: Has "Schiavo Backlash" Begun?

In 2005, Senator Joe Lieberman went on "Meet the Press" and told Tim Russert that "though the Congress' involvement [in the Terri Schiavo case] was awkward, unconventional, it was justified to give this woman, more than her parents or husband, the opportunity for one more chance before her life was terminated by an act which was sanctioned by a court, by the state...." Last night--just in case you hadn't heard--Lieberman, a three-term Senator and his party's most recent candidate for Vice President, lost the Connecticut democratic primary by a narrow margin to poitical newcomer Ned Lamont. Was "Schiavo backlash" a factor in the Lamont victory?

Clearly, Lamont's major issue, and the driving reason for his victory over Lieberman, was Lieberman's support of the President's conduct of the war in Iraq. But Lamont has often said that the Schiavo affair was one of the first events that drove him to consider running. And his standard stump-speech--the one he delivered at house parties and rallies all around the state--revolved around "a villain, a victim and a hero." The "villain" was Alaska Congressman Don Young (of "Bridge to Nowhere" pork-finding fame); the "hero" was Rep. Jack Murtha, for reversing his position on the Iraq war. The "victim" was Terri Schiavo.

Michael Schiavo--now chair of TerriPAC, a political action group aimed at defeating those who favored the federal intervention in the Schiavo case--came to Connecticut last week to campaign for Lamont. (Some of his comments on Lieberman appear here. And the Schiavo issue is mentioned in today's coverage of the primary result by the Wall Street Journal, the New York Times, the LA Times, NPR, and many of the wires.

In sum: "Schiavo backlash" probably made a difference in this race--a small difference, to be sure, but then again, Lamont's margin of victory was under 4%.
- Stephen Latham

Mining Prescribing Data? Who Let This Happen??

gThere is no reason prescription information should be made available for marketing purposes. Defenders of the status quo cite the need to maintain the quality of care by analyzing all forms of data but this is a smokescreen for tracking the pills that each doctor prescribes and marketing accordingly. This article nails this practice and what is wrong with it. - Art Caplan

Newborn Screening with a Twist:
Unproven but Expensive Test, Unproven but Expensive Treatment that Might Kill Those with Late Onset Form of Gene

New York is all set to become the first government in the world to start screening for Krabbe disease, as a result of lobbying by former Buffalo Bills quarterback Jim Kelly. The testing, which is expensive, can turn up, if there aren't too many false negatives, the 1 in 150,000 infants born with the early onset form of this autosomal recessive trait that results in terrible symptoms followed by death typically before age 2.

There is no proven treatment, but a group at Duke has an interesting experiment underway that involves destroying the bone marrow of the affected infants with chemo, then replacing it with hematopoietic stem cells intended as a bone marrow transplant. It has worked, they report, 20 times, as best they can tell, but it is incredibly risky - and many of those who have the disease inherit the late onset form - which might be very difficult to differentiate.

New York passed no law nor created a program to pay to enroll children in the experimental protocol at Duke, which isn't free, though this article claims that such payment from insurance companies might be no problem. Either way, the expenditure of this level of resource on something this rare, and where the risk of mis-identifying an infant who really has late-onset Krabbe, is difficult to justify when 30% of our nation has insufficient health insurance for far more common conditions.

Marching Off to War, A Few Million Sperm Short

Perhaps the way to peace in Lebanon is to institute a regular ritual of banking sperm for soldiers going off to war, not so that they can father posthumous children but so that they have, well, less sperm.

Hey, Where'd You Get That Body?

Remember the museum exhibit Body Worlds, which first opened in Japan back in 1995, with its 'prenatal wing' that featured the preserved corpse of a woman who died 8 months into pregnancy, including the body of her dead fetus? As you might predict, Body Worlds and its sequels (Body Worlds 3 is currently at the Houston Museum of Natural Science) have been monster hits, drawing some 17 million spectators to see the enhanced sinews and veins. Gunther Von Hagens, the creator of Body Worlds, states that his installations are all about health education and are in the best possible taste, and not at all about sensationalism or voyeurism. Take, for example, his exhibit of a corpse on horseback, who is holding the brain of the horse in one hand, and his own brain in the other. Or 'The Swimmer', cut in half down the middle, with each half doing the crawl in opposite directions. But besides the aesthetics, there has always been the nagging ethical question: where do these corpses come from? Who were these people, and how were their bodies procured?

The New York Times may have part of the answer: China. In factories in China, workers are busy skinning, cleaning, cutting, dissecting, perserving and then exporting human corpses to be used, basically, for entertainment purposes in museums around the globe. And the audit trail of the bodies seems obscure. Van Hagen has always contended that all persons exhibited in Body Worlds freely donated their bodies specifically for this purpose, and Premier Exhibitions (who runs Bodies: The Exhibition) claims that there is no way that 'their' prize corpses could be, for example, executed Chinese prisoners. But, according to the NYT article, no one connected to the multi-million dollar 'body plastination' industry seems to be in any big hurry to demand (or supply) proof that the bodies were donated, or have tried to contact family members to ask if they are aware that their loved one is currently on display somewhere.
-Stuart Rennie

John Robertson on Hyperventilating Over Embryo Banks

Guest blogger John Robertson of The University of Texas at Austin law school writes:

I’m mystified by the recent kerfluffle over the purported “made-to-order” embryo bank in San Antonio, Texas. The Director of the Abraham Center has cleverly generated international publicity for her center without giving us any proof that people are using it or would to any significant extent. Here are a few thoughts on why a center that brokers coordinated egg and sperm donations to treat a subset of fertiliy patients should not divert us from more pressing topics.

The first reason is that there is likely to be little demand for it. Cases of simultaneous gametic insufficiency with ability to gestate are a very narrow subset of infertility patients. Couples in that category might prefer two separate egg and sperm donations over the medical and social complications of leftover embryos from infertile couples. Since it is logical and reasonable to allow some selection in obtaining sperm and eggs, the fact that they chosen together and then are combined in vitro before transfer should not in itself be a problem.

A doctor will be involved in obtaining the eggs from the donor and transferring them to the recipient. That is a fiduciary relationship, with duties to protect donors and recipients. Duties to offspring are less clear, but professional guidelines and ethical duties require some attention to whether the recipient will be able to provide child-rearing.

Aside from the sirenic horror of “selling” embryos, the idea of brokering arrangements between egg and sperm donors and recipients makes sense. Adoption agencies are brokerage agencies. So are the sperm banks that procure sperm and distribute it to recipients, and the individuals getting surrogates and couples or egg donors and couples together. The Abraham Center appears to be an adoption agency that is now branching into gamete and surrogacy brokerage.

Surely one is not objecting to all brokerage arrangements for gamete donation. There is room for abuse and consumer protection is needed. But brokering coordinated egg and sperm donations seems no more offensive than brokering separate egg, sperm, and gestational surrogacy arrangements. The Snowflake organization does it for embryo donation, just as adoption agencies do it for born children.

My guess is that it is all hype. If there is a problem, let’s fix it. But no one has shown what the problem is.

Catherine D. DeAngelis on Money in Medicine

Coming back from vacation, Catherine DeAngelis too was struck with thoughts about money, conflict of interest, and scholarship. - Art Caplan

Disclosure Doesn't Eliminate Conflict of Interest

Writes Jim Fossett:

Shirley Wang has an excellent piece in last Friday's WSJ [subscription] on the effectiveness of disclosure as a means of dealing with conflicts of interest among biomedical researchers who have financial ties to the drug or medical device companies whose products they evaluate. Many journals, including bioethical ones, now require disclosure of employment, consulting arrangements, royalties, stock ownership and the like for would-be authors as part of the publications review process. Awareness of such economic interests among researchers, together with the peer review process, presumably puts readers on their guard and minimizes the effects of potential bias in reporting research results. Many journals impose higher standards for writers of editorials and other review pieces, limiting the value of such financial stakes for authors of such pieces.

Are such disclosures effective in limiting bias in the reporting of research results? Much of the evidence Wang’s article cites suggests they are not, but for complex reasons that are hard to identify and repair. Most researchers are absolutely adamant that such financial ties, whether disclosed or not, have no effect on their scientific objectivity, just as most physicians insist that getting free lunches, pens, and other small gifts from drug company representatives have little effect on their prescribing practices. What evidence there is frequently suggests otherwise. A review of over 160 studies where such ties were disclosed published last October in the American Journal of Psychiatry (R Perlis, et al “Industry Sponsorship and Financial Conflict of Interest in the Reporting of Clinical Trials in Psychiatry” American Journal of Psychiatry 162:1957-1960, October 2005 ) found that researchers with personal financial ties to drug companies were roughly five times as likely to report favorable results than those without such ties. There’s less formal evidence on the effects of lunch on prescribing, but as reported last week in the NYT, an increasing number of large medical centers are banning free lunches over concern about conflicts of interest.

Wang cites some fascinating research by Max Bazerman of the Harvard Business School, who has studied similar conflicts of interest among financial auditors. Bazerman’s work, which can be found by links from his personal website here http://www.people.hbs.edu/mbazerman, finds relatively few “bad apples” or auditors who actively collude with company management to deceive investors. Rather, he argues that most unethical behavior is less conscious and stems from informal attachments between evaluators and evaluated. Most people are prone to interpret situations in ways that favor their own interests and give greater weight to evidence which favors those interests even when they are not conscious of doing so. Researchers who get significant income from companies have a stake in avoiding negative outcomes (less than positive drug trial results, significant side effects) that may lose them that income, but they may not be aware that they have such a stake and may continue to believe that their results are objective and unbiased. Disclosure of financial ties, Brazerman argues, may not reduce biased advice; it may even increase it, as a means of counteracting expected skepticism.

What to do? Bazerman’s arguments suggest that simple disclosure of financial ties are of limited value and don’t insure audit independence. In similar fashion, disclosing financial ties to drug companies may not have much effect on improving the independence and objectivity of research reports. Having to publish corrections of data that wasn’t disclosed may be embarrassing, but the disclosure of such data is still very much a hit or miss affair. Requiring complete disclosure might help some, as might a few large verdict civil cases. The pervasiveness of financial ties between researchers and industry,however, makes silver bullet solutions hard to come by.

- Jim Fossett

Don't Bank on It:
The World's First "Made to Order Embryos"

This from The Daily Mail is just amazing. Welcome back to the Wild Wild West of Assisted Reproduction. Perhaps finally the ASRM will enact some sort of standards whereby clinics like this one in San Antonio are condemned, or at a minimum create what I've termed a "reproductive malpractice" network with clinicians whose statements with regard to ethical conduct are sworn and those who sign them agree to be deposed as necessary on the merits of the statement. Or maybe we should just let things go to this:

The world's first human embryo bank has been launched offering 'bespoke babies' for infertile couples.

For around £5,000 couples can buy ready-made embryos matched to their specific requirements - even down to choosing what eye and hair colour they would like their child to have.

In each case the embryos are made from eggs and sperm from two donors who have never even met. The moment of conception occurs in the laboratory and is determined by the genetic combination the clinic thinks will best meet the needs of the paying couples on its books.

Ethical campaigners last night condemned the move as the "absolute commercialisation of human life." They said it was heart-breaking that babies are now being treated as the equivalent of a supermarket "special offer".

Currently in the UK where one partner is infertile a couple can use donated sperm or eggs to create an embryo to be implanted in the woman's womb. Some couples can also use left-over embryos no longer needed by others who have undergone IVF.

But the new service is totally different as it allows couples to buy fresh embryos that fit their requirements but which have no biological link to either of them.

The human embryo bank is being run by The Abraham Center of Life in San Antonio in Texas. Although the clinic is in the USA, British women are expected to fly over for treatment.

It boasts that its sperm donors all have doctorate degrees and most of its egg donors have college degrees, are under 25 and healthy. So far most of the couples on its waiting lists are happy just to get an embryo and have not set out detailed requirements.

However some have asked for - and been allowed to join list of recipients that will get - embryos made from blond haired and blue eyed donors.

Whether a couple are put on the list for an existing embryo or one in the process of being created, they get 'portfolios' that include the donors' medical and social histories and usually a picture of them as a baby.

To create the embryos the chosen donor is given drugs to make her produce eggs and once collected they are combined with the selected sperm. Out of a single cycle of eggs several couples - each paying $10,000 (£5,300) - will each get two embryos for implantation.

Centre director Jennalee Ryan said already she has a waiting list of clients for embryos and so as soon as they become available they are spoken for. She said unlike other embryo donation or adoption schemes, these are not left-over embryos from infertile couples.

Because of the inherent problems that exist in such couples she said typically these only have a 30 per cent chance of producing a pregnancy. However she claimed the quality of the donor embryos she uses could offer double the chances of success.

Ms Ryan said the idea of the bank came out of her existing adoption service when she realised that many couples would be keen to use donated embryos to create a family that way instead. She said babies given up for adoption tend to come from lower social groups and there is often a history of drug or alcohol abuse.

However her egg and sperm donors are all well-educated and medically screened to ensure they have no health problems.

She said it was also cheaper than adoption or IVF with an egg donor which in the USA can cost up to $20,000 (£10,500). "It offers an opportunity for couples to have a child who could not otherwise afford it," she said.

Ms Ryan admitted some people especially religious groups have objected to the bank. "But what I say to them is Jesus was not conceived in the normal way either. I don't lose any sleep over what we are doing. I feel what we are doing is positive.

"We are helping couples and putting good genes back into the universe."

But Josephine Quintavalle of the UK campaigning group Comment on Reproductive Ethics said it amounted to the "absolute commercialisation of human life."

She said: "It is heartbreaking to see children reduced in this way to the equivalent of a special offer supermarket commodity. Cut price, tailor-made human embryos, complete with door to door delivery."

A spokeswoman for the Human Fertilisation and Embryology Authority said current rules would prevent any UK clinic from offering selection of embryos for non medical reasons [ed: is this true? . But she confirmed there is no law to stop women from Britain going to the USA for such treatment.

A big client will be all the ugly scientists of course. [hat tip to Art Caplan]

Snowflakes in My Drawer

It is really really tiresome how little patience you people have with the President's position on stem cell research. His carefully considered Veto has finally given rise to a very thoughtful, considered address, which you can listen to right here on his personal feelings about stem cells, and his own adoption of snowflakes. Shame on you liberals for doubting the sincerity of the President.

Working for An Ethical Boss Ranks High

Ethics seems to matter to more and more employees--maybe not their bosses but that is likely to change very soon. - Art Caplan

A Business Professor's Take on Assisted Reproduction

Alta found this great piece by Debora Spar, Spangler Family Professor of Business at Harvard Business School, that reframes ART in terms of the metaphors of economics, without replacing the analysis with simple economics:

To those who suffer from it, however, infertility is a wretched curse — a disease that isn’t really a disease, with an outcome that seems to defy nature. Some resign themselves to their fate; others adopt. But many infertile couples become consumed with the desire to conceive, and are willing to do whatever it takes to create a child of their own. For most of these would-be parents, the economic value of their desire — the price of a child — is literally inestimable.

Bioethics is Awfully Popular Now, Yadda Yadda

Rebecca Tuhus-Dubrow of the Village Voice published a truly dumb piece on the development of the field of bioethics, with loads of ridiculous claims, including the classic claim made by Elliot about how bioethicists are shills for industry and losing their reputation (a claim still unsupported by even a shred of data even from Elliot, in fact, arguably the claim has traction only because Elliot keeps getting paid to make it by highly public journals), and an even more dubious claim that bioethicists are getting awfully powerful, with the Kass commission as an example (um, did they actually do anything of consequence such that they can be accused of exerting too much power, apart from the highly suspect actions of Kass in lobbying the Senate and the equally dubious efforts made to sell Council products through the American Enterprise Institute?).

At any rate the new Council is run by a smart responsible bioethics scholar and it is clear there are no attempts underway for Dr. Pellegrino to become stooge to anyone, however conservative his views. And the notion that bioethicists are awfully powerful and dangerous because they take so much corporate money has become nothing but insulting McCarthyism from a single critic.

We Aren't Telling Him We Posted This
The Sacking of the Blog Hackers

To quote The Holy Grail, those who created the previous credits have been sacked. And those who sacked the previous sackers, have been sacked. And Sean reminded the juvenile delinquents who posted this tripe that Peets is better anyway. And has sacked the sackers of the sacked. Including the moose.

A Bloody Mess

In this month's The Scientist McGee opines about the trials (recently completed) of blood substitutes under the Final Rule, which allows for research without consent. It is a subject we've written about in the past, and as part of our ongoing research in the area we devoted a special issue to the trial in The American Journal of Bioethics, specifically an article entitled "Accidental Communities: Race, Emergency Medicine, and the Problem of PolyHeme and another entitled "An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial," along with many commentaries on those two articles.

As everyone knows by now the publication of the AJOB issue resulted in a huge amount of scrutiny of the trials, which continues, though the trial has now officially been completed.

Here's part of the essay, a reflection on the whole matter:

... Oxygen-carrying blood substitutes have been tried for years on consenting research subjects with mixed results, but enough hope has existed that since 1970, no fewer than three companies have fixed their sights on making one. And now Polyheme's sponsor and manufacturer, Northfield Labs, hopes it is just steps away from approval for use on the battlefield or in a trauma helicopter near you. So with what could amount to a significant advance for trauma medicine being on the brink of approval, why are the airwaves, newspapers, academic journals, and magazines riddled with stories about whether research subjects in the trial are human guinea pigs?

The answer is that the community has been caught off guard. In Phase I and Phase II trials of Polyheme, all subjects were required to give informed consent. Eventually, however, Polyheme had to be tried on typical patients who would benefit from artificial blood: victims of trauma. Regulations passed in the mid-1990s called the Final Rule allow such research, provided a list of precautions is followed, including something called "community consultation." The idea is that while enrollees would be too ill to consent, investigators would have informed the community about the trial in advance; anyone who doesn't want to participate can prospectively opt-out by, for example, wearing an armband.

In the current trial, after informing the community about Polyheme, emergency medical technicians randomly administer either saline solution or Polyheme to trauma patients who are in hemorrhagic shock. The control group receives blood, the standard of care. Those randomized to Polyheme receive it for no more than 12 hours; part of that time may be in the hospital when they would otherwise be given blood.

The problem is that most people in the communities where Polyheme trials are going on, from Illinois to North Carolina to New York, don't seem to know about it. Emergency medical research is a bloody mess right now because Polyheme, once unknown to potential subjects, is suddenly on the public radar, but only because of concerns that include undisclosed or inappropriate risks to subjects in the in-hospital phase of the study, worries about whether the sponsor has withheld data from investigators, and now new criticisms from organizations such as the Senate Appropriations Committee and consumer advocacy groups.

Our bioethics institute studied public awareness of the Polyheme trial ... It has become clear, at least to my group, that patients worry about emergency research, and that new methods for informing the community must be devised and tested before proceeding with trials that have such potential to destroy public trust in research ...

[read the entire piece]

Tony Blair Visits the Other Nation, California, to Talk Stem Cells:
Do We Really Need the Feds at All?

Jim Fossett noted this piece and rants:

one of British prime minister Tony Blair’s less publicized stops on his way home from meetings with President Bush in Washington is in California. As described by Blair’s spokesman, this visit is intended to encourage closer collaboration between Britain and California on biotechnological matters in general and embryonic stem cell research in particular. Blair is scheduled to meet with Governor Arnold Schwarzenegger and Los Angeles mayor Antonio Villaraigosa, both of whom are stem cell research supporters, and to make a speech to biotechnology industry executives on July 31. Blair’s spokesman noted that Blair has been interested in closer ties with California for some time and that a joint California-British conference is in the works for November. By contrast with the Bush Administration, British government policy is strongly pro-embryonic stem cell—the British government closely regulates research, has established the world’s first stem cell bank, and is spending some $185 million to support research on a wide range of stem cell related topics.

Scientific collaboration across national borders is nothing new; but quasi-official government to government contact with visits from heads of state, joint conferences, and publicly sponsored and financed collaboration is something different. The particulars remain to be seen, but one can easily envision, for example, collaboration between British and California scientists supported by some form of British or Californian public money, use by California scientists of British manufactured stem cell lines, or other joint activities that would require formal agreements consistent with both British and California laws and procedures.

If the state of California can negotiate what amount to its own trade agreements with the British without any official approval or participation by the federal government, then federal action or inaction is more or less irrelevant to the pace or direction of embryonic stem cell research either here or overseas. Unlike the British framework, which regulates all research regardless of its funding, current American policy only governs those activities supported with federal money, which has become less significant than state and private funds as a source of support for embryonic stem cell research. In the absence of any overarching framework to govern this research; funders, researchers, suppliers, patent holders, commercial firms and other involved parties are likely to pursue negotiated arrangements with each other that serve their economic or commercial interests and try to use existing laws to enforce these arrangements. The time to set a national policy about embryonic stem cell research and related issues, if we decide we want one, may well be past.

'Egg sharing': Please. Egg Sale is Egg Sale. Get a Grip.

Newcastle University is thrilled to announce their new plan to obtain eggs through "sharing." Egg sales by any other name are still--egg sales. Discounting 'cost of care' is paying for eggs. Who are these folks trying to kid with talk of sharing and donation?
- Art Caplan

Your Medical Tourism Has Now Become a Work Requirement

Prices are so inexpensive for medical tourists these days, particularly for procedures where going to India might really make sense (seriously - who wouldn't want to save $93,000 on a coronary bypass if the difference is negligible in terms of quality of care - and in fact you'd probably do better in a top-3 Indian hospital than in a typical American suburban facility. It's easy to figure out where to go, too, thanks to lots of coverage of the phenomenon and to websites replete with links to help you plan your Malaysian procedure so that you have plenty of time to tour afterwards.

But it had to happen eventually - health insurance companies have run the numbers and they are beginning to get it that if they provide incentives to employees to get their surgical procedures outside the U.S., patients will go, and the cost to employers will be dramatically decreased. It's a weird form of health insurance, but it could be a huge market force in a very complex healthcare marketplace particularly where employees of small companies are concerned, and that's 2/3 of the U.S. population.