Wisconsin Advanced Technology Advocates, Inc.

By Rachel Feltman February 1

 On Monday, Britain's Human Fertilisation and Embryology Authority greenlighted experiments that will attempt to edit the genes of human embryos. The work, which will be the world's first officially approved use of public funding for human-genome editing, is to be led by The Francis Crick Institute's Kathy Niakan.

The news comes less than a year after the first reports of human-gene editing — published by Chinese scientists in the journal Protein and Cell — using the fantastic and at times troubling technology known as CRISPR. By harnessing an ancient defense mechanism built into bacteria, CRISPR allows scientists to target, delete and replace specific genes. It has been used extensively in other organisms, but research in humans has been slow.

Full story.

‘Region-selective’ pluripotent cells raise possibility of growing human organs in animals.

Sara Reardon

06 May 2015

 A newly discovered type of stem cell could help provide a model for early human development — and, eventually, allow human organs to be grown in large animals such as pigs or cows for research or therapeutic purposes.

Juan Carlos Izpisua Belmonte, a developmental biologist at the Salk Institute for Biological Studies in La Jolla, California, and his colleagues stumbled across a previously unknown variety of pluripotent cell — which can give rise to any type of tissue — while attempting to graft human pluripotent stem cells into mouse embryos.

Scientists previously knew about two other types of pluripotent stem cells, but growing them in large numbers or guiding them to mature into specific types of adult cells has proven difficult. Writing in Nature, Izpisua Belmonte and his colleagues report a type of pluripotent cell that is easier to grow in vitro and grafts into an embryo when injected into the right spot. They call them region-selective pluripotent stem cells (rsPSCs).

Full story.

By Mark Johnson of the Journal Sentinel

The U.S. government has launched a $25 million program to explore the possibility of using whole genome sequencing for newborn babies, a development with the potential to transform American health care.

The five-year research program will involve reading the entire genetic scripts of some 2,000 newborns, a step that could someday lead to vast troves of electronic medical records describing the details of every person's health from day one.

Genetics experts have long discussed this futuristic possibility, but the idea came under serious discussion at the National Institutes of Health about two years ago in the wake of Nic Volker's sequencing and treatment by the Medical College of Wisconsin and Children's Hospital of Wisconsin.

Volker was 4 years old in 2009 when doctors read his genetic script and traced the cause of his disease to a single error in the sequence of 3.2 billion chemical bases. As a result of the diagnosis, Volker received an umbilical cord blood transplant that appears to have saved his life.

"We could each see that this was something looming over the horizon," said Eric D. Green, director of the National Human Genome Research Institute, whose group is collaborating with the National Institute of Child Health and Human Development on the newborn genome sequencing program.

Under the program, researchers at four institutions around the country will examine the benefits and risks of sequencing babies, looking at the accuracy and cost of the tests and the effect they would have on parents and doctors. Their efforts represent a first step into a complex world of new medical possibilities.

Full story.

The recent breakthrough in human cloning announced by scientists at Oregon Health and Science University brings to light an alternative source of pluripotent stem cells that may now get more attention.

Altered Nuclear Transfer (ANT), like Somatic Cell Nuclear Transfer (cloning), utilizes the nucleus of a somatic cell, to swap into that of a human egg in order ultimately to generate patient specific pluripotent stem cells.

But in the ANT process, scientists alter the nuclear make-up of the cell or the egg prior to transfer, ensuring that no viable human embryo is possible even in principle from the get-go.

The resulting organism can generate robust pluripotent stem cells, like embryonic stem cells, but without the ethical implications that accompany the creation and destruction of human embryos involved in the SCNT process.

Full story.

RESEARCHERS RAISE ALARM ABOUT LOSS OF INDIVIDUAL "GENOMIC LIBERTY" DUE TO GENE PATENTS THAT MAY IMPACT THE ERA OF PERSONALIZED MEDICINE

NEW YORK (March 25, 2013) — Humans don't "own" their own genes, the cellular chemicals that define who they are and what diseases they might be at risk for. Through more than 40,000 patents on DNA molecules, companies have essentially claimed the entire human genome for profit, report two researchers who analyzed the patents on human DNA. Their study, published March 25 in the journal Genome Medicine, raises an alarm about the loss of individual "genomic liberty."

In their new analysis, the research team examined two types of patented DNA sequences: long and short fragments. They discovered that 41 percent of the human genome is covered by longer DNA patents that often cover whole genes. They also found that, because many genes share similar sequences within their genetic structure, if all of the "short sequence" patents were allowed in aggregate, they could account for 100 percent of the genome.

Furthermore, the study's lead author, Dr. Christopher E. Mason of Weill Cornell Medical College, and the study's co-author, Dr. Jeffrey Rosenfeld, an assistant professor of medicine at the University of Medicine & Dentistry of New Jersey and a member of the High Performance and Research Computing Group, found that short sequences from patents also cover virtually the entire genome — even outside of genes.

Full story

U.S. government agencies fund thousands of studies on human subjects, but do not have a very good handle on the basic information about that research—possibly putting participants in harm's way, a presidential panel of reviewers has found.

The presidential bioethics commission looked into the current protections for human subjects in a review triggered by evidence of unethical behavior in a 1940s experiment that deliberately infected Guatemalan prison inmates and mental patients with sexually transmitted disease.

The commission earlier this year concluded that U.S. government researchers must have known they were violating ethical standards at the time of the experiment, shortly after World War II. They have also called for a better system to compensate medical research subjects.

Nothing like the horrors of the Guatemala study could take place under U.S. government watch now, the panel said in a report released Thursday.

But the lags in how federal agencies collect and store data about their research involving human subjects offers no assurance that all unnecessary injuries or unethical activity are prevented.

Full story.

With marrow now being extracted from the bloodstream, a federal appeals court calls it blood parts, not organ parts.

The new reading of the federal prohibition could attract thousands more donors.

By Carol J. Williams, Los Angeles Times

A federal law banning compensation for organ transplants doesn't extend to bone marrow harvested from a donor's blood, a federal appeals court said Thursday in a ruling that could attract thousands of new donors in a national campaign to save the lives of those afflicted with cancer and genetic disorders.

The 1984 National Organ Transplant Act included bone marrow in its list of "organs and parts thereof" for which donors could face criminal charges and five years in prison for providing them in exchange for money or other "valuable consideration."

Though bone marrow is naturally replenishable, unlike livers, kidneys and other whole organs, its sale was barred because the extraction method used at the time the law was passed was painful and risky for the donor and authorities feared the poor would be induced to submit to the procedure to earn money.

In the last 20 years, though, medical advances have brought about a less intrusive method by which the life-saving marrow stem cells are harvested from a donor's bloodstream in much the same way as blood is drawn at a blood bank. The new process, known as apheresis, filters out excess marrow stem cells that circulate in the bloodstream, as opposed to the surgical extraction method, known as aspiration, which inserts a large needle into the hip bone and siphons out the cells.

Full story.

By Associated Press

LONDON — British scientists say a new expert body should be formed to regulate experiments mixing animal and human DNA to make sure no medical or ethical boundaries are crossed.

In a report issued on Friday, scientists at the nation’s Academy of Medical Sciences said a government organization is needed to advise whether certain tests on animals that use human DNA should be pursued.

Full story.

Washington, DC – The Presidential Commission for the Study of Bioethical Issues today released its first report—a wide-ranging review of the emerging field of synthetic biology— issuing 18 recommendations including a call for coordinated federal oversight of scientists working in both large institutions and smaller settings.

Full report

Some question whether doctors should be allowed to do clinical trial research involving products that might enrich them or the company they work for.

By John Fauber of the Journal Sentinel

Aug. 28, 2010

In January 2002, a group of Food and Drug Administration advisers met on whether to approve a powerful new biological agent that promised to revolutionize back surgery.

The product was like nothing the burgeoning field of spinal fusion surgery had seen before. If used properly, it essentially turned whatever it touched into bone. This was a good thing if it could be confined to the tiny space between vertebrae, but potentially calamitous if it leaked out.

One of the FDA advisers at the meeting raised a concern about nine of the doctors whose research on the product had been submitted to the FDA: The doctorsall had a financial stake in the product, and their test results with it were nearly twice as good as the doctors who did not have a financial interest.

The concern by the FDA advisory panel member was laughed off with a joke, according to a transcript of the hearing, and the panel ultimately deferred to Medtronic, a company that stood to get billions in sales as the maker of the product known as Infuse.

What has happened since is no laughing matter.

Full stroy.

Oxford dairy farmer harvested DNA from champion Holstein in 2000

By Karen Herzog of the Journal Sentinel Aug. 14, 2010

Mark Rueth's Holstein cow Paradise had just been crowned supreme champion of the World Dairy Expo in Madison in 2000 when a biotechnology company salesman approached him ringside and offered a cut-rate deal to clone Paradise so she could "live forever," and make his farm more profitable.

The Oxford dairy farmer and cattle breeder agreed, and the salesman immediately pricked the prize cow's ear to harvest DNA.

The world of cloning hasn't exactly been paradise for Rueth in the decade since, and especially during the past two weeks. Recent headlines in the British press screamed that two male offspring of a Paradise clone were slaughtered for beef that entered the food chain. Milk from a daughter of a Paradise clone also was traced to the British food supply, setting off consumer fears about food safety.

"The English people get in an uproar about stuff," Rueth said last week, noting that a British reporter and photographer showed up unannounced at his farm. "It's not like you're manipulating or changing the DNA. Half of the DNA from the clone's offspring is from the father."

In the U.S., the Food and Drug Administration doesn't regulate milk or meat from offspring of cloned animals, and doesn't require labeling. Two years after the agency concluded those food products were safe, they're in the American food supply.

However, the U.S. Department of Agriculture requests that the industry continue a voluntary moratorium on placing products from original clones in the food supply to allow trade partners in other countries to pursue their own regulations.

Full story.

Arthur R. Derse, M.D., J.D., will assume responsibilities as director of the new Medical College of Wisconsin’s Center for Bioethics and Medical Humanities, effective July 1, 2010.  The new center combines the College’s existing Center for the Study of Bioethics with its Medical Humanities Program.  The Center will be part of the College’s Institute for Community, Population and Public Health.

According to Jonathan Ravdin, M.D., dean and executive vice president, “The goal of the new Center is to have an integrated approach to meet the education, research, clinical, and community health needs while enhancing the impact and academic excellence of both bioethics and medical humanities. Under Dr. Derse’s leadership we look forward to the growth of the Center as it continues to make major contributions to the missions of the College.”

Dr. Derse is currently a professor of bioethics and emergency medicine and was formerly the associate director of the Center for the Study of Bioethics and director of the Medical College’s Medical Humanities Program. He directs the Medical College’s Medical Ethics and Palliative Care course and medical humanities courses. He also directs graduate bioethics courses encompassing law, ethics education and ethics consultation in health systems. He was elected to the College’s Society of Teaching Scholars and is an Arnold Gold Foundation Humanism in Medicine awardee.

His appointments include chair of the Veterans Health Administration’s National Ethics Committee, senior consultant for academic affairs for the American Medical Association’s Institute for Ethics, and member of the American Bar Association’s Commission on Law and Aging. He is past president of the American Society for Bioethics and Humanities, and is a member and former chair of the Ethics Committee of the American College of Emergency Physicians. He is chair of Froedtert Hospital’s Ethics Committee and serves on several other institutional ethics committees and editorial boards of ethics journals including the American Journal of Bioethics and the Journal of Clinical Ethics.

Dr. Derse has been a member of many expert advisory boards and committees, including the NIH Working Group on Informed Consent in Clinical Research Conducted under Emergent Circumstances. He is a highly published investigator and scholar in bioethics and medical humanities.

By John Fauber of the Journal Sentinel

Posted: March 14, 2010

This article is part of an ongoing series about how money and conflicts of interest affect medicine and patient care.

When looking for a doctor to travel the country and tout its costly prescription fish oil pill, GlaxoSmithKline didn't select a heavyweight university researcher.

Instead, it wrote checks to Tara Dall, a Delafield primary-care doctor who entered private practice in 2001.

For just three months of speaking engagements last year, GlaxoSmithKline paid Dall $45,000, ranking her among the most highly paid of more than 3,600 doctors nationwide who spoke for the company, which released records for only one quarter of the year.

The practice of doing promotional speaking for drug companies has come under fire in recent years.

Full story.

Gene breakthrough offers hope of treatments for 'incurable' Parkinson's disease and MS

By Steve Connor, Science Editor

Scientists yesterday announced a breakthrough that could transform research into a range of incurable diseases but spark a dramatic increase in the number of monkeys used in experiments. Researchers have developed a technique to create genetically modified monkeys that suffer from human illnesses.

Experimenting on these monkeys, they believe, will advance our understanding and treatment of incurable conditions such as Parkinson's disease and multiple sclerosis. However, the scientific breakthrough has caused consternation among groups opposed to animal experiments because the development will almost certainly lead to a sudden increase in the number of primates used in medical research at a time when there are calls for fewer monkeys to be used in experiments.

The development also raises the prospect that we will be able to apply the technique to humans – another primate. This could help families affected by inherited disorders such Huntington's disease and cystic fibrosis by permenantly eradicating their defective genes from future generations.

Full story.

Where:  BioPharmaceutical Technology Center, Madison, WI
When:  April 23-24, 2009

OVERVIEW: Join us for a lively two days of information-sharing and discussion regarding this important - and often challenging (sometimes controversial) - topic! This year's program is designed to allow participants to explore these questions: How do we define “sustainability” and what are the causes of “unsustainability?” What are the most relevant technologies for us to understand? How are various sectors and organizations responding to these issues, e.g. governmental units, research/educational institutions, businesses and faith communities? What is the role of the individual decision-maker? Does what one person does - or does not do - matter?

KEYNOTE SPEAKERS:

Jaimie P. Cloud, M.A. (President, The Cloud Institute for Sustainability Education)
Calvin B. DeWitt, Ph.D. (Professor, Nelson Institute for Environmental Studies, UW-Madison)
Lewis S. Gilbert, Ph. D. (Associate Director, Nelson Institute for Environmental Studies, UW-Madison)
Regina Hauser, J.D. (Executive Director, The Natural Step Network)
Mary Ann Lazarus (Senior Vice President, Sustainable Design Director, HOK)
Robert Streiffer, Ph.D. (Associate Professor, Department of Medical History and Department of Philosophy, UW-Madison)
Paul B. Thompson, Ph.D. (Professor, W. K. Kellogg Chair in Agricultural, Food and Community Ethics, Michigan State University)

For More Information

Arthur R. Derse, M.D., J.D., director of medical and legal affairs and associate director of the Center for the Study of Bioethics at the Medical College of Wisconsin, is this year's recipient of the American Society for Bioethics and Humanities' (ASBH) Distinguished Service Award.

ASBH is the professional organization of scholars who teach bioethics and medical humanities in universities and professional schools and those who engage in clinical ethics consultation.

Dr. Derse is also director of the medical humanities program and professor of bioethics and of emergency medicine at the Medical College.  He is chairman of the ethics committee of the American College of Emergency Physicians and the Veterans Health Administration's National Ethics Committee, a member of the American Bar Association's Commission on Law and Aging, and senior consultant for academic affairs at the American Medical Association's Institute for Ethics.

He serves on the advisory board and as faculty for the Education in Palliative and End-of-life Care Project.  He is co author of Practical Ethics for Students, Interns and Residents, 3rd Edition and the Code of Ethics of the American College of Emergency Physicians.

By Mary Jordan

Washington Post Foreign Service
Tuesday, May 20, 2008; A07

LONDON, May 19 -- British lawmakers voted Monday to allow the use of animal-human embryos for research after a national debate that pitted religious leaders who called it unethical against the prime minister and scientists who said it would help cure disease.

Last month, scientists at Newcastle created part-human, part-animal embryos for the first time in Britain. An attempt Monday night to ban the process, during consideration in the House of Commons of the first major revisions to embryo research laws in a generation, failed overwhelmingly on a vote of 336 to 176.

The overall bill, argued Prime Minister Gordon Brown, would enable lifesaving research that could help people with Alzheimer's, Parkinson's and other diseases. He said in an article published in the Observer newspaper Sunday, "I believe that we owe it to ourselves and future generations to introduce these measures."

The bill would allow scientists to continue injecting human DNA into cows' eggs that have had virtually all their genetic material removed, as well as other hybrid embryo processes for stem cell research. Scientists say the embryos would not be allowed to develop for more than 14 days.

Full story.

Gehrke & Associates, SC is a proud sponsor of the Seventh Annual International Bioethics Forum: Evolution in the 21st Century taking place at the BioPharmaceutical Technology Center in Madison, WI on April 17^th and 18^th, 2008. 

Lisa M. Gehrke, JD, MA will be a featured speaker for a discussion session on Patenting Living Organisms.

For more information please visit BTCI’s website.

By Rick Weiss
Washington Post Staff Writer

It has been 50 years since scientists first created DNA in a test tube, stitching ordinary chemical ingredients together to make life's most extraordinary molecule. Until recently, however, even the most sophisticated laboratories could make only small snippets of DNA -- an extra gene or two to be inserted into corn plants, for example, to help the plants ward off insects or tolerate drought.

Now researchers are poised to cross a dramatic barrier: the creation of life forms driven by completely artificial DNA.

Scientists in Maryland have already built the world's first entirely handcrafted chromosome -- a large looping strand of DNA made from scratch in a laboratory, containing all the instructions a microbe needs to live and reproduce.

In the coming year, they hope to transplant it into a cell, where it is expected to "boot itself up," like software downloaded from the Internet, and cajole the waiting cell to do its bidding. And while the first synthetic chromosome is a plagiarized version of a natural one, others that code for life forms that have never existed before are already under construction.

The cobbling together of life from synthetic DNA, scientists and philosophers agree, will be a watershed event, blurring the line between biological and artificial -- and forcing a rethinking of what it means for a thing to be alive.

Full story.

Report says ban on human reproductive cloning, coupled with restricted therapeutic research, is global compromise most likely to succeed

The world community quickly needs to reach a compromise that outlaws reproductive cloning or prepare to protect the rights of cloned individuals from potential abuse, prejudice and discrimination, according to authors of a new policy analysis by the United Nations University’s Institute of Advanced Studies (www.ias.unu.edu).

A legally-binding global ban on work to create a human clone, coupled with freedom for nations to permit strictly controlled therapeutic research, has the greatest political viability of options available to the international community, says the report: Is Human Reproductive Cloning Inevitable: Future Options for UN Governance, released Nov. 12 by A.H. Zakri, Director of UNU-IAS, based in Yokohama, Japan.

Virtually every nation opposes human cloning and more than 50 have legislated bans on such efforts. However, negotiation of an international accord foundered at the UN in 2005 due to disagreement over research cloning (also called therapeutic cloning).

"Human reproductive cloning could profoundly impact humanity," says UN Under-Secretary-General Konrad Osterwalder, Rector of UNU. "This report offers a plain language analysis of the opportunities, challenges and options before us – a firm and thoughtful base from which the international community can revisit the issue before science overtakes policy."

For the first time, scientists have created dozens of cloned embryos from adult primates. But what are the implications of this technical breakthrough for the future of mankind?

By Steve Connor, Science Editor

Published: 12 November 2007

Thu Oct 11, 2007 9:40am EDT

VATICAN CITY (Reuters) - Pope Benedict appealed to scientists on Thursday to stop using human embryos in stem cell research, saying it violated the dignity of human life.

The Vatican supports stem cell research so long as it does not harm embryos, which the Catholic Church argues are humans from the moment of conception.

Full story.

By CLAUDIA JOSEPH

Scientists have created the world's first human-sheep chimera - which has the body of a sheep and half-human organs.

The sheep have 15 per cent human cells and 85 per cent animal cells - and their evolution brings the prospect of animal organs being transplanted into humans one step closer.

Professor Esmail Zanjani, of the University of Nevada, has spent seven years and £5million perfecting the technique, which involves injecting adult human cells into a sheep's foetus.

He has already created a sheep liver which has a large proportion of human cells and eventually hopes to precisely match a sheep to a transplant patient, using their own stem cells to create their own flock of sheep.

The process would involve extracting stem cells from the donor's bone marrow and injecting them into the peritoneum of a sheep's foetus. When the lamb is born, two months later, it would have a liver, heart, lungs and brain that are partly human and available for transplant.

Full story.

 

As long as the research meets the usual requirements for a patent, isolated embryonic stem cells should be considered for both method and product patents.

This conclusion, which runs counter to the views of the European Group on Ethics under the European Commission, was reached by an interdisciplinary group at the Center for Bioethics at the Karolinska Institute and Uppsala University in an academic article in the international journal Stem Cells.

The article is the result of a unique collaborative effort involving ethics researchers Mats G. Hansson and Gert Helgesson at the Center for Bioethics, Richard Wessman at the Department of Law, Uppsala University, and one of the world's leading stem cell researchers, Rudolf Jaenisch at the Whitehead Institute for Biomedical Research and the Massachusetts Institute of Technology.

"Our conclusion is that, in principle, stem cells can be patentable and that this is consonant with ethical views that the human embryo should enjoy special protection owing to its capacity to develop into a human being. This will be of interest to a great many people," says Professor Mats G. Hansson.

Research on embryonic and adult stem cells may yield new possibilities for treating and curing diseases. At the same time, it is ethically controversial, especially the use of stem cells from human embryos. The possibility of patenting these cells has been excluded by several instances, including several European patent authorities and the European Commission's European Group on Ethics (EGE). According to the EGE, only genetically altered stem cells or cells that have been further developed into certain bodily parts can be eligible for patents. In several European countries patents for stem cells are out of the question, and the European Patent Organization, like various national patent offices, has a wait-and-see policy.

Full story.

Mark Henderson, Science Editor
From The Times
February 27, 2007

Scientists triumph in battle over ban on hybrid embryosMark Henderson, Science Editor
Plans to outlaw the creation of human-animal hybrid embryos for potentially life-saving stem cell research are to be dropped after a revolt by scientists.

The proposed government ban on fusing human DNA with animal eggs, which promises insights into incurable conditions such as Alzheimer’s and motor neuron disease, will be abandoned because of concerns among senior ministers that it will damage British science.

While ministers will not endorse the research in full yet, they are no longer seeking legislation to prohibit it, The Times has learnt. The Government will instead provide the fertility watchdog with funds for a public debate on the subject before new laws are drafted.

Government support for an interim ban had been announced by Caroline Flint, the Public Health Minister, in December, in a White Paper reviewing the fertility laws. It provoked outrage in the scientific community, with researchers describing the proposal as “an affront to patients” that would jeopardise Britain’s position as a world leader in stem cell science.

Last month 45 scientists, ethicists and politicians, including three Nobel prizewinners, wrote to The Times to support the hybrid embryo work. It has been backed by the Medical Research Council and the Wellcome Trust, Britain’s two biggest funders of medical science, and by the Human Genetics Commission, which advises ministers on genetic matters.

Full story.

A Texas fertility center's methods raise concerns about 'designing'babies. Some say they're not much different from the usual practice.
By Amanda Paulson | Staff writer of The Christian Science Monitor

In an era when infertile couples often look to test tubes or surrogate mothers to create children, the notion of egg or sperm donors is hardly novel.

Yet a San Antonio woman's idea to bring the two together – creating complete embryos ready to be implanted into the womb – has drawn a raft of criticism, with bioethicists debating whether this is the commodification of children or just another – perhaps more effective – way to help people become parents.

The "embryo bank" at the Abraham Center of Life isn't a storage bank so much as an intermediary that creates embryos from anonymous donors of both sperm and egg, for a waiting list of interested parents.

But the ethical debate around selling such embryos has called attention to the delicate balance between harnessing reproductive technology to help people achieve cherished dreams of bearing children and the danger of selective genetics in the hopes of creating "designer babies." It's also, say some critics, one more example of why more oversight is needed in a field that is advancing rapidly but has had almost no regulation.

Full story.

The public will be asked whether scientists should be allowed to create hybrid human-animal embryos, regulators have announced.

The Human Fertilisation and Embryo Authority says it will not rule on any research applications until a consultation has been completed.

Ministers proposed outlawing such work after unfavourable public opinion.

Two UK teams have put in requests to mix human and animal cells in order to find cures for degenerative diseases.

PM Tony Blair last week said any new law would have "flexibility" to support scientific research that helped people.

There had been a question mark over whether it was within the HFEA's remit to licence such work.

But the HFEA says it should judge the work under the current law.

Angela McNab, chief executive of the HFEA, explained: "These sorts of research would potentially fall with the remit of the HFEA to regulate and licence and would not be prohibited by the legislation.

"There needs to be a full and proper public debate and consultation as to whether, in principle, licences for these sorts of research could be granted."

Controversial

But she said from the evidence considered so far, the issue was "far from black and white".

Scientists say doing the work could provide cures for conditions such as Alzheimer's. But opponents say the research tampers with nature and is unethical.

Full story.

January 05, 2007

The Pillow Angel Case--Three Bioethicists Weigh In

We asked three of the country's most esteemed bioethicists to give their professional opinion--was the "Ashley Treatment" a wise decision?

By Christopher Mims

On January 3 of this year the parents of a girl with static encephalopathy, a disorder that leaves her unable to move and with the cognitive capacity of an infant, announced on a blog that they had been using hormones to stunt the growth of their daughter for medical and quality-of-life reasons. [More details are available via the original news report of the story.] The resulting, and very public, debate--much of it carried out in the comment thread of the original blog--has ranged from support for the parents to accusations of eugenics and worse.

In order to cut through the noise, we asked three bioethicists--doctors not unlike those who, as members of a medical ethics board, authorized the treatment in the first place--to relate their professional opinion of the case.

All three bioethicists came down firmly on the side of the parents and the decision of the original ethics board--but with a few reservations. Their discussion ranged from issues of privacy raised by the media frenzy surrounding this case to the question of whether or not this intervention is a technological fix for a social problem.

Full story.

'Embryo Bank' Stirs Ethics Fears
Firm Lets Clients Pick Among Fertilized Eggs

By Rob Stein
Washington Post Staff Writer
Saturday, January 6, 2007; Page A01

A Texas company has started producing batches of ready-made embryos that single women and infertile couples can order after reviewing detailed information about the race, education, appearance, personality and other characteristics of the egg and sperm donors.

The Abraham Center of Life LLC of San Antonio, the first commercial dealer making embryos in advance for unspecified recipients, was created to help make it easier and more affordable for clients to have babies that match their preferences, according to its founder.

"We're just trying to help people have babies," said Jennalee Ryan, who arranged for an egg donor to start medical treatments to produce a second batch of embryos this week. "For me, that's what this is all about: helping make babies."

But the embryo brokerage, which calls itself "the world's first human embryo bank," raises alarm among some fertility experts and bioethicists, who say the service marks another disturbing step toward commercialization of human reproduction and "designer babies."

"We're increasingly treating children like commodities," said Mark A. Rothstein, a bioethicist at the University of Louisville in Kentucky. "It's like you're ordering a computer from Dell: You give them the specs, and they put it in the mail. I don't think we should consider mail-order computers and other products the same way we consider children."

Full story.

By TIMBERLY ROSS, Associated Press Writer
Mon Dec 18, 9:34 PM ET

OMAHA, Neb. - Research on embryonic stem cells continues to ignite national debate over the beginning of human life. And with the Legislature likely to take up the issue in its next session, many worry that inaccurate information is being perpetuated by stem cell proponents and their counterparts.

Dr. David Crouse, who oversees some stem cell research at the University of Nebraska Medical Center, said both sides are "overselling wares."

The sentiment is shared by Chip Maxwell, executive director of the Nebraska Coalition for Ethical Research. That group supports stem cell research, but not the kind involving embryos.

Maxwell said he is all for the free flow of ideas but that information should have balance. "I hope that the whole picture is explained," he said.

From a scientific standpoint, stem cells are building blocks that can turn into different types of tissue, such as kidney or liver cells. Research is being conducted on two types of stem cells — adult and embryonic — in hopes that they can lead to cures for diseases.

Adult stem cells can be found in bone marrow and umbilical cord blood, among other sources. Embryonic stem cells are derived from human embryos in their earliest stages of development.

Embryonic stem cells in particular have made headlines, as scientists attempt to harness them to regenerate damaged organs or other body parts. They're essentially a blank slate, able to turn into any tissue given the right biochemical instructions.

But from an anti-abortion standpoint, human embryonic stem cell research is immoral, because isolating the cells destroys embryos, what some believe is the starting point of human life. Anti-abortion advocates cite the same argument in opposing abortion.

"The beef is that there is no question that embryos are destroyed in the harvesting of stem cells," Maxwell said. "Now you are destroying a human being."

Many scientists disagree. Crouse, who specializes in embryonic stem cells, said it boils down to a difference in perspective about when human life begins.

Full story.

Morlino gets ally in stem cell expert
Prof's view at odds during forum
By Ben Hancock

Special to The Capital Times

Catholic Bishop William Morlino found an ally in academia as he argued during a forum at the University of Wisconsin-Madison that human embryonic stem cells should be saved from research that destroys them.

William Hurlbut, a professor in the Neuroscience Institute at Stanford University, told an audience at Union South on Tuesday that human embryos are, by their very nature, living beings, and he argued that scientific stem cell extraction procedures that destroy these embryos are immoral. He attacked notions that embryos that have only developed for a short time period are simply "clumps of cells."

Hurlbut believes that, from the moment of conception, an embryo is a human being with inviolable rights. "To interfere in its development is to transgress upon a life in progress," he said.

Putting him at odds with other scientists on the panel, Hurlbut's claims matched those of the Catholic Diocese of Madison's bishop, who spoke at the lecture as part of a panel of active figures in the stem cell debate. The Isthmus Society, a UW group formed to address divisive issues of science and religion, sponsored the event.

Full story.

Plan to create human-cow embryos
By Fergus Walsh
BBC News, Medical correspondent

UK scientists have applied for permission to create embryos by fusing human DNA with cow eggs.

Researchers from Newcastle University and Kings College, London, have asked the Human Fertilisation and Embryology Authority for a three-year licence.

The hybrid human-bovine embryos would be used for stem cell research and would not be allowed to develop for more than a few days.

But critics say it is unethical and potentially dangerous.

Full story.

NEW YORK - In a report published in a medical journal this month, two doctors describe a 6-year-old girl with profound, irreversible developmental disability who was given high doses of estrogen to permanently halt her growth so that her parents could continue to care for her at home.

The controversial growth-attenuation treatment, which included hysterectomy, was requested by the child's parents and initiated after careful consultation and review by an ethics committee.

In their report in the Archives of Pediatrics and Adolescent Medicine, Drs. Daniel F. Gunther and Douglas S. Diekema, both at the University of Washington in Seattle, explain the reasoning behind what they hope will generate a healthy debate. Gunther is at the Division of Pediatric Endocrinology, and Diekema is at the Center for Pediatric Bioethics.

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Catholics must vote, U.S. bishops agree in pre-election messages
By Nancy Frazier O'Brien
10/27/2006
Catholic News Service

WASHINGTON (CNS) – As the midterm elections near, some Catholic bishops are not finding any pressing moral issues to comment on in their dioceses, while others are jumping into the fray – especially about the moral content of referendum issues facing voters in 37 states.

. . .

Archbishop Raymond L. Burke of St. Louis said Missouri is facing "an unimaginably severe moral crisis" as it prepares to vote on an initiative that could make embryonic stem-cell research and human cloning a constitutional right.

"The passage of Amendment 2 would be a moral disaster for our state" and the nation, Archbishop Burke wrote in a column for his archdiocesan newspaper, the St. Louis Review. "If Amendment 2 succeeds in the state of Missouri, which has the reputation of being pro-life, then the proponents of human cloning and the destruction of embryonic human life will surely be emboldened to undertake the same deadly initiative in other states of our union."

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Brain Images of Woman in Vegetative State Hint at Awareness
By Thomas H. Maugh II and Karen Kaplan, Times Staff Writers
September 8, 2006

Sophisticated brain-imaging techniques suggest that a young woman in a vegetative state five months after a traffic accident had some mental functioning, even though she was unable to physically respond to her environment, British researchers report today.

The woman's brain showed mental activity virtually identical to that of healthy people when she was addressed in complex sentences and when told to imagine activities such as playing tennis, the physicians reported in the journal Science.

The findings challenge the standard diagnosis of a vegetative state, implying that some patients may have what Dr. Lionel Naccache of the French National Institute of Health and Medical Research called "a rich mental life" in an accompanying editorial.

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Ethical stem cells still horrify Vatican
27th August 2006, 9:30 WST

The Catholic church is rejecting claims in the US of new "embryo-safe" stem-cells, pouring cold water on hopes by many scientists of ending ethical uproar over their research.

A US company says it has developed a way to create the stem cells without harming the original embryo, which the Vatican holds is a full-fledged human life.

The breakthrough technique was meant to answer critics at the papal palace, the White House and beyond, who have long argued that it was ethically reproachable to attempt to save one life by taking another.

But the head of the Vatican's Pontifical Academy for Life, Bishop Elio Sgreccia, told Reuters in an interview that the new method by Advanced Cell Technology Inc failed to overcome the church's many moral concerns.

Sgreccia said the procedure was wrong footed from the start - experimenting with embryos is reprehensible, as is use of "unnatural" in-vitro embryos created at fertility clinics, like the ones the US scientists employed in their research.

Advanced Cell then made things worse by extracting what could be a "totipotent" cell, Sgreccia said.

"This is not just any cell, but a cell capable of reproducing a human embryo," Sgreccia said. He added that, in effect: "a second embryo is being destroyed".

Across the Atlantic, Richard Doerflinger, a bioethics expert with the US Conference of Bishops, has accused the scientists of "killing" 16 embryos during their research.

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Patients said to offer stem-cell solution
'we can all live with'

By Nancy Frazier O'Brien
Catholic News Service

WASHINGTON (CNS) — As the U.S. Senate prepared to consider competing proposals on the funding of stem-cell research, a representative of the U.S. bishops' pro-life office said the presence of four people on Capitol Hill showed that "there are solutions we can all live with."

Deirdre McQuade, director of planning and information in the bishops' Secretariat for Pro-Life Activities, participated in a June 20 press conference organized by Sen. Sam Brownback, R-Kan., and featuring four patients who have been treated successfully for a variety of illnesses with adult stem cells or those from umbilical-cord blood.

The four were Jackie Rabon of Waverly, Ill., a paraplegic who received a successful treatment with adult stem cells; Ryan Schneider of Chicago, who received a cord-blood treatment for cerebral palsy; Abby Pell of the Washington area, who was treated with her own cord blood for brain damage she suffered at birth; and David Foege of Naples, Fla., who was successfully treated for heart failure with adult stem cells.

"We praise these patients and families for their courage, their persistence and their willingness to come to Washington to present how ethically sound stem-cell research is paving the road to treatments," McQuade said.

"No one should think that the stem-cell debate forces us to choose between ethics and science," she added. "We can support both. There is no need to sell our souls in the quest to heal our bodies."

At the press conference Brownback said the four told "absolutely phenomenal stories of successes" using adult stem cells or cord-blood stem cells. "We need to do more of this," he added.

The Kansas senator called for a full floor debate on bioethics issues when the Senate considers H.R. 810, the Stem-Cell Research Enhancement Act of 2005, which he and the Catholic Church oppose.

"I want you to see where we're seeing successes without bioethical questions involved," he said at the press conference.

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By PAUL ELIAS
AP Biotechnology Writer

SAN FRANCISCO

On the sun-splashed Caribbean island of St. Kitts, Yale University researchers are injecting millions of human brain cells into the heads of monkeys afflicted with Parkinson's disease.

In China, there are 29 goats running around on a farm with human cells coursing through their organs, a result of scientists dropping human blood cells into goat embryos.

The mixing of humans and animals in the name of medicine has been going on for decades. People are walking around with pig valves in their hearts and scientists have routinely injected human cells into lab mice to mimic diseases.

But the research is becoming increasingly exotic as scientists work with the brains of mice, monkeys and other mammals and begin fiddling with the hot-button issue of cloning. Harvard University researchers are attempting to clone human embryonic cells in rabbit eggs.

Such work has triggered protests from social conservatives and others who fear the blurring of species lines, invoking the image of the chimera of Greek mythology, a monstrous mix of lion, goat and serpent.

During his State of the Union speech in January, President Bush called for a ban on "human cloning in all its forms" and "human-animal hybrids," labeling it one of the "most egregious abuses of medical research."

He didn't elaborate, but scientists working in the field believe that by "hybrids," the president meant creating living animals with human traits _ something they say they aren't doing.

Other critics are calling for stricter regulations of the research.

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By Robert Davis, USA TODAY
As Hilary Williams hung from her seat belt in the overturned wreckage of her truck — legs broken, colon ruptured and lung bruised — blood oozed from torn arteries and veins.
Hilary, 27, and her sister, Holly, 25, who was injured less severely in the crash, waited half an hour for medical help to arrive. By the time an air ambulance reached them at the crash site, about 45 miles south of Memphis, it was midday onMarch 15. Hilary's face was pale, her lips were blue, her faint pulse was fast, and her blood pressure was 55/0. She was in shock.

Because she was close to death, she instantly became eligible for enrollment in a controversial clinical trial. But because she was in no shape to consider the risks, the flight nurses did not have to obtain her consent before giving her an experimental blood substitute.

Within moments, fluid the color of merlot was dripping into her veins. Hilary, a singer/songwriter and the daughter of country singer Hank Williams Jr., became one of thousands of people across the nation who, while fighting for their lives over the past 10 years, unknowingly became test subjects in a medical trial.

With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection.

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Aquinas would have shunned stem cell work

By EDWARD J. RICHARD
Published Sunday, May 28, 2006

Contrary to the implication of former Sen. Thomas Eagleton in his commentary in the Tribune last Sunday, Saint Thomas Aquinas did not teach that the human embryo is something less than human.

It has become routine now, in the stem cell debate, to throw out assertions that certain writings of Saints Augustine and Aquinas are not consistent with the authentic Catholic teaching on the grave sinfulness of abortion and destruction of pre-nascent life.These saints taught the serious sinfulness of deliberate destruction of innocent life at any stage, and they believed that the child in the womb - they were not aware of zygotes and embryos, as such - was human from the start. (See Anne B. Gardiner’s article in the New Oxford Review, 2004.) In an on the subject published in the Jan. 17, 2003, National Catholic Reporter, bioethics expert and Professor Father Brian Johnstone said, "There was never any question (in Augustine and Aquinas) of whether terminating a pregnancy was sinful, but rather what kind of sin it was in the early stages - homicide or something else."

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Right and wrong become business questions
Ethicists take center stage as biotech acquires new capabilities
San Francisco Business Times - May 26, 2006
by Daniel S. Levine

Baseball's steroid scandal has focused on a question of punctuation. If Barry Bonds surpasses Hank Aaron on the all-time list of home run hitters, should the record be followed by an exclamation point or an asterisk?

But when legal scholars, ethicists, political scientists and others gather at Stanford University on May 26 to 28 for "Human Enhancement Technologies and Human Rights," their discussion will extend well beyond mundane steroids to include implantable computer chips to improve brain power, the use of bionic suits
that provide the wearer superhuman strength or the use of genetic modification to enhance human abilities.

The rapid pace of advancing biotechnology is raising complex questions about how technology should be used, who should profit from certain advances, how the benefits of these technologies should be distributed and how people should be protected from unintended effects and consequences.

Whether biotechnology companies want to listen or not, bioethics are increasingly shaping public opinion and public policy about emerging technologies and their implications.

"Bioethics are no longer restricted to the academy," said Christopher Scott, executive director of Stanford University's Center for Biomedical Ethics' Program in Stem Cells and Society. "The Bush presidency, more than any other, has shown that these individuals can actually influence public policy in a major way."

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Doyle tells bishops he won't rethink stem cell support

(Published Thursday, May 25, 2006 08:14:11 AM CDT)

By Ryan J. Foley
Associated Press

MADISON, Wis. - Gov. Jim Doyle broke with Wisconsin's two most prominent Catholic bishops on Wednesday, bluntly telling them he would not rethink his strong support of embryonic stem cell research.

"While I appreciate your thoughts on this important issue, I also feel a responsibility to promote vital research which holds the potential to save countless lives and bring thousands of jobs to our state," Doyle, a Catholic, wrote in a letter to Milwaukee Archbishop Timothy Dolan and Madison Bishop Robert Morlino.

The Democratic governor wrote in response to the bishops' letter on Monday in which they criticized an executive order he signed last month setting aside $5 million to recruit companies doing stem cell research to Wisconsin.

Doyle has consistently championed research using embryonic stem cells, which was pioneered at University of Wisconsin-Madison, and has made the issue a central part of his re-election campaign. His challenger, U.S. Rep. Mark Green, R-Green Bay, supports sharp limits on the research.

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Sleeping pill wakes men in vegetative state

Sarah Boseley, health editor
Tuesday May 23, 2006
The Guardian

A drug commonly used as a sleeping pill appears to have had a miraculous effect on brain-damaged patients who have been in a permanent vegetative state for years, arousing them to the point where some are able to speak to their families, scientists report today.

The dramatic improvement occurs within 20 minutes of taking the drug, Zolpidem, and wears off after around four hours - at which point the patients return to their permanent vegetative state, according to a paper published in the medical journal NeuroRehabilitation.

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The Psychological Strain of Living Forever
Thursday, May 25, 2006
By Ker Than

In Oscar Wilde's novel, "The Picture of Dorian Gray," the main character barters his soul for eternal youth, but becomes wicked and immoral in the process.

Leon Kass believes humanity risks striking a similar Faustian bargain if it pursues technology that extends life spans beyond what is natural.

If our species ever does unlock the secrets of aging and learns to live forever, we might not lose our souls, but, like Dorian, we will no longer be human either, says Kass, a bioethicist at the University of Chicago and a longtime critic of life-extension research.

For Kass, to argue that life is better without death is to argue "that human life would be better being something other than human."

Kass' position is controversial, but it gets at some of the central issues surrounding the life-extension debate: What is aging? Is it a disease to be cured, or a natural part of life? If natural, is it necessarily good for us?

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First baby in Britain designed cancer-free
By Mark Henderson, Science Editor

A WOMAN is pregnant with Britain’s first designer baby selected to prevent an inherited cancer, The Times can reveal.
Her decision to use controversial genetic-screening technology will ensure that she does not pass on to her child the hereditary form of eye cancer from which she suffers.

Although they did not have fertility problems, the woman and her partner created embryos by IVF. This allowed doctors to remove a cell and test it for the cancer gene, so only unaffected embryos were transferred to her womb.

The couple are the first to take advantage of a relaxation in the rules governing embryo screening.

When the technique was developed in 1989 it was allowed only for genes that always cause disease, such as those for cystic fibrosis. However, it was approved last year for the eye cancer, which affects only 90 per cent of those who inherit a mutated gene.

The pregnancy will increase controversy over the procedure, which the Government’s fertility watchdog authorised on Wednesday for genes that confer an 80 per cent lifetime risk of breast and bowel cancer.

Critics argue that the action is unethical because it involves the destruction of some embryos that would never contract these illnesses if they were allowed to develop into children. Even those that would potentially become ill could expect many years of healthy life first, and some of the disorders involved are treatable or preventable.

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S Korea scientist on fraud charge

The South Korean cloning scientist who faked his stem cell research has been charged with fraud and embezzlement.

Hwang Woo-suk was also charged with using millions of dollars in grants for private purposes, as well as violating laws on bio-ethics.

Earlier this year Dr Hwang's apparently ground-breaking work, such as producing stem cell lines from cloned human embryos, was found to be fake.

Prosecutors said that he would not be taken into custody at present.

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Biopolitics: Can't We All Just Get Along?

by Nigel M. de S. Cameron | posted 04/27/2006 10:00 a.m.

For years, some of us have been saying that the issues raised by advances in biotechnology will dominate the 21st century—not just because new technology is always fascinating, but also because they will become the key issues in our culture and our politics. Think of the culture war over abortion, and then think much, much bigger. We will move from taking human life to making and finally faking human life—by design.

The cloning/stem-cell debates have been a forerunner of that enlarged culture war. Yet it's important to make some things clear. Those of us who would be seen as "social conservatives" are not Luddites. We are not opposed to technology. We may be more skeptical than some as to its benefits or its harmlessness, because we tend to take a Judeo-Christian view of human nature. It is flawed; humans can do wonderful things, but they can also do incredibly evil things, and new technology always gives us the power to do more than we could have before. Furthermore, because we are flawed and finite, our technologies are flawed. Space shuttles explode. Microsoft Windows crashes. My PDA rearranged my schedule one day. We all have our own stories.

At a conference in Washington recently, the Center for American Progress made a push for "progressive" bioethics and against "bioconservatives." This is curious, because one of the most striking facts of our time is that just as economic and social "conservatives" have disagreed on key biopolicy issues, so also "progressives" are thoroughly divided. Many of them side with "conservatives" on a wide range of bioethics issues, from cloning to germline (inheritable) changes to the need for reform in the patenting of human genes.

Part of the problem lies with BIO, the trade group of the biotechnology industry. Many of their efforts are estimable: Biotech will lead to cures for many diseases, and we will welcome them. But the organization, which brought together nearly 20,000 people at a conference in Chicago this April, has for obscure reasons decided to take sides in the great debate about embryonic stem-cell research and cloning.

There are many reasons why their decision is strange. For one thing, whatever hype we may read in the press, the private investment in embryonic stem-cell research is tiny, and stem cells do not feature on standard lists of "10 most promising bio developments." Moreover, Pharma—the far larger group that represents drug manufacturers—has deliberately stayed out of the debate and takes no official line on the issue.

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Human organs for sale
By Debra Saunders

Two years ago, The New York Times ran a story about a 48- year-old Brooklyn woman who, facing death after years of dialysis treatments and failing health, received a kidney from a Brazilian peasant who was paid $6,000 for the organ. The chilling story bared the human misery that surrounds the black market on human parts.

Some donors faced ill health and even (unlike the recipients) prosecution. The kidney recipient talked to the Times reporter, but felt enough shame that she did not want her name in the newspaper.

Last week, The San Francisco Chronicle ran a story by reporter Vanessa Hua about a San Mateo, Calif., man who flew to Shanghai and paid $110,000 for a liver - with nary a thought about human- rights activists' contention that China has executed prisoners in order to harvest their organs. Not only was Eric De Leon's name in the paper, he even has a blog about his Shanghai transplant. The man clearly is not ashamed.

Last year, the Chinese deputy health minister admitted, as he promised reform, that the organs of executed prisoners were sold to foreigners. This month, the South China Morning Post reported that a leading Chinese transplant surgeon estimated that more than 99 percent of transplanted organs in China came from executed prisoners.

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An ethical dilemma
Embryonic stem cell research in Wisconsin isn't just about science — it raises complex moral issues.
By SUSANNE RUST and KATHLEEN GALLAGHER
[email protected]
Posted: April 24, 2006
Madison - Third of three parts

Susan Armacost and Ed Fallone are passionate about the morality of human embryonic stem cell research. They are also worlds apart.

Armacost, legislative director of Wisconsin Right to Life, says the destruction of embryos necessary to obtain the cells is murder. Her organization has added embryonic stem cell research to its traditional issues of abortion, euthanasia and assisted suicide.

Fallone, president of Wisconsin Stem Cell Now Inc., says it's wrong to put limits on research that many believe has the potential to cure diseases, including the juvenile diabetes that afflicts him, his father and his son. He formed his group to advocate for stem cell research in the state after President Bush was re-elected.

Here in Wisconsin - the cradle of human embryonic stem cell research, with no laws promoting or restricting it - the political and ethical conflicts on this issue are moving into the spotlight.

Human embryonic stem cells were first isolated in the lab of University of Wisconsin-Madison researcher James Thomson in 1998. Armed with critical patents and a planned research hub at UW that will encourage stem cell researchers from all walks of science to mingle with private industry, Wisconsin offers a hospitable environment for entrepreneurs in this field.

But whether human embryonic stem cell technology has a long-term future in the state depends on more than an agreement between science and industry. The deciding factor is a political consensus on what, if any, kind of embryonic stem cell research is morally and ethically acceptable - a consensus that Armacost and Fallone each claim their side already has, citing different polls that say 70% of the public supports their respective positions.

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