Living in the Biotech Century -- July 7, 2005

Jeff Miller / UW-Madison file / 2001

Developmental biologist James Thomson says he never expected his work in embryonic stem cells to continue attracting media attention. “It’s been seven years now: Get over it,” he says.

“Seven years ago, when James Thomson became the first scientist to isolate and culture human embryonic stem cells, he knew he was stepping into a whirlwind of controversy.

“Thomson, a developmental biologist and veterinarian at the University of Wisconsin at Madison, made history in 1998 when he and fellow researchers derived the first embryonic stem cell lines from frozen human embryos. The breakthrough came after the news that a sheep named Dolly was born as the first cloned mammal—and together, the two announcements hinted at a brave new world of medical possibilities and moral debates....

“Some of Thomson’s...pronouncements might seem...surprising: that supporters of stem cell research are overestimating the prospects for transplantation cures, that the current stem cell lines aren’t well-suited for such applications anyway, and that there’s no need to resort to therapeutic cloning right now—or perhaps ever....

“But he recently helped found a biotech start-up called Cellular Dynamics International that takes a different approach, aiming eventually to turn embryonic stem cells into human heart cells suitable for drug testing. ‘Nobody’s been able to test heart drugs on heart cells [outside the human body] before,’ he said. ‘That will change medicine a lot quicker than actually transplanting those heart cells.’

“Thomson predicted that in the long run, embryonic stem cells would play a more important role in fundamental research than in transplantation therapies—a view that doesn’t sit well with the critics....”

Stem Cell Division

“When Woo Suk Hwang and his group at Seoul National University announced their creation of human stem cell lines that matched the donors’ own DNA, the media craze began. Surely this achievement marked the beginning of eagerly awaited tailor-made therapies for patients with spinal cord injuries, diabetes, Alzheimer disease, and a host of other congenital and acquired disorders. Or did it?

“Before patient-specific stem cells, or any other stem cells, can be used for human therapeutics, there are hurdles to overcome. These barriers in the translation of bench experiments to bedside remedies do not just include the obvious ethical, political, and funding problems that are so widely deliberated. The more relevant hurdles that stymie clinical stem cell therapies are the scientific ones—those that are often overlooked in the lay press, which contributes to public unawareness of just how far we still are from using stem cells in a clinically meaningful manner....”

New Report Reveals Rapid Growth of Stem Cell Technology Research, Despite Regulatory Barriers

“Investment into stem cell technology is continuing apace despite public controversy and legal and regulatory barriers, according to a report by Marks & Clerk, one of the world’s leading firms of patent and trade mark attorneys. In its Biotechnology Report 2005, Marks & Clerk explores worldwide patent activity related to stem cell technology, bionanotechnology and cancer therapeutics.

“The report highlights that over 3,000 patent applications related to stem cell technology have been filed worldwide since 2000, with a sharp yearly incline in patents filed and granted between 2000 and 2003. As a result, patent activity was 127 per cent higher in 2003 than in 2000. Had it not been for a decline in international applications due to procedural issues in the European Patent Office, there seems little doubt that stem cells patents would have increased further in 2004. Despite these issues, there were 88 per cent more patents filed and granted worldwide in stem cell research in 2004 than in 2000....

“The message from this report seems to be simple: biotech companies are undeterred by the hostile research environment that currently governs the stem cell sector. The market is aware that there is potentially a huge revenue stream from stem cell research—the world market value currently stands at $2.7 billion and is set to grow significantly over the next few years. Consequently, biotech companies want to protect their R&D investment as much and as far as the framework will allow. Currently they are operating in a sensitive ethical and legal environment, but patents are a long-term investment. The industry is clearly taking the view that countries will adopt a more liberal approach once the potential contribution that stem cell research can have in furthering the cause of medical science is more widely understood....”

Cows Milk Benefits of Stem Cells

Photo: Courtesy of Advanced Cell Technology

Scientists invigorated the immune systems of these three cows by injecting them with bovine fetal stem cells. Researchers hope a similar technique could do the same for humans.

“Scientists have shown that stem cells can bring renewed youthful vigor to aged cows, and they hope the same will be true in humans.

“Stem cells were injected into elderly cows—animals whose age was equivalent to an 80-year-old human. Tests showed boosted immune systems and rejuvenated blood vessels more than a year after an injection of a tablespoonful of stem cells taken from cloned bovine fetuses.

“The technique is not ready for use with humans, because the cells were taken from fetuses that developed for up to 120 days, which would clearly raise ethical questions if practiced in humans. But, the scientists who performed the study believe embryonic stem cells taken from days-old embryos in a petri dish, perhaps some leftover post-in-vitro fertilization, could impart the same benefits.

“‘The cells are so competitive and youthful that they just take over,’ said Robert Lanza, vice president of medical and scientific development at Advanced Cell Technology in Worcester, Massachusetts. Researchers from the Memorial Sloan-Kettering Cancer Center in New York City, University of Pennsylvania and the Mayo Clinic also worked on the project.

“Scientists already know that bone marrow transplants can cure diseases like leukemia. The paper, published in the June 2005 issue of Cloning and Stem Cells, shows that the fetal stem cells repopulated one cow’s bloodstream without using the harsh immunosuppressive drugs or tissue-matching necessary for bone marrow transplants today. The method also eliminates the risk of graft-versus-host disease. To compare results, they administered the drugs to the other two cows at different doses.

“‘This is a brilliant paper that breaks new ground in developing a large-animal model to understand crucial aspects of therapeutic cloning,’ said Gerald Schatten, professor of obstetrics, gynecology and reproductive sciences and cell biology and physiology at the University of Pittsburgh School of Medicine....”

The technical paper “Long-Term Bovine Hematopoietic Engraftment with Clone-Derived Stem Cells,” which reported this research on cows, was published in Cloning and Stem Cells and is available online.

Genetic technology can serve justice, but it also raises other questions...

Genetic Justice

“On December 21, 2004, Brandon Moon was released from prison in El Paso, Texas, after having served 16 years of a 75-year sentence for three counts of aggravated sexual assault. Moon, who was 43 years of age at the time of his release, had been convicted in 1988 on the testimony of the three victims, who had had only a fleeting or partial view of their assailant. In 2004, after undergoing DNA testing, Moon was excluded as the contributor of the DNA collected after all three rapes. As a result, Moon became the 154th person in the United States to be exonerated on the basis of DNA evidence that came to light after the person was convicted for a crime.

“The Innocence Project, founded in 1992 by Barry Scheck and Peter Neufeld at the Benjamin N. Cardozo School of Law in New York, pioneered the use of forensic DNA testing to provide scientific evidence of guilt or innocence after conviction. As described by Gill in another ‘Perspective’ article in this issue of the Journal, the technology has improved in the past decade, but the basic purpose of forensic DNA testing has not changed. The success of the Innocence Project led to the establishment of similar projects throughout the country, staffed by lawyers and law students working pro bono. Other persons and similar organizations not affiliated with the Innocence Project also use DNA evidence to free wrongfully convicted prisoners....”

PA Legislators Ponder Laws for Egg, Sperm Donors

“Spurred by two controversial reproductive-rights cases, the state Legislature is examining whether it should give special protections to surrogate mothers and to sperm and egg donors.

“Lawmakers will meet for the second time later this month to resume discussions about the two cases—one involving a Mt. Lebanon sperm donor who is being ordered to pay child support, and another in Erie where a surrogate mother decided to keep the triplets she carried for an Ohio couple.

“‘It’s becoming common in today’s society for a sperm donor, an egg donor or a surrogate mother to be used in family-building, and it’s in the best interest of everyone in this state to create a definitive pronouncement of who is a legal parent and define the rights and responsibilities of those parents,’ said Lawrence Kalikow, an attorney in Bucks County.

“Kalikow, an expert on surrogacy and sperm and egg donation, sits on the joint subcommittee on Assisted Reproductive Technologies, which first discussed the topic in April. Its 13 members include lawmakers, attorneys and judges.

“‘There are so many issues involved here, and there are no statues on the books that address them,’ Kalikow said. ‘The technology surrounding assisted reproduction is way ahead of the law addressing those technologies. The law needs to catch up—fast—before the waters get any murkier....’”

The Ethics of Amputation by Choice

Can society legitimize amputation by choice in a world where many have lost a limb through birth, war or natural disaster? (Image: Reuters/Faleh Kheiber)

“People should be able to have healthy limbs removed by choice, say two Australian philosophers who are exploring the phenomenon of ‘amputee wannabes’.

“Amputee wannabes become obsessed with cutting off a particular part of their body, even though it may be healthy.

“Past research has suggested this rare condition may be because they believe their body part is diseased or ugly, because the notion of becoming an amputee sexually excites them, or because of a mismatch between their body and their image of it.

“Dr Tim Bayne of Macquarie University and Dr Neil Levy from the University of Melbourne argue that people who want a healthy body part amputated are suffering from a condition known as body integrity identity disorder (BIID), or amputee identity disorder.

“Writing in the latest issue of the Journal of Applied Philosophy they say ‘such amputations should be morally permissible’ on the grounds that people with BIID are not ‘globally irrational’ and that they are experiencing suffering that can be alleviated through amputation....”

Test Reveals Gender Early in Pregnancy

Ethicists fear use in sex selection

“A new blood test being marketed to American women offers them the chance to find out whether they are having a boy or a girl almost as soon as they realize they are pregnant, as early as five weeks along.

“Just two or three days after mailing the test overnight to a Lowell lab for processing, a pregnant woman can know what color to paint the nursery—or even decide whether to get an abortion if she wants a child of the opposite sex, a prospect that worries ethicists.

“The $275 test works by detecting and analyzing fetal DNA floating in the mother’s blood, a method that researchers say holds promise for serious clinical uses, from cancer testing to prenatal diagnosis of Down syndrome....

“‘You can tiptoe around it, but the fact is that if you’re sending information about sex, then you’re in the sex-selection testing business,’ said bioethicist Arthur Caplan of the University of Pennsylvania. He would not ban the test, he said, but ‘I would condemn it.’

“Sex selection, mainly using ultrasound tests and abortion, is considered a growing and potentially destabilizing problem in parts of Asia. In its most extreme form, parents kill girl babies. In China, it has led to an imbalance of about 120 men for every 100 women; and in India, one recent report from an affluent area of New Delhi found that for every 1,000 boys born in 2004, only 762 girls were born....”

Brain Pacemaker Lifts Depression

“Fitting patients with a brain pacemaker could switch off hard-to-treat depression, believe UK experts.

“The technology, already used to treat Parkinson’s disease, uses wires and a battery source to stimulate deep parts of the brain with electric currents.

“As well as helping depressed patients who have failed on all other therapies, it might also be helpful for treating obsessive compulsive disorder (OCD).

“Experts at Bristol University and the Queen Elizabeth II Hospital in Welwyn Garden City are currently looking to recruiting patients with OCD to take part in a trial that will start later in the year....”

BMA Drops Euthanasia Opposition

“Doctors have voted to drop their opposition to changes to the law which would allow terminally ill patients to be helped to die.

“The British Medical Association conference said it should end its current stance against euthanasia and physician-assisted suicide.

“When the BMA discussed the issue earlier this week, doctors spoke powerfully for and against change.

“They agreed that the question of the criminal law in relation to assisted dying was ‘primarily a matter for society and for Parliament.’

“Doctors backed a motion stating: ‘The BMA should not oppose legislation which alters the criminal law but should press for robust safeguards both for patients and for doctors who not wish to be involved in such procedures.’

Biotech and the New Babel

An interview with Leon Kass, Chairman of the President’s Council on Bioethics

Dr. Leon Kass

“We are in quest of personal immortality. The only good that everybody can now agree on is health. Life, health and longevity—those are good things.

“We have actually gotten so accustomed to the benefits of modern medicine that we are greedy. We don’t live with our improved health grateful for the fact that we no longer die of polio or smallpox. Now we expect that when we need a kidney, one should be found. And we regard anything that gets in the way of our having our organs replaced as, in fact, responsible for our deaths.

“Predictably, the satisfaction of desire has only led to the inflation of our desires.

“With the decline of the belief in an afterlife and with an increasing belief that this is the only life, the desire to stick around and not check out grows without bounds. We are more afraid of death than ever and more attached to this life than ever. The only thing we can agree is good is better health, longer life and relief of suffering.

“Yet, this pursuit of bodily immortality for ourselves is a deformation. It actually gets in the way of our trying to realize as much as we can, in this life, those aspirations for something higher to which I believe our souls naturally point.

“The immortality the various religious traditions offer us is not a promise of continuation of more of the same, only indefinitely. It is a promise of fulfillment of deeper longings, whether it is for wisdom or for full unity with a beloved, or whether it is to be in God’s presence.

“It is not the promise of being able to go shopping at Wal-Mart until the last trump, even with vigor.

“It is not an accident that it is this first truly consumer generation that is interested in harvesting stem cells, using the seeds of the next generation to make sure that the present one won’t die....”

This interview with Leon Kass was published in the Fall 2004 issue of New Perspectives Quarterly. Kass is currently Chairman of the President’s Council on Bioethics and Hertog Fellow at the American Enterprise Institute. He is also professor in the Committee on Social Thought at the University of Chicago and author of Life, Liberty and the Pursuit of Dignity: The Challenge of Bioethics.

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Stem Cell Pioneer Does a Reality Check

James Thomson reflects on science and morality