Living in the Biotech Century -- January 24, 2006

British Scientists Are Seeking Permission to Create Hybrid Embryos by Fusing Human Cells with Rabbit Eggs.

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Although made of rabbit cell material, scientists say the embryos would be controlled by human DNA.

“The scientists want to use the embryos to produce stem cells that carry genetic defects. Studying those stem cells could help understand a number of currently incurable diseases in humans.

“Although made of rabbit cell material, scientists say the embryos would be controlled by human DNA.

“They would not be allowed to grow beyond an early stage in the laboratory, and would only be used to investigate stem cell development, genetic defects and disease, they say.

“Legal experts say it is not clear whether the embryos would be regarded in law as rabbit or human....”

“...we are still talking about the unlawful killing of 2,800 vulnerable people...”

“Doctors in the UK were responsible for the deaths, through euthanasia, of nearly 3,000 people last year, it was revealed yesterday in the first authoritative study of the decisions they take when faced with terminally-ill patients. More than 170,000 patients, almost a third of all deaths, had treatment withdrawn or withheld which would have hastened their demise.

“The figures, extrapolated from the study, show rates of euthanasia and doctor-assisted suicide which are significantly lower than anywhere else in Europe, Australia and New Zealand, where similar studies have been done. The numbers immediately provoked controversy.

“‘This research proves that some doctors break the law and deliberately help patients die,’ said Deborah Annetts, chief executive of the Voluntary Euthanasia Society. ‘This is all done in secret and denied in public. Some of these doctors are acting compassionately on their patients’ wishes, but some clearly act without consent. This cannot be safe.’

“However, Clive Seale, of the school of social science and law at Brunel University, who conducted the research with funds from the Nuffield Foundation, said the proportions of respondents who had been involved in euthanasia were small. ‘I think doctors in the UK are taking important decisions to alleviate suffering, but not necessarily ones that are illegal,’ Professor Seale told the Guardian....”

Stem Cell effort Mired in Legal Bog, Global Scandal — With Prop. 71 Funding on Hold, California’s Lead Role in Doubt

“California’s Proposition 71 program was intended to create a $3 billion West Coast counterpart to the National Institutes of Health empowered to go where the NIH could not: full steam into the new field of biomedical research centered on human embryonic stem cells.

“Instead, the program has gotten stuck in a seemingly endless legal morass. Although state officials say they are optimistic about their chances in court, it’s expected that the program will take at least 15 more months to slog through appeals and start issuing the first major grants. Meanwhile, revelations of faked cloning research in South Korea have set back the scientific agenda and scandalized the entire stem cell field.

“Rather than ramping up a bold, $350 million annual grant-making operation, the California Institute for Regenerative Medicine appears to be entering a new era of declining expectations one year into its intended 10-year lifespan....”

Jaenisch

Photo: Sam Ogden

Whitehead Member Rudolf Jaenisch

“Scientists generally agree that all cloned animals are biologically flawed. But they don’t agree about what that means for stem cells derived from cloned embryos, the basis for therapeutic cloning.

“Also known as somatic cell nuclear transfer, therapeutic cloning is a promising approach to create individually customized cellular therapies for treating certain disorders. Demonstrated in mice but not in humans, it begins with stem cells derived from a cloned embryo. But if cloned embryos can’t produce normal organisms, how can they produce normal stem cells?

“Analyzing the complete gene-expression profiles of both cloned and fertilization-derived stem cells in mice, scientists at Whitehead Institute for Biomedical Research now have concluded that the two are, in fact, indistinguishable.

“‘This paper demonstrates clearly that it doesn’t matter if a stem cell has been derived from a cloned embryo or from a fertilized embryo,’ says Whitehead Member Rudolf Jaenisch, senior author on the paper that will appear online the week of January 16 in the Proceedings of the National Academy of Sciences. ‘Both can be equally good for therapy.’

“To create a clone, a scientist removes the nucleus from a donor cell, then places it into an egg from which the nucleus has been removed. The researcher then tricks the egg into thinking it’s been fertilized. The egg develops into a blastocyst, an early stage embryo consisting of no more than 100 or so cells. The scientist can then either remove the stem cells from this blastocyst, or place it into a uterus where it has the potential to develop into a fetus.

Adult stem cells may be free of the ethical concerns that hamper embryonic stem cell research, but they still pose formidable scientific challenges.

“Chief among these is the doggedness with which adult stem cells differentiate into mature tissue the moment they’re isolated from the body. This makes it nearly impossible for researchers to multiply them in the laboratory. And because adult stem cells are so rare, that makes it difficult to use them for treating disease.

“Now, researchers in the lab of Whitehead Institute Member and MIT professor of biology Harvey Lodish have discovered a way to multiply an adult stem cell 30-fold, an expansion that offers tremendous promise for treatments such as bone marrow transplants and perhaps even gene therapy.

“‘A 30-fold increase is ten times higher than anyone’s achieved before,’ says Lodish, senior author on the paper, which will be published January 22 online in Nature Medicine.

“Unlike embryonic stem cells, adult stem cells are generally tissue-specific, each one destined to develop into several kinds of cells. Chengcheng Zhang, a postdoctoral researcher in the Lodish lab, was determined to develop a way to multiply adult stem cells once they’ve been isolated from tissue. Achieving this goal required some intricate laboratory sleuthing....”

Left: Shortly after participating in a clinical trial of a new therapy using adult stem cell injections, Hwang Mi-sun, a paraplegic, was able to take a few steps at a press conference in November 2004. Right: Ms. Hwang earlier this month. After her second round of stem cell treatment last April, Ms. Hwang is unable to sit erect for long periods of time and spends most of her day in bed.

“Hwang Mi-sun, 39, was once hailed as proof that miracle cures can happen. Paralyzed from the waist down and confined to a wheelchair because of a spinal cord injury she suffered when she was 19, she met the press on Nov. 25, 2004, and took a few steps with the aid of a walker.

“The press conference was called by a team of researchers at Chosun University's medical school, Seoul National University's veterinary college and Seoul Cord Bank, a biotechnology company, who had treated Ms. Hwang with injections of adult stem cells.

“Just over a year later, Ms. Hwang says her miracle has turned into a nightmare. She can no longer even sit in a wheelchair and now spends most of her time in bed and says she is in constant pain. Her story, and others like it, suggests that there was a headlong rush by the government and medical researchers to get a step ahead of the rest of the world in stem cell therapy and that corners were cut, including by the government's medical oversight body....”

Editor’s Note: This article correctly points out that there are no treatments (the authors use the term “drugs”) available using embryonic stem cells. However, the authors are not correct to say that there is “no proof of the effectiveness of adult stem cell therapy for any disease or condition.” For a brief overview of successful treatments using adult stem cells, see “Live Patients & Dead Mice” by Dr. David Prentice. Dr. Prentice is an adjunct faculty member at Georgetown Medical School and was formerly Professor of Life Sciences at Indiana State University (Terre Haute). The text of his presentation, “Adult Stem Cells,” to the President’s Council on Bioethics is available online.

“The Supreme Court voted 6-3 to uphold Oregon’s physician-assisted suicide law on Tuesday.

“In 2001, then-Attorney General John Ashcroft said assisted suicide is not a ‘legitimate medical purpose.’ Ashcroft warned that doctors who prescribed lethal doses of drugs would lose their licenses to prescribe federally controlled drugs under the Controlled Substances Act.

“But six of the Supreme Court justices—Anthony Kennedy, Sandra Day O’Connor, John Paul Stevens, David Souter, Ruth Bader Ginsburg, and Stephen Breyer—agreed that federal authority to regulate doctors does not trump Oregon’s 1997 law.

“Chief Justice John Roberts dissented, as did Justices Antonin Scalia and Clarence Thomas.

“‘If the term “legitimate medical purpose” has any meaning, it surely excludes the prescription of drugs to produce death,’ Scalia wrote.

“Tuesday’s Supreme Court ruling upholds an earlier decision by the 9th Circuit Court of Appeals, which said the federal government cannot punish or prosecute doctors for prescribing overdoses under Oregon’s voter-passed Death with Dignity Act....”

REPLACING JOINTS: Knees, $4.8 billion.

Zimmer Holdings’ NexGen LPS-Flex

“From head to toe, aging boomers are being kept alive and kicking—or at least walking—by an expanding array of devices that combine the newest medical knowledge with the latest breakthroughs in digital electronics and material sciences.

“Already, the medical device field has become one of the most innovative and profitable segments of the economy. And as wave after wave of baby boomers enter their prime health care spending years, the medical device market is expected to grow by double digits for years to come....

“The industry’s sweet spot now is the $10 billion market for implanted devices that regulate heartbeats; Guidant has been second only to Medtronic in that field. Forecasts call for that market to expand by 15 percent annually for the next five years, with the fastest growth likely to come from the most expensive and profitable products....”

“Down syndrome in the United States is more common than previously thought, at one case for every 733 live births, according to a new government report containing what are regarded as the most reliable estimates yet on the prevalence of 18 types of birth defects.

“Previously, Down syndrome, a type of retardation caused by a genetic mutation, was estimated to occur in a range of one in every 800 live births to one in every 1,000.

“The report, released Thursday by the Centers for Disease Control and Prevention, also found that cleft lip occurs in about one in every 1,000 births, and cleft palate in about one in every 1,500.

“The report was celebrated by advocacy groups that help families affected by birth defects. They noted that the new numbers are based on statewide data, while previous estimates were derived from selected clinics and hospitals.

“‘Until now, there’s been a real dearth of good, reliable, national statistics on Down syndrome,’ said Suzanne Armstrong, spokeswoman for the National Down Syndrome Society....”

“One of the most dangerous times in the hospital for patients is when they are wheeled out of their rooms and taken to the radiology department for a test or a procedure, according to report being released today.

“Medication errors that harm patients are seven times more frequent in the course of radiological services than in other hospital settings, according to the analysis by the United States Pharmacopeia, a nonprofit group that sets standards for the drug industry.

“‘Whenever a patient is moved from one location to another, the patient should ask where they are going and why,’ said John P. Santell of the organization’s Center for the Advancement of Patient Safety, who helped prepare the study. ‘Our report shows this is when the risk is particularly great.’

“The researchers said they hope the findings will prompt hospitals to examine the problem, find ways to minimize errors and let patients and their loved ones know they should be alert to mistakes at such times.

“...We live already in a world in which the life cycle has largely lost its ethical meaning. Aware as we may be that we are on a solitary journey that ends inevitably in the grave, few of us take our bearings from nature’s eternal teaching that there is a time to be born and a time to die. We learn little from the rhythm of growth and decay, everything in its season, our own finitude transcended and redeemed by generation upon generation of new birth and renewal, transforming each singular finite trajectory into a permanently recurring cycle of life.

“This cultural myopia is no trivial matter. Indeed, in the mass geriatric society it could have deadly consequences. For unless we learn to accept both our frailties and our finitude, we are likely to find the burdens of caregiving intolerable. And unless we learn how to let loved ones die when the time comes, we will be tempted to kill—self-righteously, of course, in the guise of a false compassion. Sooner or later, when the medical gospel of healthy aging and the legal gospel of living wills are shown to have been false teachings, we may easily fall prey to the utilitarian gospel of euthanasia, whose prophets are patiently waiting in the wings for their time upon our cultural stage. Paradoxically, a dogmatic insistence that patients must be kept alive regardless of the depth of their disabilities—that severe dementia or unmanageable suffering deserves no consideration in deciding when to ‘let nature take its course’—may only make mercy killing appear to be the more compassionate remedy for the miseries of extended decline.

“In the end, there is no ‘solution’ to the problems of old age, at least no solution that any civilized society could tolerate. But there are better and worse ways to see our aging condition. The better way begins in thinking of ourselves less as wholly autonomous individuals than as members of families; in relinquishing our mistaken belief that medicine can miraculously liberate our loved ones or ourselves from debility and decline, and instead taking up our role as caregivers; and in abjuring the fantasy that we can control the manner and the hour of our dying, learning instead to accept death in its proper season as mortal beings replaced and renewed by the generations that follow.”

Eric Cohen is the director of the program in biotechnology and American democracy at the Ethics and Public Policy Center, editor of the New Atlantis, and senior research consultant to the President’s Council on Bioethics. Leon R. Kass, the Hertog fellow at the American Enterprise Institute and professor in the Committee on Social Thought at the University of Chicago, served until recently as chairman of the President’s Council on Bioethics. Parts of this article rely on the newly released Council report, Taking Care: Ethical Caregiving in Our Aging Society, available online at www.bioethics.gov.

“Cast Me Not Off in Old Age” was published in the January 2006 edition of Commentary magazine.

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