Living in the Biotech Century -- June 23, 2005

Photo Credit: Snowflake Embryo Adoption

“In politics, it always helps to put a face on a cause. For supporters of embryonic stem cell research, nobody played that role quite like Christopher Reeve, the paralyzed actor who touted the promise of such research before his death in October.

“Opponents of embryonic stem cell research also have found their face, 21 of them. They are the children who helped President Bush show what a frozen embryo has the potential to become.

“‘The children here today remind us that there is no such thing as a spare embryo,’ Bush said last month at the White House.

“The embryos that would become these children were created through in-vitro fertilization and placed in frozen storage. They were donated by couples who no longer needed them to add to their families, were shipped overnight and eventually implanted in a woman who some nine months later became their birth mother.

“So far, 81 ‘snowflake’ babies have been born through embryo adoption, the president noted.

“‘We hear a lot of rhetoric that these are just clumps of cells,’ said Dr. David Prentice, a senior fellow at the conservative Family Research Council. ‘The snowflake kids are very effective in showing that they are very young humans that need to be given their chance for development.’

“Over the past two decades, since the first ‘test-tube baby’ was born, an estimated 400,000 frozen embryos have accumulated in more than 400 fertility clinics around the country. What to do with those frozen embryos has become a matter of intense debate....”

The Snowflake Embryo Adoption program was praised by President George W. Bush on May 24 at a White House press conference on stem cell research. His remarks following that meeting are available online. More information on the Snowflake Embryo Adoption program can be found at the website of Nightlight Christian Adoptions.

“No safe and effective stem cell therapy will be widely available for at least a decade...”

Lancet Calls For Caution In Touting Potential For Embryonic Stem Cells

“A prestigious British medical journal calls recent headlines that claim research using embryonic stem cells will lead to cures for an almost unending number of diseases to be ‘sensationalist’ and ‘hype’ even though the journal favors embryo-destructive research. In an editorial in the June 4 edition titled ‘Stem cell research: hope and hype,’ The Lancet noted the findings of a recent meeting of researchers in London, also supportive of embryonic stem cell research, who found that, ‘no safe and effective stem cell therapy will be widely available for at least a decade, and possibly longer.’

“Recent news that South Korean scientists successfully cloned a human embryo has increased the visibility of bold claims by those favoring embryo-destructive research that miracle cures for everything from Alzheimer’s to diabetes are around the corner if such research is allowed. Recent debate in the House of Representative over legislation that would provide federal funding for embryo-destructive research was filled with emotional pleas from House members on both sides of the aisle who claimed that such funding offered the best hope for family members struck with a variety of diseases.

“The Lancet also published a commentary from Neil Scolding, a British neurology researcher at the University of Bristol, highlighting the numerous technical problems with embryonic stem cell research. ‘[A]n increasing appreciation of the hazards of embryonic stem cells has rightly prevented the emergence or immediate prospect of any clinical therapies based on such cells. The natural propensity of embryonic stem cells to form [tumors], their exhibition of chromosomal abnormalities, and abnormalities in cloned mammals all present difficulties....’

“Scolding goes on to say that these problems only compound the ethical concerns that come from embryo-destructive research. ‘[W]hat is unarguable is that the human embryo is alive and is human, and intentionally ending the life of one human being for the potential benefit of others (ie, for research) is not territory to which mainstream clinical researchers have hitherto sought claim—or which ethically conscious objectors could ever concede....’”

Why the Media Miss the Stem-Cell Story

A science writer says the reasons range from religion and politics to lobbying and laziness.

“There’s little doubt that opponents of embryonic stem cell (ESC) research have their work cut out for them. Polls repeatedly show large majorities (in the 60-70 percent range) want the federal government to promote and fund the research. Californians backed their opinions with money with 59 percent of those who showed up at the polls voting for last November’s Proposition 71, which will funnel $3 billion of the cash-strapped state’s funds into embryonic stem-cell research over the next decade.

“But why—on a scientific issue, about which most people know relatively little—does public opinion seem so lopsided?

“One explanation is that the polls often feature loaded questions that begin with tales of the medical miracles ESCs will allegedly bring us: cures for Parkinson’s, Alzheimer’s, diabetes, you name it. They don’t even try to find out whether respondents really have any idea of what ESC research is. And as a rule, they don’t mention possible alternatives—namely, so-called adult stem cells (ASCs), which are obtained without the ethical conflicts of harvesting human embryos.

“But the biggest reason may simply be that the mainstream media are doing a lousy job of informing the public on the state of stem-cell science. By and large, they’re telling people all about the potential of ESCs—especially the supposed ability to become any type of cell-without talking about certain little drawbacks, like a tendency for ESCs to be rejected and even to become cancerous....”

Ethics, Eggs and Embryos

Thanks to medical advances, scientists are looking for a few good women to donate their oocytes to stem-cell research.

Andrea Modica for Newsweek

Ready to help: Pat Parkhouse, at home in Greenwood Village, Colo., with her husband, Steve

“Kim Barnett would do anything to help her dad. Already, she’s changed careers. That move came after Barnett noticed her father, who has Parkinson’s, drooling on an airplane in 2001. The disease had hijacked his instinct to swallow—and it devastated Barnett, who worried that outsiders would notice only the symptom, not the smart, funny man she loved. Within two years Barnett had given up her job as an educational consultant to head up the Parkinson Association of the Rockies. Today she says she’d do something far more personal to battle the disease: she’d donate her own biological eggs to stem-cell research. ‘It’s important to keep the advances going,’ says Barnett, 35. ‘I’m a blood donor and an organ donor. I don’t see donating eggs as anything different.’

“For months, politicians have been battling over the ethics of using embryos stored in fertility clinics for stem-cell research. But scientists aren’t setting their sights on embryos alone—they want eggs, too. The purpose: somatic cell nuclear transfer (SCNT), a complex technique that merges eggs (whose nuclei have been removed) with adult cells to create specialized embryonic-stem-cell lines....

“Egg donation has its roots in fertility medicine, where the practice has exploded. In 1996, donor eggs were used in just over 5,000 in vitro fertilization (IVF) cycles; by 2002, that number had almost tripled to 13,183. Donating eggs for babymaking is one thing. A woman submitting to weeks of hormone shots, blood work and, ultimately, surgical egg retrieval for a science that has no known benefit to the donor, a family member, or anyone else raises a host of thorny questions: Is the procedure safe? Should donors be paid? Are women being co-opted? Richard Doerflinger, of the United States Conference of Catholic Bishops, calls therapeutic cloning ‘a new evil’ on moral grounds. But one of the most outspoken critics is Judy Norsigian, coauthor of the newly revised ‘Our Bodies, Ourselves,’ the health bible for generations of women. Norsigian supports embryonic-stem-cell research, but says SCNT is too premature to warrant exposing women to fertility drugs: ‘The risks to would-be egg donors are not worth the hypothetical benefits....’”

Using nanotechnology to deliver anti-cancer drugs to cancer cells without harming healthy tissue...

Nanoparticles Deliver Cancer Breakthrough

“Tiny man-made nanoparticles have been used to successfully smuggle a powerful cancer drug into tumour cells—leaving healthy cells unharmed—in one of the first therapeutic uses for nanotechnology in living animals.

“When tested in mice, the nanostructure-based therapy was 10 times as effective at delaying tumour growth, and far less toxic, than the drug given alone. The researchers believe the therapy could transform many cancers from killers into chronic, treatable diseases.

“Branching polymer molecules, called dendrimers—less than five nanometres in diameter and small enough to pass through a cell membrane—were loaded with the anticancer drug methotrexate, the vitamin folic acid, and a fluorescent imaging agent....

“The technique employs cunning Trojan horse trickery. All living cells require folic acid to replicate, but cancer cells have a particularly strong appetite for it, displaying up to one thousand more docking sites—called folate receptors—on their membranes. By attaching five folic acid molecules to branches of the dendrimer, the researchers were able to lure the cancer cells into accepting the whole package across the membrane and into the cell - including the toxic drug, which then kills off the cell....

“James Baker, professor of biologic nanotechnology, who directed the study, explains: ‘This targeted binding gave us a million-fold improvement on drug uptake for cancer cells.

“‘It’s the first time that we’ve been able to inject a therapeutic cancer treatment into the bloodstream of an animal, and have it seek out tumour cells elsewhere in the body and target them to destruction....’”

Morphine Fails to Control Pain in Preterm Infants

“Morphine is no better than inactive placebo in preventing pain during procedures performed on preterm infants, according to a new study.

“This issue is important, the investigators explain, because pain from repeated procedures may permanently affect how these individuals process pain throughout their lives.

“Dr. Ricardo Carbajal and his associates suggest in the medical journal Pediatrics that the lack of pain relief with morphine in preemies may be caused by the immaturity of morphine drug receptors in the body or by altered breakdown of the drug in the liver.

“Although morphine is commonly used during routine procedures on preemies, previous studies of morphine use in this population have yielded mixed results.

“For their own trial, Carbajal, from Hopital d’Enfants Armand Trousseau in Paris, and his team studied 42 premature infants who required a mechanical ventilator for breathing assistance. The infants were randomly selected to receive morphine or placebo during painful procedures, such as blood draws. Standard scoring systems were used to gauge pain.

“As noted, the authors found no evidence that morphine was any better than placebo at controlling pain....”

An abstract of the paper, “Morphine Does Not Provide Adequate Analgesia for Acute Procedural Pain Among Preterm Neonates,” which was published in the June issue of Pediatrics, is available online. The paper is available free to subscribers or for a fee to non-subscribers.

Doctor: Schiavo Autopsy Conclusions Flawed

“...I have had a chance to look at Dr. Nelson’s analysis of the brain tissue, and essentially, as a clinician, these are my thoughts.

“The autopsy results confirmed my opinion and Dr. Maxfield’s opinions, that the frontal areas of the brains, the areas that deal with awareness and cognition were relatively intact. To use Dr. Nelson’s words, ‘relatively preserved.’ In fact, the relay areas from the frontal and front temporal regions of the brain, to the spinal cord and the brain stem, by way of the basal ganglia, were preserved, thus the evident responses which she was able to express to her family and to the clinicians seeing her or viewing her videotape. The Spect scan confirmed these areas were functional and not scar tissue, and that was apparently also confirmed on Dr. Nelson’s review of the slides. Dr. Maxfield’s estimates of retained brain weight were apparently accurate, although there may have been some loss of brain weight due to the last two weeks of dehydration.

“Dr. Maxfield and myself both emphasized that she was a woman trapped in her body, similar to a child with cerebral palsy, and that was borne out by the autopsy, showing greater injury in the motor and visual centers of the brain. Obviously, the pathologists comments that she could not see were not borne out by reality, and thus his assessment must represent sampling error. The videotapes clearly showed her seeing, and even Dr. Cranford, for the husband, commented to her that, when she could see the balloon, she could follow it with her eyes as per his request.

“That she could not swallow was obviously not borne out by the reality that she was swallowing her saliva, about 1.5 liters per day of liquid, and the clinical swallowing tests done by Dr. Young and Dr. Carpenter. Thus, there appears to be some limitations to the clinical accuracy of an autopsy in evaluating function....”

What can you do with the stem cells once you’ve abused the embryo?

‘Two Dad’ Babies on the Horizon?

“The specter of a baby being born with DNA from two men has edged a little closer, with news from a scientific conference in Europe that embryonic stem calls can be manipulated in a lab to form the precursors of sperm and eggs.

“In theory, the finding means that in the future a child could be created using the genes of two homosexuals—the sperm of one, and an egg engineered from the stem cells of the other.

“It also could theoretically enable a single man to have a child—a clone—using his sperm and a synthetic egg created in the lab from his own genetic material. Similarly, a woman could have a cloned baby using her own egg and artificial sperm created from her own cells.

“Physical barriers that now prevent homosexuals, infertile couples, older women or even single people from having their own genetic children could therefore fall away.

“The news was announced Monday [June 20] at a European Society of Human Reproduction and Embryology (ESHRE) conference in Copenhagen, Denmark.

“Scientists from Britain’s University of Sheffield said they had proved for the first time the ability of human embryonic stem cells (ESC) to form the ‘primordial germ cells’ that eventually become eggs and sperm.

“‘This is moving the argument beyond what you do with the embryo,’ Dr. David van Gend of the World Federation of Doctors Who Respect Human Life said Tuesday. ‘It’s about what you can do with those cells once you’ve abused the embryo....’”

Scientists Study Scientists Behaving Badly

“While rare cases of scientific fraud grab headlines, more mundane misbehaviors are so common among researchers that they pose a threat to the integrity of the scientific enterprise, a new report asserts.

“One-third of scientists surveyed said that within the previous three years, they’d engaged in at least one practice that would probably get them into trouble, the report said. Examples included circumventing minor aspects of rules for doing research on people and overlooking a colleague’s use of flawed data or questionable interpretation of data.

“Such behaviors are ‘primarily flying below the radar screen right now,’ said Brian C. Martinson of the HealthPartners Research Foundation in Minneapolis, who presents the survey results with colleagues in a commentary in Thursday’s issue [June 9] of the journal Nature.

“Scientists ‘can no longer remain complacent about such misbehavior,’ the commentary says....”

The report “Scientists Behaving Badly,” written by researcher Brian C. Martinson and his colleagues for Nature, is available online.

Thousands of Guidant Heart Defibrillators Being Recalled by U.S. Regulator

“Guidant Corp. is voluntarily recalling nearly 50,000 of its cardiac defibrillators, implanted in patients worldwide, because of potential malfunctions in the devices, the company said Friday.

“Indianapolis-based Guidant said it was advising doctors about the safety of several defibrillator models, which have failed at least 45 times and have caused at least two deaths through May 30.

“‘This is a voluntary recall,’ U.S. Food and Drug Administration spokeswoman Julie Zawisza said. ‘We’re in complete agreement that they need to do that.’

“Guidant came under fire this spring after reports that it failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.

“Friday’s recall includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.

“The company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use....”

“Contrary to what one might at first think, there is no contradiction in terms here, since complacency does after all have its norms, and even its demands, to which society ultimately submits....

“The break with the notion of an objective ‘good,’ which specifically characterizes modernity, allows the rise of a ‘good’ defined by each individual within the sovereignty of his own conscience. The ‘good,’ as something objective and given from the exterior, was the product of a religious or ideological worldview and brought with it a hierarchy of norms that rested upon a truth. It proposed, or imposed, not only the meaning of existence—it identified what existence can expect—but the very blueprint of a ‘good’ existence. It brought with it the architecture or model of a respectable human life that was generally esteemed and devoted to happiness. Ancient morality, and later, Christianity—and even modern ideologies—spoke less of a series of piecemeal collection of ‘goods’ as of a ‘good life.’

“The individual who has now been left to himself to determine his own ‘good’ has not only been ‘liberated,’ in the modern sense, from this truth that weighed upon him. He has at the same time lost the overarching rationale by which the idea of the ‘good life’ is made intelligible. We might expect that the sovereign individual would become the creator of his ethics. After all, he is not supposed to receive anything from anyone, and must find within himself everything he needs to exist with dignity, which corresponds here to an idea of the good.

“However, if the human subject defines himself by the ability to create norms, each individual cannot really be expected to be able to create his own ethical blueprint. In an earlier time, each individual’s birthright was an ethical blueprint given him along with the first smile of his mother. He could of course later modify it or reject it altogether, but he then had to bear the marginalization that this choice would inevitably bring. In this respect, each individual was blessed at birth with an ethics, and it is uniquely modern to have understood this blessing as a form of slavery, since, for modern man, to have to accept an ethics from someone other than oneself is oppressive. This is why contemporary man is born into a shapeless, soundproof, de-clawed, and innocuous world, and why it is up to him to give it direction. He has to assign a name to his own dynamic impulse in the darkened absence of signs, and he has to do this alone....”

“The Morality of Complacency” was published in the electronic journal The New Pantagruel (Issue 1.2, Spring 2004) and is available online. The original essay was published as Chapter 6 in Icarus Fallen: The Search for Meaning in a Uncertain World. Chantal Delsol, a well-know political philosopher in France, is professor of philosophy at the University of Marne-La-Vallée near Paris.

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Frozen Embryos Focus in Stem Cell Debate

Lancet Calls For Caution In Touting Potential For Embryonic Stem Cells