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Living in the Biotech Century

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September 6, 2005

The politics of science...

Scientists Challenge Fetal Pain Discussion

Critics dispute findings, claim review is biased

“Doctors should not be required to discuss fetal pain with women seeking abortions because fetuses likely can’t feel pain until late in pregnancy, according to a review critics say hardly settles the contentious topic.

“Researchers at the University of California, San Francisco reviewed dozens of studies and medical reports and said the data indicate that fetuses likely are incapable of feeling pain until around the seventh month of pregnancy, when they are about 28 weeks old.

“Based on the evidence, discussions of fetal pain for abortions performed before the end of the second trimester should not be mandatory, according to the study appearing in Wednesday’s Journal of the American Medical Association.

“The review, researchers say, is an attempt to present a comprehensive, objective report on evidence to inform the debate over fetal pain laws aimed at making women think twice before getting abortions.

“Critics angrily disputed the findings and claimed the report is biased.

“‘They have literally stuck their hands into a hornet’s nest,’ said Dr. Kanwaljeet Anand, a fetal pain researcher at the University of Arkansas for Medical Sciences, who believes fetuses as young as 20 weeks old feel pain. ‘This is going to inflame a lot of scientists who are very, very concerned and are far more knowledgeable in this area than the authors appear to be. This is not the last word—definitely not....’”

AP/CNN.com – August 24, 2005

The new Harvard procedure still requires cell lines taken from a human embryo...

Stem Cell Advance Muddles Debate

Work May Stall Efforts To Lift Research Limits

“A Harvard University advance in generating embryonic stem cells may have the unintended consequence of hindering congressional efforts to lift research restrictions imposed by President Bush four years ago, leaders on both sides of the issue said yesterday as details of the discovery traveled through the scientific and political communities.

“The news that Harvard scientists have successfully converted human skin cells into embryonic stem cells—without using a human egg or new embryo—is likely to muddle the already complex debate over federal stem cell research policy.

“Even as they were describing the findings being published this week in the journal Science, the researchers cautioned yesterday that the new approach is still in the early stages. They exhorted lawmakers to press ahead with the more conventional, but controversial, technique of removing stem cells from days-old human embryos....

“The Harvard discovery complicates the Senate prospects because it offers the tantalizing, albeit distant, prospect of creating genetically tailored hybrid cells without destroying new embryos. The technique used laboratory-grown human embryonic stem cells to ‘reprogram’ the genes in a person’s skin cell, turning that skin cell into an embryonic stem cell. In the future, scientists hope to begin the process with an adult cell and convert it into an embryonic cell before fusing it....”

WashingtonPost.com – August 23, 2005

Embryonic stem cells are not immortal after all...

Embryonic Stem Cells Found to Acquire Mutations

Abnormalities Could Produce Tumors; Scientists Say Evidence May Point to Need for Fresh Colonies

“Human embryonic stem cells, treasured by researchers because of their potential to help rejuvenate ailing organs, do not remain as ageless and perpetually unblemished as scientists once thought, according to a new research report.

“Like ordinary cells, stem cells accumulate significant numbers of mutations over time, including several that could cause them to become tumors.

“The findings, reported by an international team of scientists yesterday, could bolster those who have been calling upon President Bush to allow the use of federal money to create fresh stem cell colonies.

“Embryonic stem cells, obtained from days-old human embryos, can morph into all kinds of tissues. They divide repeatedly in laboratory dishes, churning out self-replenishing colonies indefinitely—a trait that has lent them a reputation as virtual fountains of youth.

“Researchers hope to harvest batches of the cells periodically from master colonies and turn them into various kinds of tissues for transplantation into patients.

“But the longer stem cells are cultivated—and the more cell divisions they undergo—the more mutations build up in their genes, Aravinda Chakravarti of Johns Hopkins Medical Institutions and his colleagues reported in yesterday’s issue of the journal Nature Genetics....”

Washington Post – September 5, 2005

Another promising trial using adult stem cells...

Japanese Doctors Claim Heart Disease Breakthrough

“A doctor at Saitama Medical School announced Saturday that a 61-year-old heart attack patient had been successfully treated using bone marrow cells.

“Dr. Shunei Kyo said at a press conference that the patient was discharged by the hospital after being disconnected from an artificial heart.

“This could be the first case worldwide in which a patient has recovered sufficient heart function to survive without an artificial heart, according to Kyo.

“The patient had a heart attack on Feb. 3 and was admitted to the Saitama Medical Center in Kawagoe, Saitama Prefecture, which is operated by Saitama Medical School in Moroyamamachi.

“He was fitted with an external artificial heart, but because of his age and other factors, was judged by doctors to be unsuitable for heart transplant.

“On May 18, a group of doctors led by Kyo and Dr. Satoshi Gojo, a lecturer at the medical school, conducted regenerative stem cell treatment from the patient’s bone marrow. The patient’s heart function recovered to the extent that he could live without the artificial heart. The artificial heart was removed on June 30....”

TimesLeader.com – August 27, 2005

“I view the current wave of optimism about embryonic stem cells with growing suspicion....”

Stem Cell Hopes Distorted by ‘Arrogance and Spin’

“A leading scientist who pushed for the controversial research into embryo stem cells will warn today that the challenges are so huge that any cures for disease lie a long way in the future.

“Lord Winston, who pioneered fertility research in the UK, is to tell the British Association for the Advancement of Science, meeting in Dublin, that during the political campaign to push through legislation in 2001, some parliamentarians were led to believe that clinical treatments were ‘just around the corner’. Some of the lobbying came from patients’ groups, but it was stimulated by scientific observations.

“‘When disappointment sets in, as may be possible, we can expect a massive backlash by the “right to life” groups, who are always ready to pounce when they perceive a chink in our arguments,’ he will say. He singles out embryo stem cells as a case study in scientific arrogance and the dangers of ‘spinning’ a good story....”

The Guardian – September 5, 2005

A decision in the first of the Vioxx cases...

Jury: Merck Negligent

Merck blamed for death in Vioxx suit; jury awards $253 million in damages. Drug giant to appeal.

“Merck has been held liable by a Texas jury in the first lawsuit involving its former blockbuster drug Vioxx, in a case that could have a profound effect on thousands of other cases filed against the company.

“Plaintiff Carol Ernst has won her lawsuit in Texas Superior Court in Angleton, which blames Vioxx for the 2001 death of her husband, Robert Ernst, a 59-year-old marathon runner and Wal-Mart worker who was taking the arthritis painkiller at the time of his death. Ernst died of a heart attack.

“The verdict held Merck liable for the death. Jurors voted 10-2 in favor of Ernst.

“The jury awarded more than $250 million in total damages—$24 million to Carol Ernst for mental anguish and loss of companionship, and $229 million in punitive damages. Ernst’s Houston-based lawyer, Mark Lanier, said the punitive-damages figure was based on ‘the money Merck made and saved by putting off their product label changes....’”

CNN/Money – August 22, 2005

Should this decision be made on the basis of enforceability or ethics?

FDA Delays Decision on Morning-After Pill

“It’s like being in purgatory,” says Barr CEO after yet another postponement

“The government on Friday [August 26] put off its long-awaited final decision on whether to sell emergency contraception without a prescription, saying the pill was safe to sell over-the-counter to adults but grappling with how to keep it out of the hands of young teenagers.

“In a surprise move, the Food and Drug Administration postponed for at least 60 days a final decision on how to allow nonprescription sales of the morning-after pill called Plan B just to women 17 or older.

“‘Enforceability is the key question,’ said FDA Commissioner Lester Crawford....”

Associated Press/MSNBC.com – August 26, 2005

Will individualism, public relations, and money trump in the battle over organ allocation?

Debate over Appeals for Organs Heats Up

“The group that controls the nation’s organ-transplant system is debating a rule to keep patients who advertise for organs from gaining unfair advantage over others. The rule would restrict who could receive organs from a deceased donor.

“Amid an explosion in public appeals, a committee of United Network for Organ Sharing is considering ways to make sure every potential transplant patient has an equal shot at getting an organ.

“United Network for Organ Sharing manages the nation’s transplant lists and oversees distribution of deceased-donor organs.

“As wait times grow, more and more patients are asking the public for organs — in newspaper ads, on billboards and on the Internet. Those pushing for restrictions fear a free-for-all, with transplant candidates scrambling to avoid the waiting list, soon to top 90,000....”

STLtoday.com – August 24, 2005

Considering the ethics of the artificial womb...

From Foetus to Full Term—Without a Mother’s Touch

“Artificial wombs, to bring a foetus of a human being to full term outside a woman’s body, could become a reality within 20 years, scientists have predicted.

“This could present great advantages in the case of very premature babies, which could be nurtured to full pregnancy term in artificial wombs, thereby reducing the risk of long-term developmental problems.

“Such technology might also appeal to those who cannot have children naturally, such as women with a damaged uterus or no uterus at all, or to gay couples. The need for surrogate mothers could disappear.

“Experiments with human embryos, mice and goats have already had some success. But the technology raises significant ethical challenges and should not proceed without full ethical debate, Frida Simonstein, of Ben Gurion University in Israel, said.

“She told a weekend conference in Barcelona on ethics and emerging medical technologies that these problems were not insurmountable.

“‘Society now expects better outcomes for premature babies. Society also demands improvement in IVF effectiveness. Yet society should be equally aware that these demands require research that leads to the development of an artificial womb.’

“‘We must start discussing this topic now while we have still enough time to decide what we may want, and why....’”

Times Online – August 30, 2005

Finding applications for nanotechnology...

Possibility of a Continuously Functioning, Wearable or Implantable Artificial Kidney

“Researchers have developed a human nephron filter (HNF) that would eventually make possible a continuously functioning, wearable or implantable artificial kidney.

“This study is published in the latest issue of Hemodialysis International.

“The HNF is the first application in developing a renal replacement therapy (RRT) to potentially eliminate the need for dialysis or kidney transplantation in end-stage renal disease patients. The HNF utilizes a unique membrane system created through applied nanotechnology. In the ideal RRT device, this technology would be used to mimic the function of natural kidneys, continuously operating, and based on individual patient needs....”

News-Medical.Net – August 30, 2005

Worth considering...

From The Culture:  “Upstream” from Politics

by William B. Wichterman

“The primary spiritual illness afflicting the culture is the loss of an active belief in absolute truth that transcends the immanent realm or present temporal world. Transcendence, as it will be used here, refers to belief in absolute truth grounded in a reality larger than the collection of temporal events and experiences forming everyday life. C. S. Lewis refers to belief in transcendence or ‘the Tao’ as ‘the doctrine of objective value, the belief that certain attitudes are really true, and others really false, to the kind of thing the universe is and the kind of things we are.’ This is not to say that cultures rooted in transcendent truth are immune to social decay. Indeed, the content of this belief in transcendent truth is very important. Nonetheless, it is the eroding of belief in transcendence and the rise of subjectivism that is at the core of the American culture’s declining health.

“At first glance, the rejection of transcendence by Americans is not readily apparent from the evidence.... [A] significant percentage of Americans have inherited a theistic world from previous generations but they have ‘syncretized’ it with the cultural elite’s relativism, holding fundamentally incompatible ideas and affirming both simultaneously. The so-called moral majority is at best a schizophrenic majority, both embracing a transcendent God of the universe and rejecting the very basis of that belief.

“James Davison Hunter’s portrait of America as a deeply divided people, locked in a culture war with one another, does not seem to comport with the operational subjectivism of most Americans. Closer to the mark may be Alan Wolfe’s One Nation, After All. Wolfe argues that there is no culture war because the middle class does not believe in most things strongly enough to want to impose them on others. While he agrees that America’s elites are engaged in cultural conflict, he finds that America’s middle class has found a common creed in a nonjudgmentalism that trumps morality. Thus, when the Supreme Court hands down decisions overturning state restrictions on abortion and Internet obscenity, bans student-led prayer in official school functions, and mandates legal authority to enact special rights for homosexuals as a protected class, Americans register their disapproval in opinion polls, but not at the polling booth. Where the Court’s decisions should provoke legislative and electoral resistance, the public shrugs. For many supposedly theistic Americans, their morality has no legs....”

“The Culture:  ‘Upstream’ from Politics,” by William B. Wichterman, is one of the essays collected in Building a Healthy Culture: Strategies for an American Renaissance, edited by Don Eberly (William B. Eerdmans Publishing Company, 2001).

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