News from the Field (Summer 2004)

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South Korean Scientists Clone Human Embryos

Scientists in South Korea have announced that they have successfully created cloned human embryos—the first announcement of its kind to be published in a peer-reviewed journal.

The researchers took 242 eggs from 15 egg donors, successfully created 30 blastocysts, and established one embryonic stem cell line. Prior announcements of successful human cloning such as those by Advanced Cell Technology, Italian reproductive specialist Severino Antinori, and Clonaid (a company tied to the Raelian cult group) could not be independently reviewed or verified.

The article was published in the journal Science and included detailed descriptions of the cloning methods with explanations of what worked and what didn’t. The descriptions provided a very clear roadmap for other researchers to carry the work forward. Interestingly, the scientists suspended their efforts subsequent to the announcement in order to have an “ethical review” of the practice.

PCB Dismisses Two Members, Adds Three New Ones

The President’s Council on Bioethics has dismissed two of its members and added three new ones as it moves on to address new topic areas. The dismissed Council members were Elizabeth Blackburn, a cell biologist at University of California San Francisco and former president of the American Society of Cell Biology, and William

F. May, retired professor of ethics from Southern Methodist University. Both members had opposed the position of Council Chairman Leon Kass and the Bush Administration on cloning.

The changeover brought an immediate outcry from Kass’s opponents who claimed that he was attempting to stack the Council with ideologically-friendly members, a claim that Kass fervently denied. Kass responded to critics in a Washington Post op-ed citing the fact that the Council would be moving to “focus on issues of neuroscience, brain and behavior” as an appropriate reason to replace Blackburn, a cell biologist, with Dr. Benjamin Carson, director of pediatric neurosurgery at Johns Hopkins Children’s Center in Baltimore. May had indicated a desire to leave the Council since he had retired from teaching.

The other two additions to the Council are Diana J. Schaub, political scientist from Loyola College, in Maryland, and Peter A. Lawler, a government professor at Berry College in Georgia. There had already been one open vacancy on the Council when Steven Carter of Yale University resigned in 2002 due to lack of time to participate.

Doctors Begin Screening Patients for Malpractice Claims

A new web site designed to enable doctors nationwide to screen potential new patients to determine if they’ve ever filed a malpractice lawsuit has closed its doors in the face of public outcry. The web site, DoctorsKnow.Us, had been in operation since November 2003 and billed itself as a “physician designed, owned and operated” company that could help a physician with the risk management aspect of their business. It closed on March 9.

Doctors, clinics, hospitals, and insurance companies had all been courted by the web site which stated that “defensive medicine is becoming the norm as a means of fending off potential malpractice cases.” For a mere $4.95 a month (for up to 250 searches) or $7.50 a month (for constant monitoring of up to 250 existing patients), members of the medical community could determine if someone had filed a malpractice lawsuit, been a plaintiff attorney, or served as an expert witness for a plaintiff.

After a story in the New York Times quoted the site’s motto, “They can sue, but they can’t hide,” the site replaced the motto with the statement, “National Plaintiff Database. This is not a blacklist. Many patients have meritorious cases.” However, search results only offered basic case information such as where a case was filed, a filing date, and a statement of current status—nothing that indicated the merit of the claim. Less than a week after the story was published, the site shut down.

Is “Parachute Research” Ethical?

Pharmaceutical and biotech companies looking for ways to reduce costs of required clinical trials of new drugs and medical treatments are beginning to turn their attention overseas.

Referred to as “parachute research” by Dr. Lawrence Gostin, director of the Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities, the term refers to the practice of a company going into a poor foreign country, often in Eastern or Central Europe, performing clinical trials, and then leaving without making the drug available to other poor, sick residents.

Some people argue that the poor in these countries are at least receiving some benefit that they wouldn’t otherwise have. Others say the practice is exploitation of the poor for shareholder profit. Companies who are beginning to do research overseas are currently struggling with the question of what they are ethically required to do for the citizens who willingly take the risk to prove a treatment’s safety and efficacy. Look for the debate to continue as this practice continues to rise.