The Philadelphia Inquirer
Tuesday, July 17, 2001
Ethicist spurs debate on biological research
By Andrea Knox
INQUIRER STAFF WRITER

Glenn McGee, a University of Pennsylvania bioethicist,
served on the ethics advisory board of a small Massachusetts
biotechnology company until last fall, when he learned
that the company had begun to clone both animal and human
embryos without consulting its ethics advisers.

McGee quietly resigned then from the ethics panel
of Advanced Cell Technology Inc., of Worcester,
a privately held company that is cloning endangered animal
species in hopes of keeping them from dying out,
and human embryos as sources of stem cells for medical
research.

But since word of McGee's resignation surfaced last week,
he has been speaking his mind about corporate ethics boards,
calling them "rubber stamps" created primarily to give an aura
of acceptability to anything a company decides to do.

"What looked like a ringside seat to exciting research
that needed ethical evaluation turns out to be an ethics stamp
of approval," he said yesterday.

McGee's accusations have heightened a long-simmering public
unease that the tide of biological advances, particularly in the
private sector, may be outrunning society's ability to understand
and control the consequences. His charges have added fuel
to a debate among bioethicists about the ethics of advising
companies on ethics.

Michael West, the founder and chief executive officer
of Advanced Cell Technology, said yesterday that McGee's
comments puzzled him, because "there has been a debate
among the ethics advisory board for a year"
about embryo cloning.

He acknowledged, however, that the ethics panel had not
been given specific information about the endangered-animal
project. West said neither he nor the panel's chair,
Ronald Green, a Dartmouth College bioethicist, felt it necessary
to tell the other members "because it had started before the ethics
advisory board was formed and we didn't see it as a priority."

Green could not be reached yesterday for comment.

McGee, who also serves as ethicist on the Food and Drug
Administration's genetics advisory panel, left Advanced Cell
Technology's board last fall. That was about the time the company
announced it had cloned an Asian gaur, an oxlike animal that
is in danger of becoming extinct in its native India and Myanmar.
The gaur embryo, cloned from a skin cell taken from a dead gaur,
was implanted and gestated in a cow.

McGee, who had served on the company's ethics board
for at least a year, said yesterday, "I didn't resign because they did
that research, but because it seemed inappropriate for them to create
a corporate ethics board and not consult it on anything."

Many animal conservationists protested the cloning plan,
saying that the cloned animal - whose cells contained some cow
DNA - bore little relationship to a gaur born and raised in the wild.
They said cloning was no substitute for habitat preservation
and gaur breeding programs. West responded that cloning
and habitat preservation did not need to be mutually exclusive.

The gaur died of dysentery two days after it was born.

Under the glare of publicity, West and McGee are trading
accusations.

West asserts that McGee never came to a meeting of the ethics
board; McGee replies that West did not return his phone calls
seeking to set up a board meeting, and that he missed the one
meeting scheduled during his tenure because of a canceled
plane flight.

Nevertheless, McGee's larger criticisms have fed widespread
concerns about corporate use of ethics boards, particularly
at biotechnology companies.

"The highest purpose [of such boards] is probably to foster
public debate and understanding about the ethical
implications of what is being done in these organizations,"
said Thomas Murray, president of the Hastings Center
in Garrison, N.Y.

"But that debate should take place before the controversial
experiment is done, and ethics committees ought not to be used
as an afterthought, as a means to excuse the actions
of an organization."

Murray said he did not know the facts of the dispute
between McGee and Advanced Cell Technology,
and was not commenting on that case.

However, he said, recent announcements by both
Advanced Cell Technology and Virginia Medical School's
Jones Institute that they had created or intended
to create human embryos for the express purpose
of harvesting their stem cells raised troubling questions
about how those institutions were using their ethics boards.

"Both said they had consulted their internal ethics committees
before doing what they claim to have done," Murray said.
"But Jones won't tell us who is on their ethics committee.

Meeting in secret and not revealing members' identities
is not accountability.

"Accountability is making public statements of your reasons
and of what actions you intend to take. And it's better
to do that before you perform a questionable activity."

West sought to minimize concerns that companies such
as his were moving into questionable areas without giving
the public adequate warning. He said his company
had published several journal articles, including one
on the ethical issues involved in recruiting egg and sperm
donors for embryo creation.

He also said that issues surrounding stem cell use
and embryo creation could be "easily controlled"
by legislation or actions of the FDA.

But, said McGee, "There is no easy way to have oversight
of stem cells. I am an ethicist on the FDA's genetic panel,
and the FDA has neither the money nor the staffing to
[monitor stem cell research]. And the idea that you could
pass a law saying you couldn't do this is [nonsense].
The First Amendment would prevent that, so there is zero
potential that such a regulation will be written."

Andrea Knox's e-mail address is [log in to unmask]

SOURCE: The Philadelphia Inquirer
http://inq.philly.com/content/inquirer/2001/07/17/front_page/ETHICS17.htm

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