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INFO/ Human Genetics Alert

December 05, 2001

This is a daily news clipping service from Human Genetics Alert.
(www.hgalert.org <http://www.hgalert.org/> )
The articles selected do not represent HGA's policies but are provided for
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Contents

1.       Senate Declines to Take Up Proposed Cloning Moratorium
2.       Sweden Research Body Calls for Human Embryo Cloning
3.       The Weaknesses of Science for Profit
4.       Embryo clone leads to fall-out
5.       Environmentalists Stand with Conservatives on Cloning
6.       Women Who Donate Eggs To Infertile Couples Earn a Reward -- But
          Pay a Price
7.       Cloning and Stem Cells Not Good Business -Expert

December 4, 2001
Senate Declines to Take Up Proposed Cloning Moratorium
By SHERYL GAY STOLBERG
WASHINGTON, Dec. 3 Despite entreaties from President Bush to ban any type
of cloning, either for reproduction or research, the Senate today refused to
take up a Republican measure to impose a six-month moratorium on the
technology.
The measure was rushed to the Senate floor in response to an announcement
last week by a Massachusetts biotechnology company that it had created the
first cloned human embryos, not to make babies but to develop tissues for
treating disease. All the embryos died, but the experiment revived the
cloning controversy, which had been dormant since the Sept. 11 terrorist
attacks.
The bill failed overwhelmingly on a procedural motion, in part because it
was bundled with another contentious but unrelated measure that would have
allowed oil drilling in the Arctic National Wildlife Refuge. Republican
leaders had hoped to force a vote on the issues by packaging them into an
amendment to an unrelated bill governing retirement benefits for railroad
workers.
The strategy failed when the maneuvering became so complicated that even its
supporters ended up voting against it for various reasons. Of 95 senators
present, 94 voted to prevent the oil drilling and cloning bills from coming
up for a vote. The lone exception was Senator George F. Allen, Republican of
Virginia.
The Republican leader, Trent Lott of Mississippi, vowed during the debate to
bring both bills up again. "These issues are not going to go away," he
warned.
It now appears unlikely that the Senate will enact cloning legislation this
year. But the issue is expected to come up next year, and already the Senate
has scheduled hearings on cloning. The first is set for Tuesday; Mike West,
president of Advanced Cell Technology, the Massachusetts biotechnology
company that conducted the recent cloning experiment, is scheduled to be the
lead witness.
The cloning bill would have put into place, for six months, legislation
identical to a bill adopted by the House of Representatives in July. The
House measure, which President Bush supports, would ban cloning for either
reproduction or research, and would outlaw the sale of treatments developed
from cloning.
Senator Sam Brownback, the Kansas Republican who is the Senate's leading
opponent of cloning, argued that the moratorium should be put in place while
the Senate debated a permanent ban. He called it "a very modest step."
There is widespread agreement among lawmakers that human cloning the
making of babies that are genetic replicas of adults is immoral and should
be outlawed. But the question of cloning for research, also called
therapeutic cloning, is, for many lawmakers, more complicated.
At the same time, the issue is tangled up with another controversy, that of
stem cell research. Stem cells are primordial cells that can grow into any
type of tissue in the body, and scientists say they hold great promise for
treating and curing disease. But in order to realize the full promise of
stem cells, researchers will have to create cells that will be compatible
with patients' own immune systems. One way to do this, experts say, is
through therapeutic cloning.
"I don't see any problem in banning human cloning," said Senator Barbara
Boxer, Democrat of California. "I think we'd get 100 to 0 on that one." But,
she added, "Why would we want to stop and derail stem cell research?"
But Mr. Brownback urged his colleagues not to mix cloning with stem cell
research. "Some have said this is about stem cells," Mr. Brownback said.
"It's not about stem cells. This is about cloning. This is about taking a
human individual and creating him by a cloned technology similar to that
used to create Dolly the sheep."
Mr. Brownback's bill draws support from across the political spectrum,
including environmental groups, abortion opponents, women's advocates and
Christian fundamentalists. But advocates for patients, as well as the
biotechnology industry, are strongly in support of therapeutic cloning, and
therefore oppose the Brownback legislation.
Daniel Perry, executive director of the Alliance for Aging Research, a
patient's group, said today that the bill "would set a very dangerous
precedent of bringing the police powers of the federal government into the
laboratories." He added, "We need a lot fuller debate on this."

Contents

Tuesday December 4 9:53 AM ET
Sweden Research Body Calls for Human Embryo Cloning

STOCKHOLM (Reuters) - A Swedish group of experts called on the government on
Tuesday to allow the cloning of human embryos to produce stem cells for
medical research.
The Research Council, mandated by the government to draw up ethical
guidelines into research, argued that the moral risks of this work would be
smaller than the possible medical gains.
The recommendation runs counter to the Council of Europe convention on human
rights, which opposes the artificial creation of embryos. Sweden, which has
signed but not yet ratified the convention, has a long tradition of medical
research and is home to many biotechnology companies.
``The basic question of stem cell research in Sweden is already answered
with a 'Yes','' Council Chairman Bengt Westerberg told a news conference.
``When it comes to therapeutic cloning we believe that the risk of offence
is smaller than the potential to cure diseases.''
Scientists believe that stem cells can be coaxed into developing many
different kinds of tissue, possibly treating conditions such as Parkinson's,
diabetes and heart diseases.
Stem cells are a master cell found in an embryo at a very early stage of its
development, but can also be derived from fully grown living beings.
U.S. biotechnology firm Advanced Cell Technology said last Friday it had
cloned a human embryo for the first time ever in a breakthrough aimed at
mining the embryo for stem cells to treat diseases rather than creating
human beings.
President Bush ( news
<http://rd.yahoo.com/DailyNews/manual/*http://search.news.yahoo.com/search/n
ews?p=%22President%20Bush%22&c=&n=20&yn=c&c=news&cs=nw> - web sites
<http://rd.yahoo.com/DailyNews/manual/*http://search.yahoo.com/search/search
?p=George+W.+Bush> ) has called this research morally wrong and urged
Congress to ban it. Many European countries also oppose it.
In August Bush said he would allow federally funded research into the 70 or
so stem cell lines that exist worldwide whose embryos have already been
destroyed so that there is no chance of life emerging from them.
Sweden has 19 of these stem cell lines -- a reservoir of stem cells derived
from a single human embryo.

Contents

December 4, 2001
NY Times
The Weaknesses of Science for Profit
By HAROLD VARMUS
Last week Americans briefly diverted their eyes from Afghanistan to consider
the announcement by a small New England biotechnology company that it had
created human embryonic clones. President Bush expressed grave concern, and
some members of Congress made renewed calls for legislation to ban the
practice outright. One might think that a cloned human baby had been born.
In truth, what the investigators did was much less significant, and it was
undertaken for a different purpose. They attempted to adopt one step of the
process used for cloning animals the transfer of a cell nucleus as part
of a strategy to develop human embryonic stem cells. They removed the nuclei
from several human cells and placed each one in another cell, an egg cell.
In a very few instances, the reconstructed cell went through one or two
divisions, generating no more than six cells not enough to allow the
derivation of stem cell lines.
Many of us in the scientific community criticized the company's report as
premature because it showed little experimental progress and advanced no new
ideas. Supporters of medical science lamented the company's naoveti because
the announcement precipitated an unnecessary political firestorm and
provoked the threat of new barriers to potentially beneficial research.
So why did the company make its announcement? Although its executives
claimed to be excited about the findings and said the information would
promote educational debate, the actual reasons may be more self-serving.
Biotechnology companies are dependent on investors, and investors like
publicity.
Such behavior is, of course, both legal and expected, but it is one of the
unhealthy aspects of confining certain kinds of research to the private
sector. Our country is notable for doing this in areas of ethically
sensitive science. In Britain and most other countries with major
investments in science, a national decision is made at the outset about
whether to allow such work to be done at all, regardless of who pays for it.
In contrast, Americans tend to focus our debate on whether it is permissible
to use federal funds taxpayers' dollars to finance the work.
This odd strategy does have the benefit of allowing such work to proceed in
at least one venue: commercial labs. For example, over the past two decades,
federal financing for in vitro fertilization as a therapy for infertility
or as a topic for research has been prohibited. But this policy has not
kept the private sector from pursuing in vitro fertilization as a practical
solution to infertility; tens of thousands of new parents and their babies
have been the beneficiaries.
Thus the policy achieves two goals: it does not offend taxpayers who oppose
the use of federal money to support work that violates their ethical
standards, yet it allows researchers to pursue innovation on the frontiers
of science so long as it's privately financed.
On the other hand, because this policy prevents academic investigators from
studying in vitro fertilization with funds from the National Institutes of
Health, it compromises efforts to learn the fundamental principles of
fertilization and to improve the basic technology. Moreover, it leaves the
field largely in the hands of the for-profit sector where commercial
realities must be considered along with scientific progress, where full
disclosure is not the norm, and where oversight is limited.
Last week's episode further illustrates the importance of involving
federally financed scientists in work that is permitted in the private
sector. The "nuclear transfer" strategy pursued by the company in question
is not intended to produce cloned human beings ("reproductive cloning"), a
goal that nearly all agree is unacceptable. But the approach is excluded
from federal financing by a provision in the N.I.H.'s annual appropriations
bill, and federal money could not even be used to study any resulting stem
cells, since President Bush's Aug. 9 directive prevents the use of federal
funds for research into any stem cells not already in existence at the time
of his speech.
Still, stem cells made by nuclear transfer could have substantial advantages
over existing stem cell lines for studying basic processes of human
development. This is an aspect of the work more likely to be pursued by
academic scientists than by those working in industry, because its
commercial uses are much less certain, although extraordinary discoveries
might be made.
Nuclear transfer has more obvious value, both economic and medical, as a
method to make stem cells for therapy: such cells would not be rejected if
returned to the original donor of the cell nucleus (or to others with a
similar genetic makeup). This is one of the potentially viable means to
overcome immune barriers to cell- based therapies for a variety of dire
diseases.
Such research is vital not just to biotechnology companies and their
investors, but to the nation as a whole. By structuring our system so that
only those with private funds or a commercial motive do this pioneering
work, we curb our full capacity to expand our scientific understanding.
Harold Varmus, a Nobel laureate in medicine, is president of Memorial
Sloan-Kettering Cancer Center and former director of the National Institutes
of Health.

Contents

Monday, 3 December, 2001, 15:57 GMT
Embryo clone leads to fall-out
One of the editorial advisors to the online science journal that published
details of the "world's first human embryo clones" says he is resigning from
his position.
John Gearhart, one of the scientists to pioneer research into human
embryonic stems cells, said his decision to step down was prompted by
concerns over openness and integrity.
The Johns Hopkins University researcher claimed important data were missing
from the online paper featured in e-biomed: The Journal Of Regenerative
Medicine, and that the experiment was in his judgement a failure and should
not have been published.
The company behind the clone research, Advanced Cell Technology, defended
its work again at a conference over the weekend, and even released new
information on work it had done on monkey embryo clones.
Michael West, chief executive officer of ACT, said the company's researchers
had made monkey eggs start dividing like embryos even though they had not
been fertilized by sperm or activated by the transfer of genetic material
from another cell.
This process, known as parthenogenesis, was one of the techniques ACT said
it used to make its human clones detailed in e-biomed.
'Very embarrassed'
John Gearhart led one of the two teams which in 1998 announced that human
embryonic stem cells had been isolated and cultured in the lab for the first
time.
Recently, Professor Gearhart has been advising the US Senate on stem cell
legislation.
He said he tried to find out which experts had reviewed the ACT paper
published on 25 November, but claimed the editor would not tell him.
"I feel very embarrassed and very chagrined by this publication," he told
the BBC. "I thought that by staying on the editorial board I could at least
find out what happened; but clearly that's not the case, so probably the
best thing to do is to remove myself."
He said the openness of peer review was especially important in this case,
as the journal's editorial advisory board also contained scientists from
Advanced Cell Technology.
Like many other observers, Professor Gearhart said he had concerns over the
way the research was presented to the public.
He said ACT had produced "very preliminary and unconvincing evidence" to
support its claims.
Brain cells
ACT has rigorously defended its e-biomed paper and, at a conference
sponsored by the Mary Ann Liebert publishing company that put out the human
cloning study, revealed new information about its research.
Michael West said company researcher Jose Cibelli had got eggs taken from
macaque monkeys to divide up to blastocyst size - the roughly 100 to
150-cell stage of an embryo when stem cells can be extracted.
"We got 14% of them forming blastocysts and rather nice ones," West told the
conference.
He said Cibelli and colleagues were able to pull cells out of one of the
blastocysts that looked like embryonic stem cells. "These cells grow rather
well," West said, adding that the cells were then coaxed into becoming
neurons.
He claimed the neurons even secreted dopamine and serotonin, two important
hormones produced in the brain.
The hope is that one day a person's own embryonic stem cells could be
produced by cloning procedure that used a small snippet of the individual's
skin.
These stem cells would then be encouraged in the lab into becoming new brain
cells to repair the damage done by Parkinson's, or to repair a heart damaged
by heart attack, or to cure diabetes.
However, some critics say such work is unethical because it involves the
creation and destruction of human embryos. They want the US Senate to back
legislation already passed in the House of Representatives that would outlaw
human cloning.

Contents

Environmentalists Stand with Conservatives on Cloning
By Jason Pierce
CNSNews.com Staff Writer
December 03, 2001
Capitol Hill (CNSNews.com) - Human cloning is not just a conservative issue
anymore, with one of the nation's primary environmental activist groups
joining conservatives Friday in calling on the U.S. Senate to ban cloning.
The alliance between Friends of the Earth and conservatives already working
to ban cloning could prove to be valuable in persuading the Senate
Democratic leadership, which oftentimes yields to pressures from the
environmentalist lobby, to take up the issue.
Dr. Brent Blackwelder, president of Friends of the Earth, told Senate
staffers Friday that human embryonic cloning, such as the successful clone
by Advanced Cell Technologies last weekend, goes against two cornerstone
principles of environmentalists: respecting nature, and the precautionary
principle, which can be described with the old adage, "look before you
leap."
"The fundamental respect for creation and respect for nature means that you
don't try to put yourself in God's position and reengineer all of nature,
but that is the disrespect being shown in this case," Blackwelder said.
Environmental groups, he added, are educating its members on the importance
of understanding and respecting nature as well as understanding "the
interdependence between human beings and the rest of nature."
"What is going on with cloning is leading us dramatically back in the
opposite direction, of a total separation from nature which would then be
discarded and viewed as a disgustful artifact," Blackwelder said.
Trying to control nature has produced poor results in the past, he said, and
the cloning of humans is sure to follow suit.
Blackwelder described what he calls "biological pollution." European birds
that were imported to the United States, such as the pigeon or Starling,
reproduced so fast that they drove native species away, he said.
"Biological pollution is different from chemical pollution, in that chemical
pollution out there is disintegrating, where as biological is replicating,"
Blackwelder added.
"That is what will be going on when they start engineering the human race:
you will have inheritable traits with designer babies, so you have the most
flagrant violations of the precautionary principle, by arrogant scientists,"
he said.
"Also, the attempt to clone human beings and indeed to try to engineer all
of life on earth [shows] they want to fundamentally reshape human beings and
the rest of nature," Blackwelder said.
He warned that once cloning was allowed in any instance, it is sure to be
abused, which could result in the changing of the human race forever.
"We are on the cutting edge of a major decision about the future of human
civilization," Blackwelder said. Cloning places the human race "on the edge
of the slippery slope that will eventually lead to a reengineering of all
life."
"If society allows that, we can guarantee that it will be abused and will be
a serious abuse of women, and fundamentally it will be a profound change in
nature and in human beings from the way we see them today," he said.
Bill Saunders, a senior fellow at the Family Research Council who has
closely followed the cloning issue, said the fact that environmentalists
have joined their side is "invaluable."
"Washington is about coalition politics, and I honestly think that cloning
is an issue that cuts across the usual lines," Saunders said. "I think it
makes it hard to pigeonhole the opposition and to disregard it, because it
is broader than that.
"Obviously, conservatives don't agree with everything environmentalists say,
and environmentalists don't agree with everything conservatives say, but
they are united in opposing cloning, and it makes the coalition strong," he
said.
Saunders added that when usually opposing groups align with one another,
people usually think about an issue more and forget about towing the party
line.
"When you have coalitions that have groups together that aren't usual
together, people have to stop and think about an issue, and they just can't
react in a knee-jerk way," he said. "I expect more of the left-leaning
groups to join as we go along."

Contents

Ova-Compensating?
Women Who Donate Eggs To Infertile Couples Earn a Reward -- But Pay a Price
By Martha Frase-Blunt
Special to the Washington Post
Tuesday, December 4, 2001; Page HE01
"Pay Your Tuition With Eggs," reads one ad in an Ivy League campus
newspaper. Another promises $50,000 to an "intelligent, athletic egg donor"
who "must be at least 5-10 and have a 1400 SAT score."
Shantel Balentine just shakes her head in wonder when she sees such ads. The
32-year-old North Texas woman has never completed college, but in the
opinion of many fertility specialists, she has ideal donor characteristics:
maturity, demonstrable fertility -- she is amother of three -- and an
altruistic motivation. Her academic record, they believe, is far less
important than these attributes.
"Your heart has to be fully involved," says Balentine, who is undergoing her
fourth egg donation process. "It can be painful. There are delays -- cycles
can stretch out for weeks. But I won't walk away. This couple is counting on
me."
Egg donors can be stereotyped as college students eager to pay off their
student loans with a sudden windfall, and it's true that some clinics target
such women. For a student, the lure of easy money for what may seem to be no
more than a minor surgical procedure can be compelling: Those Ivy League ads
notwithstanding, a $50,000 payment can't be expected, but a donor typically
pockets several thousand dollars for having artificially ripened eggs
extracted from her youthful ovary.
But despite the preferences that many infertile couples have for the eggs of
younger, better-educated donors, experts cite psychological, physiological
and even logistical reasons to steer these couples away from college
students and toward a less-elite group of candidates.
According to Patricia Mendell, a New York psychotherapist who assesses and
counsels would-be egg donors, these women are as diverse as any societal
group, except that virtually all are healthy and between the ages of 18 and
32; many are also organ donors and blood donors.
Mendell has also found that their demographics vary by geographic area: "Egg
donors in Boston and New York are predominantly students, because of the
large student population in these cities. In California, it's split evenly
between childless women and mothers, and in the South, you'll tend to find
the majority of donors to be young mothers. Besides that, there is a lot of
diversity when it comes to personalities and backgrounds."
Seeking the Best Eggs
There's no doubt that biologically, very young egg donors are ideal. But do
they make the best egg donors psychologically? "That's the question mark,"
says Pamela Madsen, executive director of the American Infertility
Association, which is based in New York. "Are we . . . leading them to make
a decision that later in life they may regret? The money will be spent and,
in the end, she has given up her genetic child forever. We have to really
care about these women, and the babies that will be born as a result."
Egg donation has become a popular option for infertile couples, a group
that's growing in an era where women are waiting longer -- sometimes too
long -- to conceive their first child. Once a donor has taken the drugs that
prompt her ovaries to produce eggs, a doctor removes them by inserting a
needle through her vagina. The eggs are joined with sperm, typically from
the male partner, in an in vitro fertilization process and then implanted in
the recipient's uterus. In 1998 -- the most recent year for which statistics
have been compiled -- the eggs of more than 5,000 donors reached this stage
at 360 clinics across the country. They produced live births about 40
percent of the time. (Success rates were lower for the smaller number of
donor-egg embryos that were frozen before being implanted.)
Competition for egg donors is heated. Clinics and brokers advertise in print
and on the radio, place flyers in health clubs and even buy ads on movie
screens, all in an effort to reach a broad swath of the young female
population. The more egg donors an organization can secure, the more choices
it can give the recipient couples -- or, sometimes, the single women -- who
pay the donor's fee. A significant element of the transaction, after all, is
the couple's ability to select a donor who seems ideal.
Some clinics, including the Genetics & IVF Institute in Fairfax, allow
casual visitors to their Web sites to read profiles of prospective donors.
At the Annapolis office of the Center for Surrogate Parenting and Egg

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