U.S. Concedes Some Cell Lines Are Not Ready
Find a Job
Post a Job
Find a Home
Personals
All Classifieds
International
National
Politics
Business
Technology
Science
Health
Sports
New York Region
Weather
Obituaries
NYT Front Page
Corrections
Editorials/Op-Ed
Readers' Opinions
Automobiles
Arts
Books
Movies
Travel
Dining & Wine
Home & Garden
Fashion & Style
New York Today
Crossword/Games
Cartoons
Magazine
Week in Review
Photos
College
Learning Network
Job Market
Real Estate
Archives
Help Center
NYT Mobile
NYT Store
E-Cards & More
About NYTDigital
Jobs at NYTDigital
Online Media Kit
Our Advertisers
Home Delivery
Customer Service
Media Kit
Review Profile
E-Mail Options
Log Out
Text Version
Today's NewsPast WeekPast 30 DaysPast 90 DaysPast YearSince 1996
Welcome, ghora
Sign Up for Newsletters | Log Out
Go to Advanced Search
090601U.S. Concedes Some Cell Lines Are Not Ready
By SHERYL GAY STOLBERG
WASHINGTON, Sept. 5 — Nearly a month after President Bush announced
that he would permit federally financed scientists to study more
than 60 colonies of human embryonic stem cells, the administration
acknowledged today that fewer than half those colonies were fully
established and ready for research.
Testifying before a panel of skeptical senators, Tommy G. Thompson,
the secretary of health and human services, said that only 24 or 25
of the colonies, or lines, were ready for experiments. Mr. Thompson
said more — he did not know how many — would be ready by the time
government grant money became available in eight or nine months.
"We are confident that there is enough," he said, speaking to
reporters after his testimony.
Noting that private research would continue despite Mr. Bush's
restrictions, Mr. Thompson added, "And we are confident that the
private sector will fill any voids if there are any voids."
The secretary also announced that the government had "knocked down
the proprietary concerns" about whether scientists would have access
to the cells. On Tuesday evening, just hours before Mr. Thompson was
to go to Capitol Hill to defend the president's policy, his
department signed an agreement with the owner of the patent on the
cells that, both sides say, will allow scientists to use them
freely.
Mr. Thompson called it "a ground- breaking agreement."
From the moment President Bush waded into the ethically divisive
issue of embryonic stem cell research, with his first televised
address to the nation on Aug. 9, scientists, patients' advocates and
lawmakers have questioned whether his plan was adequate to support
the science.
Although stem cells hold the potential for treatments and cures, Mr.
Bush and many others have moral qualms about the work because the
cells are extracted from human embryos, which are destroyed in the
process. To ease those qualms, Mr. Bush decided to confine federal
financing to work involving cell lines that were already established
at the time of his speech.
The White House has said there are 64 such lines, developed in 10
laboratories in five countries: Australia, India, Israel, Sweden and
the United States. The day after the president's announcement, Mr.
Thompson declared of the lines, "They're diverse, they're robust,
they're viable for research."
But their quality has been a matter of intense dispute, and today,
Mr. Thompson told reporters that when Mr. Bush announced his
decision, he was not aware that only about two dozen lines were
fully developed.
"Nobody was," Mr. Thompson said. He did not elaborate.
Today's hearing was the first opportunity for lawmakers, just back
from summer recess, to scrutinize Mr. Bush's plan. Senators
questioned the secretary for nearly two hours, pressing him on
whether Mr. Bush would revisit his policy if experiments revealed
that the existing lines were insufficient.
The answer, Mr. Thompson said, was no. So several senators, in both
parties, indicated that they might reopen the discussion themselves.
While legislation that would broaden Mr. Bush's policy is unlikely
this fall, Congress could take up the issue as soon as next year,
once scientists have more to report on the usefulness of the cell
lines.
"Millions of patients and their families expect that stem cell
research will move forward as rapidly as possible," said Senator
Edward M. Kennedy, Democrat of Massachusetts, the chairman of the
Committee on Health, Education, Labor and Pensions, which held the
hearing. "It would be unacceptable to offer these patients and
families the promise of effective stem cell research but deny them
the reality of it."
Much of the discussion focused on whether any of the 64 lines would
ever be suitable for use in patients. To grow the lines, scientists
nourished them with mouse cells that had been killed with radiation.
This is a standard laboratory technique, but it raises concerns
about safety, because the cells could harbor viruses that would
infect people. While the Food and Drug Administration does not
prohibit the use of mouse cells in human therapies, it imposes
strict regulations on them, and officials do not know if the
existing stem cell lines would meet the F.D.A.'s criteria.
At one point, Senator Tom Harkin, Democrat of Iowa, told Mr.
Thompson that the lines had a "contamination problem."
"I don't classify them as contaminated," Mr. Thompson said.
"Well," Mr. Harkin said, "there's a cloud over them, a very dark
cloud."
Stem cells, the human body's master cells, can grow into any one of
the body's more than 200 cell types, and scientists hope to use them
to create replacement tissue and body parts. Advocates for patients
see the cells as their best hope for treating a range of disorders,
from Parkinson's disease to juvenile diabetes.
Those advocates have been anxiously awaiting Congress's return to
get a sense of how much support they have on Capitol Hill. Before
Mr. Bush's announcement, more than 60 senators and 200
representatives had expressed support for stem cell research that
would go beyond what the president has authorized.
"I had been hoping that the members were going to be sticking with
us, but I didn't know for sure," said Larry Soler, a spokesman for
the Coalition for the Advancement of Medical Research, which
represents patients and researchers. Mr. Soler said today's hearing
"confirmed that many members from both sides of the aisle are still
very open to the need to revisit this policy."
But the back-and-forth over the number of lines left some patients'
advocates disillusioned.
"There is this kind of numbers game, a kind of three-card monte,
which one has the real stem cell under it?" said Daniel Perry,
executive director of the Alliance for Aging Research, an advocacy
group in Washington.
In describing the status of the cell lines, Mr. Thompson told
senators they existed in three phases: the proliferation phase, in
which they start to grow; the characterization phase, in which
scientists identify their biological characteristics; and the fully
developed stage.
So, for example, scientists at the University of Goteborg in Sweden
have 19 cell lines. All meet the president's criteria, Mr. Thompson
said. But only 3 are fully developed; 12 are proliferating, and 4
are in the characterization stage.
Mr. Thompson said a registry of all 64 cell lines, listing their
properties and biological characteristics, would be posted on the
the National Institutes of Health's Web site within the next two
weeks. And he said the new intellectual property agreement "gives us
even more momentum and incentive to get to work."
The agreement is between the government and the WiCell Research
Institute, a nonprofit subsidiary of the Wisconsin Alumni Research
Foundation, or WARF. WARF, the patent owner, is an affiliate of the
University of Wisconsin, where human stem cells were discovered in
1998.
The accord allows scientists who work at the National Institutes of
Health broad access to the five cell lines created by Dr. James A.
Thomson, a developmental biologist at the university. It applies
only to government-employed scientists and covers only basic
research; if scientists want to use the cells as therapies, they
will have to renegotiate.
But the agreement is important for several reasons.
First, WiCell has said it will make the same terms available to
academic scientists in university laboratories around the country.
Second, the research institute has agreed not to use its patent to
block federally financed scientists from studying stem cell lines
developed in other laboratories — so long as the other cell line
owners do not receive more favorable treatment from the government
than WiCell does.
Third, it eliminates a so-called reach-through provision that WiCell
imposed in the past. Under the provision, any scientist who made a
discovery using the Wisconsin cells was required to offer WiCell the
first chance at commercializing it.
Because the institute has granted important commercial rights to a
California biotechnology company, Geron, some scientists had
complained that those terms made them, in effect, employees of
Geron. While Geron will undoubtedly still be involved in discussions
with scientists who want to commercialize stem cell discoveries,
Carl E. Gulbrandsen, WARF's managing director, said the new
agreement gave academic researchers much more freedom.
"It's a boon to research," Mr. Gulbrandsen said, adding, "We are
saying, `Here, take our cells, use your federal dollars, do your
research, publish what you discover, patent what you discover.' "
Home | Back to Politics | Search | HelpBack to Top
List your real estate
property on NYTimes.com