Newsgroup: it.politica.internazionale
Titolo: BUSH'S STEM CELL POLICY MAY STREAMLINE RESEARCH (NYT)

BUSH'S STEM CELL POLICY MAY STREAMLINE RESEARCH (NYT)
By NICHOLAS WADE (New York Times, 18 Agosto 2001)
Biologists may find there are fewer restrictions on research with embryonic
stem cells under the Bush
administration than they would have faced under the Clinton administration,
whose guidelines have been scrapped, officials at the White House and the
National Institutes of Health said.
The abolition of the guidelines means that researchers can now use, among
other sources, the embryonic stem cells first derived in 1998 by Dr. James
A. Thomson of the University of Wisconsin, which did not comply with the
Clinton administration guidelines in two technical respects. And the
foundation that handles the university's patents has said there was nothing
in the way of
researchers gaining access to the cells and doing any research they please
except for cloning a human or inserting the cells into other embryos.
Dr. Lana R. Skirboll, director of the Office of Science Policy at the health
institutes, said the guidelines governing embryonic stem cell research would
be replaced by the four conditions specified by President Bush in his Aug. 9
speech: that the cells were derived before that date, that donors gave
informed consent, that the cells must come from excess embryos created
solely for reproductive purposes and that donors were not offered financial
inducement.
Scientists applying for federal grants from the health institutes need only
list which of the approved embryonic cell lines they intend to use, and
there will be no further scrutiny other than the usual review of grants by
outside experts. The agency is developing the registry and will publish it
soon on the Internet, Dr. Skirboll said.
Along with the guidelines, a supervisory panel of the health institutes
called the Human Pluripotent Stem Cell Review Group has been abolished.
"We see a much more streamlined process," Dr. Skirboll said. "Once the
registry is up, if your grant application lists a cell line on the registry,
there is no secondary review."
The guidelines drawn up under the Clinton dministration "no longer pertain,"
she said, because the criteria specified by President Bush "capture the
essential elements of the guidelines and supplant them."
The four straightforward principles described by Mr. Bush replace many pages
of federal regulations specifying the conditions under which the cells must
have been obtained. The reason is that with research now confined to
existing cell lines, the guidelines are unnecessary, a White House official
said.
The new Council on Bioethics, to be led by Dr. Leon Richard Kass of the
University of Chicago, will provide general ethical guidance, and it will
not, as many scientists had expected, revise the health institutes'
guidelines on stem cell research or draw up new ones of its own. The Kass
council "will not be developing specific regulations," the White House
official said.
Dr. Skirboll said the full registry of up to 60 lines of human embryonic
stem lines would be published as soon as permission had been obtained from
those who derived them to use their names.
The 60 lines were all derived independently, from different human embryos,
and are not clones of one another, she said. Some of the derivers have
expressed interest in taking DNA fingerprints of their cells, similar to
those used in forensic cases, to keep track of who is using them. Dr.
Skirboll said that the idea was being considered for that purpose, and not
as a method of policing the Aug. 9 cut-off date.
Though some of the 60 cell lines may prove unsuitable on further study,
researchers should have a much wider choice than many had expected would be
the case.
A second respect in which stem cell research has been made easier is that
the elimination of the agency's guidelines resolves a difficulty faced by
the Wisconsin Alumni Research Foundation, or WARF, which owns the patent on
the human embryonic stem cells derived by Dr. Thomson.
The problem is that Dr. Thomson's cells, which he derived before the
agency's guidelines were written, did not fully comply with the guidelines.
The donor's informed consent was obtained before the embryos were created,
not fterward, as the guidelines required.
Also, the guidelines required the embryos to have been already frozen for
storage. Dr. Thomson used embryos from two sources. One was a United States
in vitro fertilization clinic, in which the embryos were frozen; the other
was a clinic in Israel, which may have supplied fresh mbryos. "We could not
certify that they were frozen and Jamie is not in a position to say," said
Andrew Cohn, a
spokesman for WARF.
Frozen embryos lose viability over time and fresh embryos would be better
starting material for making embryonic stem cells, which some scientists
speculate may have been one of the several factors behind Dr. Thomson's
success in being the first to establish lines of the cells.
Mr. Cohn said WARF was eager to get its embryonic cell lines into
researchers' hands with minimal estrictions. "We want to push this research
forward as fast as we can," Mr. Cohn said. All distribution of the cells to
academic researchers is handled by WARF, not by the Geron Corporation, the
biotechnology company that holds a major license to the cells.
WARF will make the cells available to academic biologists for a subsidized
fee of $5,000, and they may do whatever research they wish, Mr. Cohn said.
"Any researcher who gets our cells and makes a patentable
discovery will own that patent," Mr. Cohn said. But, as is routine practice,
if researchers wish to commercialize any discovery they make on the basis of
WARF's patent, they must negotiate a license with WARF, or with Geron for
anything that falls in the scope of Geron's license. Geron financed Dr.
Thomson's research and has commercial rights to six types of human cell that
can be derived from the stem cells.
Mr. Cohn said he was baffled by some researchers' belief that WARF's
conditions on use of the cells turned them into employees of Geron. Geron
would negotiate an agreement in the usual way, he said, and was hardly
likely to block any invention covered by its license.
In the event agreement could not be reached, Geron as licensee had no right
to go to federal court to enforce its patent, Mr. Cohn said. "They have to
come to WARF because we are the patent holder. Who would you rather have as
an arbitrator, a nonprofit, university-affiliated entity or a private
company?"
Biology has made rapid progress over the last quarter century, with several
pioneering discoveries that seemed to place their authors in a monopoly
position, like the recombinant DNA technique for moving genes between
organisms. In that case the patent holders profited without holding
researchers to ransom.
"On broad pioneering-type inventions like these it inevitably works out that
all the stake-holders are satisfied," said Todd Dickinson, a former director
of the United States Patent and Trademark Office. Mr. Dickinson, now at
Howrey Simon Arnold & White, a Washington law firm, said he expected the
same would prove true of embryonic stem cells, without the need for
legislation.
"The system has almost inevitably self-corrected and access to the
technology has been made available. I would expect that WARF would be fairly
likely to take a positive approach to making this technology widely
available," he said, noting WARF's role as the patent portfolio manager of a
leading research university.
www.radicalparty.org

can be derived from the stem cells.
[cut]
ed ecco che si torna a parlare di brevetti, ovvero profitti
enormi per pochi, ma in ogni caso a guadagnarci sarà la Geron,
che ha finanziato le ricerche del WARF sugli embrioni e 
che ha i diritti commerciali su tutte le eventuali scoperte
a partire dalle linee di cellule staminali identificate dal WARF.
mi spiace che i tanti anti-global, verdi, animalisti che 
appena sentono parlare di brevetti OGM si stracciano le vesti, di
fronte a queste notizie non facciano una piega.
naturalmente, poi, su 
www.radicali.it
 si guardano bene dal
riportare i tanti successi che si sono già ottenuti con le
cellule staminali adulte.
l'Italia è addirittura all'avanguardia in questo campo.
ma loro non sembrano interessati a queste buone notizie, 
sono fissati con gli embrioni e chi non la pensa come 
loro non ha diritto ad esistere, mah!
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