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78 Lives, er, Lines and Counting ... Latest Additions to the NIH's Stem Cell Registry
NIH Human Embryonic Stem Cell Registry ^ | NIH

Posted on 07/05/2002 3:38:30 PM PDT by Askel5

He's only okayed 60 Stem Cell Lines.

They're already dead anyway.

Plus, there is only the potential his funding
could lead to the legitimizing and encouraging of
profiteering at US taxpayer expense on
what the pro-life President termed:

                                                        EXCESS HUMAN LIFE.



On August 9, 2001, at 9:00 p.m. EDT, the President announced his decision to allow Federal funds to be used for research on existing human embryonic stem cell lines as long as prior to his announcement

  1. the derivation process (which commences with the removal of the inner cell mass from the blastocyst) had already been initiated
    ["ALREADY BEEN KILLED"]

    and

  2. the embryo from which the stem cell line was derived no longer had the possibility of development as a human being.
    ["ALREADY BEEN KILLED"]

In addition, the President established the following criteria that must be met:

  • The stem cells must have been derived from an embryo that was created for reproductive purposes;
    [a/k/a, the Sibling of a Successful Implant allowed to Develop in its Rightful Home]

  • The embryo was no longer needed for these purposes;
    ["EXCESS" MANUFACTURE]

  • Informed consent must have been obtained for the donation of the embryo;
    ["Won't you donate your unused Potential children to science for the good of the Living?"]

  • No financial inducements were provided for donation of the embryo.
    [Or shall we just dump your Unused Potential Children in the trash where they belong?"]

In order to facilitate research using human embryonic stem cells, the NIH is creating a Human Embryonic Stem Cell Registry that will list the human embryonic stem cell lines -- at varying stages of development -- that meet the eligibility criteria. Listed below are entities that have developed stem cell lines that meet the President's criteria and are therefore eligible for federal funding. Please click on the name of the laboratory or company for contact information.

  Name Number
   Arcos Bioscience, Inc., Foster City, California / CyThera, Inc., San Diego, California 9
   BresaGen, Inc., Athens, Georgia 4
   ES Cell International, Melbourne, Australia 6
   Geron Corporation, Menlo Park, California 7
   Göteborg University, Göteborg, Sweden 19
   Karolinska Institute, Stockholm, Sweden 6
New  Maria Biotech Co. Ltd. – Maria Infertility Hospital Medical Institute, Seoul, Korea 3
New  MizMedi Hospital – Seoul National University, Seoul, Korea 1
   National Centre for Biological Sciences/ Tata Institute of Fundamental Research, Bangalore, India 3
New  Pochon CHA University, Seoul, Korea 2
   Reliance Life Sciences, Mumbai, India 7
   Technion University, Haifa, Israel 4
   University of California, San Francisco, California 2
   Wisconsin Alumni Research Foundation, Madison, Wisconsin 5

If investigators or institutions have additional human embryonic stem cell lines that they believe are eligible for listing on the Registry, please contact NIH at dder@nih.gov.

Instructions for preparing requests for funding of research using human embryonic stem cells can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html. Investigators should use the NIH codes to identify in their grant applications the cell lines to be used.



TOPICS: Crime/Corruption; Culture/Society; Front Page News; Government; Israel; News/Current Events; US: California; US: Georgia; US: Wisconsin
KEYWORDS: australia; death; escr; india; nih; southkorea; sweden
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"Abortion is Vital to the Solution [of population control at home and abroad]" ... a Key Point from Kissinger's NSSM-200

Zygotes & Embryos are People

The Politics of Stem Cells

EMBRYONIC STEM CELL RESEARCH REDEFINES THE BEGINNING OF LIFE




National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells

ACTION: Notice; withdrawal of NIH Guidelines for Research Using Pluripotent Stem Cells Derived from Human Embryos (published August 25, 2000, 65 FR 51976, correctedNovember 21, 2000, 65 FR 69951).

---------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) announces the withdrawal of those sections of the NIH Guidelines for Research Using Human Pluripotent Stem Cells, http://www.nih.gov/news/stemcell/ stemcellguidelines.htm. (NIH Guidelines), that pertain to research involving human pluripotent stem cells derived from human embryos that are the result of in vitro fertilization, are in excess of clinical need, and have not reached the stage at which the mesoderm is formed.

The President has determined the criteria that allow Federal funding for research using existing embryonic stem cell lines, http:// www.whitehouse.gov/news/releases/2001/08/print/20010809-1.html. Thus, the NIH Guidelines as they relate to human pluripotent stem cells derived from human embryos are no longer needed.







[Federal Register: November 13, 2001 (Volume 66, Number 219)]
[Rules and Regulations]               
[Page 56775-56780]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no01-9]                         

=======================================================================

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

RIN 0940-AA05

Protection [sic] of Human Research Subjects

AGENCY: Department of Health and Human Services (DHHS).

ACTION: Final Rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (DHHS) is withdrawing Subpart B of its human subjects protection regulations published on January 17, 2001 and is issuing this replacement rule. These regulations provide additional protections for pregnant women and human fetuses involved in research. The final rule continues the special protections for pregnant women and human fetuses that have existed since 1975 and makes limited changes in terminology referring

[[Page 56776]]

to neonates, clarifies provisions for paternal consent when research is conducted involving fetuses, clarifies language that applies to research on newborns of uncertain viability, and corrects technical errors.

DATES: The final rule, Protection of Human Subjects, published in the Federal Register on January 17, 2001, at 66 FR 3878 is withdrawn as of November 13, 2001. The amendment published in this final rule is effective December 13, 2001.




EO 13237 (11/28/01) Creation of the President's Council on Bioethics

1 posted on 07/05/2002 3:38:30 PM PDT by Askel5
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To: Askel5
We may as just admit that the flood gate is open. Our tax dollars are funding this crap and there isn't going to be an end in sight. It's sickening.
2 posted on 07/05/2002 3:42:54 PM PDT by JMJ333
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To: Askel5
In a remarkable series of experiments, University of Minnesota researchers have shown for the first time in mice that rare stem cells taken from bone marrow can form the tissue of many different organs.

The research, led by Dr. Catherine Verfaillie of the University of Minnesota Stem Cell Institute and published in advance online Thursday by the journal Nature, is a major advance in adult stem-cell research, with implications for future medical treatments.

The research also has political implications, because those who want to ban research on stem cells taken from embryos will argue even more forcefully that research on adult stem cells offers a promising alternative.

LINK

3 posted on 07/05/2002 3:43:36 PM PDT by jimkress
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To: Askel5
You know the culture is basically gone with most people can't see anything wrong with fertility clinics..or harvesting human beings like crops...this subject angers me like crazy. Thank you for staying on them!
4 posted on 07/05/2002 3:44:39 PM PDT by JMJ333
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To: Askel5
Bush Would End Stem Cell Research Invovling Embryos

Politics/Elections Front Page News
Source: UPI
Published: 9/22/00
Posted on 09/25/2000 11:05:50 PDT by truthandlife

If elected president, pro-life Texas Gov. George W. Bush would end stem cell research involving human embryos, an aide to the Republican presidential nominee said Friday.

The controversial practice was cleared last month for taxpayer funding by the National Institutes of Health.

"It's something we would take steps to remedy," a Bush campaign health policy adviser said, on condition of anonymity, as the candidate suggested an increase in NIH funding by $67 billion over 10 years.

The adviser said Bush's public stance against medical studies using tissue from unborn children would lead a Bush administration to cut off taxpayer funding for embryonic stem cell research, which the NIH approved in August by lifting a yearlong moratorium.

Stem cells, formed in humans and animals at the beginning of life, have the ability to produce a variety of specialized cells in the body, such as muscle cells or nerve cells. Scientists believe they can cultivate stem cells to produce healthy tissues to augment or replace ailing organs.

Pro-life organziations oppose stem cell research and have been promoting life-affirming alternatives that would advance scientific research but not at the expense of killing unborn children.

"Gov. Bush as a pro-life candidate does not support things that would be the potential taking of a life, so that's why embryonic (research) is problematic for us," the adviser said.

Human Embryos Created to Supply Researchers ^

Tissue of lies: Latest stem-cell research shows no need to destroy human embryo ^

5 posted on 07/05/2002 3:46:22 PM PDT by Askel5
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To: Askel5
This should get interesting.
6 posted on 07/05/2002 3:50:24 PM PDT by nunya bidness
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To: jimkress
Hear hear.

Even some of the most enthusiastic boosters of embryo stem cell research see trouble ahead. For example, University of Pennsylvania bioethicist Glenn McGee admitted to Technology Review, a Massachusetts Institute of Technology publication, "The emerging truth in the lab is that pluripotent stem cells are hard to rein in. The potential that they would explode into a cancerous mass after a stem cell transplant might turn out to be the Pandora's box of stem cell research." Thus, it could be that adult tissue-specific stem cells are actually safer than their counterparts culled from embryos since, being extracted from mature cells, they may not exhibit the propensity for uncontrolled differentiation.

From "The Politics of Stem Cells" quoted above.

This wasn't about science or "hopeful" research. It was about nailing open the most profitable window of Human Non-Personhood with the help of Hollywood celebrities (including, sadly enough given her husband's take on human life, Mrs. Ronald Reagan).

7 posted on 07/05/2002 3:54:31 PM PDT by Askel5
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To: JMJ333
Thank you for staying on them!

I've been remiss, actually. Never did post from the flurry of Federal Register entries in the wake of Bush's decision and hadn't realized we'd topped 60 already.

Better late than never.

(Not like I've ever been immune to error ... CONFIRMED: ASKEL5 MAKES MISTAKE!)

8 posted on 07/05/2002 3:57:25 PM PDT by Askel5
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To: JMJ333
the culture is basically gone

There was supposed to be a debate on the ethics and morals of doing this. Looks like the debate was skipped following WTC911. Oh, well, hope they like their new world.

9 posted on 07/05/2002 4:02:21 PM PDT by RightWhale
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To: Askel5
lol...thanks. That is an excellent resource link, and I appreciate your efforts on behalf of the innocent and defenseless.

I actually hadn't thought to inquire about how many lines had been added. Dr Mengele and Margaret Sanger must be rejoicing in hell. It is incomprehensible to me that I pay for this garbage. Its bad enough we can't get PP defunded. I'm sure someone will be along momentarily to question my indignant behavior regarding a mere blastocyst. pfffft

10 posted on 07/05/2002 4:04:30 PM PDT by JMJ333
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To: nunya bidness
This should get interesting. Nah ... it'll be the same cadre of committed folks expressing outrage and the rest will be busy working to vote "God" back into politics by voting Republican.

Just for the hell of it ... let's remind them a second time that it's the GOP who declared abortion "vital" to US population control policies at home and abroad: "Abortion is VITAL to the Solution" ... A Key Point from Kissinger's NSSM-200

As lagniappe ... a post of mine to which Cachelot (of all people) never responded:

Death of a continent (Aids crisis in Africa) ^
      Posted by Askel5 to Cachelot
On News/Activism ^ Jul 3 9:51 PM #47 of 55 ^

It sounds like what you're saying is that America has purposefully committed genocide by "culling" the African population for purposes of grabbing their resources.

No, that's what Kissinger suggested would be a good idea. I'm merely repeating ad infinitum portions of the GOP's national defense policies on population control. Books such as Excessive Force, which I purchased at CPAC from Steven Mosher's table, also are a goldmine of information.

Sudan is an excellent example of the the more brutal connection of depopulation to resources which sounds so matter of fact when detailed in policy memoranda such as Carter's GLOBAL 2000 or the motherlode that is Kissinger's NSSM-200/NSDM-314:

Part One -- Analytical Section
--------    ------------------
Chapter I   World Demographic Trends
Chapter II  Population and World Food Supplies
Chapter III Minerals and Fuel

Rapid population growth is not in itself a major factor in pressure on depletable resources (fossil fuels and other minerals), since demand for them depends more on levels of industrial output than on numbers of people.

On the other hand, the world is increasingly dependent on mineral supplies from developing countries, and if rapid population frustrates their prospects for economic development and social progress, the resulting instability may undermine the conditions for expanded output and sustained flows of such resources.

Chapter IV  Economic Development and
            Population Growth
Chapter V   Implications of Population Pressures
            for National Security
Chapter VI  World Population Conference

Part Two -- Policy Recommendations
--------    ----------------------
Section I   A U.S. Global Population Strategy

Section II  Action to Create Conditions for Fertility De-
            cline: Population and a Development Assis-
            tance Strategy
A. General Strategy and Resource for A.I.D. Assistance
B. Functional Assistance Programs to Create Condi-
   tions for Fertility Decline
C. Food for Peace Program and Population

Section III International Organizations and other Mul-
            tilateral Population Programs
A. UN Organization and Specialized Agencies
B. Encouraging Private Organizations

Section IV  Provision and Development of Family
            Planning Services, Information and Tech-
            nology
A. Research to Improve Fertility Control Technology
B. Development of Low-Cost Delivery Systems
C. Utilization of Mass Media and Satellite Communi-
   cations System for Family Planning

Section V   Action to Develop Worldwide Political and
            Popular Commitment to Population Stability
While specific goals in this area are difficult to state, our aim should be for the world to achieve a replacement level of fertility, (a two-child family on the average), by about the year 2000 [emphasis added]. This will require the present 2 percent growth rate to decline to 1.7 percent within a decade and to 1.1 percent by 2000. Compared to the U.N medium projection, this goal would result in 500 million fewer people in 2000 and about 3 billion fewer in 2050. Attainment of this goal will require greatly intensified population programs [emphasis added]. A basis for developing national population growth control targets to achieve this world target is contained in the World Population Plan of Action.

30. The World Population Plan of Action is not self-enforcing and will require vigorous efforts by interested countries, U.N. agencies and other international bodies to make it effective. U.S. leadership is essential [emphasis added].

Just as Kissinger made no bones (give or take 40 million American unborn) about the fact that abortion was vital to the solution, I'm saying that the US makes no bones about what is and is not in our national interest. Bodies can float like logs out of a bloody Rwanda of blacks run amok which some badass Boy Scout troop could tame and it's an "internal civil conflict into which we cannot intervene". Milosevic allegedly slaughters a mere 40,000 (okay, so that was never proven) and we go in and bust up bridges, target civilian infrastructure and a substantial amount of Collateral Damage and it's a moral war because our almighty National Interests (or those of the Stakeholders, anyway) are on the line.

A bit unclear? Let Brzerzinski have a go:

CHARLIE ROSE: So, we say to the Tibetans, ``You know, we can't do it because we don't want to get into a big deal with China, a fight with China.''

ZBIGNIEW BRZEZINSKI: That's right.

CHARLIE ROSE: ``They're too big and strong.''

ZBIGNIEW BRZEZINSKI: That's right.

CHARLIE ROSE: We said with Chechnya, ``We can't do it because morality plays no issue here because, you know, we don't want to get into a big conflict with the Russians.''

ZBIGNIEW BRZEZINSKI: That's right. That is unfortunately--

CHARLIE ROSE: And we say to the Africans, ``We don't have a big stake here. It's Africa. It's not Europe, and so -- therefore -- we can't get involved.''

ZBIGNIEW BRZEZINSKI: And we can support the African states doing-- You're absolutely right, Charlie. That's exactly the reality.

CHARLIE ROSE: It's not very tidy, is it?

ZBIGNIEW BRZEZINSKI: It isn't tidy. And reality isn't tidy. And look at our own society. Look at the presence of crime in certain parts of our cities. In certain parts of a city there's much less. In other parts of the city there is much more. In certain parts of the cities certain forms of conduct would not be tolerated in daylight. In certain parts of cities they are. Unfortunately you cannot deal with all of the problems of the world at the same time. But that's not an argument for doing nothing where you can.

CHARLIE ROSE: So, the Brezhnev principle becomes--I mean, the Brzezinski principle--

ZBIGNIEW BRZEZINSKI: You're not the only one who has done this, Charlie.

CHARLIE ROSE: There is no Brezhnev-- The Brzezinski principle becomes, ``Do something where you can have an impact and where it most closely fits your national interest in terms of like people.''

ZBIGNIEW BRZEZINSKI: Well, where morality, practicality and interest coincide, obviously it's more possible. And I think it's even obligatory.
And last but certainly not least, as a Bloodhound, I'm happy to direct you to the sorts of Private Corporations (given his stint in Western Africa, Connaught's Thomas Hecht is a steller example of Stakeholder in the proces) of whom Kissinger repeatedly speaks. These Private Concerns -- with the guidance of folks at Rockefeller's daughter's Synergos Institute in conjunction with the World Economic Forum and the Global Philanthropists Circle help direct the billions in pop-control foundation monies from Stakeholders like Baroness Lynda Chalker, Bill Gates, Buffet and Turner to the right Targets.

These folks not only underwrite the researchers and academics who rotate out of "public service" (e.g., the Bill and Melinda Gates foundation floating the likes of Piotrow at Johns Hopkins and Foege at the Carter (GLOBAL 2000) Center at Emory) they act as partners of a sort in conjunction with the US, UN, USAID and other agencies charged with managing the "healthcare mechanisms" by which targeted nations could best be fast-tracked toward acceptable reproduction rates. No question but what the argument can be made that the AIDS epidemic is a product of the Blood Industry. Follow the money, as is always the case with "healthcare mechanisms".

So, given the evidence of US objectives and means as detailed in NSSM-200/NSDM-314 and carried out to this day -- particularly the protection and continued funding of the exact pharmas responsible for the epidemic -- I do believe the case can be made that the average USAIDS report on the depopulation effects of AIDS on certain African nations may well be a measure of success after all.

Despite the patently obvious agenda of so many of its cohorts and partners, even UNFPA's a bit confused, it seems:

Tuesday October 19, 1999

UNFPA MEETING JOKES ABOUT AIDS HELPING DEPOPULATION IN AFRICA

NEW YORK, Oct 19 (LSN.ca) - The Catholic Family and Human Rights Institute reported Friday that at a briefing meeting of the United Nations Population Fund (UNFPA), participants joked that AIDS was helping to do the work of population control in Africa. During the meeting a representative from Marie Stopes International, one of the largest abortion providers in the world, asked jokingly what a "demographer's approach to AIDS and STDs is since they reduce life expectancy."

A demographer and former UNFPA representative, Jan Fransen, emphasized at the meeting that, "individual rights" should not be "at the centre of development." Rather, the major concern from Fransen's view must be the number of "people which the earth can hold in a sustainable way," which he declared to be between only 700 million and 1 billion individuals. By extension, it would seem that those of like mind with Fransen in the UN, must favour extraordinary social upheaval that would be required in order to reduce the world's population by five billion people from its current six billion.

But who can begrudge the abortionists a little gallows humor as they go about their Humanitarian work on behalf of the Living?

You've got to love Brzerzinski's comment on "like people". If only we could have looked in mirrors at the moment of conception to admire the outline and the utter New Life radiance of our Big Bang. Perhaps we'd have some Human compassion for those absolute innocent lives who've only just arrived on the planet but were remiss in not showing up fully formed and fully clothed so that we Image-Oriented sorts could recognize them as our own.

(By the way ... couldn't help delving into the chessboard when Ziggy came to mind the other night. Saved some interesting links I'll try to massage into a post somewhere, somehow ... =)

11 posted on 07/05/2002 4:07:12 PM PDT by Askel5
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To: RightWhale; Askel5
I have an idea for our national slogan. We can replace "In God we trust" with "Better humans through breeding!"
12 posted on 07/05/2002 4:07:58 PM PDT by JMJ333
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To: RightWhale
Looks like the debate was skipped following WTC911

If you read the fine print of the EO, it was only scheduled to last 2 years anyway. Whooptee-doo.

13 posted on 07/05/2002 4:08:02 PM PDT by Askel5
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To: Askel5
I don't read the fine print. I'm a low-res kind of guy. But there has been time for debate of the issues here, and it hasn't happened. Looks like tacit approval by the vast majority of citizens. We'll just get on with our lives: order the new wheels and sound system for the ride, plan the weekend, pull all the remaining equity out of the house.
14 posted on 07/05/2002 4:18:07 PM PDT by RightWhale
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To: Stingray, Pig's Eye, Lndshk

On this previous FR thread, here's a companion article:

"A witness to Hitler and an official observer at the Nuremberg war crimes trials warns against what happens when a nation’s moral foundations are shattered But his years studying in Berlin in the shadow of Hitler have perhaps had the greatest effect in shaping him. Today, he has many things to say as our culture continues to wallow in abortion on demand and careens headlong toward physician-assisted suicide, euthanasia and even eugenics, the belief that we can "improve" the human race through science."

Here’s the link It Can’t Happen here…Or Can It?

Seems that it IS starting to happen here!

Most importantly BTTT

From: Stand Watch Listen



15 posted on 07/05/2002 4:35:39 PM PDT by Askel5
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To: toenail
Those links you'd asked about once upon a time are up top. (NIH's deferring to Bush's guidelines and the restated "protections" of pregnant women, fetuses and neonates used for human research.)
16 posted on 07/05/2002 4:41:57 PM PDT by Askel5
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To: Askel5
Thanks.

And regarding what we were discussing earlier, how do you keep track of information? I've looked for research software, and the closest thing I could find for my purposes is CaseSoft's CaseMap and TimeMap. But it's $600 for the combo, which isn't worth it. And have you seen Biblioscape's BiblioExpress (free)?

17 posted on 07/05/2002 6:20:12 PM PDT by toenail
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To: Askel5
Reminds of the attempt last year to treat some Parkinson's patients with injections of embryonic stem cells. All of them had extreme negative reactions. It actually made their physical condition worse, inducing uncontrollable seizures in most of the recipients.

Haven't heard much about that in the news, have you?

18 posted on 07/05/2002 7:01:50 PM PDT by jimkress
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To: Askel5
Look at:

http://www.prolifeinfo.org/stemcell012.html

5th paragraph from the bottom.

19 posted on 07/05/2002 7:26:12 PM PDT by jimkress
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To: Askel5
Or this:

This article from The NY Times March 8, 2001

Parkinson's Research Is Set Back by Failure of Fetal Cell Implants

By GINA KOLATA

A carefully controlled study that tried to treat Parkinson's disease
by implanting cells from aborted fetuses into patients' brains not
only failed to show an overall benefit but also revealed a
disastrous side effect, scientists report.

In about 15 percent of patients, the cells apparently grew too
well, churning out so much of a chemical that controls movement
that the patients writhed and jerked uncontrollably.

The researchers say that while some patients have similar effects
from taking too high a dose of their Parkinson's drug, in this case
the drugs did not cause the symptoms and there is no way to remove
or deactivate the transplanted cells.

On the researchers' advice, six patients who enrolled in the study
but who had not yet had the implantation operation have decided to
forgo it.

The results, reported today in The New England Journal of
Medicine, are a severe blow to what has been considered a highly
promising avenue of research for treating Parkinson's disease,
Alzheimer's disease and other neurological ailments. The study
indicates that the simple solution of injecting fetal cells into a
patient's brain may not be enough to treat complex diseases
involving nerve cells and connections that are poorly understood.
Some say it is time to go back to the laboratory and to animals
before doing any more operations on humans.

The findings may also fuel the debate over whether it is
appropriate to use tissue from aborted fetuses to treat diseases.
Despite their disappointment, some researchers said they hoped that
the results would not bring fetal cell research to an abrupt halt.
The research has been controversial because the fetal cells were
obtained from abortion clinics.

"This is still our one great hope for a cure," said Dr. J. William
Langston, who is scientific director and chief executive officer at
The Parkinson's Institute in Sunnyvale, Calif.

Parkinson's disease occurs when cells of the substantia nigra
region in the base of the brain die, for unknown reasons. The hope
was that fetal substantia nigra cells might take over for them.
But, the study showed, in older patients the operation had no
benefit and in some younger patients, the transplants brought on
nightmarish side effects.

Although the paper depicts the patients with the side effects in
impassive clinical terms, doctors who have seen them paint a very
different picture.

Dr. Paul E. Greene, a neurologist at the Columbia University
College of Physicians and Surgeons and a researcher in the study,
said the uncontrollable movements some patients suffered were
"absolutely devastating."

"They chew constantly, their fingers go up and down, their wrists
flex and distend," Dr. Greene said. And the patients writhe and
twist, jerk their heads, fling their arms about.
"It was tragic, catastrophic," he said. "It's a real nightmare.
And we can't selectively turn it off."

One man was so badly affected that he could no longer eat and had
to use a feeding tube, Dr. Greene said. In another, the condition
came and went unpredictably throughout the day, and when it
occurred, the man's speech was unintelligible.

For now, Dr. Greene said, his position is clear: `No more fetal
transplants. We are absolutely and adamantly convinced that this
should be considered for research only. And whether it should be
research in people is an open question."

Dr. Gerald D. Fischbach, who was director of the National
Institute of Neurological Disorders and Stroke, which sponsored the
study, said that while the operation had been promoted by some
neurosurgeons as miraculous, this was the first time it was
rigorously evaluated. It used sham surgery as a comparison, a
controversial and rarely used strategy but one that researchers
felt was necessary to understand the true effects of the operation.
Dr. Fischbach, who is now dean of the faculty of medicine at the
Columbia University College of Physicians and Surgeons, was the
director of the institute only at the end of the study.
"Ad hoc reports of spectacular results can always occur," Dr.
Fischbach said. "But if you do these studies systematically, this
is the result you get."

The surgery, he added, "is not the final solution that people
would have hoped going into it."

In the study, researchers, led by Dr. Curt R. Freed of the
University of Colorado Health Sciences Center in Denver and Dr.
Stanley Fahn of the Columbia University College of Physicians and
Surgeons, recruited 40 patients, ages 34 to 75, who had had
Parkinson's disease for an average of 14 years. The patients were
randomly assigned to have substantia nigra cells from four fetuses
implanted in their brains or to have sham surgery, for comparison.
The surgery took place in Colorado and the patients were evaluated
in New York. The fetal cell surgery involved drilling four small
holes in the patient's forehead and then inserting long needles
through the holes into the brain and injecting fetal cells. The
sham surgery involved drilling the holes but not injecting needles
into the brain. After a year, the patients were told whether they
had the fetal cell surgery and, if not, they were offered it if
they wanted it.

The study's primary measure of success was whether the patients
themselves noticed that they were better, as determined by a survey
that they mailed in a year later but before they knew whether they
had had fetal cell implants or a sham operation. The study found no
difference between the two groups — neither those who had had the
fetal cell operation nor those who had had the sham surgery noticed
an improvement in their symptoms.

Other tests, like neurologists' assessments of the patients while
they were taking their medication and the patients' assessments of
their condition in diaries they kept also showed no effect of the
surgery. And there was no difference between the two groups in the
doses of drugs needed to control the disease.

The one glimmer of hope came from assessments by neurologists
before the patients had had their first dose of medication in the
morning. By that measure, the 10 patients under age 60 who had had
the fetal cell implants seemed better than those who had had sham
surgery, with less rigidity, although their tremor was just as bad.
Dr. Freed hailed that result, saying, "It was a clear-cut
improvement."

And, he added, the fetal cells survived in most patients' brains.
"I would be disappointed if people used a strict clinical trial
approach," Dr. Freed said. "This study is about multiple
phenomena."

Others were less enthusiastic, pointing out that finding subgroups
after the fact who may have benefited suggests a hypothesis for
future studies, not evidence of an effect.

"We try to teach everybody that you have to identify beforehand
what's the primary outcome," said Dr. William Weiner, the director
of the Maryland Parkinson's Disease and Movement Disorder Center
and a professor of neurology at the University of Maryland School
of Medicine in Baltimore, referring to the measure of success
determined before the study began. "In this case, they picked a
subjective assessment by the patients themselves, which I think is
a very good one."

And so, Dr. Weiner said, when the patients noticed no improvement,
"the study was negative."

In addition, Dr. Langston said, even if a subsequent study
confirmed that the surgery had an effect on the condition in
younger patients before they took their medicine in the morning,
and even if there was a way of preventing the terrible side effect,
the operation would still hardly be a breakthrough. Parkinson's
disease is almost always a disease of the elderly, he noted, adding
that well under 10 percent of patients who would be candidates for
the surgery are younger than 60.

The wiggling and writhing movements first emerged a year after the
operation, showing up in five of the younger patients who had at
first appeared to benefit from fetal cell surgery — three who had
the operation in the initial phase of the study and two who had it
a year later, when they learned that they had originally had a sham
surgery. While doctors sometimes see such effects in Parkinson's
patients, it is caused by giving too much of drugs that act like
dopamine in the brain. And it can be controlled by reducing the
drugs.

In this case, however, drugs were not the culprit. Even when
doctors took away the drugs, the symptoms persisted.
The fetal implant study had been controversial from the start,
both because it included sham surgery and because it used fetal
tissue from abortions. But many Parkinson's disease experts said it
had to be done because doctors were already offering the surgery to
patients, and charging them for it, at costs of $40,000 or more,
with no evidence that they were helping them. Yet patients, facing
a disease in which brain cells slowly and inexorably die and in
which even the drugs that once controlled their symptoms of tremor
and rigidity would inevitably fail, took their chances with the
operation, thinking they had little to lose.

Dr. Freed said he was the first in the United States to offer the
treatment, starting in 1988 with a 52-year- old man, who is still
alive although, of course, he also still has Parkinson's disease.
Dr. Freed continued to offer it to paying patients while he was
treating those who were part of the federal study and whose
procedures were paid for by the study. He said he considered these
other operations research because he experimented with different
amounts and placements of fetal cells. He has given fetal cell
implants to 27 patients, he said, with the most recent operation
last October.

Dr. Freed said his group was now implanting less fetal tissue and
putting the tissue in a different area of the brain, hoping to
avoid the devastating side effects. But, he said it would be a
mistake to stop doing the surgery altogether.

"To say that you can't do or shouldn't do human research because
the research has uncertain outcome, I think would be a bad
decision," Dr. Freed said.

Meanwhile, a second federally financed study of the operation is
winding to a close, and some researchers say it is time to go back
to animal studies and learn more about the complex roles of the
brain cells involved in Parkinson's disease.

Dr. Weiner said that if a patient came to him today seeking
advice, he would say: "The bottom line for patients is that human
fetal cell transplants are not currently the best way to go. If you
are willing to pay for them, you can still have them done. But my
advice is you ought not to do this."

20 posted on 07/05/2002 7:36:14 PM PDT by jimkress
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