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Supporters and apologists for the American debacle in Iraq habitually promise that the situation will improve in the near future - if only support at home is maintained. A media watchdog group has noted that Thomas Friedman, The New York Times' foreign policy cliché-ist in residence, has been claiming that "the next six months" are a critical make-or-break period, and that he's been doing so for over three years. Subsequently, a progressive blogger dubbed one "Friedman Unit" (FU) as equivalent to six months of prognostication. Since then, pro-war statements by others have have been quantified in these terms.
Similarly, Geron, the leading private firm trying to commercialize human embryonic stem cell products, has stated that clinical trials will occur "next year" - for the fourth year in a row:
February 22, 2004: "The company believes it will be cleared to start the first stem-cell therapy in human tests next year, possibly for spinal-cord injury."
December 1, 2004: "According to Geron CEO Thomas Okarma, the company is aiming to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical trials using glial cells derived from embryonic stem cells to repair damaged spinal cords in 2005 or early 2006."
February 25, 2005: "Next year [Hans Keirstead] and his corporate partner, Geron, plan to try treating people who have recent spinal cord injuries, in what would almost certainly be the first human trial of any therapy derived from such cells.
April 19, 2005: Okarma "said he believes the clinical trial could begin in mid-2006."
September 9, 2005: "Geron plans to begin clinical trials on acute spinal cord injury treatment in early 2006, according to chief executive officer Tom Okarma."
November 7, 2005: "[R]esearchers at Geron of Menlo Park want to take the next step -- in people. They hope to get federal permission to inject those cells into damaged spinal cords. The procedure -- which Geron intends to do next year -- would be the first human tests of a treatment derived from human embryonic stem cells, the highly versatile body cells that can be coaxed into becoming almost any tissue in the body."
June 17, 2006: "'I'm confident that we will be in the clinic next year with the first human ESC-derived product,' said Tom Okarma, chief executive of Geron."
August 4, 2006: "One company, in particular, Menlo Park, CA-based Geron, is taking the lead in developing experimental embryonic stem cell therapies and hopes to begin human trials next year."
May 9, 2007: "The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US."
Obviously, the moral terrain is not equivalent. The militarists who misled the nation into war have proposed a variety of goals, all to be achieved at the barrel of a gun. Geron just wants to maximize profits by way of developing medical therapies. But much like war backers, embryonic stem cell researchers continually lobby for more federal funds. The result on the investment, they promise, is just around the bend - maybe as soon as one Okarma Unit (OU) from now.
Update (Aug. 3): After this post was picked up by the Wired Science Blog, stem cell researcher Hans Keirstead entered the fray.
Posted in Biotech & Pharma, Jesse Reynolds's Blog Posts, Stem Cell Research
Comments Add a CommentComment by J.Brown, Sep 14th, 2007 2:42pm
From:
http://energycommerce.house.gov/reparchives/107/hearings/06202001Hearing291/print.htm
Okarma is an old hand at promising things neither he nor Geron corp can deliver.
An intriduction by a Mr. Deutsch.
"I won't go into detail of the myriad of cures and
treatments that therapeutic cloning could provide, as Dr.
Okarma and Mr. Perry will more than adequately make this point with their testimony."
Okarma is long on descrpition of cloning, in which he played no scientific role, and short on delivery.
There has, of yet, been no therapeutic cloning by Okarma or his company Geron Corp. We are now well into 2007.
Please find Okarma's prepared testimony to the 107th Congress back in 2001.
" Mr. Okarma. Good afternoon. I am Tom Okarma, President and CEO of Geron Corporation in Menlo Park, California. Geron is a biopharmaceutical company focusing on discovering, developing, and commercializing therapeutic and diagnostic products in oncology, drug discovery and regenerative medicine.
Today, I am testifying on behalf of my company and the
Biotechnology Industry Organization. BIO represents more than 950 biotechnology companies, academic institutions, State bio-tech centers, and related organizations in all 50 U.S. States and 33 other nations.
Mr. Chairman and members of the subcommittee, thank you for the opportunity to testify today at this important meeting on cloning. In my testimony today, I would like to make three points.
First, Geron Corporation, BIO, and the overwhelming portion of scientists and physicians oppose human reproductive cloning of human beings.
Second, however in our shared zeal to prevent reproductive cloning, we must not prevent research on tissue cloning, which is fundamental to enable the development of safe and effective cellular transplant patient therapies that could, and we
predict will, revolutionize medicine.
Third, the objective of the research is to develop a
scalable process to enable the direct conversion of a somatic or body cell into a pluripotent cell without consuming oocytes and without generating embryos.
Such a process would allow the generation of transplantable replacement cells that would not be rejected by the immune system. First, ban reproductive cloning. It would be extremely dangerous to attempt human reproductive cloning. It took over 270 attempts before Dolly was successfully cloned.
In fact, in most animals, reproductive cloning is no better than a three to 5 percent success rate; that is, very few of the cloned animal embryos implanted in a surrogate mother animal survive.
The others either die in utero, sometimes at very late
stages of pregnancy, or die soon after birth. It is simply
unacceptable to subject humans to those risks.
To allow human reproductive cloning would be irresponsible. Worse yet, it could lead to a back-lash that would stifle the numerous beneficial applications of therapeutic cloning technology, some of which I will now describe.
It is critical, therefore, to distinguish the use of
cloning technology to create a new human beings from other
appropriate and important uses of the technology, such as
cloning specific human cells, genes, and tissues that do not and cannot lead to a cloned human being.
The full potential of this technology comes from its use in regenerative medicine. Many diseases result in the disruption of cellular function or the destruction of tissue. Heart attacks, stroke, diabetes, are all examples of common conditions in which critical cells are lost to disease.
Today's medicine is completely unable to restore this loss of function. Regenerative medicine is a new therapeutic paradigm that holds the potential to cause an individual's currently malfunctioning cells to begin to function properly again, or even to replace dead or irreparably damaged cells with fresh, healthy ones, thereby restoring organ function.
The goal of the research is to produce transplantable cells
that provide these benefits without triggering immune rejection
of the transplanted cells. This could be used to treat numerous
diseases such as diabetes, heart disease, stroke, Parkinson's
disease, and spinal cord injury.
For example, today, we have learned how to turn
undifferentiated human pluripotent stem cells into human
neurons, human liver cells, and human heart muscle cells. These
human replacement cells function normally in vitro, raising the
possibility for their application in the treatment of
devastating diseases affecting these tissue types.
This would, for example, allow patients with heart disease
to receive new heart muscle cells that would improve heart
function. Cellular cloning techniques are a critical and
necessary step in the production of sufficient quantities of
vigorous replacement cells for the clinical treatment of
patients.
Somatic cell nuclear transfer research is essential if we
are to achieve our goals in regenerative medicine. We must
understand the biological properties of the egg cell and the
transferred nucleus that cause a differentiated cell to turn
into a pluripotent one.
This process is called ``reprogramming,'' and we are still
not sure how it works, which is why we need to perform the
research.
At Geron, our aim is to harness and therapeutically apply
the power of this biology. Once we fully understand
reprogramming, we will be able to develop specific cells for
transplantation without immune rejection.
We will do that by taking a differentiated cell from a
particular patient, reprogramming it back to form a pluripotent
cell from which we can produce the differentiated cells we need
for transplantation back into that individual.
By using the patient's own cells as starting material, we
will avoid complications due to immune response rejection.
However, this is precisely the research that would be
banned by the Weldon bill. Because the Weldon bill does not
distinguish between reproductive cloning and the use of cloning
for research purposes, it will cutoff this work and prevent its
therapeutic applications from reaching patients.
In contrast, the bipartisan bill introduced by
Representatives Greenwood and Deutsch and others bans
reproductive cloning appropriately, but allows the continuation
of research.
BIO supports Greenwood-Deutsch because it strikes the
appropriate balance between prohibiting acts that are unsafe
and unethical, while promoting vital medical research.
Last, it is critical to emphasize that once we understand
the molecular biology of reprogramming, we will no longer need
to use egg cells or to create blastocysts. The commercial
process envisioned would transform a somatic cell, such as a
skin cell, into a pluripotent cell directly, without the use of
oocytes or the creation of blastocysts.
Moreover, understanding the biology of reprogramming is a
critical step to improve the usefulness of so-called adult stem
cells. Ironically, the Weldon bill will also be a set-back for
adult stem cell research.
In conclusion, Mr. Chairman, human reproductive cloning
remains unsafe, and the ethical issues it raises have not been
reasonably resolved. It should be prohibited.
However, as Congress seeks to outlaw reproductive cloning,
it must not write legislation that will stop research using
cloning technology.
Unfortunately, the Weldon bill fails that test. Simply put,
enactment of the Weldon bill will stop critical therapeutic
research in its tracks. Only Greenwood-Deutsch strikes the
right balance. Thank you.
[The prepared statement of Thomas Okarma follows:]
Prepared Statement of Thomas Okarma, President and CEO, Geron
Corporation on Behalf of the Biotechnology Industry Organization
Good afternoon. My name is Thomas Okarma. I am the President and
CEO of Geron Corporation in Menlo Park, California. Geron is a
biopharmaceutical company focused on discovering, developing, and
commercializing therapeutic and diagnostic products for applications in
oncology, drug discovery and regenerative medicine. Geron's product
development programs are based upon three patented core technologies:
telomerase, human pluripotent stem cells, and nuclear transfer.
I am testifying today on behalf of my company and the Biotechnology
Industry Organization (BIO). BIO represents more than 950 biotechnology
companies, academic institutions, state biotechnology centers and
related organizations in all 50 U.S. states and 33 other nations. BIO
members are involved in the research and development of health care,
agricultural, industrial and environmental biotechnology products.
Mr. Chairman, and members of the Subcommittee, thank you for the
opportunity to testify today at this important hearing on cloning. Let
me start by making our position perfectly clear: BIO opposes human
reproductive cloning. It is simply too dangerous technically and raises
far too many ethical and social questions.
That's why BIO wrote to President Bush earlier this year and urged
him to extend the voluntary moratorium on human reproductive cloning
which was instituted in 1997. I would respectfully ask for this letter
to be included in the hearing record.
It would be extremely dangerous to attempt human reproductive
cloning. It took over 270 attempts before Dolly was successfully
cloned. In fact, in most animals, reproductive cloning has no better
than a 3-5% success rate. That is, very few of the cloned animal
embryos implanted in a surrogate mother animal survive. The others
either die in utero--sometimes at very late stages of pregnancy--or die
soon after birth. Only in cattle have we begun to achieve some
improvements in efficiency. However, scientists have been attempting to
clone many other species for the past 15 years with no success at all.
Thus, we cannot extrapolate the data from the handful of species in
which reproductive cloning is now possible to humans. This underlines
that this would be an extremely dangerous procedure.
It is simply unacceptable to subject humans to those risks. Rogue
and grandstanding so-called scientists who claim they can--and will--
clone humans for reproductive purposes insult the hundreds of thousands
of responsible, reputable scientists who are working hard to find new
therapies and cures for millions of individuals suffering from a wide
range of genetic diseases and conditions.
The Food and Drug Administration (FDA) has publicly stated that it
has jurisdiction over human reproductive cloning experiments and that
it will not approve them. BIO supports that view and hopes that the
next FDA commissioner--whoever that might be--will assert FDA's current
statutory authority forcefully.
There are also many ethical concerns raised by the specter of
cloning. As noted in BIO's letter to the President, ``Cloning humans
challenges some of our most fundamental concepts about ourselves as
social and spiritual beings. These concepts include what it means to be
a parent, a brother, a sister and a family.
``While in our daily lives we may know identical twins, we have
never experienced identical twins different in age or, indeed,
different in generation. As parents, we watch with wonder and awe as
our children develop into unique adults. Cloning humans could create
different expectations. Children undoubtedly would be evaluated based
on the life, health, character and accomplishments of the donor who
provides the genetic materials to be duplicated. Indeed, these factors
may be the very reasons for someone wanting to clone a human being.''
As you can see, Mr. Chairman, many of these issues strike at the
heart of beliefs and values that are inherent in the human condition.
What does it mean to be an individual? How should we view our parents,
brothers, sisters, and children? How does the world around us influence
our intellectual, physical and spiritual development? These are just a
few of the questions raised by human cloning. In my view, reproductive
cloning would devalue human beings by depriving them of their own
uniqueness.
To allow human reproductive cloning would be irresponsible. Worse
yet, it could lead to a backlash that would stifle the numerous
beneficial applications of therapeutic cloning technology--some of
which I will describe today--that could lead to cures and treatments
for some of our most deadly and disabling diseases.
BENEFICIAL USES OF CLONING TECHNOLOGY
It is critical to distinguish use of cloning technology to create a
new human being (reproductive cloning) from other appropriate and
important uses of the technology such as cloning specific human cells,
genes and other tissues that do not and cannot lead to a cloned human
being (therapeutic cloning). These techniques are integral to the
production of breakthrough medicines, diagnostics and vaccines to treat
many diseases. They could also produce replacement skin, cartilage and
bone tissue for burn and accident victims, and result in ways to
regenerate retinal and spinal cord tissue.
Let me briefly explaining a cloning technology--somatic cell
nuclear transfer--and how it is used for research purposes. First, the
nucleus of an egg cell is removed. In its place, we insert the nucleus
of an already differentiated cell (a cell that performs a specific
function in the body). Chemicals are added to stimulate the egg to
start dividing. At about 3-5 days, a blastocyst is formed which
contains an inner cell mass comprised of undifferentiated, pluripotent
cells. These cells are removed and used for research. The research
value of these cells is enormous. These stem cells have the potential
to form any cell in the body and can replicate indefinitely. Studies in
animals demonstrate that this could lead to cures and treatments for
millions of Americans who suffer from diseases and disabilities such as
diabetes, stroke, Parkinson's Disease, heart disease, and spinal cord
injury.
As exciting as that is--it's only a part of the story. The full
potential of this technology comes from its use in regenerative
medicine.
REGENERATIVE MEDICINE
Many diseases result in the disruption of cellular function or
destruction of tissue. Heart attacks, strokes, and diabetes are
examples of common conditions in which critical cells are lost to
disease. Today's medicine is unable to completely restore this loss of
function. Regenerative medicine, a new therapeutic paradigm, holds the
potential to cause an individual's currently malfunctioning cells to
begin to function properly again or even to replace dead or irreparably
damaged cells with fresh healthy ones, thereby restoring organ
function.
The goal of Geron's regenerative medicine program is to produce
transplantable cells that provide these therapeutic benefits without
triggering immune rejection of the transplanted cells. This could be
used to treat numerous chronic diseases such as diabetes, heart
disease, stroke, Parkinson's Disease and spinal cord injury.
At Geron, therapeutic cloning technology is one of the techniques
we use to create pure populations of functional new cells that can
replace damaged cells in the body. For example, we are learning how to
turn undifferentiated human pluripotent stem cells into neurons, liver
cells and heart muscle cells. Thus far, these human replacement cells
appear to function normally in vitro, raising the possibility for their
application in the treatment of devastating chronic diseases affecting
these tissue types. This would, for instance, allow patients with heart
disease to receive new heart muscle cells that would improve cardiac
function. Cellular cloning techniques are a critical and necessary step
in the production of sufficient quantities of vigorous replacement
cells for the clinical treatment of patients.
Somatic cell nuclear transfer research is essential if we are to
achieve our goals in regenerative medicine. We must understand the
biological properties of the egg cell (and the transferred nucleus)
that cause a differentiated cell to turn into a pluripotent cell. This
process is called ``re-programming''--and we're still not sure how it
works. That's why we need to continue to perform research.
At Geron, our aim is to harness and therapeutically apply the power
of this biology. Once we fully understand re-programming we will be
able to develop specific cells for transplantation without immune
rejection. We'll do that by taking a differentiated cell from a
particular individual and re-programming it to form a pluripotent cell
from which we can produce the differentiated cells we need for
transplantation back into that individual. By using the patient's own
cells as starting material, we will avoid complications due to immune
response rejection.
However, this is precisely the research that would be banned by the
Weldon bill. Because the Weldon bill does not distinguish between
reproductive cloning and use of cloning for research purposes, it will
cut off this work and prevent its therapeutic applications from
reaching patients. In contrast, the bi-partisan bill introduced by
Reps. Greenwood, Deutsch, and others bans reproductive cloning but
allows the continuation of research. BIO supports Greenwood/Deutsch
because it strikes the appropriate balance between prohibiting acts
that are unsafe and unethical, while promoting vital medical research.
It is important to emphasize that once we understand the molecular
biology of re-programming, we will no longer need to use egg cells or
create blastocysts. Therefore, this technology is likely to be used
only for a short, finite period of time. Moreover, understanding the
biology re-programming is a critical step to improve the usefulness of
adult stem cells. Ironically, therefore, the Weldon bill will also be a
setback to adult stem cell research.
CONCLUSION
As the current Congress pursues legislative prohibitions on human
reproductive cloning, we urge caution and a distinction between
reproductive and therapeutic cloning. We all agree that given the
current safety and social factors, human reproductive cloning is
repugnant. However, it is critical that in our enthusiasm to prevent
reproductive cloning, we not ban vital research, turning wholly
legitimate biomedical researchers into outlaws, and thus squelching the
hope of relief for millions of suffering individuals.
Our nation is on the cusp of reaping the long dreamed of rewards
from our significant investment in biomedical research. The U.S.
biotech industry is the envy of much of the world, especially our
ability to turn basic research at NIH and universities into applied
research at biotech companies and in turn, into new therapies and cures
for individual patients. Using somatic cell nuclear transfer and other
cloning technologies, biotech researchers will continue to learn about
cell differentiation, re-programming, and other areas of cell and
molecular biology. Armed with this information, they can eventually
crack the codes of diseases and conditions that have plagued us for
hundreds of years, indeed, for millennia.
In conclusion, Mr. Chairman, human reproductive cloning remains
unsafe, and the ethical issues it raises have not been reasonably
resolved. It should be prohibited. However, as Congress seeks to outlaw
reproductive cloning, it must not write legislation that will stop
research using cloning technology. Unfortunately, the Weldon bill fails
that test. Simply put, enactment of the Weldon bill will stop critical
therapeutic research in its tracks. Only Greenwood/Deutsch strikes the
right balance.
Thank you for the opportunity to testify. I'll be happy to answer
any questions.
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