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Do Two Friedman Units Equal One Okarma?

Posted by Jesse Reynolds on July 20th, 2007


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


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  1. Comment 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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