Copyright 2002 eMediaMillWorks, Inc.
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Document Clearing House, Inc.)
Federal Document Clearing House
Congressional Testimony
February 5, 2002 Tuesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 3104 words
COMMITTEE:
SENATE JUDICIARY
HEADLINE: SCIENTIFIC
IMPACT ON COLONING BAN
TESTIMONY-BY: ANDREW KIMBRELL,
EXECUTIVE DIRECTOR
AFFILIATION: INTERNATIONAL CENTER
FOR TECHNOLOGY ASSESSMENT
BODY: Statement of Andrew
Kimbrell Executive Director, International Center for Technology Assessment
February 6, 2002
At the outset I want too thank you for the
opportunity of testifying today on this crucial issue. Over the last many months
I have worked with a coalition of progressive environmental, consumer and
women's health groups to attempt to ban reproductive
human
cloning and obtain at least a moratorium on
human
cloning for research, often called "therapeutic cloning." While there
appears to be little disagreement on the need to ban reproductive cloning, the
issue of halting research
human cloning has become quite
controversial. In my testimony I would like to outline a number of reasons why
many in the progressive community support a ban or moratorium on
human
cloning for research at this time. However, prior to discussing the
current cloning controversy, I would like to put our discussion today in the
context of similar issues we have faced in the last two decades. Sometimes there
is a tendency to deal with issues like cloning in an historical vacuum -a kind
of technological amnesia. George Santayana's truism "Those who cannot remember
the past are condemned to repeat it," applies equally to technology issues a it
does to political ones. Therefore I would like to begin by reviewing our past
mistakes in assessing and regulating two "miracle" cures that preceded the
current furor over stem cell research and
human cloning. I fear
that if we do not remember what happened with these prior technologies we will
repeat the mistakes that have led to grossly inadequate regulation and real
tragedy for many patients. Hyperbole Versus Healing
Last December during
a hearing before the Senate Appropriations Subcommittee on Labor, Health and
Human Services, and Education on the controversy over stem cells and
human cloning, Michael West of Advanced Cell Technology (ACT)
predicted that within six months his biotechnology company would be ready to
create "magic" cells that would save no less than 3,000 lives a day. West
claimed that he would soon successfully clone human embryos, and then obtain
stem cells from those clones which would cure everything from heart disease and
Alzheimer's, to Parkinson's disease and spinal cord injuries. West sternly
warned that even a half year halt on his embryo cloning research would cost over
half a million lives. Horrified by what they called "these real numbers," some
Senators pronounced themselves against any limit on human embryo cloning, and
vowed to "push" the technology in any way they could.
Of course, West's
promise of near term success in obtaining stem cells from clones, and the
subsequent healing of thousands a day, was unadulterated hype. While there have
been some preliminary indications that adult, fetal and embryo stem cells may
some day result in helpful therapies, no such cells have ever been obtained from
cloned human embryos. In fact, West and his Massachusetts company, ACT, had just
published a paper that revealed that they had completely failed to garner stem
cells from cloned embryos. Dr. Donald Kennedy, editor of the highly esteemed
journal Science, summarized the ACT effort, stating, "Everything I have learned
about the [ACT] study suggests that it is not an advance that would interest us.
This scientific effort did not succeed by any measure." Even more telling was
the resignation of Dr. John Gearhart, of the Johns Hopkins Medical Institutions,
from the editorial board of the magazine that published the ACT study. Dr.
Gearhart, a pioneer in stem cell research, said that the experiment"should be
considered a failure" and that the study should not even have been published.
Moreover, the same day West was predicting near term cloning success at the
Senate hearing, his colleague at ACT, Tanja Dominko was explaining the company's
failures to a medical conference. She noted that there was an unknown, unique
characteristic about primates that makes them difficult to clone. "It might be
that you just can't make humans this way," Dominko told the conference. Leading
experts share this skepticism about cloning and any near term success of stem
cell technology. Dr. Gail Martin, the co- discoverer of mouse embryonic stem
cells, warns that there are still "a gazillion issues" to be resolved. Another
stem cell expert, Dr. David Solter who directs the Max Planck Institute of
Germany said he had "no idea" how someone expected injected stem cells to
replace sick and dying brain neurons in Alzheimer's victims.
Most of us
have experienced the tragedy of disease or disability either personally or
through family and friends. Facing the crucible of disease, we search for some
hope when bodies and minds are cruelly decimated by illness. Yet however much we
want cures, it is essential to get the real facts, the full story, about medical
advances. Unfortunately, in the past we have seen a continuous pattern of
researchers and companies peddling hype instead of healing. These false promises
about healing are not merely harmless self promotion by research companies eager
for venture capital, or benign wishful thinking by naive legislators.
Researchers' hype cruelly misleads those who are suffering into thinking that
cures are imminent. Perhaps even more disturbing is that this hype is often
successful in "blackmailing" legislators and regulators into taking a "hands
off" approach to regulation of these new technologies, lest such regulation
delay cures. The resulting public policy toward new medical technologies has
been misguided, inadequate and even dangerous. It has resulted in the trampling
of some our most important ethical norms, and in some cases to increased
suffering and mortality among the very people we seek to cure.
Genetic
"Wizardry"
A paradigm case of hyperbole over healing is gene therapy. In
the late 1980s "gene therapy" was heralded as the new "miracle cure."
Researchers were hailed as "gene wizards" and the media, policy makers and
scientist/entrepreneurs predicted cures to cancer and virtually every other
serious human ailment. Billions of public and private research dollars poured
into biotechnology companies and human clinical trials. Despite public protest
by some scientists, and law suits by health advocacy groups, human gene therapy
trials were approved by the federal government with woefully inadequate
oversight and virtually no enforcement. Unmonitored and virtually unregulated,
the researchers themselves were relied on to report any adverse results in their
test. Over the last decade there have been more than 400 gene therapy trials on
patient groups. Despite all the hype, not a single person in any U.S. gene
therapy trial has been cured of any disease. Abbey S. Meyers, a patients' group
advocate noted, "We haven't even taken one baby step beyond the first clinical
experiment. It's hardly gotten anywhere . . . I have been very disappointed."
For many, gene therapy has been far worse than a disappointment. Jesse
Gelsinger was an active and altruistic 18 year old from Tucson, Arizona who
suffered from a rare gene disorder. He volunteered to take part in a
Philadelphia based gene therapy trial study on that genetic disorder. He hoped
to participate in finding a cure. Instead, the gene therapy killed him. The
media furor over Gelsinger's death resulted in revelations of serious misconduct
by researchers in his case and in others' trials. Subsequently a half dozen
other cases were found where patients' deaths were linked to gene therapy
experiments. Eventually, it was revealed that there were over a thousand serious
adverse effects potentially attributable to gene therapy trials, including
numerous deaths. Left on their own, researchers had only reported 37 of these
adverse events. As the hype about gene therapy held legislators and regulators
at bay, researchers violated the most basic ethical tenets on the use of human
subjects, which along with deficiencies in the technology, resulting in
significant suffering and the death. Wide scale reporting of this scandal has
led to an attempt to tighten regulation of gene therapy trials, but most agree
that the new policies are far too little, and for the victims of the technology,
far too late.
The Fetal Revolution
There is a similar and
equally disturbing history with the hype over fetal tissue research. By the late
1980s fetal transplants were being heralded, as the "ultimate cure of the
future." An editorial in the New York Times warned that "to interfere with these
[fetal tissue] experiments is to interfere with progress that could save
countless lives." Fueled by this hype, a moratorium on federally funding of
fetal tissue transplants was lifted in 1992, and the proponents confidently
predicted a cure for many of our most pernicious diseases and disabilities.
Ethical concerns which had led to the moratorium were given only cursory
attention. Now after 13 years of private and publicly funded trials some of the
ethicists' worst fears have come to pass. There is a thriving market in the sale
of various fetal parts from clinics to hospitals and researchers. There are also
reports that clinics are changing the method and manner of abortions,
potentially creating injury in women, in order to obtain more viable and
valuable fetal tissue.
As for the hundreds of patients who have received
fetal transplants, mainly for Parkinson's disease, there have yet to be proven
benefits, but as with gene therapy we have seen very real and shocking health
impacts. As reported last year, the most comprehensive study on the use of fetal
tissue to treat Parkinson's showed no overall benefit, but researchers described
side effects of the treatment as "absolutely devastating." The problem was that
in a significant percentage of fetal tissue recipients the implanted cells
created too much of the needed brain chemicals causing uncontrolled movements
and spasm in the patients. "They chew constantly, their fingers go up and down,
their wrists flex and distend," reports Dr. Paul E. Greene, a neurologist at the
Columbia University College of Physicians and Surgeons and one of the
researchers involved in the federally funded fetal tissue study. Greene also
described patients as writhing and twisting, jerking their heads and flinging
their arms about. The spasms were so severe in one patient that he could no
longer eat and needed a feeding tube. For others the spasms made their speech
unintelligible. Despite these effects, there is no way to remove the
transplanted fetal cells or stop them from creating these impacts on the
patients. "It was tragic, catastrophic," Dr Greene explained. "It's a real
nightmare, and we can't selectively turn it off." As for the near future, Dr.
Greene at least has seen the light: "No more fetal transplants. We are
absolutely and adamantly convinced that there should be research only."
Stem Cells and
Human Cloning As the grim
histories of gene therapy and fetal tissue use are left generally unexamined,
stem cell research, including the cloning of human embryos, has succeeded them
as the miracle cure du jour. As the testimony of West and other researchers
indicates, we are once again being subjected to a full court press of hype, as
companies and researchers vie for venture capital and federal research dollars.
Unfortunately we also continue to witness a continued and unconscionable
gullibility in many of our policy makers. Once again they appear to have become
hostages to the hype about healing. This is particularly alarming because the
stakes in this debate are very high. As noted, West and many in the research
community are pushing for an unregulated and unmonitored industry in cloned
human embryos. West and his cohorts insist that only cells from cloned human
embryos will be the panacea for all that ails us. This despite their failure to
obtain stem cells from embryos, and the current availability of adult and
placental stem cells for research.
Besides corporate profits West and
some others in the research community have another very clear aim. They want to
stop the Senate from following last year's House action in declaring a ban on
human embryo cloning, and they may well be succeeding. In the next few months
the Senate will be debating and voting on the
human cloning
issue. While there is general agreement over banning human embryo cloning to
create children, there is confusion on halting the cloning of human embryos for
research. Will our policymakers finally cut through the hype and ask the
important questions about research cloning?
A number of those in the
progressive community have several major concerns about
human
cloning for research. Environmentalists, consumer groups, women's and
children's health advocates all want to see unprecedented regulatory and ethical
questions resolved before and human embryo cloning for research is allowed.
These issues include:
1) An unregulated industry and market in the
production of cloned human embryos will inevitably lead to reproductive cloning.
Imagine fighting the drug war by banning certain uses of drugs but allowing and
even encouraging the mass production and dessemination of such drugs for 'legal'
purposes. This is what those advocating a ban on human reproductive cloning but
encourging human embryo cloning for research are advocating. It is irresponsible
legislation. Clearly the time to regulate reproductive cloning is at the stage
of the creation of the cloned embryo. Attempting to enforce a reproductive ban
after a cloned embryo is implanted into a surrogate mother is a regulatory
nightmare. Given the slippery slope from embryo cloning to reproductive cloning,
the only scenario in which embryo cloning for research would be acceptable is if
a strict regulatory procedure were in place which carefully montiored the chain
of custody of each and every cloned embryo.
2) An unregulated industry
in cloned human embryos will lead to unacceptable commodification of life. The
U.S. Patent and Trademark office has already announced that cloned human embryos
would be patentable. Additionally there is no bar on the sale of embryos or
human ova necessary for this technology. Clearly if we sold the Congressional
Medals of Honor we would degrade the meaning of this honor. If the Nobel Prize
we up for sale it would cease to have meaning. If we buy and sell children we
corrupt and demean the meaning of parenthood. Just so if we allow the patenting
and sale of human embryos and human eggs we corrupt and demean what it means to
be human.
3) As currently envisioned cloning of human embryos for
research represents a serious threat to women's health. In recent testimony a
researcher stated have stated that they could do up to 1.7 million therapies per
year. this would require a minimum of 5-8 million eggs -- assuming a very high
success rate of 1 out of 3-5 eggs -- to accomplish the therapeutic cloning
required to support these therapies . Where will they get theses eggs? From
women in this country or abroad. Egg donation can have significant health
impacts on women including the effects of hormone therapies and other drugs
administered to facilitate extraction and the extraction process itself. Most
women who are lured into this process are economically disenfranchised and
perform this operation for money. With research embryo cloning we could see a
massive expansion in the use of women as paid egg "factories." This presents
both a real threat to women and an expansion of the repugnant commodification of
life discussed above.
4) Human embryo cloning for research could deprive
us of our choice on when, how and where our genetic heritage will be replicated.
Researchers may be able to clone "copies" of us by using cells from our hair,
blood, or virtually any other tissue. There have already been several legal
cases where patients have had their cells turned into valuable cell lines
without their knowledge. Unless they are carefully monitored, how will any of us
know if a researcher of company is replicating our genetic makeup in any number
of human embryos at any time. This is a significant "choice" issue for all of
us, especially for those whose religious or moral beliefs find
human
cloning in any form unacceptable.
5) Does the cloning of human
embryos for research divert valuable health research dollars away form proven
methods into highly speculative ones? There are only limited research and health
dollars available. Diseases such as cancer are complex in origin. Genetic
predisposition, environmental pollution, diet, stress and social habits (such as
smoking) all can contribute to this disease. While it is tempting to believe
that gene therapy, fetal tissue or stem cells form cloned embryos will be the
'magic bullet' that will cure cancer, this view is hopelessly naive. We have
seen in the past that prevention is the best policy when dealing with major
diseases or disabilities. This means significant contribution of resources to
cleaning up the environment and work places, educating about diet and lifestyle,
working to reduce poverty and and changing some of our unhealthy compulsive
habits. While prevention may not be a good 'handle" to raise venture capital, it
unlike speculative "miracle" cures has a proven record of success.
6)
Cloning human embryos for research raises the key ethical issue of whether we
should intentionally create any human life form solely for its exploitation and
destruction. As a human community we have never done this before. Certainly
there should be public hearings and wide ranging public participation on this
key ethical issue before such cloning is allowed.
As we debate the
human cloning issues, we must also demand responsibility and
caution from those making claims about stem cell research. Many suffering from
serious illnesses or disabilities have been misled by the false promises about
gene therapy, fetal tissue and other medical "breakthroughs." The continued hype
about stem cells is unconscionable. Moreover, Congress must establish stringent
regulations that assure that no human trials using stem cells technology take
place until research fully justifies such trials. Should there eventually be
human trials, they must be carefully and independently regulated and monitored.
Researchers cannot be left to regulate themselves. Our elected representatives
owe nothing less to the families of those who have died, and the many now
suffering, because of Congress' past failures to cut through the hype and
appropriately regulate medical technology.
Thank you.
LOAD-DATE: February 6, 2002