Throughout my scientific career as a molecular geneticist, I have been involved in the
ethical issues confronting biotechnology and cellular biology as well as medical advances.
I was present at the Asilomar Conference where 150 scientists from 18 nations met to
debate the safety of recombinant DNA technology (rDNA) and also considered the ethics of
the research. Careful attention to both safety and scientific inquiry was incorporated
into the NIH Guidelines at that time. As a member of the first Recombinant DNA Advisory
Committee, I participated in deliberation on the development of this technology and was
keenly aware that public confidence in this new field of biotechnology was imperative.
This rDNA research using microbes and animal cells to produce medicines led to the
establishment of the biotechnology industry. For many years, I participated in recombinant
DNA research in policy deliberations on implementation of guidelines for conducting rDNA
research, and, as the Commissioner of the Food and Drug Administration, led in the
development of regulations nationally and internationally.
Today, we are considering embarking on an equally significant
revolution in cellular biology. The use of stem cells to produce tissues such as blood
vessels, brain cells and heart cells could result in the partial regeneration of organs.
Unlike the development of biotechnology, which uses bacteria, yeast and adult tissue
culture cells to produce products, the research on embryonic stem cells is dependent on
disintegration of human embryos. I contend that killing embryos by disintegration to
harvest stem cells is illegal, immoral, and unnecessary.
As a member of the American Association for the Advancement of Science
(AAAS), I commend the AAAS for engaging in the debate. I offer these comments to improve
perceived flaws in the document and offer a recommendations, which I trust, will be
considered. Simply put, in its current form, the report is embedded in the scientific
imperative to do whatever is possible. Furthermore it over-promises spectacular scientific
advances and proposes a scheme of inhumane extreme utilitarianism (sacrificing the lives
of the vulnerable embryos for research) instead of preserving life. A number of changes
are suggested to improve the report and address its major deficiencies:
1. Process: The panels debating ethical concerns should be more
representative and include scientists, physicians and members with opposing views instead
of choosing individuals who support the proposed research agenda. Additionally, general
statements of promise in the report should be substantiated by scientific data. For
example, on page 2 the reference is made to the use of fetal brain tissue in the treatment
of Parkinson's disease. The result of such treatment was not as highly successful as
implied and the identification and potential use of adult brain stem cells was omitted.
2. Public Programs: Include on the program a diverse representation of
ethicists and consumer groups who oppose this research instead of only industry and
patient groups that have a vested interest. More than one expert should be included in
each area to ensure a more representative range of opinions. More time should be allowed
for public comment.
3. Another statement on page 2 is incorrect. In my opinion, this
technology does raise new and different ethical and policy concerns. For the first
time experimental studies on embryos are proposed that mandate their destruction in
violation of the Congressional ban on embryo research. The fate of spare embryos raises
important ethical concerns! In fact, as former Commissioner of the Food and Drug
Administration, I question whether in vitro fertilization needs more regulation to ensure
that there are no spare embryos and the procedures used meet safety and efficacy
standards. Roe v. Wade does not apply to embryos. Therefore, what are the First Amendment
rights for scientific research vs. the Fourteenth Amendment rights of living embryos in
respect to slavery? Will the next approach be the development of egg and embryo factories
developed from somatic cell cloning for further research?
4. AAAS recommends broad "public dialogue". Accordingly, the
AAAS should ensure that people with a range of views are recruited to serve on policy
panels. Additionally, AAAS should sponsor policy and ethical debates between ethicists,
theologians, physicians and scientists and publish the abstracts in Science. A one-day
meeting is a step in the right direction, but this is more the release of a report than a
process.
5. I concur that the existing federal framework is adequate providing
a broad-based bioethics committee is chartered by both Congress and the Administration.
The committee should consist of members nominated by the Congress, the Administration and
the Institute of Medicine to ensure broad representation of views. This committee should
make annual reports to the Congress thereby ensuring public participation and
accountability. This issue is too significant for the appointments to be in the
jurisdiction of a single branch of government
6. On page 4 of the report, it states, " We realize that there are
segments of American Society that disagree on moral grounds with using public monies to
support stem cell research." Recognizing this, it seems inconsistent to focus on the
support of research on embryo-derived stem cells (possibly option 2) rather than
accelerating and emphasizing adult human stem cell research. More discussion should be
presented on why the panel chose to proceed with embryonic cell research rather than
option 3. Was the choice merely a scientific imperative to support a constituency that
wished to feed at the trough of the Federal largess, or an expedient use of embryos for
research, or a wedge issue to break the Congressional ban, or a scientifically based
analysis of the need to use embryos now? The study of adult stem cells is more consistent
with the Hippocratic principle of "do no harm".
7. Moral accountability: The use of public funds for research on
embryonic stem cells and embryonic germ cells but not the procurement of the these cells
(page 6) is a hypocritical attempt to distance the researcher from the original decision.
This is an example of the "Pontius Pilate Syndrome": denying responsibility for
that for which one bears moral accountability. Either fund the harvest and the use of the
cells or call for a moratorium during the ethical debate. It defies the cardinal principle
of scientific objectivity to proceed while there is a sincere effort to determine whether
the practice is appropriate.
8. The support "of guidelines for conducting stem cell research,
where appropriate, that can attract professional and public support," assumes the
development of guidelines without consideration of an objective ethics report. I suggest
this recommendation be deleted or modified to merely endorse the development of
guidelines. Do not sugar coat it with a shroud of objectivity.
Our Declaration of Independence states that "we hold these truths
to be self-evident, that all men are created equal, that they are endowed by their Creator
with certain unalienable Rights, that among these are Life, Liberty and the pursuit of
Happiness." Throughout American history, our Nation has striven to protect the
vulnerable. The Americans with Disabilities Act, our efforts in Kosovo, the recent Clinton
Administration's Conference on Mental Health and the 60 member search and rescue team
from Virginia that aided Turkey by rescuing 4 victims are contemporary examples of our
National commitment in this regard.
News of past promising avenues of research has been followed in many
instances by the bones of failure. Embryonic stem cells do offer many advantages for
therapy. However, rather than sacrificing human embryos for the potential utilitarian
benefit of the living, we should instead develop and evaluate adult stem cell technology.
If our society chooses to kill and disintegrate embryos, we are compelled to reflect on
the question of whether this path leads to a new eugenics. Is this research avenue one
that leads to an imperative to preserve the life of people with disease at the expense of
the vulnerable? Now is the time to pause in order to ensure that our ethical standards
befit our democratic principles of equal opportunity and civil rights. Now is the time to
focus on the alternative technology of adult stem cell therapy. To do less, in my opinion,
is a betrayal of the public trust of science that is supported by taxpayer dollars.
Therefore, I recommend:
A moratorium on research embryo derived stem cells.
A substantial increase in funding for adult stem cell research
Appointment of a committee chartered by Congress and the
Administration, composed of members nominated by the Congress, the Administration and the
Institute of Medicine, to address the ethical, safety, public, scientific and theological
concerns of embryo research prior to embarking on embryo disintegration to harvest stem
cells for research.
In the interim, as an added layer of safety, the FDA should examine
whether additional guidelines and regulations are required for in vitro
fertilization in view of the AAAS support for embryo research therapy with stem cells
regardless of the source.
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