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Congressional Testimony
May 15, 2002 Wednesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 3750 words
COMMITTEE:
HOUSE GOVERNMENT REFORM
SUBCOMMITTEE:
CRIMINAL JUSTICE, DRUG POLICY AND HUMAN RESOURCES
HEADLINE: ETHICS AND CLONING
BILL-NO:
H.R. 2505 Retrieve Bill Tracking Report
Retrieve Full Text of Bill
TESTIMONY-BY:
PROFESSOR, DR. PANAYIOTIS ZAVOS, ED.S., PH.D.,, DIRECTOR OF THE
AFFILIATION: ANDROLOGY INSTITUTE OF AMERICA,
BODY: Statement of Professor, Dr. Panayiotis Zavos,
Ed.S., Ph.D., Director of the Andrology Institute of America,
Testimony
before the Subcommittee on Criminal Justice, Drug Policy And Human Resources
House Government Reform
May 15, 2002
I am a Reproductive
Specialist and Scientist that has dedicated the last 24 years of my life in
helping infertile couples have children and complete their biological cycle (see
Attachment). In January 2001, we have announced the possibility of using
reproductive regeneration technologies as a means of treating infertility, and
our intention to develop these technologies in a safe and responsible manner.
However, we have received great opposition from fellow scientists, news media
and the general public. It seems that the great opposition is due to the lack of
complete understanding and comprehension of what in actuality
human
cloning really is all about. The British Medical Association however,
has so appropriately stated: "Public hostility to human reproductive cloning may
be based on an illogical transient fear of a new technology". Much of the
confusion is caused by the variance in opinions coming from different scientific
sources, politicians, news media and Hollywood. Due to the limited knowledge of
these technological and medical procedures in the Scientific Community, we have
organized, hosted and attended meetings involving scientists from all over the
world to discuss and debate the issues of human reproductive regeneration (1).
We have even presented our intentions before the Congress of the United States
last year. Do You Care About Infertility?
Infertility affects
approximately 10-15% of couples of reproductive age throughout the developing
world. Assisted Reproductive Technologies (ART) have played a major role in
treating various causes of infertility. In fact, about 65% of the couples who
seek medical help will eventually succeed in having a child. However, in cases
where there are no sperm or eggs present (possibly due to loss of testicular or
ovarian function), the only options these couples face are sperm donation,
oocyte donation or adoption. These are difficult choices for couples to make and
many do not want to use sperm or egg sources other than their own or do not wish
to consider adoption. Reproductive regeneration (RR), which is synonymous to
reproductive cloning, can therefore play a very real role in the treatment of
severe male or female infertility in couples that wish to have their own
biological children.
After a lot of time, money and suffering, many of
the infertile couples have been able to have children using present IVF
techniques. Personally, it has given me great satisfaction to assist them in the
creation of their own families. However, some of these infertile couples have
not been able to experience the joy of creating their own families because the
present technologies are not advanced enough to help them. For them, human
reproductive cloning is the only way they can have their own children. As a
Reproductive Specialist and a scientist who cares about their plight, I am
trying to develop safe techniques of
human cloning so they can
have the healthy babies they want. Mr. Chairman, am I wrong in wanting to help
couples become parents?
If you care about these unfortunate infertile
couples, why are you considering legislation that would make both them and the
people that are trying to help them, criminals? Criminalizing human reproductive
cloning in the United States will only make it less safe and more costly for
these infertile couples. They will be forced to travel outside the United States
to pursue their dream of creating a family. After all, according to the
Americans with Disabilities Act (ADA), infertility is a disability and
reproduction is a major life activity for the purposes of the ADA (Bragdon v.
Abbott, 118 S.Ct 2196; 1998). In light of this, it is the right of each and
every American citizen to bear a child.
Cloning cannot be Curbed
Mr. Chairman, experts state repeatedly that history proves the point
very clearly that scientists will clone even if President Bush and the Congress
forbid it. The House of Representatives may vote against
human
cloning but that will not stop scientists from doing it and people from
wanting it. The American Society for Reproductive Medicine (ASRM) of which I am
a long standing member of, recently stated that "thousands of years of human
experience have shown us that governments cannot bottle up human progress, even
when you want to "and that "there is every reason to believe that if passed,
this kind of prohibition would not be effective". In another case made by a
infertility patient, who wants her own genetic baby so badly that she would go
wherever she had to, in order to clone either herself or her husband "if they
called me right now and said, 'We're paying for everything and giving you the
chance to have your own genetic child,' I would be on a plane so fast it's not
even funny," she said. In the words of a bioethicist "The best way to control
this research is to fund it by the federal government, because then you create
rules," and in my words Mr. Chairman, this Genie is out of the bottle and it
keeps getting bigger by the hour. There is no way that this Genie is going back
into the bottle. Let us find ways to develop it properly and disseminate it
safely.
Banning human reproductive cloning in the United States will not
stop
human cloning. In fact, the first cloned pregnancy may
have occurred already. If you institute a ban, all that will happen is exactly
what happened when the first IVF baby was born in 1978. The United States banned
IVF when it first came out and then after several years, decided it had made a
mistake and spent the next several years catching up with the technology that
was advanced in other countries. The only people that suffered were the
infertile U. S. couples who were unable to have children or had to travel
outside of the United States to receive these treatments. Let us show the proper
compassion for those suffering American infertile couples. Let us give them some
hope and let us not turn our backs on them They deserve something better than
that.
If you are concerned about the risks of
human
cloning, the proper approach is to fund it and then institute
regulations that will insure that
human cloning is done
properly with a minimum of risk for the baby just as is done in other medical or
drug innovations. This is what our team is working on and we will not go forward
with
human cloning until the risks are comparable with other
IVF procedures. Of course, because of the present political climate in the
United States, we have been forced to look elsewhere in the world for a proper
venue. We have no intentions of doing this in the USA whether any legislation is
passed for or against this technology. Furthermore, Mr. Chairman, we have no
intentions of breaking the laws of this country or any other country to
accomplish this. We are law abiding citizens of this great Nation of ours, but
we are compassionate group of people that wish to help our fellow man and woman
have the gift of life. The gift of life that most of us have been so fortunate
to have, enjoy and take for granted. Let us not be so uncompassionate and so
insensitive to tell those people that we are not willing to listen to them and
unwilling to help them. This is not what our Country's constitution and
principles are based on. We believe in creating families, not preventing them.
In God we trust!
Reproductive Regeneration as a Means of Infertility
Treatment
The incidence of developmental abnormalities following natural
sexual reproduction in humans is 3% and is significantly higher when maternal
age is over 40. As recently reported in the New England Journal of Medicine, the
risks are even greater from IVF and other more advanced ART procedures yielding
more than 30,000 children per year in the USA. It is vividly clear that
thousands of potential parents accept these risks to conceive a child. If human
reproductive regeneration is banned as a reproductive technique on safety
grounds, then we may find ourselves in the untenable position of having banned
all reproductive techniques which suffer equal or higher risks, thereby,
possibly even banning natural sexual reproduction with its 3% risk, a situation
that the majority of people would consider ridiculous. It appears reasonable to
suggest that the incidence of developmental abnormalities as to the safety of
human reproductive regeneration is negligible when compared to current risks
associated with IVF and other ART procedures.
It is quite evident to us
along with other competent human reproductive specialists that with further
elucidation of the molecular mechanisms involved during the processes of
embryogenesis, careful tailoring of subsequently developed culture conditions
and manipulation strategies, and appropriate screening methods, will eventually
allow infertile couples to safely have healthy, genetically related children
through SCNT methods.
The opponents of
Human Cloning or
Reproductive Regeneration
The most prominent opponents to human
reproductive regeneration and spokesmen for animal cloning are Drs. Ian Wilmut
from the Roslin Institute and Rudolph Jaenisch from the Massachusetts Institute
of Technology (MIT), who have misled and have misdirected the public and its
leadership for their very own gains, whatever those gains might be. They have
repeatedly stated that the application of animal cloning technologies to humans,
is extremely dangerous, not because of ethical and social implications, but
because of the foreseeable possibility that cloning humans might result in a
very high incidence of developmental abnormalities, large offspring syndrome
(LOS), placental malfunctions, respiratory distress and circulatory problems,
the most common causes of neonatal death in animals (2). They also noted that
the rate of success as an ART method is extremely low, being only 3%.
Furthermore, they state that because since the production of Dolly the sheep in
1995, they have not improve on these technologies themselves, they have
concluded that reproductive regeneration is not safe and efficient for use in
humans, and would like for the world to believe this. Let us examine the facts
as they appear.
If one reviews the animal cloning literature, one can
deduce that the poor cloning success rates noted by the "animal cloners" are
mainly due to experiments that were (i) poorly designed, (ii) poorly executed,
(iii) poorly approached, and (iv) poorly understood and interpreted. These
experiments were mostly done under non-sterile and uncontrolled environments and
having a "hit- and-miss" type of outcome. Also, when the cloned animals died, no
clear view of their cause of death was ascertained. In short, their
experimentation methods lacked the seriousness of purpose that is vital when
performing similar studies in humans. Furthermore, the same scientists
responsible for Dolly, the sheep, now plan to utilize similar crude technologies
to experiment on cloned human embryos for medical purposes.
According to
a recent article in Time Magazine (3), Wilmut and Jaenisch stated "animal
cloning is inefficient and is likely to remain so for the foreseeable future".
On the contrary, a number of studies have already demonstrated far higher rates
of success and, in some cases, matching or exceeding successes noted in human
IVF today. Also, if history is any indicator, one can reasonably expect that
further refinements to the cloning process will improve efficiency rates.
Scientists have reported success rates of 32% in goats and 80% in cows since
1998, as opposed to the poor 3% success rate Wilmut obtained when cloning Dolly
in 1995. Furthermore, scientists at Advanced Cell Technologies in Worcester,
Massachusetts, in association with others, have recently produced 24 cloned
cows, that were all normal and healthy and have survived to adulthood (4).
Despite the overwhelming data that exists showing refinements in the RR
technology that yield improving success rates, Wilmut and Jaenisch still insist
that it is inefficient based upon their poor success using very crude and
uncontrolled experimental techniques , almost seven years ago. One can only but
question their motives for their illogical arguments. They do not seem
interested in developing and refining techniques, but they rather seem to have
immense private interests and want to patent and control the technologies for
themselves. Interestingly enough, the Roslin Institute scientists who cloned
Dolly the sheep have changed their agenda on the cloning subject and have stated
recently that they plan to seek permission to experiment on cloned human embryos
for medical purposes. What are their true motives?
Animal Cloning vs.
Human Reproductive Regeneration
It has been very clearly shown that
animal cloning and its difficulties appear to be species-specific, and the data
cannot be extrapolated with a great degree of accuracy to the human species. In
a recent study by scientists from Duke University Medical Center, it was
demonstrated that it may be technically easier and safer to perform somatic cell
nuclear transfer (SCNT) in humans than in sheep cows, pigs, and mice because
humans possess a genetic benefit that prevents fetal overgrowth, one of the
major obstacles encountered in cloning animals.
The genetic benefit is
based on the fact that humans and other primates possess two activated copies of
a gene called insulin like growth factor II receptor (IGF2R). Offspring receive
one functional copy from each parent as expected. However sheep, pigs, mice and
virtually all non-primate mammals receive only one functional copy of this gene
because of a rare phenomenon known as genomic imprinting in which the gene is
literally stamped with marking that turn off its function. Since humans are not
imprinted at IGF2R, then fetal overgrowth would not be predicted to occur if
humans were cloned. If this theory is correct, the incidence of developmental
abnormalities following human SCNT would be significantly lower. Also, the
authors concluded that the data showed that one does not necessarily have these
problems in humans. This is the first concrete genetic data showing that the
cloning process could be less complicated in humans than in sheep.
The
political Status on Cloning
In the United States, the House passed in
July, 2001 the Weldon Bill or the
Human Cloning Prohibition Act
of 2001 (bill H.R. 2505). This bill would prohibit any person or entity, in or
affecting interstate commerce, from (i) performing or attempting to perform
human cloning, (ii) participating in such an attempt, (iii)
shipping or receiving the product of
human cloning, or (iv)
importing such a product. The bill currently pending in the US Senate, S 790,
written by Sen, Sam Brownback (R Kansas), would criminalize all cloning with a
fine of up to $
1 million and 10 years in prison and it is
almost identical to the bill (H.R. 2505) passed by the House in July 2001. The
Council of Europe has introduced a protocol that prevents any abuses of such
techniques by applying them to humans, banning "any intervention seeking to
create a human being genetically identical to another human being, whether
living or dead". Finally, the Protocol leaves it to countries' domestic law to
define the scope of the term "human being". In April 24, 2001, England has
banned "reproductive regeneration" but not "therapeutic cloning".
The
political situation with cloning in general remains very fluid, mainly because
of the inability of the politicians to understand, comprehend and act decisively
on the issues that cloning presents to society. After all, their inability to
act decisively may have a great deal to do with their resistance to debate and
face the facts that humans will be cloned.
Recent Statements by
President Bush
In his speech to the American public, President Bush made
an appeal for a global ban on cloning, whether it be for therapeutic or
reproductive cloning, on the basis that we should not use people for "spare
parts" and we should not "manufacture people". Reproductive cloning does
neither. As opposed to therapeutic cloning which results in the inevitable death
of an embryo once the stem cells have been removed, reproductive cloning aims to
protect and preserve life in allowing the embryo to grow and be implanted into
the uterus for a subsequent pregnancy. From an ethical point of view, there is
no destruction of life.
Quoting President Bush: "Life is a creation, not
a commodity. Our children are gifts to be loved and protected, not products to
be designed and manufactured. Allowing cloning would be taking a significant
step toward a society in which human beings are grown for spare body parts, and
children are engineered to custom specifications; and that's not acceptable."
And that's not acceptable to us either, Mr. Chairman! We agree with President
Bush and uphold the sanctity of human life. Reproductive cloning does not
involve the destruction of human embryos, nor does it modify or "engineer" the
genetic code to custom specifications. Reproductive cloning involves employment
of similar technology used for Intra cytoplasmic Sperm Injection (ICSI), which
is routinely employed in IVF centers throughout the World. The only difference
is that instead of using a sperm cell from the father, scientists can use a
somatic cell nucleus and inject it into the mother's anucleated egg. The
resulting embryo would have its genetic makeup from the father, but the
expression of the genetic code and characteristics and personality of the baby
born will be completely different and unique. Reproductive cloning is nothing
more than another modality for the treatment of human infertility in giving the
gift of life to a childless couple that have exhausted all other choices for
having a child. What is so wrong about this?
Is History Repeating
Itself?
This is not the first time that the scientific community has had
to deal with controversial issues regarding new technologies. Exactly the same
events happened with IVF in the Kennedy Institute in Washington in 1978.
Professor Robert Edwards and Dr. Patrick Steptoe were faced with such criticism
from hundreds of reporters, senators, judges, scientists and doctors, when they
proposed the idea of in-vitro fertilization. The language and accusations were
the same as what we face today, including "they ignored the sanctity of life,
performed immoral experiments on the unborn", "subject to absolute moral
prohibition", "no certainty that the baby won't be born without defect" and to
"accept the necessity of infanticide. There are going to be a lot of mistakes"
(6-11).
Twenty-four years later, the exact opposite of everything the
"experts" predicted happened. IVF has become an acceptable and routine treatment
of infertility worldwide. The abnormalities that were expected to have been
unacceptable proved to be the same, if not less than with natural conception
(11). Ironically, those critics of IVF have become the "pioneers" of IVF. These
same critics might have delayed the introduction of IVF but their actions mostly
harmed patients, and also the medical and scientific community. I am certain
that the reproductive cloning procedures will follow in the same footsteps.
Recently, I have had the opportunity to openly debate Professor Robert Winston
from the UK, on the issue of human reproductive cloning at an Oxford Union
Debate at Oxford University. Ironically enough, he was one of the leaders
originally opposed to IVF, and who is currently a leading IVF specialist in
Britain. The technology that he was vehemently opposed to, almost twenty-five
years ago, is now the very same technology that he uses to earn a living. Once
reproductive regeneration is commonplace in the ART treatment market, will he,
along with all the other critics, "jump" on the bandwagon and offer this new
technology in their own IVF centers? I believe so. They have done it before and
they can do it again. Mr. Chairman, we can not afford to behave this way and
most importantly wish to repeat the same mistake.
Conclusion
As
Professor Robert Edwards, the great English scientist who helped create the
world's first test-tube baby in 1978, so eloquently prophesied recently
"Cloning, too, will probably come to be accepted as a reproductive tool if it is
carefully controlled" (12). No doubt, humans will be produced via reproductive
regeneration. Recent scientific and technological progress demonstrates that
very clearly. Similar to IVF, the technology of reproductive regeneration will
advance, techniques will be improved, and knowledge will be gained. Reproductive
regeneration's difficult questions can be answered only through a dedicated
pursuit of knowledge and an exercise of our willful rationality, and in the end,
the answer to the debate over human nature may be simply that man's nature is
the product of his own will.
Mr. Chairman, science has been very good to
us and we should not abandon it now. Consider why America has the best medical
care in the world. It is because we have the freedom to investigate, research
and market the latest medical techniques, all within proper procedures and
safeguards. This is not the time to panic and try to turn back the clock. The
Genie is already out of the bottle. Let's make sure it works for us, not against
us. Let's do it here. Let's do it right.
By banning cloning, America
will be showing the world that she is hesitant and/or reluctant to take the lead
in this new arena of technological advancement. The world today is looking at
the most powerful nation on Earth for leadership on this issue, and walking away
from it by banning it is not a sign of leadership, but cowardice. Do not let the
future of this technology slip away through our fingers, because we are too
afraid to embrace it. I believe that it is the right of the American people to
choose whether or not they want to have this technology available to them. Let
us educate ourselves and debate the issues and not make irrational decisions
based upon fear of a new technology. Banning this technology would only give our
enemies license to use it to their advantage. Let us learn from history and
forge ahead in this brave new world as leaders, not spectators, the American
way.
LOAD-DATE: May 20, 2002