Subcommittee on Criminal Justice, Drug Policy and Human Resources
Wednesday, May 15, 2002, 1 p.m
Rayburn House Office Building, Room 2154
Hearing to examine Issues related
to Human Cloning
document is also available as an Adobe Acrobat File. Please click
here to read Dr. Zavos' speech in Chinese
cloning advocate Dr. Panayiotis Zavos of the Andrology Institute
of America testifies before the House Government Reform Subcommittee
on Criminal Justice, Drug Policy and Human Resources on Capitol
Hill Wednesday, May 15, 2002.
(AP Photo/Dennis Cook)
before the House Subcommittee on Criminal Justice, Drug Policy,
and Human Resources
© 2002 Dr. P. Zavos.
Reproduced by the Zavos Organization with permission from Dr. Zavos.
Professor, Dr. Panayiotis Zavos, Ed.S., Ph.D.,
Director of the Andrology Institute of America,
Associate Director of the Kentucky Center for Reproductive Medicine
President and CEO of Zavos Diagnostic Laboratories, Inc..
Professor Emeritus of Reproductive Physiology & Andrology
University of Kentucky
P.O. Box 23777, Lexington, KY 40523 USA
Room 2154 Rayburn Office Building
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.
You Care About 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.
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
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.
cannot be Curbed
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 an 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.
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.
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!
Regeneration as a Means of Infertility Treatment
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.
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
opponents of Human Cloning or Reproductive Regeneration
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.
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.
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
Cloning vs. Human Reproductive Regeneration
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
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
The political Status on Cloning
the United States, the House passed in July, 2001the 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
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.
Statements by President Bush
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?
History Repeating Itself?
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"
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.
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.
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.
- Zavos, P., and Antinori, S. (2001): If the Royal Society is having a
debate on cloning, then let's have a debate, not a monologue.
Sunday Herald, November17, Glasgow, Scotland.
- Humpherys D, Eggan K, Akutsu H, et al.(2001): Epigenetic instability
in ES cells and cloned mice. Science, July 6, 293(5527): 95-97.
- Gibbs, N. (2001): Baby, it's you! And you, and you. Time Magazine
February 19, Vol. 157 No. 7, 46-58.
- Lanza R.P, Cibelli, J.B. Faber, D. et al (2001): Cloned Cattle
Can Be Healthy and Normal. Science, November 30; 294: 1893-1894.
- Killian K., Nolan C.M. Wylie, A.A. et al. (2001): Divergent evolution
in M6P/IGF2R imprinting from the Jurassic to the Quaternary. Human
Molecular Genetics, 10 (17): 1721-1728.
- Cooper G (2001): The double vision of Dr Miracle Washington Post,
- Edwards, R.G., Steptoe, P.C. (1980): A Matter of Life. Hutchinson,
- Hawkes, H. (2001): Outrage as doctor prepares to clone babies.
London Times, August 8.
S.G. (2001): Despite warning, 3 vow to go ahead in human cloning.
New York Times, August 8.
- Weiss, R. (2001): Scientists declare progress on human cloning.
Washington Post, August 7.
- Edwards, R.G. (2001): Is scientific history cloning itself? RBM
Online 3(2) September/October.
- Schmickle, S. (2001): Human-cloning researcher has scientific
roots in 'U' animal science lab. Star Tribune, October 28.
MICHAEL ZAVOS, Ed.S., Ph.D.
February 23, 1944, in a small village of Tricomo in Famagusta, Cyprus,
Panayiotis Michael Zavos is the second youngest son of Michael and
Theodora Zavos. He comes from a very successful family, holding
numerous national and international companies and institutions.
He grew up in Tricomo, and attended the Agricultural Gymnasium of
Morphou (High school) in the city of Morphou. He worked at the Agricultural
Research Institute of Cyprus as a Research Assistant and served
as a Lieutenant in the Cypriot Army from 1963-1966. He immigrated
to the United States for University studies in 1966.
Panayiotis Zavos received his B.S. in Biology-Chemistry in 1970,
his M.S. in Biology-Physiology in 1972 and Education Specialist
in Science (Ed.S.) in 1976 from Emporia State University in Emporia,
Kansas. He earned his Ph.D. in Reproductive Physiology, Biochemistry
and Statistics in 1978 from the University of Minnesota in the Twin
Cities, Minnesota. He received the Distinguished Alumnus Award and
the Graduate Teaching Award from Emporia State University and the
Student Leadership Award from the University of Minnesota.
Zavos has a long career as a reproductive specialist and he has
devoted more than 25 years to academia and research. He is the chief
scientist in the development of several new and innovative technologies
in the animal and human reproductive areas with worldwide implications.
He has authored or coauthored more than 400 peer-review publications,
along with a number of solicited reviews, book chapters and popular
press releases. He has presented more than 300 abstracts and other
presentations at a large number of national, international and professional
scientific meetings all over the world. Dr. Zavos' studies and findings
have been reported in the local, national and international press.
He served as an ad hoc reviewer for the NIH and other scientific
Zavos is currently serving as a Board Member of the Middle East
Fertility Society, and is a past Board Member of the China Academy
of Science. He was awarded the first ever Honorary Professorship
by the Chinese Academy of Science awarded to an American by Chinese
Scientists. He has given plenary lectures nationally and internationally
at a number of Scientific Societies meetings, has been and continues
to be a visiting scientist for a number of international collaborations
Zavos has numerous scientific collaborations nationally and internationally
and his publications have appeared in eight languages. He is a member
of the American Society for Reproductive Medicine (ASRM), the American
Society of Andrology (ASA), the European Society for Human Reproduction
and Embryology (ESHRE), the Middle East Fertility Society ( MEFS),
the Japanese Fertility Society, the International Society of Cryobiology
Sigma XI, Gamma Sigma Delta and a number of other Scientific and
Professional Societies. He has served on a large number of
committees for the International Society of Cryobiology, ASRM, MEFS,
ESHRE and others.
Professor Zavos has received a great deal of media coverage both
within the scientific and reproductive arena and the mainstream
press for his many scientific accomplishments and pioneering ventures.
He has made many television and radio appearances including: NPR
Radio, 60 Minutes with CBS, Twenty-Twenty with ABC, Dateline NBC,
Face the Nation, BBC World, Tech TV, Nightline, Fox TV, World News
Tonight, Good Morning America ABC, The Early Show, CBS This Morning,
CNN News, CNN, CNN International, Reuters, HBO, The View with Barbara
Walters, National Geographic, Televisione svizzera (Swiss TV), Cyprus
Broadcasting Corporation, Antena TV of Cyprus and Greece, Tokyo
Broadcasting System International, NHK Television (Japan), Nippon
Television of Japan, TV Asahi (Japan), ZDF TV (Germany), Deutsche
Welle TV (Germany), Nine Network TV (Australia), National TV (Israel),
Live Talk with Sabine Christiansen (Germany) and a great deal of
other local and regional TV programs throughout the US, Canada and
Europe, too numerous to mention.
Zavos is recognized worldwide as a leading researcher and a strong
authority in the areas of male reproductive physiology, gamete physiology,
male infertility, Andrology and other ART procedures including the
development of in-vitro round spermatid manipulations (ROSI procedures).
Dr. Zavos is also recognized as an international authority on smoking
and its effects on human reproductive performance.
Dr. Zavos founded and serves on various companies as:
- Founder, The Zavos Organization, www.zavos.org
- President and CEO of Zavos Diagnostic Laboratories, Inc., a private
corporation that markets infertility products and technologies,
in the USA and worldwide, www.zdlinc.com
- Founder, Director and Chief Andrologist of the Andrology Institute
of America, www.aia-zavos.com
- Founder and Executive Director of the Home Fertility Network, www.homefertility.com
- Founder, Semen Tests, for "Online" Semen Analysis, www.sementests.com
- Co-Founder and Associate Director of the Greek-American Andrology
Institute of Athens, Greece
- Professor Emeritus of Reproductive Physiology-Andrology at the
University of Kentucky, in Lexington, KY, USA
- Honorary Professor, China Academy of Science