Testimony before the House Subcommittee on Oversight and Investigation; Hearing on Issues Raised by Human Cloning Research

Copyright © 2001 Dr. P. Zavos.  Reproduced by the Reproductive Cloning Network with permission from the Dr. Zavos. 

 

Report Author:

Dr. Panayiotis Zavos, Ed.S., Ph.D., Professor Emeritus of Reproductive Physiology & Andrology from the University of Kentucky,
President and CEO of Zavos Diagnostic Laboratories, Inc. 
Director of the Andrology Institute of America,
Associate Director of the Kentucky Center for Reproductive Medicine & IVF.

Wednesday, March 28, 2001 

Room 2123 Rayburn Office Building

Washington D.C.

 

Contents:

1. Introduction

2.  Current events in the ART market

3.  Current status of Animal Cloning

4.  Current status of Human Cloning

5.  Who should develop this technology?

6.  What quality controls are necessary?

7.  Closing Remarks

 

 

Introduction

Over the last 25 years I have been involved in the area of reproductive physiology, andrology, and assisted reproductive medicine. I have received extensive formal education by obtaining four College degrees in Biology, Chemistry, general physiology and reproductive physiology. I have also received extensive training in the areas of gamete physiology, manipulation, cell culture and in-vitro gamete manipulation. I have been involved in the development of various technologies and products and I have published on those subjects quite extensively. I have developed technologies in gamete culture and manipulation, cryopreservation and others (See short biography; Exhibit I).

Recently, I was involved with a scientific group in Yonago, Japan in the development of ROSNI during which immature spermatozoa (spermatids) were harvested from the testes of infertile men and their nuclei were transferred into nucleated oocytes and electrofusion was applied and pregnancies were achieved. This clinical service is available to infertile couples all over the world today.

I own several US patents and have developed products that are currently in use in ART centers throughout the world. Both my wife, who is an OB/GYN and REI board eligible (Director of KCRM and IVF) and my self as the Director of the Andrology Institute of America, are involved in the infertility market and we also own a company that markets infertility products throughout the world. In my family, we are totally dedicated towards the treatment of infertility and we regard our patients as our primary target for offering them the best infertility service available.

It is because of our total dedication and belief in those principles that I have decided along with Prof. Antinori to undertake the great effort and to offer our infertility patients that have exhausted all options available to them, to bear a biological child of their own through the option of human therapeutic cloning.

 

Current events in the ART market

With the advent of in-vitro fertilization (IVF) and all the other advanced assisted reproductive technologies (ART), we are able today to perform incredible maneuvers and offer infertility couples options that can give them hope for having a healthy biologically related child. Never before in the history of mankind have we been so fortunate to treat the infertility epidemic so incredibly well, and with such high probabilities for success in a safe and responsible manner. We all know that when our infertile couple comes for a visit they want two things:

1. A child, (yesterday if possible), and

2. A healthy child.

These incredible developments in the ART market today are no pure accident but rather the end result of various forces that came into play. These forces and capabilities came about because of the abilities and the freedom that scientists and clinicians have to develop such efforts and work together in organized groups such as ASRM, ESHRE MEFS and others throughout the world. I have been, and continue to work, with such groups in a very energetic and positive fashion, because it is essential that those efforts should continue towards the development of safe and effective modalities for proper infertility diagnosis and treatment. In all the years that both Prof. Antinori and I have been involved in the diagnosis and treatment of both male and female infertility, we have never been involved in taking unnecessary risks. This same principle will remain in place as we venture into the development of new frontiers in the infertility medicine.

 

Current status of Animal Cloning

A variety of mammalian species have been cloned utilizing S.C.N.T. (somatic cell nuclear transfer).  These include sheep, cattle, mice, goats, and pigs.  As pre-implantation and pre-natal chromosomal and genetic screening was not performed in any of the aforementioned animal cloning experiments, a small but significant proportion of the resulting offspring exhibited developmental abnormalities and/or perinatal death.  On the 9th of March 2001 our international consortium of scientists announced that the intention to perform human S.C.N.T. to allow infertile couples to have their own biological children.  To avoid the developmental abnormalities observed in the unscreened animal experiments, we propose to conduct a variety of screening protocols on the nuclear transplant embryos.  Comprehensive screening, although expensive, would ensure that only healthy developmentally normal embryos would be conceived.  This is a fundamental aspect of our Consortium's proposal, as producing developmentally abnormal human children is clearly not ethically acceptable.  We have submitted a report that reviews the scientific literature, results and protocols regarding somatic cell nuclear transfer (S.C.N.T.) and contemporary morphological, chromosomal and genetic screening procedures required to accompany this procedure.

This report can be obtained from the Reproductive Cloning Network:

http://www.ReproductiveCloning.net/Articles/zavos.htm

It is anticipated that the Consortium will utilize a range of screening protocols similar to (if not the same as) those discussed in this report.  Only future research will elucidate which of these protocols are effective.

 

Current status of Human Cloning

Although no one has (as of yet) publicly claimed that a human clone has been produced, the rumors are that the development of cloning technology for application in humans may not be too far off. If one examines other events by studying historical data, one can conclude that the development of human cloning is inevitable. In a recent report by 60 Minutes, during which a group of scientists and others participated, it was concluded that the recent developments are in tune with these trends. Human cloning is around the corner and (as I stated over and over), when it comes to human cloning "the genie is out of the bottle". The technology for cloning a human being exists and it almost every high tech IVF laboratory across the world. They are 55 such IVF labs in New York City alone. So the questions that we should be answering today are:

1. Who should develop this technology, and

2. What quality controls will be necessary to be developed and/or applied in order to make this technology safe, with minimal risks to those using it and most importantly to those that will be born from such effort.

 

Who should develop this technology?

The human therapeutic cloning technology should be developed by a group of scientists and medical experts that understand this type of work and the seriousness for its development. Furthermore such teams should be focused on this effort, and work with leaders and governments to see that this technology can be made safe and be disseminated properly. This technology (like others) can have negative ramifications if it is not developed properly and it is allowed to end in the hands of the exploiters and the "pushers". It is because of those possible developments that our government (along with others) should join in and participate in rational, constructive debate and dialogue, and contribute something logical to say about its development and dissemination, rather than taking the attitude that "I don't want to play". I believe that our government recent attitude with similar situations, has adopted the principle of establishing a dialogue with hostile groups and governments throughout the world, and it did pay off great dividends. This is not to imply however that the CHTC is either hostile or has any hostile tendencies towards anyone, or any government in the world.

 

What quality controls are necessary?

As stated before, during animal experimentation with cloning, no pre-implantation or pre-natal chromosomal and genetic screening was performed.  This resulted in a small but significant proportion of the resulting offspring exhibited developmental abnormalities and/or perinatal death. This according to the CHTC principles, this is totally inhumane, and irresponsible for those that carried those experiments and gave the world this "horrible" picture and impression that cloning can not be offered and made to be safe in humans.

On the contrary, this Consortium in order to avoid the developmental abnormalities observed in the unscreened animal experiments, wishes to develop and apply a variety of screening protocols on the nuclear transplant embryos that could ensure that only healthy developmentally normal embryos would be transferred to produce only healthy children.  This is a fundamental aspect of our Consortium's proposal, as producing developmentally abnormal human children is clearly not ethically acceptable. The Consortium has developed such array of testing procedures, and wishes to make them available to this Committee for review and as part of this testimony (Exhibit 2).

For this committee’s benefit, I would like to make the following comments before I proceed further:

1.  Our Consortium (the Consortium for Human Therapeutic Cloning) has no intentions of developing this technology within the continental USA. I am saying this to you Mr. Chairman at this time so that this Committee will not have to worry about this Consortium breaking any rules, laws, or having to be legislated out of extinction by this Congress.

2.  "Name calling" is not on "our cards", and those that participate in this activity, do so because they believe that they are "better" medically, scientifically or ethically.  This serves no constructive purpose, and the public is not served in any positive fashion at all by these actions.

3.  We have received several offers by people to pay to have them cloned to have their own biological child. Such offers are not accepted by us because we have no technology to offer to anyone. It is still at its experimental stage.

 

Closing Remarks