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September 24, 1998

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The Institute's Testimony to the National Institute of Health's Recombinant DNA Advisory Committee In Utero Genetic Engineering on Human Fetuses

FROM:
Dr. John S. Hagelin, Director
Dr. John Fagan, Associate Director
SUBJECT:
Testimony Recommending a Ten-Year Moratorium on Pre-Protocols for In Utero Gene Transfer Therapy to Allow a Comprehensive Evaluation of its Long-term and Short-term Safety to Fetus and Possible Side-Effects on the Human Germ Line

With regard to his two pre-protocols for in utero somatic cell gene transfer, Dr. French Anderson has stated "the likelihood is high that at least some of the germ line cells will be affected."

Such germ line manipulations on humans, whether they are the primary purpose of an experiment or merely a probable consequence of an experiment, are illegal in most OECD countries. Similarly, in the U.S., the NIH Recombinant DNA Advisory Committee has ruled against germ line research at this time. Hence, the pre-protocol for in utero somatic cell gene transfer are contrary to law, and the NIH will certainly face serious legal challenge if the experiments are allowed to proceed.

Recombinant DNA technology is inherently risky because of the high probability of unexpected side-effects. The genetic engineering of various agricultural products has been accompanied by unanticipated health and environmental side effects, which have caused widespread concern and even caused numerous international trade partners to boycott American genetically engineered produce. That the NIH would now consider proceeding with similar experimentation with humans, with potentially dangerous side effects to the subjects and potentially irreversible side-effects for future generations is unconscionable, and is precisely what the current regulations against such germ-line experiments are intended to safeguard against.

When the RAC considers whether to approve pre-protocols for in utero somatic cell gene transfer, it would be good to consider the following points:

  • Despite the millions of dollars invested in somatic gene therapy to date, not a single clear-cut clinical success has been reported.
  • The proposed therapy should be considered a germ line intervention because the risk of affecting germ cells in the developing embryo is high.
  • Due to the imprecision of the proposed techniques, harmful mutations can occur to the subjects involved, as well as to the germ line.
  • The human physiology is simply too complex to allow us to predict how newly introduced genetic material will interact with other genes and influence cellular and physiological functioning.
  • One source of unanticipated side-effects stems from the fact that genes, and the proteins they encode, often serve multiple functions. We often identify one gene on the basis of one function and are completely unaware of its other essential functions.
  • In utero interventions with germ-line consequences could cause harmful gene pollution due to unanticipated interactions of the altered gene with other genes in the human gene pool. Germ line changes carry the risk of creating new heritable genetic diseases, birth defects, and cancer.
  • In utero therapy may interfere with the natural course of human evolution and have unforeseeable consequences on the development and survival of the species. In utero interventions may unintentionally disturb the finely tuned function of one or several genes and create devastating long-term consequences for the species worldwide. Such threats to a species are already starting to be observed in certain genetically modified crops, such as cotton.
  • The ethics committee of British Royal Society of Medicine has stated:"All members of the committee were agreed that germ-line therapy should not be attempted at the present time. This agreement was not based on some moral or ethical precept, but solely on the safety factor: there are too many unknowns in the possible outcome" (Journal of the Royal Society of Medicine 1994; 87: 302-304).
  • Since Dr. Anderson is a founder of Gene Therapy Laboratories, we might rightly question whether his haste to implement these risky pre-protocols is profit motivated.

If the RAC's principal concern is for health, then it should surely support a moratorium on implementing these pre-protocols until the safety of such in utero interventions can be scientifically verified. It will take at least ten years to assess the long-term side effects of the proposed interventions.

If prior experience with nuclear technologies can serve as a guide, we must acknowledge that science is fallible when applied in haste. Moreover, if current experience with recombinant DNA technology is representative of the uncertainties inherent in this technology, then we must conclude that the potential danger to humanity is unknown and could be extremely great. We must therefore be prudently cautious.

We therefore strongly recommend a moratorium of at least ten years on pre-protocols for in utero gene transfer therapy, in order to enable a comprehensive evaluation of its long-term and short-term safety for the developing fetus and possible side effects on the human germ line.


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