In March of l995, Harold Varmus, director of NIH (National Institutes of Health), announced in Science magazine, that he has some doubts about trends in gene therapy. This is an alarming comment coming from the man who delivers the final "OK" for all genetic research. And if he is doubtful, how can we be sure that somewhere some scientist hasn't "accidently" mutated a gene producing some unprecedented fatal disease. (Test.)

Motivation 

So what, you may ask? The gene therapy experiments being performed today may cause you to be discriminated against in the future job market. Your future children may be vulnerable to unimaginable genetic defects due to premature genetic experimentation being performed as I speak.

Thesis 

The U. S. Congress should ban all genetic research until universal guidelines are established because the current approval process is biased and exclusive while technology is advancing too rapidly.

Based on the research I have done, first I am going to discuss the problems associated with the current guidelines for genetic research, then my plan for solving this problem, and finally how my plan would be implemented.

Transition: I'll begin with the problems that exist with the current status quo.

I. Need Step

A. Status quo: According to the U.S. Code, the Congressional Biomedical Ethics Board was established by Congress in l985 to evaluate the ethical implications of genetic breakthroughs.

1. Although this committee continues to exist on paper, according tothe 1991 CQ Researcher, it is inactive. (Test.)
2. For a gene therapy proposal for research to pass, it must be approved by five separate bodies including the NIH and FDA. Finally, the director of the NIH must sign off on all experiments. (Expl.)

B. Problems:

1. Federal and private research teams are not treated equally.
   1. According to the August 9, l99l Science magazine, the NIH is biased because it provides funding for federal projects. (Test.)
   2. Research teams in the private sector can bypass the NIH in the review process and go straight to the FDA. (Expl.)
      1. Many questions whether the FDA has the ability to judge whether a gene therapy proposal is safe and effective.
      2. Furthermore, unsafe proposals could easily slip by because the FDA conducts its reviews in private. (Expl.)
2. The fact that the private sector can bypass parts of the review process raises major ethical concerns.
   1. As the 1991 CQ Researcher points out, premature genetic experimentation runs the risk of unleashing something dangerous and irreversible into the human gene pool.
   2. The identification of possible "defective" genes could lead to discrimination by insurance companies and employers.
   3. In the quest for the "perfect" child, the number of abortions could rise significantly. (Test.)
3. Gene therapy is a fairly new field - - being approved for use only since 1990. Technology is developing so quickly that we have failed to consider its implications. (Expl.)

Scope/Transition: Because every human being has a genetic code that can now be manipulated, these problems affect everyone in the world. Due to the large magnitude of these problems, we must seek a solution.

II. Satisfaction Step - - Plan/Solution

1. Plan Details: My plan is to ban all genetic research until a non-biased committee is established with strict guidelines by which both federal and private funded research proposals must pass.
2. Implementation:
   1. Enactment: The U.S. Congress has the power to ban all genetic research and give review power to a committee.
   2. Administration: The office of Science and Technology at a September 28, l994 hearing before Congress entitled "Gene Therapy: Status Prospects for the Future and Government Policy Implications" suggested that a National Bioethics Advisory Commission (NBAC) consisting of a panel of non-governmental experts in various disciplines be created in order to review both federal and private research proposals.
   3. Enforcement: All research laboratories would have to be registered with the NBAC and monthly check-ups would occur. Failure to follow the designated guidelines would result in fines, suspensions, or in extreme cases termination of research. (Expl.)

Transition: Now that you have a general understanding of my proposed plan, let me tell you why it would be effective and the benefits involved.

III. Visualization

1. Workability: My proposed ban on gene therapy could be easily compared with the current U.S. ban of the abortion pill RU-486. (Analogy)
   1. According to U.S. News and World Reports December 27, l993, currently clinical trials are being conducted and guidelines for its use are being evaluated and established. (Test.)
   2. This ban was also imposed for the sake of human safety. (Expl.)
2. Practicality: (Inoculation Theory) Probably most of you can see that gene therapy guidelines need to be more defined, yet you may question a temporary ban on research.
   1. You may be concerned that patients would be denied life-saving techniques, yet that is not a concern. Currently gene therapy is so experimental and expensive that it is not widely used. (Expl)
   2. According to the November 4, l994 Science magazine, the NIH l995 budget for biomedical research was listed as $l.9 billion. Therefore, the ban would be cost-effective and allow us to better assess our need for spending. (Test. And Expl.)
3. Benefits: With the implementation of my proposed plan, both federal and private research proposals would be treated equally. The temporary ban on genetic therapy would give everyone a better perspective on the implications involved. (Expl.)

CONCLUSION - - Action Step

A. Underview: 

As you now know, the current status quo involving gene manipulation is ineffective. The review process is biased and exclusive to private research. Because the private proposals are not as carefully scrutinized, ethical concerns arise. A temporary ban on genetic research and the establishment of a committee such as the National Bioethics Advisory Commission would allow the current situation in gene therapy to be assessed and stricter guidelines imposed. Much like the ban on the abortion pill, my plan would be cost-effective and would not endanger human lives.

B. Call for Action (involving the audience): 

However, there is something that almost everyone in this room can do to help. Carol Mosely-Braun represents you and me in Congress.  By writing to her at 708 Hart Building, Washington, D.C. 205l0, you can voice your concern about the current gene therapy review process. But do not delay - - we must reverse the trends of gene therapy review before the results become irreversible. (Expl.)

C. Last Thought. 

As my speech comes to a close, I leave the rest up to you. We don't have to sit here idly and watch genetic breakthroughs run out of control.  As an unknown author put rather eloquently, "A word spoken in season is like an apple of silver, and actions are more precious than words."

Griffin, Rodman G. "Gene Therapy." C.Q. Researcher l8 Oct. l99l: 777-800.

Marshall, Elliot. "Early Budget Proposals for NIH Draw Fire". Science 4 Nov. l994: 727

Marshall, Elliot. "Varmus Orders Up a Review of the Science of Gene Therapy." Science l7  Mar. l995: l588.

Palca, Joseph. "Changes Ahead for Gene Therapy Review Process?" Science 9 Aug l99l: 624-5.

Schrof, Joannie, M. "Will the Abortion Pill Remain Banned?" U.S. News and World Report 27 Dec. l993: 78-79.

U.S. Codes. Biomedical Ethics Board. 42 USC Sec. 275.

United States. Cong. House. Committee on Science, Space and Technology. Gene Therapy:  Status, Prospects for the Future, and Government Policy Implications. 103^rd Cong., 2^nd sess. Washington: GPO, l994.