Human Radiation Experimentation, Ethics, and Gene Therapy

Washington, D.C. The subcommittee met, pursuant_to_notice, at 10:00 a.m., in Room 2318, Rayburn House Office Building, Hon. Marilyn Lloyd [chairperson of the subcommittee] presiding.

Mrs. LLOYD. [presiding] The subcommittee will come to order. Good morning, ladies and gentlemen. Thank you for being here. I would like to ask unanimous consent first that today's proceedings to be covered by the media and, without objection, so ordered. I called this hearing in order for members to review the human radiation experiments that were recently revealed by the Secretary of Energy. Although many of the experiments that we've been reading about occurred many years ago, the Secretary has also stated that there are ongoing human radiation experiments as well. So I think it's very important for members to get a clear report about the issues involved with human experimentation.

For instance, what is informed consent and how much material can be made available to a person participating in such an experiment? How do the scientists understand or rate the risks to the individuals, and what procedures and rules are in place to protect the participants?

It behooves us to remember that this research did give us a new technology, nuclear medicine. And, as a breast cancer survivor, I know firsthand the benefits that were developed by early radiation research. As a matter of fact, I know that today's accepted diagnostic and treatment procedures are a direct result of this human research. I know this is true for both the radiation and the chemotherapy treatments that I had two years as a part of my treatment program and the reason that I'm here today.

First, this morning we will hear from the Department of Energy witnesses about past, as well as current, experiments. We'll also review the current procedures to protect patients and, hopefully, learn how these procedures have evolved over time. Members, I'm sure, will be interested in the Interagency Working Group which is coordinating the efforts to review and gather all of these experiments. This is no small task, and the individuals must be protected through this process.

And our second panel today will discuss the ethics involved in human experiments, will examine the procedures and the peer re

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view process which now precedes any experimentation on people. These witnesses have reviewed these issues in relation to human radiation experiments and also in the context of other human research experiments, and I, for one, am interested in their thoughts regarding the adequacy of existing standards and any recommendation they may have for improving and further protecting individuals.

And then our third panel looks at the biological revolution taking place in the medical profession. Recent research, including programs of the Department of Energy and the National Institutes of Health, to map basic genetic material in humans is unlocking information about the linkage of abnormal genes to a number of diseases such as cystic fibrosis and cancer. Gene therapy applies this knowledge to treat diseases, and we're pleased to have one of the very first practitioners working with cystic fibrosis here with us. today.

Because gene therapy is gaining increased interest by both the public and the medical community, this is an ideal time, an ideal opportunity, for us to assure ourselves that gene therapy and the related use of human subjects is conducted with adequate safeguards. And I should like to add that gene therapy offers us a unique example to compare the differences between governmentsponsored, predominantly secret research and this research that's open and subject to peer review and public scrutiny.

We're looking at the status of our current research guidelines to determine the adequacy of the guidelines, the implementation of the guidelines, how some of these things could have happened, why, and review what we're doing right now-if this happened today-and ask could this happen tomorrow?

Mr. Fawell, I recognize you for your opening remarks.

Mr. FAWELL. Thank you, Madam Chairman.

I'd like to join you in welcoming the witnesses, of course, for today's hearing on human radiation experimentation, ethics, and gene therapy.

First, I'd like to compliment Secretary O'Leary for her openness initiative and her commitment to declassify and release information about the activities of the Department of Energy and its predecessor agencies, the Atomic Energy Commission and the Energy Research and Development Administration.

It is vital that the American people be fully informed about past human radiation experiments and that we apply the lessons learned to ensuring that all future experiments involving human subjects are carried out under the highest ethical and scientific standards. What needs to be kept in perspective, however, is that many of the past human radiation experiments were consistent with the ethical standards that existed at that time and provided invaluable contributions to nuclear medicine, to radiation therapy, and to the establishment of radiation standards and safety practices, which provide numerous benefits today.

As Dr. Mossman will elaborate in his testimony, over 10 million. patients each year have nuclear medicine studies or therapy for management and diagnosis of a variety of diseases, and radiation therapy is now used to treat one-half of all cancer patients, including about 500,000 this year. We all have concerns, however, that

a number of these experiments were carried out without the informed consent of the involved individuals and may even have caused them great harm.

I look forward to hearing testimony of today's witnesses, although I guess when I say "hearing," it isn't exactly correct. I happen to have three subcommittees going at the same time and it's rather difficult to cover all of them at the same time. I happen to be head of a particular caucus on OSHA. So I'm going to have to take my leave so I should be able to be at that meeting at 10:30. So I look forward to hearing some of the testimony.

I am in the process of reading all of the testimony and I will eventually get through it all, but I do appreciate that this hearing is being held and it certainly will give me more light and knowledge in regard to the subject matter, because I have a number of my constituents of mine who are asking me about it.

Thank you, Madam Chairman.

Mrs. LLOYD. Thank you very much, Mr. Fawell.

Are there other members that have opening statements they'd like to make? Mr. Bartlett?

Mr. BARTLETT. Thank you very much.

In another life I had the privilege of working in the basic science world. I have about 100 papers in the scientific literature, a fair number of them using humans for the experimentation. And so I can understand the problems of properly designing experiments, the difficulty sometimes of articulating to the media the nature of the experiments and the need to use human subjects.

I look forward to the testimony today and for the opportunity of explaining more fully the nature of the experiments and the context in which they were performed and the need for most of these experiments. I'm glad to be here today and glad that you all are here.

Thank you.

Mrs. LLOYD. Thank you, Mr. Bartlett.

Mr. Schiff?

Mr. SCHIFF. Thank you, Madam Chairman.

First of all, I want to thank you and commend you for holding this hearing.

Mrs. LLOYD. Thank you.

Mr. SCHIFF. It's on, as usual, a very timely subject that you've selected to bring out this testimony.

I want to say that in my view of the situation on past radiation experiments, as I've seen them discussed, I think the most important issue right now, the most important goal is for a complete public accounting by all government agencies into exactly what those agencies did even in years past. And I say this for two rea

sons.

First of all, I think the public always has a right to know what its government agencies did. Whether that turns out in the judgment of the public to be right or wrong is beside the point. People are always entitled to an accountability from their government officials as to what the government does now and what the government did in the past.

Further and more specifically to the radiation experiments, I serve on another committee of the House, the Judiciary Committee,

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