Statement of Rep. Christopher Shays Page 3 For some, participation in the study could increase the avoidable risk of getting hepatitis B, for which there is an effective vaccine. A series of reviews by the local IRB and NIH failed to correct that ethical deficiency or detect flaws in the proposed informed consent materials. This self-policing, self-validating and in some ways self-satisfied system of bioethical review and enforcement may be vulnerable to institutional pressures to conform and to cronyism. Missing are the periodic evaluations and external oversight needed to maintain a rigorous bioethical review system. We begin our part of that external oversight today, and we look to our witnesses for suggestions to improve patient protections and informed consent procedures. Welcome. Mr. Towns. Thank you very much, Mr. Chairman. African-Americans have had a long and unhappy history of involuntary participation in medical studies. From 1932 to 1972, U.S. Public Health Service embarked on a 40-year study of African-American men who had contracted syphilis. Known as the Tuskegee Study, the Government agency withheld treatment and administration of a cure in order to study the effects of the disease on the black male. In the 1950's, a University of Cincinnati Medical Center exposed 82 charity ward patients to 10 times the amount of radiation that was known to be safe at the time. In this study on the effects of full body radiation, three-quarters of the patients in the study were low income black men and women. Their consent signatures had been forged. During the 1970's, one group of parents in Baltimore thought they were enrolling their boys in a free child program at John Hopkins University. During the course of these 3 years, NIH-funded study of 7,000 boys, over 90 percent African-American, had their blood drawn. This blood was subjected to genetic testing without the knowledge or consent of any of the parents. This long and troubling history has made the African-American community extremely leery of medical research, and let me also add, the medical community. Although representing about 15 percent of the general population, they account for only about 2 to 4 percent of volunteers in cancer prevention trials. For instance, overall, African-Americans have lower cancer survival rates than whites. However, blacks who participate in clinical trials have survival rates equal to those of whites. In some instances, this unwillingness to participate in trials may hamper later treatment. There is a lot of evidence that racial minorities and other vulnerable groups have been exploited doing medical research. I believe it is the powerlessness of these groups which make them targets for medical exploitation. Surely we cannot allow some members of this society to be sacrificed for the health and well-being of others. On the other hand, there's evidence that research improves the overall health of the population. We must strike the right balance and ensure that any opportunity for exploitation is eliminated. Current Federal guidelines require the inclusion of women and minorities in clinical research to ensure that biomedical and behavior research findings are applicable to all populations. Therefore, the HHS, CDC, NIH, and FDA must ensure active recruitment of volunteers in minority communities. However, the Federal Government must also ensure that researchers and research facilities fairly represent the American people. Federal reviewers and local review boards should become suspicious when minorities seem to be purposely excluded or seem to be the exclusive subjects. We may be able to accomplish these modest goals by enacting additional safeguards to protect the rights of the patient. We may need to expand the membership on the institutional review boards, provide additional advocates for patients, include greater participation by those not associated with the research facilities and provide a Federal ombudsman specifically to receive questions or complaints of study participants. I hope that this hearing does not advocate eliminating Federal research support or placing regulatory restrictions on the receipt of Government funding for research that few institutions are able to meet. I don't want to see that happen. I hope that we can use this opportunity today to build on the existing framework of the Federal regulations to improve our system for the benefit of all future patients and study participants. That's what I hope to accomplish. Mr. Chairman, thank you for raising this important issue and it is important. I look forward to working with you on this issue and hearing the testimony of today's witnesses, to determine in terms of what we can do to correct the wrongs and to try to move forward by making them right. Thank you so much. Mr. SHAYS. I thank the gentleman. At this time the Chair recognizes Mr. Pappas, Congressman Pappas from New Jersey. Mr. PAPPAS. Thank you, Mr. Chairman. I want to thank you for calling this hearing and focusing on an issue that I think more and more Americans are becoming concerned about. The examples that both you and the ranking member, Mr. Towns, mentioned both about the Tuskegee experiment as well as that which some of our Persian Gulf war veterans may have experienced. I'll just point out that the ends do not always justify the means. And there are many people in our country that have a great deal of concern that in folks' overzealousness and excitement with regard to the advances that are being made in research that people could not necessarily just be helped by some of the research and advances that are taking place. So I welcome the opportunity to hear from the panelists here today. Thank you. Mr. SHAYS. I thank the gentleman. Congressman Kucinich of Ohio. Mr. KUCINICH. Thank you very much, Mr. Chairman and members of the committee. I want to thank the Chair for holding a hearing on this subject, join with Mr. Pappas' comments, and also express my concern with my good friend Congressman Towns about the way in which minorities are treated on issues like this. The central concern of my constituents is, can public trust and confidence be maintained in such programs? We're concerned about how risks are identified and how they're communicated to human subjects. All of us clearly understand that medical technology and research is part of the unfolding of the possibilities for improved public health. But we also know that we have a moral and ethical responsibility to see to it that anyone participating in any type of experiment receives the information that they need so that they know what the risks are and that they know what their rights are. There are ethical issues that we'll be reviewing today. And we want to see the extent to which violations of informed consent requirements, whether those requirements were ethical, or in fact rules and regulations may have been violated. It's very clear this is an area of public policy that the Federal Government needs to step up to. A few years ago we had a couple of laws which regulated bioethics. The National Commission for the Protection of Human Subjects of Biomedical Research and also the President's Commission for the Study of Ethical Providence in Medicine and Biomedical and Behavioral Research were established. Neither are in existence today. And with the exception of the common rule, which only applies to Federal agency, there's no provision of U.S. law explicitly requiring informed consent and independent review of research involving human subjects. As we review the biomedical ethics questions here today I am confident that this committee with the cooperation of those who will be testifying will be able to lead the way to establishing some new standards which will derive from ethical considerations. And I'm very grateful, Mr. Chairman, that you have chosen this moment to bring this issue to the forefront. Mr. SHAYS. I thank the gentleman. And we are joined by the vice-chairman of the subcommittee, Mr. Snowbarger, who is from Kansas and would just as soon we get on with the hearing. So we're going to do what we do at all our hearings. We swear in our witnesses, including any Member of Congress, who come and testify. So if you would stand and raise your right hands, we'll swear you in. [Witnesses sworn.] Mr. SHAYS. Thank you. Note for the record that our witnesses have responded in the affirmative. And I will tell you who our witnesses are for the record. We have Dr. William Raub, acting executive director, National Bioethics Advisory Committee and Deputy Assistant Secretary, Department of Health and Human Services. We have Dr. David Satcher, Director, Center for Disease Control and Prevention. We have Dr. Harold Varmus, who is Director, National Institutes of Health. And we have Mary Pendergast, who is Deputy Commissioner, Food and Drug Administration. I would prefer that we go in the order that I mentioned our witnesses: Dr. Raub, Dr. Satcher, then Dr. Varmus, and then Ms. Pendergast. We'll go in that order. And we don't have our traditional clock. We have asked that you speak for about 5 minutes. But we do recognize that this is a very important subject. And we do want your testimony on the record. We will just deal with two housekeeping issues and ask unanimous consent that the members of the subcommittee be permitted to place any opening statement in the record and that the record remain open for 3 days for that purpose. And without objection, so ordered. I also ask unanimous consent that all witnesses be permitted to include their written statements in the record. And without objection, so ordered. Your testimony is important. And we want to make sure that we cover it. So if you go over, a little over the 5 minutes, we recognize, because this is a very important subject. I just say for the four witnesses that will be following, we're happy to have you listen to some of the questions that are asked of the first panel and include them in your opening statements as well. So if you want to just make some notes and so on, that's fine as well. So we'll start with you, Dr. Raub, and welcome. Mr. RAUB. Thank you, Mr. Chairman. Mr. SHAYS. Maybe since you haven't started it would make sense for us to vote and then come back. And then we won't have the interruption. And I might say if we have any students here, we will allow students to sit in those first three seats there to give a little more room. So we'll be back. We stand at recess. And we will hustle. [Recess.] Mr. SHAYS. I feel I have tremendous power with this. What I'd like to do, I understand that some of our witnesses have others who have accompanied them who might assist them in responding to questioning, which we actually would want to encourage. But we do need to swear them in. So if any of you have someone you would like to respond to a question, I think it would be good to take care of that now. So do any of you have a witness that might Mr. RAUB. Yes, we do. Mr. SHAYS. Would you identify who they might be? They can just stand where they are for now. Here's what we're going to have to do. We will swear all of you in. And then if you do testify for the recorder, we'll then ask you to give your name then. Let's do it that way. And I'll try to remember faces. [Witnesses sworn.] Mr. SHAYS. Thank you very much. I really appreciate your cooperation in this regard. And then if you testify, if you would be prepared just to leave your full name and title for our recorder so he makes sure that he has it. Dr. Raub, we welcome your testimony and you're on. STATEMENTS OF WILLIAM RAUB, DEPUTY ASSISTANT SEC- Mr. RAUB. Thank you, Mr. Chairman, and good morning. Mr. RAUB. I'm the Deputy Assistant Secretary for Science Policy within the Office of the Assistant Secretary for Planning and Evaluation in the Department of Health and Human Services. I also serve as the acting executive director of the National Bioethics Advisory Commission, heretofore labeled as NBAC, pending completion of recruitment for that position. I appreciate this opportunity to present background information on NBAC and to describe its current activities. President Clinton established NBAC by Executive order dated October 3, 1995. The order describes that function as follows: (a) NBAC shall provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities regarding the following matters: (1) the appropriateness of departmental, agency or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and (2) applications, including the clinical applications of that research. (b) NBAC shall identify broad principles to govern the ethical conduct of research, citing specific projects only as illustrations for such principles. (c) NBAC shall not be responsible for the review and approval of specific projects. (d) In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council. |