Not having been aware of the specifics of the 47 million additional funds for AIDS research, it was difficult to respond to your query as to whether the federal government was "turning over every stone". Clearly the priorities set for the use of this money are the issue here. As I stated at the hearing, the burning issues are prevention and treatment (ie. vaccines, drugs, antibodies, and immune reconstitution). Hopefully the lion's share of the monies will be aimed in those directions. Anything having to do with etiology, epidemiology, and public education should be secondary. This virus is moving fast and must be stopped without ambiguity. As I see it the work being done under the auspices of NIH, particularly NCI and NIAID is where the action is. To this point they have been forced to consume their own resources in order to engage forcefully in AIDS research. Not having to reprogram from other important areas of research would be of major benefit in developing vigorous programs in AIDS prevention and treatment consistent with the seriousness of the medical emergency which exists. It was With best wishes for continued success, Yours sincerely, Di Bly Dani P. Bolognesi DPB/kr After seeing the breakdown of the new monies for AIDS, I would strongly advise that you schedule another hearing if you want meaningful answers to your questions. My response to you in Washington, that the additional funds represent a strong and positive message to the scientific community, assumed an appropriate and equitable distribution of the funds. As I see it now, it is the total opposite. No one in their right mind could interpret this budget as an effort to deal seriously with the question of prevention, and treatment. I'm sure my colleagues who also testified at your hearing would support this view. As I noted to you in my letter of July 23, the NIH should be the lead organization for developing preventive and interventive measures for AIDS. Yet, some 20 million dollars were removed from the NIH budget to return 8 million for AIDS research. Such reprogramming of badly needed funds for other research is the worst possible step the government can take. It will deeply affect in a negative way an already stressed situation resulting from the Stockman directive. If you recall, a similar scenario occurred last year with 12,000,000 dollars for AIDS research being allocated disproportionately ($10,000,000 to CDC and $2,000,000 to NIH). While it is evident that other agencies such as FDA and CDC play major roles, the development of anti-viral agents and vaccines requires a close interaction between the intramural and extramural efforts of the National Institutes of Health. HTLV-III was discovered within the National Cancer Institute by Dr. Robert Gallo. Ironically, the NCI is being hit the hardest in terms of new monies for AIDS research. Most of the essential research in how the virus functions which relates to development of approaches to control its cytopathic effects rests within the auspices of NIH, particularly NCI and NIAID. This is of particular importance with regard to clinical trials in prevention and treatment. To stop this virus it is important to do much more along the basic research lines. Please refer to my written testimony on this point. Many of us in the scientific community are poised to strike at the very heart of this matter. Help us receive the proper message that the Federal government does not in fact have its head in the sand; but rather, perceives the real needs to conquer this horrible epidemic. Yours sincerely Dan Boly' Dani P. Bolognesi HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT, Washington, DC. The subcommittee met, pursuant to call, at 9:45 a.m., in room 2123, Rayburn House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. WAXMAN. The meeting of the subcommittee will please come to order. This morning's hearing is about volunteers. While there have been disagreements about how much of society's work the Government should expect volunteers to do, no one can question that we already rely on volunteers to do much of the work of health care. Clearly in some cases, no one could buy the services that Americans are willing to volunteer. This morning we will be looking at two specific types of volunteers who give of themselves for health: those who participate in research studies and those who donate blood. Research subjects are the living clues in the study of disease. In many ways they give not only their bodies to science but the details of their lives as well. For some research projects, those on mental illness, sexually transmitted diseases, genetic diseases, to name a few-research subjects give over to science parts of their private lives that no one could coax, pay or force them to give publicly. By doing so, however, they may privately provide the best public health and the best social good. In much the same way, blood donors privately give in the line of public duty. Blood donors give the gift of life, and while no donor knows to whom his or her blood will go, they do know that their services are needed to make modern medicine function at all. I am concerned that as Government reaches further into records and as lawsuits reach wider for defendants, scientists and blood banks may become less and less able to recruit volunteers. There are few rewards to volunteering for research or blood except knowing that you have contributed to other people's health. That knowledge of a job well done cannot compete with fears of publicity, liability or even just the uncertainty of who knows what about you. As a nation we cannot afford to pay for the kind of research subjects and blood donors that now enter into service on their own. Americans do not sell their private lives cheaply. We could end up with high costs, bad science and inadequate supplies of blood. And we cannot wait until such fears are realized: The first project to expose subjects could be the last that can get enough participants. The first disclosure of blood donors could jeopardize supplies for years. I believe that there should be protections of the confidentiality of research subjects and blood donors. As a society we depend on both types of volunteers to give their time, their services and literally their life's blood. If we hope for such generosity to continue, we cannot expect them to give up their privacy as well. We have a number of witnesses to testify today on the subject before us. We are pleased to call for our first witness Dr. Frank Young, Commissioner of Food and Drugs, Department of Health and Human Services. Your full statement will be made a part of the record. STATEMENT OF FRANK E. YOUNG, M.D., PH.D., COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY RICHARD RISEBERG, ASSISTANT GENERAL COUNSEL FOR PUBLIC HEALTH SERVICE Dr. YOUNG. I have with me Dr. Charles McCarthy, Director for the Office for Protection from Research Risks at NIH, Mr. Richard Riseberg, Assistant General Counsel for the Public Health Service, and Dr. Paul Parkman, Deputy Director of the Center for Drugs and Biologics. We concur the need to protect the privacy of individuals has always been of concern in the practice of medicine, and in research, but it has assumed special significance in connection with our efforts to find means to prevent and cure acquired immunodeficiency syndrome [AIDS]. The recognition of that condition has raised new and troublesome questions about the use and disclosure of personal medical information about individuals. Improper disclosure of information can threaten family relationships, job security, employability and ability to obtain credit, insurance and housing. I will merely focus, Mr. Chairman, on the highlights of my statement and submit the entire statement for the record as well as the attachment mentioned in the statement, if I could, sir. In regard to research, we have become aware over the years that sexually-transmitted diseases in general have social overtones that could produce significant problems for individuals. As you know, gay men and intravenous drug users constitute a large proportion of the individuals with AIDS. But concern is not limited to these populations. Since the virus is now known to be transmitted heterosexually, it is likely that information about sexual practices in the heterosexual population will increasingly be required to understand transmission of the disease. Researchers and clinicians have repeatedly shared a sensitivity to confidentiality needs. Examples, to our knowledge, of inappropriate disclosure by researchers are virtually nonexistent. Within the research community, the issue is not peculiar to AIDS; confiden tiality is often essential to secure the cooperation of participants in research which requires the collection of sensitive information. Thus, we have had experience with protecting the confidentiality of research data for many years. The IRB's that review research from the ethical standpoint have sought advice from the Department concerning the special protections needed in research studies pertaining to AIDS. The NIH Office for Protection from Research Risks has issued guidance to assist IRB's and researchers in designing the necessary protections. I am providing the committee with a copy of that guidance. With respect to the use of information about individuals, the guidance counsels: That subject identifiers not be recorded unless needed for the study; that potential subjects be given a clear explanation of how information about them will be used, and be advised with care of the confidentiality protections available, and of the limitations of those protections, so they can make thoughtful, informed decisions, in light of their own circumstances, as to whether to participate; that there be administrative, management and technical safeguards to control authorized use and disclosure of identifiable information and to protect against unauthorized disclosure; fourth, that researchers and IRB's take account of the possibility of attempts under compulsory legal process to force disclosure of records and how they will be responded to; fifth, that researchers and IRB's address whether and how to notify subjects' physicians of findings about a subject; and, sixth, that protocols set forth how to respond to requests for information from third parties who have authorizations for disclosure of information signed by subjects. While we have done a great deal to assure confidentiality through rules and guidance, I should make clear that protections for research information are not absolute and, in the nature of things, cannot be. There may be some occasions on which people other than the researchers will have access to this information. I would like to turn in general to the focus on blood banks to augment this testimony. The blood and blood products community has had policies and procedures that called for confidential treatment of donor information, and there was little in the way of challenge to such policies. As a practical matter, before the AIDS issue, there was not much interest in obtaining information about donors from blood banks. The transmission of AIDS by blood transfusion and related developments like use of the test for the HTLV-III antibody to screen all donated blood and plasma have focused attention in this area. These developments have precipitated debate about the ethics of disclosure of the results of tests and of other blood donor information. Transfusion of blood contaminated with HTLV-III virus presents a public health problem, and knowledge of who donated blood, and who received that blood, and the health status of each, have become important to epidemiologic and clinical research and to public health and safety. Furthermore, the availability of screening tests has caused some to view blood banks as sources of information about individuals. For example, litigation in Florida seeks to name donors in an effort to contact the donors and establish some possible correlation be |