Mr. WAXMAN. Thank you very much for your statement. Let us talk about blood donations for a minute. We want to encourage people to donate blood. They are doing it voluntarily. If they thought that information that was private to them would be made in any way public or given to someone else without their consent, many people would refuse to go to a blood bank. Is there any conflict with wanting to protect the confidentiality of people who give blood with the society's need to protect those who are going to receive that blood from someone who may have AIDS and transmit it through that blood donation? Dr. YOUNG. I think through careful analysis both goals can be met. We have had experience with this in the hepatitis B program in blood banks. There is a deferred donor list that can be developed and safeguards can be put into place for those instances where infectious disease and public health issues might be aided by having some degree of disclosure. We believe that this can be put in place, and particularly this would be relevant as treatment becomes much more available. Mr. WAXMAN. We want to assure the person donating the blood that their confidentiality would be respected. Otherwise, they may not donate blood. On the other hand, we want to assure those people who receive the blood that they are going to be receiving blood that will make them well, not sick. Are we able to do both? Dr. YOUNG. I think we are able to do both, Mr. Chairman. Mr. WAXMAN. How can we do both, respect the confidentiality of the donor and assure that the blood is going to be safe? Dr. YOUNG. The very strategy that was put into place, giving guidance and providing information to the donor as to the types of informed consent that he or she would be involved with and the protection by not revealing this donor lists are the important ingredients. That type of protection of the individual is very important. The concern I believe that I have heard the most is in the case of subpoena or other methods to try to obtain the names of these donors, and that type of protection is another case. In regards to the protection of the blood supply, we feel that the development of the screening test for HTLV-III antibody reaches that goal. It raises the level of detection such that we try to be sure that positives and even in the case of repeat positives on the ELISA test are such that we can set that quantity aside so the American public would at least be free from the risk of having blood that has an HTLV-III antibody positive test. Mr. WAXMAN. For the person to receive a blood transfusion, we have given them the assurances that the screening of the antibodies in the blood will remove from that blood supply any blood that has AIDS or may be transmitting AIDS, pretty good assurances? Dr. YOUNG. The best we can do at this time and on July 31 there will be a summary of this research at NIH to really evaluate the first million units of blood; but at the present time the test looks quite good, but it really only detects antibodies to HTLV, not the virus. Mr. WAXMAN. We are screening blood to try to remove from the blood supply as much, if not all, of the blood that may be transmitting disease. Now, for the donor of that blood, if we found that donor had a positive test on HTLV-III which indicates the antibodies from AIDS, what do we do with that information? Dr. YOUNG. In the guidance that we have put out, we felt that if it is repeated and positive we have advised that information be transmitted confidentially to the individual so that he or she may seek the best treatment or support possible. There is no way of determining at this point whether antibody reactivity to HTLV-III virus will indicate the person will go on to the progression of the disease, but it is important for that individual to know so they can take the appropriate medical precaution. Mr. WAXMAN. We want to respect the individual's confidentiality. Dr. YOUNG. Absolutely. Mr. WAXMAN. What about society's concern about that disease spreading? Should we make that information available to public health officials so they can do some tracking or something to contain the disease? Dr. YOUNG. There are multiple viewpoints on this. The most important issue I believe as a principle is to make that information available to the person who has the potential positive antibodies and potentially harboring the viruses. One can see informed consent forms where an individual might be willing to share that information with public health officials. I could also envision cases in which it might be very helpful for the individual's case as well as the public health to share information with public health officials, particularly when we have a treatment for this disease. Mr. WAXMAN. Well, for the individuals who are informed they have an antibody for AIDS, it must be very difficult to explain quite what that means. It does not necessarily mean that individual is going to come down with AIDS? Dr. YOUNG. No, it does not, but I raise the last caveat only in the event and as we progress in our research to be able to determine that. But I do think that the principle of confidentiality is the most important one to protect here, and only in the circumstances that we can foresee in the use of this information, public health, should we consider that, and then that can be part of an informed consent. But in the blood donor arena, the informed consent information and the emphasis that we placed on confidentiality are appropriate. Mr. WAXMAN. You do not see a conflict between respecting the confidentiality of the blood donor, protecting the blood supply for the blood donee and the broader public health concern about limiting the spread of this disease? Dr. YOUNG. No, I do not. We have had experience with this in the past with other diseases, and I think that it can be so structured. Mr. WAXMAN. In your testimony on research you suggested that some areas of research are sensitive and should be protected, but that other areas do not require such protection of confidentiality. I can guess some of the areas that are certainly sensitive: Informa tion on family matters, genetic disease, sexual information, alcohol, et cetera. What are the areas that you think do not require such protection? Dr. YOUNG. We have not found in our experience, as I have discussed this with individuals at the National Institutes of Health and CDC, that cases that deal with research on the diseases that are outside of sexually transmitted disease these classifications seem to be much problem. For example, diseases of gallbladder, peptic ulcer, some of the more common ailments, infectious disease such as streptococcal infection, rheumatic fever, do not seem to pose historical problems. Looking at this with counsel and with individuals at NIH, it appeared that there were rare events where there were problems in informed consent in regards to research in either enrolling subjects or in the ability to carry this out. However, I emphasize that AIDS and sexually transmitted diseases in general pose a very different threat in confidentiality and there is much more sensitivity here. Mr. WAXMAN. I am concerned by your suggestions that we should wait until there is a significant breach of confidentiality before giving legal protection to volunteers. The current AIDS epidemic is a research subject that we want fully explored. Since it is primarily transmitted sexually, it involves a lot of sensitive and private information. If the names of a hundred AIDS research volunteers were given out to the press tomorrow and on local news shows tomorrow night, how long do you think it would take for scientists to convince a hundred more people to volunteer once the damage is done to the image of science? How long would it take to recover? Dr. YOUNG. That would be extraordinarily unfortunate and would prevent the type of research that both you and I feel is important in understanding this dreaded disease. I tried to focus on the difference between sexually transmitted diseases and AIDS in contrast to the broader issue of research on other subjects. It was in the other type of subjects, that vast majority that we did not have any indications as to any substantial problem in the past, and in AIDS we do understand the very great sensitivity here. Mr. WAXMAN. We need legislation to be adopted to give this kind of protection. Dr. YOUNG. There are about three or four ways we could look at this with some degree of protection under the existing circumstances. If I could, I might ask counsel to speak on this. Mr. RISEBERG. This is simply to review what is available under current law, and you may already be aware of some of this through prior testimony. First of all, of course, a researcher in entering a research project makes a commitment to confidentiality that, insofar as he can live up to that commitment, it is something that is enforceable through the civil process. But at the Federal level, of course, if we get a request, as you know, under the Freedom of Information Act, we have available to us the exemption from disclosure that allows us to withhold information where it would be a clearly unwarranted invasion of per sonal privacy, and to my knowledge, there has been no instance where information of this type has been released despite our attempt to exercise that exemption. In addition, I think you are aware of the Privacy Act, which places additional constraints on us, in the area of alcohol, drug abuse, and mental health research, we have even additional stringent requirements, and epidemiological research is protected and CDC takes advantage of that exemption, and so, there are considerable protections. In addition, however, the area that has involved the greatest expression of concern relates to subpoenas of information in the context of judicial proceedings, and in fact, we have within the last several months resisted attempts by attorneys to subpoena what we considered confidential information, and we were successful in establishing some significant precedent in this area, so the Federal Rules of Civil Procedure are being upheld by the courts and followed by the courts and are being used, so that we can protect the information under provisions in the Federal rules that allow judges not to enforce these kinds of subpoenas. Mr. WAXMAN. We have a great deal of protection now in the law to protect confidentiality. There seemed to be some concern about subpoenas and what other areas? Mr. RISEBERG. Subpoenas have been spoken about most. However, the actual number of instances of subpoenas are very small, and I guess what I am saying is that in those rare instances where someone has pressed a subpoena, at least up to now, we have been able to convince the judges not to enforce those subpoenas. Mr. WAXMAN. Well, I appreciate this testimony very much. It is very helpful to us, and we look forward to working with you, Dr. Young, on legislation, and as it might be needed to make sure that we have accomplished what we all want to accomplish, and that is protecting the public, and also protecting those who will volunteer for experiments, or to give blood so we can encourage other people to continue to volunteer for those purposes. Dr. YOUNG. Thank you, we are prepared to work with you in any way that we can. [The following material was submitted for the record:] The Public Health Service (PHS) published Interagency recommendations for testing blood and plasma for antibodies to HTLV-III on January 11, 1985. FDA then issued a memo to all registered blood establishments on February 19, 1985 in order to give guidance on the implementation of the general PHS recommendations. Shortly thereafter the first company was licensed to market an ELISA test for HTLV-III antibodies. Because the PHS recommendations and the FDA implementation memo were written in advance of having worked out the details of the package inserts for the antibody test kits, some of the terminology has not been uniform. The purpose of this memo is to clarify the terminology and the current position of the PHS and the FDA with respect to certain aspects of test implementation. The major Interagency recommendations were: 1. all blood and plasma should be tested for antibodies to HTLV-III 2. 3. A11 POSITIVE units must not be transfused or manufactured into other products capable of transmitting infectious agents notify the donor if REPEATABLY POSITIVE ELISA test results are obtained, OR if other tests are positive If The package inserts for all licensed HTLV-III antibody test kits state that a |