AIDS or AIDS-related illnesses. Until these studies are completed, the results reviewed, and a determination made regarding their effectiveness in treating these conditions, they can not be obtained commercially in this country. The Food and Drug Administration (FDA) has been extremely sensitive to the AIDS problem and has expedited all requests for the study of experimental drugs for AIDS. Requests for the investigational study of isoprinosine, HPA-23 and ribavirin have been received and approved by the FDA. HPA-23 has also been made available for a small number of Americans who had received the drug on a regular basis in France. When data are available to support the safety and efficacy of any drug intended for treatment of AIDS, FDA reviews it expeditiously. It should be noted that some of the drugs being developed have already been found to have significant toxicity and may cause severe irreversible adverse affects. Consequently, studies must begin with a small number of patients intensively monitored by qualified expert investigators to assure patient safety; they then will be gradually enlarged as we become more knowledgeable in how to use the drug and preliminary safety and efficacy data are obtained. Q. Can you review for us how many drugs have been shown to have antiviral activity against the AIDS virus? A. A number of drugs have been shown to have antiviral activity against the HTLV-III virus in the laboratory including: ribavirin, phosphonoformate, suramin, BW A509U, ansamycin, and HPA-23. Of these, FDA has approved experimental human studies with all but ansamycin and phosphonoformate; however, we are discussing such studies with their respective manufacturers and expect them to begin soon. Q. Where and how do you plan to test them? The A. Clinical trials are normally conducted at medical centers by qualified investigators who have the scientific capability of making observations regarding the safety of the drugs, the effects of the drug on virus replication, and the effects of the drug on the manifestations of the disease. Clinical Center at the National Institutes of Health (NIH) is conducting such clinical trials as are a number of other medical centers, particularly in cities with large high-risk populations. The NIH generally sponsors its own trials; trials in other locations are being sponsored by NIH, pharmaceutical companies, or individual investigators. It is anticipated that the number of institutions involved in clinical studies will continue to expand. Q. Do you feel that the drugs that are currently tested for antiviral activity against the AIDS virus or drugs that will be tested should be made available to every person with AIDS who wants some type of treatment, even if it is still in the experimental form? A. We believe that it is in the interest of the public health as well as the patients that any AIDS-patient who is interested in being treated with an experimental drug be enrolled in a scientifically sound clinical study and monitored by a qualified expert to assure their safety to the maximum extent possible. The advantages to the patient involve safety and optimum medical care. The advantage to society is that this approach has been shown to be the most rapid and efficient means of demonstrating a drug's usefulness, and for developing a proper method for using the drug. When it has been determined that a drug is demonstrated to have some clinical benefit for patients, it is the Public Health Service's intent to make these drugs more widely available. Q. What effect would making drugs available in this manner to everyone have on the outcome of controlled clinical trials? A. The normal course of drug development is to proceed from small, intensively monitored studies at a limited number of locations to larger trials involving more patients and/or more locations. This approach speeds the acquisition of data received for the drug's eventual approval for general use and minimizes the risk for patients. We would encourage any patient who is interested in being treated with an experimental drug to discuss with their physician the possibility of being included in a clinical trial. Any other use of the drugs at this time is neither safe nor useful and would make their development more prolonged. QUESTIONS SUBMITTED BY SENATOR WILLIAM PROXMIRE Q. Dr. Young, I notice in the documents which accompanied the budget amendment tht part of the $2.9 million requested by your Agency would be used to and I quote CLARIFY THE POSSIBLE TRANSMISSIBILITY OF AIDS THROUGH FOOD. Can you tell us more about this? A. At the time when we were developing the budget last summer, our philosophy on AIDS research was that we should pursue all avenues of research because, at that time, we were still unsure of all the ways that AIDS could be transmitted. However, since that time there has been substantial epidemiologic evidence developed through studies of families of AIDS patients as well as other recently provided biological evidence showing that AIDS is not likely to be transmitted through foods. Although for this reason, the research contract on the transmissibility of AIDS through food which was cited in our budget materials last September has been diverted to other AIDS research, the FDA will continue to monitor and evaluate the increasing body of evidence on this disease and will explore other research approaches to this issue of transmission in foods to assure the safety of the food supply. MEMORANDUMS FROM JOHN C. PETRICCIANI, M.D., DIRECTOR, OFFICE OF BIOLOGICS, NATIONAL CENTER FOR DRUGS AND BIOLOGICS, FOOD AND DRUG ADMIN ISTRATION March 21, 1983 FROM: SUBJECT: TO: Director, Office of Biologics, Recommendations to Decrease the Risk of Transmitting All Establishments Collecting Human Blood for Transfusion. The Acquired Immune Deficiency Syndrome (AIDS) has caused serious concern among members of the blood banking community because of the implications for transfusion recipients if this disease is proven to be transmissible by blood or blood products. The major organizations engaged in blood collection have recently reached a consensus as to steps which should be taken to decrease the risk of transmitting infectious diseases by blood transfusion. Consistent with the recommendations of the American Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers, the Public Health Service Interagency Committee (copy attached), the Office of Biologics is advising all establishments collecting blood for transfusion to institute additional measures designed to decrease blood collection from individual donors and donor groups known to be at increased risk for transmitting infectious diseases. The following steps should be included: 1. 2. 3. Educational programs should be instituted to inform persons at Re-education of personnel responsible for donor screening should Re-education of personnel responsible for donor screening should 4. Donors should be examined for lymphadenopathy. The initial and annual physical should provide an opportunity for an examination by the physician for generalized lymphadenopathy, while a more limited *Such drug abusers are already excluded by existing regulations. examination should be performed by an adequately trained individual on each donor on the day of plasma collection and a record made of the results of the examination. 5. An accurate record of each source plasma donor's weight prior to 6. The SOP should inform the staff that any products collected from a Approved procedures developed by one of the major organizations such as the American Blood Resources Association, the American Red Cross, the American Association of 3lood Banks and the Council of Community Blood Centers may be referenced in the licensed establishment's SOPs without individual submission to the Office of Biologics. Alternatively, licensed establishments which develop their own procedures should submit them to the Office of Biologics for approval concurrent with implementation. Revised labeling for plasma collected from high risk donor groups and intended for further manufacture of plasma derivatives should be submitted to the Office of Biologics (HF-825). This memorandum is intended to be an interim measure to protect recipients of blood and blood products until specific laboratory tests are available. John C. Petresciani, H.D. John C. Petricciani, M.D. March 24, 1983 FRO:1: SUBJECT: TO: Director, Office of Biologics, Recommendations to Decrease the Risk of Transmitting All Establishments Collecting Source Plasma (Human) The Acquired Immune Deficiency Syndrome (AIDS) has caused serious concern because of the implications for recipients of plasma derivatives if this disease is proven to be transmissible by blood or blood products. The major organizations involved in plasma collection have reached a consensus as to appropriate steps which should be taken to decrease the potential of blood or plasma donation by individuals who might be at increased risk of transmitting AIDS. Consistent with the recommendations of the American Blood Resources Association, the American Red Cross, the American Association of Blood Banks, the Council of Community Blood Centers, and the Public Health Service Interagency Committee, (copy attached), *Such intravenous drug abusers are already excluded by existing regulations. the Office of Biologics is advising that the following steps should be taken by all establishments collecting Source Plasma (Human): 1. Educational programs should be instituted to inform persons 2. 3. If plasma is collected from a donor belonging to any of the groups The SOP should specifically inform staff that all blood or blood products inadvertently collected, or collected for therapeutic purposes, from a donor known or suspected of having AIDS should be considered highly infectious and must be immediately quarantined and disposed of expeditiously unless designated for investigative use related to AIDS. If not destroyed, such products must be labeled, stored and shipped in accordance with the standard procedures for handling bio-hazardous materials. Appropriate disposal procedures include autoclaving or controlled incineration; overwraps are required to protect staff in case of breakage. Approved procedures developed by one of the major organizations such as the American Red Cross, American Association of Blood Banks, Council of Community Blood Centers and American Blood Resources Association may be referenced in the licensed establishments' SOP without individual submission to the Office of Biologics. Alternatively, licensed establishments should develop their own procedures and should submit them directly to the Office of Biologics for approval concurrent with implementation. This memorandum is intended to be an interim measure to protect recipients of blood and blood products until specific laboratory tests are available. SUBJECT: Source laterial Used to Manufacture Certain Plasma Derivatives TO: All Licensed Manufacturers of Plasma Derivatives Extensive discussions among licensed manufacturers, the Office of Biologics and concerned groups such as the National Hemophilia Foundation, have led to a consensus concerning an appropriate approach to decreasing the potential |