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Guerra: There is also [Dr. Herbert] Sandy Morse.
Gallin: He continued his work on the mouse immunodeficiency syndrome, but it has not panned out as an AIDS targeted program. There are other examples of that in the institute. The main people who have obviously stuck with AIDS and continually have made relevant and extremely important observations are Dr. Fauci and his team, Malcolm Martin and his laboratory, and Bruce Chesebro, who started with a percentage of his effort in AIDS, and continues to have a percentage of his effort in AIDS. His primary area of interest is slow viruses. He works on scrapie and other slow viral diseases. He continually makes important observations on AIDS out at the Rocky Mountain Laboratories.
Tom Kindt's rabbit model has received a lot of criticism in terms of its relevance to human disease and how important it is. Despite that criticism, Dr. Kindt continues to have confidence in it. He has put in much effort and made many advances in just the last few years. He believes the rabbit will prove to be an important model of HIV.
Guerra:: What about Bernie Moss's vaccinia work?
Harden: Where does that stand at this point?
Gallin: In relation to HIV?
Gallin: It keeps waxing and waning. I think the principles of the technology, of being able to package a variety of genes in a virus which can be shown to be immunogenic, are obviously important. Dr. Moss's work has broad implications for a childhood vaccine and potentially for HIV. For details of that project, I think you should speak to Dr. Moss.
Harden: We need to speak to many individuals for details of these developments.
Gallin: On your list, here are the people I would recommend for you to meet. You should meet with Tom Quinn to get a perspective on the Zaire project, Projet SIDA. He knows that better than anyone. I think you should meet with Bernie Moss. I think you should meet with Mal Martin for sure. If you can get out to RML, or do it through our teleconferencing system, I think you would get a very interesting perspective from Bruce Chesebro.
Guerra:: How about Cliff Lane regarding the Clinical Center program?
Harden: We have already talked to Dr. Lane, and we will be talking to Dr. Fauci for the second time next week.
Gallin: The other money matter that we should mention, and one that was a major event on your list, is this building we are sitting in [A-wing addition to the NIH Clinical Center]. I will tell you how it came about in 1988.
We needed more space for AIDS. We needed it on this campus. The Cancer Institute was getting more, and so Dr. Fauci spun his magic again. He went back to his friend Senator Weicker and asked him to help us. There was apparently some drama in this. If you want to understand administrative drama in terms of getting something through Congress for something like this building you should speak to Mike Goldrich [the Executive Officer of NIAID]. What he tells us, and I believe him, is that while everybody was out at a cocktail party one night, he was told to stay late and work up a justification for an AIDS wing to the Clinical Center. He stayed until midnight doing it, and they hurried the justification down to Senator Weicker, right before he was to give a major statement about NIH needs in the Senate. Apparently Weicker's influence helped to get us this new building, the A wing to Building 10.
A third of the space is for administrative support, two thirds for research. The space is shared with NCI and the Clinical Center. What we decided to do was to move the administrative limb of the intramural program, the bulk of the Scientific Director's Office, and the Administrative Management Branch down here and thereby free up additional laboratory space, which we desperately needed, on the eleventh floor of Building 10. We have done this and are now in the process of a complex round robin providing laboratory space up on the eleventh floor.
In addition to that there is a floor of this building that is devoted exclusively to AIDS. It has some high containment facilities for safely handling the AIDS virus. The NIAID component of that is shared between two laboratories, the Laboratory of Immunoregulation, Tony Fauci's laboratory, and the Laboratory of Molecular Microbiology, Mal Martin's laboratory. There is some space set aside there, for people who may need access to a safe place to handle the AIDS virus from other laboratories. They can go in there and work for a short period of time.
Harden: Do you have any tuberculosis work going on here?
Gallin: The tuberculosis effort is something that I would like to touch on because it is clearly related to AIDS. The biggest public health threat today with regard to tuberculosis is multiple-drug-resistant tuberculosis (MDR-TB), which probably had its origin in the AIDS epidemic. AIDS patients provided a perfect culture medium for growing this infectious agent. It is extremely difficult to determine if these patients have tuberculosis because they do not get an immunologic reaction to infection. MDR-TB first was seen in the inner cities, places like New York City. MDR-TB is of major concern because it is transmitted by the aerosol route. It has a high mortality.
Intramurally, we had no tuberculosis work at all prior to about a year and a half ago. There are three things we have done that I think will be significant. We have convinced the NIH community that we need to resurrect a high containment facility, Building 41T. We were able to convince Dr. [Bernadine] Healy to appropriate from the Gallo-French-American AIDS royalty fund some dollars to make it possible to redo that facility. NIAID is going to be the lead institute to manage the research in that facility, which will be shared by intramural and extramural colleagues.
We are setting up a similar facility in Montana, but a less elaborate one. My objective would be to have a facility there to serve the West Coast.
Four units are being set up in the Clinical Center to make it possible safely to bring patients with tuberculosis to NIH. We have received some funding from Congress to start investigations of tuberculosis. Several laboratories are pursuing basic bacteriology and bacterial pathogenesis.
The clinical program is also pursuing the tuberculosis effort. The major project to date is an extension of work that my own laboratory did in patients with chronic granulomatous disease (CGD), showing that gamma interferon protected CGD patients from infections by boosting the immune system. We have also been able to show that in patients who have a disease related to tuberculosis, atypical mycobacterium infection. We identified a group of patients who had highly drug resistant atypical mycobacterium infection and demonstrated that gamma interferon had dramatic effects on the clinical course in those patients. We hope that this will provide a precedent for applying this drug to tuberculosis.
Harden: Do you have to deal also with the danger to staff working with drug-resistant tuberculosis?
Gallin: Yes, and the major emphasis on their safety originates with me. When I was a house officer at Bellevue, I decided to work on tuberculosis and I got tuberculosis. Fifteen years later, I had to have a thoracectomy because I had tuberculosis. I got it because I was not, at the time, working in a good environment. I will not have my staff working with the organism unless the conditions are right. That is why we are setting up Building 41T, why we are setting up this facility in Montana, and why we are having units built in Building 10 for patients.
Harden: Let me follow up with one more question relating to safety issues. Some of the people we have talked to have indicated that they have had personal fall-out from working on AIDS. Their children did not like to tell their friends that their parents worked with AIDS patients, or dealt with AIDS in some way, because then the friends would not want to play with them. Have you experienced any personal consequences like this?
Gallin: No. I have had people ask questions, but it is just a matter of education.
Harden: Maybe we should talk a little more about some of the budget and FTE questions that we had. When you say that you had X number of FTEs devoted to AIDS or non-AIDS, and when you state that some people had a portion of their projects devoted to AIDS, I would like to know how you came up with the numbers. I also want to know whether the numbers include clerical and other non-scientific staff.
Guerra:: When we first got the additional FTEs for AIDS, we found out who needed to have extra FTEs on projects. When we gave out FTEs, we gave them per laboratory and we tracked them per laboratory, giving them an AIDS allocation and a non-AIDS allocation. We have done that over time. Actually, our automated computer system calculated our AIDS FTE usage. We were very careful when we gave out our AIDS FTEs. When we used them administratively, there had to be a reason for it. For example, when the budget doubled, obviously the procurement side of things increased dramatically. A number of FTEs went to procurement people to improve the processing and ordering time. And the HOPE Amendment–that is one thing in the budget I would like to touch upon–came along in 1988 and 1989. Through it we got about six million dollars one year, and that drove our budget up. It had an incredible impact on the clinical side of our program and on FTEs.
Harden: Maybe you could explain about the HOPE Amendment. What did HOPE mean?
Gallin: I forget what HOPE stands for, but it is the 1988 legislation mandating AIDS Clinical Evaluation Units at the Clinical Center. It resulted in an infusion of money to expand the outpatient clinical activities at NIH, and it mandated that there be a certain amount of clinical space for AIDS. That was a major event because there was no space in the Clinical Center available for this. Ultimately it required the action of the Director of NIH, Dr. James Wyngaarden, to identify space for the new AIDS clinic. That was the first time, to my knowledge, that a Director of NIH had actually stepped in and reassigned a significant amount of space in the Clinical Center.
Guerra:: The space had been used by the National Institute for Child Health and Human Development but they were not using it for clinical space. I think they were using it for office space.
Gallin: But they claimed they had plans to use it. Anyway, they were relocated very quickly.
Harden: We have read some of the Medical Board Minutes about that, and they did a lot of negotiating.
Gallin: This AIDS Clinic was critical for us to carry out the drug trials that Cliff Lane and Tony Fauci wanted to do. It remains a very dominant part of the program. In fact one of the things that is happening over this period of time is that the use of the Clinical Center is shifting from primarily inpatient use to primarily outpatient use.
Guerra:: This shift had a dramatic impact on the resources too. When we increased the number of outpatients, then we had to have research nurses and medical technicians' support. Some AIDS FTEs were devoted to that. I think we also had an administrative position to help do some of the administration related to that whole new effort. So the administrative positions coincided with the projects that were approved. John [Gallin] decided if projects warranted the administrative infrastructure to go along with the scientific support. Those decisions are made bit by bit as you can actually see. We used to keep a tracking system where we would show the date that things were added and whether they were AIDS or non AIDS FTEs. You can see how very delicate decisions were made. They were not just made in a vacuum. They were very thoughtful processes.
The other interesting thing that happened, occurred at Frederick [Maryland], when the clinical program expanded. AIDS had a big impact in terms of budget for our clinical management fund. Part of the dollars that we got supported the clinical program, both inpatient and outpatient. But the clinical support required for the program–immunology support and neurology support–we did through contracts. That was because of the FTE and space limitations and competition. We could not hire everybody to do everything that needed to be done. We initiated some big contracts to support the clinical program, one at Georgetown and one up at Frederick. We utilized the contract mechanism to renovate a building at Frederick. There was an under-utilized building there that had basically been a freezer repository, and we got the money to renovate it. We were able to convert it into a laboratory building that ended up supporting the clinical program through an expanded contract.
Gallin: I would like to elaborate on that freezer repository, which people had initially called Ken [Dr. Kenneth] Sell's white elephant. We thought this gigantic freezer repository was just ridiculous at the time because it seemed like an endless amount of space to preserve specimens. But it turned out to be a visionary and correct thing for Dr. Sell to do. As soon as we started seeing all these AIDS patients, and with the beginning of Projet SIDA, all these materials started being sent to us and we needed to freeze them. It has turned out to be a marvelous freezer facility, which has been completely consumed. We have had to expand it. That resource was a very valuable and important contribution to support our programs.
Guerra:: It was a good idea, but basically it was used for storage. We gave two floors to storage, and then we used the rest for other work.
Gallin: Now that whole building [Building 469] is in a high-containment level so everybody has to wear a gown, gloves, masks, and so on to do everything all day long. That is the way the research is done in that building.
Harden: Who has to worry about making sure that the power does not go off and cause you to lose the frozen specimens?
Gallin: The freezer does not require power. It works off liquid nitrogen. You have a long protective period but there are also all sorts of alarms, and there is policing.
Guerra:: That is a rule. You have to have a back-up system. As soon as one element goes down, another kicks in.
Gallin: We have another freezer repository that is part of the infrastructure of our institute, and a very complex backup system is in place with people who police it twenty-four hours a day to make sure it is working right.
Harden: I want to come back later on to further discussion of the stored samples. But I would like to get through a few more of these questions first. My question is that Dr. Fauci is, of course, an intramural investigator as well as the director of the institute. Both you and he doubtless understand that this could cause the appearance of a conflict of interest. How do you decide, when the director wants something for his intramural laboratory, how to allocate the potentially scarce resources?
Gallin: It is simply because I have known Dr. Fauci so long and so well. There is an element of trust between us that has worked to each person's advantage. But we made it very clear from the beginning that, if I were going to be the Scientific Director, in that capacity he worked under me as a laboratory chief. He has never once in eight years challenged me when I have made a decision about resources for his laboratory. If I must turn him down, I say, “I am sorry. We are not going to do that.” That is how it has worked. I think if it had not been that way, I would have left a long time ago.
It has worked because he has wanted it to work. He has been very sensitive to the fact that he is a very visible person. He knows very well that there are many people who would love to take pot shots at him. The last thing he wants is to have anything happen to his intramural research activity. I think ultimately, that Dr. Fauci's intramural laboratory is the most important thing in his professional life. If he had to give things up, research is the last thing he would ever want to give up. He is not going to compromise that and he never has.continued on Page 05
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