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III The AIDS Epidemic

First AIDS Cases

In early 1982 I started to deal directly with AIDS cases. Six months prior to that is when the first cases had been reported in the MMWR [Morbidity and Mortality Weekly Report] and the New York Times, et cetera. I was at a meeting in San Diego and I remember specifically talking about the cluster of cases with Harold Jaffe.

What was that meeting?

It was just a standard STD [sexually transmitted diseases] annual meeting. I had just been to China, and had heard nothing about this new disease. One evening I was at dinner with some of the people I'd been working with in the hepatitis B vaccine trial. Bill Darrow and Harold Jaffe from CDC were talking about this cluster of cases, a few in New York, a few in Los Angeles, and apparently a couple in San Francisco too.

Now, he was talking about KS and PCP at that point?

Yes. KS, which was being called a type of cancer, was the focus of the conversation. It was what was more unusual, these guys were presenting with getting purple spots or lesions on their skin. It sounded so bizarre compared to a pneumonia, even a pneumonia that people didn't seem to respond to treatment to. But these purple lesions were really new and different. That meeting was the very first week of June, in 1981.

So by the end of '81 you have a licensed hepatitis vaccine, but now no one was interested in hepatitis B. I mean, all of a

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sudden, you've got alarm bells going off about this new disease that may be coming through the community.

Why was your attention drawn to it?

Initially it had more to do with friends than with my profession. Sid and J.B. were an older gay male couple whom I saw almost as parents. They owned the apartment building in which I lived in the Castro district. They had been very sexually active for years in San Francisco, and they used to always joke that although the enjoyed life to the fullest, they also were prone to picking up STDs, and that's why everyone knew them at the clinic! They used to joke that clinic staff had to get a dolly from the back room to bring out their medical charts.

In August 1981, after I told them about what I had heard at the STD meeting, J.B. said, "You know what? Sounds like another sexually transmitted disease to me." And I remember he said to Sid, "We're not going to the bathhouses until they find out exactly what the hell is going on." J.B. also added, "With our luck we'll get this new illness if it is an STD." The ultimate irony is that they both did get it. They got sick in late 1982, and both dies of AIDS in 1984. It's clear that by the time we were having this conversation, in 1981, they were already HIV-infected. We also know from the hepatitis B study's stored serum specimens that gay men were already showing positive [for HIV] in '78 and '79.

The gay physicians I was working with at that time were in denial, and the sad thing is that most of those doctors died of AIDS. If they used their logic they probably would have realized that, Hey, there's a good chance this is a sexually transmitted disease. But to accept that meant that they had to accept that they were all at risk as well. In retrospect that denial is understandable.

I had been diagnosed with cancer the year before, in '80, just before all this happened. I think my recent bout with cancer helped prepare me for this new epidemic and not succumb to fear and irrational explanations as to what was occurring. I thought that the STD theory made sense. I acknowledged that I was at risk as well, but I didn't consider myself at high risk. This was back in the days before we realized there was a long incubation period, and I had been relatively inactive sexually while I had cancer. I had dated two people. When this new disease started unraveling, I felt like maybe my risk was low. There also were implications that drugs played a role

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in this new disease. I felt my risk was low in that regard as well.

AIDS Research Interest in Hepatitis B Blood Samples

The focus of AIDS research on the hepatitis study began when it was discovered that one of the very early AIDS cases, diagnosed in late '81, early '82, had been interviewed for the hepatitis B Study. Then Carlos Rendon who worked closely with Selma Dritz was investigating all the early [AIDS] cases for the Health Department. Our patient from the hepatitis B study was interviewed by Selma and he must have mentioned to her that he'd been in our hepatitis study.

Selma and Carlos contacted me. The patient had signed a release of medical information. They were looking for whatever information we might have on him. I mentioned that we had some stored blood specimens and interview data. This was early '82. I remember very clearly saying, "But you know, this is information from '78 and '79. We're talking about serum and interviews that are three and four years old." I thought it was pretty dated information. Now that we know what we do know about HIV, it was actually right in the important time frame in which people were first becoming infected with HIV. We decided to look for more individuals with AIDS that may have been we screened for hepatitis B.

Did you have any particular rationale?

It was more of a hunch initially. I thought that the stored serum and interviews covered the three years prior to the AIDS outbreak, and might provide clues to this new disease. I did not make a strong connection at this time. I did not think hepatitis B was connected with AIDS. I just thought both diseases might be blood borne agents, since similar groups were at risk.

Information was starting to trickle in on a few other AIDS cases that were not in gay men--in IV drug users, transfusion cases. Every new risk group they come up with seemed to match risk groups for hepatitis B. So again I was thinking, Maybe we've got another sexually transmitted disease here that's caused by a blood-borne virus, just like hepatitis B. Except we didn't have documentation then that it had such a long incubation period.

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Confidentiality Issues with Hepatitis B Study Participants

We had old logbooks of hepatitis B cases in gay men in SF. This was long before anything was computerized. We were working out of shoe boxes in those days. It was a very cumbersome task, but we went looking for hepatitis B study participants who matched cases of AIDS that were being reported.

You did that on your own, or were there others involved?

No, I did this on my own. These men had entered a research study, and there are certain rules around the integrity of the research process--who should have access to names. I was the coordinator of the study and also worked for the health department, so they could justify letting me have access to the names of the AIDS cases. But I said, "It can't work the other way. I cannot be turning over these logs to non-research study staff in the health department. The consent forms that were signed are very clear. Not just anyone in the health department can see who's in these studies."

Would that have been true of any sort of study you had done through the health department, or were these confidential issues because these were gay men?

Even before HIV there were concerns about discrimination and stigmatization. We had to be very careful about maintaining confidentiality in any research study, whether with gay men or not. If a consent form states limited access, you abide by those rules and regulations. Additionally, the gay community was already distrustful of government, just like other disenfranchised populations in our country.

Was it rather a new thing to take a detailed sexual history?

Well, people came in with STDs and had to talk about their sex partners with clinicians and counselors. But yes, to interview people whose names you knew about a variety of sexual practices and illicit drug use and then to record their answers on a questionnaire, that was very new.

One of the reasons CDC came to San Francisco and proposed doing the hepatitis B study was that there was a long history of trust, in San Francisco, between the health department and the gay community. I'll use my own example. I went to get an STD check at the clinic during my first six months in San Francisco. This was before I worked there. I knew about the

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clinic because Sid and J.B. told me. They said, "This is the place to go. The doctors are great; they're sensitive." It was a word-of-mouth thing that got around in the gay community to use the clinic.

So people, for the most part, were trusting. But there were always people that had concerns. How do I know where my name might end up sooner or later? People round up gays, whatever. The mid-seventies were post-Watergate and Nixon, followed by the CIA scandal, etc. There was still an enormous amount of distrust of government in the community at large, not just in the gay community.

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The hepatitis B vaccine was a plasma-derived vaccine; the manufacturers used the blood of hepatitis B carriers to make this vaccine. One fear voiced was that the [AIDS] virus may have been around longer than people realized; maybe even in the late seventies. Some people had this fear that the vaccine itself could potentially be contaminated with HIV. You couldn't get people even in the health care professions to take the vaccine once it was licensed. Now there is a genetically engineered vaccine where that just couldn't be the case.

Due to this concern, Merck, Sharpe, & Dohme, the hepatitis B manufacturer, put the blood of someone who was infected with both hepatitis B and HIV through the vaccine preparation process to prove that the virus could not survive the preparation process and contaminate the vaccine. This was an issue that had been addressed even before we knew about HIV, due to other infectious agents like typhoid fever. Part of the vaccine preparation process is to ensure you destroy any disease agent that could potentially be in a person's blood.

Gay Community Conspiracy Theories About AIDS

The distrust of government within the gay community lead to the articulations of many fears. Several gay newspapers and individuals started postulating that the hepatitis B vaccine

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might have been a government plot to infect the community with HIV. They said, "Isn't this interesting? They did those hepatitis B vaccine trials in '78, '79 and '80 in New York and San Francisco. And then in '81 the AIDS epidemic begins." This rumor was completely shot down, because once we started testing old blood specimens, we could clearly show that people were infected with HIV in '78, '79, before the first gay men had received the hepatitis vaccination, and we clearly showed that the prevalence of HIV was actually less in the men in the vaccine trial than in the larger population. Men that had not been exposed to hepatitis B were more likely to have not been exposed to HIV.

Speculation About Etiology

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Mr. O'Malley, last time you told me that you first heard about what we later recognized as the AIDS epidemic at a meeting in San Diego in May of 1981?

It was actually end of May, first week of June, yes.

Was there any assumption that this new disease might be sexually transmitted, or were there too few cases at that point to think about that?

I think no one jumped to the conclusion initially that it was sexually transmitted, although in retrospect, why wouldn't it have been right there high on the list? Many people were afraid to verbalize their thoughts, because of what the broader implications might potentially be if it was an infectious agent.

But here are some of the things that legitimately steered people away from thinking it might be a sexually transmitted disease. We knew there had been this sexual revolution that had gone on throughout the seventies here in San Francisco. There wasn't just a handful of gay men that had been very sexually active; there had been large numbers of gay men that had been sexually active with large numbers of partners. And they were not getting sick. Additionally, the first question people would ask when they heard about a new case of AIDS was; Okay, well, John Doe has this rare cancer, or John Doe has this pneumonia. Well, if he has a steady partner and that partner is totally healthy, how could this be an infectious disease?

If this is sexually transmitted then why aren't the partners sick? It was hard to argue that point, it was a good question.

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Clearly, there was immune suppression, but maybe it was chemically induced or drug induced or some people are just more susceptible than others.

I think there may have been some researchers who right from the get-go might have been fearful that what we were witnessing was a disease that was sexually transmitted. At that meeting, I was thinking it might be something environmental.

At that time I thought it might be the cumulative effect of having multiple sexually transmitted diseases, and subsequent treatments, and that's why the most sexually active gays who had had the largest numbers of partners seemed to develop the syndrome in the beginning. But of course, now it all makes sense. When you have a new agent introduced into a community, it's going to be the ones who are the most sexually active that are going to cross paths with it first.

Did you see cases in the clinic that you thought might be related to the new disease?

That happened six months later in was early '82. As I mentioned last time, an individual that I knew who had been in the hepatitis study had been diagnosed with Kaposi's sarcoma in November of '81. So he was one of that first handful of [AIDS] cases here in San Francisco.

One thing that helped motivate the CDC to do a research study in this hepatitis B group is we started collecting information on AIDS cases diagnosed in '81. I think by the end of '82, early '83, we realized that of the twenty-four cases that were reported with AIDS in 1981 in San Francisco, eleven of them were amongst men we had screened for this hepatitis B cohort study. If almost half the men diagnosed with AIDS in 1981 were screened by us, then clearly the hepatitis B was the place to start looking for a causative agent. It was probably going to be found in the blood of these men. Since the blood we had on these men was from '78, '79, and 1980, and this was now 1982, early '83, the question was whether we had serum close enough to the time that these men were diagnosed with AIDS.

I got a few calls from CDC like, "What do you think is going on?" They valued my opinion as to what might be happening.

This conversation occurred amongst this dinner group after the San Diego meeting?

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It was during the May-June 1981 San Diego STD meeting with Dr. Harold Jaffe and Dr. Bill Darrow from the Centers for Disease Control. There was a little something in the San Francisco Chronicle shortly thereafter about these cases.

CDC Involvement with the Gay Community

Jaffe didn't say anything about whether the CDC had any plans to investigate this outbreak?

Well, yes, CDC had sent a CDC case officer to New York and L.A., but it was just like they would do with any new diseases. There wasn't any discussion about broader national responses. I mean, they had this little outbreak and it appeared to be only occurring in gay men. A lot of data had been collected on gay lifestyle; there was a lot of drug use; there were a lot of sex partners, et cetera. So there were clear ideas about what would probably need to be investigated.

Was the CDC used to dealing with the gay community prior to the epidemic?

Yes. Bill Darrow is a good example. Bill Darrow had come to San Francisco, to L.A., and went to every one of the five sites selected for the hepatitis B study. He came to these cities in late '77 and spoke to me directly. He clearly was very familiar with the gay scene and knew people within the gay scene. I didn't get to know him really well until later when the epidemic became full-blown, when he would periodically visit our clinic in San Francisco.

CDC was providing federal grants to STD clinics all over the country. Additionally, there were federal assignees to most of these clinics.

Who were the federal assignees?

They were public health advisors. During those years Dr. Braff, a local physician, was the titular head of the clinic, but there was also a man named Don Hawkins who was a federal assignee who really ran the place. He ran the place with an iron fist. The clinic was clearly run by the "feds" that were working there, the federal government assignees, public health advisors. Hawkins was there all through those years.

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So CDC definitely had a presence which was felt at the clinic. Hawkins and his assistants knew all these people at CDC as well. He'd been an old-timer with the U.S. Public Health Service. CDC was well aware of what was going on in the gay community.

There was a tendency for CDC to be paternalistic or try to hide what was going on to some degree regarding what populations were generating the high STD rates. They didn't want front-page news stories about STDs in gay men. All this changed with the AIDS epidemic.

What was the motive there?

I think there was concern about homophobia and public reaction. Just like people sometimes say today, "Why the hell should we spend all this money on AIDS? They're not innocent victims." I think there was a concern that if it became common knowledge to the average citizen in the United States of America that a lot of their tax dollars were spent running these STD programs around the country which were needed in part due to the high rates of STDs in gay men, there would be a homophobic reaction. So CDC would always try to hide the statistics if they could.

Do you have any feeling about the government's motive? You could look at it in at least two ways: The government wants to keep the gay population healthy, because they're American citizens. Whatever rationale they wanted to use. Or, they could say, We want to keep the gay population healthy, because we don't want them infecting the rest of us, the larger population.

Well, I think you could say both. It was also partly that government creates their bureaucratic fiefdoms. Federal officials sometimes do not want anything to jeopardize the infrastructure they have created. People say this about AIDS now too. "What are you going to do if they find a cure tomorrow? That could put you out of work." So I think there was some of that going on as well with some of these federal bureaucrats. They weren't always motivated by great love or interest in taking care of gay men and making sure they stayed healthy or protecting the larger community.

The way the clinic's mission was put to the public was keeping STDs under control so that they don't explode into a larger and larger problem. I think they used to say that about TB and other diseases as well.

So homophobia wasn't patently obvious.

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No, I don't think it was patently obvious. God knows what many of them said behind closed doors about all this money being spent on gay men. It would not have reached my ears since everyone knew I was gay. I will say that I was always treated with respect by CDC staff and the federal assignees at City Clinic.

Defining AIDS

From what you told me last time, it sounded as though the immune overload theory was an old idea, that it wasn't developed specifically in the context of the AIDS epidemic.

Yes. When the first cases were being diagnosed, it seemed very logical that this was put on the platter as one of the possible answers. It made sense in connection with the diseases that gay men were getting--Kaposi's sarcoma was a known disease in older Jews and Mediterranean males, and all these other opportunistic infections. It all fell back on, Well, something's causing immune suppression, and immune overload obviously was a very logical way to explain it.

Case Clusters

But then Bill Darrow's cluster study made it look clear that this new disease was probably caused by an infectious agent because of the clustering of cases. It was very serendipitous in a way that Bill Darrow was able to tie things together the way he did. We now realize that there were many gay men that were already infected. They blamed that Canadian airline steward in Randy Shilts' book

, Gaetan Dugas, for infecting everyone, but there were a lot of so called "patient zero"s by that time. If he was spreading virus, there were a lot of others doing the same thing at that point. He clearly was not Patient Zero or the first infection.

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Are you saying that Darrow was lucky that he could actually link these cases, because it actually was much more complicated than it at that time appeared to be?

Yes. We now know people progress at such different rates that it was very lucky in those early years to be able to tie them together. Let's use a hypothetical example, twenty gay men go to a party on Fire Island in the summer of 1978 and have an orgy. Let's say they all got HIV-infected at that party. We now know that people progress to AIDS at varying rates after infection. But in the case I just described, only half of those men, 10, would probably become immune suppressed with AIDS ten years after their initial infection at that party.

AIDS as a Gay Disease

Did you think of it initially as a gay disease?

Well, I guess you couldn't help but think of it initially as a gay disease, because gays were diagnosed with the first cases. At the dinner with Harold Jaffe, when I first heard about it, I heard that it was in gay men. It wasn't like I heard, Well, they've got some hemophiliacs and some transfusion recipients. It was, They've got these gay men in New York and L.A. So yes, it was being called gay cancer and gay pneumonia; you couldn't escape the association with gay men right off the bat.

And you thought that was fair enough, to characterize the disease in that way?

Well, I didn't question it initially, because that seemed to be the case. Gay men were the first cases. Again, it wasn't like we were automatically thinking of a blood-borne agent at that point, especially in that first month or so after I heard about it. So as the data started trickling in about transfusion cases, it became much more logical to make the jump that maybe this is a blood-borne agent of some sort that's causing this and that the risk groups may be much broader in scope.

But some members of the community objected to the names, particularly GRID [Gay-Related Immune Deficiency]. Because whether or not you thought that it was a disease limited to the gay community, the "in" thinking was that the name of the disease shouldn't indicate that.

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I agree. Whether it turned out to be an infectious agent, or even if it was something about gay men's lifestyles, like immune overload from repeated treatments, then it was an environmental thing that technically could have happened to anybody if they'd had similar exposure.

I wasn't overly excited about the fact that we were calling it gay pneumonia. I could be in a social situation where someone said, "That guy over there I heard has the gay pneumonia." It just seemed so ridiculous that even within the community gay men were using the term amongst themselves.

But I all along thought, the main thing we've got to focus on is trying to get to the bottom of this disease and to do everything possible to make gay men feel comfortable about participating in getting to the answer. Distrust of government was something that was going to be a battle right from the get-go. There were fears that were voiced early on like, Could this be some kind of massive plot on the government's part to do in the gay community?

Was that a prevalent suggestion?

Not right from the get-go, but as time passed it was. When you think of the seventies and everything that came out about Watergate, everybody was, Oh, my god, who knows might be going on? The Reagan administration's apparent lack of concern also helped to foster these feelings.

It was an us-against-them attitude?

Well, in '77 there was the Anita Bryant affair. The gay community's eyes were opened to the potential of real discrimination. This was followed up by the Briggs initiative against gays as school teachers, and then Harvey Milk was assassinated at the end of '78. To think on top of all of that, at the same time this virus was taking hold in our community.

CDC Interest in the Hepatitis B Study

As I mentioned last time, in early 1982, I brought to the attention of CDC this AIDS case in one of the participants in the hepatitis B study. I told them that we had stored blood specimens and interview data on this man. Then I started cross-referencing to see if there were other men with AIDS that

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were in our hepatitis study, and we found there were others and notified CDC.

In 1982 the only money provided by CDC was for hepatitis B vaccine trial follow up. My position was the only one funded at that point. It was a wrap-up activity of the vaccine trial. Luckily, I was there and I had this established connection with people at CDC--Don Francis, Bill Darrow, Harold Jaffe--they were calling me up, asking me for suggestions, advice, information as to what I thought was causing this disease.

For example, we had an unusually high number of men in the trial become hepatitis B carriers once they became infected with hepatitis B. The data on hepatitis B is about one in ten become carriers. If six months after the date of infection they're still showing positive but don't have hepatitis, then that's an indication they're probably going to be a carrier.

We started noticing that among these men, we had seen a higher number of carriers than usual. The question was, does it have something to do with gay lifestyle? Maybe their immune systems aren't functioning as well as they should, and maybe that's why some of them are having a harder time clearing the hepatitis virus than you would expect from the general population. But then again, is there something new happening in our midst here? These men are all "healthy"; they hadn't been diagnosed with AIDS, but why is it they're becoming carriers at a higher rate than you would expect.

We asked these carriers to come back for further evaluation. Everyone suspected that something was probably going on in this group, and possibly immune suppression. There were suspicions early on that HTLV-I, the leukemia virus, might be the causative agent. While NIH and the Pasteur Institute were doing their research on the causative agent for AIDS, they were actually using some of these specimens. These specimens were blinded. CDC, NIH and Pasteur did not have access to the names. We knew that whatever the disease agent was, it was going to be found in this group of men.

We operated without extra funding from CDC during 1982 and most of 1983 on the hepatitis B study's investigation of AIDS. And this is where the criticism comes, Why didn't the government jump faster? Why didn't they offer us money sooner? ##

In all fairness to CDC, a CDC man did come to the clinic independent of the hepatitis B study to conduct a case control

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study which is to look for men who were using clinic services who would match the profile of the [AIDS] cases.

Did the CDC run the study using the City Clinic?

They worked with the federal assignees at the clinic. We would get involved in it in some cases, but generally by accident. I just got in with the CDC because I was working with the hepatitis group at the time. I didn't go out of my way to get involved. I did not need to--they came to me. If they wanted to conduct research on the hepatitis B study they had to work with me. There were tensions. We used to always feel that the feds had too much power at the clinic. A lot of the tension had to do with Don Hawkins. There were constant personnel problems in those days between local and federal staff. I take a lot of credit for being a good supervisor, and I say the only reason I'm a good supervisor is when conflicts come up, I think about how conflict was handled in those days, and I always do the opposite--180 degrees, and it always seems to work out better!

First AIDS Study Using Hepatitis B Samples

During '83, we were offered $100,000 [by the CDC] to go after approximately a 10 percent weighted random sample of the 6,700 men that we had screened for hepatitis B. I was working very closely with Bill Darrow at this point. I think the CDC first wanted to see if we could attain our objectives. In retrospect, they should have taken chances and thrown even more money at us. We could have tried to reach a larger percentage of the 6,700 men than we did in 1984.

But the reason I say it was a weighted sample is because we interviewed the first 800 men that had been enrolled in the hepatitis B study. They had had blood drawn and were interviewed about risk factors before we even knew whether they'd been exposed to hepatitis B or not. After four months, as I told you last week, we discovered we were finding too many men who had already been exposed to hepatitis B, and they wouldn't have been eligible for a vaccine trial. At that point we changed the rules and then screened everybody first. Those who had a negative test result for hepatitis, we'd call back and then interview and follow them every four months. We changed this protocol in May of '78 and we clearly were moving away from the riskiest people at that point, because we were trying to get only men who were seronegative for hepatitis B.

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The thing that was really valuable about those first four months of '78 and those 800 people we interviewed is that we clearly interviewed a lot of very high-risk people who were either exposed or about to get exposed to HIV. We had this weighted sample, and in that first year we were able to locate about 80 percent of these men. In general, people were willing to participate.

So back to this question you asked a little while ago, What was the feeling in the community? Were people nervous about participating? There was some nervousness, but in general, people were much more likely than not to participate. And that had a lot to do with the clinic's reputation in the gay community. I had worked in the clinic since '73, so I was a known commodity as well to a lot of these guys. They knew I was a gay man, there was a lot of gay presence in the clinic, [gay] doctors, nurses, clerks, counselors, so people felt comfortable participating.

Then between '84 and '85, CDC threw a little more money at us and said, "Okay, go after another 10 percent weighted random sample of the 6,700. Additionally, anyone diagnosed with AIDS would be enrolled in the study.

Between year one ['83-'84], and year two ['84-'85], the development of the HIV antibody test occurred with the announcement of isolation of the HIV virus. This was considered great news, We've got a causative agent! Maybe we'll have vaccines, treatments, a few years down the line.

Paranoia

Then there was a sea change within just a few months in the attitude of the community regarding this scientific advancement. The implications surrounding the taking of this test, and how it could be stigmatizing and discriminating. Some gay men soon felt that you've got to be out of your mind if you would take the test in anything other than an anonymous setting. There were a lot of fears like, What if this disease really does get out of control and really does start spreading into the general population? There might be roundups. They may want to lock everybody up that's HIV-positive. So there were a lot of reasons why people were hesitant about getting tested for HIV in a non-anonymous setting.

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Additionally, nobody really knew what exposure to the virus meant. You can find out you've been exposed to this virus, but then what do you do? Sit around and wait to get sick? Am I going to die tomorrow? There weren't treatment options then.

There was an enormous change in attitude. We had had people more than willing to participate, and all of a sudden most people just said, "No way, I'm sorry. I won't give you permission." They'd say, "You have this stored blood on me?" Some didn't believe that we were actually seeking their permission to test their blood samples for HIV, they assumed we had already tested all those stored samples anyway, and that we were actually calling to see if they were alive, sick, or just to keep track of them.

It was hard, because it was very clear that from a purely scientific standpoint it would have been convenient to be able to test those 6,700 samples. Instead of trying to find 6,700 people, you'd want to try to find the ones that showed up positive and see what was going on in their lives healthwise. I thought we would lose in the long run if we did operated that way. Although a lot of information could have been gained quickly, there would have been a bad taste left in everyone's mouth because of the method's we'd used. Bottom line, the end does not justify the means.

As it was, it was horrible. A lot of people were very upset. They were paranoid about the fact that we even had the stored serum. Like, Oh, isn't this interesting, that the year the virus first starts showing up is the year you started saving these specimens? So a lot of people thought, Oh, this is just a little too much of a coincidence. So there were justifiable reasons for paranoia.

Some people have said that even the hepatitis study was all a big front for something else that was going on on an even larger level than we realized. After all my years of working with the government, I'd never really given much credence to that idea because the government's just not that intelligent and organized. I really do think it was serendipity that we were doing the hepatitis B trials at the same time that the AIDS epidemic broke.

As I remember, there were five--or was it six?--centers for the hepatitis study?

Well, there were six, counting the New York Blood Center, which wasn't really part of the CDC group.

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Why wasn't New York part of the CDC group?

Well, the New York Blood Center did the first hepatitis B vaccine trial. They were ahead of us. I think the FDA wanted two trials conducted, and the New York Blood Center was seen as one trial. They started in '79, and then there were the five multicenters, which started in 1980, a year later. So yes, from the outside looking in, there were six sites.

Primacy of the San Francisco Database

Why, in terms of the AIDS epidemic, was it San Francisco where the valuable information was gathered from those sera?

That's a good question. Partly because our records were maintained. The L.A. Community Health Center shut down--they didn't have any infrastructure in place to even try to relocate all these guys. I think their logs were destroyed when the center closed. So to this day, there's no way of matching people with those blood specimens in Los Angeles. I think that was the problem with the New York Blood Center as well--destruction of records once the trial was completed.

It could have happened here too. The original master logs are in our safe. I've looked at them; they're just torn and tattered. They're priceless when I think of all the research those logs have given to us over the years.

But the fact that we had these old logs, plus we had clinic records on most of the 6,700 men, I think was why the CDC realized San Francisco had the best shot at reaching a significant portion of these men.

Did the other centers have log books?

Yes, Chicago and Denver. I think of what could have been done if more money had been made available for Denver and Chicago in 1983 for contacting former hepatitis B participants. CDC obviously didn't have enough money to provide Chicago, Denver and San Francisco all at the same time, they only had money for us.

Also, they had all these stored specimens at CDC that had not been catalogued. We're talking about 6,700 men who had provided 15,000-something specimens. One of the things we were up against right at the beginning, once things really started

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moving along and we started getting people in and asking permission to pull their blood, is it became very clear that we needed to hire people at CDC to go into these freezers and get these samples organized so that the specimens could be easily located. It took them almost a year to get all these specimens catalogued. I think CDC just didn't have the money to invest in all these necessary tasks in the early 1980s to get this study off the ground at both CDC and multiple clinic sites.

Where were the serum samples located?

They initially had been sent to Phoenix, Arizona, the location of the CDC hepatitis branch during the 1970s. They moved to Atlanta

in the early 1980s. By the time specimens were being pulled for this study, they were all stored in Atlanta, Georgia.

When you needed to test them the CDC did that?

Yes. We had a whole mechanism set up through our computer with the code numbers. CDC never had access to the names of the hepatitis B study participants. We were the only ones that had the connection with the name and code number. Once they had all the specimens catalogued it was a weekly activity: we sent off a list of specimens that had to be pulled, and they would send us the test results.

There were 800 individual specimens that they had tested for HIV antibody by 1985. I received all the results of all these tests all at one time in 1985. This is, by the way, where this story becomes much more interesting (and upsetting I might add) and why it became so clear how valuable this study was.

Two things became clear in late '84, early '85, when CDC started providing test results on these specimens. We were able to document when the virus entered the community. We could see that about 4 percent of the specimens from '78 were positive, 12 percent from '79, and then it jumps up to 20, 25 percent by 1980. So there was conclusive proof. It becomes clear that at least three or more years before the first case was diagnosed, the virus was present in San Francisco. Obviously there was a long incubation period.

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AIDS as a Disease Continuum

Additionally, some of these guys who were HIV antibody positive since '78, '79, '80 were walking around in totally perfect health. People were obviously progressing at different rates. A few years later we made the association between duration of HIV infection and the risk of developing immune suppression. Initially, we thought AIDS might be like some other diseases. AIDS was an endpoint for some people, but lymphadenopathy or another symptom, like hairy leukoplakia or what was then called ARC [AIDS-related complex] was an endpoint for others.

Sadly, no symptom was an endpoint. We now know there is a continuum that runs at different rates for different individuals but that ultimately leads to AIDS for most HIV infected individuals if treatment is not provided. By '85-'86 when we had these results, it was seven years from '78, six years from '79. We knew some of these guys had been infected for five, six, and seven years and were healthy. There was a feeling of hope: Well, if something's going to happen, why hasn't it happened by now?

The government started to spend more money on the study. After those first two years of going after two percent random samples, CDC basically said, "Hire as many people as it takes to locate these 6,700 people." They wanted us to increase the samples of men that were what we called "well-characterized" HIV positive. These were study participants whom we could pinpoint within one year as to when they became HIV infected.

Confidentiality Issues

The Hepatitis B Study

The AIDS study followed very closely on the hepatitis study. In fact, there's an overlap.

Yes.

Say there had been ten years in between, would the hepatitis serum samples still have been available?

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Well, the samples would have been available. The question would have been whether the logbooks would have been there. For example, if I had decided to leave I would have been a little bit uncomfortable about those logbooks being left behind. I might have recommended they be destroyed. There's only a certain number of years you are required to hold onto these documents.

Why would you have destroyed the hepatitis B logbooks?

Well, confidentiality concerns. I just wanted to make sure that these individuals' confidentiality was respected. Their names, addresses, and phone numbers were in this logbook and the code number which linked them with their serum specimens, test results and sexual and drug histories.

That's what I thought you meant, but then you turned it to, Well, scientifically, this information isn't of much interest any more, why hang onto it?

Well, only partly. It was clear that you wanted to hold onto information from the group in the vaccine trial. I had been told right from day one by vaccinologists, "You never know, five years, ten years from now, we may need to get hold of these people to find out whether they're still immune to hepatitis or if there's any longterm side effect." So I knew the information on those individuals was important, but only 359 out of 6,700 were in the vaccine trial. I could have destroyed the other logs. Of course, now I think no one will ever throw anything away ever again.

Selma Dritz and Randy Shilts

Selma Dritz

told me that some of her notebooks were destroyed when she retired. She didn't know who had done it. Do you have any more information?

This is purely speculation, but I think there may have been some concerns that some of the stuff she collected had served their purpose and was extremely personal. The health department believed it was no longer important to hold on to this information.

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There was some concern as to how Randy Shilts knew some of the information he wrote in his book. He was someone who lived here in the community, and he wasn't like an outsider coming in here; he was very savvy at what he did. I don't think Selma may have realized that he was able to ask questions and put two and two together sometimes, because he was so familiar with what was going on in the community. I don't really know who destroyed her books. She might be really irritated to hear this, but I would rather see health information like this destroyed if it is no longer relevant to investigating this epidemic.

What about the use of specific names, which of course Shilts does all the way through his book? It's a very personal story.

That's because he interviewed a lot of those people himself. The concern always was, How did he get confirmation on some of this information? Usually if you're a good reporter, you try to get a second and third confirmation of what somebody is saying.

Health Department Policy

Has confidentiality and perhaps the resulting methodology that grows up around those concerns escalated because of the epidemic, or has the health department always been very concerned about it?

The health department has always been very concerned about confidentiality. We realize a lot of disenfranchised people have reasons to fear that information about their sex lives, or diseases they've had, or drugs they've taken, will be used against them. So I always felt that we had to bend over backwards to protect them. Confidentiality is paramount, even during so-called "worst-case" scenarios. For example, you get a phone call from the police department, and they've arrested someone because they've molested a three-year-old. The police have found their clinic card that says they're in our hepatitis study, and they want to know whether somebody's infected with HIV or not. I'd ask, "How are you going to deal with something like that?" It's an interesting moral dilemma but we the health department would always choose confidentiality.

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Effect of the LaRouche Initiative

So you have more or less a flat policy not to release personal data?

Yes. Especially since the the LaRouche initiative and Proposition 103.

There were times where we were really concerned that we were going to be stuck with this law saying, "You've got to report HIV-positive status on your study participants." We thought out how we would fight it out in the courts. I used to think about these logbooks. What am I going to do if the elevator door opens up some day and the police say, "We're going to confiscate your records." Am I going to burn them on the spot? I used to think about how we would hide them; I didn't want them to get into the wrong hands. I was also aware what a terrible loss to science it would have been if we had destroyed this information.

Had you always realized what a scientific gold mine they were?

Oh, yes. It was very obvious because I realized L.A., which was another early center of the epidemic, had all these blood specimens and they had no way of linking them to the study participants because their logs had been destroyed when the clinic closed.

You had the serum samples on one hand, and you had a logbook with the names on the other.

Yes, and the interview data.

Finding the Participants in the Hepatitis B Studies

Obviously some of these people were still here in San Francisco, and you could find them. How did you find people that had moved away?

We would start with the clinic registry, which we had access to. The first thing we'd do is see how many of them had visited the clinic recently, to see if we could get and updated address and phone number on them. So those were the easy ones. We'd just call the number, and there were a certain percentage of people that we found that way in the city.

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Then we used the voter registry. Everybody has access to the voter registry. And we had birth dates on a significant number. One of the flaws we discovered was that we didn't have everybody's birthday. But in any case, we were able to find an awful lot of people through the voter registry.

We'd send address requests to the DMV [Department of Motor Vehicles]. The DMV occasionally had information besides address updates. For example, families will sometimes let the DMV know when a family member dies, so we did find occasionally that some men were deceased. Additionally, if someone goes to another state and registers with their DMV, the California DMV was often notified by the state. We'd get a clue to where they went. For example, the form would say, "Moved to Florida." The DMV no longer provides this information to the Health Department.

Also, being part of this community, I knew where gay men were moving. I knew many gay men were moving to Los Angeles, San Diego, New York and Miami. So we would look for names in these cities. If your name was John Smith, that wouldn't help, but if your name was somewhat unusual then you might be the only one there with that name.

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Technically, you probably should notify a local jurisdiction health department when you're calling somebody about something like this. But we thought, There's no way we could make such a call and maintain confidentiality, especially if someone lives in a small town. We feared that if the word got around town that we were investigating someone regarding an HIV study stigmatization could occur. So a lot of times, I would just call Information. I had all these skills from working at the STD clinic for trying to locate people without breaching confidentiality, so I knew how to call people out of the blue and ask questions. You try to find out if you've got the right person without breaching confidentiality.

Can you give me an example of how a conversation might go?

Well, luckily, the medical charts sometimes would have just enough information so I could identify a person. We would say we were a friend, or trying to find the person for a reunion or whatever. I took classes with Joe So-and-so that used to live in San Francisco, and I'm trying to find him. If you got the right person on the line he'd say, "Oh, yes, that's my brother," or, "That's right. He used to live in San Francisco."

When you did find the right person, what in general was the reaction?

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In general, it was amazing. People who had lived in San Francisco saw it as an island of safety. So gay men never reacted like, "How the hell did you find me," or, "My god, how did you track me down?" to a call from San Francisco. Once I described who I was and what I was doing they generally wanted to help.

People here in the city would get more paranoid. Locally you had activists and everybody screaming from the rooftops to watch out for this, watch out for that, they're gonna round us all up. It was the reverse of what you'd think it would be; there was more paranoia locally than there was out there in the boondocks about the San Francisco Health Department and governments sponsored HIV studies.

How did you present yourself?

Well, I learned how to do this: it was to not come across like the bill collector or whatever, and to be as relaxed as possible. I used to say, "Now, Paul, think of it as trying to find somebody you went to college with twenty years ago. Think of it that way. Don't set off alarm bells in people.

Did you make it clear that you were gay?

I wouldn't automatically preface everything by saying, "I'm gay," but I think in the course of the conversation, it probably was apparent. People would say, "Oh, god, this horrible disease; I lost somebody." I would let them know that yes, I understand what you're going through; I've been there myself. Sometimes they would remember me from the clinic and seeing me out and about in the gay community. I lived in the Castro district.

I read that, despite all this, there was about 29 percent of those 6,000 whom you could not locate. Does that sound about right?

Yes. We've actually located and tested about two-thirds of the men. There were also flat-out refusals in addition to the untraceable. There were people that we just reached a total dead end on. Not surprising, when you think of the number of years that went by before we started this search. It wasn't until '89 that we completed our attempt to reach every one of those men. We tried to locate 10 percent of the sample in '84, another 10 percent in '85, and the remaining 80 percent between 1986 and 1989.

Why the 10 percent limitation?

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Well, I think there were two things. There were the budgetary restraints and CDC also felt that we only needed to locate a ten percent sample. If we could get a representative ten percent sample, they figured, then we make some generalized statements about the entire sample.

Usefulness of the Hepatitis B Study Data

But that changed in '85. In '85, CDC finally realized that they were sitting on a gold mine here with these specimens and the data that we were uncovering, so they sent Dr. George Rutherford, who was an M.D. epidemiologist. He was followed by Dr. Alan Lifson from CDC, and we then had the expertise we needed. They were very competent and knowledgable and sensitive to the needs of the community. But from '81 to '85, for four years, we lacked the local support we required.

It took a while to realize fully the significance of this data. The reason CDC now wanted to locate everybody was to develop a significant sample of men who were "well characterized" positives. The public health implications were, Okay, we have 500, 600, 700 men about whom we can say, "This is when they got infected, and this percentage progressed after X number of years to AIDS." They started doing similar studies in hemophiliacs. You could get some sense of what was going to happen as this epidemic progressed. The demands on the public health would be considerable if all HIV infected individuals were eventually going to progress to AIDS.

So in '86-'87 the first projections were made about the spread of AIDS, based in part on our study. There was an enormous amount of publicity around the Kaplan-Meier progression curve, which estimates the progression rates to AIDS. It was our study that first came out with the projections that roughly 50 percent of the HIV infected would progress to AIDS in ten years.

Before Dr. Rutherford and Dr. Lifson were assigned here, how close were your ties with the CDC, and under what circumstances were you contacting them or vice versa?

Oh, there was a lot of contact. Bill Darrow visited periodically, and I was talking to Don Francis all the time. Dr. Braff and Dr. Dritz were focused on other issues. Keeping track of cases was a full-time job. They did not have time to focus on this study. Most of the attention I received was from

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CDC. I did not have local expertise available. They also knew I was self-motivated, but I think they were just overwhelmed with everything that was going on here in the community, setting up all the service organizations that were required.

That wasn't specifically your responsibility?

No, it wasn't. That's another whole part of the response of the health department to the epidemic.

Did you see it as part of your job to educate the gay community?

Yes, but that's another whole story. There were people that were assigned to deal with education. We would pass information around to them. I remember feeling like I was working morning, noon, and night just dealing with the research end and also dealing with the disease in my personal life. In retrospect, though, I wish I had screamed from the rooftops a little more about all the implications for the gay community regarding this burgeoning epidemic.

Reluctance to Talk About Gay Sex Practices

There was a lot of hesitation to get up and publicly say, "We think receptive anal sex is the primary risk factor for HIV transmission." There was such concern that everyone was going to say, "Well, of course the health officials are going to say that, because they're being judgmental, moralistic, anti-gay and all that, and of course they're going to automatically assume that's the major risk factor. And here we are as a community finally starting to feel comfortable about our sexuality and about engaging in these practices, and all of a sudden someone's saying, 'No. Don't. Sex has to be protected, or don't do it at all.'"

So there was a lot of hesitation, even though some of the early signs were that receptive anal sex was probably a major risk factor. We didn't really get up there and scream and holler about it, because of the feeling that there was going to be negative feedback and if we were wrong we would lose all credibility and leave ourselves open to charges of homophobia and raising unnecessary fears.

It seems to me that those very concerns of yours are epitomized in the bathhouse episode, which polarized the gay community.

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Yes, and it's funny, because you talk to some people today who were adamantly against closing the baths at the time but will now say, "Well, I guess it was the right thing to do at that time."

Did you have any sentiment one way or another about the bathhouses?

I didn't get drawn into it. I remember feeling, because I was dealing with research, I am not going to take a public stance and become controversial. I thought it might jeopardize study participation. There were men on both sides of this issue participating in the study. I felt that I had to keep my sights on the fact that there was so much to be gained from this study and getting the cooperation of the gay men. I would also like to say more about the struggle it was for gay men when trying to decide to participate in a study which required testing without anonymity. They worried about losing their civil liberties in the long run if they chose to participate, and about losing their lives if they chose not to participate in these studies. I could sympathize completely with gay men who said, "I'm sorry, I'm just not going to take the risk that information I provide you could come back to haunt me later." Luckily there were many men who finally said, "Maybe that's a possibility, but I also feel that this disease may do us all in, so I am going to take that risk." I wanted to try to provide the best environment possible so people felt comfortable making that decision. I felt that there were a lot of people that were not going to participate. People were saying, "Don't get tested, and even if you get tested as part of research, don't get your result, because who knows what it means."

But I also thought, The only way that this community is really going to deal with these issues and push treatment research was by having a groundswell of participation in research. Men were ultimately motivated by the fact that their friends and lovers were getting sick, and the possibility that they were positive. Once gay men dealt with their fears and came forward, there would be a groundswell of activity on numerous fronts--political, scientific, education and healthcare. And that's indeed what finally played out.

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Andrew Moss's Epidemiological Studies

Well, a name that we haven't mentioned yet is that of Andrew Moss,

who as you well know was doing epidemiological studies, and ran into turf problems in the early part of the epidemic. I found a letter, which I'll show you.

[reading letter] This is really mind-boggling. I can't believe that I never knew that Andrew was supposed to have access to this hepatitis screening cohort. I can't believe he never told me this either. I knew he was interested in the cohort and would have liked to have access, but I never knew that it was formalized in writing. I mean, I worked with him in '82.

In '82 Andrew started up a study at General in which was interviewing cases and partners of cases, and there were people that they found coming through Ward 86 the AIDS Clinic at San Francisco General Hospital. Martha Rodriguez, who I worked with at the time in the hepatitis study, and I, volunteered, and we went up and started interviewing cases, because Andrew needed help and we had interviewing skills.

But this letter is really interesting. [reads] I know one thing: the confidentiality of the hepatitis study data would have been a roadblock. The question of who should have access to these participants' names was a question within the health department, and Andrew was not a health department employee. I told them, "I think there's justification for me having access to the names of the cases because I work for the health department. But I don't think the people doing case reporting should have access to our lists of names. They're not employed by the research study, and the consent form is very clear that only people on the research staff have permission to have access to their names."

The Health Department AIDS Surveillance Unit was annoyed because I wouldn't even tell them who was in the cohort and who wasn't. They asked me, "At least when you do get a match, let us know that they're in the cohort." And I said, "Well, the

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only way that will happen is if I can get in touch with these people and get permission to let them know that this is information that we would like for research purposes."

I know there were personality problems between Andrew and people at CDC, and I know there were some tensions between Bill Darrow and Andrew at one point. I can tell you right now that I would have been a roadblock, although I wasn't aware of Moss's request for access. It had nothing to do with my opinion of Andrew. He was well respected, competent and ethical, but Andrew, again, was not an employee of the City and County of San Francisco.

I'm surprised Andrew didn't try to head this off by coming to me directly. This letter also helps me understand a little better why he was irritated with Harold Jaffe and Bill Darrow.

How was Moss's request for access resolved?

Well, he never had access to the hepatitis B cohort. It never occurred. He was working on the General Hospital cohort. There was also the San Francisco Men's Health Study directed by Warren Winkelstein. There were three HIV-related studies in gay men at that time. I do not think AIDS research suffered either locally or nationally due to the restrictions that were placed on accessibility to data by the health department.

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As you see in that letter, Moss protests the CDC's plan to start a study of sexual partners of AIDS cases.

Well, the first year of the study we did the 10 percent random sample. The second year, there was talk about recruiting a new, younger cohort, looking at sex partners of study participants, another 10 percent sample, following 50 percent of the guys that we had enrolled in the first year of the study. But the sex partner study was thrown in there with everything else, and it never really got off the ground. Partly because we knew that Andrew Moss was doing something similar, I think a lot of us felt that there were other things that made more sense using this cohort. This cohort had very specific value. You could do interviews of sex partners of AIDS cases with any group of AIDS cases. What we had, of course, was the history of the stored samples. I understand Andrew's position on this matter.

[continuing to read letter] Some of these personalities aren't around any longer. Dean Echenberg was hired by the health

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department to replace Selma Dritz in the Bureau of Communicable Disease Control. He did not fit well in this position.

Why?

The position required working with numerous other AIDS researchers on the the local and national level. Tensions developed with several of these researchers and he finally decided to vacate his position.

For example, CDC's Dr. Bill Darrow and Echenberg locked horns. Dean wanted to get much more involved in all that was going on, where Dr. Braff hadn't really paid any attention on a day-to-day basis. CDC had developed a relationship with me over four years, and Dean was seen as interfering. In retrospect, this was somewhat unfair to Dean because he really was my boss and had a right to be involved.

Shift of AIDS Services from UCSF to SFGH

In the very earliest years of the epidemic, it seems as though the center of power was at the university, first at UCSF because of the KS Clinic--

Yes, Dr. Conant and Paul Volberding.

And then it began to shift. For complicated reasons, the major effort of the university moved over to the General. Where do you see the center of power in AIDS medicine lying from about 1983 on?

I know very little on this subject other than that Jay Levy, Paul Volberding, Marcus Conant, were the most prominent M.D. researchers. They were experimenting with the treatments, and that was an enormous focus of what was happening with AIDS at that point in time. At the end of '86, of course, there was AZT, but even long before AZT there was progress occurring with treatment of opportunistic infections. UCSF was the center of power, and you're right, Andrew Moss worked right there alongside Donald Abrams and Paul Volberding.

How did the health department feel about that UC's prominence in AIDS medicine?

There was definitely some competition there. Our roles were very different. I was not involved and not concerned. I

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thought the health department role and the university's role were distinctly different and should be non-competitive. The AIDS Activity Office at the health department was run by Jeff Amory and Michael Bala. They oversaw the provision of health services and HIV prevention education. Mike Bala is the only one around now who can speak from the perspective of the health department's initial response. He took care of all the contracts that had to be set up for service organizations here in the city to take care of the needs of people that had AIDS.

Our study was housed at the City Clinic from '81 to '85, and then, due to growth, there was no longer enough space at the clinic and we rented offices on Market Street in '85. We moved into this building here at 25 Van Ness in '89.

This building is?

Well, the AIDS Office. All the health department AIDS related operations are now conducted in these offices.

Multiple Uses of the Hepatitis B Cohort Data

In retrospect I think there was definitely competition between CDC and the local researchers concerning the hepatitis B study. I think CDC saw this study as their baby in a lot of ways; they have reaped a lot of favorable publicity due to this study over the years. It's continued to be a source of pride for them. Susan Buchbinder is at the International AIDS Conference in Japan right now giving an update on our study participants, and people are always interested in the latest on this cohort.

Fast-forwarding a little bit, in '89-'90 the focus changed again here. We were still interested in progression rates, but then what became interesting was a subset of men that apparently weren't progressing to AIDS. This has been the main focus of this study for the past ten years and that's where most of the recent media attention is focused.

The AZT study used the same group of men, right?

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Well only the AZT-acyclovir study in 1987. It was a very small phase I study. It involved twenty study participants. They had to be asymptomatic. It was a Burroughs-Wellcome sponsored study. They had to be asymptomatic and have T cells above 500. The idea of testing this drug in people that were healthy positives was new. It also had broad implications for Burroughs-Wellcome. If all of a sudden there was this much larger population which might be accessing drugs. But that's another story.

The Health Department's HIV Vaccine Preparedness Study, 1993-1996

Do you want to briefly say something about the vaccine study that you're working with now?

Yes. Just prior to the vaccine research study, my lover, Doug Franks, died. Additionally, the office, in '89, '90, '91 had also lost several staff members to HIV. We lost several of the interview staff; we lost doctors, nurses. It was just an awful time and we needed a boost.

Luckily, the boost was when CDC approached us about doing an HIV vaccine preparedness study, and they approached Denver and Chicago as well. Denver and Chicago, of course, were also sites where the hepatitis B study had been conducted, and they did do some HIV studies in those cities as well during the eighties. Everybody always asks, "Well, what do you mean by an HIV vaccine preparedness study?" Actually, it was very similar to why we did the hepatitis B vaccine preparedness study: we needed to get some information on prevalence and incidence of HIV in the community, updated, well-documented information on HIV-seronegative men and what the risk factors for HIV transmission were. Then we could develop a good screen for people that would be eligible for a vaccine trial and obtain a population of men who potentially could be enrolled in a vaccine trial if a vaccine product came along that looked promising. So the idea was to set up an infrastructure now, so that if a vaccine comes down the pike, you've got an infrastructure in place to go forward. So that was part of it.

Another factor, which is very different from the hepatitis B vaccine trial, was the complications around conducting HIV vaccine trials. The concerns people have about vaccine-induced seropositivity, was a new concern and the stigmatization around that term, HIV-positive, whether due to infection or vaccine.

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Then people were concerned about the vaccine itself. Would it cause HIV infection? Or if it didn't cause HIV infection, would it cause immune irregularities? There were issues of enhancement, that is the concern that if you get vaccinated and you have a breakthrough infection, are you then susceptible to progressing more rapidly to AIDS than if you hadn't been vaccinated at all? There are a lot of serious scientific questions.

Additionally, we don't know the correlates of immunity. We're not sure exactly what a vaccine is supposed to do, immunologically, to provide protection. With hepatitis B, you could always look at the immune profile of someone who cleared hepatitis B infection and say, "Okay, this is what we want the vaccine to do. We want them to produce these markers in their blood. Then we'll know we've got a vaccine that will be efficacious." We don't have that with HIV, because we don't have a cured individual. We have healthy longterm positives, and we do do immune profiles of those guys, because that's part of solving the mystery for creating an effective vaccine and therapies for that matter. So I think this is a wonderful area to be working in now, because it's an area of hope.

Just this week with all these news stories coming out about the International Conference on AIDS, they talk about advances in therapies and how things have moved along with education and that even condom usage is up in some of the developed world. But it always ends, "Ultimately, we're going to need a vaccine." They're talking about technology now where you might even be able to put a vaccine in a banana.

And that's the other thing: even with a vaccine, which is a lot cheaper than therapies, how are developing countries going to afford them? The distribution of the vaccine is a problem, even if you could reduce the cost.

This is why we need to conduct this HIV vaccine preparedness study. We still find people getting infected, and we're trying to nail down, with education and all the information that's out there, why people are still putting themselves at risk. It's very complicated. It's self-esteem and drug use and a variety of things. For all these reasons we need a vaccine and continued HIV prevention education.

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Current Collaborative AIDS Studies

I was wondering, Paul, about the tie-in with the longterm survivors of HIV infection and Jay Levy's virological work on the same subject.

Jay Levy is one of many of our research collaborators. These collaborations have developed over the last five or six years, as it became more and more apparent that we had these unusual individuals that weren't progressing. Jay in particular is very interested in the CD8 cells, the suppressor cells, and the fact that healthy longterm positives tend to maintain very high levels of CD8's. We send blood samples to him on these select participants. We also refer individuals to UCSF directly and they are involved in studies there independent of what we're doing.

We're also doing collaborations with the National Institutes of Health. We've looked at genetic factors that may play a role in non-progression. We're also sending blood specimens to Massachusetts General Hospital. Those researchers are looking at white blood cells known as cytotoxic lymphocytes, which may be controlling viral replication. We have a collaboration with the Gladstone Institute for Virological Research at San Francisco General Hospital. Mark Feinberg is looking at the virus itself as a factor in explaining non-progression.

We have probably about twelve collaborators at this point. A big staff responsibility here is the coordination of blood specimen shipment around the country to these various research institutions. It's a major undertaking, believe me, in dealing with FedEx and the hazardous material regulations. We're lucky that we have prominent researchers like Jay Levy and Mark Fineburg in our own community.

Well, thank you.

Transcribed by Shannon Page

Final Typed by Grace Robinson