NIAID Director Anthony Fauci, MD is globally renowned for immunology research.
Editor’s Note: Anthony “Tony” Fauci, MD, has been the director of the National Institute of Allergy and Infectious Diseases (NIAID), since 1984, but to anyone who lived through it, his name will likely be forever linked to HIV and the progression to the early AIDS epidemic. Globally renowned for his research in immunology, Fauci also helped change the conversation of AIDS research at a time when AIDS patients and activists felt shunned by medical officials. Fauci was able to get the US Food and Drug Administration (FDA) to speed up their approval process to allow some drugs to be readily available. In recent years, Fauci has personally treated a patient afflicted with the Ebola virus. Fauci believes emerging infectious diseases will stay re-emerging, and plans to remain at the forefront of immunodeficiency research.Fauci was a keynote speaker at the American Academy of Allergy, Asthma, and Immunology (AAAAI 2017) conference in Atlanta, Georgia, and spoke to MD Magazine in a video interview.
Before there was antiretroviral therapy (ART) you helped change the way the FDA pipeline worked. Tell us about the “parallel track”.
The parallel track was a concept that originated with the activists groups like ACT Up and Project Inform, a concept that I ultimately embraced. I felt that what they were saying about the needs of the infected community for access to drugs that were experimental made sense. You couldn’t get on some of these trials. They wanted to take their chances. The proposal was to have the rigidity of the clinical trial, but, in parallel, allow the drug to be available with informed consent to a larger group of people to test for safety. That opened up the availability. As it turned out, this idea was much pushed back against by the FDA. But I was pushed [by activists] and endorsed it. I got up at a large Town Hall meeting in San Francisco and said, “I now break from the government approach”. It caused a lot of ruffled feathers, but the government ultimately embraced it.
Is there room for more FDA change towards clinical trials?
The parallel track transformed the way we do things.
Things have changed greatly. Now we don’t have that rigidity in clinical trials, community activists groups are involved and monitor them, and the FDA is a much-changed organization. It was a pivotal event in the 1980s
Do you recall when a man with HIV asked you why he had to choose between dying and going blind?
Yes, it was very moving. Marty Delaney of Project Inform was concerned about the parallel track. Then we only had azidothymidine (AZT), and individuals were on it, but it was a single drug not a combination. Many did well then deteriorated, and at the time it was the only proven antiretroviral. But there could be a complication; cytomegalovirus can attack many organs and also attack the eye. That can cause loss of vision. At the time, ganciclovir was being tested in a clinical trial; problem was that because of the FDA’s rigidity, exclusion criteria said you could not be in a trial if you were on other drugs that might interact.
It seems ridiculous now, but that’s how it was. In San Francisco, before the parallel trial event, Marty DeLaney brought me to a friend in the Castro district. In his apartment, a young man with HIV was losing his vision. He was on AZT, but he wanted to go on ganciclovir, and I’ll never forget the words he said: “Dr. Fauci, what the hell is matter with you — what kind of choice have you given me? I’m going blind; you are telling me I can die or go blind.” I said that’s it; we’ve got to be more flexible in what we do.
If PrEP had been available during the epidemic would it have been more widely accepted than it is now?
That’s a scenario that couldn’t have happened because there were no retrovirals then. Of course if there had been it would have completely transformed everything.
What are the obstacles to widespread use of PrEP?
One obstacle is that people are not aware of how effective it is. The CDC found there are 1.2 million people at high risk who could benefit from PrEP; however, only about 2/3 of the community care, and local physicians have never even heard of PrEP. We’ve got to do a much better job; it’s a highly effective way to prevent it.
Is it only awareness that’s the problem?
Two things: more awareness and more adherence. If you don’t adhere it doesn’t work. The original studies of the drug showed it had only a 47% efficacy. Not everyone who said he was taking it was actually taking it. When we looked at blood levels of the drug, the people who’s had blood levels showing they were taking Truvada — that group turned out to have over 90% efficacy.
Will we ever get rid of HIV? There are predictions like that for hepatitis C, what about HIV?
It depends on what we mean by getting rid of it. Hepatitis C is different. There are drugs that can actually cure it. The goal now is to treat everyone so that becomes a health care delivery challenge.
We don’t have a cure for HIV, but do have something important, which is to put everyone on ART treatment and get his or her viral loads down so low they won’t transmit it. You may not cure it, but can suppress it enough to prevent infection. Of course, not everyone is on ART or even aware that he is infected.
Globally there are 18 million people of 36 million infected who are on ART, but there are 18 million who are not. We need a vaccine, but it’s problematic. HIV is very elusive; it integrates itself into the genome; it hides, it changes, it mutates, and it has glycosylation that prevents antibodies from getting to the binding site that neutralizes the virus.
I would say in 2017 we are much closer to a vaccine, but we have a lot of challenges.
There’s a generation that got most of its information about HIV from films, has that had an effect?
The more awareness, the better, it doesn’t have to be as dramatic as a movie like Dallas Buyers Club. Popular movies don’t have to be dramatic. There’s radio, there’s television, and there're newspaper articles like personal articles about people with HIV who’ve come a long way.
What’s the role of public health officials?
There’s the CDC, which does surveillance and tracks new trends of microbes in the US and globally.
There are public health measures and the basic research we do at the NIH.
The ultimate goal is to take countermeasures like rapid diagnostics therapeutics and develop a vaccine, which is what we are doing right now with Zika. As soon as we were aware it was a problem with infection in pregnant women and with congenital defects, we started immediately to work aggressively on a vaccine and we are ready to go into a phase 2 trial.
We expect resurgence in Brazil and Puerto Rico. Those are the things to do to counter emerging infections.
How did you transition from research on RA to HIV?
I tended, in my research prior to HIV, to get involved in immune mediated diseases and diseases like lupus and RA — the underlying theme was the dysregulation of the immune system.
That got me very interested in immune response. When HIV came along in 1981, I immediately shifted to look at this strange disease, which likely was an infection even though we didn’t know the pathogen. Only in 1983-84 did we learn it was an infection. It looked like an infection, smelled like an infection, and turned to actually be an infection. The manifestation was a markedly suppressed immune system. For me it was the bridge between immune system dysfunction of hyperactivity with immune deficiency of HIV.