This past June marked the 30th anniversary of the recognition of the first cases of a strange new syndrome that became know as HIV and AIDs. In the months that have followed much attention has been given to this landmark through symposiums, memorial services, ceremonies, blogs and numerous newspaper articles. Although considerable scientific advances have been made towards the diagnosis and treatment of this heart-wrenching disease, the anniversary brings back some powerful memories of an much earlier time.
A member of our West Coast IRB, a health educator, shared her experience from a retrospective AIDs activity at San Francisco General Hospital which led to conversation including the usual hand-raising: Who treated patients in 1981? Who remembers what the name of the disease was at first? And, who wasn’t even born yet? So here are three stories from members of the E&I West Coast IRB that illustrate, in their own words, exactly how small the world is and how very far we have come.
Story 1 – Erica Heath, CIP, Director of Regulatory Affairs, E&I
For many years, I have counted myself as being responsible for the first AIDS treatment protocol. What a claim!
I was secretary (Administrator by today’s terms) to the UCSF IRB, called the Committee on Human Research or CHR.. One day I got a call from Dr. Connie Wofsy, a physician at San Francisco General Hospital, who said she was treating a young male patient with pneumocystis carinii, a rare form of pneumonia. She knew of only one drug that might help. Pentamadine was investigational and was available only from CDC. Could she use it? On my own, I said yes.
There is an exemption from the IRB review requirement. It reads:
“§56.104 Exemptions from IRB requirements: (c) Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.”
Although such situations occurred rarely, each event was urgent so I had prepared a handout and short report form that could be sent through inter-office delivery (there was no e-mail and few faxes then).
I said yes (as if I had a clue what PCP was) and sent the hand-out. A week later Dr. Peter Jensen called from Fort Miley VA (they also used the CHR) with exactly the same story. So, different institution, I sent off the same paperwork. A little later I got a call from someone at the newly opened Long Hospital and then Moffitt Hospital (which was really one unit but could maybe be considered two hospitals). On the 7th or 8th call I finally picked up the phone and called Dr. Wofsy. My message was … You must write a protocol. Any kind of protocol. Some excuse for a protocol. Anything. And do it quickly please. She did.
Another IRB member was listening and laughing as she realized the connection from 30 years ago.
Story 2 – Judith, IRB member
In the early ’80′s, I was on the Epidemiology faculty of the Graduate School of Public Health in Berkeley. Two of my advisees asked me to come over to S.F. General Hospital to discuss some mysterious signs and symptoms among patients who were apparently healthy young men, but were dying rapidly from a cause or causes unknown. Caring for them was challenging, because while the cause appeared to be infectious, no one knew how virulent the infection was, or how it was transmitted. Those who were providing the care worried about “Catching It” but did not know what to do, other than to observe the usual precautions for treating those with infectious diseases.
We met with Dr. Connie Wofsy, the Infectious Diseases Attending Physician, who was the first to identify what was then a rare pneumonia, pneumocystis carinii (PCP), later defined as diagnostic for AIDS. We were soon developing the first study to gather more information from patients and providers about use of Pentamidine with pneumocystis carinii.
Dr. Paul Volberding, new to San Francisco, and young Dr. Donald Abrams soon joined in. Many SFGH staff members were heroically providing care regardless, unlike the situation in many hospitals as news of the “Plague” became widespread. Out of the SFGH team effort grew the famous San Francisco model of AIDS care that showed among other findings, that AIDS was not casually transmitted.
Story 3 – Fern, IRB member
I was working as a communicable disease specialist for a very early incarnation of the State Office of AIDS circa-1983-1985 and while assigned to the Bay Area Field Office in Berkeley, I was tasked with visiting all the hospitals in the Bay Area, meeting with the Infection control nurses to identify how they were going to identify, track and report their AIDS cases. Essentially we were setting up the active surveillance systems that would get cases reported.
No one wanted to report, it was like being a door-to-door salesman, I would come home each night and have a cocktail frustrated and defeated! My motivational counseling included how this was going to mean $$$ for PWAs (People with AIDS) and for your hospital ultimately.
The most memorable encounter was the day I visited a catholic Hospital in San Mateo Co. and while speaking with the Intensive Care Nurse who was also a nun, I was delicately informed that I was “wasting my time because they were NEVER going to have an AIDS case at their hospital – those types of patients would not be receiving care at this hospital”.
I want to thank these valuable members for their very relevant contributions to the research community, as well as to our board and for sharing their experiences related to this dark period in medical development.
As an aside, I would also like to thank Paul Volberding. In 1984 I left UCSF on maternity leave and had some spare time. I got a call from Paul. His coordinator, Debbie Hahn had left for industry and would I come in just to prepare his now numerous studies for submission to the IRB… the same one I had just left. Every IRB administrator should be required to submit an application to their IRB just to learn how hard it is to walk in the other guy’s shoes. Thank you Paul for that great education.