My first AIDS study at NIH was titled “Interferon – α in Patients with Asymptomatic Human Immunodeficiency Virus Infection – A Randomized, Placebo-Controlled Trial”. The study was one of the last placebo-controlled trials at NIH. There were ethical concerns, share by many, about some people getting placebos when others in the same study might be getting drugs that saved their lives. Most of the following studies measured one drug against another, or the same drug at different doses. The people on this study given placebo were given first priority and choice of what study to be involved in next.
With this study you knew within hours of your first dosing if you had the drug. All of the people on the interferon were started at a dosing of 35 million units. Every effort was made to keep these people on the study and the doses for most of us were lowered to a level that kept us from becoming anemic. I ended up about 23 million units daily by the end of the study. I did complete the entire 12 weeks.
The average dosing for patients is 5 million units on a daily basis. That is considered a high dose. Suffice it to say, we were given very high doses. The drug carries the following warning; “Alpha interferon’s, including INFERGEN (interferon alfacon-1) , cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping interferon alfacon-1 therapy.
The usual side effects, in 80% of the users, are mostly similar to severe flu symptoms. Other symptoms I had included severe depression, aggressive behavior, numbness or weakness, headache, confusion, and problems with vision, speech, and balance. These were not the worse part of the study. The constant blood draws were not the worse part of the study. For me personally, the worse part of the study was that were sharing a floor and study nurses with a childhood leukemia study.
Every week I sat in that sterile waiting room, Lime green walls, tattered chairs and sofas with mothers and fathers desperate to find anything to save their child. Some actually talked, opened up and when the children were sleeping, broke down and cried. Many times the children seemed stronger than the parents. The children all believed the adults. They thought they were going to get better. Many of the mothers knew that was unlikely that the child would last the month. Sometimes not even the week..
My first week there, after an hour in Phlebotomy, where I passed out from all the blood, I went to our waiting area in a foul mood and met Matt. Matt was 7 from Wisconsin. His mother was there and told me most of their story. His father could not afford to be there because of work. The family did not have much money but NIH and the producer of the drug being tested paid the expenses for the mother and Matt. This was his third trial. It would probably be the last chance. He sat there quietly in his hospital gown sucking a lollypop.
The following week I bought Matt in one of my Pooh Bears from my collection and his eyes lit up bright. For the next eight weeks it never left his side. Whenever I saw him, he would have pooh in one hand and his IV-pole in the other. When I went in for week 10, neither Matt, nor his mother, were to be found. His room was empty. My case study nurse told me that Matt had not made it. His mom asked to keep the bear. I had told Matt that I wanted it back when he got better. The nurse assured mom that I would want her to have it.
It was times like these I realized how lucky I really was. I had a chance.