I am lying on an exam table at Strong Memorial Hospital in Rochester, N.Y. I stare at the ceiling and try to keep my legs apart while nurse practitioner Kay Rust threads a catheter through my urethra and instills a cool liquid into my bladder. This is not part of any usual exam, and I would rather be just about anyplace else on earth. But I lie here quietly because I volunteered for a National Institutes of Health (NIH) double-blind clinical trial, and even with that catheter sliding up my urethra, I am convinced this is the right place to be.
I have a condition called interstitial cystitis (IC), an inflammation of the bladder lining that results in a frequent and urgent need to urinate; sometimes it also results in pain. There is no known cure for this condition and no sure way to ease the symptoms. But researchers are conducting a variety of studies on treatments that show promise. My particular clinical trial is testing the efficacy of instilling a weakened cow tuberculosis bacteria, bacillus calmette guérin (BCG), directly into the bladder; BCG has been used successfully for 30 years to treat bladder cancer. In a pilot study, some IC patients experienced marked improvement.
So here am I, a biological anthropologist, helping researchers figure out whether this treatment might really work.
Across the country, volunteers like me are participating in more than 24,000 clinical trials funded by the NIH; thousands more trials are conducted and paid for by medical research facilities, drug companies and makers of medical devices. Those of us who have offered our bodies up to science understand that testing on human subjects is the only way that medicine can move forward. Lab work and animal tests can go only so far in trying to predict what works in homo sapiens; sooner or later humans have to take their own medicine and see if it works.
Clinical trials aren't just science, they are a social experiment. Who is willing to step up and be a subject so the rest of us can get effective and safe treatments? If not I, who should lie on that table? What about you?
Facing the Placebo Question
The process of a clinical trial is, by design, rigorous. First, researchers must find subjects. I was recruited during my first appointment with Robert Mayer, a urologist and specialist in IC at Strong Memorial. After we discussed the various options available -- I had already tried most of them -- Mayer brought up the BCG trial. As a scientist, I knew that a clinical trial aims to produce trustworthy results by removing as much human bias as possible. But was my faith in science strong enough to put my own body on the line?
I took home all the information about the trial, read what was involved and spent some time on the Internet looking up BCG. Then I sought the opinion of a physician friend. (He voted yes.) In the end, I decided to go for it. The risks were small, and -- who knows? -- it might just work.
I had also made a promise to myself and my family that I would try anything to make this condition better, and this trial was an "anything."
As in most trials, once subjects are recruited, they are randomly divided into two groups, treatment and placebo. In other words, I had a 50-50 chance of going through all the treatment only to discover I had received the placebo. In this trial, that possibility was not such an issue because, after the results of the placebo-controlled study were in, every subject in this trial was to be given the real thing. The researchers figured that the results of the pilot study were good enough, and BCG involved no real risk, so it was worth giving it to all of us at the end.
But that's not always standard procedure. Some studies have built-in stopping points where preliminary results are reviewed; if the treatment is clearly advantageous, the trial is halted and everyone is given the medication. In other trials -- for example, a cancer or HIV trial -- it can be harder for subjects to accept the chance of receiving a placebo as a way to move science forward. In such cases, participation requires having your eyes wide open.
Volunteers also need to be committed. For my trial, I gave up 14 afternoons to drive two hours each way to Rochester and back, and I spent many more hours monitoring and recording my reaction to the treatment.
I also had to keep logs of my medications, down to each aspirin or vitamin C tablet. At various times I even had to chart the number of times I went to the toilet and measure how much I peed. This might sound obsessive, but that diary is a baseline record of my toilet needs; I now know when things get better or worse.
Focusing on the log also gave some purpose to all those visits to the bathroom -- I wasn't just urinating, I was contributing to science.
A Call for Patience
Participation in a clinical trial also takes patience. Findings may not be apparent for months or years, which in the case of terminal illnesses, is often deathly slow. IC won't kill me, but I would certainly like some relief. Travel is torture: Waiting out an airline delay strapped in my seat is simply not possible; long car trips become even longer with hourly stops. The pain, when it comes, affects my relationship with my husband and daughter. Some days at work I just put my head down and cry.