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My Body on the Line - Take Me, for Example

By Meredith F. Small

Special to The Washington Post
Tuesday, April 19, 2005; Page HE01

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.

I would love medical research to happen faster. But participating in a trial decreased my frustration with the pace because I saw firsthand just what it takes -- all the visits, all the exams, all the treatment and the mountains of data to be analyzed. By doing it, not just reading about it, I gained respect for the process.

Even so, lying on that table I still often asked myself: Is this the only way to make progress in dealing with IC?

Until 50 years ago, there was no gold standard for judging any new treatments or medications. Physicians relied instead on their powers of observation and memory: If it was common to give this or that treatment, they used it, and then watched to see if it worked. The standard of care was based on history, not testing.

But in 1946 researchers in England tested the effect of the new antibiotic streptomycin on tuberculosis. All the patients in the study received the standard of care for that time -- bed rest -- but half were also given the antibiotic. Equally important, no one working on the study knew which patients were on the drugs; the staff and the patients were doubly "blind" to the treatment and therefore could not project an outcome in either direction.

The results were striking. Fifty-one percent of those on streptomycin improved, compared with only 8 percent of those on bed rest alone.

The double-blind clinical trial rapidly became the gold standard for medical science and a standard for government approval for medications.

Beyond the science, I quickly became a big fan of clinical trials. The process, I learned firsthand, is not as dispassionate as the rules imply.

Royal Treatment
I really didn't mind the afternoons in Rochester. In fact, I looked forward to them. For once, people wanted me to talk endlessly about my condition. Instead of hiding it or being embarrassed, I could complain as much as I wanted.

For a year and a half, a team of physicians, nurses and administrators monitored my health in person, by telephone and by e-mail. I didn't take a pill or feel an ache without this team's knowing what was going on with my body. For the only time in my life, I received the health care of presidents and kings.

For example, when I tried a medication for the acute pain that comes with this condition, it gave me occasional heart palpitations. I was quickly sent for an EKG and consultation with my primary care physician. And on the next visit to Rochester, my team was all over me. Suddenly I had Dr. Mayer, Nurse Rust and the program administrator waiting in turn to take my pulse. They could have left this up to my regular doctor, but they didn't.

I also learned that I was not just a subject in one isolated clinical trial, but contributing to a wider understanding of IC. All the notes and the urine samples would also serve to fill in gaps about the natural history of IC, which in turn will point the researchers toward the next step.

"Any type of medical research is a learning experience," explained my urologist, Robert Mayer. "During clinical trials, we gather all sorts of information that is fundamental to understanding the condition, as well as the treatment."

Still, I worried that the study might end up being useless to the IC community if the results weren't positive or if the treatment only worked for a few people. I answered my concerns this way:

As health consumers, we are left with three options. You could let your doctor sort through the studies and decide what is best for you. Or you could bone up on your condition, read about the possible treatments and then weigh the evidence yourself.

Or you could jump in there and be involved.

In my case, I am not waiting for any body of evidence, but trying to produce it. This kind of participation takes not just dedication, but a certain kind of enthusiasm, even in the face of negative results.

Moving On
A recent letter just informed me that I had been given the placebo in Phase One of the study. In any case, whatever went in there hadn't reduced my symptoms a bit. Even after I received the real substance in Phase Two, there was no improvement in my bladder. This month, the study results were published in the Journal of Urology. There, I learned the treatment appeared to help 21 percent of the subjects, compared to 12 percent in the placebo group who saw improvement. So BCG may offer relief to some patients with interstitial cystitis, if not to me. Researchers, though, continue their search for a more effective treatment.

Meanwhile, I am in contact with the research group in Rochester. I miss them. Maybe all that enthusiastic participation did nothing for my particular bladder, but it did a lot for me. I was treated well, listened to, and I felt like part of the process. It gave me hope.

For that reason alone, I'd offer up my body to science any day. . . .

Meredith Small is an anthropology professor at Cornell University. She was trained as a primate behaviorist and spent many years observing various species of macaques in captivity and in the wild. Her primatology focused on female mating behavior, alloparental care, and biological and physiological measure of reproductive success. Today, Dr. Small is interesting in the intersection of biology and culture and the evolution of human behavior. For the past few years she has focused on how biology and culture influence parenting styles. Although Dr. Small has published widely in academic journals, she currently works most often with the popular media. She is the author of four trade books, and she is a regular contributor for Discover, Natural History Magazine, Scientific American, and New Scientist, among others. Her articles cover a wide range of topic from chimpanzee hunting to family structure among the Bari of Venezuela. Small is also a commentator for National Public Radio's "All Things Considered."

Reprinted with permission of the author