Human Guinea Pig
Sat., May 3, 06:44 AM
When you start talking about new medical procedures or chemicals, sooner or later you have to try them out on real people. Test tubes (in vitro testing) or animals (with apologies to PETA) cannot guarantee that the methods will work safely on human beings. But have you ever wondered why anyone would volunteer to be a test subject?
Many years ago, when I worked at Sloan-Kettering Cancer Center, the public relations department often received inquiries regarding participation in whatever tests the Center was conducting. Occasionally we had actually solicited these calls – seeking physicians who had patients that were appropriate to the treatment. Unfortunately, most of the calls were from people who were not suitable subjects, people who had been told they were beyond treatment; they were grasping at straws.
From the time I began studying science, I had considered the possibility of volunteering for some kind of test, but the right test did not appear until I was nearly fifty. Yale School of Medicine advertises all the time, but this was the first ad that talked to me; actually, it was yelling:
So I called and asked. I had several motives. Test subjects would have medical examinations and care for the duration of the tests. I had undergone major surgery several months earlier, and being accepted for the tests would indicate that I was all right again. Depending upon which course of medications you were assigned, there might be protection against uterine cancer. (That wasn’t one of my worries.) There was a small remuneration offered, but it wasn’t important in the greater scheme of things.
They were looking for women past menopause who had not taken hormones, either as birth control or as a treatment for the more unpleasant symptoms of the change. It turned out such women were hard to find; I was only the second woman who was accepted. What they were trying to prove was that hormone replacement therapy would help control cholesterol levels.
Subjects agreed to:
- report regularly for examination and blood drawing;
- undergo three uterus biopsies – one at the beginning of the test, one at six months, and one at the end of the study;
- take the daily pills that were distributed each month. These would be either estrogen alone, or estrogen plus another hormone (blind study);
- remain in the study for one year. (You could, of course, decide to discontinue, but you would forfeit the payment).
I actually did stay with it for a year, despite month-long bleeding and feeling hungry all the time. (I thought I was through with that!) One of the doctors asked me, just incidentally, whether I had any symptom relief from taking the medication. Of course, I had not; women with hot flashes and such were already taking hormones and not eligible for the study in the first place. The first biopsy sent me into mild shock, but the second one – with the aid of the hormones – was not bad.
At the end of the year, I was told that I needed to take corrective medication to undo the heavy bleeding and whatever else the estrogen had done to me. They would perform the final biopsy after that. Once again, the biopsy was unpleasant. And then came the kicker. The nurse in charge of the project phoned to say that the lab had decided it “didn’t get enough cells for a positive diagnosis” and would I consent to a D and C. I refused; they had plenty of cells – from four different sites. The doctor called too, explaining that the D and C wouldn’t be that bad, yada yada, and why didn’t I want it. I didn’t need a D and C, and I knew that my mother had experienced long-term difficulties after hers. I certainly hope I’m smart enough to figure out priorities here; I wasn’t going to go through an outpatient procedure including twilight sleep, just so they could cover their behinds! By refusing to undergo that final procedure (which was not specified in the original agreement), I did not receive the money that was supposed to cover my gas and parking. (Good thing I wasn’t counting on it!)
My opinion of Yale…well, it wasn’t too good before either. I did participate in a couple of shorter projects – no financial benefits involved – although I did receive a free bone density scan.
Several years later I had the opportunity to look at one of these tests from another viewpoint. I was temporary secretary for a Yale project trying to prove that hormone therapy would lessen the likelihood of new strokes in women who had already suffered either strokes or TIA’s (or ministrokes). This study was using Estrace®; the earlier one had used Premarin®. Who do you suppose supported these grants – someone other than the manufacturers? The patients were referred to the project by their physicians, and the physicians were solicited by the project; we read the hospitals’ patient lists for the names of doctors not already on our lists. The doctors were also paid a small honorarium for their referrals.
I became familiar with the initial screening process, as I overheard our registered nurses interviewing by telephone. Imagine that you are a woman who has just had some kind of ministroke; you’re scared, and this strange woman calls and starts asking you personal questions. Or suppose that it was your mother who had a stroke, and she’s unable to speak, so they call you. And they want to know when your mom last had a menstrual period. (That’s when I decided to produce my own medical history and keep it available to my family.) Oh, I hated that kind of project! And I had very little faith in its validity. Even though the department was very appreciative of my work, I was glad that their regular secretary was returning.
In case you’re interested, any literature that I have seen on the subject – either study – indicates that the hormone therapy was not effective.
I still volunteer for medical studies on occasion, though not at Yale. I’m a little more skeptical, but I realize that someone has to fund them. But the clinic where I’ve volunteered recently is much more candid with its prospects. (They tell you who is funding, for example.) In addition, the payment – $25 per visit – is paid within the month, not dangled like a carrot so that you’ll commit until the end. I underwent screenings twice and discovered I was “too healthy” for the project (the information is a bonus); nevertheless, I received payment for my time.
I think people really have to volunteer for these things. Not only do they have to work on humans eventually, but I have serious reservations about animal testing. There is a point beyond which we really don’t have to go. I just wish some other kinds of people were controlling the tests.
