“It worked last time. It made a huge difference.” The test drug, a synthetic hormone, has been available since the ’70s and is used to treat endometriosis, a condition in which tissue similar to the lining of the uterus grows outside the womb, causing intense pain.
“I was going to the emergency room once a month for pain meds. There was nothing I could do. I couldn’t walk. I couldn’t eat. My husband would have to take care of me. I would have to take time off from work.”
She came across the first study when she was researching her surgical options. In that study, the hormone was delivered via a vaginal ring. The idea behind both studies is that if the drug is delivered locally, instead of in its current pill form, the side effects would be less severe. These side effects include hair loss or growth in undesirable areas, weight gain, voice changes, loss of libido, and a host of others.
For the four months of the first study, Lisa had little or no pain. She still feels better than she used to. This time, the company wants to test the drug in a vaginal suppository. The potential downside of participating in the trial? She might get the placebo while other study participants get the real drug. But Lisa is philosophical about that.
“If you have a good local delivery system, this drug could make a huge difference to a lot of women. If I can be part of it, I want to be. I will be as happy about this product getting to market as any of the products I work on at my company.”
Questions More Invasive Than Needles
I arrive for my own assessment with the kind of rejection anxiety usually triggered by job interviews. But I relax when Kosheleva meets me on the walkway outside the maze of UCSD research offices off Villa La Jolla Drive. An armload of papers jiggles as she shakes my hand, and a few tendrils of brown hair slip out of her ponytail.
On the way to her office, Kosheleva tells me I am patient 39 of the 40 she must recruit. I represent the last lap before the finish line. But before either of us can get too excited, there are some hurdles to clear.
She leads me through a door into a cubbyhole crowded with desks, computers, and chairs full of slumping students staring intently at monitors. Through another door, we enter a room the size of a closet, and the pile of papers and folders in Kosheleva’s hands are suddenly stacked on the table in front of me, an imposing four inches. Hurdle number one.
On the plus side, two vouchers worth a total of $75 lie next to the stack, and these will be mine as soon as I fill out the papers and submit to the physical scheduled for later on. Even if I am found unsuitable for the study, I get to keep this money.
Later, I learn that one way would-be guinea pigs scam the system is to say whatever it takes in the prescreen so they can make the assessment. They get a free physical and the first installment of their money, knowing from the outset that they will not make the cut.
But I am still an innocent, so I smile at the vouchers and get ready to dig into the pile of questionnaires in front of me. My answers, Kosheleva explains, will assess my mental health. I later learn that Lunesta is not recommended for use in people with depression or dependencies on drugs or alcohol.
“Look at these first, and let me know if you have any questions,” Kosheleva instructs, tapping the top of the pile. “These” turn out to be informed consent documents. My signature means I know what I am getting into. This is when I realize that there are actually two studies, the main one, “How sleeping pills affect pain in the brain,” and something called “Genetic polymorphism and human behavior,” which involves an extra blood draw and one questionnaire.
The first document gets my attention with the word “pain.” This study will involve pain applied via a “small ceramic plate, about the size of a credit card,” as part of the experiment. It won’t be enough to damage my skin. I am looking for a little more reassurance than this, and I find it when I read the part that says I can stop the experiment at any time. A final warning tells me I may feel some restlessness or fatigue when filling out questionnaires.
I glance at the stack in front of me as it dawns on me just how long it might take to get through it. But I am not going to back out now. I sign this form and then, barely reading, the other one too. What is one more vial of blood, one more questionnaire?
Two hours later, I’ve given blood, passed a Breathalyzer, and submitted to an EKG and a full physical conducted by Dr. Paulus, an intense but considerate man who seems to wear his long title casually. He is unhurried and patient. I like this man, and I like Kosheleva.
However, I have only reduced the stack of questionnaires by half. It isn’t just the size of the stack, it is the questions themselves, all multiple choice or rating scales and all designed to make a happy, well-adjusted person reassess every aspect of her life and personality. “Do you enjoy social situations?” “Do people find you cold?” “Are you confident?” “Were you afraid of the dark as a child?” “Did you have a favorite blanket or stuffed toy?” Other questions probe for emotional, physical, or sexual abuse.
To top it all off, Kosheleva asks many of the same questions in person. She does this with the help of a student. He reads along while Kosheleva asks me about the events that most transformed my life and what I felt then.