San Diego Reader

Human Lab Rats

I am stranded inside an MRI machine. My arms are pinned to my sides; my head is immobilized; my nose lies seven inches from the ceiling of the high-tech shaft. I am trying not to think about what will happen if I start to hyperventilate.

“Betsy?” The light Russian accent of Elena Kosheleva pipes through my earphones. “We’re having a little problem with the computer. Can you bear with us a few minutes?”

She could get me out, but she doesn’t want to. The brain-imaging machine costs her boss $1500 per hour, and she has just a few more tests to run on me, research volunteer number 39, in a study called “How do sleeping pills affect pain in the brain?” The breezy confidence of her tone is undermined by a plea. She only recently graduated from UCSD, and this is her first full-time job.

“Sure,” I say.

But I am not sure. I cannot turn my head. The walls are getting way too close. My only diversion is the screen of the offending laptop, visible through angled mirrors. Screen savers flash onto the screen each time Kosheleva reboots: island sunsets, Alpine skiers, then “fatal error.” Palm trees. Skiers. Crash. Again and again. Sweat trickles from behind my ear down the back of my neck. I try deep breathing, but there does not seem to be enough room for my lungs to expand fully.

* * *

My journey to the lab began with the want ads for medical research volunteers in the Reader. Here, you learn that the same condition that makes you suffer also makes you valuable: Worry too much? Are you…tired of dealing with dry eyes, allergic to milk, afraid to show your feet, self-conscious, constipated, shy? Are you smoking too much pot, a heavy drinker who wants to stop, a heavy drinker who does not want to stop? In some cases, you don’t even have to have a disease. All they want is your 18-to-45-year-old healthy body to test the safety of a drug or other therapy that, until now, has been tested only in animals.

If national Harris Poll figures are any indication, 10 percent of the people aged 18 to 65, or about 90,000 San Diegans, have participated in or will participate in a clinical trial, experiments that test new treatments for a disease. That means 90 percent haven’t. They either do not qualify or are happy to let someone else do it.

So who are these people who make up the 10 percent? How desperate do they have to be? How far are they willing to go for the chance of treatment or compensation or the chance to help in the “development of new medical advancement for those who need it most,” as one advertisement read? And can we trust them?

These questions first occurred to me during my years in pharmaceutical marketing. In those days, one of my jobs was to turn study findings into value propositions. The job was made easier because the data came in the form of comforting, faceless numbers, as in “less than 0.2 percent of people” taking a particular drug experienced arrhythmia, dry mouth, or death, or “85 percent of people experienced significant improvement in their symptoms.”

It wasn’t until I moved to San Diego and was confronted by the weekly catalog of clinical research ads that it dawned on me how close to home these people could be. Curiosity took hold. What would it take to be one of them?

Turns out insomnia and back pain would do just fine. I had both in the wake of an accident a year ago. My doctor did what he could, but I still hurt and I was still tired.

The ads began to speak directly to me. “Not sleeping?” “Lower back pain?” Maybe there was something new I could try. I combed the Reader, then craigslist, and then clinical trial websites for studies that addressed at least one of my problems without much risk and without a lot of inconvenience. Before long, I was auditioning for my first job as a human guinea pig.

Human guinea pigs are essential to the livelihoods of thousands of people right here in San Diego. As of June, 2454 clinical trials were preparing to recruit subjects, were in the process of recruiting, or had just closed in San Diego, according to a count on clinicaltrials.gov, a clearinghouse for trials conducted nationally. This represents about 25 percent of trials in California and virtually equals the number listed for the entire state of Connecticut. It does not even reflect all the opportunities in San Diego because not all sponsors list studies with clinicaltrials.gov.

All the players are here: more than 500 biotech companies (many of them partners with the large pharmaceutical firms that fund most drug studies), doctors, hospitals, academic institutions, nurses, recruiters, study coordinators, middlemen. All, however, are ultimately dependent on those willing to volunteer their bodies, minds, and time.

* * *

My role in the San Diego research economy is not top of mind when Kosheleva interviews me during the telephone “prescreen.” I just want her to pick me. I’d already been rejected from my first study choice. It had seemed perfect: a treatment for insomnia that did not involve drugs or anything invasive, and I could bring home up to $350 for my trouble. All I had to do was meet the criteria, one of which was to fall between the ages of 18 and 50. I lied. What difference would a few months make? And it was all fine, we had made our first appointment, and then the recruiter said, “Just bring an ID with you.” I later learned that not all recruiters card volunteers. But I confessed, and we canceled the appointment.

So I tell the truth to Kosheleva. She asks me about my sleeping patterns, whether I am using antidepressants or anti-anxiety medications, how much alcohol I consume, and whether or not I can handle the confinement of an MRI machine or, more specifically, a functional MRI machine, one that can take moving images of the brain, videos, while the brain is involved in specific functions.

The idea behind this study is that pain and sleep problems often go hand in hand. Addressing one problem may help the other. But it will also help UCSD researchers in a quest to understand how the machine itself can be used as a tool to match patients with the right treatment for anxiety, depression or, in this case, pain.

The first brain scan will shoot a video of the blood flow to the amygdala and the insula, parts of my brain that are involved in processing emotions, anxiety, and pain perception. The second scan will take images of the same areas after one week of taking an insomnia drug, eszopiclone, better known as Lunesta.

I might receive a placebo, a sugar pill, as some call imposter drugs used for comparison in clinical research. But I have an equal chance of receiving Lunesta, an FDA-approved drug, to see if it helps me sleep. Either way, the study will be relatively quick and easy: only three visits of about three hours each, a couple of brain scans, and a week of taking pills.

The brain scans do not loom large as a problem. Over the past year I have had two MRIs. They weren’t fun, but they were over quickly. The pay, $275, is not bad — about $30 per hour if I get through all three sessions. I will also receive a picture of my brain.

But I am not yet in. The final judge will be the lead investigator, Dr. Martin Paulus, professor of psychiatry, Department of Psychiatry and the Laboratory of Biological Dynamics and Theoretical Medicine at UCSD. Kosheleva tells me she will email me shortly to let me know if I have made it to the next round, the assessment.

* * *

Google “human guinea pig,” and you’ll find plenty of reasons to have second thoughts about this line of work. Over the past few years, a steady stream of articles and columns has raised old and new ethical questions triggered by the increasing concentration of trials in the hands of industry and has assailed the lack of independent oversight.

The primary focus remains on the pharmaceutical industry, which, in 2006, spent a reported $55 million on research and development. About two-thirds of research-and-development funds are spent on clinical trials, making them the most expensive element of the R&D process, particularly when you consider that only one in five drugs that goes into these trials is actually approved by the FDA.

As recently as the early 1990s, academic institutions conducted over 80 percent of the clinical research for new pharmaceutical products. Today, more than 70 percent of trials are conducted in company-owned clinics or subcontracted to clinical research organizations, physicians, or hospitals. Academic institutions typically use their own internal review boards to oversee the rights and safety of human volunteers. For studies conducted in the private sector, this responsibility is assumed by companies called central internal review boards. These are paid directly or indirectly by the pharmaceutical companies sponsoring the research.

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