Human guinea pig or journalist?

by Jordan Green

On one of those late July days marked by stupefying heat, I pull my car into the freshly laid asphalt parking lot in the pines off Interstate 40 in the frontier of corporate campuses that separates Chapel Hill from Durham. I rush into the modern glass structure, 15 minutes behind schedule, sign in at the front desk, and ride the escalator to the second floor where a group of nurses wearing flowery smocks cart away urine samples and draw blood.

The pretty, blond-haired doctor taps my knees with the mallet, digs her hands into the corners of my belly to feel my breathing and feels my groin. She asks me a series of questions about my physical and mental health history, and makes a mark on my form when I tell her how I had some chest pain after failing to treat my spring allergies.

‘“I don’t see that as a problem, but I just have to put that down on the record,’” she says. ‘“You seem like a relatively healthy thirty year old.’”

The doctor asks me if I understand the ‘“risks and discomforts’” of the drug. I do. Two nurses have already informed me, and I’ve had to read and sign a seven-page consent form, initialing each page. Yup. Allergic reactions, headache, nausea, vomiting, itching and muscle aches are all potential side effects of the drug, a generic version of Genpharm’s Methimazole. In one confinement period I’ll receive the brand-name drug; in the other confinement period I’ll receive the generic substitute. After each dosing, I’ll surrender a sample of my blood so my metabolism can be monitored.

She asks me what I know about the medication, and I tell her I don’t know anything. I’ve read that the purpose of the drug is to treat hyperthyroidism.

‘“What exactly does the thyroid do?’” I ask her.

It’s the body’s thermostat, she cheerfully explains. It regulates the body’s temperature. People with an overactive thyroid become skinny and their eyeballs look like they’re about to bug out; people with under-active thyroids become lethargic and overweight.

The study calls for healthy adult males and females who don’t smoke cigarettes. I’ll have to abstain from alcohol and caffeine 12 hours before I check in for the study and then spend two nights in confinement. I figure, what’s wrong with taking a break from my normal bad habits, chemically altering my body for the study period, letting it wear off and then going back to my normal routine? Yet, I have to admit that there is something strange about ingesting a substance my body neither needs nor desires. There’s no way around it, I’m signing up to be a human guinea pig.

The truth is that I’m in it for the money. It pays a thousand dollars for two confinement periods, each followed by one blood draw. After that, the other reason is to fulfill the journalistic mission of getting firsthand information about North Carolina’s burgeoning pharmaceutical research industry.

I got interested in this subject because several of my friends participate in these studies. One is a Trinidadian immigrant in Durham who is studying to be a pharmacist. His visa lapsed during a period of personal transition and he found himself out of status with the Immigration and Naturalization Service and therefore unable to work. Another is a punk rock drummer in Greensboro who is currently on tour, whose musical endeavors don’t quite keep her financially afloat. In both cases, drug studies provide a welcome infusion of cash.

There are some drawbacks, for sure.

When I was staying at her house last summer, the drummer came home from one of the studies and immediately disappeared into her room complaining of a headache. My Trinidadian friend signed up for a study that paid more than two thousand dollars and every one of the participants became violently ill halfway through. They all received their full pay and went home early. After all, the study provided conclusive evidence that the drug shouldn’t be on the market.

Drug studies are big business in North Carolina. Since I expressed interest in participating, I’ve probably received a half dozen e-mails from the company, AAI Clinic, informing me of new studies. One company, Pharmaceutical Product Development, received an incentives package worth $6.2 million from the city of Wilmington and New Hanover County, including money for landscaping, parking and sidewalks, to secure the company’s commitment to build its new world headquarters there.

I’ve been curious about what medical ethicists have to say about the practice of paying consenting adults to take drugs for research purposes. The first person I ran across on the internet, who is probably more accurately described as an activist, did not have kind things to say about the drug companies.

‘“Clinical trials are nothing but business,’” says Vera Hassner Sharav, president of the Alliance for Human Research Protection in New York. ‘“The purpose is to obtain data that the manufacturer can submit to the [Food and Drug Administration] so they can get the drug approved. They are now admitting that really you don’t know the risks until it’s out there being marketed. They cherry pick the most healthy individuals for the studies and they leave out those who are most likely to use the drug when it’s on the market.’”

She points to two people who have died while participating in studies in the past five years. One, 24-year-old Ellen Roche died of lung failure after inhaling an experimental compound as part of an asthma study conducted by Johns Hopkins University in 2001, according to a The New York Times story. Another story, reported in the Indianapolis Star, tells of how 19-year-old Traci Johnson hanged herself while she was participating in a clinical trial for a new antidepressant manufactured by Eli Lilly & Co. The drug, Cymbalta, is now on the market.

There are now professors who specialize in biomedical ethics at dozens of universities in North America. I thought perhaps they might shed some light on the practice of medical research using human subjects. After about five hours of phone calls that included pleas of being too busy, disconnected lines, requests for a set of questions sent by e-mail and offers for phone interviews days after my deadline, I conclude they aren’t going to be much help.

The best I can find is a paper on the internet entitled ‘“Biomedical Ethics’” by Paul M. Cox, vice president of the International School of Theology in San Bernardino, Calif.

Experimentation on human subjects without their informed consent is definitely out, he says. The defining agreement on that is the ‘“Nuremberg Code,’” adopted in the aftermath of the atrocities carried out by Nazi Germany.

Other than that, Cox mostly poses ethical dilemmas, but refrains from passing judgment. He writes: ‘“The three troubling groups used in research are the following: children (can they really give consent and does parental consent apply?), prisoners (does their situation make it so that their consent cannot be sufficiently free and informed?), and paid research subjects (does payment for research take advantage of the economically deprived?).’”

In the end, I decide to stay clear of the Methimaziole. For one thing, I’m not too thrilled about the blood draw during my evaluation; the nurse bruises my arm, apparently by double piercing my vein. At the time of the decision I am also getting freaked out about completing some other assignments, and the idea of being strung out in a research lab ‘— and feeling itchy ‘— suddenly doesn’t seem so attractive.

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