Students often have spare time, a tendency to experiment with substances and no money in their bank accounts. Combined, these factors could make for a carefully budgeted night of Natural Light and Netflix at home. Or they could follow a significantly more lucrative and risky path.
Clinical trials, also known as ‘medical studies’ or ‘research studies,’ are what pharmaceutical companies in the U.S. and other countries use to test whether new drugs are safe and effective. The trials are generally conducted in four different stages and, during the first stage at least, healthy volunteers are recruited as test subjects. The volunteers — who can be anyone from students to prisoners as long as they meet the specific qualifications of the study — can earn thousands of dollars, depending on how long the trial lasts and what the drug is. But, also depending on the drug and the genetic makeup of the volunteer, the risks aren’t always worth the money.
“Some of [the trials] are definitely risky. There’s no doubt about that,” said Dr. Marvin Shepherd, a professor in the College of Pharmacy. “Sometimes you don’t have any choice if you’re going to do a trial. Phase 1 studies, where they just have 50 to 100 people involved in them, and they’re all healthy and everything — they’ll start them out with real low doses. You think you’d be pretty safe that way, but some people just react differently to the drug than the others. There’s always a risk.”
Premier Research and PPD are two contract research organizations (CROs) with facilities in Austin that regularly enlist volunteers for phase 1 clinical trials (full disclosure: PPD advertises their study opportunities in The Daily Texan). Shepherd said that both are “good quality facilities” and that the pharmaceutical industry has too much money tied up in drug research to waste time with “a shaky place.”
Both CROs in Austin have numerous available study opportunities listed on their respective websites that call for all types of participants for all kinds of trials — everything from pain killers for wisdom teeth and bunion removal to treatment for migraines to unlabeled studies. Volunteers have to be at least 18 years old, healthy, weigh a certain amount and usually be non-smoking.
Neither organization returned calls for a statement.
No doubt, CROs have a lot to keep an eye on regardless of the treatment in question. Clinical trials aren’t new — one of the earliest known studies is recorded in the Old Testament with Daniel — and over the last few decades research gained from the studies has been crucial to the development of important treatments. But hand-in-hand with the advances come increasingly complicated diseases and viruses, treatments and drugs for those illnesses and side-effects of those treatments. Not to mention the fact that every volunteer is different. The complexity has led to rigorous screening processes.
Matt Nelson, who has a doctorate in kinesiology from UT, said he volunteered for a PPD study in 2008. He ended up being chosen as an alternate (CROs recruit more volunteers than they need in case someone drops out), but he stayed overnight, endured medical screenings and blood tests and eventually earned $150 for his troubles.
“They only want healthy individuals because if you have a history of something, it affects the outcome,” Nelson said. “They try to control every aspect of it that they can.”
He said that once the screening process has begun, further information regarding the trial is generally available. Wary volunteers can do research on their own, too, which both Nelson and Shepherd encouraged.
“You can find out some basic information about them and do a little bit of outside research,” Nelson said. “The stuff that I found, I wasn’t too concerned about. But I definitely knew that if I found something that would have been a red flag to me, I was going to pass on that study and find a different one.”
For others, the red flags are too red and the benefits aren’t enough.
“For a few hundred dollars, I wouldn’t subject myself to unknown things like a guinea pig,” said English senior Willa Cockshutt. “If I was more desperate for money, probably yes, it’d be more appealing to me. It’s relative to a sliding scale of need. But there are less cynical ways of making extra money in college, like babysitting.”
Printed on Tuesday, November 8, 2011 as: Students risk safety in trials