Professional Lab Rats
For those of you who know me, you know that I rarely take a pill if I don’t absolutely need to. It’s not that I necessarily think medicines don’t have their place as a solution for what ails me; rather, I am cautious about over-using drugs, regardless of whether it’s a simple painkiller or a powerful antibiotic, and therefore consider giving my body’s natural defenses the time they need to fix the problem. I know not everyone feels the same way I do, and I certainly wouldn’t preach my method as the only “right” one — to each their own — but I was surprised to read a special report in the April issue of “Men’s Health” magazine about people who have become professional guinea pigs for clinical trials in the United States, and subject their bodies to new chemical entities in the name of science.
Obviously, not all clinical trial participants treat their participation as a job; some are people who are donating their body in the hope of finding a cure for some disease that afflicts them, while others are health but participate for extra cash. Many, however, are like Brandon, a 30-year-old professional lab rat that spends a good part of his free time in a research facility. In the last 18 months, he earned $25,000 in a number of trials in Michigan, Indiana and Texas, likely earning more than in his previous career path: a part-time, minimum-wage job hopper. As he puts it:
“This is the longest I’ve ever done anything,” says Brandon. “I don’t plan on doing it forever, but it sure beats the heck out of working at a regular job.” (1)
Brandon’s lifestyle may not be right for me, living study after study, subjecting my body to likely safe, but still experimental chemicals (only 1 in 10,000 will suffer a fatal side effect).(2) For now, though, it seems to work for him and guinea pigs do help determine what drugs are safe to bring to market.
Or do they?
The biggest problem with these volunteers is what they do for the money they earn for each study. In a Johns Hopkins survey, 10 percent of a sample group of research volunteers admitted to participating in more than one study at a time — double-dipping, so to speak — and most likely doing so without the knowledge the researchers. (3) In most other careers, this kind of multitasking would probably be applauded, but in clinical research it is risky behavior. Treatments for the different studies may interact in unpredictable ways, skewing test results, causing harm to the volunteer and subsequently blocking the drug’s path to approval.
Federal regulations exacerbate the problem because personal information that could identify study participants are supposed to be kept confidential. This wouldn’t be as much of a problem if there were only a select few research facilities where the drugs were being tested. But that coupled with the pharmaceutical industry’s increasing reliance on subcontracted, for-profit contract research organizations (CROs) makes tracking these moonlighting individuals difficult, if not impossible. As a result, the system is set up to almost encourage participation in multiple studies. Organizations that specialize in running clinical studies take advantage of this group of guinea pigs because the most time-consuming (and therefore costly) part of any clinical trial is finding those volunteers.
What does this mean for us? It means that as the prevalence of these professional clinical trial volunteers who participate in more than one study increases, so do the risks of results being skewed. These results, once reviewed by the FDA for approval, could prevent a critical drug from reaching the market because of its reaction with an entity about which the researchers weren’t aware. A worse scenario in my mind would be a drug prone to present a patient with more side-effects, but that was effectively neutralized by a drug that was being taken by a patient in another study. Forgoing the scientific process for the sake of earning a few extra dollars could put more people at risk down the line than just these professional volunteers.
To guard yourself against any kind of adverse event that slipped through a clinical trial, follow these four steps outlined by the Jenna Stumpf as a sidebar to “Drug-Test Dummies:”
Don’t be first
Unless there’s no comparable durg available, try to stick with a medication that’s been on the market for 2 years or longer. Like a new car model, a brand-new drug may still have bugs that weren’t worked out (or even detected) in clinical trials, says Steven Scott, Pharm. D., an associate professor of clinical pharmacy at Purdue University.
Stay at One Store
If a doctor hands you a prescription and you forget to mention that you’re on other medications, you risk a drug interaction. That’s why Robert Freeman, Ph.D., a professor of pharmaceutical sciences at Texas A&M, recommends that you fill all your scripts with the same pharmacist- and run any over-the-counter drugs or supplements by him too.
Use a Safety Net
Add extra insurance against an interaction with a free account at epocrates.com. This database acts as a virtual pharmacist, cross-referencing your meds to see if any don’t play well together. Used by more than 500,000 health-care professionals, Epocrates alos provides a layman’s summary of the indecipherable drug-info pamphlet.
Watch Yourself
Before you start a new medication, take stock of how you feel. While upset stomach, headache and drowsiness are all relatively common reactions, they should pass as your body adjusts to the drug, says Freeman. If they persist for longer than 3 days or you feel any muscle or abdominal pain, see your doctor.(4)
While it may be clear there is a problem with the system, even the strongest critics agree that it is necessary to ensure the safety of drugs brought to market. However, until new safeguards are implemented to prevent people like Brandon from taking advantage of the flaws, there is always a chance there will be skewed results dictating the fate of that new drug. That is a shame, because though I know I am conservative about taking medications, I do believe many drugs provide a benefit that cannot be measured by those people who depend on them. In a scientifically tainted clinical trial, they are the ones who stand to lose the most.
(1) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p128.
(2) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p128, sidebar: the high cost of clinical trials.
(3) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p128.
(4) See “Drug-Test Dummies,” Melba Newsome, Men’s Health, April 2008, p130, sidebar: Prescription Protection by Jenna Stumpf.
