For Bob Helms, a day at work can literally be a draining experience.
"I've gone home with ugly track marks on my arm that take a week to heal. I've fainted, I've passed out for eight hours afterward," said the 44-year-old Helms. "It can be dreary and very boring."
Helms is a self-described human guinea pig who, for seven years, has taken money in exchange for his time, blood, urine and sometimes feces as a paid volunteer in drug research trials.
Helms has written a book called Guinea Pig Zero about the experiences of human guinea pigs in clinical trials to come out this May. He may sound like a hero of sorts — as someone who braves the uncertain effects of new medicines to help researchers ensure they're safe for future patients.
But he's clear his motives are not selfless.
"I do it because it's a way to catch up on my bills and earn a little," said Helms, who earns $150-$400 a day for his contributions.
Drug Testing ‘Terribly Flawed’
The real heroes, and the ones most vulnerable to risk, Helms claims, are those who are already sick and undergo clinical trials at their doctors' advice, out of desperation, or even unknowingly.
Sometimes the trials help save lives — like Tom Christerson, 70, who just became the longest living recipient of a totally implantable artificial heart after six months with the device. But occasionally, they jeopardize them, as what happened last month when 15 Alzheimer's patients suffered brain inflammation after taking an experimental vaccine.
The failed Alzheimer's vaccine trials, conducted by the Dublin-based Elan Corp., has caused bioethicists to revisit the drug testing system that past mishaps had already revealed as flawed. Despite some reforms, many conclude the system still poses serious risks to both healthy test subjects like Helms and ones seeking treatment.
"It's kind of like democracy," said Paul Root Wolpe, a sociologist at the Center for Bioethics at the University of Pennsylvania. "It's terribly flawed and problems fall through the cracks, but it's still a better system than all the others."
A Long Road to Market
The process goes like this: Once a drug company has formulated a new drug and tested it on animals, they must then test the drug in a series of human trials. Phase I trials test the safety of the new drug on a small group of healthy volunteers (like Helms). Phase II tests the safety and effectiveness on a small group of sick patients. And phase III trials test the drug on a large group of patients.
Before conducting any drug trials all publicly funded and some privately funded researchers must submit their projects to an Internal Review Board, or IRB. The IRB then evaluates the risks and protections for future trial subjects. Publicly funded projects must meet federal standards enforced for clinical trials as outlined by the Food and Drug Administration in 1991.
Some argue all clinical trials — public and private — should be held to these federal standards. In fact, a bioethics counsel operating under President Clinton's administration recommended this step five years ago but it hasn't yet been taken.
"There's a great deal of commercial research that isn't regulated at all," said Beverly Woodward, a medical ethicist at Brandeis University who has monitored the system.
But past trials have shown even enforced government standards can't prevent tragedy.