Get Poked, Get Paid

Clinical drug trials offer good money, comfy dorms -- and sometimes even a free buzz. But beware: They're gonna suck your blood like Dracula.

The following year the study's parameters were changed to allow monogamous women. Says SLU spokesman Joe Muehlenkamp: "The older parameters led to some confusion over just who was eligible for the trial -- which led to the misperception that we were looking for 'promiscuous women,' which we are not. We found that this unfortunate misperception discouraged some women from enrolling who otherwise were good candidates. So we made the changes to clear up the false perception."

The drug trials themselves present even more potential for perilous misperception, according to activists at the New York-based watchdog group Alliance for Human Research Protection. Vera Hassner Sharav, president of the alliance, argues that the drug-testing industry is fraught with lies and conflicts of interest. Often, Sharav contends, sick participants are "misled and told that [an experimental drug] is the only way to survive. They're told that this trial is state-of-the-art, that you get the best treatment. In fact, you do not get individual treatment in most clinical trials."

Healthy people may also be deceived, she argues. "Consent forms never disclose as fully as they're supposed to the risks involved," Sharav says. "They never tell you the truth."

A veteran of paid medical studies at Gateway Medical 
Center in St. Charles, Alecia Hoyt is always nice to her 
phlebotomists.
Jennifer Silverberg
A veteran of paid medical studies at Gateway Medical Center in St. Charles, Alecia Hoyt is always nice to her phlebotomists.

Guinea Pig Zero's Robert Helms concurs. "It's routine to withhold information from test subjects -- it's the basic plan of action," he says. "They do not publish the results of studies that tell them something negative about their drug. They only publish the ones that help get the drug on the market."

That said, the industry is heavily regulated, with Institutional Review Boards (known as IRBs) composed of scientists, physicians and lay members of the community such as lawyers and priests overseeing each and every trial under the aegis of the FDA.

"They bring a collective wisdom to the evaluation of a research proposal, with an eye toward not only the quality of the science, but specifically with respect to the protection of the participants," says Dr. Greg Koski, a former director of the Office for Human Research Protections, an arm of the Department of Health and Human Services, which oversees all federally funded human clinical trials.

But Koski, who is now a professor at Harvard Medical School and serves as vice president for ethics and professional conduct for the American Academy of Pharmaceutical Physicians, acknowledges that IRBs aren't as effective as they should be. "There has been a huge growth in the numbers of IRBs over the years, but one of the problems is that there has been no system for keeping track of all of them. This raises some concern, because if in fact this board is appointed by an institution [performing the tests] and supported by an institution -- does that set up a situation in which the objectivity of the group could be compromised? Are they there to protect the interests of the institution, or of the participants?"

Washington University, Saint Louis University and Gateway each has its own IRBs -- and each organization maintains that its boards are committed to safe protocols and patient advocacy. "All research that involves people must be reviewed and approved by the IRB," asserts SLU's Muehlenkamp. "The purpose of the IRB is to assure the protection and welfare of volunteers in research projects. These IRBs are not contracted privately."

But increasingly, research is being outsourced overseas. Providence, Rhode Island-based Clinical Research Centers International (CRCI), for example, recently announced it was moving into Romania, joining overseas testing centers in India, Africa, South America and elsewhere around the globe.

Part of the reason the industry is moving abroad, Helms maintains, is to escape scrutiny.

"They're getting too much hassle from journalists, from doctors and families of people who are getting badly treated or killed in the U.S., and they're going places where populations are a softer target," the zine master says. "It's cheaper to do it in Eastern Europe, China, wherever, and they're under less pressure to follow the ethical guidelines."

An equally thorny aspect of the ethical issue involves the participants themselves. Even if all the potential dangers of a trial were clearly spelled out in consent forms, some participants would be at risk. Many lab rats who were interviewed for this story confessed that they don't always read their consent forms, and nearly all said they'd lied in order to be eligible to earn cash.

"They ask about your family history," says Alecia Hoyt. "The best thing to say is that everyone's okay and everyone's dandy, because that's what's going to get you into the study. If you start talking about mental-health issues and family issues, you likely won't be let into the study." [Editor's note: A correction ran concerning this paragraph; please see end of article.]

Alliance for Human Research Protection president Vera Hassner Sharav says she's particularly troubled by non-academic clinical settings such as Gateway. "Taking it into the commercial setting can only mean increased risk, fewer safeguards and skirting of safe methods," Sharav contends. "You can call them factories -- actually more like assembly-line studies."

Even worse, Sharav says, is the fact that some of these institutions rely heavily upon young people to fuel their studies. "Essentially they're exploiting students' lack of knowledge, lack of maturity, lack of skepticism," Sharav argues. "They're not wary. Students tend to be risk takers. The trouble is that this is their health, their bodies, and they don't know what some of the hidden risks may be."

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