SCENES FROM THE NEW ECONOMY
Like a lot of executives these days, Harry Alcorn Jr. doesn’t precisely know what toll the tanking economy will take on his business. Still, Alcorn, the chief scientific officer for the Minneapolis-based DaVita Clinical Research, needs not fret about one critical aspect of his operation these days: finding enough healthy volunteers willing to be drugged, pricked and poked for a paycheck.
“I’d say there’s been about a 20 percent uptick [in volunteers], starting in November and December,” said Alcorn. Alcorn doesn’t have much doubt as to the main cause: increasing numbers of people desperate to pick up extra cash. Currently, DaVita maintains a database of about 7,000 volunteers interested in participating in paid drug trials, according to Alcorn.
Across town, at the St. Paul-based Prism Research Inc., the story is much the same. Jeffrey Cosgrove, the founder and co-owner of the four year old company, said there has also been a shift in the demographic characteristics of the volunteer pool.
In 1990, when he started in the industry, Cosgrove estimates that about 75 percent of drug trial volunteers were college students. Now he pegs that figure at about 40 percent, with artists, the unemployed, and the self-employed adults participating in ever greater numbers.
And in the past year, Cosgrove noted another particularly distinct demographic spike: Out of work real estate agents.
The lure of guinea pigging? Cold cash, of course
Within the drug testing industry, human research subjects are typically called “volunteers.” And while participants do volunteer, the term is misleading, if only because most volunteers are in it strictly for money. A smaller subset of volunteers earns most of their spending money from drug trials, a vocation referred to informally as “guinea pigging.”
Depending on the length and nature of the trial, volunteers typically earn between $25 and $75 an hour. At Prism, the better paying studies yield about $6,000. Nationally, experts say, volunteers can earn as much as $20,000 per trial.
The money — and the flexible schedule necessary to accommodate the testing protocols — have long attracted college students to the work. But as the clinical testing industry has expanded over the past two decades, the pool of volunteers has broadened.
Cosgrove said that’s partly attributable to a mellowing in the public perception of the clinical research industry. In the early 90s, industry surveys found that only about 10 percent of the public considered participating in a drug trial. Now that figure is about 30 percent.
Other factors have contributed to the changing demographics. As pharmaceutical companies increasingly target research dollars towards the aging baby boomers, boomers have been recruited in ever greater numbers. And senior citizens, once rare in healthy volunteer studies, now represent 10 to 15 percent of the volunteer base at Prism, Cosgrove said.
The guinea pigs speak
Still, the plurality of guinea pigs are people like Jeremy Nienow. Nienow, 34, participated in his first drug trial about five years ago when he was working on a PhD in anthropology at the University of Minnesota. While many volunteers are recruited through radio and print advertising campaigns, Nienow learned about the work from his best friend — at the time, a pharmacist in training in Fargo.
“He financed his entire way through school doing drug trials, so I’d call him and say, ‘Hey, this is the drug I’m thinking about testing,'” Nienow recalled. “He’d say ‘Yes, you’ll be OK in that study’ or ‘Yeah, maybe you shouldn’t do that one because you have a family and you’re my best friend.'”
Over the ensuing years, Nienow estimates, he participated in about three inpatient studies per year, as well as scores of less demanding outpatient trials. During one trial, Nienow said, the drugs he ingested caused him to pass out; another time, he had a bad reaction and threw up.
But such “unbearable stuff” was far less common than the merely unpleasant aspects of the work: the tedium of lengthy confinement at testing sites, strict dietary restrictions, including a ban on caffeine consumption, and, worst of all, the repeated blood draws.
“In the better paying studies, they’d take copious amounts of blood — 15 to 20 draws a day,” Nienow said. “If you weren’t getting a lot of blood draws, you would only make a couple hundred bucks.”
Still, Nienow said his experiences at Prism and other sites were generally positive. “If you’re a college student with no real demands on your time, this is an easy way to make money.” With the considerable amount of down time, he was able to work on his dissertation. When he didn’t do that, he played World of Warcraft on his laptop.
Mark, a 46-year-old unemployed cook from Minneapolis who didn’t wish to be identified by full name, recently completed a week long, in-patient trial at DaVita. Laid off in January and living on unemployment, Mark learned of the study from a recruitment ad in the Star Tribune.
At first, he said, he had trouble making contact with DaVita because, an employee later told him, the company been swamped by responses. Mark persisted and, after dieting for a week to get to within the weight parameters for the study, was enrolled in a diabetes study.
Like Nienow, Mark found the repeated blood draws, which occurred every 20 minutes for the first three days, to be the most taxing aspect of the trial. After a week on the inside, he also became a little stir crazy. Sill, Mark plans to enroll in another study if he qualifies.
He said he didn’t worry about possible health impacts from taking experimental drugs. “You have to sign a bunch of waivers before you go on there,” he explained. “But I hardly even read the fine print. I just signed it. The money was more important.”
Mark said he will use his $2,500 paycheck to cover his rent for next six months. If he qualifies for another study, he said will put that money toward a vacation in Thailand.
While the weakening economy presents a recruitment boon for clinical research companies like Prism and DaVita, critics of the industry worry that increasingly financially strapped volunteers will be left vulnerable to exploitation.
“The concern are the same [as before the recession], but the problems will be exacerbated. The system of protection for the human subject is broken,” said Dr. Adil Shamoo, a molecular biologist at the University of Maryland and the founder of the advocacy group, Citizens for Responsible Care and Research. http://www.circare.org/
According to Shamoo’s research, about 10 million Americans participate in drug trials annually. While many of those trials are subject to federal oversight, he said, gaps still persist and so do abuses.
Last year, University of Minnesota professor Dr. Carl Elliott documented some of the industry’s problems in an article in The New Yorker magazine. In 2006, according to Elliott, the nation’s largest clinical testing site — housed in a former Holiday Inn in Miami-Dade County — was forced to shutter its doors after it was revealed that the testing company “was paying undocumented immigrants to participate in drug trials under ethically dubious conditions.”
Ultimately, the company paid $28.5 million to settle a class action lawsuit.
In another notorious instance, the pharmaceutical company Eli Lilly came under fire in 1996 for its practice of recruiting homeless alcoholics to a drug testing operation in Indianapolis. A company executive defended the action, saying the recruits were participating for altruistic reasons.
According to Cosgrove, Prism has measures in place to prevent such abuses. Among other things, volunteers are required to demonstrate proof of residency. And to reduce the likelihood of professional guinea pigging — which can foul research results if volunteers enroll in too many tests — Prism only takes volunteers from within 100 mile radius.
Cosgrove declined to comment on the larger ethical question of paying healthy people to participate in potentially harmful drug studies, saying only the company adheres to legal and industry standards.
He is not alone in that apparent ambivalence about the practice. While critical of both private businesses and government, Shamoo, who has studied the industry for decades, said he hasn’t made up his mind.
“We live in a capitalist country. Poor people need income. The majority [of volunteers], especially in phase one clinical trials, do this for money,” Shamoo said. And while that creates the possibility of exploitation, Shamoo noted that participation of paid volunteers is critical to medical progress.
“All drug development would stop without them,” he said. “Who would volunteer? Why would they?”
Mike Mosedale, who has written for City Pages and newspapers in Connecticut, Wisconsin and California, reports on the environment, Indian affairs and other topics.