|
In Reply to: PROZAC'S CLINICAL TRIALS posted by Daniel on February 18, 2006 at 23:58:36:
Lilly's 'Quick Cash' to Habitués Of Shelters Vanishes Quickly
By LAURIE P. COHEN
Staff Reporter of THE WALL STREET JOURNAL
INDIANAPOLIS -- Sitting in a drab hospital room at the Lilly Laboratory for Clinical Research, his home for 57 days, Louis Checchia lifts the sleeve of his navy-blue scrubs to display a right arm that is badly bruised and scarred from being pierced dozens of times.
Homeless and a hard drinker, Mr. Checchia can't say what kind of drug is being tested on him, although he has signed an informed-consent form. Nor has Eli Lilly & Co.'s "Subject No. 7" reported to the researchers any of the head and muscle aches he has suffered in recent weeks, as Lilly requires. He reckons these are simply the price of quitting drinking cold turkey to get into the study, not the possible side effects of Lilly's experimental drug, known only as LY315920.
The Food and Drug Administration chastised Lilly in 1994 for using alcoholics in a drug study.
For the 51-year-old ex-convict, any short-term discomfort seems well worth it. When he leaves in five days, Mr. Checchia, who has lived on the streets of Indianapolis for the past 14 years, will take with him $4,650 -- "in hundred-dollar bills," he emphasizes.
Mr. Checchia is what Lilly calls a "healthy volunteer." Each year, some 40,000 ostensibly healthy individuals are used by U.S. pharmaceuticals companies to participate in so-called Phase I drug tests. The Food and Drug Administration requires companies to do such tests to find out whether experimental drugs are safe enough to give to actual patients in Phase II testing.
Day Rates
For the pharmaceuticals industry, persuading able-bodied people to sample untried and potentially dangerous drugs is a tough sell. To woo their human subjects, most companies have to advertise heavily and shell out $125 or so a day, occasionally as much as $250; SmithKline Beecham PLC even pays referral bonuses. By contrast, Lilly advertises less frequently and, at $85 a day, pays what competitors believe is the lowest per diem in the business.
Alone among its peers, Lilly has become a potent magnet for homeless people. For more than two decades, Lilly's testing clinic has drawn from the ranks of the homeless, often alcoholic men who drift in and out of Indianapolis's church-run inner-city missions. Some mission directors privately express misgivings about this but say they are reluctant to speak up because they receive funding from a foundation built on Lilly stock, even though the foundation is independent of the company and its clinic.
Word of mouth about testing at Lilly -- a company best known for the blockbuster drug Prozac -- has gradually spread through soup kitchens, prisons and shelters from coast to coast. Today, so many homeless men come to Indianapolis seeking admittance to Lilly's research clinic that Matias Vega, medical director of the local Homeless Initiative Program, credits the clinic with creating a "shadow economy." One veteran nurse at the Lilly Clinic says that the majority of its subjects are homeless alcoholics.
'Temporarily Employed'
A Lilly official describes that notion as "completely inaccurate." In a written response to questions, T. Dwight McKinney, executive director of clinical pharmacology, says that "the vast majority of our volunteers (roughly 94%) have a residential address."
Earlier, in a face-to-face interview in July, Dr. McKinney described the volunteers as "retired or temporarily employed." Test subjects welcome the free physical exams and the money they get, Dr. McKinney said, and, above all, are driven to participate "by altruism ... . These individuals want to help society."
But Vaughn Bryson, who was Lilly's chief executive officer for 20 months before being ousted in 1993, says the company's use of homeless drinkers is "no secret." Two homeless-shelter officials concur, as do another former Lilly executive and two staffers at Indiana University Medical Center, where Lilly doctors teach. Moreover, The Wall Street Journal interviewed 12 men who described themselves as homeless people who drank daily and who said that they, and many others like them, had participated in Lilly's Phase I tests.
Room and Board
In many ways, the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug, say former Lilly employees and advocates for the homeless. As for the subjects, they get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call "easy money."
Still, Lilly's approach raises unsettling questions. Under FDA rules governing Phase I trials, drugs can be tested only in people who are able to make a "truly voluntary and uncoerced decision" to participate. Roger Williams, deputy director of the FDA's Center for Drug Evaluation, contends that using the homeless creates the very situation the rules were designed to prevent. He says the regulatory intent was to discourage disadvantaged people from participating in studies simply to escape "the horrible situation of their daily lives."
In addition, some public-health officials and test experts say the use of heavy drinkers in Phase I tests risks giving a distorted picture of an experimental drug's safety, which has to be ascertained before the drug can be given to actual patients in Phase II testing. "Alcoholism is a confounding feature," Dr. Williams says. "When something goes wrong, instead of saying this is a problem with our drug, you can say this is due to his alcoholism."
John Arnold, a pioneer of Phase I research who founded one of the nation's first clinics for such tests, is more outspoken. "Lilly isn't getting the safety it needs to take drugs into Phase II trials," he contends. "It's for the safety of Phase II patients that you even do Phase I."
Lilly asserts that any prior use of alcohol by volunteers has no significant effect on its drug data. It says that most people who either are undergoing alcohol withdrawal or have liver disease severe enough to skew the data will have abnormal physical exams and laboratory screening tests, and thus will be excluded.
But on the streets, Lilly's confidence in its subjects hardly seems justified.
From the Salvation Army Mission
At 6 o'clock on a muggy Thursday morning, Joseph LaDuke, Mark Slone and seven others leave the Salvation Army's Harbor Light Center, a mission where they spent the night, trekking a little more than a mile to the Lilly Clinic. Two days earlier, when Messrs. LaDuke and Slone showed up at the clinic to inquire about their prospects, the recruiting nurse had taken down their Social Security numbers and local residences (a day shelter for the homeless called Horizon House from Mr. LaDuke and an outdated address from Mr. Slone). The nurse then instructed them to return for a screening.
Mr. LaDuke says he heard about Lilly's studies from an acquaintance on the streets of Nashville, Tenn. A cocky 23-year-old who has been wandering the country for two years, Mr. LaDuke says he used to be a crack addict but now just drinks. "The only reason I came here is to do a study so I can buy me a car and a new pair of shoes," he says.
Mr. Slone, a soft-spoken former truck driver who is 34, also heard of the Lilly studies from a homeless buddy, a man in Louisville, Ky. Mr. Slone says alcoholism forced him into poverty. He hopes Lilly's bounty will enable him to "get my life back."
At 6:45, a Pinkerton security guard admits the pair to the Lilly Clinic, housed on the sixth and seventh floors of Wished Memorial Hospital in downtown Indianapolis. Lilly nurses take blood and urine samples from about a dozen potential volunteers. Three hours later, the screening is over. One candidate is rejected on the spot because he is overweight. The rest are told to return on Monday morning at nine to be examined by a Lilly doctor. (All but one will end up getting into a five-week safety study of a schizophrenia drug.)
Outside, Mr. LaDuke reports that Pattie Patrum, the recruiting nurse, had admonished the group to stay off alcohol for the next four days. But Mr. LaDuke and Mr. Slone will later recall that they wound up guzzling a stash of Budweiser 36 hours before getting admitted to Lilly.
No matter: Hard-drinking test subjects pride themselves on their skill at hiding the evidence of their binges. Regulars of Lilly studies spend much time sampling and swapping all manner of "detoxifiers" they insist guarantee entry to the clinic. Some swear by Herbal Clean, a tea, or golden seal, an herb grown in the Ozarks. Others say imbibing mineral oil or vinegar does the trick. James Picco, 57, who claims to have logged about 30 Lilly studies in 18 years but now is too old, downed "raisins, spinach and liver, anything with iron."
Most of those interviewed use more mundane techniques to mask their addictions. James Hart recalls that he would quit drinking anywhere from three to 10 days before a screening and fudge those dates to Lilly staffers. "I might tell them I'd been sober for two months when it was only three or four days," says Mr. Hart, who hasn't been able to get into a Lilly study since 1994, when he was diagnosed with hepatitis. Jerry Bienz, a 39-year-old who is sitting outside the Lilly Clinic waiting to be screened, confides this: "The night before you come in, drink a gallon or two of water 'cause that will get your liver count down."
GO TO THE LINK FOR THE REST OF THE STORY
