Friday, November 26, 2004

Drug pushers and the homeless

From the Austin Chronicle


When Austin's homeless shelter moved from Fourth and Nueces to the new Austin Resource Center for the Homeless at Seventh and Neches, shelter director Robert Petersen and his colleagues hoped to leave several old problems behind, including the ubiquitous street drug salesmen. Unfortunately, the shelter staff now fear that at least one high-priced pusher has made the move with them: the local human-subject clinical drug-trial testers.

According to Petersen, about a year and a half ago "recruiters" from a local drug-testing company called FutureSearch began hanging around the old shelter, looking for subjects to participate for pay in clinical trials designed to test new schizophrenia medications. After shelter officials confronted the reps, telling them to stay out of the building, Petersen said, the recruiters simply took their clipboards and moved to the sidewalk across the street. At press time, J. David Morrison, general partner of FutureSearch, had not returned a call requesting comment.

For a while the activity appeared to slack off, Petersen said, and the truce continued when the shelter moved to the new Seventh Street ARCH. Then several months ago, Petersen and other shelter officials noticed a billboard across the street from the new facility. "Diagnosed with Schizophrenia?" reads a billboard for Community Clinical Research Inc., the text layered over a background scene of an arid desert. FutureSearch may have taken a break Downtown, but its absence had been abruptly filled by another pharmaceutical trial recruiter.

"This is an ethical issue," Petersen said. While at least 30% of the shelter's clientele have some form of mental illness, said Helen Varty, executive director of Front Steps (the nonprofit that manages the ARCH), it is not the only issue the clients struggle with. Many, for example, also have substance abuse and/or addiction problems, and all are financially strapped. In other words, says Varty, the drug testers have found a vulnerable population to prey upon – which has produced, on occasion, disastrous results.

"Changing medications when you're schizophrenic is a big deal; it's not like other meds," said Varty. "Healthy people who are schizophrenic would never go through the physiological changes just to have to change [medicines] back again," which often happens since trial meds are generally unavailable outside the trial. In fact, Varty said, the shelter has had several clients who had "never acted up before" return from clinical trials acting "so wild that we had to kick them out of the shelter." Petersen agrees. "We know people by name who've not been able to follow through [with after-trial follow up] and are out on the street in a bad way."

Kris Brown, president and director of CCR Inc., says that she was unaware that ARCH officials were upset about their schizophrenia billboard and that she "didn't realize" the ad had been placed across the street from the ARCH. "We've not heard anything about it," she said. "We have no intention of offending anybody." Brown said that every potential trial subject is questioned and counseled for three hours and that participation in the test is based on "informed consent." That doesn't satisfy Varty or Petersen, nor resolve the ethical concerns shared by others in the mental-health community.

"It's been a long[time], potentially sore point with us," said Jim Van Norman, medical director of the Austin/Travis County Mental Health and Mental Retardation Center. There's an obvious need for clinical research, he acknowledged. "The upside potential is that we get a new medication that works wonders," he said, but when the "enticement of reimbursement is too easy to go for," the methods of recruiting become ethically questionable. "You don't want to make the offer so good, so much money, that it sways someone. That's way outside ethical bounds. So, I think with the homeless, [these types of recruiting methods] get shaky." When the compensation is relatively high for the potential subjects, it is more difficult "to make a relatively dispassionate choice" about participation.

Varty is less generous: "What they're doing may be legal," she said, "but it is sleazy and real, real creepy." Still, Brown insists that her company does not want to offend anyone. "We're trying to be sensitive," she said. CCR does more research at their Austin clinic than is done at the UT med school in San Antonio – people with schizophrenia, she said, "deserve" the best treatment available. However, she said in a Nov. 18 interview that the company would be happy to remove the billboard. According to ARCH officials, the billboard was removed on Nov. 19.


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