Staying Safe

Another approach to drug trials

Dr. Isaac Montoya sits on a sagging couch in ripped blue jeans and a sport shirt. His professional dress -- the tie and jacket, the pressed white shirt -- is confined to the closet today on doctor's orders.

Montoya has left the shelter of the broad executive desk and towering floral arrangements favored at his River Oaks office for the inconspicuous comforts of Affiliated Systems' nondescript community clinic.

The doctor's normally cautious speech becomes relaxed as he shares iced tea with the poor and homeless participants of his drug study. He has even caught himself rolling on the floor with the subjects' children, for whom a special room is reserved, to encourage young mothers to include drug trials on their list of income options.

"I slouch on the couch with them, just try to fit in," says the Affiliated Systems CEO, whose list of affiliations stretches for most of a printed page, including past board member positions with the Brandeis/Harvard Research Center on Managed Care and the Greater Houston AIDS Alliance.

These days he's experimenting with drugs that may one day extend the lives of his patients' livers -- livers their alcoholism seems intent on destroying. To combat the unpredictability of his patients, a group likely to lose track of time because of their destructive drinking, the pill bottles distributed have a microchip implant that allows Montoya to determine the last time the jar was cracked and even how many pills were removed.

Medical investigators such as Montoya draw the majority of their test subjects from the homeless and poor populations of Houston.

"Most of us in research, the easiest place for us to go is to the poor, LBJ, Ben Taub," Montoya says. "And that's the easiest place for us to do our research."

It's called community-based research, and it's housed in a single-story home planted in the same neighborhoods as its subjects, with no telltale signage.

"There's no way I'm going to get that population to go to the Medical Center. If I did, they would go once, they would not find a parking place. They would get lost. They would tell me I'm an idiot and tell me to get lost."

Montoya is a clinical professor in the college of pharmacy at the University of Houston. He also sits on the UT Health Science Center's institutional review board. In his investigations he has helped shut down two other IRBs for failing to live up to their responsibilities. He is currently fighting another investigator because, as he puts it, "their informed consent does not really inform the patient. The way that it's written, it protects the organization."

He says the most dangerous thing about drug trials is the popular assumption they offer the latest, greatest drugs, or even a cure, for difficult medical conditions. They don't. Not necessarily.

"It's research. It's not treatment," says Montoya. "People go there and some physician will approach them and say, 'We have a clinical trial,' and they think it's the newest and best treatment. It's not. It's research. It's an experiment."

But that is often lost on participants. For example, 49 percent of those surveyed by CenterWatch in 2000 said their greatest concern about joining a drug trial was getting the powerless placebo. Another 29 percent said they were worried about not being able to get the drug after the trial was over.

For instance, considering that trials for drugs that target mental illnesses -- whether major depressive disorder, panic disorder or schizophrenia -- usually require the subjects to be suffering such conditions themselves, participants are more likely to make rash choices.

"At that point, the state of mind of the patient is such that they are very vulnerable. They feel really desperate. They feel out of control. And anything they perceive might help them, and not necessarily will but just might, they want to jump in. And it's hard to get them to understand this is an experiment," Montoya says.

Meanwhile, conflicts of interest are huge in privately funded studies. The money is much better than in government-funded studies, and doctors conducting them don't have to reveal to patients if they are stockholders or even consultants to the companies whose drugs they are testing.

Even the money paid to test subjects can be considered coercive, according to Dr. Alan Lockwood, who sits on the board of directors for Physicians for Social Responsibility.

A study recently killed by the U.S. Environmental Protection Agency was intended to measure the impact of pesticides on children. Families stood to earn up to $970 and would be able to keep the video camera they were given to record their experiences.

"Part of the problem with the monetary award was to some extent they were targeting poor people," Lockwood says. "I think the most coercive element of that was the longer you stayed in the study, the more money you stood to make…It's designed to keep people in the study."

Imagine receiving a couple hundred dollars a month for doing nothing more than marking a few checklists and rolling some footage with your new camera every week. A couple of months go by. The cash means that for once you can actually keep up with the rent and are able to buy better food. For the first time, thoughts of a college fund for Junior appear in your head. Then you find out the poop in your child's diaper contains higher-than-expected levels of pesticide residue. No one can tell you if this is dangerous -- that's why it's being studied. It's the unknown. You plan to pull out, but then the test administrator offers you another $100 a month to stay in.

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