State Hospital Drug Studies

Nanci Wilson
Reporting

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(CBS 42) AUSTIN When someone is committed to a state mental hospital, the public assumes that person will get the help he or she desperately needs.

So why is the state allowing big pharmaceutical companies to use patients as guinea pigs to test experimental drugs?

Austin is home to one of Texas' state hospitals. These hospitals are where mentally ill Texans, who have nowhere else to go, are supposed to get the psychiatric treatment they desperately need.

The Texas Department of State Health Services Web site boasts of its adolescent program and its unit for Spanish-speaking patients.

But there's one unit the state doesn't want to talk about – the clinical research unit.

Sixteen beds are set aside to allow big pharmaceutical companies to sponsor drug studies using mental patients, under the state's care, as test subjects.

CBS 42 has obtained records showing that staff at state hospitals help recruit patients into studies of experimental drugs. These are drugs not approved by the Food and Drug Administration.

Some are being tested on mentally ill patients for the very first time.

"I think this is just shameful abuse of people that are in the mental hospitals here in Texas," said
Austinite Jim Harrington, director of the Texas Civil Rights Project.

CBS 42 Investigates asked Harrington and Austin psychiatrist Deborah Peel to review some of the records obtained.

"I think there are serious problems whether this is moral and ethical treatment,” Peel noted. “Once again, we have people who have no means, who are dependent on the state system, and the state system is working hand-in-glove with private corporations. They are essentially turning the state hospital population into research subjects"

In many studies, patients are taken off the medications that are working for them.

"It’s very, very risky to do that," Peel said.

Some patients get the new study drug, while others get what is called a ‘placebo’ -- a sugar pill.
The patients don't know which they are getting and neither do their doctors.

“To take people off medication when they have just been admitted for an inability to function and might have even been a harm to themselves or others, that raises real questions for me,” Peel said.

What's worse, according to Peel, patients aren't told if they are taking the placebo even if they are discharged from the hospital during the study.

"I think there are real ethical questions about taking people off medications when the consequences can be severe harm to them,” Peel said. “They could get suicidal. They could harm others. They certainly can't be productive or work, and, so, I think there are real ethical questions about taking people off effective medications."

"How can you not expect to have problems when that occurs, and how can you not understand that you are playing pretty dramatically with someone's mental health when you do that?" Harrington asked.

For patients who are given the new medication, there's no guarantee it will help, and the risks and long-term side effects are unknown.
If something does goes wrong, the drug companies say they won't bear responsibility. One company wrote: "We have no plans to give you any money if you are injured."

So, how can this happen? The state claims that these mental patients give what's called 'informed consent.' They sign a detailed document describing the risks and benefits of the study.

"I think that's a very shameful argument, really, because the reason people are in the mental hospital to start with is because the judge has made a finding that they are a danger to themselves or others,” Harrington said. “There really is a kind of limited capacity."

"I think there are real questions how informed their consent would be under those situations, because these are not people who have the means to choose to go elsewhere for treatment, and so, there's a powerful element of pressure, of coercion that they have to feel," Peel said.

The state says all studies are monitored by a review board. But that board's activities are secret.
Months ago, we asked the Texas Department of Health Services for detailed records about these studies. The state claims those are secret too, even writing to 19 pharmaceutical companies and researchers suggesting they send letters to the attorney general's office to fight our request and stop us and you from seeing those records.

This past week, the attorney general ruled in our favor. In future reports, CBS 42 will further investigate these secret studies and examine how the state is treating the mentally ill it is supposed to be protecting.

CBS 42 requested an on-camera interview addressing the issues in this story from the agency that oversees Texas’ mental hospitals. The Department of Health Services said no one was available.