Chapter 6.

Introduction

Student Video Activities for Abnormal Psychology
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A Tragic Consequence of Research Misconduct

Author: Ronald J. Comer

Photo Credit: Photodisc

Princeton University

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6.1 A Tragic Consequence of Research Misconduct

This video focuses on the case of a man with schizophrenia who died after participating in an experimental drug trial at an inpatient treatment facility. Given the man's background and mental illness, as shown in the video, consider as you watch whether he was able to make decisions relating to his own treatment. As you will see from the video, there are many questions about the ethics of research using severely mentally ill patients for experimental drug trials. As you watch, you might consider the implications of such practices for the patients and their families.

A Tragic Consequence of Research Misconduct

Maria Santana last saw here 36-year-old brother, Joseph, alive when she went to visit him on October 11 at the Bronx Psychiatric Center.

As soon as he saw me, he just started crying. He was like, mija, mija. Help me. Help me.

An hour later, Joseph was rushed to an emergency room in a coma. Two days later, he died.

They killed my brother. I'm not saying they intentionally tried to kill my brother. But yes, they are responsible for my brother's death.

The Santanas say it was only after his death that they learned that Joseph had been part of a clinical trial for a new drug--

My brother was used as a guinea pig.

--a drug so new and experimental, it didn't even have a name, just a number.

We're hurt, and we're very angry.

He was well.

It's been six months since Joseph Santana died, and his sisters still don't know how or why. The family's biggest question-- did Joseph, institutionalized with schizophrenia for 12 years, know and understand that he was part of an experimental drug trial?

Joseph had been a patient at the Bronx Psychiatric Center since he was 24.

He still didn't know, really, right from wrong.

No, he didn't

You really had to guide him.

How old was he in this picture?

He was young.

Schizophrenia took away almost everything from Joseph--

My brother got sick in the '80s. He's still in the '80s.

--including his sense of time.

All he wanted to do was to shop for Sergios or Jordache.

His sisters, who took him out most weekends, say Joseph had been taking clozapine, an anti-psychotic drug that seemed to be working.

Did any of you suggest to the doctors that he be taken off that drug?

No.

No, no.

He was doing good on it. He was able to communicate with us.

But sometime in September, Joseph was suddenly taken off clozapine. The family only found out, Maria says, when she got an anonymous call.

I'm sure it was a nurse. That I know. It was a nurse.

Maria called his doctor--

I'm sorry, what's going on with Joseph?

--who was also a researcher. And he told her that Joseph had agreed to try new medication.

If you tell my brother, throw yourself off the roof, he would jump. He would do that.

But the doctor insisted that Joseph did understand and had signed a consent form. The problem is--

My brother wasn't able to read anymore.

Yeah.

What did he read? What did he read to sign?

Hospital records confirm that and also state Joseph was in the borderline range of mental retardation.

These kind of experiment-- let's face it, [? Arianne-- ?] doesn't happen to your kids, my kids. They happen to the politically powerless, to the poor, uneducated, and the elderly and the vulnerable and the sick.

And it happens, says bioethicist Dr. [INAUDIBLE], because hospitals, like the Bronx Psychiatric Center, receive large grants from drug companies to test medications.

What if this had turned out to be a drug that would work for him better?

But it didn't. Do you want to risk it?

But without drug studies, there won't be new treatments. And in fact, Joseph himself wouldn't have been helped by the drug clozapine if it hadn't been tested on someone else a decade ago.

Joseph, don't worry. You're out of that hospital.

In Joseph's case, the medical examiner ruled that he died from a lack of oxygen to the brain, a consequence of a course of drug treatment. In this letter to 48 Hours, the drug company states all laws and regulations were followed concerning patient consent.

He's trying to tell us that my brother consented. The reason my brother is in the hospital is because he couldn't think for himself.

Bye, Joseph. We love you. We miss you. See you next weekend, OK?

6.2 Check Your Understanding

Question 6.1

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Correct!
Incorrect.

Question 6.2

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Correct!
Incorrect.

Question 6.3

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Correct!
Incorrect.

Question 6.4

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Correct!
Incorrect.

6.3 Activity Completed!

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