Wrongful Research

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GLOBE EDITORIAL

Wrongful research

11/22/2003

ANY TESTING of experimental drugs for the mentally ill is complicated by the

difficulty of getting informed consent from patients who have diminished

competence, especially people who are confined to an institution. Yet successful

treatment of the mentally ill has relied increasingly on new and better drugs,

so researchers have to find ways to secure full informed consent from patients

or their guardians within ethical guidelines.

The state Department of Mental Health's guidelines, which are stricter than

those of the National Institute of Mental Health, were breached last year at

the DMH's Fuller Mental Health Center in Boston. Boston Medical

Center doctors were preparing four patients to participate in a study of a new

injectible drug for schizophrenia.

The patients were switched from drugs they had been taking to an oral form of

the new drug. A switch to the injectible form of the drug would have been the

next step if the study had gone forward, but one patient suffered severe side

effects from the first switch.

As soon as officials from the DMH and the state Disabled Persons Protection

Commission heard reports early this year that patient medications had been

changed without informed consent and before the study had even been approved by

institutional review boards, they and Boston Medical Center began

investigations. The DMH stopped the study in February, and the medical director

of the

Fuller Center resigned. Both he and another doctor who was

criticized in the state report are appealing its findings.

The question now is how to ensure there is no recurrence of such a violation.

The DMH and Boston Medical Center are considering a number of joint

proposals. On its own the medical center is asking its mental health researchers

to be

recertified in the ethics of human research.

This is certainly useful, but greater protection would come from having

closer supervision of all trials by directors and department heads who hew

strictly

to the accepted rules of research on humans. Officials should also be alert

to any financial relationships that researchers might have with firms

sponsoring drug studies, as there appear to have been in this case.

More broadly, all researchers into medications for the mentally ill must be

especially mindful of medicine's first rule: of doing no harm. To change the

medication of stabilized mentally ill patients not for medical needs but to make

them eligible candidates for a drug trial runs an unacceptably high risk.

The violation of human research principles at the Fuller

Center may have been a one-time mistake. Still, better supervision as well as

continuing education of researchers should make it less likely this will happen

again.

© Copyright 2003 Globe Newspaper Company.

© Copyright 2003 The New York Times Company