Correspondence

Withholding Proven Treatment in Research

N Engl J Med 2002; 346:455-456February 7, 2002

Article

To the Editor:

In their editorial (Sept. 20 issue),1 Huston and Peterson discuss developments in the debate about withholding proven treatment in clinical research. Unfortunately, the editorialists, citing the transcript of a television report in which plaintiffs in a pending lawsuit described their allegations, do not accurately describe the clinical research on schizophrenia that was conducted at the University of California, Los Angeles (UCLA). In the UCLA study,2 which was conducted between 1982 and 1993, patients consented to discontinue medication only after clinical stabilization had been achieved, and they were monitored closely. Offering patients with stabilized illness a trial period without medication in the initial course of illness was within the standard of care and did not constitute a withholding of proven treatment. In response to complaints in 1991 by two families that filed lawsuits, the Office for Protection from Research Risks found that the clinical treatment of the patients adhered to “currently accepted clinical standards.”3 Moreover, the unfortunate suicide of one patient with schizophrenia occurred nearly three years after his participation in the study had concluded.

Keith H. Nuechterlein, Ph.D.
University of California, Los Angeles, Los Angeles, CA 90024-6968
keithn@ucla.edu

3 References

1. 1

   Huston P, Peterson R. Withholding proven treatment in clinical research. N Engl J Med 2001;345:912-914
   Full Text | Web of Science | Medline

2. 2

   Gitlin M, Nuechterlein K, Subotnik KL, et al. Clinical outcome following neuroleptic discontinuation in patients with remitted recent-onset schizophrenia. Am J Psychiatry 2001;158:1835-1842
   CrossRef | Web of Science | Medline

3. 3

   Office for Protection from Research Risks. Evaluation of human subject protections in schizophrenia research conducted by the University of California, Los Angeles. Rockville, Md.: National Institutes of Health, May 11, 1994.
   

Author/Editor Response

The editorialists reply:

To the Editor: We illustrated the concern regarding the withholding of proven treatment during the washout phase of a trial by reference to a treatment trial for schizophrenia that is now the focus of an ongoing legal case.1 We described the allegations only; direct causality cannot be assumed.

Patricia Huston, M.D., M.P.H.
Robert Peterson, M.D., Ph.D.
Health Canada, Ottawa, ON K1A 1B9, Canada

1 References

1. 1

   Superior Court of the State of California, for the County of Los Angeles, Case No. SC015698 (Aller) consolidated with Case No. SC016260 (Lamadrid).