Treatment INDS: Research for Hire?
Monaco, Grace Powers
Gottlieb, M. Gail
JAMA. 1987 Dec 11; 258(22): 3296-3297.
Since June 1987 the Food and Drug Administration has permitted "desperately" ill patients (those with serious or immediately life-threatening illnesses) to purchase investigational new drugs (INDs) conditioned on an absense of comparable or satisfactory therapy and on an adequate enrollment in ongoing clinical trials. The authors question the assumption by large numbers of patients of the risks of new therapies, usually restricted to small numbers of research subjects, before there is any certainty of benefit. They predict that insurers will be exposed to litigation over reimbursement for these "treatment INDs," whose status in insurance contracts is ambiguous, as will physicians who because of their professional judgment fail to disclose experimental options. The authors suggest that since insurers and patients are becoming sponsors of research, insurers should be encouraged to develop new policies that will permit reimbursement for experimental therapies when appropriate. (KIE abstract)
Clinical Trials; Contracts; Critically Ill; Disclosure; Drugs; Federal Government; Food; Government; Government Regulation; Health; Health Insurance; Human Experimentation; Insurance; Legal Aspects; Legal Liability; Life; Liability; Patient Care; Patients; Physicians; Regulation; Research; Research Subjects; Risks and Benefits; Supreme Court Decisions; Terminally Ill; Toxicity;
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