journal article
LitStream Collection
doi: 10.1001/jama.1986.03380140015003pmid: N/A
MEDICINE CONTINUES to be news, and this was especially true at last week's fifth annual Science Writers Conference, cosponsored in Baltimore by the American Medical Association and Johns Hopkins University School of Medicine. For example, the International Agranulocytosis and Aplastic Anemia Study's report on analgesics and their relation to agranulocytosis and aplastic anemia was presented at the conference. Samuel Shapiro, MD, director of the Drug Epidemiology Unit, Boston University School of Medicine, announced that the group's multinational epidemiologic study concluded that the risks of persons developing agranulocytosis and aplastic anemia in relation to analgesic drug use are very low (JAMA 1986;256:1749-1757). There were 15 other presentations at this year's conference for science writers. Seven papers from the October issues of AMA specialty journals were among those presentations. The following is a roundup of presentations about which JAMA had information by the deadline for this issue. PET Developments Patients with schizophrenia
doi: 10.1001/jama.1986.03380140061007pmid: N/A
To the Editor.— The article entitled "Deferred Consent" by Abramson et al1 is both interesting and provocative; however, the authors slide over two very important points that are of major concern. The first of these two points touches on the distinction between experimental therapy and research and the standard of care the law assigns to both. The authors are quite right in stating that a physician may, under appropriate circumstances, consider and employ an experimental therapy that might benefit his patient in an otherwise hopeless situation. The obligations imposed here by law and by ethics as well are to be found within the constructs of a physician-patient relationship. This relationship is different in many respects from that of a researcher-subject relationship. The duties inherent therein shift as the concept of the relationship shifts. For example, the definition of research itself dismisses any immediate idea of a direct benefit to
Sprung, Charles L.; Schein, Roland M. H.
doi: 10.1001/jama.1986.03380140061008pmid: N/A
To the Editor.— Abramson et al1 are to be congratulated for merging the legal doctrines of informed consent with the medical realities of research in the critically ill patient. They have thereby formulated a practical solution to a difficult problem. The institutional review boards (IRBs) of the various hospitals in the study should also be commended for their acceptance of this sorely needed concept. The authors have noted federal regulations that foster research and at the same time protect individuals. Unfortunately, despite these guidelines many IRBs and attorneys are reluctant to allow research to occur without the actual consent of the patient himself. Some people view research as a risk rather than as a benefit for subjects, especially if the subject has a 50% chance of receiving a placebo. Often forgotten is the Hawthorne effect-the fact that one may benefit solely by being part of a research project.2
Abramson, Norman S.; Meisel, Alan; Safar, Peter
doi: 10.1001/jama.1986.03380140061009pmid: N/A
In Reply.— We agree with Dr Marsh that there is a difference between research and the use of an experimental therapy to benefit an individual patient. However, the obligation of the physician-investigator in these two distinct settings is still, above all, to benefit the patient. We do not believe that we "slide over" this point; indeed, it is the crux of our article. We strongly disagree that the "definition of research dismisses any immediate idea of a direct benefit to the patient-subject." In fact, the research referred to in our article, and clinical research in general, often involves the study and comparison of therapies, which, by definition, are intended to benefit the patient. This is sometimes referred to as "therapeutic" research, but we agree with Levine1 that such a term is best avoided and that, instead, we should speak of "research on therapy." We also take issue with Dr
doi: 10.1001/jama.1986.03380140062010pmid: 3761490
To the Editor.— In his response to the question regarding screening ultrasonography for ovarian carcinoma, Dr Ferrucci1 beautifully reviews the current state of the art and then concludes with erroneous recommendations. Certainly, ovarian carcinoma is a significant disease, accounting for 25% of all gynecologic cancers and over half the gynecologic cancer deaths.2 As Dr Ferrucci says, "the clinical benefit of early detection of ovarian cancer" has not been shown. Dr Ferrucci's list of "high-risk" patients deserves closer attention. "Difficulties in physical examination due to obesity or vaginal stenosis" and "cancerophobia" are not risk factors for ovarian cancer. Many known risk factors (nulliparity, early menopause, type A blood, pelvic irradiation, breast cancer, high-fat diet, and others)2 were omitted from the list. But this is a moot point since even in high-risk patients ultrasonography has no demonstrated benefit. Dr Ferrucci refers to the "less experienced" examiner and "difficult performance
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