Cytokine Storm and an Anti-CD28 Monoclonal Antibody
To the Editor: The events of the phase 1 trial of TGN1412, as detailed by Suntharalingam et al. (Sept. 7 issue), 1 are a sobering reminder of the risks that research volunteers take when they participate in trials, but the article did not contain any comments on the subjects' mental state as th...
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Veröffentlicht in: | The New England journal of medicine 2006-12, Vol.355 (24), p.2591-2594 |
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Format: | Artikel |
Sprache: | eng |
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Online-Zugang: | Volltext |
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Zusammenfassung: | To the Editor:
The events of the phase 1 trial of TGN1412, as detailed by Suntharalingam et al. (Sept. 7 issue),
1
are a sobering reminder of the risks that research volunteers take when they participate in trials, but the article did not contain any comments on the subjects' mental state as they emerged from this near-death experience. The volunteers did not just suffer insults to kidney and pulmonary function; they were afflicted emotionally and perhaps intellectually as well. When an experimental drug has such serious adverse effects, it is worth reporting the psychological effects, which inform the ethical impact of . . . |
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ISSN: | 0028-4793 1533-4406 |
DOI: | 10.1056/NEJMc062750 |