Year: 2011
Type: article
Abstract: duce the likelihood of litigious arguments concerning who knew what and when. 5Individual manufacturers should not be in the position of determining what information is considered material for public dissemination.Physicians are also well aware that our noninfallible but important recommendations are based on our best assessments of incomplete data, with levels of evidence ranging from firm to anecdotal.With the finality afforded by the Supreme Court decision in Matrixx, investors can be assured of increased access to statistically nonsignificant information regarding reports of adverse drug experiences.Although the medical establishment lacks legal authority, it could use its standards-setting powers to improve access to the same level of information.The resulting flood of data, though likely to represent biologic noise rather than evidence sufficient to establish even "probable cause," would contribute to the total mix of available information and might, under some circumstances, influence reasonable prescribers and patients to alter their treatment plans: a sommelier, for example, might consider any report of anosmia to be material.
Source: New England Journal of Medicine
DOI: 10.1056/nejmp1103464
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W2009093622