Letters Statistical analysis: Arthur, Wayant. investigators (W.A., J.A.): the public speaker’s name, the orga- Supervision: Vassar. nization that he or she represented, the drug being discussed, Conflict of Interest Disclosures: None reported. whether the speaker had the disease for which the drug was in- 1. Center for Drug Evaluation, Research, Peripheral, and Central Nervous dicated, whether the speaker took the drug, the speaker’s dis- System Drugs Advisory Committee. https://www.fda.gov/AdvisoryCommittees/ closed COIs, and whether his or her statements about the drug CommitteesMeetingMaterials/Drugs/ werepositive,neutral,ornegative.Thisstudyusedpubliclyavail- PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/default.htm. Accessed August 2, 2018. able data and was therefore exempt from institutional review board approval. Logistic regression was used to examine the as- 2. US Food and Drug Administration. Peripheral and Central Nervous System Drugs Advisory Committee meeting [transcript]. https://www.fda.gov/ sociation between declaring a COI and having the disease for downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ which the drug is indicated and positive statements about the PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM510390. drug. We attempted to include a third variable (whether the pdf. Published April 25, 2016. Accessed August 30, 2018. speaker took the drug) but were not able to because no patients 3. Kesselheim AS, Avorn J. Approving a problematic muscular dystrophy drug: implications for FDA policy. JAMA. 2016;316(22):2357-2358. doi:10.1001/ who took the drug spoke
JAMA Neurology – American Medical Association
Published: Mar 22, 2019
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