Background: Alopecia areata is a common condition of patchy hair loss that has been postulated to have an autoimmune pathogenesis involving inflammatory cytokines, including tumor necrosis factor (TNF) ␣. Etanercept is a novel medication that blocks TNF-␣-mediated processes. We report a case involving the recurrence of alopecia areata in a patient receiving etanercept.Observations: We describe a 49-year-old man with a history of rheumatoid arthritis and alopecia areata who developed a recurrence of his alopecia areata while being treated with etanercept for more than 2 years. Conclusions:The anti-TNF-␣ effect of etanercept therapy may not be sufficient to prevent the recurrence of alopecia areata. The possible role of TNF-␣ in the pathogenesis of alopecia areata may be called into question if our observation is repeated.

HSS appears to be a safe, well-tolerated biological dressing with equivalent comorbid factors to secondary intention healing. HSS, however, seems to produce a more pliable and less vascular scar than those developed through healing by secondary intention. HSS also appears to produce more satisfactory cosmetic results when compared to secondary intention healing.

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Background: Excess vascular deaths in the PLATO trial comparing ticagrelor to clopidogrel have been repeatedly challenged by the Food and Drug Administration (FDA) reviewers and academia. Based on the Freedom of Information Act, BuzzFeed won a court order and shared with us the complete list of reported deaths for the ticagrelor FDA New Drug Application (NDA) 22–433. This dataset was matched against local patient-level records from PLATO sites monitored by the sponsor. Study Question: Whether FDA death data in the PLATO trial matched the local site records. Study Design: The NDA spreadsheet contains 938 precisely detailed PLATO deaths. We obtained and validated local evidence for 52 deaths among 861 PLATO patients from 14 enrolling sites in 8 countries and matched those with the official NDA dataset submitted to the FDA. Measures and Outcomes: Existence, precise time, and primary cause of deaths in PLATO. Results: Discrepant to the NDA document, sites confirmed 2 extra unreported deaths (Poland and Korea) and failed to confirm 4 deaths (Malaysia). Of the remaining 46 deaths, dates were reported correctly for 42 patients, earlier (2 clopidogrel), or later (2 ticagrelor) than the actual occurrence of death. In 12 clopidogrel patients, cause of death was changed to “vascular,” whereas 6 NDA ticagrelor “nonvascular” or “unknown” deaths were site-reported as of “vascular” origin. Sudden death was incorrectly reported in 4 clopidogrel patients, but omitted in 4 ticagrelor patients directly affecting the primary efficacy PLATO endpoint. Conclusions: Many deaths were inaccurately reported in PLATO favoring ticagrelor. The full extent of mortality misreporting is currently unclear, while especially worrisome is a mismatch in identifying primary death cause. Because all PLATO events are kept in the cloud electronic Medidata Rave capture system, securing the database content, examining the dataset changes or/and repeated entries, identifying potential interference origin, and assessing full magnitude of the problem are warranted.