Six months after discontinuing a Phase 3 finasteride trial, a man’s sexual adverse experience was unresolved. There were also 16 men whose drug-related sexual adverse experiences were unresolved at the conclusion of the trial.
These documents from 2006–2009 concern Merck’s response to postmarketing reports of persistent erectile dysfunction, male infertility and depressive disorders, among other adverse events, associated with use of finasteride. In 2006, the Swedish Medical Products Agency asked Merck for an analysis of all adverse events affecting the male reproductive system which persisted after stopping Propecia. In … Read more
Selected documents from Propecia litigation were released by court order in 2021. This series walks through these documents, revealing Merck’s strategy for discounting safety concerns arising from clinical trials and adverse event reports. The collection is divided into three parts: 1. An inside look at the development of Propecia (1994–2001) 2. Merck responds to regulatory … Read more
See also: The Merck files: a series In regulatory, internal and media communications in the 2000s, Merck responded to concerns about reports of adverse events associated with Propecia, including persistent erectile dysfunction and depression. These documents seek to discount the validity of these reports by way of the following points: “insufficient” information including lack of … Read more
A 2018 article disclosed that Dr. Kevin McVary had been retained as an expert for Merck’s defense in litigation regarding persistent adverse effects (AEs) of finasteride.1 Dr. McVary has also been relatively active as a contributor of three conference abstracts, an original article, an expert review, a quote in a media story and a symposium presentation … Read more
A fourth study has been published in the ‘literature of doubt’. Read the rebuttal. Background on the co-author of Baas et al, 2018 with a disclosed conflict of interest is here. Three studies analyzing adverse event (AE) data related to finasteride and dutasteride were published from 2018–2020 (the “AE papers”).1–3 The first to appear, by Baas … Read more
The Bald Truth is a radio show about hair loss which, according to its website, “has been advising listeners on issues ranging from building self confidence and creating sexual attraction to overcoming…the modern man’s Achilles’ heel, male pattern baldness.” Host Spencer Kobren founded the show over 19 years ago, and there are over 2,200 episodes … Read more
Quotes from adverse event reports received by FDA in 2020
Where to find firsthand reports of experiences with finasteride
Comments on adverse effects of finasteride gathered from social media.