The Merck files: a series

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

When medical treatment brings on disease: iatrogenic disorders

Those who have lasting dysfunctions after taking finasteride or dutasteride are not the only ones whose lives have been altered for the worse because of a medical treatment. This post summarizes diseases and conditions that may arise from medical treatments: five in dermatology, four in psychiatry and one in general medicine. ↓ Jump to the … Read more

Merck communications regarding reports of persistent erectile dysfunction and depression associated with finasteride

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

Tapped by Merck for litigation defense, a physician-researcher sowed doubts about finasteride harms

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

Responding to a literature of doubt: limitations of three studies of adverse events of finasteride and dutasteride

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

Research review: Alterations to penile and prostatic tissue associated with finasteride and dutasteride treatment

Simple summary: Numerous studies have shown that treatment with finasteride and dutasteride can change the size, tissue composition and function of the penis and prostate. Changes in the penis linked to finasteride or dutasteride treatment include: reduced size and weight; reduced erectile response; decreased smooth muscle; increased collagen density; fibrosis (scarring or other tissue abnormalities); … Read more

Adverse events affecting reproductive anatomy and sexual function in younger men who took finasteride

Summary This post documents adverse events (AEs) of finasteride affecting male reproductive anatomy and sexual function in men age 18–40, reported to US FDA from 2000 to 2020. See the Methodology section for more details. Categories in the table are not in the source data, but were applied based on AE descriptions: Category Adverse events(2000–2020) … Read more

The most-published researchers on adverse effects of finasteride for the treatment of hair loss

Most-published researchers This post covers researchers who have published at least three papers on adverse effects of finasteride and 5-alpha reductase inhibitors when taken as a treatment for hair loss, typically by younger men. Collectively, this group has published more than 60 papers on this topic. Keep in mind these caveats: This list does not … Read more

Paper: Differential gene expression in post-finasteride syndrome patients

By arrangement with the publisher, full text of the following paper is available: Howell S, Song W, Pastuszak A, Khera M. Differential gene expression in post-finasteride syndrome patients. J Sex Med. 2021;18(9):1479–1490. doi:10.1016/j.jsxm.2021.05.009. PMID: 34247957. Abstract Background An organic etiology underpinning post-finasteride syndrome, a constellation of persistent sexual, neuropsychiatric, and somatic symptoms reported by men … Read more