Adverse event reports

A rebuttal to yet another analysis of finasteride adverse events: Nguyen et al, 2022

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This post responds to a recent research letter, Nguyen et al, 2022, published in the Journal of the American Academy of Dermatology. Originally posted on Twitter, the thread is reproduced below. Bolding has been added for easier scanning. See also: a critique of three previous papers with similar designs, findings and conclusions. Twitter thread Nguyen … Read more

Since 1994, Merck has been aware of unresolved sexual dysfunction in men who stopped taking finasteride

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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.

The Merck files: a series

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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

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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

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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 clinician-researcher sowed doubts about finasteride harms

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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

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A fourth study has been published in the ‘literature of doubt’. Read the rebuttal 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 et al., included Kevin T. McVary, MD as a co-author. The article disclosed that Dr. McVary had … Read more

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

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Summary This post documents adverse events (AEs) of finasteride affecting male reproductive anatomy and sexual function in men age 18–40, which were reported to US FDA and downloaded from the Federal Adverse Event Reporting System Public Dashboard. The data range is January 1, 2000 to December 31, 2020. This shows AEs assigned to categories which … Read more