Sexual adverse effects

Rules of engagement: how sensitive concerns are hidden from drug trials

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Alan, a 28-year-old man who experiencing hair loss, is participating in the Propecia clinical trial. Alan brings high hopes that the new drug will stop hair loss. An investigator examines Alan’s scalp and hair, recording figures on a form. She asks Alan if he experienced any side effects. None, he replies. He is then given a form to fill out…

Meta-analysis launders safety data from old pharma trials; blames patients for drug harms

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Despite serious methodological shortcomings—including the preposterous use of on-drug safety data as a proxy for a post-drug condition—the authors nevertheless blame the post-drug syndrome on patient shortcomings. Zhang et al. have yoked bad logic to biased data in order to deflect attention away from drug harms.

A tweeted rebuttal to yet another analysis of finasteride adverse events

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A thread originally posted on Twitter is reproduced below. For an in-depth version, see the essay Context matters. See also a critique of three previous papers with similar designs, findings and conclusions. Twitter thread Nguyen et al, 2022 is the fourth analysis of adverse events of finasteride to appear since 2018. All four studies play … 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, part 2: Merck responds to regulatory concerns about persistent adverse effects of Propecia

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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

The Merck files, part 1: An inside look at the development of Propecia

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Merck first developed finasteride for benign prostatic hyperplasia, a condition typically found in men aged 55 and older. After receiving approval for the application in 1992 and bringing the drug to market as Proscar, Merck decided to seek approval of finasteride for male pattern hair loss—to be branded as Propecia. In a 1994 memo below, … Read more