Merck

How Merck buried finasteride’s full impact on hormone signaling

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Merck held that finasteride had a simple and selective mechanism. In fact, it disrupts hormonal pathways much more broadly. These pathways support the brain, reproductive system and other organs. Merck’s selective account concealed risks which would surface in the decades after approval of Propecia.

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…

Hair or manhood—choose one?

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In ancient Greece, Hippocrates and Aristotle observed that eunuchs did not go bald. Jumping ahead to the early 1940s, American anatomist James B. Hamilton reviewed histories of men with testosterone deficiency and found a pattern: the earlier the age of hormone deficiency, the less balding occurred.

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.

How was finasteride invented?

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Although finasteride came on the market in the 1990s, the underlying research began two decades earlier. The rationale for the drug emerged from a study of a unique group of people in a remote village in the Dominican Republic called Las Salinas. Locals there have long known about children who follow an unusual developmental path: … Read more

Merck’s Propecia business

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HIGHLIGHTS Merck received FDA approval for Propecia (finasteride 1 mg/day) in December 1997. Sales in the first year of marketing were reported to be $76 million. The peak years were 2010–2011, when Merck reported $447 million in Propecia sales in each year. In total, Merck booked an estimated $5.2 billion in sales of Propecia. We … 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.