A rundown of new bibliographies & research guides

The research base spans many disciplines and goes back almost 50 years. To help researchers get oriented, an on-ramp was added. In the Systems & functions area, a new bibliography was added: Adverse effects on skin, comprising nine case reports. The gynecomastia bibliography has been expanded. The bibliography on the musculoskeletal system has been expanded … Read more

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

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…

Recent developments

In June 2022, the FDA required the addition of ‘suicidal ideation and behavior’ to the Propecia (finasteride 1 mg) label. In July, France’s national drug regulator ANSM added materials to help patients better understand the risks of finasteride.

Hair or manhood—choose one?

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.

From the depths: why finasteride harms took decades to emerge

Physician-researchers blamed growing safety concerns on patients, overlooking social context and weaknesses in safety regime The official view of Propecia, fashioned by Merck at a reported cost of $450 million, is that the drug is safe and effective. Upon approval by FDA in 1997, this view was carried forward by dermatologists, some of whom were … Read more

Merck’s Propecia business

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

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.