The lost men: how Merck, GSK papered over bad outcomes in trials
A re-examination of clinical trials of finasteride and dutasteride reveals warning signs of long-term harms to surface later.
History
The lost men – appendix
A summary of men who had unresolved and severe adverse events in clinical trials of finasteride and dutasteride.
Elements of a drug safety disaster
Over the past 25 years, finasteride harms have spread invisibly, altering lives and giving rise to confusion and disagreement. This post identifies common themes across all these spheres. Many of these have to do with biases, omissions and collusion among industry, physicians and regulators.
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
How was finasteride invented?
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
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