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.
Merck
The lost men – appendix
A summary of men who had unresolved and severe adverse events in clinical trials of finasteride and dutasteride.
How Merck buried finasteride’s full impact on hormone signaling
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.
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.
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…
Polls vs. official data on side effect rates
Since online polls are anonymous, there is less risk to disclosing embarrassing side effects. In online polls, the rate of side effects was 6.2x greater than the rate of adverse events in a clinical trial. The clinical setting may suppress safety concerns in sensitive areas such as sexuality and mental state.
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.
Meta-analysis launders safety data from old pharma trials; blames patients for drug harms
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?
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