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.
Clinical trials
The lost men – appendix
A summary of men who had unresolved and severe adverse events in clinical trials of finasteride and dutasteride.
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.
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.
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.