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.

Appendix: Results of online polls on side effects

This is an Appendix to the post: Polls vs. official data on side effect rates. Summary Mobile users: swipe left to see more columns. ID & source Date posted Participants % with side effects % with severe or persistent side effects P1. r/tressless Jan 2016 146 53.4% NA P2. r/HairLoss Jul 2021 110 27.3% NA … Read more

Musculoskeletal adverse events of finasteride

When men take finasteride for hair loss, their attention is directed to the hair and scalp. When adverse events (AEs) occur in other systems and areas of the body, it might not be obvious that finasteride could be the culprit. But the drug serves to lower dihydrotestosterone in the blood as well as peripheral tissue … Read more

Disability and deaths in men who used finasteride

Databases of drug adverse events contain tremendous variation. They include reports from patients of all ages, and many took other drugs that might explain outcomes. In this analysis, cases were limited to men ages 18–40 where the ‘Suspected Product’ field only contained finasteride (or, in the comparison below, minoxidil). This is only a fraction of … Read more

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

FDA quashed internal warning on suicidality linked to Propecia; changed course in 2022

KEY POINTS In 2010, Merck requested to add ‘depression’ to adverse events in the Propecia label. A safety group within FDA concurred, and also recommended adding ‘suicidal thoughts and behavior.’ FDA’s dermatology products group did not support adding a suicidality warning. Only ‘depression’ was added to the label in 2011. Over a decade later, in … Read more

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.

A tweeted rebuttal to yet another analysis of finasteride adverse events

A thread originally posted on Twitter is reproduced below. For an in-depth version, see the essay Context matters. See also a critique of three previous papers with similar designs, findings and conclusions. Twitter thread Nguyen et al, 2022 is the fourth analysis of adverse events of finasteride to appear since 2018. All four studies play … Read more