Study of depression from prostate drugs loses the signal by including past users

Response to: Hagberg KW, Divan HA, Nickel JC, Jick SS. Risk of incident antidepressant-treated depression associated with use of 5α-reductase inhibitors compared with use of α-blockers in men with benign prostatic hyperplasia: a population-based study using the Clinical Practice Research Datalink. Pharmacotherapy. 2017. doi:10.1002/phar.1925 SUMMARY: Hagberg et al, 2017 fails to assess the risk of … Read more

Study of ED risk loses the signal by including past users of finasteride

There is a major limitation: the analysis included past and recent users of 5ARIs, as well as current users. Past users are defined as those who stopped taking a 5ARI at least 91 days before getting diagnosed or treated for ED. Recent users are those who last took the drug 31-90 days before diagnosis or treatment for ED.

Response to Campbell et al on finasteride-associated suicide and depression in men treated for hypogonadism and impotence

The clear and concerning results in this abstract are statistically significant RORs for suicidal and self-injurious behaviors, anxiety disorders and depressed mood disorders in the finasteride-only group. The suggestion that combination therapy could “decrease” risk or have a “protective” role is unwarranted because the risk ratios are derived from unrelated sets of cases. This study seems to treat pharmacovigilance data as if it were a controlled, prospective study, when the data is uncontrolled and retrospective.

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

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

In 2010, Merck requested to add a warning of depression to the Propecia label. A safety group within FDA concurred, but FDA’s dermatology products group did not support the change. Over a decade later, FDA required the addition of ‘suicidal ideation and behavior’ to the Propecia label.