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.
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…
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.
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
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 alters levels of chemical messengers in the blood as well as peripheral … Read more
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
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
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.
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.
This post responds to a recent research letter: Disproportional signal of sexual dysfunction reports associated with finasteride use in young men with androgenetic alopecia: a pharmacovigilance analysis of VigiBase.