Merck’s former physician-allies sowed doubt while Propecia litigation was pending

After FDA approved finasteride for male hair loss in 1997, the drug’s reputation stayed untarnished for a dozen years in the United States. However, the tide shifted in the 2010s: label warnings were added about risks of depression and lasting sexual dysfunction. Lawsuits about persistent sexual dysfunction were filed against Merck. These were later consolidated … Read more

Medical journals and physicians ignore conflicts of interest after a few years

Physician-researchers known as key opinion leaders have a crucial role in launching a drug into the marketplace. While Propecia litigation was underway in the 2010s, a number of opinion leaders who had helped Merck launch Proscar and Propecia wrote articles defending the drug’s safety.

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.

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.