More than half of men older than 50 will experience male pattern baldness, according to the U.S. National Library of Medicine (NLM), and that rate climbs to 80 percent for Caucasian men. Male pattern baldness, medically known as “androgenetic alopecia,” begins above both temples, causes thinning at the crown, and often results in partial or complete baldness, states the NLM website, MedlinePlus.
While androgenetic alopecia in men can be linked to insulin resistance, coronary heart disease, and prostate conditions, it also presents an appearance issue for many men who feel that they may look prematurely old or less virile. Consequently, baldness treatments such as finasteride, sold under the brand name Propecia, have been lucrative products for drug makers.
Finasteride inhibits 5-alpha-reductase, the enzyme that converts testosterone into the androgen 5-dihydrotestosterone (DHT), which tells hair follicles on the scalp to stop producing hair. Developed by Merck, finasteride was approved by the Food and Drug Administration (FDA) for treatment of benign prostatic hyperplasia (BPH), or prostate gland enlargement, in 1992 in a preparation called Proscar—and for treatment of male pattern hair loss in 1997 in a preparation called Propecia. Finasteride is also sometimes prescribed for use in hormone replacement therapy for transgender women.
The year after Propecia’s approval, Merck launched a $60 million print and television ad campaign with the slogan, “Helping make hair loss history.” Direct-to-consumer advertising, which began to supplant drug representatives selling to doctors, had just been legalized, and the Propecia campaign was so groundbreaking that it was debated by Harvard Business School alumni for its marketing value.
In 2019, 8 million prescriptions were written for finasteride in the United States, and it was the 86th most commonly prescribed medication in the country.
Concerning Side Effects Emerge
Even before the Propecia launch, serious side effects surfaced. One of the first suggestions of adverse sexual side effects associated with finasteride appeared in 1996 in the peer-reviewed journal BJU International before the baldness indication had been approved by the FDA. Impotence, ejaculatory failure, decreased libido, and gynecomastia (swelling of male breasts) were noted by researchers in patients taking finasteride. In 2010, a Cochrane Library review found that men on finasteride for BPH were at an increased risk for erectile dysfunction, decreased libido, ejaculation disorder, and impotence. By 2012, the side effects were so established that the term “post-finasteride syndrome” (PFS) had been coined and thousands of patients had contacted a group called the PFS Foundation.Research in the Journal of Sexual Medicine in 2012 echoed the findings, noting that patients taking finasteride reported “changes related to the urogenital system in terms of semen quality and decreased ejaculate volume, reduction in penis size, penile curvature or reduced sensation, fewer spontaneous erections, decreased testicular size, testicular pain, and prostatitis. Many subjects also noted changes to their mental abilities, sleeping patterns, and/or depressive symptoms.”
Worse, as early as 2013, research suggested that the sexual and psychological side effects may not go away when the patient stops finasteride, but may be permanent.
Today, medical literature contains almost 800 articles about finasteride’s adverse effects, and mainstream media outlets have covered them. Men’s Journal published a report, “The (Not So Hard) Truth About Hair Loss Drugs,” in which it stated: “Emerging research and a slew of lawsuits suggest that finasteride may be more dangerous than previously believed, with side effects—inability to orgasm, painful erections, chronic depression, insomnia, brain fog, and suicidal thoughts—that can last long after patients stop taking the pill.”
CBS News ran a story about a mother who blamed her 22-year-old son’s suicide on Propecia, and last year, Reuters published a story called “Merck anti-baldness drug Propecia has long trail of suicide reports, records show.”
Some medical studies draw parallels between post-finasteride syndrome and post-SSRI sexual dysfunction.
Finasteride’s clinical trials raise more concerns. They appear cursory and some had very few participants. One FDA reviewer wrote that “the data on ejaculatory volume are inconclusive,” and another reviewer cautioned about drawing conclusions from a trial with only 12 subjects. Still another FDA reviewer noted that those with sexual adverse events may have already “exited from the study,” thus skewing results.
The FDA also advises that finasteride patients don’t donate blood or plasma for at least one month after taking their last dose of finasteride.
Merck Responses
In 2012, multidistrict litigation was aggregated from more than 1,100 Propecia-related lawsuits and heard by U.S. District Judge Brian Cogan in Brooklyn federal court. Six years later, in 2018, Merck agreed to settle most of the cases with $4.3 million to be divided among plaintiffs, a surprisingly low settlement compared with Johnson & Johnson’s $2.2 billion settlement for misbranding the antipsychotic Risperdal and Eli Lilly’s $1.42 billion settlement for false promotion of the antipsychotic Zyprexa.The drug’s many risks were hidden from patients, said the plaintiffs. Neither patients taking finasteride for hair loss or to treat the symptoms of an enlarged prostate are necessarily fully warned, said Dr. Steven Belknap, a dermatologist at Northwestern University Feinberg School of Medicine.
A Reuters investigation published in 2019 adds to the evidence of hidden risks. It found Merck “knew roughly 20 years ago that sales of the drug would suffer if the public became aware of Propecia’s possible long-term effects on men’s sexual health,” and consequently the drug maker likely buried the side effects and risks.
“A redacted section of one plaintiffs’ motion, reviewed by Reuters, cites correspondence from a Merck executive in which he objected to what he described as ‘misleading’ information about the incidence of sexual dysfunction in men taking Propecia,” Reuters reported.
“In a statement to Reuters, Merck said it ‘stands behind the safety and efficacy of Propecia,’ noting that the drug has been prescribed safely to millions of men since the late 1990s. While the drug’s label lists erectile dysfunction and other sexual problems as possible side effects among a small percentage of men, the company rejects allegations that Propecia causes those problems to persist after men stop taking it or that it can lead to mental health issues. Merck says the symptoms themselves could be caused by a variety of other factors,” reported the news organization.
Last year, U.S. Magistrate Judge Peggy Kuo in Brooklyn ordered Merck documents unsealed. The public’s right to access outweighs Merck’s arguments for keeping internal documents that might show hidden safety risks secret, she ruled. A patient group has also sued to have Propecia removed from the market.
Some Discredit Post-Finasteride Syndrome
Some medical voices discredit post-finasteride syndrome and question its existence. The BMJ likened it to “mystery syndromes” such as multiple chemical sensitivity and called PFS ”ill-defined and controversial.”Research in the journal Skin Appendage Disorders in 2019 read: “We present the first case of PFS in our 20-year prescription practice of oral finasteride for treatment of male pattern baldness, with circumstantial evidence that PFS may represent a delusional disorder of the somatic type, possibly on a background of a histrionic personality disorder, and with the potential of a mass psychogenic illness due to its media coverage. PFS demonstrates analogies to controversial ‘mystery syndromes’ as amalgam illness, multiple chemical sensitivity, Morgellons disease, and Koro.”
Still, with millions of prescriptions written for the Propecia every year, documentation of side effects, and evidence of risks hidden by Merck, this anti-baldness preparation should be used with caution if at all. No one should have to choose between their health and their hairline.
| Martha Rosenberg is a nationally recognized reporter and author whose work has been cited by the Mayo Clinic Proceedings, Public Library of Science Biology, and National Geographic. Rosenberg’s FDA exposé, “Born with a Junk Food Deficiency,” established her as a prominent investigative journalist. She has lectured widely at universities throughout the United States and resides in Chicago. |
