证词促使首次对支持非那雄胺 1 毫克与神经精神反应之间因果关系的证据进行系统性审查
2025年9月26日
亲爱的朋友们：
我们很高兴地报告，PFS全球舆论法庭终于开庭了，其首要议题是这个紧迫的问题：
“谁应该承担责任，等了二十年才警告公众非那雄胺会引起严重的神经精神反应，从而使数百万患者面临自杀的风险？”
Earlier this week, in a rare coordination of medical literature and expert testimony, Mayer Brezis, MD, published a systematic review of post-marketing surveillance aimed at indicting those responsible for this epidemiological debacle.
His verdict?
“The FDA could and should have requested disproportionality analyses, but it did not. The manufacturer [Merck & Co.] was aware of underreporting but dismissed the problem.”
Titled Failing Public Health Again? Analytical Review of Depression and Suicidality From Finasteride, the 4,000-word paper appears in The Journal of Clinical Psychiatry, which boasts 1.3 million annual visits to its Psychiatrist.com platform, as well as an impact factor of 5.3, placing it in the top 5% of medical journals worldwide.
Notably, Dr. Brezis, who holds a Master of Public Health degree and serves as Professor of Medicine (Emeritus) at Hadassah Medical Center in Jerusalem, dedicates his research to the memory of a friend who died by suicide shortly after beginning, then quitting, finasteride therapy for hair loss.
He discloses as well that he served as an expert witness on a trial involving another person who died by suicide after taking finasteride for alopecia, which prompted him to publish his evidence presented in the litigation. Among Dr. Brezis’s arguments:
▪ Causation is biologically plausible
[S]tudies have shown that finasteride, by inhibiting 5α-reductase, reduces the synthesis of neurosteroids, brain hormones that regulate mood. The reduction in neurosteroid levels, particularly allopregnanolone, is hypothesized to contribute to the neuropsychiatric side effects… such as depression, anxiety, and cognitive dysfunction. Often lasting long after medication discontinuation, neuropsychiatric reactions are sometimes severe enough to lead to suicide.
▪ Problems first emerged 23 years ago
As early as 2002, 19 patients were reported to develop depression during finasteride treatment for [androgenic alopecia]… In 2006, a prospective study on 128 patients showed a significant increase in depressive scores and concluded that finasteride should be prescribed cautiously for patients at high risk of depression.
▪ When regulator’s ears pricked up, Merck covered up
In 2010, the FDA discussed including depression as a possible side effect of finasteride, but also noted that suicide ideation, attempts, and completed suicide were reported in numbers lower than expected. The actual degree of underreporting was not explicit as Merck kept the number of finasteride users confidential…
Despite suspicion before 2011 leading the FDA to include depression as a finasteride side effect, not one of the studies presented in Table 1 was performed by Merck or requested by the regulator. The manufacturer’s failure to perform disproportionality analysis on adverse event reporting systems is remarkable since Merck itself scientifically examined the value of this tool, concluding in 2006 that “[It] demonstrate[s] sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.”
▪ Smoking gun uninvestigated
In a disproportionality analysis of FAERS data recently reported by Gupta et al, signals for suicidal ideations were reported in individuals taking finasteride only after 2013. This could reflect underreporting by clinicians and patients who were unaware of the possible link between finasteride and psychiatric risk… However, the finding and its reporting took a decade to occur: the signal was buried in the FAERS data in 2013, waiting for a disproportionality analysis to uncover it. Still, it was discovered and published only in 2025 by a group independent from the manufacturer and the regulator.
▪ Defendant exhibited egregious hypocrisy
[Merck]’s omission to perform data mining in health plan records is also surprising given that Merck has invested, since 2013, millions of dollars to get hands-on, real-world patient databases. These omissions contradict Merck’s claims on its website: “The safety of patients treated with our medicines is our top priority” and what Organon…recently said: “Nothing is more important to Organon than the safety of our medicines and the people who use them.”
▪ Massive damage done (now the script needs flipping)
Extrapolating from the baseline prevalence of depression and suicidality in the population, exposure to finasteride of 4 million worldwide over 20 years might translate into hundreds of thousands who endured mood alterations up to depression with suicidality, while hundreds to thousands might have died by suicide.
Although speculative, these numbers indicate a potentially significant public health hazard. According to the precautionary principle, such a risk from a cosmetic medication suggests an unfavorable benefit-to-harm balance that justifies action to protect the public, and the burden of proving that the intervention is NOT harmful falls on manufacturers.
Dr. Brezis also offers suggestions for assessing the scope of the current PFS epidemic, while preventing similar scenarios in the future:
▪ A promising approach to estimate the magnitude of the problem would be a systematic recording of medication history for all suicides determined at a coroner’s or a medical examiner’s office… Comparing the rate of suicide in people exposed to finasteride to the rate of suicide in a control population might allow an estimate of the number of suicides caused by finasteride.
▪ [B]efore approving a medication for the market, regulators should require manufacturers to commit to performing and disclosing ongoing postapproval analytical studies.
▪ An informed consent form has been suggested to help preserve a patient’s right to get a self-enhancement drug while being aware of its potentially severe side effects.
Furthermore, he adds:
The societal costs of [finasteride’s] adverse effects are prohibitively high: the average direct and indirect costs…of depression are [approximately] $24,000 per patient per year. An increase in depression rate by 50% among finasteride users may translate worldwide into 200,000 people suffering from depression at a cost of $4.8 billion per year. This external cost, higher than the industry’s profit from the drug, makes it a bad deal for society
Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar (5 mg, for enlarged prostate), and again in 1997, as Propecia (1 mg, for hair loss).
In June 2021, Merck spun off its Organon subsidiary as an independent public company (NYSE: OGN). Founded in the Netherlands in 1923, Organon bills itself as a “global health care company dedicated to making a world of difference for women, their families and the communities they care for.”
Among the Merck products Organon acquired in the deal were Proscar and Propecia. To report adverse events for either finasteride product, call the Organon Service Center at (844)674-3200, or email Service_Center@Organon.com.
Anyone living in the US who suffers from PFS should also report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local DRA, as directed on our Report Your Side Effects page.
If you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org
Thank you.