2015 PFS Foundation Annual Address

Aug. 4, 2015

Dear Friends:

By many accounts, we’ve reached a tipping point on post-finasteride syndrome awareness within the medical community. The most significant advancement occurred in March, when the U.S. National Institutes of Health added PFS to its Genetic and Rare Diseases Information Center.

“Studies are under way to understand the safety profile of 5-alpha reductase inhibitor drugs with respect to adverse events…and their permanency,” the agency noted, linking to our website.

Few events could have encouraged me more. For one of the most common frustrations among PFS patients is that their doctors have never heard of the condition, let alone lend a sympathetic ear. And if pressed, many dismiss it as psychosomatic.

But with the federal government validating PFS, more and more health professionals are becoming educated on the potential dangers of finasteride, and passing that information onto patients and colleagues.

Now, to mark the PFS Foundation’s three-year anniversary, I’d like to share some additional milestones of the past 12 months:

Clinical Studies: On Dec. 9 we announced the funding of a third major research initiative, this one conducted by Dr. Guido Cavaletti, head of the Neuroimmunology Center at San Gerardo Hospital in Monza, Italy, and Dr. Roberto Melcangi, head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences at the University of Milano. The objective of this study is to determine why PFS patients develop neurological and psychological dysfunction. Meanwhile, our studies at Brigham and Women’s Hospital and Baylor College of Medicine continue to progress steadily.

Sponsored Research: In addition to those clinical studies, we co-sponsored a meta-analysis of clinical-trial data by Dr. Steven Belknap of the Northwestern University Feinberg School of Medicine. Dr. Belknap’s analysis, Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia, was published in the June issue of JAMA Dermatology, and concluded that “Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of [androgenic alopecia].”

Supporting Research: Peripheral to the studies funded by the foundation, there has been an increase in the quantity of published research supporting the thesis that finasteride does in fact cause PFS. Cases in point: Finasteride, not Tamsulosin, Increases Severity of Erectile Dysfunction and Decreases Testosterone Levels in Men with Benign Prostatic Hyperplasia (Hormone Molecular Biology and Clinical Investigation, June 2015), which cautioned that “Clinicians are urged to discuss the impact of 5α-RIs therapy on sexual function with their patients before commencing this therapy”; and Persistent Sexual Dysfunction and Suicidal Ideation in Young Men Treated with Low-Dose Finasteride (Pharmacotherapy, July 2015), which concluded that the risk of sexual dysfunction “might contribute to [suicidal ideation]. Our findings provide a strong hypothesis for pharmacoepidemiologic studies to further examine this association.” (For a full directory of PFS-related studies, please visit our Published Research page.)

Organ Donor Program: On July 15 we announced the establishment of The Southwest Brain Bank in the Department of Psychiatry at the University of Texas Health Science Center. The SBB’s mission is to collect and study post-mortem human brain and spinal cord tissue in patients with PFS in order to better understand the pathology and etiology of the condition.

Public Awareness: We expanded our distribution list of doctors and other health care professionals who have backgrounds in finasteride use and research from 500 to more than 2,500, focusing on faculty members at the top 25 medical schools in the U.S. Soon thereafter, we issued a Public Health Advisory on NIH recognition of PFS and Dr. Belknap’s meta-analysis to those medical pros, more than 100 public-health agencies in 83 nations, and 450 members of the news media worldwide. Meanwhile, the latest analyics show that, since the foundation’s launch in 2012, people in 167 nations have accessed information on PFS from our website, while website traffic is up 40% year over year.

Media Coverage: In tandem with the increased volume of clinical research on PFS has come increased media attention. Recent coverage has ranged from domestic publications like the Milwaukee Journal Sentinel and MD Magazine to international outlets like Agence France-Presse and Australian Financial Review.

As year four of our mission to fund research and increase awareness of PFS while helping support those afflicted by the condition gets under way, I ask each of you to continue giving generously to the foundation so that we may continue this vital—and often life-saving—work.



John Santmann, MD