2024年度致辞

“When we began investigating PFS more than a decade ago, we were pretty much groping in the dark as to the nature of this phenomenon from a molecular point of view,” said Prof. Melcangi. “But the past two years have brought several breakthroughs that, when considered with the entire body of PFS research published to date, tell us it’s critical to complete the Milano Project as soon as possible—if we ever hope to identify effective therapies.”

Among those breakthroughs were two studies published over the past 12 months:

• Exploring rat corpus cavernosum alterations induced by finasteride treatment and withdrawal (Andrology, August 2023), which demonstrated that “finasteride treatment, but not its withdrawal,” affects the penile tissues facilitating erection. In other words, PFS ED may be related to brain damage rather than groin damage—an important distinction when searching for effective therapies.

• Analysis of the finasteride treatment and its withdrawal in the rat hypothalamus and hippocampus at whole-transcriptome level (Journal of Endocrinological Investigation, March 2024), which, via a next-generation sequencing technology known as RNA-seq, identified 186 brain genes that are likely linked to major PFS symptoms, including depression, anxiety, insomnia, and cognitive dysfunction.

The Milano Project carries a price tag of $300,000, about 15% of which is already subscribed, leaving $255,000 to fulfill over the next two years. So we plan to fund-raise aggressively for the initiative at every possible juncture, including this one:

Harvard queries clinicians

If we’re living in a world where large swaths of doctors remain so ill-informed of finasteride’s true risks that a subset of them pop Propecia like candy—and subsequently develop PFS—how safe can their patients be? Worse, what’s to be said of doctors who exacerbate the situation by penning review articles and commentaries that question the existence of this condition?

Such questions were top of mind with Michael S. Irwig, MD, of Harvard Medical School when formulating his latest study, Beliefs and Counseling Practices Among Dermatologists Regarding Sexual and Other Adverse Effects of Finasteride (Journal of Impotence Research, August 2024).

In all, Irwig and his team of four researchers surveyed 100 dermatologists and resident dermatologists at two annual meetings: the American Academy of Dermatology (March 2022), and the Society for Investigative Dermatology (May 2022).

Despite the fact that the finasteride product label has included depression and persistent loss of libido as possible side effects going back more than a decade, Dr. Irwig, an endocrinologist practicing at Beth Israel Deaconess Medical Center, found that the majority of dermatologists are either unaware or skeptical of these potential adverse reactions.

Additionally, 31% of dermatologists said that when starting their patients on finasteride, they would counsel 0% to 25% of them on the drug’s potential to cause persistent sexual side effects. Only 40% of the respondents, however, said they would counsel 76% or more of their patients on the drug’s potential to cause persistent sexual side effects. And yet, of the 90 respondents that initiated at least one patient on finasteride, 21% of dermatologists and 25% of dermatology residents reported that at least one of those patients suffered persistent sexual side effects.

REGULATORY ACTIVITY

Going hand in hand with the need for new PFS research is the need for more nations to warn their citizens accordingly of finasteride’s many potential dangers. So we tip our hat to Canada and the UK this year for doing just that, while welcoming a new ally to the PFS-awareness table.

Asian analysis off the charts

That ally would be Japan. In August 2023, the nation’s drug-regulatory authority (DRA), Pharmaceuticals and Medical Devices Agency, published a disproportionality analysis of suicidality associated with finasteride and dutasteride. (Like finasteride, dutasteride is a 5 alpha-reductase-type-2 inhibitor, and is used to treat enlarged prostate, but was originated by GlaxoSmithKline.) Based on 19,913 adverse reaction reports (ADRs) for finasteride housed on the World Health Organization’s VigiBase database, the analysis concluded that:

“The number of [suicidality ADRs] was significantly higher than would be expected for the entire database. The results…suggest a relationship between finasteride and suicide-related events.” Most striking within that analysis are the expected number of ADRs (a calculation based on the proportionate reporting ratio for all drugs in the database, other than—in this case—finasteride) for “suicidal ideation” and “completed suicide”:

• For suicidal ideation, the number of expected ADRs was 43, but the actual number was 470, representing a 993% increase.

• For completed suicide, the number of expected ADRs was 40, but the actual number was 148, representing a 270% increase.

Such analyses, according to Uppsala Monitoring Centre, which manages VigiBase, are designed to “generate hypotheses on possible causal relations between drugs and adverse effects.”

Canada acts after fourth probe

In January 2023, Health Canada (HC) completed its fourth finasteride-safety review, the findings of which are delineated, in part, as follows:

• [HC] reviewed 401 cases…of suicide, suicidal ideation and/or self-injury in patients using finasteride from the Canada Vigilance database. Of the 401 cases, 25…met the criteria for further assessment to determine if there was a link between the use of finasteride and suicide, suicidal ideation and self-injury.

• Of the 25 cases, 23…were found to be possibly linked to finasteride use.

In January 2024, via its monthly Health Product InfoWatch bulletin, HC informed its nation’s healthcare professionals that:

The Warnings and Precautions and Patient Medication Information sections of the Canadian product monographs [aka, labels] for Propecia [finasteride 1 mg, for hair loss] and Proscar [finasteride 5 mg, for enlarged prostate] have been updated with the risk of mood alterations.

The agency went on to highlight key messages, including:

• There have been post-marketing reports of serious psychiatric symptoms in patients treated with finasteride that sometimes continued after treatment discontinuation. Mood alterations including depressed mood, depression, self-harm injury, suicidal ideation, as well as worsening of pre-existing depression have been reported in patients treated with finasteride.

• It is recommended that all patients be screened for suicidal ideation, self-harm, and depression and/or associated risk factors before treatment initiation.

• Clinical monitoring of all patients for signs and symptoms of psychiatric disorders should continue throughout treatment and afterward.

Britain sounds second alarm

In April, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a Drug Safety Update alerting health care pros that finasteride patients risk developing psychiatric and/or sexual side effects that can persist post-treatment.

The hallmark of this public-health campaign, scheduled for implementation by year end, will be a patient card packed into all finasteride products, including Propecia and Proscar, as well as generic versions of both drugs. It read, in part: “This medication can cause side effects including depression. In some cases, it may lead to having thoughts of suicide.”

Additionally, the following guidelines have been set forth for health care pros:

• Before prescribing finasteride, ask patients if they have a history of depression or suicidal ideation.

• Advise all finasteride patients to read the PIL, which contains a full list of known possible side effects, and to tell family and friends that finasteride can negatively impact psychological well-being.

• Advise patients prescribed finasteride 1 mg to quit immediately if they develop depression or suicidal thoughts, and to contact their doctor asap. Advise patients prescribed finasteride 5 mg to consult their doctor asap if they develop depression or suicidal thoughts.

• Monitor all finasteride patients for psychiatric and sexual side effects, and report adverse drug reactions (ADRs) to the MHRA’s pharmacovigilance database, aka Yellow Card scheme.

A previous Drug Safety Update, citing reports of depression and suicidal ideation among finasteride patients, was issued in 2017. But back then, there was insufficient evidence that those ADRs could persist, said the MHRA.

(For a listing of all nations known to have issued PFS warnings, please consult our PFS Global Warning Map.)

EPIDEMIOLOGY

The heights of adversity

We continue to monitor and publish ADR data for finasteride housed on VigiBase, so that health pros, consumers, DRA staffers, and members of the media are aware of global trends. As usual, all key indicators have risen year over year, with suicidal ideation leading the pack at 13.9%, followed by psychiatric disorders (7.9%), and completed suicides (6.2%).

From an aggregate perspective, the total number of finasteride ADRs rose 9.6%—more than doubling last year’s rise. The absolute number of 1,871 new ADRs during this period translates into more than five likely cases of PFS reported each day to the WHO. And the absolute number of six completed suicides means one every eight weeks.

This past year also saw the arrival of two distressing milestones. In December, the total number of reports of completed suicide contained in VigiBase hit 100, and currently stands at 103.  Four months later, the total number of finasteride ADRs in VigiBase broke 20,000, and currently stands at 21,287.

(For a more detailed epidemiological snapshot, see our PFS by the Numbers page.)

MEDIA AWARENESS

Protracted professor

After a decade of being reduced to mere soundbites on TV news reports, Prof. Melcangi finally got some quality time in the spotlight. In December, Italy’s Byoblu TV—having been inundated with viewer complaints about adverse reactions to finasteride—invited Prof. Melcangi to sit down for an uninterrupted, 25-minute interview about his chief area of expertise: PFS.

Conducted by Byoblu news anchor Davide Porro, the discussion appeared on La Salute Che Viene (Health Horizon) (English-subtitled version here), which boasts 500,000 viewers.

“As someone who deals with pharmacology, I can say that, so many times, plenty of young men—due to our current struggle with the chaotic Internet market—take these drugs without a prescription,” said Prof. Melcangi of the online proliferation of finasteride-based hair-loss remedies. “We’re aware of people who, even 10 to 20 years after quitting, continue to suffer from these side effects, which are mainly sexual, but also affect other areas. For example, depression, anxiety and psychological instability. Many young patients suffering from these symptoms have committed suicide.”

Prescribee beware

Also in December, La Revue Prescrire ran its annual For Better Health, Drugs to Avoid list. Topping the Dermatology category? Yes, finasteride. “It slightly increases the density of hair on the top of the head, and only for the duration of treatment,” noted the French medical journal, which is wholly independent of the pharmaceutical industry. “Patients are exposed in particular to sexual disorders, depression, suicidal ideation and breast cancer. When medication is the selected option, local minoxidil is less dangerous.”

In explaining its rationale for selecting all the drugs on its list, LRP wrote:

How can we justify exposing patients to medications that cause more side effects than others in the same pharmacological class? The health authorities need to take concrete measures to protect patients, and to encourage caregivers and patients to seek treatments with a favorable benefit-risk balance. There is no valid reason for these drugs, which are more dangerous than useful, to remain on the market.

Enablers everywhere

Just when we thought we’d heard every variation of the prevalent PFS experience—man takes finasteride, man’s life is irreparably damaged, man considers suicide—along comes a new twist. This one was chronicled in the April edition of The Economist’s 1843 Magazine. Headlined Would you risk a breakdown to cure baldness? the 4,400-word feature by John Phipps recounts how a twentysomething British man named Ben took finasteride in 2021—only after his psychiatrist advised him to do so. Two months later, Phipps writes, “the shitstorm started”:

As [Ben] queued for lunch, his heart started pounding. His surroundings fractured. The light and noise of the food court were suddenly unbearable, as if the world around him was screaming. It felt as though some inhuman entity bent on harming him was trying to force its way in at every nerve ending. He staggered home, texting his psychiatrist, who told him to go to the emergency room if he was really worried.

Within a few months:

Ben was having four or five panic attacks a day. He was 40lbs below his normal weight. Using a cocktail of sedatives, he could manage three hours of sleep a night. Otherwise, he lay awake taking deep breaths, eating calorie-laden nuts and bracing against the next onslaught of terror. He would wake into an all-consuming brain fog. It became impossible for him to read or concentrate. The terror became relentless. He began thinking about ways to kill himself.

Since Phipps, who’s not losing his hair and is in perfect health, is a personal friend of Ben’s, he didn’t want other men meeting the same fate. So he decided to find out how easy—or difficult—it currently is to obtain finasteride in the UK. In recent years, he wrote:

[A] slew of startups have emerged that claim they will relieve men’s embarrassment around going bald. Hims, an American website that prescribes treatments for baldness, skin care and erectile dysfunction, was founded in 2017. When I first tried to order finasteride from Hims…the website asked me if I had any relevant medical issues. I invented a history of suicidal thoughts and erectile dysfunction. A doctor contacted me to say that, in light of this medical history, he was not able to prescribe me the drug.

On Freshman, a British website, I added finasteride to my basket and, when prompted before checkout, ticked the boxes for suicidal thoughts and erectile dysfunction. A notice popped up: unfortunately I wasn’t eligible for the drug. I unchecked the symptoms. The notice disappeared and I was able to order a prescription. A week later Freshman emailed me to say the site had been acquired by the company that owned Hims. Though it had deemed me unfit for treatment, Hims would now be dispensing my finasteride prescription every month.

(For a complete listing of PFS press coverage, please visit our Media Awareness page.)

MEDICAL AWARENESS

Telemed terror

John Phipps isn’t the only one for whom Hims elicits antipathy. A month before his 1843 feature dropped, we received an email from a 42-year-old Californian—let’s call him Gary—which began, in part: “I believe I’ve developed PFS from topical finasteride.”

Gary went on to say he’d begun using the product six months earlier:

A few weeks after that, I was stricken with severe gastrointestinal issues. I didn’t link it to finasteride. Instead, I believed I’d caught a severe stomach bug. But I was so ill that I quit finasteride on December 13. The day after Christmas, I had a complete mental breakdown, developed tinnitus, lost all feeling in my private areas, and began having horrendous thoughts. I’ve since seen at least 20 doctors in multiple specialties. I’ve been to the emergency room three times for severe high blood pressure, rapid heart rate, and feeling like I was going to pass out.

 The doctors have no idea what to do. They tell me finasteride couldn’t have caused this. Still, they’re also perplexed as to the source of my high-blood-pressure episodes and abnormal pulse. They’re looking into possible neurological or hormone issues as a cause. And I’m worried I could end up in cardiac arrest.

Now back to the beginning of Gary’s email, which read—in full: “I believe I’ve developed PFS from topical finasteride that I got from Hims.”

No shortage of admonitory MDs

Clinicians, pharmacologists and researchers continue to voice their concerns about finasteride use, particularly in young men. Year over year, the number of such professionals aggregated on our Doctors & Researchers Speaking Out page rose from 126 to 158.

Among the 32 new entrants is Ted Schaeffer, MD, Chair of the Urology Department Chair at Feinberg School of Medicine. In October, he told The Drive podcast host Peter Attia, MD:

There’s significant pathology associated with taking finasteride. We used to think it was just in those main structures—follicles for hair, prostate—but now we know there’s profound potential impact, centrally, in your nervous system. It can affect your sex drive, your sexual performance, etc., etc… I think about one in 10 guys will have appreciable issues with [finasteride]. There are people I know who have [PFS] permanently.

That same month, Fabio Castiglione, MD, a Urologist Consultant at King’s College Hospital NHS Foundation Trust in London, wrote in his AskFabio blog:

The exact cause of PFS is not fully understood. However, the wide localization of the 5-ARI enzyme in the body, including the brain, bones, and muscles, leads to the reduction of DHT in related tissues… [PFS] is a complex condition that requires further research and understanding. Collaborative efforts among researchers, health-care professionals, and patient advocacy groups are essential to develop evidence-based guidelines and novel therapeutic approaches.

In May, Pierre-Marc Bouloux, MD, Director of the Centre for Neuroendocrinology at University College London, told The Telegraph:

There is clear evidence that the symptoms of some patients who have been exposed to finasteride are unexplained, and the pharmaceutical industry has been extremely reticent to explore this. Add in relational difficulties plus premature hair loss and you could have a perfect storm to make some people more vulnerable.

In June, Xin Xi, PhD, a researcher in the Pharmacy Department of Chongqing Medical University, published A Pharmacovigilance Study of Drug-reduced Male Semen Quality Based on the Food and Drug Administration Adverse Event Reporting System Database (Andrology), which found that finasteride massively overshadowed all other medications. Xi wrote:

This study aimed to identify culprit drugs that reduced male semen quality based on the United States [FDA’s] adverse event reporting system… [T]he five drugs with the greatest number of cases were finasteride (845 cases), dutasteride (163), tamsulosin (148), testosterone (101), and valproic acid (54).

POSTHUMOUS AWARENESS

ME too

In June of 2023, a decorated US Air Force pilot who’d been suffering from PFS for seven years—let’s call him Brian—positioned a loaded pistol behind his right ear and pulled the trigger. The shot killed him instantly, splattering blood, brain tissue and bone fragments on the wall of his Florida flat. But Brian, being a conscientious soul, had prepared for that by taping large sheets of clear plastic on the wall, so cleanup would be minimal.

His suicide note read, “Please Stick with life. I’m dumb. Don’t EVER follow what I did, it just hurts others. Soon I’ll be a skeleton.”

We know of Brian’s case because in 2016, soon after he was medically discharged from the USAF due to PFS, he donated $100 to the PFS Foundation, for which we thanked him, and he thanked us back. Up until 2019, he was a regular reader of our newsletter, looking, like thousands of PFS patients worldwide, for clues to an effective therapy for his condition, which by the end included coagulation disorders and congestive heart failure.

When we read Brian’s obituary (from which, incidentally, we learned that both his parents are MDs), we wondered if the local authorities had any inkling that PFS led to his demise. We thus contacted the medical examiner’s office with the information we had concerning Brian’s case.

Certainly, the ME would take note, and at least include a line in his report about persistent finasteride side effects possibly contributing to the deceased’s death. And perhaps the ME would mention the case to fellow MEs at the next National Association of Medical Examiners annual meeting, and maybe even present it as a poster. And perhaps, going forward, other MEs—when standing over the corpse of a previously healthy, previously happy, once successful young man who had no discernible reason for committing suicide—would at least ask the question, Did he ever take finasteride?

But that was just wishful thinking. Shortly after informing the ME of Brian’s PFS, we requested a copy of the autopsy, which is public information in Florida. Five months later, the records arrived, and we combed through them for references to finasteride use.

There were none.

ME three

Lest you think Brian’s case was a one-off, read on. In the wee hours of the morning, exactly 1 month before Brian shot himself, a 37-year-old St. Louis man—let’s call him James—threw back a shot of booze and crept into the garage of his parents’ house. He was living there because PFS had forced him to leave his job, his apartment, and his girlfriend, in Florida.

In the garage, James proceeded to hang himself with a rope. His suicide bid would have worked then and there had his father not woken up 10 minutes later, dashed into the garage, cut down his brain-dead son, and called 911. Still, five days after being wheeled into the emergency department of Mercy Hospital, James’ family had no choice but to take him off life support. We know of this case because, shortly after James was admitted to the ED, his brother called us wanting to know how he could help prevent such future tragedies among PFS patients. One of the things we advised was to let the attending MD, and the ME, know about James’ PFS, so that it could be included in the respective reports they’re required to file, and in turn make its way into epidemiological data aggregated by the FDA and WHO.

Though James’ brother did just that, finasteride wasn’t mentioned in the ME’s report (a public record in Missouri, which we obtained for our files). The only reference to anything even vaguely resembling PFS was this:

“The decedent suffered from depression.”

Must-See autopsy

On October 28, 2023, four months after Brian took his own life, Matthew Perry was found dead in the pool of his Los Angeles home. Now, know that we’ve never been conspiracy theorists, and have no plans to ever start down that road. Also know that everything we’ve ever reported on these pages has been based on fact or pure science, an editorial policy that will never change.

That said, we’d heard rumors over the years that the Friends star took finasteride for hair loss. So in December, upon completion of his autopsy report, which is a public record in California, we requested a copy for our files.

As the world by now knows well, the ME summarized this tragic event as follows:

Matthew Perry’s cause of death is determined to be from the acute effects of ketamine. Contributory factors in his death include drowning, coronary artery disease and buprenorphine effects. The manner of death is accident (drug and drowning related). No signs of foul play are suspected in this death.

Reading deeper into the file, however, we were struck by three things:

(1) In the Evidence section of her Investigative Summary Report, LA County Department of Medical Examiner Investigator Jennifer Hertzog noted that among the prescription drugs she collected in Perry’s home was Propecia.

(2) In the Informant/Witness Statements of that same report, Hertzog noted that she interviewed someone (name redacted) by phone, who told her that the actor had a medical history of diabetes, depression, and anxiety. Additionally, he was getting testosterone shots, “which she believes were causing him to be ‘angry and mean’ for the last couple of weeks.”

(3) In the External Examination section of Perry’s autopsy report, Senior Deputy ME Raffi Djabourian, MD, wrote: “The scalp hair is gray-brown. There is no temporal or vertex balding.”

No vertex balding?

In 2015, Splash News photo agency took, and published, pictures of Perry that showed him with a textbook case of vertex balding. Eight years later, just eight months before his death, another photo agency, Coleman-Rayner, took, and published, similar pictures, which showed a slightly more pronounced bald spot.

How the highest profile ME’s office in America could commit such an error, particularly in the case of such a beloved, world-famous figure, is beyond us. But it arguably underscores the need for MEs to pay more attention to finasteride use, and its possible role in premature death.

Takin’ it to the slabs

True to our mission of generating PFS awareness, we didn’t throw up our hands in the wake of such cases. Instead, we spent weeks researching MEs in major cities throughout the US and other English-speaking nations. That yielded 347 names, all of which were added to our mailing list. The question was, would they read?

While there’s nothing pleasing about the upward trend of men taking their own lives due to PFS, we’ve been pleased to see that, yes, MEs appear to be engaged in the issue. For instance, our most recent report, Brother of UK PFS Patient Who Took His Own Life Speaks out in the Wake of New Finasteride Warning, was opened by more than 40% of them, while achieving a click rate of 15%, and being shared with 116 colleagues, for a total readership of 239 MEs.

(If you’re a forensic pathologist and would like to be added to our mailing list, please email us at social@pfsfoundation.org, and be sure to include the name of your agency.)

DIGITAL GROWTH

Seven figures in sight

In January, according to Google Analytics, traffic to our website surpassed 800,000 unique users and 2.3 million page views since our 2012 launch.

Continued digital growth has been driven largely by our four foreign-language editions: Spanish (launched 2019), Chinese (2019), Russian (2020) and Hindi (2021). Of the 91,668 new users to our site from August 1, 2023 to July 31, 2024, 80% came in via our English-language edition, while 20% came in via the overseas editions.

At the current rate of growth, we expect that unique visitors to our site will hit one million by the end of 2025.

As we embark on Year 13 of our mission, we ask everyone to continue giving generously so that we may continue this urgent work. In particular, we’re making a plea to medical professionals.

In the meantime, as directed on our Report Your Side Effects page, anyone living in the US who suffers from PFS should report his or her symptoms to the FDA. Anyone living outside the US who suffers from the condition should also report to the FDA, as well as to his or her local DRA.https://www.pfsfoundation.org/news/2017-pfs-foundation-annual-address/

Finally, if you or a loved one are suffering from PFS and feeling depressed or unstable, please don’t hesitate to contact us via our Patient Support hotline: social@pfsfoundation.org

Sincerely,

Philip Recchia
President

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