Dr. Michael S. Irwig - Late 2021 Medical Journal Publication

Earlier this year, I introduced myself to Dr. Michael S. Irwig (who of course needs no introduction here!). He has been incredibly kind, helpful and responsive. In our most recent discussion, he shared with me his latest medical journal publication: “How routine pharmacovigilance failed to identify finasteride’s persistent sexual side effects”.

While technically not finished yet, this is where it will appear, so please keep an eye on the following link: https://pubmed.ncbi.nlm.nih.gov/34713622/


You have to buy the pdf

I did not realize that, I was given my copy and just wanted to spread the word.

Can anyone who purchased it summarize it on this thread?

This is what’s written about PFS.

Finasteride, dutasteride and saw palmetto are 5 alpha-reductase inhibitors that can trigger an enduring sexual dysfunction with a very similar profile to PSSD [32]. As the name suggests, PFS is most commonly associated with finasteride which was licensed for the treatment of male pattern baldness in 1997. In 2011, a warning for erectile dysfunction that persisted after stopping treatment was added to the US product label for the finasteride products, Propecia and Proscar. This was updated in 2012 to include libido disorders, ejaculation disorders and orgasm disorders that continued after discontinuation of Propecia, and decreased libido that continued after discontinuation of Proscar [33]. There should be no prior use of isotretinoin or an SRI when making a PFS diagnosis. Sexual dysfunction that happens on finasteride but clears after treatment stops is not PFS.



(1) Prior treatment with a 5 alpha-reductase inhibitor.

(2) Enduring sexual dysfunction after stopping treatment.


(3) Enduring reduction or loss of sexual desire.

(4) Enduring erectile dysfunction.

(5) Enduring reduction in genital and orgasmic sensation.

(6) The problem is present for ≥3 months after stopping treatment.

There should be

(7) No evidence of pre-drug sexual dysfunction that matches the current profile.

(8) No current medical conditions that could account for the symptoms.

(9) No current medication or substance misuse that could account for the symptoms.

(10) No other prior medication that could account for the symptoms.

A number of related features may stem from finasteride without being diagnostic for PFS:

  • gynecomastia
  • altered seminal quantity and quality.

Additional finasteride effects that can occur independently of any sexual difficulties but may also accompany sexual problems include:

  • cognitive impairment
  • depression
  • suicidality.

There is some evidence for penile curvature or other penile effects in men with PFS [25], but it is not clear if this was present prior to treatment or has resulted since. Alterations in neuroactive steroid levels [34], methylation of 5 alpha-reductase type 2 in cerebrospinal fluid [35], and gut microbiota population [36] have also been found in PFS patients. But again, it is not clear whether these were present before treatment.


According to this guy I wouldn’t even have pfs then because i have no sexual symptoms :roll_eyes:

And I took Accutane 25 years ago? Others here such as soccerguy who was a participant in the Baylor study and they ran that local news piece on was told by Irwig he didn’t have pfs…He had to get a diagnosis from Jacobs in New York I believe even though Irwig appears in that same news clip it was him that gave the diagnosis

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There is some evidence for penile curvature or other penile effects in men with PFS [25], but it is not clear if this was present prior to treatment or has resulted since. Alterations in neuroactive steroid levels [34], methylation of 5 alpha-reductase type 2 in cerebrospinal fluid [35], and gut microbiota population [36] have also been found in PFS patients. But again, it is not clear whether these were present before treatment.

I hate that they have to state that it is not clear whether these alterations were present before treatment because the mechanism of action by which finasteride does this has not been proven. However, patients who experience these symptoms such as penile tissue changes, 100% know it was caused by finasteride. Same thing with the Baylor study where they have to state that causation could not be established when it is way beyond a reasonable doubt that finasteride induced on these changes. It’s sad that Baylor doesn’t even get any press due to this. We are basically the only ones who know all about Baylor. Doctors don’t know and people considering finasteride will be hard pressed to ever come across this study. It is infuriating to me and it’s why we desperately need more research.


Although Irwig is to be rightfully praised for the significant work he has done in promoting awareness, I am concerned that he only appears to talk of either sexual dysfunction or depression, and I wouldn’t want yet another gate keeper to come along which would in effect actively deny the very real suffering of those exposed to this drug when it comes to determining who actually has pfs. I have also taken anti-depressants and continue to do so, so my own waters are decidely muddy, but as Irwig himself says, we know our own bodies and if enough people speak of specific side effects from a specific drug, then we kind of know the causality. It is easy to dismiss patients that don’t have a “clean” medical record, but like a lot of things in real life, we sadly don’t come to the table with a clean slate. Although many pfs sufferers would be dismissed from a trial or from receiving compensation due to pre-existing conditions or medical history, when it comes to diagnosis, there shouldn’t be the same strictures in place, in recognition of the complexity of the drugs impact and the holistic status of the symptomology of the patient. I wouldn’t want any future pfs prognosis tool to carry with it the same flaws which have gas lit almost all of us.


such articles were meaningful a few years ago,but not today . Baylor’s research has pointed out the next direction for us, and the new research set by axo and Mitch has begun. I believe these scientists axo is looking for will publish the results of the new research in a journal that can win everyone’s trust (axo takes so much effort to make the new research effective and influential). We need to take good care of ourselves, maintain a good attitude, work in one direction, and don’t care too much about other things.Just a personal point of view

By the way, one of my classmates and I also discussed my condition today. He thinks that we are not up to the point of using CRISPR. If we find key gene expression errors, we can develop specific drugs to correct them. Therefore, I am very optimistic about the new research of axo, because it is likely to help us establish correct animal models, I have a hunch that we won’t struggle for too long


I’m gonna DM you man

I don’t know man sounds like a very very long shot It is crazy to think we can just edit one of those thousands genes affected its like finding needle in haystak
I think we are many decades away from even starting that
I really think our best option are ppl who r familiar with the pharmacology
all those articles are great for awareness and credibility but we need someone actually trying to treat with something aside from usual trt clomid hcg ect

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I’m not sure if we can create novel treatments for this syndrome, our best bet would be to use existing technology to treat PFS once we figure out of course the mechanics of PFS. Costly wise it would also be the best option.

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I totally agree. In fact, I see that most of the significant studies on PFs are published after 2015. In other words, the biggest problem is that we move very slowly, but the establishment of pfsnet will change this situation. We are confused, but I don’t think finding the cause is like looking for a needle in a haystack, That’s what two people with biological backgrounds told me. Now that axo has found the top experts to study this matter, I believe we can really solve this problem in a visible time

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Yes, once the pathogenesis is clear, we can model, design appropriate drugs and experiment on mice. By the way, there are many public scientific research institutes in China, which can apply to the state for funds for scientific research. I am sparing no effort to find people who are interested in our situation


For what it’s worth, I don’t feel it’s ethical to test on animals. That’s pretty much what has been done to us. It’s not right. That being said, I would consider myself as a treatment test subject. I’m sure we all would.


Do you think China will seriously invest in PFS research?

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I think the “most serious” and “most valuable” research is definitely the research to be carried out by axo. Although no one knows PFS better than us, we are seriously short of funds. 80000 euros is a very small cost for any scientific research team in China. Many Chinese institutions hold hundreds of thousands or even millions of euros of national scientific research funds every year, They are fully capable of carrying out some research. Our problem is not that the disease is terrible, but that our strength is too weak. In China, there is no pharmaceutical group controlling the medical sector. I think it is worth trying, but I still strongly hope that everyone will enthusiastically donate to the new research of axo. I am more willing to put my fate in my own hands than asking for help.
In addition, I have sent emails to seven medical research institutions, and so far I have only received one reply (he said he could not help) :roll_eyes::roll_eyes::roll_eyes:, I’m working hard and donating regularly. I just want to do something