Italian story on PFS featuring Professor Melcangi: Finasteride: the risks of the drug against hair loss

The PFS foundation have shared a translation of a recent article in a widely read italian magazine. Please see below.

Starbene (Italy)
August 2019

Editor’s note: This English translation was done by a third party. The original digital story can be accessed here.

With this Hair-loss Medication Comes Great Risk

It’s finasteride, and it contributes to hair growth in men. But it can cause a syndrome leading to impotence, loss of libido and even depression. This is what we uncovered.

by Adriano Lovera

The entire world, including Italy, is experiencing a tragedy that requires our attention. It’s that of men, often young, who in hopes of treating their hair loss, experience much more serious issues after a number of years: erectile dysfunction, loss of libido, sleep problems, even anxiety and depression—so serious in some cases as to lead them to commit suicide. These are tragedies that end up ruining the lives of entire families. As the mother of a 25-year-old, who decided to write to our editorial staff, says, “I’m defenseless against this condition. My son has been in a black hole for a good five years, without any way out.” Following her letter, we decided to investigate.

From the prostate to alopecia

Finasteride was conceived and produced in the 90s in the United States by Merck, and reached Italy in 1999. It’s a drug with a unique history. It debuted as Proscar, and is used by andrologists and oncologists, in doses of 5 mg, to treat enlarged prostate. But it soon came to light that the drug also helps with hair growth. So, after some years, the drug appeared in 1 mg for, as Propecia, prescribed by dermatologists for the most common form of hair loss, androgenetic alopecia.

“This drug, which has an effect on a specific enzyme, reduces the levels of DHT, a hormone that’s among those responsible for the increase in the size of the prostate, but also for the atrophy of the piliferous follicle. An effective drug,” says Roberto Cosimo Melcangi, professor of endocrinology at the department of pharmacological and biomolecular sciences at the University of Milan, who has been conducting studies on the issue for years. “The problem is that this alopecia therapy is often recommended even prior to 20 years of age.” And the unluckiest of these young people fall into a spiral in which it becomes impossible for them to lead a normal life. The American PFS Foundation (acronym for post-finasteride syndrome) notes that the World Health Organization already reviewed more than 15,000 cases of adverse reactions to finasteride, 23% of which are psychological issues, 19,5% erectile dysfunction, 12% libido issues, and 10% cases of anxiety and depression. “My team in Italy, over the years, has received about 100 reports. We already published three clinical studies and are able to estimate a PFS incidence rate of 3% to 4%. The WHO collected 15,000 cases of adverse reactions to the drug. In Italy, the number of patients who reported adverse reactions exceeded 100,” Melcangi adds.

The patients’ battle

But it’s not enough. Among virtually all other drugs, side effects appear during the period of intake, and they disappear after therapy is interrupted. With finasteride, this is not so. “This is the real obstacle. In the cases of those whose side effects remain persistent for a number of years, we categorize them as PFS,” Melcangi explains. Over time, as the number of clinical studies has increased, patients suffering from the condition have been identified all over the world, including in Italy. Meanwhile, the drug’s package insert has been updated to include “suicidal ideation” among its rare side effects. In the United States, Merck is involved in several class-action lawsuits for having failed to suitably inform patients of all possible adverse side effects. “We entrusted in-depth studies to experts, and after the summer, will be ready to file some lawsuits. In a criminal investigation, the possible offenses would have passed their statutes of limitations. But civil reparations are possible,” says attorney Laura Cagnin, from the Calvetti law office, which is working with the Association of Victims of Finasteride. “The majority plaintiffs assisted by us, about 20 of them, have taken the drug in the past decade and they are still suffering the consequences today.” In Italy, Propecia is produced by MSD Italia, a subsidiary of Merck & Co., which tells us: “MSD fully supports the value of Propecia, prescribed to millions of men since its approval. As with all drugs that are subject to medical prescription, the package inserts correctly inform the patient and the physician of all of the advantages, risks and adverse reactions. Nothing is more important for MSD than the safety of its own drugs and of the persons using them. We encourage patients to talk with their family physician with regard to any doubts or questions relating to their health.”

Is it possible to recover from the syndrome?

Unfortunately, there is no way to “go back” and return one’s body to the state it was in prior to using the drug. “Many studies have been carried out by now, but we still have not succeeded in even precisely defining post-finasteride syndrome. It will take years,” Melcangi adds. “The good part is that nowadays many dermatologists are aware of the risks and, as a result, they are more cautious when prescribing the drug. Those who suffer from the condition should speak to an andrologist or psychologist, based on the type of side effects. It’s essential not to give in to the temptation of trusting some forum that recommends do-it-yourself therapies. There is a risk of causing even more damage.”

AIFA (Italian Medicines Agency): 17 cases in the past 2 years The last action by the Italian Medicines Agency (AIFA) concerning finasteride dates back to July 2018. It is an “important note” of pharmacovigilance that encouraged physicians to be aware of the drug’s risks prior to prescribing it. The annual number adverse reactions recorded by AIFA has remains steady, at 17, over the last two years. But is there a predefined numerical threshold, beyond which a drug should be taken off the market? “No, we evaluate on a case-by-case basis and it depends on the type of reaction,” the agency tells us. “If the pathologies caused by a drug are very rare relative to the entire population, even very few cases are enough to generate a warning. If it instead concerns frequent occurrences, the number of cases must be greater.” And, at least at this time, finasteride falls within the latter category, considering that it is difficult to ascertain with certainty whether the more common reactions were not already present in the patient even prior to the therapy, perhaps in a latent state.

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uhg…

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Yup, It made me think about how very little hope is conceivable when reading this…

But what about the few people that have recovered ?

That should tell us that’s its not Impossible to recover.

I really doubt most of the posted “recoveries”

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umm…

so we have to wait till were old

No mention at all of endocrine and metabolism shutdown, complete changes to muscles and skin, mental disconnection from the world around you, visual issues. This syndrome still continues to be misrepresented. “sexual dysfunction and depression” was described to me by the doctor. That’s the risk I took taking this medicine. I suffer far, far worse than sexual dysfunction and depression.

yup and “depression” is a complete understatement of what i experienced in the months following my crash.

every prescription for fin/dut should come with paximperia’s post printed alongside it. would people take the poison then?

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That’s why I’m an advocate of pumping out these youtube videos dude. If I would have seen more videos with users telling their stories (I think I saw 2 and thought they were horseshit), it might have dissuaded me from taking the drug.

How is this guy doing now?

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He took his own life unfortunately. Paximperia was the son of Dr. John Santmann who founded the PFS foundation

And yeah i too saw warnings on propecia on youtube. But still took it. I thought the videos were bullshit too

My English vocabulary is not rich enough to find the precise word here. Can someone help me please? What is it called when you know full well (better than anyone?) that there is no cure, treatment, studies or even awareness about a condition and yet you advice patients to seek medical help about it?

So I shouldn’t listen what my fellow-PH-ers say about how Tribulus affects them, for example. Fine. What paper on the effects of Tribulus (or anything else) on PFS should I read instead? How many treatment protocols have Melcangi tested and which ones are proven to work or not to work?

I guess Merck’s statement is only slightly more the-word-I-am-looking-for-here than Melcangi’s advice: “We encourage patients to talk with their family physician with regard to any doubts or questions relating to their health.”

Well as we’ve said before, unfortunately his working hypothesis and comments in publications do not recognise the physical symptoms of PFS. More than any theory, the most important thing we need is for people (inside the community as well as out) to recognise the full scope of the syndrome. This is why the standardised data from the survey is so important.

And I totally agree re YouTube. Humanising this problem is a huge priority.

@Sibelio: he does explicitly say “recommend”, and in my view he’s right. There is an immense survivorship bias and it is absolutely the case that far too many forum members across any of the issues insist on playing doctor/guru. That is very different to simply reporting your own positive outcomes and if you have thoughts, why you think that might be, which is very positive. As this is such a lord of the flies-esque scenario in which we’ve been disgracefully dismissed by the medical profession, this really contributes to the initial impression patient communities make on rational people as well as endangering patients. However, I very much take your point. The sum of patient clinical experience, often with the psychology profession and their (sometimes insisted upon) prescriptions, has shown that the exact same risks apply. They do not know what they are talking about either. Ultimately, this boils down to the simple fact that the systematic disregard of this issue is putting lives at risk, because it entails a wholly abnormal fragility to further endocrine disruption, particularly amongst the worst patients. As of 2019, that’s the same in a forum or in a clinic, and the solution is basic science, which literature review clearly concludes is direly lacking - and far outweighed by commentaries.

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Which is why a separate page dedicated to explaining the moderators current causal theory re PFS would be of a huge benefit. It would be competition to the absurd homebrew theories that are presented as fact by their proponents. Obviously you would want to wait for Baylor to be published and for any article you are working on to be submitted for peer review. It could also help people to appreciate why a new study is necessary and how it could advance or disprove the current causal theory.

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I do appreciate that and it’s in the roadmap. I think it will be apparent it’s not a trivial thing to write up, and the primary audience is our friends in the scientific community. I am, alongside this, doing a huge amount users don’t see under the hood with our programmer. As well as user management systems to record participation in the main survey, I will later on today be explaining how users will be able to use two new systems launching next week. One allow users to record and share their therapeutic responses and notable reactions in standardised data, while another allows the submission of records of test results. Unlike the main survey (which is more for outreach to scientists and representation), as these are for the benefit of users and data integrity isn’t so critical, users can update their therapies submissions any time, and continually submit new test reports whenever they want. The amount of work I put in is inordinate - please give us some time.

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There would have to be two versions. One version for the scientific community that will be submitted for peer review and a “translation” of the version into something patients with no medical background can understand. Otherwise the mentioned benefits for this forum (i.e. competition to homebrew theories and motivation to donate towards futher research) will not be realized, as nobody will be able to understand it except people who are steeped in the material.

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My question is, if they can’t definite what PSF is, how you can state that there’s is not way to recover from it ?

Because Melcangi knows you cannot reverse this depletion of neuro steroids…

How he knows that is not possible? If you don’t know the cause
…Oh well of course if you don’t know the cause it can’t not be reversed, but only until you found what is causing it.

The fact that not everyone that take 5alpha inhibitor develop PFS point to a epigenetic issue, today there are technology that can reverse it.
Just to mention an example
In my case I have all the mental symptoms suicidal thoughts, depression, anxiety, panic attacks constantly…
All those symptoms are gone.

Recently for an entire month I was feeling in the sexual side complete recovered, even having low free testosterone, I been able until now to have enjoyable sex with my wife.

It tell me that it can be reversed, and what he stated is not totally true.

A better answer should be:
Until now we didn’t found have the way to reverse it.

I don’t know how accurate the translation is, even though this kind of post is what makes people to commute suicide.

I think that Moderator should be careful about this kind of post in the future.

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Any of those drs will tell you there is no “known” way to reverse this change to brain hormones…If it is no one has found a way to do it…