FDA responds to the Citizen Petition of the Post-Finasteride Syndrome Foundation

General Discussion Media & Awareness
#21

The harsh reality of our struggle is that most ppl see PFS patients as an inconvenient nuisance esp since young balding men are not a sympathetic social category.

People have cared about cigarettes and nicotine for decades and everybody knows that the tobacco industry has held a death grip on Americans for generations.

I think what is needed is some other reason to get people interested in PFS. The FDA refused to even disclose that finasteride disrupts neurosteroid production on the product label and they gave a totally lazy and BS reason. But when people start to get interested in the underlying science, people will be more likely to look at PFS patients as an interesting and tragic case study.

Neurosteroid science is beyond the scope of mainstream science now, epigenetics is practically further out in my opinion, but once the causal scientific mechanisms start to become clearer and more practical, people will possibly be willing to revisit this.

Sage Therapeutics had a trial for brexanalone for major depression but it failed largely because they tried to cut corners and design a bad clinical trial. I think they are trying it again with a better designed study.

EDIT: It looks like Sage (with Biogen) recently re-did their phase 3 trials for the pill version of Zuranolone for major depression and the results were acceptable. They’ll apply for an NDA by the end of 2022 and hopefully this drug will be available to try for PFS patients to see if it an provide any symptomatic relief.

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#22

To be honest I don’t think we can accurately say whether or not we are a sympathetic social category. There are different ways to view our situation. A narrative involving impressionable young people who have their insecurities preyed upon is not necessarily unsympathetic. I could see how that narrative could garner significant sympathy.

Recovering drug addicts get sympathy in society. Why shouldn’t we? They knowingly abused things which are known to be harmful. We did nothing wrong and will get sympathy when we are more vocal. It’s only now that patients are really starting to speak out.

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#23

I think sympathy-wise we’re more like botched cosmetic surgery than drug addicts.

#24

I’ve seen you write this before, is this how people have reacted when you have shared what’s happened to you? All of the people I have told have been supportive, some find it difficult to understand but they certainly haven’t been dismissive of my problems.

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#25

I’m sure botched cosmetic surgery victims get support from loved ones too. I think by ‘most ppl’ @Frustrated was talking about the world at large, not our friends and family.

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#26

I refuse to accept or believe that. We trusted doctors and took something that is perfectly legal and socially acceptable. We deserve and will get support and sympathy from the world. If people who inject illegal harmful drugs into their bodies can get support and sympathy then we bloody well can too.

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#27

I can see your point. I don’t think it’s much of a barrier to progress though. Our group are small in number, but not tiny. 1000 patients donating €100 a month would be enough for multiple studies per year. It’s a lot of money, but it’s difficult to put a price on health. Add on top of that support from personal networks and we could make a real dent in this problem pretty quickly.

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#28

The shit is until we have a biomarker to identify PFS the medical community denys the existence of this horrible syndrome. No ICD 10 entry, no disease. That’s the fact. If we get the entry, they say ok you have been fucked with PFS but you can’t sue Merck because Merck doesn’t sell it anymore. And to your time they didn’t know about PFS as a disease. The only thing, they make than a microscopical miniature advice in anecdotal cases patients reported a PFS anywhere at the miniature leaflet.

It’s s long fight. Only if prince Harry for example gets PFS the entire world is crying and people delight thousands of candles and headlines all over the world.

#29

It’s not much different though is it? They trusted doctors who prey on insecurities and when things go wrong doctors hide behind their lawyers. It’s socially acceptable enough that celebrities do it and even they get screwed up. Your refusal to accept or believe it kind of belies the same level of sympathy we should expect, no?

#30

A 19 year old boy is chemically castrated and lobotomised for taking a mass marketed drug that his doctor told him was perfectly safe. He then commits suicide.

A 19 year old junkie continually shoots heroin into his arm after having been warned his entire life that heroin is destructive and harmful. He overdoses and dies.

Objectively speaking, the former narrative is far more sympathetic. It just needs to be promoted and humanised. Which is what is happening now with people finally speaking out.

#31

We will be able to sue Merck and other manufacturers once the basic science gets done. There’s no statute of limitations. Merck is still selling this crap anyways.

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#32

I’ve said it in the past but will say it again, i’m sure people would be more sympathetic towards us if we were less finasteride-centric, if we said that we just have a rare condition in which we are damaged by anti-androgens like finasteride, accutane or SSRIs, not only people would be more understanding, that could even get some more attention. We are not only balding young men with ED, accutane is prescrived to children too, for example.

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#33

There are several biomarkers that have been identified. The good news is that doctors who are at least a little interested in patient care are starting to recognize the condition. The FDA didn’t bother to dedicate a fraction of time to this petition that it deserved and they dismissed it as a nuisance. When there are clearer at a fuller mechanistic level then people will pay a lot more attention and be able to draw comparisons to other illnesses to draw lessons. The process for discovering scientific truth takes more time than I would have hoped.

#34

If a causal mechanism is identified that ties together all of these disparate cases and syndromes, that would be a huge breakthrough and the patient population would multiply instantly. Right now, it is not fully clear how these syndromes are related beyond sharing some of the same symptoms and being seemingly caused by a pharmaceutical.

#35

Which ones? There are some irregularities, but they’re all over the place and doesn’t always correlate with symptoms AFAIK.

Only thing that’s been consistent is high CSF T and low CSF DHT + DHP. But that isn’t something you can test at your GP’s office.

#36

What can you expect from a country in which money rules the world. I am not a communist and neither a capitalist but the truth is pharma companies have the best lawyers because they have lots of money. Donald trump was able to candidate because of his money, OJ Simpsons got away with murder or at least didn’t get the lethal injection which non celebrities would have gotten if they committed the same crime.

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#37

I agree with you. The question is what actions are you taking to help make this the case?

#38

I don’t think the issue is that people lack sympathy for PFS. The problem is that almost no one knows about it. Most people probably assume that if a drug could cause such a debilitating side effect, it would either be taken off the market, there would be a warning, or the drug company would be sued. It seems unbelievable that commonly used drugs, which have been on the market for decades can cause side effects that patients still aren’t warned about even if they read all of the fine print. What is needed is for someone famous with a large audience to make people aware of this condition. There are lots of people around the world who won’t vaccinate their children because some influential people spread the idea that autism is a potential side effect of vaccines. What the PFS/PSSD community really needs to gain sympathy is for a big television show host to bring attention to the issue. I think we should try to get “Tucker Carlson Tonight” to do a segment on PFS. It seems like something right up his alley. He talks about the end of manhood, declining sperm counts and how the US government fails to protect its citizens. I know that half the country really hates Tucker Carlson, but when he makes claims about the Covid vaccines or testicular tanning to boost testosterone other media outlets report on what he says.

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#39

I agree. The key question really though is how are we going to effectively go about taking action to make this a reality. We really need a different model. People come up with ideas and then there is no follow through or coordination on a bigger scale which would be necessary to see results.

We aren’t going to be able to reach people like Tucker unless we have a small army of committed patients who keep contacting regularly.

#40

I actually have a good friend who was one of the original employees at this news website that Tucker Carlson set up before he became really famous. I read that Tucker no longer lives in DC, where this company was but my friend might know some other employees there who still keep in touch with him.

I did a google search of Tucker’s opinions on pharmaceuticals. I can’t find that he personally ever mentioned Finasteride or Isotretinoin, but he has criticized SSRIs and psychiatric medication several times, including recently promoting this conspiracy theory that the government wants to lace our water supply with SSRIs. We really need to get in touch with him! Make him tell his viewers that SSRIs in the water supply could lead to mass sexual dysfunction and falling fertility. Also, I read an article that former President Trump takes Finasteride. This might peak Tucker’s interest, although maybe he won’t cover it on air because he probably has a personal relationship with Trump and won’t want to embarrass him publicly by stating that he may have drug induced sexual dysfunction. We need to get the media to cover this, sensationalize this, scare people and force Congress to allocate money for research.

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