Talk:Finasteride/Archive 5

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Adverse effects

@Alexbrn:: concerning your undoing of my edit to revision 696482475 by Frap about certain ambiguous claims about finasteride's side effects, you stated "Primary studies, drug leaflets & low-quality journal articles - nothing here meets WP:MEDRS. (TW))." Save for the report by the FDA (which I agree should have been quoted as supplementary evidence and not as main supporting literature), the other sources, namely Singh and Avram (2014), and Irwig (2011, 2012), are of secondary nature. The subject of permanent loss of sexual function and depression induced by the drug is a very generic one and given that most studies attempt to go into the specifics of the biochemistry of the drug's action, the information available about these claims is limited to a few journal articles. The meta-analysis by Singh and Avram (2014) establishes valid points to counteract the extraordinary claims on permanent effects made by Irwig (2011, 2012), mainly that the studies were conducted badly and with selection bias. Despite this was published in a non-influential journal (Journal of Clinical and Aesthetic Dermatology), this shouldn't make the paper's argument, if logical, any less valid. The respective impact factors and H indices of the cited articles are reported below, according to SRJ and ResearchGate:

• Journal of Clinical and Aesthetic Dermatology - H Index: 15 ; IF: 0.00
• BMC Clinical Pharmacology - H Index: 25 ; IF: 1.36
• Journal of Sexual Medicine - H Index: 72 ; IF: 3.15
• Journal of Clinical Psychiatry - H Index: 163 ; IF: 5.50

Furthermore, the observation that no permanent change to sexual function can be detected between test and control trials is confirmed by other articles in higher impact journals (some studies even suggest that differences are only perceived, which is a significant factor given that most studies claiming sexual dysfunction rely on test-subjects' reported information), such as the following:

• Cunningham, G. R., & Hirshkowitz, M. (1995). Inhibition of steroid 5 alpha-reductase with finasteride: sleep-related erections, potency, and libido in healthy men. The Journal of Clinical Endocrinology & Metabolism, 80(6), 1934-1940.
• Van Neste, D., Fuh, V., Sanchez‐Pedreno, P., Lopez‐Bran, E., Wolff, H., Whiting, D., ... & Tosti, A. (2000). Finasteride increases anagen hair in men with androgenetic alopecia. British Journal of Dermatology, 143(4), 804-810.
• Mondaini, N., Gontero, P., Giubilei, G., Lombardi, G., Cai, T., Gavazzi, A., & Bartoletti, R. (2007). Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon?. The journal of sexual medicine, 4(6), 1708-1712.
• Silvestri, A., Galetta, P., Cerquetani, E., Marazzi, G., Patrizi, R., Fini, M., & Rosano, G. M. (2003). Report of erectile dysfunction after therapy with beta-blockers is related to patient knowledge of side effects and is reversed by placebo. European Heart Journal, 24(21), 1928-1932.

A causal relationship between testosterone levels and mood is not clear among medical studies, although a correlation loosely exists, although ambiguous. If discontinuation of use of finasteride would lead to baseline testosterone levels, the mood should also return to baseline values. Studies specific to depression and finasteride use are very few, and because of this only inductive conclusions can be made from indirect studies on hormone activity:

• Amore, M., Innamorati, M., Costi, S., Sher, L., Girardi, P., & Pompili, M. (2012). Partial androgen deficiency, depression, and testosterone supplementation in aging men. International journal of endocrinology, 2012.
• Bain, J. (2007). The many faces of testosterone. Clinical interventions in aging, 2(4), 567.
• McIntyre, R. S., Mancini, D., Eisfeld, B. S., Soczynska, J. K., Grupp, L., Konarski, J. Z., & Kennedy, S. H. (2006). Calculated bioavailable testosterone levels and depression in middle-aged men. Psychoneuroendocrinology, 31(9), 1029-1035.

If it would make it more acceptable, I may renew the literature to the additions I made to the article, but I believe that the points I have raised are in line with the facts being available to the scientific community and my additions should remain. — Preceding unsigned comment added by Rrobotto (talk • contribs) 16:00, 2 January 2016 UTC‎

Both Irwig papers are primary sources (prospective study and an interview series). Sing & Avram is in a low-quality journal (non MEDLINE indexed, which is a red flag). Please use WP:MEDRS-compliant sources to source this kind of health information. Alexbrn (talk) 16:08, 2 January 2016 (UTC)

@Alexbrn:: The NLM Unique ID for the J Clin Aesthet Dermatol is 101518173. The WP:MEDRS advise against low quality journals but do not prohibit using them in absence of better sources of information. Irwig's paper is a primary source, I correct myself. However it is being cited to introduce Singh and Avram's conclusions. According to WP:NOR "unless restricted by another policy, primary sources that have been reputably published may be used in Wikipedia; but only with care, because it is easy to misuse them. Any interpretation of primary source material requires a reliable secondary source for that interpretation." (Rrobotto (talk) 11:01, 6 January 2016 (UTC))

Quite. We don't allow careless of primary sources, such as to make claims or imply things about human health as you wish to do. We don't use poor-quality sources for the same reason. Alexbrn (talk) 12:33, 6 January 2016 (UTC)

Your argumentation makes little sense. I have encountered another study on this topic on a high impact journal, and this uses a sample size of 3 patients to draw its conclusions.

• See: Melcangi, R. C., Caruso, D., Abbiati, F., Giatti, S., Calabrese, D., Piazza, F., & Cavaletti, G. (2013). Neuroactive Steroid Levels are Modified in Cerebrospinal Fluid and Plasma of Post‐Finasteride Patients Showing Persistent Sexual Side Effects and Anxious/Depressive Symptomatology. The journal of sexual medicine, 10(10), 2598-2603.

If you understand anything about reliability of data, you'll easily understand how it is quite bold to extrapolate such results to the wider public. High impact does not immediately translate to good research. Good findings are good findings, regardless where they are published. Thus, publishing in low impact journals does not affect the quality of research findings. Journal impact can be affected by the number of researchers who read and quote the article, be this in the positive or negative. Also, some of the high impact factor journals make the entire process so tiresome and difficult for researchers that they prefer other journals. Also in some cases the final published copy is almost entirely different from the original manuscript just because the journal didn't find it as per their norms. Rrobotto (talk) 20:54, 13 January 2016 (UTC)

Rrobotto - please do read WP:MEDRS - what you write above is not in accord with how we craft content about health in Wikipedia. The quality of the source matters a great deal. What is even more important is that the source is secondary (which you do not address in your comments - and the source you cite is primary) and that the source is independent. Glad to have you in the conversation but you need to base your arguments on the spirt and letter of Wikipedia's guidelines and policies. Thanks. Jytdog (talk) 21:26, 13 January 2016 (UTC)

I have read the WP:MEDRS and find it patronizing on your end to be assuming otherwise, especially when it seems like you skimmed through my reply without noticing that I pointed out that Singh and Avram (2014) is a review of other studies and by definition it is a secondary source. Anyway, I'm dropping this for the time being, since it's not an issue on which it is worth wasting time. Critical reviews on the side-effect topic on finasteride are very rare to come by and have to agree with you that it is not discussed in popular journals. Rrobotto (talk) 07:54, 15 January 2016 (UTC)

@Doc James: You deleted the following, stating that you trimmed a primary source:

Finasteride prevents the generation of DHT, however the impact of DHT is broad ranging, and is not limited to activity within the prostate and hair scalp. DHT also influences the synthesis of neurosteroid derivatives in the central nervous system which may impact mood, rhythm, stress, sleep, memory, anxiety, and sexual function. From the knowledge of the mechanism of action of 5α-reductase inhibitors it has been speculated that the unnecessary lowering of such neurosteroid derivatives may give rise to iatrogenic effects. The inconsistency in encountering side effects in users of 5α-reductase inhibitors has been hypothesized to involve genetic variations in androgen receptors sensitive to these chemicals. However, more research is required to determine the frequency of side effects, to assess if there is a true causal relationship for persistence of these symptoms, and thus identify who may be at risk.

References

Can you kindly identify the primary source you are mentioning? The references you removed are a review and an expert opinion, the latter of which is being clearly indicated as such (i.e. a hypothesis). What is your own definition of a primary source? Rrobotto (talk) 08:54, 18 January 2016 (UTC)

If you look at the "Publication Types, MeSH Terms, Substances" part of the pubmed record for those two sources, you will see that one is an editoral and the other is a letter commenting on the editorial. Both are considered PRIMARY per MEDRS; neither are SECONDARY per MEDRS. Jytdog (talk) 14:07, 18 January 2016 (UTC)

@Jytdog: WP:MEDRS states A primary source in medicine is one in which the authors directly participated in the research or documented their personal experiences. They examined the patients, injected the rats, filled the test tubes, or at least supervised those who did. Many, but not all, papers published in medical journals are primary sources for facts about the research and discoveries made.

Reviews, unless the reviewers were part of the initial study, cannot be secondary sources according to this definition. The editor is Irwin Goldstein, an expert in sexual dysfunction and male sexual physiology; under normal circumstances I'd be inclined to think that his opinion counts. Rrobotto (talk) 18:44, 18 January 2016 (UTC)

We should be using review articles. Letters and commentary are not very good sources for commenting on health issues. Doc James (talk · contribs · email) 21:13, 18 January 2016 (UTC)

rrobotto please search MEDRS for "editorial" and you will see what the guideline says about them. Jytdog (talk) 21:16, 18 January 2016 (UTC)

@Doors22: You deleted the following, stating that the primary source is taken out of context:

No significant difference in depression scores and loss of libido, compared to unaffected individuals, has been confirmed. A number of such studies carried an important selection bias among the participants, many of which were recruited from an Internet website for individuals with persistent sexual side effects after using finasteride.

References

The only part which can be considered "out of context" is perhaps the first sentence if it does not give sufficient information, which should be complemented with more information not deleted altogether. The second sentence has nothing wrong with it. It is simply wrong to cite studies and their conclusions without pointing out their limitations if the conclusions are important. In finasteride, the occurrence of side effects related to sexual function is of about 6%. The studies saying that the FDA approved the drug without significant importance given of side effect, dates back to 1997. That's nearly 20 years ago when not even type III 5ARIs were known to exist. Experts say that more research is needed because a portion of the population does experience the side effects. Removing updated information without suggesting otherwise is not constructive. Please, suggest different wording. Rrobotto (talk) 08:54, 18 January 2016 (UTC)

@Rrobotto:, I see you are new here so please realize there is a learning curve to editing Wikipedia. It takes a little bit of time to get used to and can be very frustrating initially. There are subtle differences between primary, secondary, and original (reference) sources that you should get used to. Even once you get used to it, Wikipedia has strict rules that are not always the best in supporting an open-source encyclopedia but it is the best we've got right now.

May I ask what point you are trying to make? From my perspective, the issue with your text was that your first sentence directly quoted a comment about one particular study that didn't necessarily apply to the entire body of research. In the next sentence, you mentioned that some of these studies have a selection bias but these studies are not even used as reference sources on the Wikipedia article. When you put them both together, it really doesn't make much sense to me at all. Doors22 (talk) 15:20, 18 January 2016 (UTC)

@Doors22: It did make sense before the paragraph was butchered by previous editors. It made reference to the claimed incidence of the drug to cause depression, and went on to say that the studies were inconclusive, quoting the most quoted study in this sphere by Irwig (2011, 2012). As a side note, one of the pillars of wikipedia is "there are no rules" WP:5P5. Sorry, but there are no "strict rules." People have made guidelines as part of a community, but they do not need to be followed every time if they impair the scope of Wikipedia, which is information. I will not continue editing this Section of the article. Rrobotto (talk) 18:44, 18 January 2016 (UTC)

@Rrobotto:, maybe a better word to use would be norms over rules. With experience and observation, you will get a sense of what type of edits are supported by Wikipedia community. It can be very frustrating at times and appear to be bureaucratic. While the "rules or norms" are sometimes implicit rather than explicitly laid out, there is a method to the madness. The impact factor of the journal in which an article is published does matter to the community here and will likely not be accepted by the community, especially if the factor is zero. Doors22 (talk) 23:17, 18 January 2016 (UTC)

While the source is a review article its impact factor is zero [1]

What it says is that evidence of concern is not well supported "The authors conclude that the reports of potential irreversible sexual dysfunction and severe depression do raise concerns about the safety of finasteride; however, these studies are wrought with significant bias"Doc James (talk · contribs · email) 21:13, 18 January 2016 (UTC)

I have come across this study, which was published in the Journal of the National Cancer Institute ... it is a primary source but in a reputable journal and using a large sample group Rrobotto (talk) 18:38, 21 January 2016 (UTC)

@Rrobotto:, as you pointed out this source was published in a higher quality journal which is a strong improvement but it is a primary source and an older study. Also, there have been several more recent studies that have been published as well. If you take another look at WP:MEDRS you'll see that it is strongly emphasized we do not use primary sources for biomedical content on Wikipedia and secondarily it is preferred to use newer sources over older sources. I imagine this will be annoying to you but I encourage you to keep at it because there is a steep learning curve as I mentioned earlier. In my opinion, there are other issues with this study but the reasons I gave above are why the article does not qualify as WP:MEDRS which is a critical standard to meet for Wikipedia. For better or worse, I have come to accept that is just how things work around here.Doors22 (talk) 02:14, 22 January 2016 (UTC)

break at new discussion

I think it would be better to quote the ENTIRE SENTENCE from the article being referenced instead of just bluntly taking it out of context with the claim "Adverse effects are rare" as if the case is closed and there is no cause for concern or alarm. The full sentence is "Drug-related adverse effects for finasteride are rare; nevertheless, men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo." Ywaz (talk) 16:00, 19 April 2016 (UTC)

Writing back in kind. NO. Jytdog (talk) 16:49, 19 April 2016 (UTC)

The reason men need to know about "rare" events is because those taking it for hair loss are ostensibly doing it to increase attractiveness to the opposite sex. The side effects are from 4% (libido) to 10% (erection). These are, I'd say, 10x worse than what is being treated and in the same category, so it deserves attention. Imagine a drug for increasing heart ejection fraction that carried a 10% risk of heart attack. Should that be called a "rare" event and using only 1 author's perspective to make that out-of-context contention?

References

` Ywaz (talk) 17:15, 19 April 2016 (UTC)

The article is plenty clear about this rare side effect. Believe me we have guys coming here all the time all anxious about this. Jytdog (talk) 17:20, 19 April 2016 (UTC)

You are not the first editor to come here. Review this page and its archives. Jytdog (talk) 17:28, 19 April 2016 (UTC)

I am looking at a problem with the article itself. I do not take it. Is there a reference after 2010 that calls 10% a "rare" event? Is the 2012 article I cited referencing a metanalysis to get the 10% in error? I am not wanting to debate, I want to correct what appears to be an overt error. Why express an opinion by reverting my edit in order to hide what the reference actually says? Ywaz (talk) 17:40, 19 April 2016 (UTC)

No one is hiding anything. You are putting UNDUE weight on something that has been talked about to death here already. Again, read this page and its archives. We get these waves of editors trying to ramp up weight for this Oh My God SO IMPORTANT THAT I BETTER WRITE ABOUT IT IN CAPITAL LETTERS rare, possible side effect.Jytdog (talk) 18:12, 19 April 2016 (UTC)

Why is quoting the percentages from a review of 72 studies less weight than you wanting one comment from one abstract, taken out of context? I am not interested in the blogging here. I am only interested in the science. Again, do you have a scientific review that explains why that abstract is calling 5% and 10% "rare"? International standards are that 1% to 10% is "common". "Rare" is supposed to be for 0.01 to 0.1%. And if the science is problematic in making a determination, then the assertive claim "rare" can't be used. In pharmaceuticals, the assumption is "guilty until proven innocent" because that is usually the case for non-natural compounds. Ywaz (talk) 18:26, 19 April 2016 (UTC)

now you are just misrepresenting your actual edit, where you ignored the discussion of this topic that is already in the article further down in that section, and inserted this as a topline thing, more important even than the warning about prostate cancer that the FDA demanded the drug makers put high on the label in a section called WARNINGS. UNDUE out the wazoo, and again, completely ignoring the content and sourcing already in the article, and the oceans of discussions that have already happened here. You are ignoring everything that has already gone on at this article. That is not how Wikipedia works. And you are misrepresenting your edit. Stop doing that. Additionally, we have newer and higher quality sources than the one you are bringing, which is this one. Newish journal, online, that is aiming to grow the Indian dermatology community per this. We actually discussed that source already (again, believe me when I say that you are not the first editor to come here All Freaked Out About This Very IMPORTANT Side Effect) and we decided not to use it due to its low quality. See archive 4. Jytdog (talk) 18:32, 19 April 2016 (UTC)

How have I misrepresented my edit? Also, the percentages are not originally from the Indian article, but from a 2003 article. Have those percentages been overturned by a newer review? Ywaz (talk) 18:46, 19 April 2016 (UTC)

I am too frustrated with you to talk more now. You are not dealing with anything I am saying. Not with the fact that you shoved this content in first thing in the side effects section, completely out of touch with the existing content about this aspect of things and more important than any other side effect (even the one that could literally kill you). No acknowledgement of that from you. None. I am also sick of dealing with men trying to force their penis anxieties into Wikipedia. I am going to walk away from Wikipedia for a while. But please, read the actual content in the article and the sources there, and read the talk page and its archive. And re-think how you might want to introduce this content in a way that fits what is already in the article, and what has already been discussed here. Please write a new note when you have a reasonable proposal. Jytdog (talk) 19:03, 19 April 2016 (UTC)

@JytDog:, let me apologize again for not seeing the most recent discussion on the talk page. However, it is not right for you to accuse me of making a "pointy" edit. It was a coincidence (or not) that I naturally agreed with his very reasonable comment. You claim to be frustrated with this new editor yet your first response to him was a quite rude "Writing back in kind. NO." I happen to completely agree that it is very misleading to take the first half of the sentence with the intention of conveying that the side effects are "rare" without including the second half of the same sentence. You do not own this page and cannot simply continuously revert edits without providing a logical explanation or compromise. Doors22 (talk) 02:21, 26 April 2016 (UTC)

Sure, and thanks for coming to talk. Jytdog (talk) 03:10, 26 April 2016 (UTC)

Justification for sexual dysfunction termed "rare"?

EU and WHO standards:

• less than 10% is "common"
• 1% to 10% is "less common"
• 0.1% to 1% "uncommon"
• 0.01% to 0.1% is "rare"

The manufacturer's 2014 insert shows the following side effects are the most common ("Due Weight")
Most common side effects
PLESS, 1524 patients, over placebo 1st year:

• 4.4% impotence
• 3% decreased libido
• 2.9% decreased ejaculate

MTOPS 3047 patients

• 6.3% impotence
• 4.9% abnormal ejaculation
• 4.3% decreased libido
• 1.4% sexual dysfunction

The sum of "sexual problems" may qualify as "common". For reference, the gleason score for prostate cancer was 0.7% higher than placebo. The insert describes as "rare" the voluntarily reported continuation of sexual dysfunction after termination stating "not always possible to reliably estimate their frequency".
Drugs.com called the following More common

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Reviews:

• 2015: With finasteride, at 12 months, the highest frequency was 9% vs. 5% for erectile dysfunction, 4.4% vs. 1.5% for ejaculatory disorders and 6.4% vs. 3.4% for reduced libido.
• 2015: The largest studies always showed >2% see table two
• 2012: finasteride or dutasteride 5 to 9% erectile dysfunction:
• 2003 "ejaculation (2.1-7.7%), erection (4.9-15.8%), and libido (3.1-5.4%)"

Then there's the 2 reviews that seem to disagree. I believe these should not be given credence unless teh full papers can be reviewed. Why do they disagree in the abstract for what seems cut and dry by everyone else who provides detailed information?

• 2014: "not significant;y differnt from placebo"
• 2010: "Drug-related adverse effects for finasteride are rare; nevertheless, men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo." [

References

- Ywaz (talk) 21:26, 19 April 2016 (UTC)

What is the content you are proposing, and how does it fit with the existing content on sexual side effects? Please be clear in the proposal with regard to transient and persistent effects. Thanks. Jytdog (talk) 21:50, 19 April 2016 (UTC)

I have already attempted fair edits that reflect the most common side effects as mentioned by the manufacturer, but they were reverted by you. But now with further research, I would not think leaving the word "rare" in is honest at all. Primarily, as the above shows, sexual side effects should be given a simplified introduction as the most common side effect and not declared "rare". I advocate stating the percentages as mentioned in the product insert, and not using the legally correct term "less common" because "less common" may make a reader think that is referring to its commonality compared to other side effects for this drug when they are actually the "most common" side effects. "Most common" would be a correct term because it is not a legally defined phrase. Drugs.com used "More common" but I do not think that is as accurate. I wonder if the WHO would group these side effects and therefore mandate these sexual side effects be called "common". If the prostate cancer is a big concern, that can be mentioned first, but I am not sure the Gleason score increase (prostate cancer measure) has been as well established, or what percentage of men do not already have a Gleason score concern. It's possibly the most common cancer in men and I believe the least deadly. I do not think the article calling the sexual side effects "rare" should be included because it is contrary to the other information we have, and we do not have the full article to review to see how they could say that. The sexual effects percentages reduce after the first year, but I do not know how they adjusted for men getting of it during the first year as a result of the effects. You have complained several times about men coming here and getting excited because it's a sexual thing but that is exactly the same reason that it needs more due weight, not a reason to diminish its weight. Also remember the Indian article link was removed in the past because it was supposedly not a "high quality" journal but I've shown the data in it came from a different source, presumably with higher quality. I will let you edit as you please since I do not care to fight over it. Ywaz (talk) 16:16, 20 April 2016 (UTC)

I explained to you already why your actual edit was not OK. I have asked you to propose something else - actual content, with sourcing - to change the section that exists, if you are unhappy with the existing content. Jytdog (talk) 17:56, 20 April 2016 (UTC)

As I stated, I do not agree with your reasoning (which is not comprehensible to me and at least one other in the archives) and I believe I did not go far enough as required by the facts in an attempt to appease your complaints. By your invitation, are you agreeing to not be the editor, 3 times in a row, to revert my edits? How can you post an "edit war" warning to my talk page as a result of your two reverts of my edits (which did not delete a word of the article and only added factual quotes), and then invite me to make more changes? I cannot in good conscience make such appeasing edits simply to avoid further conflict. As others have probably found out in the past, the article is simply a lost cause in regards to accurately warning readers of the sexual side effects. A third edit by me would go even further from your desire to claim the ~10% sexual side effects are "rare". Your desire to keep the full sentence and the high percentages hidden from readers is indicative of a bias. Your reasoning, based on "undue weight", against mentioning the percentages of the most uncommon side effects at the top is also indicative. If your motive was simply not to keep it at the top instead of keeping the information hidden, you would have moved it lower instead of reverting. I am not going to constantly try to edit and be accused of an edit war in an effort to try to divine incomprehensible reasoning. Without your agreement to leave the article alone, I will leave it be and hope someone else will come along and conclude as I have that the article is being commandeered under a pretense of cooperation. Ywaz (talk) 19:14, 22 April 2016 (UTC)

One of the very reviews you quote above comments on rarity. It has "Drug-related adverse effects for finasteride are rare". Seems plain to me. Alexbrn (talk) 06:23, 23 April 2016 (UTC)

Ywaz I answered your questions above. Again, please propose content you would like, that integrates with the existing content, so we can discuss something concrete. If you choose not to, that's your call. Jytdog (talk) 06:40, 23 April 2016 (UTC)

Just because a word is used in the underlying reference, does not mean it is suitable for a Wikipedia article for many reasons. The word "rare" by itself is a Weasel word and a meant to convey an impression without really having meaning. This is especially the case if you want to cherry pick the first half of the sentence only.

There are a few options we can discuss here. 1 - Remove the text entirely. 2 - Add in the full context of the reference document. 3 - Summarize actual data of adverse event prevalence from meta studies. YWaz already tried to do 2 and 3 and was rejected without reason.Doors22 (talk) 02:38, 26 April 2016 (UTC)

You mischaracterize their edits to the article which were this and this, both of which introduced sexual side effects prior to the prostate cancer thing and weren't integrated with the discussion of sexual side effects already in the article.

That said, I have no objection to these edits. Jytdog (talk) 03:12, 26 April 2016 (UTC)

context

The thing that kills me about editors who come here focused on the one-eyed monster, is how they completely miss the fact that this is remarkably clean drug, outside of the sexual effects. Look at, oh, say Paracetamol#Adverse_effects or Statin#Adverse_effects. Those are generally drawn straight from the label. Now look at the labels for the indications for finasteride here and here. No GI effects, no CNS effects, no CV effects, no harm to kidney or liver. If you are thinking with your big head, it is freaking remarkable. Look at this from the Cochrane review: "We compared adverse effects - events that were possibly causal by the active drug - that were generally associated with each. So, for finasteride, we recorded erectile dysfunction (ED), impotence, ejaculation disorder, gynecomastia, and decreased libido. For alpha blockers, syncope (spontaneous loss consciousness from insufficient blood to the head), asthenia (abnormal loss of strength), fatigue, cardiovascular events, headaches, dizziness, and postural hypotension (a sudden decrease in blood pressure, which can cause syncope)." (there are actually a lot more for alpha blockers) That is amazing.

So when the Cochrane folks in their review for BPH say "Finasteride provides moderate relief of symptoms, especially after 1 year follow up, with few adverse effects that dissipate over time." (first sentence of their conclusion on page 39) or "Drug-related adverse effects for finasteride are rare; nevertheless, men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo." this is what they are talking about. None of that wide range of side effects that are extremely common with drugs - GI, CV, CNS, kidney, liver. None of that. I have been continually baffled by the men who come here and just cannot see this. Yes, I know it is a big deal when you cannot get it up. For most men, this goes away. For some, it appears to be a longer term problem; whether those longer term problems are caused by the drug is unclear. Jytdog (talk) 06:13, 26 April 2016 (UTC)

What you are downplaying is that Propecia is not a medication, it is a cosmetic product. Male pattern baldness is not a disease, however Propecia can actually cause disease. The sexual dysfunction that it sometimes causes is severe and thus the risk/benefit should be appropriately presented. The way it is presented now is such that the side effects are effectively de minimis and not worth worth factoring into the calculus, but in reality there is a small but real chance you will irreversibly ruin your life. It is a false equivalence to compare this to statins and paracetamol. Doors22 (talk) 13:15, 26 April 2016 (UTC)

Why don't we just summarize what the high-quality reliable sources say? Editors need to please put aside any personal experiences. Zad68 13:48, 26 April 2016 (UTC)

Yes, I agree. The issue has always been WEIGHT. And Doors, if, when you say "Propecia can actually cause disease", you are referring to PFS, that is not a disease. I know that you are among those advocating that it be considered as one, but that ship has not come in, and you need to stop bringing your advocacy here to WP. Jytdog (talk) 13:58, 26 April 2016 (UTC)

No, I am not referring to PFS. PFS is a syndrome, or a constellation of symptoms. "A disease is a particular abnormal condition, a disorder of a structure or function, that affects part or all of an organism." Any of these side effects are a form of disease or abnormal function when MPB is not a disease. I am not an "advocate", I am trying to make this article as accurate and balanced as possible so people who consult this article will be empowered to make the best decisions for themselves. On the contrary, your forceful efforts to remove this information comes across as advocacy. Doors22 (talk) 14:44, 26 April 2016 (UTC)

Your contribs show you are an advocate for emphasizing the sexual side effects of this drug - that is all you do here. That is how we define "advocate", and WP:SPA as well. Jytdog (talk) 15:33, 26 April 2016 (UTC)

There is no need to emphasize these effects: they are the 3 most common adverse effects, making them one big whopping adverse effect when considered as a group, which I would think most men would. This gives it more than 10x the increased risk for prostate cancer. Prostate cancer is so common, I doubt men are more interested in the prostate cancer than losing their "manhood". The primary concern with prostate cancer is that removing the prostate is often (if not usually) NOT done to stop the progression of it because of these same sexual side effects. On the contrary Jytdog, you seem to be an "advocate" for blocking a fair description of the overwhelming side effects. I take that back if you don't delete my edit from this morning. Ywaz (talk) 16:08, 26 April 2016 (UTC)

Let's have another section

Something needs to be done about the sentence that says, "Whether finasteride causes long-term sexual dysfunction in some men after stopping drug treatment is unclear." First of all, this is original research and is not supported by any underlying reference. Secondly, it isn't neutral as I have pointed out. The tone of the sentence very much presumes the drug is safe but there are mounting studies that indicate otherwise. It isn't within the spirit of Wikipedia, or even personally responsible, to phrase the sentence that way. Do you have any alternatives you can propose? I still think the word controversial is very much appropriate. A quick Google search for Propecia side effects will validate that for you. Doors22 (talk) 01:13, 29 April 2016 (UTC)

It is neutral, and it is supported. I do understand it upsets you because you believe something else to be true, but we don't know; it is unclear. I do know that one of the missions of the PFSF is to prove it exists and to advocate that people treat it like it exists, but that is not what Wikipedia is about, per WP:NOT. Jytdog (talk) 01:31, 29 April 2016 (UTC)

I don't agree with you and I'm not sure how many times I have to tell you I am not involved in the PFS Foundation. Nor does the Foundation advocate PFS be "treated" in any specific way because all evidence unfortunately points to the fact this an untreatable and permanent condition. Please find a single source that says the evidence is "unclear" and it will be fine to keep it, otherwise it is WP:OR or WP:SYNTH and neither have any place on Wikipedia, for better or worse. You have tried to use policies both ways historically and it is not acceptable. Doors22 (talk) 02:07, 29 April 2016 (UTC)

I didn't say you were involved with PFSF. Jytdog (talk) 02:08, 29 April 2016 (UTC)

In my view the Belknapp paper that you added to this article the very day it published supports that. The content you added says "we don't have the data to know". The label and the 2014 we review we use also say "may" and if anything the Belknapp paper makes even that claim more shakey. So no, we don't know.. It is uncertain. Jytdog (talk) 02:22, 29 April 2016 (UTC)

You implied that I was involved in the foundation, otherwise it made no sense for you to bring it up. Likewise, you are trying to imply something else by commenting that I was aware of the article on the day it published. Anyway, the Belknap article specifically comments on the finasteride clinical trials and criticizes their methodologies. That issue is entirely separate. The evidence comes from many other sources other than clinical trials - i.e. post-marketing reports, retrospective studies, and numerous case series. It is still WP:OR because your argument is trying to (incorrectly) analyze Belknap's article for subtext, which isn't accepted here. Once you can directly quote an article that says what you are trying to include, that will be fine, but until then it needs to be removed or modified so that it accurately represents a secondary source.Doors22 (talk) 02:37, 29 April 2016 (UTC)

The content you added says "valuated 34 clinical trials that used Propecia to treat androgenic alopecia. The study concluded none of the clinical trials had adequate safety reporting and published reports provide insufficient information to establish the safety profile for finasteride in the treatment of hairloss". If there is insufficient information to establish the safety profile, that includes the long term effects profile. That, in combination with the "may" in the labels and the 2014 review, are plenty of support. Jytdog (talk) 03:02, 29 April 2016 (UTC)

The fact that you are trying to make all these logical jumps shows you are conducting WP:OR. Putting that aside, I still don't agree with your conclusion but that is besides the point. Please find a reference that supports your claim directly and does not require synethesis or original research and this will be put to rest. Thanks.Doors22 (talk) 04:24, 29 April 2016 (UTC)

I did your job for you and located a reference that addresses the current state of scientific understanding without having to do "original research" and put words in the mouths of these authors. This is taken almost verbatim from the article and maintains a NPOV without presuming the effects exist or do not. The state of scientific literature is dynamic and you absolutely must adjust as more research is published even though it is against what you want on this article, whatever reason it is you do.Doors22 (talk) 04:40, 29 April 2016 (UTC)

With this edit, Doors22 replaced:

Whether finasteride causes long-term sexual dysfunction in some men after stopping drug treatment is unclear. (PropeciaLabel)(ProscarLabel)(Belknapp)

with:

The full safety profile for finasteride has yet to be determined.(PMID 25871957)

So, we (the group of us) are moving toward some agreement that it's better not to use a loaded term like "controversial" here and instead use a phrase like "has yet to be determined", so that's good. But I'm a bit unsure about the new source introduced, PMID 25871957. This is a 2015 MEDLINE-indexed review article, so that's good, but it's published in a journal in the Current Opinion series. And the abstract summary for the source "Multiple animal studies provide a biological basis for many of the persistent effects seen in humans such as erectile dysfunction, depression and decreased alcohol consumption. Prescribers of 5α reductase inhibitors should discuss the potential risks with their patients seeking treatment for androgenetic alopecia." I don't see from the abstract that the new article content would be directly supported, but I haven't tried to get my hands on the full text of the source. And Irwig, the Opinion article's author, appears to be something of an agitator related to finasteride.... just Google "Irwig finasteride" and there's some interesting reading. At a minimum I'd think we'd have to double-check that the content is backed by the cited source and attribute the content to Irwig, but I'd like opinions of others on this source's fitness.
Also I'm not sure Belknap deserves to be removed from supporting this content, if anything Belknap appears more attractive to use than Irwig. Why would Belknap be removed?
Thanks... Zad68 13:21, 29 April 2016 (UTC)

In the real world, everybody recognizes that 1) the drug has side effects of sexual dysfunction (a fact, this happens) 2) in a small percentage of men (see table above) and 3) some percent of those men (we don't know how big, but we know it isn't huge) actually have persistent sexual dysfunctions after stopping the drug (a fact, this happens) and 4) the persistent sexual dysfunction that some (a fraction of a fraction) men experience MAY OR MAY NOT BE CAUSED BY THIS DRUG (this is what we do not know). So there is a sliver of a sliver of the safety profile that is not worked out. Turning that into a topline Wikipedia content that says "The full safety profile for finasteride has yet to be determined" is way out of whack. Do not elevate a minority view like that. Thanks. Jytdog (talk) 14:07, 29 April 2016 (UTC)

Zad, the content is taken directly from the full text of the article, not the abstract as you have noted. Feel free to access the article and verify if you'd like. The Belknap article is OK to use in my opinion, but the text included in the article does not accurately reflect Belknap's view stated in the article. JYTDog is trying to squirm his way into including a statement that is not backed up by any reference. If you visit http://archderm.jamanetwork.com/article.aspx?articleid=2212246, you can see in Belknap's interview that he doesn't espouse this view.

Secondly, Merck is currently a defendant in 1,400 lawsuits regarding Propecia. Many more victims are suffering from this disability without any understanding of why and many more simply do not want to bother dealing with litigation when it cannot possibly restore their health. To try and say we are talking about a "sliver of a sliver" is simply wrong.Doors22 (talk) 20:26, 29 April 2016 (UTC)

Your response doesn't meet Jytdog's point, please address it before restoring the content. Zad68 20:58, 29 April 2016 (UTC)

I'm not sure how my response doesn't meet Jytdog's point. He is trying to portray my statement as a "minority opinion, yet he is conducting original research and can't provide a single source that uses the word "unclear" which has quite a different meaning. Please review the following link where you will find dozens of doctors have published articles about finasteride's persistent side effects. http://www.pfsfoundation.org/published-research/ For years, he has been trying to paint this as a "fringe" viewpoint but overtime more and more evidence is mounting which he is conveniently ignoring. He previously tag-teamed a lot with another user that was banned and was discovered to be using sockpuppet accounts. Jytdog has also recently been topic banned from GMO articles. I have never gotten the sense he is interested in building an encyclopedia in good faith and has spent a tremendous amount of effort eliminating or reducing edits that harm the interests of specific companies and their products. Doors22 (talk) 21:13, 29 April 2016 (UTC)

Please raise editor behavior issues elsewhere, use article Talk pages for discussing article content.
Anecdotes and advocacy websites really hold no weight here... Zad68 21:19, 29 April 2016 (UTC)

These aren't anecdotes. The source of the website is irrelevant. It is just a nice listed of many, but not all, of the articles that have been published in the medical literature to show this is not the "minority" view. You can click through to see each source.Doors22 (talk) 22:58, 29 April 2016 (UTC)

I just did a little bit of counting and found that just from the PFS list of articles, there are 51 different doctors that are in published articles that specifically research persistent side effects of Propecia. This is before you include the articles that will soon be published from Harvard and Baylor, probably in the next 12 months. I took special care to remove articles that did not specifically mention finasteride's persistent side effects, but did not include anything that was not on the foundation's website. To say this is a "fringe" or "minority" viewpoint is untrue and obstructionist. Of note, the only groups that really dispute the existence of these side effects are hair transplant surgeons and Merck, the original manufacturer. However, as this has gained increasing interest in the medical literature over the years, I think it is worthy of more inclusion.Doors22 (talk) 15:02, 1 May 2016 (UTC)

How do you know when scientists at Baylor and Harvard are going to publish? And you are missing the point of the objections three of us are making here; please respond to what we are actually saying. Thanks Jytdog (talk) 19:59, 1 May 2016 (UTC)

I don't know when they are going to publish, which is why I used the word probably. I have addressed your points, despite your protests, but you still have not addressed my concerns that this is WP:SYNTH and WP:OR. You have not provided a single source that backed the conclusion you are trying to present. Whereas, I have presented a source that discusses something similar but you don't like the message.Doors22 (talk) 04:59, 2 May 2016 (UTC)

I prefer the prior wording as I find it more specific. Not seeing justification / support for changing it. Doc James (talk · contribs · email) 17:17, 1 May 2016 (UTC)

Refs

The sentence in question is "Whether finasteride causes long-term sexual dysfunction in some men after stopping drug treatment is unclear"

• Ref says "Recent reports describe that impotence, loss of libido,13,14 low androgen levels, and severe oligospermia15 may persist long after discontinuation of finasteride at a dosage of 1.25 mg/d or less. Yet, a medical literature review of the use of finasteride for AGA concludes that finasteride is safe for AGA and notes that “permanent sexual adverse events have yet to be established in higher quality studies, such as randomized controlled trials.”16(p493)"

So looks like the current wording is supported. http://www-ncbi-nlm-nih-gov.ezproxy.library.ubc.ca/pubmed/?term=Adverse+Event+Reporting+in+Clinical+Trials+of+Finasteride+for+Androgenic+Alopecia%3A+A+Meta-analysis Doc James (talk · contribs · email) 07:49, 2 May 2016 (UTC)

The main point of the Belknap article is to discuss that each and every one of the clinical trials conducted for finasteride were not conducted with the requisite care to support the belief that the drug does not cause uncommon, long-term adverse events. His article does not support the notion that it is "unclear", this is still original research by drawing a new conclusion based on what he has written. I think this article could support a claim that says something to the effect of, "There are conflicting opinions in the medical literature as to whether finasteride causes long-term sexual dsyucntion in some men after stopping drug treatment." However, as it stands right now, JYTDog has put words in the mouth of Belknap.Doors22 (talk) 13:04, 2 May 2016 (UTC)

I think "is unclear" is good wording here. Alexbrn (talk) 13:09, 2 May 2016 (UTC)

You are not engaging in "discussion" or constructive editing by saying "Nah, it was better before" without offering any rationale. In fact, it is even rude...Doors22 (talk) 13:23, 2 May 2016 (UTC)

It's a tidy summary of the point "permanent sexual adverse events have yet to be established in higher quality studies". Alexbrn (talk) 13:26, 2 May 2016 (UTC)

Those are two separate points, not a summary of the other. Your assumed premise (which makes this original research) is that once these adverse events have been established in higher quality studies it will suddenly become "clear". Conversely, the implication is that it is the ONLY way the existence of these adverse events will come "clear". Both claims involve original research or synthesis.Doors22 (talk) 13:34, 2 May 2016 (UTC)

No it's called summarizing the conclusions of secondary sources. It's a bit preposterous to state that there's a problem with the logic that once there are high-quality studies, it'll be clear--that's more or less the definition of a high-quality study. Zad68 13:48, 2 May 2016 (UTC)

It's not summarizing. If you read the Belknap article he criticizes the quality of these "high quality" articles for not being designed well enough to pick up side effects like sexual dysfunction that are naturally going to be under reported. Nowhere does Belknap say it is unclear that these side effects exist and if you read other interviews he conducted (admittedly not MEDRS standard) he indicates otherwise. I think the statement should be taken out all together because it is WP:OR but it is nice to have it in writing that as soon as a "high-quality" article is published showing evidence of this the controversy will be resolved.Doors22 (talk) 01:16, 3 May 2016 (UTC)

I have read what you have written here three times Doors. Are you asserting that it is clear that finasteride causes long term sexual dysfunction in some men? Jytdog (talk) 01:25, 3 May 2016 (UTC)

My intention is for this matter to be given WP:due weight and to not superficially dismissed as merely "unclear". The presence of dozens of articles in the medical literature with at least 51 independent scientists having written about this justifies it. At the very least, the fact that 51 independent scientists have written about it indicates this is a notable issue. Several years ago, when you first decided to cause tension on this article for whatever reason you had, there were only a few authors that published on it but now the level of public interest is irrefutable and only growing.Doors22 (talk) 02:05, 3 May 2016 (UTC)

Would you please answer my question? Thanks. Jytdog (talk) 02:07, 3 May 2016 (UTC)

You are attempting to create a false dichotomy. I think there is strong evidence to support a causal relationship that taking finasteride causes permanent side effects in some of its users. I think that viewpoint is currently not given sufficient due weight. Belknap would agree and disagree with the statement it is "unclear".Doors22 (talk) 02:58, 3 May 2016 (UTC)

Something is either clear or unclear. Belknap's 2015 review radically undercuts claims that we can know if long term sexual dysfunction in some men is caused by the drug or not. That makes it definitively unclear. There is nothing false about that. I do find it strange that you would claim to know what Belknap would be comfortable claiming in the peer reviewed literature. Bizarre even. This is the second time you have made claims to this kind of insider information in this discussion. Jytdog (talk) 03:41, 3 May 2016 (UTC)

I never claimed to have any special information. What I told you to do is review his other public comments on the subject which you haven't done. As I stated before, you should have looked at his interview which you haven't done. You don't really do any research other than to meet your objective on here which is to minimize the reporting of side effects, not just on this drug but across others. What his paper absolutely does not do is undercut claims that we can know if long term sexual dysfunction is caused by the drug. What he does do, is undercut the credibility of the clinical trials that have been reported to date. It is increasingly unbelievable to me how much you have distorted these articles and my "clear" words even.Doors22 (talk) 03:49, 3 May 2016 (UTC)

The two insider statements are: " Belknap would agree and disagree with the statement it is "unclear"" (diff) and " articles that will soon be published from Harvard and Baylor, probably in the next 12 months" (dif). About these other things you are apparently looking at: here in Wikipedia, we deal with high quality reliable sources, and we don't rely on whatever other things you are looking at. My objective is to accurately summarize high quality sources. When high quality reviews come out and make it very clear that F does cause persistent sexual dysfunction in some men (which I imagine will include a discussion of mechanisms) then we'll be having a different discussion. Those sources don't exist yet, as far as I know. Jytdog (talk) 03:59, 3 May 2016 (UTC)

I have seen status updates on the studies from patients who participated in them on PropeciaHelp. I have not participated in the studies so this is just speculation. As a patient, I keep up to date on these items because it obviously affects my life. I previously provided a link to the interview which you neglected to review. Towards the end of the interview with Belknap (around 9 min), there is a direct quote "There is substantial evidence that some of the side effects of finasteride persist after discontinuation and we had no reliable systems in place to detect persistent side effects after cessation of treatment." I'm not so sure that translates into anything being "unclear". That is your own false interpretation. The same interview refers to a large clinical trial for finasteride where they did poorly track persistent side effects and it showed that the drug group experienced 2% higher persistence than the controls. Doors22 (talk) 04:12, 3 May 2016 (UTC)

Please limit discussion in Wikipedia to what high quality sources say; that is all we are going to use as sources for the article, and this page is only for discussing improvements to the article. Jytdog (talk) 04:17, 3 May 2016 (UTC)

I'm referencing an interview with the author which directly comments on the article you have misrepresented. His explanation in no way supports how you have referenced his article, in fact it strongly contradicts it. Not only is your statement not verifiable, you can verify the source supports the opposite of what you want to say. You aren't being remotely honest about this discussion. Moreover, the interview is listed under related multimedia and really could not be more relevant to this discussion or even more valid as a source for Wikipedia. Doors22 (talk) 04:23, 3 May 2016 (UTC)

The current text satisfies WP:V perfectly well. It is time to move on. Alexbrn (talk) 06:21, 3 May 2016 (UTC)

In an related media interview, linked on the exact same page as the JAMA Dermatology article, it is said verbatin, "There is substantial evidence that some of the side effects of finasteride persist after discontinuation." How you use that to "verify" in good faith that the side effects are unclear is truly beyond me. The word clear or unclear is not mentioned a single time in any source. I can't even say you are giving undue weight really because it is a viewpoint that has not been expressed in any quality source.Doors22 (talk) 15:43, 3 May 2016 (UTC)

Not that the media interview has any place in this discussion, but it was Moore who said that (who wrote the accompanying editorial, which does take that stand on this issue). Belknap did not say that or anything like it in the discussion. Nor did he in the peer-reviewed article that he wrote, where he had a responsibility to be scientific (and a reputation to protect and maintain). Your "it is said" is interesting. Jytdog (talk) 20:34, 3 May 2016 (UTC)

You are actually right, I apologize. Moore, not Belknap, is the one who said that towards the end of the interview. However, the same team who wrote the paper presented to the World Congress of Dermatology and unequivocally supports the existence of persistent side effects. Here the authors conclude additional awareness is needed. Unfortunately, this study was not published in a peer-reviewed journal but still represents the message of the team. Nowhere in the JAMA article do they say it is unclear whether or not finasteride causes persistent side effects. It merely says the usual studies are not useful in supporting claims of safety. [[2]] With many doctors calling for increased awareness to educate consumers, I find it alarming you are so resistant to catch up. Doors22 (talk) 23:41, 3 May 2016 (UTC)

That is great if the authors want to "raise awareness". Wikipedia is not a vehicle for raising awareness. See WP:SOAPBOX which is policy. Many many many people mistake Wikipedia for a soapbox and almost all of them get all moralistic when they are denied. That is how it goes in WP. Jytdog (talk) 23:47, 3 May 2016 (UTC)

Yep, I am well aware. And my commitment to objective, NPOV discussion in the article ensures that isn't a problem. For whatever reason you have, you have vigorously worked to shoot down any edits that give any weight to the growing evidence and medical literature supporting the claim that persistent adverse events are real. Wikipedia isn't about "raising awareness" but it is about striving for accuracy and complete knowledge. For years, your edits have aggressively worked towards dismantling this latter, noble goal.Doors22 (talk) 00:21, 4 May 2016 (UTC)

Nope. Jytdog (talk) 00:37, 4 May 2016 (UTC)

We reflect reliable medical sources, not "media interviews", for this kind of subject matter. Alexbrn (talk) 15:45, 3 May 2016 (UTC)

Doors your response demonstrates persistent lack of understanding or adherence to MEDRS, in particular MEDASSESS and MEDREV. Zad68 15:54, 3 May 2016 (UTC)

This is not a "media interview" in the way you think it means. You have directly reviewed the source. It was an interviewed published by JAMA Dermatology, alongside the article. It is called related media because it is a "medium" of conveying research separate from written articles. In this, the authors "clearly" state their view on the overall evidence of persistent adverse events caused by finasteride. I strongly suggest you review this before commenting.Doors22 (talk) 16:00, 3 May 2016 (UTC)

So, we stick with the reliable part of the source. Please see WP:MEDRS. Also, you've unfinished COI business to attend to. Alexbrn (talk) 18:51, 3 May 2016 (UTC)

Shame on you. You know very well the message of the source does not represent how you and Jyt have portrayed it in the article. You have yet to provide a single excerpt that is remotely in line with how you have "summarized" it. The very strong counter-evidence I provided is a direction quotation from an audioclip published by the same exact peer-reviewed journal that you are misrepresenting. This is not an media interview from CNN. Doors22 (talk) 21:00, 3 May 2016 (UTC)

Media clips are not reviews published in the biomedical literature nor are they statements by major health authorities. You can take that issue to any board you want and will get shot down in a heartbeat. I am not responding further on this. Jytdog (talk) 21:15, 3 May 2016 (UTC)

Alexbrn revert today discussion

Alexbrn, in your revert just now, what do mean by your justification "Let's just go back to neutrally reporting the sources, eh." ? As I explained in my edit, the whole last paragraph should be deleted because it is based on a 1997 FDA document which is outdated. The other reference I deleted was not even relevant to where it was cited. The text I added is straight from the product insert. How more neutral can you get than that? What is your reference for wanting to maintain the sexual side effects are controversial? You and Jytdog constantly blocking all fair edits are the only source of controversy I've seen, and that's not a valid reference. Ywaz (talk) 16:32, 26 April 2016 (UTC)

I don't think you've ever written anything to me. Are you also Doors22 (who has)? The 1997 document is referenced as such. The statement about rarity is straight from the source. As for your wholesale replacement of secondary material with fragmented English and figures pulled out of primaries (it's hard to tell because sources aren't cited) - well, we don't do that. Looks like advocacy again. Alexbrn (talk) 16:39, 26 April 2016 (UTC)

I left a note on my edit. I am not doors22. Stating the information is outdated is not a sufficient reason to include it in the article. The English was not fragmented, [edit: OK, yes, I fixed it] but if you think it was, you could have fixed it. The secondary source (the product insert) is a nice summary of primary sources. By your definition of secondary source, all reviews are secondary. And since the pharmaceutical has to pay for the large studies, it's kind of strange to call it a secondary source. The 1997 FDA article is secondary. My source was cited, if you had cared to check. Again, you and Jytdog are advocating an incredible amount of wholesale censorship without any clear reasoning process or effort except to maintain the censorship (as the long archives show), all the while accusing fair-minded editors of whatever you can dream up such as some sort of twisted sexual bias. How that one review of several you guys are blocking concluded adverse effects were "rare", I do not know because I do not have access to any of the data like we do in the other reviews. Ywaz (talk) 20:53, 26 April 2016 (UTC)

I disagree with using the FDA document to cite particular chosen outcomes from individual primary studies. Better to use independent secondary sources. Zad68 21:13, 26 April 2016 (UTC)

Then please delete the two portions of text and two FDA references that Jytdog and Alexbrn are forcing on the article in order to make the side effects appear less relevant. The reference I included is hosted on the FDA website, but it is copyrighted by Merck, the ones who paid for the studies. I did not chose particular outcomes, I chose the most common side effects. The next highest item was "enlarged breasts" at 1.5%. I would limit the list to everything above 2% which would be 3 items in each list. I think you should undo your revert as this shows your conditions were met before you did the revert.Ywaz (talk) 21:32, 26 April 2016 (UTC)

Perhaps everybody can live with this. Jytdog (talk) 05:12, 27 April 2016 (UTC)

Seems a fair compromise! Alexbrn (talk) 05:21, 27 April 2016 (UTC)

In what sense is that a "compromise" or "fair" in regards to any of my complaints?

1. Only 1 of the 3 or 4 reviews uses the word 'rare' and it is the one we have least access to for trying to find out why they would say that. The universal definition of "rare" is 0.01% to 0.1% incidence, a factor of 1000x to 100x lower that the established incidence of adverse sex-related effects during the first year, and 150x to 15x lower than the number of men quitting during the first year due to the sexual side effects, over placebo.
2. I see no justification for saying its side effects are "less common" let alone "rare" compared to other drugs. It's ~5% incidence of impotence in a cosmetic drug.
3. There are two FDA articles not satisfying Zad's conditions to remain in the article. They seem to be specifically chosen despite their age and lack of quality or detail in order to misrepresent the dangers as questionable.
4. Maybe you did not understand me, but male breast enlargement, although 2 levels more common than "rare", is still number 4 or 5 down the list of sexual side effects, so it should not get such prominent placement. I mentioned it only to show how the side effects I mentioned were the most common, 3 to 4 times less common than impotence.
5. Instead of so much text, a simple listing of the side effects and their percentages would be a lot more helpful to readers.
6. The one review being cited is the least useful as the full length is not available, it's complicated by comparison with a different drug, it provides no percentages, and its use of the word "rare" is going against the accepted definition. Ywaz (talk) 15:44, 27 April 2016 (UTC)

Yawz, your lack of access to a source is not a reason for Wikipedia not to use it. Cochrane reviews are gold standard per MEDRS. Jytdog (talk) 19:19, 27 April 2016 (UTC)

User:Zad68, this edit was awesome. Thanks. Jytdog (talk) 19:19, 27 April 2016 (UTC)

I don't think that edit resembles a reasonable compromise. (1) The word rare is a weasel word per WP:AWW. (2) It is also "weaselly" to say finasteride's adverse events are rare compared to other drugs. This statement is not backed by any source, but even if it were it should still not be included. All you have to do is find two other drugs that are more dangerous and this statement would be "true". It is meaningless and misleading. (3) The word unclear does not represent the scientific body of literature as well as the word controversial. There are several doctors who do not think it is "unclear" at all. (4) The old FDA documents from 1997 really are too old to be included as a quality medical reference. There are other sources that are already in the article that are much more recent so the FDA reference should be removed. Doors22 (talk) 20:08, 27 April 2016 (UTC)

I'm scratching my head over the word 'rare' "not backed by any source"... it's used repeatedly in the Cochrane 2010 source, which is considered top-tier, so unless you'd like to argue against having our article faithfully represent a word emphasized repeatedly by a top-tier source, your argument is really a non-starter. Regarding "unclear"... per WP:MEDASSESS, 'several doctors' is bottom-rung support. Zad68 20:18, 27 April 2016 (UTC)

You don't appear to be having a discussion in good faith here or at least you aren't taking the time to carefully evaluate what I'm saying. I didn't say the word rare was not backed by any source. I said it is a weasel word and has no place in the article. The source you reference did not compare the prevalence of AEs for finasteride to "other drugs". That was the statement I said was not backed. You are also misrepresenting my comment on "several doctors". There are several research studies on the topic that would no qualify as "bottom-rung support". This is a controversial debate that is becoming less controversial over time. To say it is unclear does not really present a NPOV and gives the impression that the possibility of AEs is negligible. Doors22 (talk) 20:28, 27 April 2016 (UTC)

"Rare" isn't a WP:WEASEL word and there's no problem using it. Cochrane 2010 does indeed have separate sections for "Finasteride versus doxazosin", "Finasteride versus tamsulosin" and "Finasteride + doxazosin versus finasteride" that all say AEs were "rare" (their word), just like finasteride vs. placebo, so that's where "compared with other drugs" probably comes from. Are you suggesting we change the current article wording from Adverse effects from finasteride are rare compared with other drugs to just Adverse effects from finasteride are rare? That'd be well-supported by the source and an improvement in clarity/fidelity to the source, so I'd support it.
Re the range of views (you said 'several doctors' so that's what I responded to)--If you'd like to bring high-quality reliable sources that support what you're talking about please provide them, but there's still no reason to use an emotive word like 'controversial' when discussing the state of the evidence. Zad68 20:43, 27 April 2016 (UTC)

Ref uses "rare" and tehrefore it is perfectly appropriate for us to do so. Doc James (talk · contribs · email) 20:49, 27 April 2016 (UTC)

Zad, do you have the full article? The abstract seems to say "rare" only once. Also, that sentence no longer has any reference. Doc James, is not OK to use say "rare" simply because one review out of several inexplicably says it in the abstract without explaining what the justification is, going against all other research establishing the incidence. "Rare" has a precise pharmaceutical definition as I've explained, and all the research shows it does not meet that condition. No one has contradicted the facts as I've explained them, so there is only a pretense of discussion going on here concerning "rare". Are any of you a doctor who has prescribed this? I'm trying to figure out why there is such a strong bias against the facts. Zad, rare compared to other drugs in this category still does not have any precise or useful meaning. Reference 16 should be deleted because no useful text is available. Again, the last paragraph and ref 17 needs to be deleted for being nearly 20 years old. Ywaz (talk) 23:24, 27 April 2016 (UTC)

Ywaz yes I have the full article, it's here. The full article uses "rare" quite a bit, I hope I'm not infringing on copyright here but I'll pull the uses:

• Finasteride versus placebo: Drug-related adverse effects for finasteride were rare; nevertheless, men taking finasteride were at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo.
• Finasteride versus doxazosin: Drug-related adverse effects were rare; none were greater than 5 per 100 person-years of follow-up.

• Finasteride versus tamsulosin: Drug-related adverse effects were rare and not significantly different.
• Finasteride + doxazosin versus finasteride: Drug-related effects were rare, with no more than 5.4 (dizziness) per 100 person-years of follow-up.
• Authors' conclusions: Implications for practice:

• Regarding vs. placebo: Drug-related adverse effects for finasteride are rare; nevertheless, men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo.

• Regarding with doxazosin: Drug-related adverse effects are rare,...

• Regarding finasteride and tamsulosin: Drug-related adverse effects are rare for both

• Regarding combined therapy: Drug-related effects are rare

Is that sufficient? I don't mean to beat anyone over the head with this but if we're accepting this Cochrane review, using the word "rare" is very soundly supported. Zad68 01:09, 28 April 2016 (UTC)

If you go back and reference what I said, I never said the word rare is not supported by the text. Ywaz makes a great point, which is why Wikipedia does not condone weasel words. Rare means different things to different people, but the connotation conveys a sense of being negligible. Weasel Word lists the #1 category of weasel words on Wikipedia as numerically vague expression. Is rare so unlikely that only 4% get this adverse event? One in a million? The word itself is very unclear but it carries a strong message that erodes the article's POV. Doors22 (talk) 01:55, 28 April 2016 (UTC)

There are three paragraphs at WP:WEASEL, please read the middle one see why 'weasel' doesn't apply here. Nonetheless I'd be happy to support adding a clear and concise summary of the statistics that go with "rare" to eliminate the issue you're describing, if we can figure out a way to do it that doesn't make things more confusing. Zad68 02:03, 28 April 2016 (UTC)

arbitary break

fwiw i liked my version  :) -- Jytdog (talk) 04:49, 28 April 2016 (UTC)

Jytdog help me out here, looks like the wording you're pointing to as preferable was Adverse effects from finasteride are rare compared with other drugs. I think the issue we were having with that was that it's hard to tell what it means. Does that mean that the AE rates of comparable drugs are much higher? Or only when used in combination with other drugs? Does it open the door to the idea that there's "relative rare-ness" so that finasteride by itself doesn't have a rare rate of AE but when compared to other drugs, the non-rare AE rate of finasteride is rare in comparison? The source cited supports a plain statement that AEs are "rare". So can you help explain here what nuance or shading is added by "...compared with other drugs"? Thanks... Zad68 13:54, 28 April 2016 (UTC)-

As Ywaz pointed out above, the rates of sexual side effects are not rare in the sense we use that word; I think Cochrane uses the term somewhat idioscyncratically. The only way I can make sense of it is the lack of GI/CV/CNS/kidney/liver side effects like I mentioned in the "context" section above. Jytdog (talk) 14:50, 28 April 2016 (UTC)

I think the way out would be to supplement "rare" with hard numbers. Cochrane seems to term things in AEs per 100 person-years or the like. Can you help parse the source to extract these sorts of ratios in a way that will be understandable to the general reader? Zad68 14:55, 28 April 2016 (UTC)

on page 15 of cochrane paper they start discussing their meta-analysis of the pooled trials, and table 5 is the most clear discussion they have. I've changed my mind; I think the mostly-vanishing of most of these side effects compared to placebo after year 1 is why they say "rare". Do you think we could use this table in the article?

Table 5 Adverse effects by age in Cochrane 2015 meta-analysis of pooled trials in BPH

	< 65 yrs old Year 1	≥ 65 yrs old Year 1	< 65 yrs old Years 2-4	≥ 65 yrs old Years 2-4
Impotence	%	%	%	%
Finasteride	8.8	7.4	5.5	4.6
Placebo	3.8	3.7	6.1	4.0
Decreased libido
Finasteride	6.8	6.1	4.2	1.9
Placebo	4.5	2.3	3.2	1.8
Ejaculation disorder
Finasteride	1.5	0.8	0.1	0.5
Placebo	0.3	0.1	0.0	0.1
Gynecomastia
Finasteride	0.5	0.5	1.0	2.5
Placebo	0.0	0.1	0.8	1.5

- Jytdog (talk) 02:04, 29 April 2016 (UTC)

Clearly the Cochrane review doesn't mean "rare" as defined/used by the EMA (European Medicines Agency), NHS and WHO. Those definitions are sometimes listed in Patient Information Leaflets (at least where I live), so the term is likely to mislead some readers. The FDA on the other hand (in Guidance for Industry) discourages the use of terms like "rare", "frequent", "infrequent", because they do not provide meaningful information.

I didn't find guidelines regarding the use of the term in the Cochrane Handbook or Cochrane Style Guide. I did notice a discussion paper by the Cochrane Adverse Effects Methods Group (http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/1471-2288-7-32), mentioning that "Good data on a well-recognized, easily detectable adverse effect may potentially be available from randomized clinical studies. In contrast, information on new, rare or long-term adverse effects are unlikely to be found in trial reports". Clearly a different kind of "rare".

The abstract raises some questions about the peer review process for Cochrane reviews. It doesn't follow the guidelines listed in 11.8 of the Cochrane manual version 5.0.2 (published in 2008): Main results: This section should begin with the total number of studies and participants included in the review, and brief details pertinent to the interpretation of the results Prevalence 14:30, 6 May 2016 (UTC)

We don't perform peer review on sources. See WP:MEDASSESS. Jytdog (talk) 17:22, 6 May 2016 (UTC)

Good thing I didn't have the complete text then, or I might have been tempted. But you don't need qualifications to notice that the number of studies and participants is not included in the abstract, or to know that "rare" is an imprecise term. I favor including the table btw (with doxazosin and terazosin results if such data is available). Provided all relevant info is given (number of participants, number of dropouts...). Prevalence 11:36, 7 May 2016 (UTC)

Edit Request

I'm copying this from Doc James's talk so that others can comment. I've added {{edit request}}. Note that Doors22 has not said he has a COI, but he has agreed not to edit directly. SarahSV ^(talk) 02:43, 13 May 2016 (UTC)

Hi Doc James,

I'll address this edit request to SlimVirgin as well since DocJames is on vacation. Would you please add a sentence to the finasteride "society and culture" section about the ongoing product liability issues? I have not added this in the past because I expected it would be rapidly removed due to the degree of tension on that article. Nonetheless, I think it is notable and WP:MEDORDER specifies that legal issues should be included in the "society and culture" section.

I recommend a simple sentence that closely mirrors the company's quarterly report. "As of March 31, 2016, approximately 1,385 product liability lawsuits have been filed by plaintiffs against Merck who allege that they have experienced persistent sexual side effects following cessation of treatment with finasteride." The source should be their latest financial report at http://s21.q4cdn.com/755037021/files/doc_financials/quarterly/2016/Q1/1Q16-Form-10-Q.pdf.

I also think the first paragraph of the section about the historical finasteride ban is no longer notable since it the drug has been re-instated. I would like to have that paragraph deleted as well but mostly just see it as trivial information.

JYTDog has offered to "walk away from the article" if I refrain from editing indirectly, so this is my effort to uphold my part. Thanks - Doors22 (talk) 22:27, 12 May 2016 (UTC)

Doors22, it would be helpful if you were to phrase your requests something like this:

• Please add to the Society and culture section: "As of March 31, 2016, approximately 1,385 product liability lawsuits have been filed by plaintiffs against Merck who allege that they have experienced persistent sexual side effects following cessation of treatment with finasteride."
• Source: add full citation, including page number where appropriate.
• Quote from or summarize the part of the source that supports the edit.

That format will make it easier for other editors to check it. SarahSV ^(talk) 03:05, 13 May 2016 (UTC)

You reference the complaint itself. Has any press picked up on it? Doc James (talk · contribs · email) 03:17, 13 May 2016 (UTC)

SlimVirgin and Doc James, thanks for moving this over. I'll try to make edits in the suggested format going format. The lawsuits have been mentioned in several credible news sources. Here is a sampling:

• Mens Journal,Toronto Star, and Australian Financial Review.
• The relevant information in the quarterly filing can be found page 19 and the text directly says, "As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Propecia and/or Proscar. As of March 31, 2016, approximately 1,385 lawsuits have been filed by plaintiffs who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar". I do however, suggest used my slightly edited version.
• Thanks. Doors22 (talk) 19:20, 13 May 2016 (UTC)

Doc James, now that it appears you have returned from vacation, would you mind taking a look at the requested edit and news sources? Thanks.Doors22 (talk) 10:46, 16 May 2016 (UTC)

Hi Doors, responding to your note on my talk, please write the edit out exactly as you want it to go into the article, along with a full citation (including page numbers where appropriate) in whatever format the article is using. Then we can check for objections. The wording you suggested:

"As of March 31, 2016, approximately 1,385 product liability lawsuits have been filed by plaintiffs against Merck who allege that they have experienced persistent sexual side effects following cessation of treatment with finasteride."

makes it appear that Merck experienced the side effects. It is also very close to the source, so either a rewrite or attribution is needed (X reports that):

The source says:

"As of March 31, 2016, approximately 1,385 lawsuits have been filed by plaintiffs who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar."

SarahSV ^(talk) 03:13, 20 May 2016 (UTC)

SlimVirgin, thanks again for the input, as always. As for the grammar, it makes sense in American English but British English treats collective nouns differently so I have changed it. How about the following:

• "According to the company's 1Q2016 financial filing, Merck is a defendant in 1,385 product liability lawsuits which have been filed by customers alleging they have experienced persistent sexual side effects following cessation of treatment with finasteride."

Unless someone objects, I'll go ahead and add that. Pinging Doc James. Doors, for future requests, please add page numbers and exactly where the text should be added. SarahSV ^(talk) 05:43, 22 May 2016 (UTC)

Sure regarding the last bit. Doc James (talk · contribs · email) 05:47, 22 May 2016 (UTC)

Done. Doors, if you also want the ban text removed, please open a separate request. It's easier to deal with one thing at a time. SarahSV ^(talk) 06:14, 22 May 2016 (UTC)

Semi-protected edit request on 5 June 2016

Please change the term "male-to-female transsexuals" to "male-to-female transgendered individuals" in the "Medical Uses" section, under the heading "Off-label uses". The correct term for people who transition from one gender to another is transgender, even though some people still choose to refer to themselves as transsexual. The term transgender is more commonly used in the medical world, because this issue is not related to a person's sexuality, it is related to their gender identity. Lsmedley5135 (talk) 14:34, 5 June 2016 (UTC)

Not done: please establish a consensus for this alteration before using the {{edit semi-protected}} template. I'm not convinced transgender would be the "correct" term. From looking through transgender, the second sentence reads, "Transgender people are sometimes called transsexual if they desire medical assistance to transition from one sex to another" and the lede goes on to mention that some transgender individuals do not seek medical or surgical sexual reassignment. If all this is true, then if finasteride is being used in HRT for these individuals, the term transsexual seems to be more applicable than transgender. I also don't believe that transsexual is ever used to refer to someone's sexuality changing, only to their sex. Feel free to discuss this change further, I'm just one dissenting opinion Cannolis (talk) 17:18, 5 June 2016 (UTC)

I'm definitely not an expert on that topic, but Cannolis opinion seems reasonable to me. My impression is that transsexuals are thought of as a sub-category of the transgendered population who undergo some kind of medical treatment to transition from one sex to another. This wouldn't apply to all transgendered people. The term "transsexual" does kind of feel out-dated but I think it is more accurate in this instance.Doors22 (talk) 04:28, 6 June 2016 (UTC)

Request for Edit

SlimVirgin, will you please make the following edit if you deem it to be appropriate? Even though JYTDog has been banned from Wikipedia, I think it's still wise to have you moderate my proposed changes on the article, despite his interference being the reason I agreed to edit the article in this way.

Will you please delete the first paragraph of the Society and Culture Section that says: "From 2005 to 2009, the World Anti-Doping Agency banned finasteride because it was discovered that the drug could be used to mask steroid abuse.[31] It was removed from the list effective January 1, 2009, after improvements in testing methods made the ban unnecessary.[32] Notable athletes who used finasteride for hair loss and were banned from international competition include skeleton racer Zach Lund, bobsledder Sebastien Gattuso, footballer Romário and ice hockey goaltender José Théodore.[32][33]"

The finasteride ban is a policy that was overturned almost 8 years ago and does not seem notable to a discussion of finasteride today. Thanks. Doors22 (talk) 00:22, 25 July 2016 (UTC)

Hi Doors, Jytdog has not been banned, just blocked indefinitely, and, as I explained at the time, there's no link between whether he is active here and your being asked not to edit the article directly. I'll leave this request open for a few days to see whether anyone objects to the removal of that text. Pinging Doc James in case he has a view. SarahSV ^(talk) 06:51, 25 July 2016 (UTC)

Have moved it lower. It is interesting that people were banned from sports for its use. Doc James (talk · contribs · email) 06:54, 25 July 2016 (UTC)

Doc James, thanks. Doors22, given the objection I can't proceed with the edit request. But thanks for posting the request on talk rather than going ahead with it. SarahSV ^(talk) 04:20, 26 July 2016 (UTC)

Doc James and SlimVirgin, I appreciate that you took a look at my requested edit. I personally see it as less notable, not being a bobsled fan, but I'm willing to accept the compromise of moving it further down in the article.

Regarding the agreement to submit edit requests, it was in response to JYTDog's offer https://en.wikipedia.org/w/index.php?title=Wikipedia:Conflict_of_interest/Noticeboard&diff=prev&oldid=718390531 to walk away and end his disruption. Now that he has been blocked, this is basically a given. His accusation that I had a COI was baseless but I am happy to post on the talk page for this article to invite other reasonable editors to disagree and I believe this will more effectively build consensus. Thanks. Doors22 (talk) 02:19, 27 July 2016 (UTC)