Talk:Finasteride/Archive 4

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Controversy Section

The current statement in the controversy statement inaccurately states that finasteride does not differ significantly from the placebo in eliciting sexual dysfunction. This statement is contradicted by the drug's original clinical trials for both proscar and propecia and even a more recent meta study in a higher quality scientific journal. I propose my recent edit should be upheld or at modified subject to compromise since the way it is currently worded makes it seem as though there is no controversy relating to sexual side effects. It also inaccurately gives the impression that finasteride does not even cause short-term sexual side effects which has been incontrovertibly established for decades.

Yobol's uncivil threat of telling me to go elsewhere was not appreciated.Doors22 (talk) 04:30, 12 January 2015 (UTC)

@Yobol:, please review the reference document before reverting as the prior edit was in fact inaccurate. I realize my edit was also partially inaccurate as well so I have made the necessary correction. The prior edit stated there is no causal relationship between finasteride and sexual side effects (even short term) but this is objectively untrue. In particularly, please review the following answer from the Q&A section of the FDA's press release:

Q2. Are any similar side effects already listed in the labels of Proscar and Propecia?

A2. Yes. Sexual side effects were reported by patients during clinical trials, and this information was included in the Proscar and Propecia’s labels at the time of approval in 1992 and 1997, respectively. In controlled clinical trials, these side effects resolved in patients who stopped finasteride, as well as in most patients who continued therapy. In 2011, both Proscar and Propecia’s labels were revised to include erectile dysfunction that continued after drug discontinuation.

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm Doors22 (talk) 05:33, 12 January 2015 (UTC)

Doors you are putting WP:UNDUE weight on matter that departs from how things are discussed in recent secondary sources. Please mind WP:MEDRS. Thanks. Jytdog (talk) 07:47, 12 January 2015 (UTC)

Agree. This was gone over in great detail just a few months back, and Doors22's efforts to edit war similar material into place were rejected by other editors at that time. Formerly 98 (talk) 09:17, 12 January 2015 (UTC)

Jytdog, with all due respect, I disagree with your statement that the current finasteride article reflects due weight of the literature on sexual side effects. It currently gives complete weight to a single study. I don't know if you have personally read this study, but it is one of maybe only a few articles to make the claim that finasteride is not associated with sexual side effects of any kind. Surprisingly, the included data do not even support the claims that are made by the authors. I am afraid this article is falling prey to bullshit, in your own terminology, and would appreciated it if you would take the time to investigate this complicated issue more thoroughly since you have chosen to make edits. There are dozens of article that high quality by MEDRS standards that demonstrate causality between finasteride and sexual side effects and I will include just a few for example. The real controversy is whether finasteride can cause persisting sexual side effects as it has been established for over two decades that finasteride causes sexual side effects in a subset of its users.

• http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

This FDA page references both the clinical trials for Proscar and Propecia (finasteride in different dosages) and really represents the recent medical consensus on the topic. It states, " Sexual side effects were reported by patients during clinical trials, and this information was included in the Proscar and Propecia’s labels at the time of approval in 1992 and 1997, respectively. In controlled clinical trials, these side effects resolved in patients who stopped finasteride, as well as in most patients who continued therapy. In 2011, both Proscar and Propecia’s labels were revised to include erectile dysfunction that continued after drug discontinuation."

• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481923/

This 2012 meta-study investigates a much larger scope of finasteride related studies than the single study currently presented in the article. It states, "A comprehensive review of a total of 73 papers on medical therapies for BPH was conducted, with a focus on the effects of different pharmacological agents on sexual function.[6] The review revealed that finasteride is infrequently associated with problems of ejaculation (2.1-7.7%), erection (4.9-15.8%), and libido (3.1-5.4%)."

• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4064044/

A June 2014 article (published even more recently than the currently included article) states, "Considerable evidence exists from preclinical and clinical studies, which point to significant and serious adverse effects of 5α-RIs, finasteride and dutasteride, on sexual health, vascular health, psychological health and the overall quality of life."

• http://www.ncbi.nlm.nih.gov/pubmed/12639651

One of the largest double-blinded long-term studies to date (3,040 patients) showed that despite both the test/control groups having similar prior medical histories of sexual side effects, 15% of the test group reported sexual AEs versus only 7% for the placebo group.

If you take the time to review the evidence and quality of articles, you'll see there is much more evidence demonstrating a causal relationship between adverse events than the single currently quoted article.

Please let me know if you have any proposed compromises or feedback. Thanks in advance for your cooperation. Doors22 (talk) 04:11, 13 January 2015 (UTC)

the last source is PRIMARY and we don't use them. The other two journals are from very low quality journals. The FDA page is more compelling. But the 2014 review I cited is from a high quality journal and takes that all RCT's up to 2012 into account. You are completely discounting that source. Thanks for talking. Jytdog (talk) 05:30, 13 January 2015 (UTC) (corrected per remarks below Jytdog (talk) 06:44, 13 January 2015 (UTC))

and I have to say, coming back here and adding back information that was discussed and resolved three months ago, and then edit warring to keep it in, is bad behavior. In addition, your sole focus in this article has been engorging the content on sexual sex effects suggests you come here with an ax to grind - that is a comment about your behavior, evident from your contributions - there is plenty there to serve as a basis for having you topic banned, especially if you edit war again in the future. Please tread lightly, and please check your ax at the login page. Thanks. Jytdog (talk) 06:07, 13 January 2015 (UTC)

You do not appear to have read the study because it doesn't mention the FDA review, the clinical trials, or really even explain the conclusion it draws. The article you cite is not from a high quality journal and there are other recent (within the past several years) higher quality journals (for example, the one reference that was removed). I am not discounting that single source but there are many more higher quality sources you are dismissing. Here is another article from a journal with an impact factor that is significantly higher than the Journal of Dermatological Treatment and also in a much more relevant specialty to the topic at hand.

• http://informahealthcare.com/doi/abs/10.1517/14740338.2013.742885

This is another meta study that reviewed all PubMed articles over 2 decades from 1992 to 2012. Frankly the quality of the methodology is far superior as well. If you access the article you will find the text, "5ARIs have a recognized, consistent association with sexual AEs, including decreased libido, erectile dysfunction (ED), and ejaculatory dysfunction (EjD)."

I have provided you with plenty of evidence although there is much more and I don't get the sense you are being receptive. "Thanks for talking" is dismissive and rude and I would appreciate if you would continue with a more cooperative tone. Doors22 (talk) 06:28, 13 January 2015 (UTC)

No I meant it. Thanks for talking. It is much better than edit warring. Jytdog (talk) 06:30, 13 January 2015 (UTC)

That was a good point that I was sloppy. The 2014 review takes all RCTs published prior to 2013 into account. That is the most recent review. That paper is quite clear: "Results from our network analysis demonstrated no significant difference between active treatments and placebo for the outcome global sexual disturbance and reinforces the safety of these drugs. Although persistent sexual side effects associated with finasteride have been highly publicized in the lay press (31–33), controlled-clinical trial data shows a low incidence of sexual side effects that resolve on cessation of treatment (34,35). Until cases of persistent sexual side-effects can be further evaluated, there remains a paucity of direct evidence for the validity of persistent sexual side effects as a result of 5α-reductase inhibitor treatment." Jytdog (talk) 06:44, 13 January 2015 (UTC)

I think you may be misunderstanding. Like I have said, the controversy remains regarding persistent sexual side effects. This is what I introduced in my edit from the FDA. It is not controversial that finasteride causes sexual side effects.Doors22 (talk) 06:48, 13 January 2015 (UTC)

If you have a chance to actually access the article, you will see they start with 349 potential randomized control trials and winnow it down to a mere 11 for the their global sexual disturbance analysis. They don't offer any explanation or show any work and then draw conclusions.

On the other hand, the other study actually offers both a comprehensive literature review and analysis on a full set of RCTs. They did not choose to winnow away RCTs without offering satisfactory explanation. The quality of the journal is much more highly respected and has a higher impact factor and the authors are very highly respected in their field. If you are trying to argue the Gupta paper carries significant weight because it is a more recent paper, it is really a moot point. They could have only possibly collected 3 months of additional RCTs but they eliminate the overwhelming majority of their data which makes it a rather poor 'meta-analysis'. This shouldn't surprise anyone when they are the only one's to draw the conclusions they have. The current state of the article needs to change. Are you willing to discuss potential edits at this point? Doors22 (talk) 06:57, 13 January 2015 (UTC)

Just use the later study: it doesn't even contradict the earlier review but confirms that the "association" between Finasteride and long-term effects isn't causative (but imagined), by my reading. Alexbrn ^{talk|contribs|COI} 07:16, 13 January 2015 (UTC)

That isn't an appropriate interpretation because randomized controlled trials are specifically designed to tease out the percentage of patients who simply report 'imagined' adverse events. The first study states the association is consistently recognized while the second denies this from its own analysis. The first study represents 27 controlled studies and it is possible to look at every single one to show that the 2014 metastudy is a single outlier. Even the 2014 article acknowledges real side effects reported in the clinical trials. Doors22 (talk) 07:36, 13 January 2015 (UTC)

No, the beginning of the abstract (even) in Gupta acknowledes "post-marketing reports of persistent sexual dysfunction with the use of finasteride" - there's your "association" right there. Alexbrn ^{talk|contribs|COI} 07:43, 13 January 2015 (UTC)

I'm sorry, I misread your statement as it is late where I am. The 2014 study really did not test or examine the post-marketing reports. The FDA did this. For whatever reason, it did not stop the authors from offering an unqualified opinion. But again that is why they are offering a fringe opinion in an inferior medical journal. How about we mention the case reports under the controversy section and then we can quote papers that call for additional investigation because that is really the prevailing thought at the moment.Doors22 (talk) 07:55, 13 January 2015 (UTC)

Per MEDRS, we don't use case reports because they fall below minimum standards of evidence. Heres why:

Combined sales of proscar and propecia ran about $1B per year for 12 years, so assuming a monthly cost of about$100, thats 10 million patient years. If we assume there are 1000 cases for each one of the 50 or so reported to FDA (the usual assumption is 10 to one) you get about 60,000 guys with persistant sexual problems, or 0.6% per year of therapy. Studies show about 40% of men in their 50s have sexual problems, suggesting there is a significant rate of new onset sexual dysfunction in the absence of drug treatment. Simply put, if permenent sexual dysfunction is a real side effect of finasteride, it will be impossible to prove because its rate is low relative to that of new onset problems from smokimg, obesity, aging, and other causes. And the low rate of reports suggests they are explicable by these other fsctors.Formerly 98 (talk) 08:06, 13 January 2015 (UTC)

It is not true that case reports aren't used per MEDRS. MEDRS states, "Case reports, whether in the popular press or a peer reviewed medical journal, are a form of anecdote and generally fall below the minimum requirements of reliable medical sources." In this case, the case reports were analyzed and published the FDA, the world's leading regulatory body. The context of their analysis included controlled for confounding factors such as obesity, smoking, age etc. and led to an updated statement on the product's safety label. Most case reports generally fall below the minimum requirements but there are exceptions and an analysis by a regulatory body that leads to a product warning label would certainly qualify.Doors22 (talk) 13:27, 13 January 2015 (UTC)

we do mention the case reports and we cite FDA update and a recent review for that. Jytdog (talk) 13:33, 13 January 2015 (UTC)

The way the article is set up, the FDA update is juxtaposed against the single low quality article that undermines the significance of the FDA report. It is misleading and untrue. It is a thinly veiled statement that is analogous to saying although there have been case reports reported to the FDA... they are not true. Undue weight is assigned to a single study versus the world's foremost regulatory body and a whole body of literature & studies. It would be more accurate to remove any mention of such side effects to avoid creating a misleading idea. 13:59, 13 January 2015 (UTC) — Preceding unsigned comment added by Doors22 (talk • contribs)

If you were looking at the article as a whole - which you are not doing - you would see that the side effects section has appropriate WEIGHT. We will not give WP:UNDUE weight to this topic so we are not expanding it. With regard to the content, the article currently reflects the evidence and the way we use evidence per MEDRS, which is that we emphasize reviews of RCTs. You don't have a leg to stand on with regard to the policies and guidelines that govern content. Jytdog (talk) 14:10, 13 January 2015 (UTC)

I am very thoroughly reviewing the article as a whole and I disagree with you still. If you look through PubMed, a very large proportion of articles written about finasteride involve at least some mention of sexual side effects. You have included a single inaccurate sentence in the adverse events section. You are also WP:Cherrypicking your one study to get across the point you want to make. Not just that, but you have deleted the reference to superior sources. The only value your source has is that it was published within the last year, but it is inferior in every other way to other pieces in the medical literature that satisfy WP:MEDRS criteria. As is the case for you, if you choose to not collaborate constructively and dig your heels in, I will escalate this dispute and bring in external review. From [WP:NPOV]]:

"Neutrality assigns weight to viewpoints in proportion to their prominence. However, when reputable sources contradict one another and are relatively equal in prominence, describe both approaches and work for balance. This involves describing the opposing views clearly, drawing on secondary or tertiary sources that describe the disagreement from a disinterested viewpoint." 02:15, 14 January 2015 (UTC) — Preceding unsigned comment added by Doors22 (talk • contribs)

Doors, I don't see anywhere that the FDA examined these cases to exclude other causes, nor can I imagine how it would be possible to do so. I do see where they say causation remains unestablished. So there are two issues: The first is unestablished causation. The second is extremely low incidence, with less than 100 case reports in 10 million patient years. The latter makes your proposed changes undue weight and the former makes it speculation. We have discussed this to death on many occassions and there is no consensus for your position. Formerly 98 (talk) 14:37, 13 January 2015 (UTC)

I don't deny that the FDA post-marketing reports did not definitively establish causation. However, you conveniently are ignoring the second half of the same sentence that states, "the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs".

You are taking immense liberties in trying to calculate a frequency for reported persistent side effects. There are many problems with how you went about doing this but it is simply prohibited by WP:NOR and should be stricken from this discussion.

The idea that you conveniently present half of a sentence to represent your opinion/objective and ignore the second half of the same sentence is Cherrypicking. If you are unwilling to discuss constructively I will bring in an outside review.

"In the context of editing an article, cherrypicking, in a negative sense, means selecting information without including contradictory or significant qualifying information from the same source and consequently misrepresenting what the source says. This applies both to quotations and to paraphrasings."Doors22 (talk) 02:09, 14 January 2015 (UTC)

Added a request for comment to medicine Talk page Formerly 98 (talk) 03:27, 14 January 2015 (UTC)

Controversy sections are not generally recommended. If you draft a RfC for the change you wish we can look at it further. Unsure why you removed a 2014 review article though. Doc James (talk · contribs · email) 04:54, 14 January 2015 (UTC)

I was looking through PubMed and I found this review which states that "Both Finasteride (OR 2.70; P < 0.0001) and Dutasteride (OR 2.81; P = 0.0002) were associated with significantly higher risk of EjD [ejaculatory dysfunction] than placebo." Should we include it? Everymorning talk 15:53, 14 January 2015 (UTC)

Yes we appear to have one review which says no difference overall regarding sexual dysfunction[1] and a second review that states increased ejaculatory dysfunction [2] And we have a Cochrane review that states "men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo" but that this is rare.[3] Doc James (talk · contribs · email) 01:17, 15 January 2015 (UTC)

Anyway added some details. Doc James (talk · contribs · email) 01:22, 15 January 2015 (UTC)

i appreciate that you added the bit at the start that side effects are rare. But that is left out of the additional matter you added on the sexual side effects. You know Doc James that men are insane about their penises (hence all the hysteria). The weight here is UNDUE - the side effects, if the signal is real, are rare - more rare than the widely accepted side effects. Jytdog (talk) 02:29, 15 January 2015 (UTC)

@Doc James: your assistance on this dispute is very truly appreciated and I found your objective input to be very reasonable. I have at least two other meta-analysis that demonstrate causality and believe that one variant viewpoint is receiving undue weight. I don't believe you will find another meta-study that states there is no causal link and it should be easy to find at least several more that indicate this. Also, do you think it is worthwhile to include details about the FDA label change since this has previously existed in the article and was removed. Would you please share your thoughts? I don't want to make changes myself since they will undoubtedly be reverted as they have in the past so I am seeking your advice and input.

• 1st Meta-study - This is a lower quality journal but still is fairly recent but states finasteride is causally related with sexual adverse events.
• 2nd Meta-study - This article was written by a thought leader in urological medicine and was published in a journal with a much higher impact factor than the dissenting meta-analysis. If you don't have access, one excerpt states "5ARIs have a recognized, consistent association with sexual AEs, including decreased libido, erectile dysfunction (ED), and ejaculatory dysfunction (EjD).Doors22 (talk) 02:32, 15 January 2015 (UTC)

JYTDog, the side effects are rare but very significant when you consider this is a drug given for hair loss that temporarily maintains and does not restore hair. The sexual adverse events are not merely cosmetic and in my opinion quite significant because they can destroy relationships.Doors22 (talk) 02:34, 15 January 2015 (UTC)

I am so not going to respond to that last bit. Jytdog (talk) 02:38, 15 January 2015 (UTC)

I think it is enough to say some reviews do not find concerns while others do. What is fthe impact factor of the "Indian Dermatol Online J"?

We have 4 sentences on the issue of sexual dysfunction. And less words than on discussion of male breast cancer. Doc James (talk · contribs · email) 02:54, 15 January 2015 (UTC)

@Doc James: I think the two references you cited refer to Proscar and not Propecia. This is an important distinction as Proscar (for BPH) is a 5 mg daily dose and Propecia (for MPB) is a 1 mg dose. Its an important difference as no 35 year old wants to give up sex to have hair, but the 65 year old who is treating BPH potentially faces impotence from surgery as the primary therapeutic alternative to Proscar. Context is important. Formerly 98 (talk) 02:52, 15 January 2015 (UTC)

Yes we should make that clarification and have done so. Doc James (talk · contribs · email) 02:54, 15 January 2015 (UTC)

@Doc James:The two sources I cited reference finasteride and 5-alpha-reductase inhibitors generally, not specifically proscar. The dose response curve is actually very similar for dosages of Proscar (5mg) versus Propecia (1mg). The impact factor for the Journal of Sexual Medicine is 3.15 which is the article that seeks out finasteride in general. JSM Article This article specifically mentions finasteride as being used for hair loss and BPH. I'm not sure about the other journal. I can try to locate additional articles that confirm Propecia and finasteride generally cause sexual adverse events but I feel there are already enough references. Please let me know if you disagree. Also, are you opposed to adding the statement from the FDA suggesting the post-surveillance reports suggest a broader range of side effects than what was originally included in the label? (persistent sexual adverse events) Doors22 (talk) 03:13, 15 January 2015 (UTC)

@Doc James: The impact factor of the journal you asked about (Indian Dermatol Online J) is 1.325 according to this source (http://www.medknow.com/journals.asp?sj=&sin=Jonmoqdrq&subject=Jonqdofrq&index=). TylerDurden8823 (talk) 03:41, 15 January 2015 (UTC)

User:TylerDurden8823 that impact factor is for "Indian Journal of Dermatology, Venereology, and Leprology" Doc James (talk · contribs · email) 04:17, 15 January 2015 (UTC)

You're right, I misread. I don't see an impact factor listed for the journal you asked about on the page I listed. My bad TylerDurden8823 (talk) 15:03, 15 January 2015 (UTC)

User:Doc James The abbreviation for that journal is Indian Dermatol Online J which matches the article.Doors22 (talk) 04:21, 15 January 2015 (UTC)

That impact factor appears to be for a different journal. Doc James (talk · contribs · email) 04:30, 15 January 2015 (UTC)

Thanks a lot. Formerly98 and JYTDog criticized that article for being in a poor journal but the impact factor is not much lower. The IF for the Journal of Dermatological Treatment is 1.483. If you look at just the 2013 number and not the 5-year number it is a bit higher 1.764 but still lower than the rest of the sources. JDT Ranking.Doors22 (talk) 03:51, 15 January 2015 (UTC)

EDIT: Apologies, I realized I made a mistake and didn't realize I was looking at two separate studies. Both state 5-ARs as used for androgenic alopecia and BPH cause sexual side effects. We neglected to mention gynecomastia which is also somewhat important as it is permanent and requires surgery to remove. JSM article has impact factor of 3.15 and Expert Opinion on Drug Safety article has impact factor of 2.735, both higher than the dissenting study and both reference finasteride for male-pattern-baldness.Doors22 (talk) 03:46, 15 January 2015 (UTC)

Doors, first of these two papers that you have represented above as "stating that finasteride is casually related to sexual adverse effects" literally states

"The persistence of sexual side effects appears to be a rare event, and it has yet to be determined whether these recent reports represent a true causal relationship, or if they are simply coincidental and related to other factors such as the high incidence of sexual dysfunction in the general population, and/or the placebo effect. Also, little data is available concerning the medical and psychological work-up of these patients to exclude other potential causative factors."

So please read these articles more closely before summarizing them in the discussion. This paper appears to have reached the opposite conclusion from your summary. Formerly 98 (talk) 05:09, 15 January 2015 (UTC)

That is incorrect. I was referring to adverse events of any kind, not persistent side effects. The article should still be edited to reflect finasteride (both Propecia and Proscar) cause sexual adverse events. It should also more clearly reference the FDA label update discussing the post-marketing reports of persistent side effects. Thanks Doors22 (talk) 05:24, 15 January 2015 (UTC)

doc james made edits that i will not oppose that go as far as we should go. You've got a compromise. You are trying to take a mile and that is not going to happen. Jytdog (talk) 05:49, 15 January 2015 (UTC)

This is a work in progress and remains inaccurate on two accounts. 1 - the evidence overwhelmingly shows finasteride causes sexual adverse events 2 - Both proscar and propecia cause sexual adverse events 3 - The actual controversy, the persistent sexual side effects should be fleshed out more. As Doc James stated, the section on breast cancer is longer but discussion about breast cancer comprises a much smaller part of the medical literature and public discussion in the media. Additionally, the evidence in support of finasteride causes breast cancer is much more thin. I am still awaiting additional impartial and objective input. Thanks. Doors22 (talk) 05:57, 15 January 2015 (UTC)

One review found no sexual issues with the hair formulation. The formulation for BPH has found some concerns but they are rare. Persistence is not well defined but has been reported. Not much more to say. Doc James (talk · contribs · email) 09:33, 15 January 2015 (UTC)

@Jytdog: I'm not sure why you insist on starting an edit war. Your attempted edit does not provide proper weight or WP:BALANCE.

Neutrality assigns weight to viewpoints in proportion to their prominence. However, when reputable sources contradict one another and are relatively equal in prominence, describe both approaches and work for balance. This involves describing the opposing views clearly, drawing on secondary or tertiary sources that describe the disagreement from a disinterested viewpoint.

The 2014 Gupta article is from the lowest rated journal and presents an argument that is directly contradicted by many other higher quality meta-studies. Doc James chose to previously include multiple meta-reviews to provide proper balance after only briefly investigating this article. Unless you can provide a good reason (or additional sources) to show that this is not a fringe viewpoint, the edit will be reinstated to show proper balance. I don't even believe the Gupta article should be included but for the sake of preserving proper balance, I don't see any harm in presenting it with proportional balance. Doors22 (talk) 05:18, 19 January 2015 (UTC)

Doors, if @Doc James: agrees with you, how does it work out that you are editing his version of the document to change the exact section that deals with this issue? The accusations of edit warring you offer here are a little over the top, given that you are editing the article for POV over the opposition of 3 other editors. Please stand down. Formerly 98 (talk) 08:58, 19 January 2015 (UTC)

I am actually reversing the POV that you have attempted to wikilawyer into the article, as usual. I have discovered two additional useful articles after further reviewing the literature. They are both meta-reviews that conclude both Propecia and Proscar cause sexual adverse events, not just the latter as you have argued. DocJames was in favor of showing the # of reviews that represent each viewpoint, presumably to represent the weight that each argument represents. The fact that there are at least 5x the amount of reviews that indicate the presence of adverse events versus a single review against is just that, a fact. As for edit-warring, I'd like to note that both you and JYT have been the ones to aggressively revert my edits when that has not been my policy. I'd kindly like to remind you of WP:ROWN. Thanks. Doors22 (talk) 15:20, 19 January 2015 (UTC)

Doors, it seems the central problem in every difference of opinion that you encounter boils down to bias and conflict of interest on the part of the other party. You might want to think about whether this makes sense to bring out as an argument of first resort.

Currently we have the phrase

"However another review from 2014 found increased risks of impotence, erectile dysfunction, decreased libido, and ejaculation disorder when used for benign prostatic hyperplasia and androgenic alopecia."

which is sourced to a Journal of Sexual Medicine article. But when I look at the abstract, I see only reference to BPH treatment. Could someone please quote me the passage from this article that supports the statement about alpoceia? Thanks Formerly 98 (talk) 16:01, 19 January 2015 (UTC)

If you review the recent edits you will see that JYTdog removed references (at 02:19) that both I and Doc James added. He supplied the reason that only the most recent article need be included which doesn't make sense to me. This creates an imbalance and as you mentioned and ignores the literature specifically on AGA and more generally on finasteride (both dosages). Since I thought I made it clear that JYTDog removed references, it looks like we are seeing evidence you are experiencing the Confirmation Bias.Doors22 (talk) 16:17, 19 January 2015 (UTC)

I agree with Jytdog that the 2010 report is a little long in the tooth given the availability of other sources. The Sexual Medicines Review journal is not a Pubmed indexed journal, and would normally be excluded for that reason. In any case, the rates are very, very low. If you want to push this argument toward greater consensus for finasteride inducing sexual side effects, we should add material indicating that the rate was only about 0.5% greater than in the placebo group (which is part of why it is ambiguous), and dropped to essentially zero on long term dosing. We should also add the statement that claims of persistent sexual side effects have not generally been supported by randomized double blind clinical trials. Formerly 98 (talk) 17:13, 19 January 2015 (UTC)

The 2014AA review mentions risk of sexual dysfunction in androgenic alopecia, so I put an instance of that already-used source there. added reference to updating FDA label

PubMed is not the only source of medical journals that meets MEDRS standards and in fact 'Arch Dermatol' is the highest quality journal (measured by impact factor) of any source that has been provided on sexual adverse events in this article to date. I am OK with the state of the article as things are. Are you OK with leaving things as is until additional research is published or there is additional outside input? This is a compromise as I still feel there is an imbalance with respect to the meta-reviews but generally I think readers will have a general understanding of the research that exists. Ideally, I would prefer to settle at this point for the sake of saving effort. Thanks. Doors22 (talk) 17:45, 19 January 2015 (UTC)

glad you are OK enough now. I am OK enough too. Jytdog (talk) 17:46, 19 January 2015 (UT

I still think its phrased a little too strongly and thus misrepresents the source. "The FDA updated the label to communicate this risk" will be read by most people as meaning that the FDA confirmed that taking finasteride creates a risk of permanent sexual dysfunction. What the source actually says is:

Q: "Has FDA notified healthcare professionals about the risk of sexual adverse events associated with finasteride use?"

A: "FDA has notified healthcare professionals who would normally prescribe finasteride products—dermatologists, family practice professionals, internists and urologists—about FDA’s review of postmarketing reports and the label changes. This communication informs prescribers that FDA has not established a cause and effect relationship between finasteride and the sexual adverse events that continued after stopping drug use."

Note that the word "yes" was not in the response. The response says "the FDA notified of postmarketing reports" and "a cause-effect relationship has not been established".

I think that "The FDA has updated the label to inform healthcare professionals of these reports" more accurately reflects the source. Formerly 98 (talk) 19:29, 19 January 2015 (UTC)

The response was definitely confirmatory and it is not really relevant whether they used the word yes which would be redundant. I think you are trying to push further after we agreed upon a consensus. I am willing to let that slide if you agree to establish this as a consensus until additional medical research is published either supporting/contradicting/adding to what is already in this article. In the past, you have waited several months before unilaterally making changes and I want to make sure we agree that will not happen without the appropriate catalyst. JYTDog and I had reached an agreement and I will let your recent edit slide so long as you agree. I will not speak for him though since you most recently changed his edit. Thanks. Doors22 (talk) 20:08, 19 January 2015 (UTC)

Let's wait until we hear from Jytdog before I stipulate that you are "letting this slide". We have not heard his response yet. But yes, I can be satisfied that this this language is fine until such time as new data becomes available or other editors comment. I would similarly ask that you confirm that you will avoid making edits to unrelated articles that could be readily be interpreted as retaliatory. Your only edits the last several months that were not on this exact article involved reverting my edits or jumping into discussions on the other side of the issue from myself on articles you had never edited before. While I don't want to assume intent to harass, the edits were certainly unusual and out of character with your past editing habits. Formerly 98 (talk) 20:21, 19 January 2015 (UTC)

consensus should include everybody. Formerly's suggestion is fine with me. Jytdog (talk) 20:56, 19 January 2015 (UTC)

OK, thank you. So we agree this achieves consensus until additional data is released or other editors comment. Doors22 (talk) 05:00, 20 January 2015 (UTC)

drug usige simplified

Please add a picture to show what the pill looks like, searching among a dozen pills to find the right ones and time of day or multiple pills at staggered times becomes a task for increasingly old and less than able aged persons. Doctors and drug suppliers do not think this is their problem, but the correct usage of these medications lead to their successful use, no one is addressing this issue, we need to do better! 24.189.155.118 (talk) 17:30, 20 March 2015 (UTC)

Funding of 2015 meta analysis

I added the funding source for the 2015 meta analysis, as multiple studies have shown that conclusions are strongly affected by the source of funding. Notably, the abstract of the article itself notes suggests that the credibility of the adverse reporting in the clinical trials was low in part because 56% of the trials were "funded by the manufacturer", thus showing that the auhors of the paper themselves subscribe to this viewpoint. And given that the CEO of the Foundation believes that his son committed suicide as a direct result of finasteride use, its really difficult to see the operations of this Foundation as completely independent of the ongoing litigation. Formerly 98 ^{talk|contribs|COI statement} 02:51, 16 April 2015 (UTC)

user:Jytdog and I have each added this information, and user:Jfdwolff has expressed support for it by sending me a "thank". So there is no consensus for your position. The information is considered relevant by the journal the article was published in, multiple meta analyses have shown that funding affects conclusions, and the authors of the cited support this by pointing out that many of the trials were funded by manufacturers. Please don't edit war. Formerly 98 ^{talk|contribs|COI statement} 02:21, 17 April 2015 (UTC)

Your commentary is truly unbelievable, more so when considering you advocated for deleting the article on the post finasteride syndrome foundation. The funding of research has generally not been included in wikipedia - manufacturer or otherwise especially because this constitutes original research. Your edit involves substantial undue weight, especially when you selectively choose to ignore the main grant from the National Institutes of Health and highlight a small minority donor. People who run foundations very often have a personal connection to the cause. It shouldn't be any surprise the CEO had a family member that suffered from the drug. The logic you invented that tries to show a connection between the foundation and litigation is just simply wrong. JYTDog has unsuccessfully tried to do this in the past as well.Doors22 (talk) 02:25, 17 April 2015 (UTC)

Moreover, the author applied an objective criteria to evaluate the quality of each study. Source of funding was not the only criterion. You have no established any form of consensus. JYTDog did not discuss after I made the point that including funding from the PFSF is undue weight and a 'thank' certainly doesn't contribute towards consensus in the slightest because its not public. You are edit warring and I suggest you find additional feedback from others before reverting again and that you refrain from escalation.Doors22 (talk) 02:33, 17 April 2015 (UTC)

"The funding of research has generally not been included in wikipedia" - Generally people avoid adding content with funding COIs to articles, because it just gets tagged as such by other editors. I certainly avoid adding manufacturer-funded meta analyses to articles. But if you want an example of how this has been handled, see, Atrazine -"A 2014 systematic review, funded by atrazine manufacturer Syngenta, assessed its relation to reproductive health problems."

• "you selectively choose to ignore the main grant from the National Institutes of Health and highlight a small minority donor". The paper doesn't explicitly state the size of the funds obtained from each source, and it doesn't really matter.
• "Moreover, the author applied an objective criteria to evaluate the quality of each study. " As did the investigators in the 56% of studies that were criticized due to having been partially funded by the manufacturer.

The bottom line is that the journal mentioned it, and so it can't be argued away as trivial. That would be WP:OR Formerly 98 ^{talk|contribs|COI statement} 03:24, 17 April 2015 (UTC)

This article utilized objective "Ioannidis and Lau criteria" for evaluating the quality of clinical trials. It could have been funded by Merck and would have come up with the same conclusions. It is certainly WP:POV for your to include a small 'gift' from one party while ignoring the main financial support, especially when the disclosure clearly says, "The funding organizations had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication." Still waiting for another editor to contribute, even though your actions indicate your sole input constitutes consensus.Doors22 (talk) 03:43, 17 April 2015 (UTC)

Well, what you know right now is that both Jytdog and I have added the same statement to the article. Perhaps you are right and s/he has had a change of mind since your reversion. Let's wait and see. Formerly 98 ^{talk|contribs|COI statement} 03:55, 17 April 2015 (UTC)

Regardless, two people do not make a consensus. Stop trying to Wiki Lawyer and bully your way into every pro-industry edit you wish to incorporate into articles. Of note - both you and JYTDog both advocated removed the post finasteride syndrome foundation article due to its lack of notability and now you feel like including it in a reference to advocate for your own biases. Doesn't cut both ways.Doors22 (talk) 04:53, 17 April 2015 (UTC)

i think it is reasonable to mention the funding. i had suggested something similar for an article funded by bayer, if that is any comfort to you. the source had only been proposed as an example of what a "review" is, and it was never actually used. See Talk:Neonicotinoid/Archive_1#Discussion_of_Bayer-funded_source where i wrote, " I would accept it, if others wanted attribution. (my thinking may change! I am interested in what others have to say on this, grounded in policy/guideline/essay, not just hand waving)" I don't think you should have a cow about this - it is not like formerly or i are advocating taking it out altogether. Jytdog (talk) 04:59, 17 April 2015 (UTC)

"Post-Finasteride Syndrome Recognized by the NIH"

"Post-Finasteride syndrome" was recognized by the National Institutes of Health's Office of Rare Disease research group in 2015." was added to the article and two meta analyses that were added as the result of a lengthy discussion were removed. I think both of these edits were inappropriate.

With respect to "recognition by the NIH", what the source actually shows is a link to the NIH Genetic and Rare Diseases Information Center (GARD). If one clicks the "Disclaimer" link on the left of the page, the following statement appears;

"Any materials that the ORDR provides are for information purposes only and do not represent endorsement by or an official position of ORDR, NCATS, the National Institutes of Health (NIH), or any Federal agency. "

With respect to the two meta analyses, no explanation has been offered for why they were removed. Formerly 98 ^{talk|contribs|COI statement} 14:31, 19 April 2015 (UTC)

That is a fair point I suppose. A disclaimer is probably overly conservative especially when the organization is funding research to explore the syndrome further but I can understand you are coming from. I did not click the disclaimer as it is on a separate URL. I imagine the vast majority of people that visit this page would not check out the disclaimer unless they were seeking out criticisms. I am fine removing that but at some point the NIH or another credible institution will formally recognize the condition and this should be noted on the article. Doors22 (talk) 03:47, 23 April 2015 (UTC)

Whether it's officially endorsed or not does not remove the fact that information has been published. I don't see what's the problem. Just don't say that it's "recognized" but keep the source. FishDestroyer (talk) 07:43, 5 May 2015 (UTC)

And having been published in this context validates it in exactly the same way that the CDC investigation of Morgellons, validates Morgellons - i.e. not at all. People use the term colloquially, it has not been established as fact.

What puzzles me is why an editor with under a hundred edits, who normally edits articles on race politics in South Africa, should appear out of the blue and revert an edit on this article, as his first contribution for over a month. Guy (Help!) 11:06, 5 May 2015 (UTC)

I don't think we are speaking about the same topic. Nothing need to be "validated" or "recognized". Just keep the source and say that they are investigating the adverse effect of the product. Then, people who read this page know not to use the product until we know if it's safe or not. FishDestroyer (talk) 12:50, 5 May 2015 (UTC)

"Then, people who read this page know not to use the product until we know if it's safe or not." That's exactly the problem. You are trying to make a statement about health effects that go above and beyond what is found in WP:MEDRS compliant sources. We mention in the article that the FDA has added a statement to the package insert about case reports of persistant sexual dysfunction. As far as secondary sources go, that is pretty much what we "know". We don't insinuate the existence of problems that we dont' have MEDRS compliant sourcing for in order to "warn" people, any more than we add case reports of people whose migraines magically disappeared after taking Xanax in order to "inform" them. Formerly 98 ^{talk|contribs|COI Statement} 13:34, 5 May 2015 (UTC)

Exactly. Tis is an abuse of Wikipedia to drive external procedure, rather than an accurate reflection of the world as it is. We can certainly document the activities of the (currently minority) anti-finasteride campaign, but we may not, by policy, reflect their POV as anything other than a fringe view until we have credible independent sources to back that up. Guy (Help!) 16:21, 6 May 2015 (UTC)

Mechanism of action

@Doc James: I'm not sure I understood the rationale for your your edit. There are two basic classes of drug for this problem, one of which provides near immediate relief of symptoms by modulating the autonomic nervous system. The other has little short term effect but has been shown to reduce the need for surgery by actually shrinking the prostate. I thought the info was both useful and not excessively technical. Can you expand on your rationale for the partial deletion? Thanks. Formerly 98 ^{talk|contribs|COI statement} 22:30, 18 April 2015 (UTC)

Which edit? Doc James (talk · contribs · email) 01:18, 16 May 2015 (UTC)

You mean this one [4] These sorts of details are not needed "The study was published in JAMA Dermatology and was supported by grants from the National Institutes of Health with an additional gift from the Post-Finasteride Syndrome Foundation. " If people want to they can look at the ref. Doc James (talk · contribs · email) 01:20, 16 May 2015 (UTC)

JAMA dermatology is a decent journal and should have subjected this to peer review. Doc James (talk · contribs · email) 01:32, 16 May 2015 (UTC)

Also, I was interested in your removal of the information about the source of funding for the meta analysis of AE measurement. This has been a topic for considerable discussion above. In a prior discussion on Tamiflu, there was a CDC summary of the evidence that concluded that Tamiflu should be used in certain circumstances, and the text of our article implicitly criticized the CDC's review as being based on industry funded studies. I argued that the CDC was fully capable taking the funding bias into account for itself, and that we should not argue with the secondary source (CDC). Your reply at that time was "t is very well supported that funding affects the conclusions people reach. This is why Cochrane is so exceedingly important." and the text criticizing the CDC review remained intact.

I hate to beat the drum of consistency too hard, but we are also arguing about this issue over on the GlaxoSmithKline article, with @Slim Virgin: arguing that we should note that the RECORD trial of avandia was industry funded, even though the secondary sources explicitly discussed and took this fact into account in reaching their conclusions.

So what in your opinion is the best way to handle these situations? I rarely cite industry or other COI funded secondary sources because of this bias issue, and when I do I am inclined to note the funding source. In the case of secondary sources that discuss primary studies funded by COI agencies, I assume that the secondary source has taken the funding of the primary studies into account in reaching their conclusions, and I should not second guess them.

Your thoughts? Formerly 98 ^{talk|contribs|COI statement} 12:53, 19 April 2015 (UTC)

Couple of Questions

@Formerly 98:, will you please explain your reasoning when you say "While the overview of safety assessment is secondary research, the conclusion that "most men who would be prescribed finasteride were excluded from trials" is from a primary, single site research study and fails MEDRS"? What do you mean by a primary, single site research study? This was one conclusion drawn from a meta-study which by definition makes it a secondary, rather than a primary study.

Additionally, will you provide a link to the FDA approval summary for finasteride? It is unclear when you are referring to a Propecia or Proscar related document. The FDA text should specifically say something to the effect of we conclude the questionnaire is a sensitive measure of sexual dysfunction otherwise this is original research. Permitting a questionnaire to be used in a clinical trial is not the same thing as proactively concluding it is a sensitive measure. So long as there is a parallel statement I am OK with your edit. Doors22 (talk) 01:08, 15 May 2015 (UTC)

-Hi Doors, The paper describes both primary and secondary research. Secondary research is defined at WP:RS as follows:

"Wikipedia articles should be based mainly on reliable secondary sources, i.e., a document or recording that relates or discusses information originally presented elsewhere."

And in WP:SECONDARY as

"A secondary source provides an author's own thinking based on primary sources, generally at least one step removed from an event. It contains an author's interpretation, analysis, or evaluation of the facts, evidence, concepts, and ideas taken from primary sources."

WP:SECONDARY Further states:

"Articles may make an analytic or evaluative claim only if that has been published by a reliable secondary source."

The secondary research in the paper is the review of the quality of the recording and reporting of adverse effects in previously published trials. The statement that "most men who recieve Propecia would have been excluded from the clinical trials" is based on a comparison of the eligibility criteria in the published clinical trials to the health records of men who had recently been prescribed Propecia at a single institution. The latter data has not been published before, was aggregated and analysed by the authors, and is primary research.

The statement about the FDA finding the questionairre a sensitive measure of sexual side effects is on page 98 of part IV of the FDA approval summary, which can be found here. The quote in the Summary of Key Findings is:

"The sexual function questionairre seems to have given a sensitive reflection of the disturbance in sexual function"

Formerly 98 ^{talk|contribs|COI Statement} 02:31, 15 May 2015 (UTC)

Thanks, that was helpful. I am not very familiar with updating references so would you please include the URL so readers can access the original document? To translate the FDA's statement that the questionaire "seems" to have given a sensitive reflection to "concludes" changes the message a little bit in my opinion. I'll tweak it a bit in a way I believe maintains a NPOV and is more descriptive than interpretive. Let me know what you think. I do agree with you that it is useful to include the FDA's commentary on the quality of the study.

Moreover, I think I can see things from your point of view regarding the meta-study but I do not agree. I think it is important to reference WP:MEDRS specifically since medicine is somewhat unique from other fields given regulatory approval plays a large role in stimulating research. MEDRS classifies clinical trials from regulatory bodies as primary sources. "...the biomedical literature contains two major types of sources: primary publications describe novel research for the first time, while review articles summarize and integrate a topic of research into an overall view. In medicine, primary sources include clinical trials, which test new treatments." The top of MEDRS article clarifies, "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." The current author neither participated directly in research or documented personal experiences. I'll re-add this statement but I'll open it up for an RFC to get more eyeballs and objective opinions. Thanks. Doors22 (talk) 10:20, 15 May 2015 (UTC)

Well, here we go again. I'm tired of fighting about this which explains why I have not pursued the mention of the funding of the study you recently added. I suppose we can go back at it again, but it would be awfully nice if we could split the difference on some of these issues.

I am genuinely uncomfortable with the study you added. It appears to me that the studies being funded by the Post Finasteride foundation are part of a publicity campaign, and as I mentioned earlier, may even be in support of litigation. We can argue about whether or not accepting money changes researchers conclusions, but I think it is a foregone conclusion that the availability of money helps determine what studies get done. And it is difficult to imagine that the foundation, which could pick any researcher they chose to give money to, didn't actively seek someone sympathetic to their concerns. As it turns out, they picked someone with a recent history of evaluating adverse event data collection in trials of other drugs and concluding that it was inadequate. See here and https://www.ncbi.nlm.nih.gov/pubmed/24030903. I don't think this was an accident, and I believe it shows how private money can distort the medical record by throwing funding in the direction of researchers considered likely to produce "favorable" studies.

I'm further concerned that your rephrasing of the FDA text leaves it unclear to the reader. I had to read the paragraph a second time to figure out what that sentence was saying and why it was relevant, and I'm the one who added the info in the first place.

So here is what I propose:

• You are of course welcome to do an RFC on the issue of the part of the study I consider primary research. Easier yet, just ask the question on the MEDRS talk page, as that is the group that is most competent to ask the question. I am not concerned because I'm pretty sure that people will agree with me.
• If you want to contest the language on the FDA description of the sexual side effects questionairre, we can ask for outside opinion on that too. But I will then revisit the quesiton of the funding of the study. Alternatively, we can compromise, leave the funding out (agreement applies to this study only), and use my preferred language for the questionairre.

Let me know what you think. Formerly 98 ^{talk|contribs|COI Statement} 12:06, 15 May 2015 (UTC)

I'd like to remind you that Doc James was the editor who removed the reference to the funding. Also, you have argued yourself against including the funding for studies because it implicitly "raises questions about the reliability of their conclusions". This really isn't the place to be having this discussion anyway so I'm going to bring this part of the discussion to a head. What is important is that this is a peer-reviewed article in one of the highest ranked journals that is sourced in this article and MEDRS compliant. I don't know if you completely disagree with its conclusions of the study but that is besides the point.

With respect to the FDA comments, it is original research (and frankly incorrect) to say the FDA 'concluded' the questionnaire was a sensitive measure of sexual AE. There are oceans between saying something seems to be the case and something 'conclusively' holds. If you look just above the sentence you cite, the author of the letter leaves open the possibility the compound can cause ongoing sexual AEs.

Before you posted this most recent edit, I had already opened a RFC in the wiki medicine project as you suggested. I don't know whether the community will agree with you or me but as long as I feel there is objective, clean input I will be happy to accept the outcome. It is counterproductive if you continually provide input (JYTDog as well) because you are both involved in this article.

I don't know if this is possible, but it would be nice to have a 3rd party mediator be a regular editor to help sort out these points of disagreement. It would need to be somebody who will take the time to do the independent research and not rely so heavily on community commentary. DocJames has filled this role before and done a good job for the most part and might worthwhile contacting him if you are amenable to this.Doors22 (talk) 22:57, 15 May 2015 (UTC)

I left a note at your user page that the request for comment at the Medicine Talk page seems to be going nowhere and that we should try harder to reach a compromise. I don't know if you are open to that. I have no objection to Doc James as a third opinion if he is willing to play that role. But he has in the past argued in favor of including the discussion of funding sources in articles. I've pointed this out in the section (mechanism of action), and he never responded. Not as a threat, but just to be honest about my intentions, I will raise that issue with him if we bring him in as a third party.

From the last year of experience, it seems that after fighting over this article, criticizing each other, and trying to get each other sanctioned, we always end up with a compromise document that is pretty much the same one we would have gotten by politely negotiating. May I suggest that we try the latter, and both acknowledge that we are going to end up with a document that neither of us is completely happy with after doing some horse trading? I'm tired of all the conflict. Formerly 98 ^{talk|contribs|COI Statement} 00:12, 16 May 2015 (UTC)

That sounds good to me. If he thinks the source of funding is worth mentioning I will be OK including that but he should also be consulted on whether the NHS grant is worth mentioning too. I'll write a brief message on his talk page and ping you if you would like to contribute. I think the best way to approach this is to be as concise as possible since long edits have repelled interest. I think it is important for none of the involved parties to interfere to an unreasonable level to preserve objectivity. If he is not up to the task, I will ask if he can recommend another good editor or approach to take. I'll wait until you agree before I post anything on his talk page.Doors22 (talk) 00:35, 16 May 2015 (UTC)

He already pinged me about the approval summary reference, and I left him a note. Please feel free to respond separately if you disagree with myh comments. Formerly 98 ^{talk|contribs|COI Statement} 00:38, 16 May 2015 (UTC)

"most men who would be prescribed finasteride were excluded from trials" appears to be supported by the conclusion "most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for AGA." from http://www.ncbi.nlm.nih.gov/pubmed/?term=25830296 Looks okay to me Doc James (talk · contribs · email) 01:30, 16 May 2015 (UTC)

@Doc James:, thank you for stopping by. Having invited you to mediate, I don't want to be tendentious, but I will attempt a single cycle of checking to make sure you understood my concerns. The conclusion that "Only 31% of men prescribed finasteride met the eligiblity criteria for the pivotal trials" required two logical steps.

1) The authors reviewed the eligibility criteria for the pivotal (pre-approval) clinical trials, and

2) They aggregated and interpreted previously unpublished data about men prescribed the drug from the Northwestern University Enterprise Data Warehouse. Specifically, they set criteria for choosing a comparison population (those administered 1.25 mg or less per day) and analyzed the characteristics of this population to determine the frequency of men having conditions that they believed would have excluded them from the aforementioned trials. This gathering and interpreting of unpublished data to my mind represents pretty much the definition of primary research.

The latter step involved a number of judgement calls that I believerequire review by a secondary source in the same sense that primary research normally requires review by a secondary source.

1) The authors determined "eligibility" by matching the ICD-9 codes of patients from the Northwestern database to relatively vague statements of exclusionary criteria such as "A history of any illness or condition that might confer additional risk or confound the results".

2) A secondary source is needed to assess whether the population that these authors analyzed is representative enough to make the study itself significant. According to Table 2 of the source document, 8.5% of the patients prescribed propecia at Northwestern would have been ineligible for the pivotal trials because they had cancer. 7.1% were ineligible because of substance abuse issues, 27% were ineligible due to heart disease or hypertension, and nearly 17% had "disorders of the male genital organs". I personally find it it difficult to believe that nearly 10% of those prescribed propecia nationally have cancer. This seems to me to be primary research in every sense of the word, and in need of a secondary source for interpretation.

All these things being said, I invited you to mediate, and will not pursue this issue further should you still disagree with me after reviewing these comments. Formerly 98 ^{talk|contribs|COI Statement} 23:20, 16 May 2015 (UTC)

Just dropping a note to let you know that I am supportive of you pursuing your case in this way. I'm willing to uphold Doc James' opinion if he feels your argument is persuasive. In terms of pursuing edits going forward, I am in favor of this approach. Do you agree? I thought including the FDA's commentary in this form was objective and actually helpful in providing context around how the safety profile was initially viewed. The public sometimes gets confused about this issue because there are so many conflicting views on the internet. It would very positive if we could develop this into a source where readers could walk away feeling they decently understand the controversy. Hopefully we have both found mutual ground and a process that works at this point. Doors22 (talk) 00:13, 17 May 2015 (UTC)

per WP:DR we discuss content based on sources, policies, and guidelines on the talk page, and if that fails, we get further community input. There are many ways to do that. I am looking forward to input at WT:MED. From my perspective Formerly's instinct was correct here - the source is WP:PRIMARY for the results stating that people who actually take the drug would have been excluded from the clinical trials. This is not ambiguous in my view. And per MEDRS we do not include content based on PRIMARY sources. Jytdog (talk) 02:58, 17 May 2015 (UTC)

The others reviewed the results of a number of studies both published and unpublished and came to these conclusions. That is what it means to do a review. They did not conduct a trial themselves. Do we have another review that comes to different conclusions? If so we can also present its conclusions. Doc James (talk · contribs · email) 11:47, 17 May 2015 (UTC)

OK, I can't find any discussion of the issue of "most men who actually take the drug would have been excluded from the trials" in either paper except for the study I describe above, so I'm a little confused by your response. But I asked you to mediate, and you have done so, so I'll just say thank you and drop this. The inclusion of the FDA remarks gives the section reasonable balance overall I think. Formerly 98 ^{talk|contribs|COI Statement} 14:13, 17 May 2015 (UTC)

• Doc James the contested content here is based on a sentence from the abstract of PMID 25830296. That sentence is "In a cohort of men prescribed finasteride for routine treatment of AGA, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for AGA. That statement was lightly paraphrased in the article, and Formerly removed it here with a garbled edit note. If you read the paper and see what they did, here is part of the Methods section:

To assess generalizability, we evaluated eligibility for the 3 manufacturer-sponsored trials26,27,32 referenced in the Clinical Studies section of the full prescribing information for finasteride, 1 mg, using as our data source the Northwestern University Enterprise Data Warehouse, a clinical data repository of ambulatory and hospitalized patients, providing laboratory data and diagnosis codes from 1992 through 2013 and comprehensive electronic medical record data from January 2001 through September 2013. We applied a 1.25-mg dose threshold because tablet splitting of the 5-mg dose was widely used as a cost-saving measure. We identified all International Classification of Diseases, Ninth Revision (ICD-9) codes for the cohort of men prescribed finasteride, 1.25 mg/d or less, in the clinical data repository and identified 345 exclusionary ICD-9 codes based on the exclusion criteria for the 3 trials26,27,32 referenced in the full prescribing information for men younger than 42 years. Principal exclusion criteria included significant abnormalities on screening physical examination or laboratory evaluation.26,27

So, the authors did a database lookup of all patients that had been prescribed finasteride, matched those patients' various diagnoses with ICD-9 codes (much judgement required), then turned and did the same with classification of the exclusion criteria for the clinical trials (and again much judgement required), then compared them. That work and the results and conclusions, are research first reported in the Belknap paper - it is PRIMARY for that. We don't know how the field will respond to what they did and the conclusions they drew from it. The Belknap paper also has sections performing a review of the clinical trial literature for which the source is SECONDARY, but that part in particular is their research first reported in that paper, and the Belnap paper is PRIMARY for that. Can you please respond to this? Thanks. Jytdog (talk) 15:23, 17 May 2015 (UTC)

This would be like arguing that a meta analysis is not a secondary source as they do further analysis based on primary sources (both published and unpublished). I would disagree with this statement. I am of the position that paraphrasing the conclusions of secondary sources should be fine. Doc James (talk · contribs · email) 00:21, 18 May 2015 (UTC)

Would your analysis make other retrospective cohort studies such as this one secondary research though? Formerly 98 ^{talk|contribs|COI Statement} 02:05, 18 May 2015 (UTC)

No as it is not listed as a review. And thus they would not have looked for all articles on that topic to include in the analyses. Doc James (talk · contribs · email) 02:48, 18 May 2015 (UTC)

Thanks, I'll let it go now.Formerly 98 ^{talk|contribs|COI Statement} 03:34, 18 May 2015 (UTC)

Doc James i hear your analogy but in this case it is not apt. In a meta-analysis the authors run a new analysis on data already published and analyzed in the literature. In this article, the part of the work they did, where they went into their own database, pulled out everybody who had been prescribed finasteride, applied ICD-9 codes to that, applied ICD-9 codes to the clinical trial exclusion criteria, and compared... all that work, is nothing like meta-analysis. Right? Jytdog (talk) 13:58, 18 May 2015 (UTC)

A meta analysis may take place on unpublished literature. This is part of the way a good meta analysis takes care of publication bias.

Will look at the details. Was it just their own data they looked at? Doc James (talk · contribs · email) 14:11, 18 May 2015 (UTC)

Yes - their own patient database, their own application of ICD-9 to that data and the exclusion criteria. Here is the methods section:

To assess generalizability, we evaluated eligibility for the 3 manufacturer-sponsored trials referenced in the Clinical Studies section of the full prescribing information for finasteride, 1 mg, using as our data source the Northwestern University Enterprise Data Warehouse, a clinical data repository of ambulatory and hospitalized patients, providing laboratory data and diagnosis codes from 1992 through 2013 and comprehensive electronic medical record data from January 2001 through September 2013. We applied a 1.25-mg dose threshold because tablet splitting of the 5-mg dose was widely used as a cost-saving measure. We identified all International Classification of Diseases, Ninth Revision (ICD-9) codes for the cohort of men prescribed finasteride, 1.25 mg/d or less, in the clinical data repository and identified 345 exclusionary ICD-9 codes based on the exclusion criteria for the 3 trials referenced in the full prescribing information for men younger than 42 years. Principal exclusion criteria included significant abnormalities on screening physical examination or laboratory evaluation.

Jytdog (talk) 14:51, 18 May 2015 (UTC)

Doc James would you please have a look at that Methods section I copied above, and let me know if you agree that the source is PRIMARY (as defined in MEDRS) for that specific work and its conclusions? I agree that the rest of the source is SECONDARY as defined in MEDRS in that it reviews the literature. Thanks. Jytdog (talk) 13:33, 22 May 2015 (UTC)

Not sure if I am happy cutting up sources into what is primary and what is secondary. We have had people try to due this with primary sources, stating that the intro is a secondary source and therefore they should be able to us it. Doc James (talk · contribs · email) 23:27, 22 May 2015 (UTC)

Thanks for replying some. Yes, MEDRS mentions that - it says "Research papers that describe original experiments are primary sources. However, they normally contain introductory, background, or review sections that place their research in the context of previous work; these sections may be cited in Wikipedia with care." So that concept is already embedded in MEDRS with appropriate cautioning. This is the flipside of that. Look, you know that I uphold the use of great sourcing. That is what I am trying to do here. Jytdog (talk) 09:55, 23 May 2015 (UTC)

In reviews the authors do pick out what they consider to be of important. With good peer review and good editors the conclusions should generally reflect accepted opinion. It is not unheard of for people writing reviews to do further analysis of the data in question and for it to still be considered a review. We do attribute the statement to them. JAMA dermatology is a good journal. I do know you uphold high referencing standards. I am just not seeing a huge issue here.

Many trials exclude most people for whom the medication will be eventually used. Most people in trials are way healthier and have way fewer comorbidities than in the real world. They also take way less other medications. This review is interested in the fact that they say this. Most of the time it is just brushed acid. Doc James (talk · contribs · email) 11:14, 23 May 2015 (UTC)

Sorry, I'll jump back in here. I see your point Doc, but I'm not sure that what they did here was much better than pulling a number out of a hat. Here is what I come up with comparing the exclusion data in the paper to the eligibiity criteria in the approval summary;

Paper's exclusion criterion	% excluded	Most Related exclusion criteria in FDA doc	Comment
Age < 18 or ) 41	22%	Age < 18 or > 41	Same
Disorders of male genital organs	17%	Low sperm count or infertility	These are not the same and 17% seems too high for low sperm count/infertility
Anxiety,dissociative, somatoform disorders	14%	Does not appear to have been an exclusion criterion	WTF?
Heart disease	14%	Patients must be "healthy"	14% seems high depending on your definition of heart disease
hypertension	13%	"Significant abnormalities on laboratory tests including subnormal TSH or T"	Seems like a judgment call
Malignant neoplasm	8.5%	Malignant neoplasm	8.5% seems very high given national prevalalence of ever having had cancer is 4%
Depressive disorder	8%	Must be "healthy"	seems like another big judgment call
Asthma	7%	Must be "healthy"	seems like another big judgment call
Obesity	5%	Must be "healthy"	seems like another big judgment call

So it would be good to know exactly how these exclusionary criteria were actually used in conducting the trials, but I really don't think we know, and I don't think that the authors know either. Here we have almost 25% excluded for psychological issues, which were not listed explicitly as exlusionary criteria in any of the trials. Everything is a huge judgment call, and one that is influence by the funding of the study.

While the sponsor will generally want to recruit the healthiest population compatible with getting a non-population restricted label, the trade off is that the duration of any phase 3 clinical trial is overwhelmingly set by the rate of recruitment, and each day of delay to market for a $400M drug is $1M gone forever. The individual investigators are paid by the number of subjects they recruit, and it seems unlikely to me that they would take broad sponsor entry criteria such as "must be healthy" and use them to exclude patients with modest blood presssure elevation, or the sort of low level psychological problems that one encounters in 25% of patients who come through the office door. Formerly 98 ^{talk|contribs|COI Statement} 12:47, 23 May 2015 (UTC)

If we let this debate become too verbose we reduce the likelihood 3rd party editors will be interested in getting involved so I will be concise. I really don't understand why you think it is a primary source. Take a look at WP:SECONDARY. Secondary sources provide "an author's own thinking based on primary sources, generally at least one step removed from an event. It contains an author's interpretation, analysis, or evaluation of the facts, evidence, concepts, and ideas taken from primary sources." In this case the clinical trial is the primary source and the debated study interprets, analyzes, and evaluates the primary source. Also the author of the debated study was not directly involved in the clinical trial (a requirement to be considered a primary source). Secondary sources don't have to simply summarize primary sources, although they do occasionally. That is for tertiary sources (encyclopedias, textbooks, wikipedia etc). Doors22 (talk) 19:31, 17 May 2015 (UTC)

the reference is secondary for some things (its review of the literature) and primary for others - the research they did out of their database, and comparing that to the exclusion criteria of the clinical trials. it is not uncommon for papers to do more than one thing. Jytdog (talk) 20:03, 17 May 2015 (UTC)

Funding of 2015 review

Do we have a high quality source that raises concerns regarding the funding of the 2015 review? Doc James (talk · contribs · email) 01:39, 16 May 2015 (UTC)

i looked and didn't find any at this time. looks like we leave that out. Jytdog (talk) 03:18, 16 May 2015 (UTC)

Semi-protected edit request on 6 June 2015

100.38.60.6 (talk) 23:22, 6 June 2015 (UTC) Ali Alharbi decided that it is used for alopecia.  Not done - no source provided. not clear who this even is. Jytdog (talk) 02:05, 7 June 2015 (UTC)

Reference to Foundation

http://www.menshealth.com/health/hair-raising-effect

The above URL lists one of countless mentions you can find to "post-finasteride syndrome" that existed well before the PFS Foundation ever existed. Please use a little bit of common sense when deciding what to use. Moreover, nowhere in the article or anywhere else does any source refer to the foundation as an advocacy group. This is just the POV have been trying to push. Doors22 (talk) 16:22, 18 January 2016 (UTC)

@JYTDog:, despite having been recently topic banned you don't seem to have gotten the message and are continuing to edit-war. Please make sure deal with this situation more appropriately. After I started this message, I see you have changed the reference link to health advocacy group which is much more acceptable to me. The prior implication that it was a political group is simply untrue. We still need to deal with the inaccuracy that the foundation named the syndrome because the term existed before the foundation. Doors22 (talk) 16:40, 18 January 2016 (UTC)

See the definition of patient advocacy organizations here: Patient_advocacy#Public_policy. The Margo article is very clear that PFSF is an advocacy organization. Margo writes: "A new wave appears to be forming in men’s health. Just as the women’s health movement gathered momentum last century and became a powerful political force, so it seems that men are beginning to mobilise. Over the past 20 years, the issue of men’s health has slowly become part of the public agenda. Now that men are becoming increasingly aware of their health, they are also becoming critical of what is being dealt out to them. ...In North America, men are now organising around a male drug that is used by millions. The drug is used to treat both male pattern hair loss and benign prostate problems. These men claim it can have long- term sexual side effects. They have formed a foundation and have commenced legal action..... The drug, called finasteride, is also widely used in Australia but there does not appear to be any political action relating to it here. They have coined the phrase “post finasteride syndrome" which they say is characterised by sexual, neurological, hormonal and psychological side effects that can persist in men who have taken finasteride for hair loss or an enlarged prostate.... They have established the Post Finasteride Syndrome Foundation with the primary goal of finding a cure and a secondary goal of raising awareness of the syndrome..... " This exactly fits the definition. PFSF is an advocacy organization for men concerned about PFS. Jytdog (talk) 16:31, 18 January 2016 (UTC)

doors, what is your understanding of the origin of the PFS term? Do you know any sources for it? I just made this edit to reflect the Margo source more closely. Please discuss content, not contributors. Jytdog (talk) 17:16, 18 January 2016 (UTC)

@Jytdog:, I don't know what the origin is for PFS but it has been around a long time. Using the wayback machine on Propecia Help's forum, I am able to find the earliest reference from April 2010 which is well before the foundation came into existence. The term existed long before this but it appears as though the wayback machine didn't log earlier snapshots. I know the reference sources mentions the foundation "coined the term" and although it is "original research" to demonstrate the article is inaccurate, I don't think we need to include something that is wrong just because it was said. I also think we should add the goals of the organization which are mentioned in the article and clearly stated on the foundation's page. Doors22 (talk) 01:30, 19 January 2016 (UTC)

We have a very clear reference to men in the US/Canada coining it here so I guess we just go with this. let me know if you are unhappy w the current version. Jytdog (talk) 01:41, 19 January 2016 (UTC)

Ah, OK I see now. I support this edit. I think it should be moved to a new paragraph so it is a little more clear the foundation is separate from the men who came up with the name. I'd also like to add a sentence one the goals of the foundation which I think you will be OK with. Thanks for the cooperation. Doors22 (talk) 02:23, 21 January 2016 (UTC)

I meant to make my previous post to the section above, so I moved it there. Ywaz (talk) 17:13, 19 April 2016 (UTC)