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Edits of September 28

(Moving this discussion from User Talk pages to this page.)

Several changes made on September 11 were reverted with the explanation "Please don't remove sections that have been discussed and agreed upon months/years earlier - Discuss further on talk page if you wish)". First I'd say that I don't see anything on the Talk page clearly indicating that the language you have reverted back to is "consensus". The discussion ended on February 24, with me asking you a series of questions that you never responded to.

• "In December 2008, the Swedish Medical Products agency concluded a safety investigation of finasteride and advised that finasteride may cause irreversible sexual dysfunction. The Agency's updated safety information lists difficulty in obtaining an erection that persists indefinitely, even after the discontinuation of finasteride, as a possible side effect of the drug"

As my edit summary explains, the quoted insert only says that there have been case reports and causation is unestablished. It is WP:UNDUE to call this a "warning". I've literally come across AERS reports in which people have reported "death of pet" as a side effect of medication. If we included every spontaneous adverse event report as a "warning" for other drugs we'd need several hundred thousand KB just to list them out. This is not meaningful evidence in support of a causative relationship. Furthermore, the link does not work, making this claim unverifiable and subject to immediate removal under WP:VERIFY

I am not the person with whom you were conversing on February 24th. I am not sure if you were aware of that or not but either way this discussion does not involve the PLESS trial. I have updated the reference with a live, verifiable link. These AERS cannot be compared to reports indicating "death of pet". The relevant regulatory bodies discovered a sufficient number of reports and decided it warranted including a statement on their respective labels. Your reference to "death of pet" is potentially misleading too as a pet could have accidentally consumed the medication, leading to death, which makes the report completely valid not so humorous. Doors22 (talk) 06:39, 21 October 2014 (UTC)

• "The UK's Medical and Healthcare Products Regulatory Agency (MHRA) cites reports of erectile dysfunction that persists once use of finasteride has stoppedIn April 2011 Merck revised the United States' warning in consumer and medical leaflets to include erectile dysfunction that may persist after stopping finasteride."

As noted in my edit summary, the cited document from MHRA appears to say nothing about sexual dysfunction. Being unverifiable, it is subject to immediate deletion per WP:VERIFY. You've restored this material without addressing my explanation for the edit, and in contrast to your comment, there is no consensus on the Talk page for including this material. Even if there were, it would violate WP:CONEXCEPT as the material is unverifiable.

• In April 2012, the warning label was further strengthened to include reports of persistent libido disorders, ejaculation disorders, orgasm disorders, and decreased libido. According to FDA, these warnings were added as precaution after reviewing 678 case reports of post-treatment sexual dysfunction received over an 18 year period. The Agency further stated that "despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs."

This is probably an acceptable source as the FDA issued a release around the label changes.

I've deleted the Swedish Medical Agency and MHRA references and left the FDA one in place.

• "regulatory authorities have listed mood disorders as among the possible adverse effects of finasteride,"

As I noted in my edit summary, the cited reference does not support the statement "regulatory authorities have listed mood disorders as among the possible adverse effects of finasteride". You reverted my deletion of this material without commenting on the reason for the deletion. "Prior Consensus", which I see no evidence for on the Talk page, is insufficient to overcome the fundamental pillar of Misplaced Pages that all content must be sourced.

I've deleted the reference to "regulatory authorities" as unverifiable.

• "Some studies have shown that the dose of finasteride needed to treat male pattern baldness may be smaller than 1 mg. Petitions to the FDA to re-examine the approved dosage in light of the statistical evidence and possible long-term risks, were met with the response that a study had shown increased effect of a 1 mg dose compared to 0.2 mg without added risks; the same study also concluded that doses of 0.01 mg per day were found to be ineffective in treating hair loss."

Once again you've reverted me without responding to the reasons in my edit summary and appealing to a "consensus" for which there is no evidence on the Talk page. As I noted in the edit summary, this petition is non-notable. I could write a petition to the FDA tomorrow requesting that they re-examine the dosage for Lipitor. But I am not a well known expert in the field of cardiology, so its really not notable unless the FDA actually acts on it.

The statement that doses needed may be less than 1 mg cites an FDA document, in which I can find no discussion of dosing issues. Like any other statement without verifiable sources, it can and should be deleted. Verifiability is one of the 3 pillars of Misplaced Pages. I've deleted the paragraph. Formerly 98 (talk) 11:10, 28 September 2014 (UTC)

You posted on my talk page that the most recent edits on the talk page were you asking questions to which I didn't not respond. This isn't correct for two reasons. First, your comments were directed at an entirely separate editor and secondly, you were asking questions about the PLESS study which has already been removed from the article. You even mention you aren't influential enough to reverse decisions made after extensive discussion, but several months later this is exactly what you did.

"I suppose we should talk about what the goals of this discussion are. I know that there has been a lot of discussion of this topic before, and I am certainly not influential enough to reverse decisions that were made previously after extensive discussion. What reason has been given previously for not including the observations from the PLES trial? Formerly 98 (talk) 12:03, 24 February 2014 (UTC)Thanks"

The previous consensus was attained much earlier in the history of the talk page or in the direct notes of the edits. Some of your points are valid - I did not notice that some people had given incorrect references or maybe the reference links had broken, since as I mentioned, the edits were made a long time ago. I will take your comments into consideration and try to fix the reference links where possible. Doors22 (talk) 14:54, 28 September 2014 (UTC)

@Doors22: I don't think a consensus reached a year or so ago is necessarily still consensus, and my general openness to your concerns about AEs was not intended as agreement to use poor sources. But I don't want to have a huge argument over this, I'll be satisfied for the most part if you fix the sourcing. Prefer that we drop the FDA petition from a physicist. Thanks. Formerly 98 (talk) 15:05, 28 September 2014 (UTC)

I'm getting a sense of deja vu. Didn't we agree that we needed to be very selective about sources in this highly disputed area? Doors22 isn't anything if not persistent. JFW | T@lk 22:41, 6 October 2014 (UTC)

I'm really not sure to what your comment pertains. The edits have used sources that high quality according to the Wiki community. This problem has been visible for a long time now and as a consequence several of the links have died after a period of years. They have been updated accordingly. I am not sure if your suggestion that I am nothing if not persistent is some failed attempt at humor given the discussion on persistent side effects of the drug, but in any case it is in very poor taste. The Misplaced Pages community should expect and require more from members it makes administrators. Doors22 (talk) 06:46, 21 October 2014 (UTC)

Doors22 No, my comment about "persistence" relates to the fact that you've been editing Misplaced Pages as a single-purpose account since February 2011. During that time we have had repeated discussions about using Misplaced Pages to promote awareness of a phenomenon that has been very poorly studied. Without wanting to be particularly patronising, I think your time might be better spent by collaborating with academic andrologists on improving the pathophysiological understanding and documenting the phenomenon using validated objective measures. JFW | T@lk 13:20, 21 October 2014 (UTC)

Regarding today's change, if you look at your recent statement you said you would be mostly satisfied so long as sourcing is fixed which is done. To reach a consensus, I have left out the commentary on dosing and I hope you are not going back on your word. It isn't compatible with your statement that you chose to reverse the edit. However, I have revised the statements to make them much less wordy. Side effects that are non-life threatening are not the only side effects worthy of mention. The outcome leads to permanent injury and a significantly reduced quality of life, which on the occasion unfortunately has led to suicide. The outcome is not as infrequent as you suggest although frequency has not yet been discussed in peer-reviewed medical journals. As mentioned in the article, more than 600+ accounts were reported to FDA which is a very small subset of those living with side effects. Thanks. Doors22 (talk) 01:52, 22 October 2014 (UTC)

Its WP:UNDUE Doors. There is no evidence of causation (FDA comments to this effect seem to have been the main thing removed in your edit "to make the section less wordy".

You re-added the WP:OR assertion "Despite updating European information leaflets, Merck left the US label unchanged until April 2012" even though the first FDA reference at the end of that sentence states that "persistent erectile function was added to the label in 2011". I have adjusted that sentence and will make other changes later if needed.Formerly 98 (talk) 11:40, 22 October 2014 (UTC)

I have provided two additional sources which show the statements were not original research. I get the sense that you are engaging in a revert war as you have reverting edits nearly a dozen times over the past couple of months. In the future, please abide by Misplaced Pages regulations and edit rather than revert to avoid giving off a sense of hostility. WP:ROWN Thanks Doors22 (talk) 03:13, 23 October 2014 (UTC)

I added another meta analysis draws the opposite conclusion. They both look at a similar number of studies, but one journal is of a higher quality than the other. Formerly 98, are you getting paid to edit Misplaced Pages? It seems to be a full time endeavor for you since you are editing at all hours of the day. The majority of your edits involve reversions about side effects or information that is not favorable to pharmaceutical companies. Doors22 (talk) 00:28, 24 October 2014 (UTC)

Doors, please take a look at WP:GF, and when you have done so, strike your remark above. Disagreeing with you does not constitute evidence of COI. Formerly 98 (talk) 00:43, 24 October 2014 (UTC)

I am familiar the concept of assuming good faith and would like to refer you to WP:AAGF. I don't think you are malicious or even that you disagree with me. I am just inquiring about your background since you are a very prolific editor on Misplaced Pages. By the way, I happened to realize you added the reference to the meta analysis without having ever read the study - I saw this on JFDWolff's talk page. Will you please explain why you are adding references without having fully read them? I personally have read the article and can vouch that it is not a very high quality article in a not highly respected journal. An answer to my previous question would be appreciated as well. 01:47, 24 October 2014 (UTC)

Yes, I read the abstract and the article was summarized in other articles. I felt that the abstract and these additional descriptions provided sufficient understanding of the material to add it. Judging from your edit, you interpreted it differently than I did (may I assume you read the entire article before writing your own summary?) and I did not think it appropriate to challenge your interpretation without reading the entire text.

Are you aware of quality secondary sources that support your contentions? I believe that the 5-10% of this article that is spent on this subject is undue weight. I further believe that the article is written in a way that implies that this is well-established science, when it is actually quite speculative. The highest quality sources I have found either refute this hypothesis or give it only passing mention.

1) The FDA safety announcement that said that information was being added to the Propecia label as a precaution in spite of lack of proof of causation.

2) The label itself, which dedicates one half of a sentence out of 18 pages of text to this putative side effect.

3) The Swedish and MHRA labels. The British package insert contains one sentence on this subject.

4) The meta analysis which I added and which I will refrain from modifying your interpretation of until I see the full text.

5) The American Urology Association treatment guidelines for BPH, which refers to sexual side effects as follows: "These events are reversible and uncommon after the first year of therapy."

6) The guidelines of the European Association for Urology contain 2 paragraphs on adverse effects of finasteride. Sexual dysfunction persisting after discontinuation of therapy is not even mentioned.

And no, I will not respond to your completely inappropriate question. I find it remarkable that you would direct me to WP:AAGF after point-blank suggesting that I am performing undisclosed paid editing. Formerly 98 (talk) 04:00, 24 October 2014 (UTC)

Reading the abstract of a meta study or any article is not sufficient. You, yourself, have posted that you don't like meta studies on your own talk page because you can't understand why the author drew conclusions even AFTER reading the article, let alone from a quick abstract. While it is inappropriate that you are asking me if I read the article because it is a minimum standard of editing, I will let you know that I did in fact read both meta studies. The one you quote narrowed hundreds of articles down to 12 and did not explain how it concluded that active intervention did not increase risk of sexual dysfunction. A rather ridiculous interpretation coming from a low quality journal, especially when industry sponsored studies indicate otherwise. Nonetheless I kept your inclusion, even though you should have never added this edit without opening the source, and added another higher quality meta study that concludes the opposite. Yes, I have read both.

Your commentary that the Wiki article should reflect the PI is not a valid statement. If it had any relevance, Misplaced Pages articles on drugs would just reiterate the PIs. Drug companies argue with the FDA for months over single words which they deem to be critical so your response is irrelevant.

I also never "suggested" you were performing undisclosed paid editing. I did not express any certainty this was a fact, but just asked a question since there is more than enough evidence this is a possible, and just expected an honest answer. Had you truthfully responded something like 'no, I am not paid for my engagement on Misplaced Pages' the issue would have been over. Your refusal to answer and even your defensiveness raises additional questions.

My question was had little to do with your disagreement with me but rather your being very quick to revert edits, your very extensive history of diminishing commentary on pharmaceutical side effects, and reverting comments on litigation against pharmaceutical companies. In fact, I have rarely seen you add information rather than remove it. Additionally found evidence of administrators and other scientists concerned with your edits. http://wp.rxisk.org/post-ssri-sexual-dysfunction-wikipedia-falls/

While much less significant, I also noticed you live in San Diego, where a lot of pharmaceutical/biotech companies are located and you have referred to yourself as an "industry guy". For all I know, you could simply own Merck stock and nothing more. Do you have any conflicts of interest that would affect your edits on this article? Doors22 (talk) 11:00, 25 October 2014 (UTC)

Please note that Formerly98 has privately refused to disclose any conflicts of interest, whether or not they exist, and admonished me for discussing this on the talk page. Prior to filing a formal investigation, this really is an appropriate place to bring this up. I suggest that he treads carefully, as long as he abides by Misplaced Pages norms there won't be any troubles but if he continues with excessive reversions rather than editing and referencing sources without having read them additional action will be taken. Healthy discussion and dissonance can improve the quality of Misplaced Pages articles so the norms and values of the community are upheld. Doors22 (talk) 15:17, 25 October 2014 (UTC)

Doors22 It is a sadly typical mistake to personalize disputes over content. I suggest that you tread very carefully to avoid violating WP:AGF and WP:NPA. You have zero evidence of a COI. If you want to run the risk to your reputation and run the risk of a WP:BOOMERANG you are of course free to file a case at COIN. Outside of that, per WP:TPG please comment on content, not contributor. Jytdog (talk) 15:54, 25 October 2014 (UTC)

Worked this over today

i worked the article over today. Brought it into compliance with WP:MEDMOS in terms of sectioning, level of detail, and putting things into plain English as much as possible. Fixed a bunch of dead refs or bare URL refs. Seems like it is in decent shape now. Happy to discuss any of the changes. Jytdog (talk) 20:37, 25 October 2014 (UTC)

Post-Finasteride Syndrome Foundation

I reviewed the talk page and I think I see what some of the struggle is about. A group called the Post-Finasteride Syndrome Foundation formed in 2012 and appears to be trying to establish the validity of this syndrome, to educate folks about it, and to work toward a cure for it. My sense is that the arguments over sexual side effects stem from this foundation's efforts, or folks aligned with them. I searched pubmed and there no reviews on this Syndrome yet, so it appears not to be accepted by mainstream medicine, yet. So the syndrome should not be mentioned per se in the side effects part of the article as there are no MEDRS-compliant sources for it. Yet. As for the organization itself, there are few indepedent secondary sources about it (you can see that the source I found - the best one I could find - is something called the "Australian Financial Review"), so per WP:NPOV the foundation should get little weight in this article. With this kind of thing, I think it is useful to give a mention, but the mention should not be used to coatrack content into the article about their agenda. This is an effort to "give an inch" - I hope no one takes a mile. Jytdog (talk) 21:25, 25 October 2014 (UTC)

Thanks, I think it is sensible to have a blurb about the PFSF in the society and culture section. If I recall, I tried putting that in awhile ago with a similar type of news source but it seems like everything is met with a lot of resistance. By the way, "post finasteride syndrome" is a little bit of a colloquial phrase which is why it more likely belongs in society and culture. If you search the terms "finasteride" and "persistent" on pubmed you will see maybe a dozen articles from different doctors describing things like hormone/semen levels, neurosteroid levels, and several case series.Doors22 (talk) 23:09, 25 October 2014 (UTC)

Thanks Jytdog for your input. And Doors22 - without a strong secondary source it will not be appropriate to work PFSF into the article, even the "society and culture" section. Until stronger sources exist, it has the same level of importance as any random theory. Can I once again suggest you stimulate the work of academic andrologists to demonstrate or disprove the syndrome along the lines of formal scientific enquiry? JFW | T@lk 21:28, 26 October 2014 (UTC)

This has been several years in the works already. As an MD, I am sure you are more than acquainted with the timelines associated with conducting medical research. If you look through the foundation's website a bit more thoroughly, you will see a couple globally respected institutions have already taken up this task while a handful of doctors have already published on the subject. Baylor College of Medicine is the first and Harvard's Brigham Women's Hospital. Very different than any random theory which hasn't been tested. A substantial amount of data has been collected and a couple lab assays have been published on patients. I also think its very unlikely any random theory would attract the attention of a Harvard teaching hospital. Doors22 (talk) 01:50, 27 October 2014 (UTC)

Doors22 you took the bait. may i ask you guys to take this elsewhere? this is not a forum for discussing the topic; the key thing for Misplaced Pages and this article is that there are no strong secondary sources yet, so per WP:MEDRS (and RS for that matter) we shouldn't discuss it in the article. thanks. Jytdog (talk) 08:55, 27 October 2014 (UTC)

Jytdog This is not a matter of "bait". I've been trying to explain this to Doors22 for some time. As it is relevant to the article it does not necessarily violate WP:TALK. Until there is sufficient evidence, this remains a "random theory". JFW | T@lk 09:02, 27 October 2014 (UTC)

As we have additional eyes on the article now, I've added a proposed modification to the text for consideration.

• We formerly had one sentence to describe the fact that there were case reports of persistent sexual dysfunction, a second sentence to describe the fact that the Europeans had added mention of these to their package inserts, and a third sentence stating that the U.S. had done so as well. I've collapsed these to a single sentence. I find it difficult to believe that adding a separate sentence for each place the report appeared would be considered acceptable if we were discussing, for example, a preliminary positive result seen in a single arm phase 1 trial.
• I moved the meta analyses on sexual dysfunction during treatment to the beginning of the paragraph to avoid the impression that they dealt with post-treatment effects.

You guys can decide. I think I've made my position pretty clear, and if there is no support among those with an outside perspective I will drop this, as I've spent far too much time on it already.Formerly 98 (talk) 10:00, 27 October 2014 (UTC)

I am fine with your changes. Jytdog (talk) 11:24, 27 October 2014 (UTC)

Agree. JFW | T@lk 21:39, 27 October 2014 (UTC)

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?utm_source=fdaSearch&utm_medium=website&utm_term=finasteride&utm_content=2 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?utm_source=fdaSearch&utm_medium=website&utm_term=finasteride&utm_content=2

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. 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 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 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 ]:

"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 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 and a second review that states increased ejaculatory dysfunction 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. 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)

Breast cancer

I've simplified the discussion. This is an Adverse Events section, and the focus should be on assessing these. We don't really need to discuss each regulatory agency adding the same warning to the label in separate sentences, which seems to be a common method used for adding undue weight to the discussion of rare adverse events of unknown causation.

Also, the sentence that Merck modified the label to "give warning of increased risk of breast cancer" is incorrect. The label refers to a "possible increased risk" and specifically states that causation has not been established. The prior wording very much left the impression that both an increased incidence of breast cancer among finasteride users and a causative relationship have been established. I don't see anything in the label stating that either has been. Formerly 98 (talk) 14:14, 15 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". Formerly 98 02:51, 16 April 2015 (UTC)

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