| Revision as of 03:24, 17 April 2015 editRenamed user 51g7z61hz5af2azs6k6 (talk | contribs)6,460 edits →Funding of 2015 meta analysis← Previous edit | Revision as of 03:43, 17 April 2015 edit undoDoors22 (talk | contribs)Extended confirmed users624 editsNo edit summaryNext edit → | ||
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| ::* "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. | ::* "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 ] ] <sup>]|]|]</sup> 03:24, 17 April 2015 (UTC) | ::The bottom line is that the journal mentioned it, and so it can't be argued away as trivial. That would be ] ] <sup>]|]|]</sup> 03:24, 17 April 2015 (UTC) | ||
| :::You have proven yourself to be a dishonest person time and time again. 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 ] 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.] (]) 03:43, 17 April 2015 (UTC) | |||
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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)
- 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)
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.
-
- 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."
- 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%)."
- 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."
- 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
thatall 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.
- 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)
- 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)
- 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)
- 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)
- 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.
- 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)
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)
- 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 ]:
- 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)
- 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)
- 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)
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)
- @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.
- 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)
- I am so not going to respond to that last bit. Jytdog (talk) 02:38, 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)
- Anyway added some details. Doc James (talk · contribs · email) 01:22, 15 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)
- 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)
@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)
- 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)
- 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)
- @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)
- @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)
- 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)
- 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)
- 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)
- 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)
- 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)
@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)
- 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 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, 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)
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)
- 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)
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", 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 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 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 03:24, 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 have proven yourself to be a dishonest person time and time again. 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)