Talk:Fulvestrant

Patent extension

The patent extension seems to be an issue.

This isn't a WP:RS, but it has some useful links. http://patentcircle.blogspot.com/2006/11/fulvestrant-expiring-in-december-2007.html --Nbauman (talk) 19:05, 16 January 2012 (UTC)

NICE

I am placing the statement here

NICE evaluation

The U.K. National Institute for Health and Clinical Excellence (NICE) said in 2011 that it found no evidence Faslodex was significantly better than existing treatments, so its widespread use would not be a good use of resources.

The first month's treatment of Faslodex, which starts with a loading dose, costs £1,044.82 ($1,666), and subsequent treatments cost £522.41 a month.

A month's supply of anastrozole (Arimidex), which is off patent, costs £5.99, and letrozole (Femara) costs £84.86.

because as of now it looks like a mostly political statement and lacks essential medical information like scope and applicability. In particular it says "found no evidence Faslodex was significantly better than existing treatments, so its widespread use would not be a good use of resources" - in my opinion the scope and circumstances of the statement such as (primary/metastatic/treatment refractory) breast cancer and compared treatments must be made clear. A link to a NICE page listing numerous PDF documents is not an acceptable source unless the reader knows which of the PDF documents is supposed to prove which point. What level of evidence is there? What was compared? The other news sources are not good enough for me. It is not acceptable leave the task of finding sources and filling in essential missing information to the reader.

Also as far as I know it is not generally the scope of wikipedia to provide detailed cost comparisons of treatments. The medical aspects - if there is sufficient evidence - should be elaborated to much greater detail while the cost considerations kept to a minimum.

Furthermore I am wary about having here a political statement from NICE elaborated to such lengths but not one from FDA, not that I looked if any exists. Richiez (talk) 14:48, 19 January 2012 (UTC)

That's your personal opinion. Do you have any WP:RS to support your claim that it is a political statement, and lacks essential medical information? That sounds like WP:OR.

Wikipedia routinely refers to NICE guidance. NICE is a WP:MEDMOS secondary source. According to WP:MEDMOS, secondary sources are preferred to primary medical reports, because collecting primary reports in a Wikipedia entry would be WP:OR and WP:SYNTH. NICE is a notable organization, with its own Wikipedia entry.

Wikipedia routinely refers to the cost of expensive drugs, because the cost is often discussed in many WP:RS, including major medical journals like NEJM, which makes it a significant issue and meets all the standards of WP:NOTABLE.

"Please do not delete well-sourced material without discussing it first in Talk" means first you discuss it in Talk and then you delete it if there is consensus to delete it. Under WP:PRESERVE you should not delete well-sourced material unless there is a consensus to do so. If you disagree with it you can add WP:RS that you agree with, such as FDA documents or review articles. --Nbauman (talk) 15:42, 19 January 2012 (UTC)

Can you easily get the missing information from the sources that you have provided? 2-3 sentences what exactly NICE did examine and what level of evidence they claim would make the paragraph much better. Did they study metastatic cancer only, or anything else? What groups and subgroups of patients? Were they using internal data? I notice there is not much in medline. It is the overgeneralization that makes it appear like a political statement.

Also wondering, is there some hype to use Faslodex over anastrazole that I have missed? Did not notice anything like this recently. Richiez (talk) 20:07, 20 January 2012 (UTC)

According to PubMed clinical queries systematic[sb] AND ("fulvestrant" [Supplementary Concept] OR "fulvestrant"[All Fields]) :

Fulvestrant in the treatment of advanced breast cancer: a systematic review and meta-analysis of randomized controlled trials. Valachis A, Mauri D, Polyzos NP, Mavroudis D, Georgoulias V, Casazza G. Crit Rev Oncol Hematol. 2010 Mar;73(3):220-7. Epub 2009 Apr 14. Review. PMID:19369092 http://www.ncbi.nlm.nih.gov/pubmed/19369092

Analysis of costs associated with administration of intravenous single-drug therapies in metastatic breast cancer in a U.S. population. Kruse GB, Amonkar MM, Smith G, Skonieczny DC, Stavrakas S. J Manag Care Pharm. 2008 Nov-Dec;14(9):844-57. PMID:19006441 Free Article http://www.ncbi.nlm.nih.gov/pubmed/19006441

Fulvestrant for systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women: a systematic review. Flemming J, Madarnas Y, Franek JA. Breast Cancer Res Treat. 2009 May;115(2):255-68. Epub 2008 Aug 6. Review. PMID:18683044 http://www.ncbi.nlm.nih.gov/pubmed/18683044

--Nbauman (talk) 21:15, 24 January 2012 (UTC)

OK here's my 2p's worth. This (the issue of whether NICE info is 'political') is itself a political issue. Its also only really relevant in a UK setting - the UK NHS makes decisions on cost-effectiveness using calculations relevant to, and based on, data from the UK population. That said, it's highly relevant to any UK cancer patients coming to this page. I'm in favour of keeping this paragraph but will add a few edits to clarify things. It is unfortunate that the NICE website does not do such a good job of laying out their reasoning in a user-friendly way, but they are a rigorous, evidence-based organisation entirely suited to being a reputable source on these pages. HenryScow (talk) 20:24, 1 March 2012 (UTC)

All that is before the FIRST, CONFIRM and FALCON trials. Pretty sure this assesment is meaningless today. Biasuz (talk) 17:41, 23 January 2017 (UTC)

• 'Keep the clarified paragraph' IF its the last thing NICE has reported on fulvestrant - otherwise add their latest recommendation (if it overrides this one) - perhaps the cost of alternatives should go in a breast cancer article re UK ? - Rod57 (talk) 12:44, 27 July 2017 (UTC)

Fulvestrant as an estrogen membrane receptor agonist

There seems to be some evidence (such as http://www.ncbi.nlm.nih.gov/pubmed/15764600) that fulvestrant can actually act as an agonist for certain membrane bound estrogen receptors - what are the thoughts on including this in the article? — Preceding unsigned comment added by Rpzrz (talk • contribs) 12:04, 23 October 2014 (UTC)

MEDRS

User:Biasuz - about this, please read and follow both WP:MEDRS with regard to sourcing and WP:MEDMOS with regard to article structure. Thanks. Jytdog (talk) 01:48, 23 January 2017 (UTC)

I'm sure you know what you are talking about. I thought you believed the fifth pillar of Wikipedia. You are removing content. Helping in this thing is pointless if people like yourself keep removing accurate data just because it does not fit your particular esthetic. — Preceding unsigned comment added by Biasuz (talk • contribs) 01:53, 23 January 2017 (UTC)

MEDMOS and MEDRS are not "my aesthetic" - they are community guidelines. Every time you edit, you agree to follow the Terms of Use, and the Terms of Use obligate you to follow community policies and guidelines. I have requested help from other editors, so we should get some more input soon. Jytdog (talk) 02:37, 23 January 2017 (UTC)

Yes we do not use bunches of primary sources. Doc James (talk · contribs · email) 03:04, 23 January 2017 (UTC)

Again with the deleting? how come you guys are "authorized" to delete revisions without any justification? Contribute towards better aesthetic if you feel you must make a contribution at the same time over the same subject. What is wrong with you two. This fucking crap is used in the first and second treatment lines, that info is again deleted. That surely does not help... Kindly explain to me, i fucked up the article for citing too many primary sources? this is demented behavior. Have fun in your private encyclopedia. Its a waste of time to help. — Preceding unsigned comment added by Biasuz (talk • contribs) 03:15, 23 January 2017 UTC) (UTC)

Yes if you do not want to use high quality secondary sources than Wikipedia is probably not for you. Best Doc James (talk · contribs · email) 03:32, 23 January 2017 (UTC)

Here are your reputable secondary sources ESMO and ASCO... now piss off and undo your revert. As far as I can understand the procedure, YOU ARE NOT FOLLOWING PROTOCOL. You are reverting my edits with NO BASIS. As soon as I figure out how to call here someone above your paygrade for arbitration, we'll get to the bottom of this deleting with no fair arguments as demonstrated in the Wikipedia:Dispute resolution. Biasuz (talk) 14:53, 23 January 2017 (UTC)

A press release based on a conference presentation and solely using that presentation/presenter as source is essentially a primary source, not independent of the original work. And a conference is likely not referreed as a med/sci publication, so it's not a highly reliable source even at the level of primary. That's not a MEDRS-specific small detail, that's a fundamental WP:RS aspect. DMacks (talk) 15:50, 23 January 2017 (UTC)

Sorry I am going to disagree with you and say they are worse than primary sources (I know semantics). A press released based on a conference presentation is a secondary citation which IMO is an even bigger no no. SportsMedGuy (talk) 19:45, 23 January 2017 (UTC)

This is a phase 3 trial on one of the most reputable medical journals on the planet. How come this does not count as evidence? Biasuz (talk) 17:33, 23 January 2017 (UTC)

BIasuz, if you would please stop arguing for a bit, and read MEDRS and think about it, the answer is right there. You might also want to read WP:Why MEDRS? There is a lot to learn here but you need to actually engage with the policies and guidelines - to try to understand them and follow them. Jytdog (talk) 17:59, 23 January 2017 (UTC)

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)32418-7/abstract There is your fucking secondary source. Theres nothing on WP:RS that says that you cannot use primary sources. It is clear that you can do so, but they are tricky. One can imagine why, low reputable sources are plenty. But this is the Lancet we are talking about and this is fucking phase III trial, not a kiddie experiment or my own personal experiment. now, since the evidence is there, from a fucking secondary source, kindly reinstate the edit. — Preceding unsigned comment added by 131.0.19.23 (talk) 18:25, 23 January 2017 (UTC)

First, it needs to be "my", or "our" secondary source. By editing here, you are a member of the community, and you too need to be mindful of the policies and guidelines that the community (not me or Doc James) put in place. Second, the Lancet classifies that source as a "Comment". It is not a review and so is not a secondary source per MEDRS. People familiar with the biomedical literature understand already that journals publish several kinds of documents, including original research articles, letters to the editor, comments on other articles, and reviews. But in case you are unaware of this, the issue is briefly discussed in the last paragraph of the WP:MEDSEARCH section of MEDRS. Jytdog (talk) 21:02, 23 January 2017 (UTC)

• what is kind of tragic here, is that if you actually go look for MEDRS sources (there is a link to a pre-formatted pubmed search in the box at the top of this page) you get these results, which show that there is a brand new Cochrane review on this drug: PMID 28043088. I will update the article accordingly in a bit - am in the midst of some other things right now. Jytdog (talk) 21:10, 23 January 2017 (UTC)
  • Yes agree it is always disappointing when this happens when we have high quality reviews avaliable. I am currently travelling. Doc James (talk · contribs · email) 21:57, 23 January 2017 (UTC)

I would hazard a guess that most of the low quality primary articles that get referenced on Wikipedia are in some way connected with the authors. Why else would people push these references with as much passion as most seem to. SportsMedGuy (talk) 22:30, 23 January 2017 (UTC)

Are you are insinuating that I am somehow involved in such a trial? The Cochrane review he found has this one article on the subject matter (first-line setting). Somehow the same data became Wikipedia material because, as it turns out, it's a newfound secondary source. I won't hold any petty grudge over the participants in this discussion. While I admit most of this distress was because my lack of experience, it was never my intent to be such pain. But none conceded the least bit of credibility to the first quoted source. There were certainly a lot better ways to have corrected the edit instead of a full revert. — Preceding unsigned comment added by Biasuz (talk • contribs) 22:55, 23 January 2017 (UTC)

There are tons of garbage studies and studies/trials with erroneous conclusions. By using secondary sources we ensure that Wikipedia only includes knowledge accepted by the medical community. Boldly editing, being reverted, and then having a discussion (WP:BRD) is one of the fundamental processes of Wikipedia. Everyone has had their ego hurt by process but it makes for a better encyclopedia. But welcome! I hope you'll stick around. Sizeofint (talk) 23:28, 23 January 2017 (UTC)

I'll make one final edit over this issue. I've finished reading the Cochrane review that turned out. Data inclusion ceased in july of 2015 and one of the last trials accepted was the FIRST trial. In essence, what everyone here is saying is quite simple. This review takes a lesser trial (a phase 2 trial) and somehow sugarcoats it into something more important than it should. This question was answered the day FALCON trial was published. I understand the general idea of the guideline, but that's what it is... a guideline. In this particular case, we are going to have to agree to disagree. This quoted evidence is NOT good evidence. It might be a "high quality" review as Doc James calls it, but it is outdated already. Biasuz (talk) 23:57, 23 January 2017 (UTC)

No, it is not outdated. I won't explain why because you are not listening to anybody. If you are ready to listen I will explain. Let me know. Jytdog (talk) 03:25, 24 January 2017 (UTC)

The aim of Wikipedia is to summarize accepted knowledge, not necessarily be on the bleeding edge of science. The best way we currently have of knowing if knowledge is 'accepted' is if it is cited by reviewers. Give it a year or so and there should be a review out that we can cite. Sizeofint (talk) 03:42, 24 January 2017 (UTC)

″Fulvestrant is used for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy; it is given by injection. It is as safe and effective as other first line or second line agents.″ there is something wrong with this sentence. if it's a first line endocrine therapy which says so in the very next sentence then it's not used in disease progression following antiestrogen therapy, since this is an antiestrogen therapy. The very same mistake appears at the beginning of the article. Since I'm not able to fix it without having the banhammer issued in my direction, at least I can nag someone in here to do it for me... Biasuz (talk) 01:00, 25 January 2017 (UTC)

fixed Jytdog (talk) 01:23, 25 January 2017 (UTC)

I'll make a small edit, essentially because I need to go sleep and since my apologies won't do you much of anything. U can issue the ban / block / permanent ban thingy in a couple of minutes. It is of no importante. It;s just an attempt to help. — Preceding unsigned comment added by Biasuz (talk • contribs) 01:29, 25 January 2017 (UTC)

the beggining of the piece still reads funny. The association with palbociclib has also been tested in both lines but I wouldn't quote any sort of reference with regards to sequencing because that is currently unknown and subject to a lot of speculation. maybe that should be medical use instead of the description... Biasuz (talk) 01:48, 25 January 2017 (UTC)

it is in the label. Jytdog (talk) 01:51, 25 January 2017 (UTC)

The paloma trials fast tracked FDA acceptance. FDA will aprove stuff on phase 2 trial pending phase 3 evaluation. thats how palbociclib was approved. No current sequencing data exists for these treatments. it's just an observation ... ok. now i'm done. Biasuz (talk) 02:02, 25 January 2017 (UTC)