Talk:Bioidentical hormone replacement therapy/Archive 4

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Boothby table

In responses to this question, the answer is yes - the whole table is based on Boothby 2008, who addresses specific claims made by BHRT practitioners. For me the use of the footnote fronting the table is fine (in my mind it says "everything that follows is sourced to this document") but I don't object to it being moved elsewhere if it's better practice. Note the same issue is faced in Terminology with the table of nonbioidentical and bioidentical hormones. WLU (t) (c) Wikipedia's rules:simple/complex 02:21, 3 December 2009 (UTC)

Since this heading is so handily in place, I will note here that I revised the one entry regarding progesterone, but suggest it would be better replaced with some statement to the effect that "No research has been done that compares the side effects of bioidentical vs CE estrogens" which I am sure Boothby will support somewhere. Riverpa (talk) 16:58, 4 December 2009 (UTC)
Can we say "CE" without engaging in OR (i.e. X is a CE, Y is a CE, Z is a CE, therefore we can use "CE")? I've suggested asking TimVickers what he thinks of this specific statement (I'm assuming this is about the "WHI results were due to synthetic hormones" line, as discussed on my talk page). Boothby states that progesterone and pregnane derivatives didn't change risks, but "certain progestins are associated with increased cardiovascular risk". I'm almost tempted to use a direct quote if we can't do any better. This is neither a condemnation of all synthetic hormones, nor a blanket endorsement of bioidenticals, nor is it a statement that BHRT has CV benefits. WLU (t) (c) Wikipedia's rules:simple/complex 18:06, 4 December 2009 (UTC)
I'm not committed to the use of the term CE, but when you use progestin in that table you should specify somewhere close by that it is non-bioidentical by definition, because that table is supposed to be about bioidentical performance, not conventional, and most people would not make that distinction. And if you do that, you really lose the logical progression that should occur in the claim/evidence table, so why bother at all. Boothby clearly indicates that pregnane derivatives and progestins are not bioidentical, progesterone is bioidentical: the encompassing term for both bio and non-bio is progestogen. The specific progestins he was referring to here were CEE's because they were the ones used in the WHI study, but I agree, I don't see where he connects the dots. Tim may feel it is acceptable, I don't really feel that it is OR since none of the facts are controversial, but I am not committed either way. Which is why I can come down to "No research has been done that compares the side effects of bioidentical vs (non-bioidentical or synthetic, whichever) estrogens" if that is more in line with his article.
Another source that I am looking at that indicates the movement toward greater acceptance of the term bioidentical as applied to FDA approved products is here: [[1]] from NAMS, 2007. Riverpa (talk) 20:49, 4 December 2009 (UTC)
Use a direct quote. Then there can be no question of taking the source to state any more or less than they intend. Tim Vickers (talk) 19:26, 5 December 2009 (UTC)
Done. WLU (t) (c) Wikipedia's rules:simple/complex 18:35, 10 December 2009 (UTC)

Information Warfare

I'm unable to post frequently. The responses to my last post are way up the page, so please allow me to respond here. WLU, You are correct in saying that the majority of published sources on the topic of bioidentical hormones are negative and, although most admit that bioidentical means chemically identical, proceed to talk about BHRT as a package deal involving unproven compounded hormones, saliva testing, intensive marketing, etc. Welcome to modern society, where, as a famous author recently pointed out, we don't have information exchange anymore, we have only information warfare. One of the oldest tools in information warfare is to use the straw man and package deal fallacies. In this case, one doesn't admit that there is any truth in the opponent's position, one instead creates a straw man by bundling together any false or unsupported ideas expressed by anyone who supports your opponent's view. That way you mix the opponent's true ideas with untrue ideas and delegitimize whatever they say.

An encyclopedia article must do more than just quote info. warriors on both sides, give weight according to amount published on each side in the mainstream journals, and call it good. An encyclopedia article should seek the truth, and should choose to present what is most reasonable and consistent with the evidence from both sides. It should not repeat obviously propagandistic, unsupported statements as if they were true. It should not use anecdotal information as a scare tactic.
For instance, the paper mentioning three cases of endometrial cancer occurring in women on bioidentical hormones has no place in this article. I have removed it. It is anecdotal evidence, the lowest-quality evidence in science. Unnopposed estradiol--meaning without progesterone, does increase the risk of uterine cancer several-fold, but these women were being given progesterone also. All doctors give women a progestin or progesterone with any estrogen if the uterus is intact. You need to realize that women do develop uterine cancer even while taking FDA-approved estrogen/progestin combinations. Those cases just don't get written up because the regimen was FDA-approved. Persons on FDA-approved combinations have a risk of uterine cancer that is believed to be equal to women on no hormone therapy, or possibly as low as 4/10ths the risk. So uterine cancer occurs in thousands of women world-wide on all estrogen/progestin combinations. If the bioidentical hormone replacement played a causative role in these women's cancers, it would have been due to an excessive estradiol-to-progesterone ratio. See--it is about balance. What better way to see what the hormone balance is than to actually measure serum levels at mid-point between doses? Oh--you've been told by "experts" that measuring levels is one of those crazy unsubstantiated bioidentical hormone ideas. For substantiation of the above see [2] [3][4]

I agree with WLU that once one abandons the "one drug for all" conventional approach to HRT and start using bioidenticals, many questions arise: What is the right dose? To achieve what level? How much progesterone is needed to oppose estradiol effects in the breasts and uterus? By what route should the hormones be delivered? We know that oral and even sublingual estrogens should be avoided due to increase in blood clotting. Prometrium, the primary FDA-approved progesterone, is highly sedating when swallowed--and especially so in the 400mg dose needed to produce effects on the uterine lining identical to that of endogenous progesterone production. (see reference added by Riverpa above). Slamming bioidenticals is not the correct response to these problems--pointing out the holes in our knowledge and the problems with some approaches used by BHRT practitioners is correct.
—Preceding unsigned comment added by Hillinpa (talkcontribs) 12:51, 7 December 2009 (UTC)

You've insinuated that bioidentical molecules are not actually identical to the human hormones. You need to know that both pharmaceutical companies and compounding pharmacies use the same USP-certified bulk hormones, so you're contradicting the claims of pharmaceutical companies now too. You also need to look into USP certification. I don't know any doctor or scientist who doubts that USP-certified estradiol is identical to human estradiol.

What's ironic is that the anti-bioidentical campaign is backfiring. Women are now thinking that the ONLY way they can get bioidentical hormones (smart) is with COMPOUNDED bioidentical hormones! They're refusing FDA-approved bioidenticals from their doctors. What else can one expect them to think when propagandists are constantly conflating the two? It's funny that you take time to include a graph showing how many FDA products are bioidentical, yet you insist that bioidentical means compounding, saliva testing, etc. This is inconsistent.

There is simply no way you can claim that research involving estradiol or progesterone has no relevance to the article unless the author used the term "bioidentical". You're position requires you to also hold that any research involving the FDA-approved bioidenticals--the ones you put in the article--is not admissible in this article! Indeed the research on estradiol and progesterone was all done with FDA-approved bioidenticals, or their European equivalents. Your position is wrong, and you cannot even maintain it consistently. Research done on bioidentical hormones is not OR in an article on bioidentical hormones!

This article should give women high-quality information---they should know how to get these hormones in FDA-approved forms. They should know too that several recent studies and review articles show a clear superiority in safety for transdermal estradiol over oral estrogens in clotting risk, and for progesterone over progestins in breast cancer risk. They should also hear the warnings from organizations. Try to be objective. Hillinpa (talk) 11:46, 7 December 2009 (UTC)

Encyclopedias seek truth? Read our policies on verifiability and truth. You have apparently no idea what the purpose of wikipedia is, nor how it is constructed. We fundamentally do not seek truth.
The concern in the Australia paper contains a clear rational about the ratio of estrogen to progesterone was inadequate. That is verifiable and of sufficient concern that the case reports are published in a medical journal. Your concerns are original research based on your opinion. If your opinion is sufficiently expert, I suggest you sign up for Citizendium, where speculation and expertise are more welcome. Neither are welcome here. And did you read the paper? It mentions the estrogen to progesterone ratio, in fact that information was in the article.
I've been told that measuring both blood and saliva levels are worthless - see Boothby for details, the citation that I used to verify the information I included.
You still show evidence of advocacy (another policy you should read). Wikipedia is an encyclopedia, not a source of medical advice. It's meant to generally inform. If women are concerned, they should talk to doctors, not seek advice from wikipedia. WLU (t) (c) Wikipedia's rules:simple/complex 13:36, 7 December 2009 (UTC)
I defined very clearly what "seeking the truth" means in terms of an encyclopedia. I also clearly stated that women should be given all the facts about progesterone and estradiol from the high-quality literature available--and you try to construe this as giving medical advice? You should deal with evidence and arguments, instead you simply repeat your assertions or inappropriately invoke Wiki policies. You've made it quite clear that you are indeed on a soap box--promoting an anti-estradiol, anti-progesterone viewpoint that is not supported by evidence or literature. You are attempting to pidgeonhole bioidentical hormone replacement as something other than using bioidentical molecules--which is the definition of the term.
I see you've reverted to your statement in the lead claiming that progesterone is a bioidentical estrogen. Shall we leave it there so people will know that this is a carelessly written article-- like we did with your previous lead that stated that the major organizations claimed there was no benefit to bioidentical hormones? Why did you remove the reference to testosterone? Don't know know that testosterone is mentioned in many articles on BHRT and is commonly prescribed in BHRT? Why leave it out?Hillinpa (talk) 12:36, 8 December 2009 (UTC)
And I very clearly cited the policies against original research, the truth and verifiability, repeatedly, but still have to re-cite them and you still keep suggesting changes that contradict them. I also stated that people should be getting this information from their doctor, not wikipedia. I would define getting "the truth" about BHRT (i.e. that it's safer than CHRT) to be giving advice, and a violation of WP:NPOV. I'm not placing my opinion anywhere on the page, I'm citing, often using multiple citations, the evidence and discussion in the scholarly literature and community. I wouldn't be doing so if it weren't so clear that that community considers BHRT to have no demonstrated advantage. Read the references, all of them, and tell me I'm wrong (without referring to primary literature). I don't hate estradiol or progesterone, but I am demonstrating, with citations, that these molecules are not considered a) innocuous, or b) better than the molecules that are actually scientifically tested. If your belief is correct and they are better than CHRT, then eventually this will be demonstrated in the literature and we can adjust the page. Note that the very term BHRT is contested and has varying definitions. We have a section discussing this.
See WP:LEAD - testosterone should be discussed in the body before being included in the lead. Again, read the policies that I cite in my edit summaries and my talk page postings. If you can find sources discussing bioidentical testosterone, expand the body, see how much text it represents and include it in the lead. Most of the sources I've read don't discuss bioidentical testosterone at length (though I do recall minor mentions). WLU (t) (c) Wikipedia's rules:simple/complex 13:10, 10 December 2009 (UTC)
Once again, sorry, original research does not apply to the citation of official statements, reviews, and studies that deal with the efficacy or safety of estradiol and progesterone--as they are the bioidentical hormones, and bioidentical hormone replacement therapy is defined as the use of these molecules. It's like claiming that an article on atomic power can't mention any sources that only say "nuclear" and not atomic! Your position is not even remotely defensible. Get over it.Hillinpa (talk) 14:57, 10 December 2009 (UTC)
WP:SYNTH and WP:MEDRS#Respect secondary sources. Please tell me how your edits do not contradict this? The official statements are critical of bioidentical hormones, which you do not seem to appreciate or are ignoring because it seems to be inconvenient. As I and TimVickers have said, you can add that information to the estradiol and progesterone pages, but you can't use it to contradict statements about bioidentical hormones as a class.
What you are trying to do is akin to using individual studies of quantum physics to refute claims made about the safety of nuclear power plants, or individual fossils to refute the theory of evolution. You are ignoring the larger context in favour of isolated, tangential issues. WLU (t) (c) Wikipedia's rules:simple/complex 16:05, 10 December 2009 (UTC)
Your analogy is poor. The larger context here is that estradiol and progesterone are among the most studied molecules in biology. There are many thousands of articles, tens of thousands, on just what effects they have, what benefits they produce at the cellular and sub-cellular levels. There are also thousands of articles comparing the non-bios to estradiol and progesterone in various ways--cell cultures, biochemical studies, and human dosing studies. The bios almost always have the greater benefit and lower risk. None of this basic research needs to go into this article and I don't propose using basic research to refute replacement studies or reviews. The problem here is one of mere definition: the "class of bioidenticals" you are trying to create is an artificial construct. "Bioidentical" is only a word used to describe molecules that are endogenous, natural parts of human biology. Practitioners who realized that one should only use the biochemically-correct hormones needed a word to describe how what they were doing was different from conventional HRT, as non-human molecules were called "hormones" then, and still are. So one needs a word to describe using hormone molecules that don't come from humans, but are identical to the human hormones. Unless one is trying to hide facts, that is. "Bioidentical" is perfectly suited to this purpose. Only because of information warfare do some people turn it into a term of derision--part of the "package deal"-"straw man" fallacy you find everywhere you look, in so many "official" sources. All "critical" statements refer only to the package deal, not to bioidentical hormones per se.Hillinpa (talk) 19:07, 10 December 2009 (UTC)

Undent. My point is that the analogy is misapplied. We shouldn't use these studies because we don't need to use the studies. There are lots of articles dealing with bioidentical hormones in general and therefore no need to build the page using individual claims. In addition, bioidentical molecules have existed and been used for years - yet another reason why doctors don't think there's any reason to believe they're any less risky or more beneficial than what's already out there. Ultimately you seem to be asking for all the statements of the specific articles dealing with bioidentical hormones to be discarded in favour of individual articles dealing with individual molecules that are bioidentical. I think that's against policy, and again unnecessary. WLU (t) (c) Wikipedia's rules:simple/complex 19:40, 10 December 2009 (UTC)

Endometrial Cancer mention and Estriol

WLU, I agree with Hillinpa about the endometrial cancer mention. It is anecdotal and does not rise to the level of indicating anything, other than that a particular practitioner may not have been prescribing properly. Or it may have been entirely coincidental. They were not a part of a study. WP:MEDASSESS "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."

Also, the FDA ban of estriol is currently tied up in the courts. It has more far-reaching implications than just the ban on use in compounding, it is being viewed by some as FDA interference in the states' regulation of compounding pharmacies. Also it may set a new precedent allowing the FDA to ban a substance that was grandfathered in as a USP product when regulations were first put into place, without suitable justification for doing so. Riverpa (talk) 15:24, 7 December 2009 (UTC)

The endometrial article states that the reason these case examples are highlighted is because they suggest that BHRT, contrary to assertions, carries the same risks as CHRT. It could be fairly phrased as such.
Need sources for the estriol/courts statement. The FDA has been beaten down by political pressure in the past, to the detriment of consumers. Without a source it's rather fruitless to discuss. WLU (t) (c) Wikipedia's rules:simple/complex 18:24, 10 December 2009 (UTC)

Text for review

Here is a link to some text that I am working on that describes BHRT history and methodology.[5] I am putting it here for discussion. If anyone has access to any references that will fill in the gaps on the history of the development of BHRT methodologies I would appreciate seeing them. Also, looking for references that track the pharmaceutical companies interest in and development of bioidenticals. Please note that the refs that are not fully developed indicate the obvious link to the refs that are currently in use in the article. Riverpa (talk) 15:26, 7 December 2009 (UTC)

Make sure they are reliable sources for any medical claims and don't use original research - sources should state that this is a discussion of bioidentical hormones, not just a hormone that is bioidentical. WLU (t) (c) Wikipedia's rules:simple/complex 15:36, 7 December 2009 (UTC)
So far I don't think there are any specific medical claims in there - except those made by Boothby, Cirigliano, and Fugh-Berman. Of course, it does describe the claims that were made some some practitioners, but those are not couched as medical claims, they are couched as claims being made by so-and-so. Did you actually read the text, or are you just speculating? Riverpa (talk) 15:46, 7 December 2009 (UTC)
""bioidentical hormones", not just a hormone that is bioidentical"" It's hard to believe you actually wrote those words. Let's see ""nuclear energy", not energy that is nuclear"", ""African-American musicians, not musicians who are Africans". If this were to become Wiki policy, Wikipedia would be a very funny place!Hillinpa (talk) 15:33, 10 December 2009 (UTC)
If you have to ignore the actual sources dealing with bioidentical hormones specifically in order to make your points, you're doing it wrong. You can't use primary sources to refute secondary sources. You can't use articles that don't use the term "bioidentical hormones" to refute articles that do use the term. Instead of reading articles about progesterone, estriol or estrone, read the articles that use the words "bioidentical hormones" in the title. You may believe that you are righting a great wrong here, or being clearer about the hitherto-unappreciated benefits of bioidentical hormones, but all you are doing is engaging in original research that promotes a minority point of view that is clearly contradicting the opinions of many, many authoritative bodies and the opinions of scholars published in peer-reviewed journals. This is against wikipedia's policies, which you either have not read, have not understood, or are ignoring. Stop referring to journal articles that don't discuss bioidenticals as a category, and start reading the one that directly address them. If your source contradicts wikipedia's policies, your source loses. WLU (t) (c) Wikipedia's rules:simple/complex 16:01, 10 December 2009 (UTC)
Sorry, no restricting our references to those that have the words "bioidentical hormones' in the title. You are setting an arbitrary restriction with no justification. If an article discusses bioidentical hormones it is a valid cite, it does not have to have it in the title. If you want to impose this you need to find a higher authority to back you up. Riverpa (talk) 18:37, 10 December 2009 (UTC)
I'm not opposed to articles that lack "bioidentical" in the title. I do oppose articles that lack the word "bioidentical" in any way, shape or form. It's not an arbitrary restriction, it's our policy on original research, synthesis and soapboxing. The only way such articles could be used would be to make claims about specific bioidentical hormones. Think of it this way - if I started digging and pulled up a dozen articles that showed that progesterone, estriol, estrone and other bioidentical hormones were deadly, damaging, toxic or harmful, would you support their inclusion? They are not suitable, it's not arbitrary, it's policy. The only time I would support judicious use of such articles, would be if there were a complete lack of secondary sources. There are not. There are many articles on bioidentical hormones, both those addressing general claims about them as a class, and addressing specific claims about individual molecules. That they all tend to be critical is a serious, serious indication of the direction of the page. WLU (t) (c) Wikipedia's rules:simple/complex 18:52, 10 December 2009 (UTC)
Excuse me, you said "read the articles that use the words "bioidentical hormones" in the title". Then you rebuke me for not agreeing to your arbitrary distinction. You wasted a lot of time and words there when you were the one that mis-wrote in the first place. Stop with the wikilawyering already. And somehow you manage to interpret every article as critical, even when it has positive content - as the IMS article has - yet you only see the negative. Riverpa (talk) 05:02, 11 December 2009 (UTC)

Undent. Use common sense but fairly represent the sources and don't start writing a new article based on your definition of what bioidentical hormones really are. WLU (t) (c) Wikipedia's rules:simple/complex 15:20, 11 December 2009 (UTC)

Changes to lead

Regarding this:

  • My biggest issue is that the statement by the International Menopause Society is summarized as "The International Menopause Society, however, states that progesterone may be associated with no increased risk, or a lower risk of breast cancer than progestins" when the document itself states "There are no medical or scientific reasons to recommend unregistered ‘bioidentical hormones’." There is absolutely no reason to cherry pick specific statements and blatantly ignore criticisms and doubts about the approach as a whole. What on earth would make anyone think this is appropriate? The IMS clearly lines up with ACOG, the FDA, Mayo Clinic and NAMS in criticizing bioidentical hormones, and does not endorse them.
  • The edits removed Eden, 2007 from the lead - the article further substantiates the points made by Boothby and Mayo. Absolutely no reason to remove it, particularly given its further demonstration that BHRT is not considered a panacea.
  • "Estrogen" and "Progestin", "invented" and "animal derived" don't need quotes or mention - they can be elaborated in the body. The lead doesn't need huge specifics, just general information
  • "Some argue" is a weasel word and it's not "Some argue that these claims for pharmacy-compounded BHRT's superiority are not supported by research, and the risks and benefits of this form of hormone replacement therapy are unknown" - the majority of the articles converge on the idea that BHRT is not superior to CHRT and there is no research to support assertions that it is. Again NPOV requires that we portray things as believed by the majority, not by three people who sell bioidentical hormones for a profit.
  • "Most of the criticisms of BHRT" are not directed at compounding, saliva testing, bogus benefit claims and endorsements, BHRT is soundly, generally and primarily criticized by the experts. I've taken the line out completely, as there are legion criticisms and they're not all aimed at these issues. Compounding, marketing, lack of evidence, fake naturalness, safety, potency, etc. are all things criticized and are all included already. No need for an OR summary of what the "real" problems with BHRT are. The real problems are a lack of evidence. I've removed the line.

This is basic stuff that has been covered before, and blatant POV-pushing that actively misrepresents the evidence. WLU (t) (c) Wikipedia's rules:simple/complex 15:39, 10 December 2009 (UTC)

And we will continue to cover this stuff until you stop mixing definitions. What the IMS says regarding progesterone and breast cancer risk is relevant as progesterone is the bioidentical hormone. The IMS statement on "bioidentical hormones" clearly refers to unregistered compounded hormones and saliva testing, that's why it's in quotes in the paper. The other organizations claim that there is no difference between estradiol and other estrogens, or progesterone and progestins regarding risks, they are not talking just about compounded BHRT. The fact that IMS disagrees should be mentioned.
You cannot limit the definition of BHRT to the "straw man" of compounding, saliva testing, etc. Many physicians do BHRT without using saliva testing for sex hormones. BHRT is defined at the beginning of this article--the use of estradiol and progesterone, the bioidentical molecules. Criticisms of certain practices of some BHRT physicians and pharmacies needs to be stated as such, not as a blanket condemnation of BHRT--a mistake you make repeatedly in the article. You will not find ONE physician criticizing the preference for estradiol and progesterone instead of non-bios. They are not critizing BHRT per se, they are criticizing compounding, saliva testing, etc. This is so simple. Only a propagandist would try to HIDE scientifically-demonstrated differences between estradiol/progesterone and non-bioidenticals.Hillinpa (talk) 16:37, 10 December 2009 (UTC)
Show me in the ACOG, IMS or any other "critical" document where it says "compounded bioidentical hormones are bad but noncompounded are good". Show me a reliable source beyond Holtorf, Shwartz and Moskowitz where it discussses the unambiguous benefits of bioidentical hormones as a class, based on research evidence. Even arguments made about specific compounds are dubious, as evidenced by Cirigliano and Boothby & Doering. You have been told before that the page should discuss bioidentical hormones, not specific molecules. Don't draw upon your definition of good research and bioidenticals, draw upon the actual research. You have a venue for information about progesterone, estrone and the like. It is not here. Again, the overall conclusion is not that bioidenticals would be ideal if compounding were removed, it's that there is no research supporting bioidenticals as inherently superior. WLU (t) (c) Wikipedia's rules:simple/complex 17:09, 10 December 2009 (UTC)
This source, says this, There are no medical or scientific reasons to recommend unregistered ‘bioidentical hormones’. Unless I am interpreting the statement wrong, they are saying that bioidentical hormones can't be recommended due to lack of evidence to support superiority to licensed therapies. "Unregistered" I take as meaning not having been through appropriate safety approval processes and thus safety and effectiveness has not been demonstrated adequately.--Literaturegeek | T@1k? 17:38, 10 December 2009 (UTC)
I think in this sense they are using "unregistered" to mean not approved by the National Health Service in UK, since this is a UK based journal, similar to not FDA-approved in the US. It has already been established in the article that there are plenty of bioidentical hormone products that are FDA-approved in the US. I do not have access to National Health Service information, the UK site blocks access from the States. In general, Europe and the UK use more bioidentical products including estriol based products, but I don't have a list of products or any specific numbers. Riverpa (talk) 18:21, 10 December 2009 (UTC)
OK WLU, let us take a representative example from the NAMS statement:
"Bioidentical" hormones" (title of section)
NAMS recognizes that one area of confusion in clinical practice is so-called "bioidentical" hormone preparations. This term has been used to refer to many well-tested, regulatory agency-approved, brand-name HT products containing hormones chemically identical to hormones produced by women (primarily in the ovaries), such as 17B-estradiol or progesterone. However, the term is most often used to describe custom-made HT formulations (called "bioidentical hormone therapy," or BHT) that are compounded for an individual according to a healthcare provider`s prescription."
So we see that even this drug-company funded organization is careful to put the "bioidentical" in quotes, in the title and in the text, since they are referring to a specific, non-standard use of a term, or at least referring to a term whose meaning is ambiguous. Notice that they they do not criticize estradiol and progesterone products that are FDA-approved, even though they admit that they are bioidentical. You do the same in your table where you list the bioidenticals that are FDA-approved. NAMS goes on to offer the usual criticism of compounded HRT, saliva testing, etc. NAMS is saying that FDA-approved bioidenticals are as good as any FDA-approved HRT products. They do not have that the same neutral/positive opinion of compounded bioidenticals--obviously. The other organizations say essentially the same--"FDA-approved bios are as good as any other HRT products, but compounding-bios is bad." But there's more, the IMS breaks ranks with them since it specifically states that progesterone may have a safety advantage over progestins. So IMS is saying progesterone may be better than progestins, but unregistered/compounded "biodenticals" bad. So your argument that they don't discriminate between FDA-approved and compounded bioidentical is false.
You're playing a word game. It's very tedious--all this time wasted on a merely verbal argument. Scientific studies including estradiol or progesterone, and reviews of their benefits as opposed to non-bios, will not use the word "bioidenticals". It's redundant--every scientist knows that they are the endogenous hormones. There's no need to say "bioidentical" unless trying to address the information war. Scientists have studied estradiol and progesterone hormone replacement--and they are the bioidentical molecules.
In sum: "bioidentical" is used in two senses, as "estradiol, progesterone, estriol" as defined at the start of this article, and as "compounding/Suzanne/saliva/marketing/bad" as also mentioned in the first paragraph--but secondarily. This dual definition is universally recognized. "Bioidentical hormones" is a larger class than estradiol and progesterone, but this article is about bioidentical menopausal hormone therapy--and that means estradiol and progesterone. The article MUST reflect both uses and should present statements and reviews about both definitions/practices. There is room enough! If you insist on using the latter definition only, then you must be consistent. For instance, the definition at the beginning of the article must be changed. It should define BHRT as "compounding/Suzanne/saliva/marketing/bad therapy, that just happens to use the chemically-identical molecules--whose safety and benefit profile will not be discussed here." Then you could fill the article with invective about untested compounded products and disputed practices. However, this will require a complete rewrite of the article. As it is, you are trying to have it both ways, to bait the reader with the scientifically-clear definition, then switch to the information warfare definition and carry on with your diatribe. It's not defensible. It's not honest.Hillinpa (talk) 18:37, 10 December 2009 (UTC)
Mmmmm, drug company funded organization. Well, let's also immediately discount the FDA, NAMS, and all doctors since they all get money from the drug companies. Sometimes in the form of free pens at conferences.
There is no standard term. That's kinda the point of the "terminology" section. "Bioidentical" has been used in many ways by many people. Including Erika Schwartz, Kent Holtorf and Moskowitz who make a direct profit from sales of bioidenticals and Susanne Somers who profits in the form of book sales. We can not set our own definition of terms. And other organizations say "bioidenticals are expected to have the same risks and benefits of other studied hormones". This isn't a "word game" or "verbal argument" - this is part of the disagreements about bioidentical hormones. There has not been a specific set of studies established to study "bioidentical hormones" and compare them to "nonbioidentical hormones" (and why would they, since the molecules are all different and should have different effects). There is minimal clarity except on the point that these hormones are not expected to be any different from already-studied ones. That is quite clear. WLU (t) (c) Wikipedia's rules:simple/complex 19:01, 10 December 2009 (UTC)
I explained above WHY no researcher is going to study "bioidentical hormones" and announce their work as such. They study estradiol and progesterone, period. The bioidentical hormones available for menopausal treatment are estradiol and progesterone. There are studies comparing the effect of using transdermal estradiol vs. oral estrogens, there are long-term hormone replacement studies comparing progesterone to progestins--those researches didn't need to say they were comparing "bioidentical" to "non-bioidenticals"! As I've pointed out several times, even the claim that there's NO evidence that FDA-approved bioidenticals are safer than non-bios is false. The IMS, based on solid evidence, says that progesterone may be safer then progestins. There is a large review study that concludes his more definitively, referred to above. IMS also says that transdermal estrogens safer than oral. The transdermal estrogen that's consistently proven safer in respect to blood clots is estradiol--also directly mentioned in reviews of HRT and blood clotting.Hillinpa (talk) 19:23, 10 December 2009 (UTC)
So then why wouldn't you report specific studies of specific hormones on those pages? If anything will ever come out of the whole BHRT debate, it'll be in a massive review article or comprehensive tome which exhaustively reviews all the evidence, but not for another couple years. I don't want the page to end up with 40-odd headings, half of which are ===oral estriol===, ===transdermal estriol===, ===oral progesterone===, ===intravaginal suppository progesterone===, each heading discussing a different preparations of a different hormone. This is kinda why (in my mind) the medical establishment is irritated with BHRT overall - claims are made that a priori because something is bioidentical, it's better - ignoring dosing, delivery, pharmacokinetics, and previous literature indicating that innate hormones are themselves risky. There's a reason we use herceptin to block estrogen receptors, it's because innate (i.e. bioidentical) estrogens can promote the growth of tumours even if they're produced by a woman's own body. WLU (t) (c) Wikipedia's rules:simple/complex 19:32, 10 December 2009 (UTC)
This page is about "Bioidentical Hormone therapy"..... vs. what? vs. Conventional hormone therapy of course. So the issues are: 1. Is there evidence that bioidentical molecules, in tested FDA-approved forms, offer advantages like greater efficacy or safety? Most organizations and reviews say no, some say yes; both deserve appropriate space. 2. Is the compounding of bioidenticals a good idea or not? No one's preventing you from dissing "BHRT" as you like to define it. However, everything relevant to point 1. from top quality reviews or "expert" organizations belongs in this article--especially in this article in Wikipedia. It's that simple. Yet you are deleting every positive statement, review, or study that shows advantages of FDA-approved bios over non-bios, yet including any opinions, anecdotal description, etc. that trashes bioidentical hormones--which you define as compounded. Only fools would claim that using the right molecule is all that counts, that neither dose or route matter. Your invoking this "argument" is another example of your frequent use of the "straw man" fallacy. And at no time did I, or anyone I've heard of, say that unopposed estradiol won't cause any problems since its bioidentical.
So does point 1 belong in this article or not? (Hint, it's already there in your own paragraphs). Since point 1 is actually unavoidable in this article, are you going to stop removing citations of reviews and organizational statements about the benefits and safety profile of FDA-approved bios vs. non-bios admissible in this article or not? If not this is going to a higher authority.Hillinpa (talk) 20:09, 10 December 2009 (UTC)
I am deleting inappropriate statements made in articles that do not mention bioidenticals at all. Your statement suggests that there is a "truth" to be gotten at in this article - are BHRT better than non-BHRT. That's inappropriate. What is appropriate is "what have people and organizations said about BHRT"? Can you justify your suggestions per our policies? Which ones support the use of individual studies on a topic that isn't mentioned in the article? Can you point to a noticeboard discussion that suggests your edits would have community support? I don't define BHRT as compounded, but many sources point out that the two are highly linked, sometimes indistinguishable, and irrespective problematic. So no, I will continue to insist that articles cited discuss bioidenticals directly and refer to them as "bioidentical hormones", hints be damned. WLU (t) (c) Wikipedia's rules:simple/complex 20:19, 10 December 2009 (UTC)
Hillinpa, you said that "most organisations say no" as to whether bio identicals are superior to non identicals but say some say they are. This would mean per WP:DUE that most of the weight should be given to the viewpoint that bioidenticals have no benefits over non-identicals with less weight given to the opposing view. Perhaps a better understanding of policies can be the first step to resolving this dispute and working out some sort of agreement or whatever.--Literaturegeek | T@1k? 22:41, 10 December 2009 (UTC)
The article is chock full of anti-bioidentical statements. It is heavily weighted already. What WLU is trying to do is prevent the inclusion of any high-level statements or reviews mentioning the greater safety of FDA-approved progesterone and transdermal estradiol over FDA-approved non-bios.Hillinpa (talk) 11:40, 11 December 2009 (UTC)

undent Here's what IMS says "However, natural progesterone and some progestogens have specific beneficial effects that could justify their use besides the expected actions on the endometrium." and "Micronized progesterone or dydrogesterone used in association with oral or percutaneous estradiol may be associated with no increase in risk or lower risk than use of synthetic progestogens for at least 4 years, and perhaps even 8 years, of treatment."

That seems pretty positive to me. Sorry it's not discussing compounded bioidenticals, but the article makes it clear that it is discussing bioidenticals, as does Boothby when referencing the same data. Compounding does not define bioidentical anywhere but in your mind. Yes, they are associated, but that does not mean that they always go together.

Here's another quote from a NAMS post-graduate course[[6]] - "BHT is principally a construct within conventional HT that can usually be fulfilled by the use of existing commercial products that are familiar to all practitioners. There are valid reasons for prescribing compounded BHT for an individual patient, including lack of response from conventional manufactured HT, greater dosing flexibility, lack of a commercial equivalent, and especially patient preference." They were teaching that almost three years ago. You talk a lot about convergence, and I think that some of these articles are converging on a place that you cannot or will not see, because you are so focused on only what you want to see. Riverpa (talk) 05:28, 11 December 2009 (UTC)

The IMS statement equals NAMS/Endocrine Society statements in all respects. IMS disagrees with NAMS and the others who state that progesterone has no better safety profile than progestins. The IMS statement mentions "bioidenticals", referring to the compounded forms, yet still states that progesterone may be superior. Therefore, even by WLU's criteria, the IMS opinion belongs in the lead with the contrary NAMS opinion. I have reinstated the IMS statement, making it clear that the progesterone mentioned does refers to the FDA or European-Union approved forms. Hillinpa (talk) 11:59, 11 December 2009 (UTC)
Of course, it's a good idea to put on the progesterone page that the IMS supports it's judicious use. Of course, it's more important on this page to put what they think about bioidentical hormones in general. I've put in the full quote which does make it look more like a specific discussion of compounding, but this also illustrates that in the field BHRT is synonymous with compounding and that actual sources do not treat bioidentical hormones as a class. In other words, if you want to talk about progesterone, it happens to be bioidentical but this is less important than the fact that it has research to justify its use. So put it on that page. WLU (t) (c) Wikipedia's rules:simple/complex 15:05, 11 December 2009 (UTC)
Following your ill-logic then, ALL references to the bioidentical hormones, progesterone and estradiol, should be removed from this article unless they specifically refer to compounded estradiol and progesterone. All citations referring to reviews or studies involving non-compounded estradiol and progesterone should be removed. For the same reason you claim to want to remove the IMS statement from the lead, you must also limit the NAMS, Endo society, Mayo quote to "compounded bioidentical hormones may have additional risks" as their comments regarding safety of progesterone and estradiol vs non-bioidenticals should be on the estradiol or progesterone page and not here. Boothby's statement about progesterone and breast cancer should be removed, etc, etc. Actually there will be very little left, and the reasons why women are interested in bioidentical hormone therapy will be entirely missing from this article. In essence, in your ill-logic the article should consist of nothing but statements about the compounded bioidentical hormone therapy construct--i.e. basically that it has never been studied because no one ever studies an individual pharmacy's products.Hillinpa (talk) 15:37, 13 December 2009 (UTC)

Dec 22nd

Is there a way to make "certain levels of hormones in the blood" more specific? I don't think "certain" really captures the intention, does it? What about something like "blood hormone levels the practice takes to be normal"? Or "blood hormone levels regarded as normal". Or does it mean youthful hormone levels? Leha Carpenter (talk) 21:14, 22 December 2009 (UTC)

Also, WRT "Advocates have portrayed ...", the reference here is not from a BHRT advocate, but from a book that argues against BHRT (as far as I can tell). The one fairly solid-looking article I saw linked to on the Academy of Compounding Pharmacists website that seemed to favor BHRT disputed the "naturalness" claim, so it doesn't seem fair to characterize serious advocacy of the theories/methods as pushing "naturalness." Why not cite a reference that comes from an actual advocate in this case, since the sentence speaks for them? Leha Carpenter (talk) 21:25, 22 December 2009 (UTC)
I haven't seen a reference that discusses exact numbers for levels of hormones in the blood, Wiley and some others have been called "dangerously high" but I've never seen a mmol/dl or anything else. Part of the problem is that there is no "ideal reference" used for HRT - it's treated based on symptoms and symptom relief rather than on a specific level. The idea is that testing is used (spuriously according to most sources) to work towards an "ideal" goal while CHRT uses purely subjective criteria.
The book is specifically discussing BHRT from the perspective of what advocates have said and what others have said, actually using the word "proponents". That's actually a better source for "what advocates have said" because it is secondary - summarizing - rather than requiring us to paraphrase. The book isn't really against, it's pretty neutral in my mind. If you can't read the actual pages, 151-152, I think a gmail or other google account lets you see more because you're not limited by what your IP address has already viewed. I use a gmail account and seem to have much better access than a lot of other editors. Can you link the ACP article? There's a hierarchy of reliability (WP:MEDRS) and if the ACP is actually "advocacy" rather than a recognized body, they may be less reliable than even a general audience book. With the book we can actually say "advocates/proponents" while with the ACP we would have to say "The ACP..." because it can only speak to their own opinion.
The "naturalness" is one of the primary claims used by advocates, even though scholars call it useless. WLU (t) (c) Wikipedia's rules:simple/complex 23:10, 22 December 2009 (UTC)
On certain hormone levels: Yes, I understand that the BHRT testing methodology might not be clearly and uniformly defined. I was hoping that it would be possible to at least hint at the theoretical aspect of the practice. So maybe it could be something like "ideal levels of hormones in the blood, as established by ongoing testing and reevaluation"?
On the book ref: My mistake about the book--I was skimming and formed a skewed interpretation. I actually think the "Essential" tip at the the top of page 152 is refreshingly neutral and succinct.
Side note: After reading the (WP:MEDRS) article, I'm actually kind of confused as to why BHRT is considered a medical article in Wikipedia at all, when it seems there is so little citable material on what BHRT is to the field of medicine, in particular. I mean, I do get it, but I'll bet there will be a much clearer path for the article in a few years.
On naturalness: It seems to me that two distinct sets of "advocates" are arising: those whose primary motive is to sell something, and those whose primary motive is to help people/advance medicine. Maybe those could be teased apart somehow to make things a little clearer. This also leads into the next topic, which is the article I saw linked from International Academy of Compounding Pharmacists (IACP). The article is already sourced here from PubMed, it turns out. It is the Holtorf article (ref 9, I think), from Postgraduate Medicine. He writes about the question of "naturalness", and argues that it is an inappropriate term for bioidenticals. He seems like a proponent of a different flavor than, say, Suzanne Somers, who is obviously making money hand over fist (not to imply she doesn't believe in what she's doing, but just that there is a blatant conflict of interest in her case). And also not to say that Holtorf isn't a minority source with a POV that differs radically from the mainstream medical view, but he did take the trouble to get a degree in medicine, write a peer reviewed secondary source article, document a long list of relevant primary sources, etc., and to my mind, that puts him in another class from someone who is a popular, and non-medical figure, for example. So the point I'm making is that if there is more than one type of "advocate" being talked about, it might not be representative to lump them together where their views differ on a subject as critical as the definition of BHRT. Maybe if it's important to leave the "naturalness" claim in, the "advocates" under discussion could be qualified as "popular advocates"?
IACP: Here is a link to the list of BHRT-related links I found from the IACP page: IACP on bioidenticals Leha Carpenter (talk) 03:26, 23 December 2009 (UTC)
None of the sources I've read gave specifics on doses, and at least one (Boothby, 2008 I think) stated that even though saliva testing was used, practitioners were actually basing their prescriptions on symptoms (plus saliva testing itself is seen as so flawed it is essentially useless). It's there in the sources, there is clear and extensive discussion, but little focus on whether X blood/saliva level is actually a good thing - there's no research to support that doctors or women should aim for a specific number. The sources cover a lot of this, and it's always better to go to the source - they should guide editing and citation and we should stray from them only after considerable discussion and strong consensus.
BHRT is blessed with a fair number of sources (relative to a lot of CAM-type subjects). Because the article makes medical claims, it essentially falls within the scope of MED and MEDRS, though there are nuances and shades of gray. Doctors and researchers have looked into BHRT and published articles on it, which is why we have a lot to work with.
Ya, the "natural" gambit is essentially seen as nonsense - bioidenticals are no more natural than any other hormone, bar perhaps CEE (in the sense that CEE isn't modified from the horse's urine) and hormones extracted from the urine of pregnant women (not used because it's not economical).
The IACP could possibly be cited (I'd be happier if there were an indication it was notable and respected) but the Holtorf paper is a convenience link - the actual citation is to Holtorf, not the IACP. The IACP looks more like an advocacy organization than a neutral professional association, and I would hesitate to cite them for anything directly. WLU (t) (c) Wikipedia's rules:simple/complex 16:46, 23 December 2009 (UTC)

Testosterone

I've added the little I can find about testosterone, so far it's only 2 articles. I've requested the full text for Sites and both Cirigliano and Boothby 2008 have more information. Stubby, pubmed turns up only four sources (Sites, Ogilvie, Boothby and Cirigliano). WLU (t) (c) Wikipedia's rules:simple/complex 18:06, 10 December 2009 (UTC)

Once again illustrating that you define BHRT as "unregulated, compounded hormone replacement". There are many, many scientific articles on the importance of optimal testosterone levels in women and on the benefits, especially for libido, of replacing testosterone. Once again you also resort to an anecdotal, scare-mongering report of inappropriate dosing/absorption. Extrapolating from the WHI, we could say in this article that over its years of use in millions of women, Prempro killed 10s of thousands, maybe hundreds of thousands, due to heart attacks, strokes, and breast cancers. Should the article state that fact? Is it OK to scare-monger only against bioidentical molecules? Or is scare-mongering against non-bios also OK in this article?Hillinpa (talk) 20:17, 10 December 2009 (UTC)

Side effects

I have read over the article. Why is there no side effect list? Contraindications section, where is it? Interactions? Are side effects a class effect or differ between compounds? Any sources? These sections should be added if any kind person can find sources.--Literaturegeek | T@1k? 18:50, 10 December 2009 (UTC)

The discussion of side effects of Hormone Replacement Therapy is in that article. This article specifically discusses things particular to BHRT, and there are apparently no side effects, contraindications, or interactions specific to bioidenticals that are not also an issue with Conventional HRT. So they are discussed there.
Since you are interested, see if the inclusion of this text [7] would be an improvement to the article, though it is not complete. Thanks Riverpa (talk) 19:04, 10 December 2009 (UTC)
At this point we'd be discussing side effects of individual hormones, such as endometrial cancer or virilization with testosterone. I agree that the benefits and side effects are expected to be similar to regular hormone replacement therapy - a point explicitly made by several sources. BHRT isn't so much a specific "thing" as a set of claims made about a whole bunch of molecules, the sole uniting characteristic of which is they are identical to those made in the human body. This is part of the debate and problem - "pro" sources claim this means they are inherently better because they are identical molecules, "con" sources say "we haven't studied them, there's no factual basis for these claims, and really we pretty much think they're about as risky as the ones we use right now". WLU (t) (c) Wikipedia's rules:simple/complex 19:26, 10 December 2009 (UTC)
Ah right I see what you mean, you are right, we don't want lots of side effects for each individual hormone in the article. Is it worth doing a wiki inlink in the lead somewhere to hormone side effects or would that be a bad idea for the same reason? Right I get the background better now of what this content dispute is about. Well the its natural argument is not relevant without good sources. Alcohol occurs naturally 24 hours a day in our bodies, in very small doses but still has a range of side effects when used for a pharmacological/recreational effect, more so actually than other sedative-hypnotics, so naturally occuring in the body is not necessarily means less side effects. Perhaps not an ideal comparison but it was the first thing that entered my mind. Side effects I would imagine be related to dose rather than slight differences in molecular structures as they are all working at the same receptor sites with the same mechanism of action, unless one was say a partial agonist rather than a full agonist. These are my instincts. Feel free to disagree with me, I am not a "hormone expert" hehe and need to familarise myself a bit more with the literature. :)--Literaturegeek | T@1k? 22:08, 10 December 2009 (UTC)

Referred to Mediation Cabal

See [[8]] Hillinpa (talk) 21:34, 10 December 2009 (UTC)

Titles

WLU, do you really doubt that Schwartz, Holtorf and Moskowitz are doctors? Why else would you repeatedly delete the title Dr from in front of their names? Do I need to cite some of their articles in order to get Dr in front of their names?

This is not rational, and it is the type of edit that you make to skew the POV of this article. They deserve to be described as such. If I was calling Wiley a doctor I could see that you might have a point, but they earned their titles. Riverpa (talk) 19:33, 11 December 2009 (UTC)

WP:CREDENTIAL. Note that Boothby, Doering and Kipersztok also don't have a "Dr." in front of their names. To indicate they're opinions are of a higher calibre than Suzanne Somers or Oprah, I've included that they were publishing their opinions in a peer-reviewed journal here. If you can find a policy that indicates the use of their titles in-line is appropriate, then we can add it. To my eye it seems unusual and I would normally remove them irrespective of the title or article. I didn't delete their names because I doubt they are doctors. I know they are doctors (Schwartz and Holtorf anyway, Moskowitz is a naturopath and not a real doctor). WLU (t) (c) Wikipedia's rules:simple/complex 19:47, 11 December 2009 (UTC)
Alternative medicine shouldn't have a capital "m", it's not a proper name. Also, this article doesn't really comply with MEDMOS for drugs (WP:MEDMOS#DRUGS) but it's not really about a specific compound so I don't know how much we should work towards trying to comply with it. Anyway, for diseases the history section comes last, for drugs it is first, so I've moved it back - my mistake. WLU (t) (c) Wikipedia's rules:simple/complex 22:09, 12 December 2009 (UTC)
I agree that it is not customary or necessary to mention an author's title. But we have another problem, for in taking pains to say that Holtorp and Schwartz are BHRT practitioners, and Schwartz and Moskowitz are associated with compounding pharmacies, WLU is implying bias. Well if it's appropriate to imply bias, citing the personal or financial interests of a source, then it is fair to also mention the drug-company ties and financing of authors of anti-bioidentical statements, like NAMS, ACOG, the Australian Menopause Society, and the Endocrine Society [[9]]. Right? Balance is a good thing? See this article for some background on Wyeth's dilemma and involvement in the anti-bioidentical propaganda war. [[10]]Hillinpa (talk) 17:00, 13 December 2009 (UTC)
Do you want to cite the business week? WLU, what are your views? Should there be a controversy section at the bottom of the article?--Literaturegeek | T@1k? 01:06, 14 December 2009 (UTC)
Here is an interesting 2009 review which actually appears to support the use of bioidenticals over non-identicals. Maybe what is needed is a controversy section? Would welcome comments on this paper. We need to move forward to find ways of resolving this dispute between you all.--Literaturegeek | T@1k? 11:58, 14 December 2009 (UTC)
The Holtorp paper is already mentioned in this article. Yes, the Business Week article should be included so that the article includes information on the nature of this controversy and who the protaganists are. Please write it in.Hillinpa (talk) 12:18, 14 December 2009 (UTC)
Ok, sorry I should have checked the article references before making the post here. Are there any better sources than the news article, such as good quality books (see google books, or if possible library might help) or good quality reviews which discuss this controversy that Business Week talks about? It is still possible to use news sources cautiously but idealy better sources would better. Thank you for replying, I shall wait on WLU's response and see where we go from there.--Literaturegeek | T@1k? 12:28, 14 December 2009 (UTC)

Undent. That Business Week article is an editorial, which aren't really considered reliable sources and the author is a business editor, not a doctor or researcher. What exactly would it be used to say? Wyeth filed a complaint with the FDA? Sure. All the complaints about BHRT are based solely on greed and Big Pharma? No. There are valid safety concerns about BHRT and the products have not been tested. The main proponents in the medical literature are actively profiting from the sales of BHRT. And in response, there are vague claims that all doctors hate BHRT because they're getting paid off by Big Pharma. No, that seems dubious to me. Get a specific claim in a reliable source and then it's worth discussing. Right now it's just mud-smearing by the very people who make money off of this. WLU (t) (c) Wikipedia's rules:simple/complex 21:38, 14 December 2009 (UTC)

If you really want to get technical, you need the conflict of interest statement from the Boothby article. It doesn't appear to be included in the review, partly because the review was first published in 2004, I think, and COI's were not required then. But I know that I have seen it somewhere. Boothby has her own history with accepting money from big pharma. So maybe we need to publish that info if we are going to use Boothby's data, to provide parity with the background info for Schwartz, et al. Riverpa (talk) 22:55, 14 December 2009 (UTC)
Do you have a citation for that particular claim? Boothby may have received research grants, but you can't do research without funding, and it's only the alt med crowd who believes that conflict of interest arises only on one side of the debate - most alt med practitioners benefit far more directly from the products and services they sell than a researcher who has a university appointment. It's not a convincing argument and it usually stems from the inability to convincingly support a point with actual research - an effort to poison the well. Boothby has published a variety of articles, Doering also, Schwartz less so (one of those is probably a different "Schwartz ET") and Holtorf as well. WLU (t) (c) Wikipedia's rules:simple/complex 00:18, 15 December 2009 (UTC)
Poisoning the well doesn't occur on Talk pages and it is inappropriate for you to raise it here since I put nothing on the Article page. If I had the citation at hand I wouldn't have speculated as to where I had seen it. Your list of links doesn't help unless it contains COI's which I don't believe it does. If you have a link to a Boothby COI that would be helpful, everything else there is just a waste.Riverpa (talk) 00:38, 15 December 2009 (UTC)
Poisoning the well can occur on talk pages, it is an effort to discount a source or expert based on an ad hominen rather than a legitemate criticism or counter-source. Every claim that the FDA, ACOG, Endocrine Society or NAMS can't be trusted because they are a Wyeth patsy attempts to poison the well, as well as falling afoul of WP:REDFLAG by claiming a conspiracy. In particular, claiming a massive group of scientists that form the bodies of many professional associations are biased because of drug company funding (particularly when those very scientists have published studies which indicate there are dangers to the products produced by drug companies) is an absurd effort to strenthen a weak argument - it neither makes the bioidentical position stronger, nor weakens the arguments against it. It is particularly egregious when you do not apply a similar standard against actual practitioners who profit directly from sales of bioidentical hormones. Claiming you can't trust ACOG, NAMS and the FDA when the three primary sources of praise for BHRT all have direct income streams from bioidentical products (Schwartz), consultations based on bioidentical products (Schwartz and Holtorf), working for a company that makes bioidentical products (Moskowitz) and sales of books promoting bioidentical products (Schwartz) is an absurd double-standard. If anything was going to be discounted because of associations and COI, it would be these three sources, but since they are reliable sources, without a better reason than vague aspersions there is no reason to do so. What is inappropriate is Hillinpa's continuous assertion that you can't trust these agencies because they're basically patsies and agency spokespersons, and therefore we should ignore their criticisms. These are solid criticisms - there is no concrete proof, if you're going to make specific claims about specific products, you need evidence to support the claims. That research has not been done. That's a far more solid criticism than vague mutterings of bribery and collusion. WLU (t) (c) Wikipedia's rules:simple/complex 12:44, 15 December 2009 (UTC)
Are there any sources which discuss conflict of interest, both manufacturers of bioidenticals and non-identicals?--Literaturegeek | T@1k? 12:13, 16 December 2009 (UTC)
There is a lot of popular articles which generically assert that a) Wyeth is against BHRT and is using it's resources against them (possibly true, but they are doing so through legitemate venues such as complaining to the FDA that BHRT claims are not proven - which is true) and b) all these agencies and researchers are in the pockets of drug companies. But I am aware of nothing I would see as a reliable source making a specific claim against a specific person or agency. I think this is a red herring that should be dropped without specific sources. WLU (t) (c) Wikipedia's rules:simple/complex 12:26, 16 December 2009 (UTC)
I think that we can all agree that many dubious claims have been made about the benefits of BHRT by charlatains, so the drug companies are right to complain about that. If there was a source where the drug companies were misrepresenting BHRT against the evidence or other malpractice or misdeeds then that would be a different story.--Literaturegeek | T@1k? 10:45, 17 December 2009 (UTC)

One section at a time

Ok, I am going to try and get some sensible format to resolving this dispute with you all. What is wrong in your eyes Riverpa and Hillinpa with the introduction part of the article?--Literaturegeek | T@1k? 03:40, 12 December 2009 (UTC)

The most glaring issue, I think, is that the first sentence defines BHRT/BHT as being about menopause relief. Yet most of the article is edited as a diatribe against the compounded BHRT modality that advocates the use of hormones as anti-aging, as promoted by Suzanne Sommers, et al. Compounding. saliva testing, lots of hormones that have nothing to do with menopause. Use of hormones to maintain a specific hormone level, rather than to relieve symptoms of menopause.
There is BHT for menopause relief - it is FDA approved and prescribed by mainstream physicians every day, with possible use of compounding reserved for when manufactured products are not suitable. But you wouldn't really know that from this article.
This is a hard thing to differentiate, as WLU will not really acknowledge that it exists. He prefers to see BHRT as only the anti-aging modality of treatment, because that is what has received the most publicity, and the most written treatments from mainstream medicine, as they try to debunk the anti-aging, lifestyle use.
To say that there is a lot of confusion regarding terminology is certainly accurate, but this article does little to dispel it, and indeed, unnecessarily contributes to it.
Please keep in mind that until about 10 days ago this article did not mention Schwartz et al at all, so this is indeed an improvement.
I have added some history of the evolution of the BHRT treatment modes. I think it is written in a neutral way. There is plenty of criticism of it in the rest of the article, I do not think that there is need for criticism in the historical statement of fact. I have more stuff to add, but I want to differentiate between the Alternative medical uses and the move toward bioidenticals in mainstream medicine, which is currently under way, so there is not a lot of written documentation on it.
There are plenty of extreme references on both sides of the compounded BHRT issue. I think that the spectrum of viewpoints should be represented in this article, and that they should be differentiated, instead of just lumping everything into pro-compounded-bioidenticals-complete-with-saliva-testing, and the anti-anything-that-mentions-the-word-bioidentical. Riverpa (talk) 17:43, 12 December 2009 (UTC)
Ok thank you for replying. Can you highlight parts in the lead section/intro and say what you think should be changed, reworded and added? Then we can get WLU's comments after and aim towards consensus. I think that to begin with we should focus on what can be agreed on between both opposing sides rather than not agreed on.--Literaturegeek | T@1k? 17:49, 12 December 2009 (UTC)
Since the lede should be a summary of the entire article, it is kind of tough to start with it. But if you want a sample of the type of acrimonious editing going on, look at the history just this afternoon, the addition that I made (which I have been asking for comments on for days, and I feel was written in a neutral manner) and how it has now ended up after WLU re-wrote it and deleted half the content. He made no comments on it before I added it to the article other than copyedits. No history, no context for the concept of BHRT beyond what is in his limited vision. That is why this is so frustrating.Riverpa (talk) 23:01, 12 December 2009 (UTC)
Good point, starting with the lead would be better done last. I shall take a look but lets start with the History section.--Literaturegeek | T@1k? 23:05, 12 December 2009 (UTC)
The lead needs attention at all times, as it is the only thing most people will read, and it defines the terms and the tone of the article. At this point we have a serious problem as WLU wants to include statements from organizations saying that there is no difference between bioidentical and non-bioidentical hormones, yet exclude the statement of a comparable organization, the IMS, that progesterone is safer than progestins, and transdermal estradiol is safer than oral estrogens. There are other problems with the lead too, but one thing at a time.Hillinpa (talk) 17:19, 13 December 2009 (UTC)
Well the idea was that we would go through the article one section at a time and then come back to the lead. This dispute has been going on for months and months, what is the rush? Why not try a structured approach?--Literaturegeek | T@1k? 01:14, 14 December 2009 (UTC)
Is this the edit Riverpa today that you are disputing?[11]--Literaturegeek | T@1k? 23:21, 12 December 2009 (UTC)
That edit, deleting information without good cause is a problem since it is not WP policy to delete information without a valid reason. Not a person's opinion, a valid, citable, WP policy. Also, separating the Alternative Medicine section from the History section is a problem since it is a sub-section of the History section, and is part of the history. This information is fact, not opinion. It is historical, but WLU wants to treat it as medical opinion. He may not like the quality of the references, but they are not being cited as medical policy, they are being used as historical documents and need not rise to the level of research citations. They are simply describing historical opinions and statements. I am still working on the mainstream medical history, so I put the Alt Med section header in, but since it has proved to be a problem I have now removed it. Riverpa (talk) 06:01, 14 December 2009 (UTC)
Well it is specific health unproven health claims by a single person which have not been put into context; the context from what I have read is that there is no scientific evidence for most or all of those health claims. This is a medical article as well, so sourcing and context of health claims is very important, if they are bogus claims then it should be cited that there is no evidence or else has been proven to be false etc. As you know these bioidentical hormones are therapeutic drugs/substances, so listing unproven even dubious uses is not warranted unless they are put into context. I think that if they are not put into context then WLU's edit should stand. We should not be listing dubious claims of uses (which may have been made by a charlitan many years ago simply to make money) for bioidenticals which can have potentially significant adverse effects, just like the non-identicals.--Literaturegeek | T@1k? 10:14, 14 December 2009 (UTC)
If the paragraphs were still part of the History section, which they were written as, and still had the heading of "Alternative Medicine use" which they were written under, then they would be in context. It is not rational to remove them from context, and then complain that they are not in context. They state "claims", they state "promoted", they describe "proponents": all of these are referred to and contested in the rest of the article. What this article has lacked is the actual claims made by the proponents of the therapy. —Preceding unsigned comment added by Riverpa (talkcontribs) 13:39, 14 December 2009 (UTC)
I put in a disclaimer to the only statement that had any possible interpretation as an endorsement and didn't already have a disclaimer, though I think it is overkill, since the whole "Criticisms" section is a counter to the bioidentical claims. But I changed it. Riverpa (talk) 15:43, 14 December 2009 (UTC)
Stating what claims have been made by early bioidentical advocates is perfectly objective. It would not be objective if one attempts to endorse those claims. For instance,notice how this article blatantly endorses anti-bioidentical claims throughout, even claims that are obviously false and contradicted by facts. For instance the article begins with the scientifically clear and unambiguous definition of bioidentical hormones as molecularly identical to endogenous hormones, but then quotes all the propagandists who claim that "bioidentical" has no meaning, is a marketing term, etc. This makes the article completely confusing and non-sensical. The article repeatedly claims that there is no evidence supporting bioidenticals--progesterone and estradiol--over non-bioidenticals when in fact that are many reviews and primary studies that show superiority for bioidentical molecules.Hillinpa (talk) 12:16, 14 December 2009 (UTC)
Thank you for your response and views. I am honestly trying to listen to all people's views objectively. You say that there are reviews, why not list them? Also can you take a look at the above section where I posted a review and suggestion. You are continuing to make controversial edits when you have someone (myself) trying hard to find some sort of consensus and middle ground. Can you and other editors be a bit more relaxed in editing while we are working this out?--Literaturegeek | T@1k? 12:22, 14 December 2009 (UTC)

Undent. Without a firm medically reliable source, specific health claims should not be made, and further there is no need to specify exactly what conditions he believed to be caused by "estrogen dominance", which has no mainstream medical use that I've been able to find. What advantage does the page have by listing five specific conditions alleged to be caused by something most doctors don't believe in? I fail to see how this helps the page. WLU (t) (c) Wikipedia's rules:simple/complex 21:30, 14 December 2009 (UTC)

You don't need a valid medical source to state what claims were made for a product, when you are refuting the claims elsewhere in the article. You do need some discussion of the actual claims being made, by whom, and in what context, not just as an intro to their refutation. More detail is preferable according to WP, which requires a reason before deletion of valid information that contributes to the article. You have no such reason.
The information that they made the claims is a fact, not a medical opinion, and is presented as such. The Acupuncture article has a three column list of indications for the which the use of acupuncture is unproven. If that is valid per MEDRS, why is not a list of a few items here?
Oddly enough, estrogen dominance has an article in WP. I was not under the impression that WP was a bastion of only mainstream medical opinion. I thought it was an encyclopedia.Riverpa (talk) 22:25, 14 December 2009 (UTC)
Encyclopedia gives weight according to the mainstream medical opinion, an essential point of WP:NPOV. If estrogen dominance has only popular, and no scientific support, it's dubious to include it. We are also supposed to summarize scientific consensus and assess quality of claims - if only popular books claim estrogen dominance exists, and there is minimal or no serious scientific scrutiny, it should not be a substantial area of focus. We're also supposed to use up to date evidence and use independent sources. From what I've seen, estrogen dominance fails all of these, and should carry minimal to no weight. Where did Lee publish his ideas? Was it university press? Peer-reviewed? Or popular? I've searched for estrogen dominance in various scientific sources and found virtually nothing. Certainly nothing to demonstrate that it is widely used by doctors. Claiming "estrogen dominance" causes fibroids, cancer, etc. places too much emphasis on a) estrogen dominance existing, and b) that it actually causes these problems. Where is the evidence? Where are the peer-reviewed articles? Or is it just a doctor going on his own experience, and not bothering to publish in scientific venues? The level of detail on a nonnotable, fringe practitioner, non-researcher's belief system is not necessary. WLU (t) (c) Wikipedia's rules:simple/complex 00:11, 15 December 2009 (UTC)
Riverpa acupuncture is not a medical article so it is not a good comparison.--Literaturegeek | T@1k? 10:59, 17 December 2009 (UTC)

History

Lets start with the history section. Is there anything wrong with it in your opinion Riverpa?--Literaturegeek | T@1k? 23:05, 12 December 2009 (UTC)

The information re-added in this diff is problematic. Many of the sources in the section are not great but the claims they are sourcing are not outrageous so that's OK. The level of detail about non-notable practitioners is excessive. John Lee is a GP, he's not a researcher. He invented the term "estrogen dominance", which I don't believe has any mainstream credibility. He has published it looks like primarily letters to the editor, and one article in the essentially worthless Medical Hypotheses. He hasn't proven his theory that "estrogen dominance" has contributes to breast cancer, fibroids, fibrocystic breasts, premenstrual syndrome, osteoporosis, and other conditions and only made these claims in popular books, not in scientific literature. He also made the claim that saliva testing was useful in the dosing of hormones, which many sources consider without merit. And the section finishes off with the statement "...bioidentical progesterone has been proven to have fewer detrimental effects than some synthetic progestins, (a medical claim) there is no research to support these additional claims." So why are we mentioning it?
Next the section discusses Johnathan Wright, who claims hormones can extend the lifespan (without evidence, sourced to a non-scientific alternative medicine magazine - which is sourced twice on the page). The section also spends a lot of time on the credentials of both people, which both adds undue credibility to their anecdotes (Boothby and Doering are both published researchers, yet we don't add their qualifications and education to their names - and we don't need to. They are either a reliable source, or they are not). Next we mention specific bioidentical products for sale, sourced to a sales site, written by Wright himself, in which he plays the "Wyeth controls the world and kills women to make a profit" card. This is followed-up by a specific claim about bioidentical hormones which should be elsewhere in the article - probably uses. WLU (t) (c) Wikipedia's rules:simple/complex 13:13, 15 December 2009 (UTC)
This is the history of this treatment methodology. This is how it evolved over time. How do you write an encyclopedia article without the history? I know that you think that compounded BHRT began with Suzanne Sommers, post WHI, but it did not. The current popularity is due to a confluence of several factors, building on the foundation that these two practitioners (and probably others) provided. "Estrogen Dominance" was the original concept that Lee came up with that he used bioidentical hormones to treat. The fact that he is a family practitioner is germane since it indicates that he is not a specialist or researcher, and is allowed because he is a minority opinion per whatever WP policy I referred you to before. Boothby et al are part of the mainstream opinion and do not warrant credentialing because they have the back-up of the entire medical establishment. I know you don't like their unproven claims, but why do you think I used the word 'claim' after warning you off of using it for Schwartz et al? Both Lee and Wright have been mentioned in some of the mainstream research articles as progenitors of various facets or theories of this therapy, should I try to dig out those ref's to make you happier? Wright is claiming anti-aging benefits for this therapy, which is probably where Sommers, Wiley, and others picked up the idea. If you're going to discuss the whole compounded BHRT concept don't you have to discuss what they are claiming before you can refute it by saying there is no evidence? Even the lede does not indicate the anti-aging claims and they are very much a factor in the whole compounded BHRT theory. The lede says menopause therapy only, while anti-aging is not restricted to menopausal women, but is directed at basically everyone over 30.
I would like to present a continuation of the history, including the impact of WHI and the Sommers books, which might indicate the perfect storm that led to the popularity of this treatment, but I doubt that you would tolerate that.
Another similar article is Atkins Diet, which has an extensive history section and explanation of the medical ramifications of the diet, though it is also very controversial.
What you really don't get here is that I am not a proponent of compounded BHRT. See WP:ENEMY. But there is this article, about this topic, and it deserves to be treated in a manner that does not immediately scream "biased" to whoever reads it, which was the case 2 months ago when I turned to it for information. It required me to do my own research to get the information that I had hoped to find in this article, and since I have done it, I may as well share it so no one else has to go through the same process that I did. It also impacts on the credibility of WP as a whole if an article is not encyclopedic. Riverpa (talk) 15:24, 15 December 2009 (UTC)
I don't mind history, but I don't think we need a lot of details on the beliefs of individuals who had minimal weight on how medicine is conducted and who only published popular books (and the odd letter to the editor). I don't think Lee and Wright's opinions should be removed, but they don't need a fine-grained documentation when there is no evidence that they had a point. Using popular press and direct-to-customer publications you can cite a lot of stuff, but it's trivial if it didn't have an impact until, say, the WHI. Further, if Lee's ideas on estrogen dominance never reached the mainstream, it's hardly worth a mention or a wikipedia page. Therefore, either not worth mentioning, or only worth a very brief mention. The policy you are looking for is WP:UNDUE, which says in general minority views don't get as much detail as the majority view. This is a history of a minority view. How much detail should it get? Please review WP:UNDUE, it has a huge bearing on this page. I would certainly be happier if you could reference this section with more emphasis on peer-reviewed articles, because they also give context regarding the majority viewpoint - for instance, Cirigliano discusses Lee but criticizes his use of saliva testing. Fugh-Berman discusses Lee, in the context of progesterone being a panacea and specifically refers to his books as "popular". Boothby 2004 also discusses in reference to saliva testing only. Rosenthal 2008 also discusses Lee briefly, as pioneers and for 'estrogen dominance', with scare quotes. I've searched through all my sources and that's it, including Schwartz & Holtorf and Moskowitz, which are pro-BHRT. So, why do we give so much emphasis on specific details when scientific papers virtually fail to mention him, and do not actually address his points in detail? And if mainstream practitioners don't believe BHRT has an anti-aging effect, why give it more than a bare mention? I was certainly surprised to see it come up. I don't think the history section needs to be long, particularly since these ideas were so fringe for so long, right up until it hit Oprah and the popular imagination. The history is still being written, it's not yet complete.
A question - how much emphasis do you think should be given to the proponents' perspective, when they get almost no scientific press and certainly carry minimal credibility among researchers? The reason there are so many societies, agencies and regulators against BHRT is because they do not believe there is evidence to substantiate the claims. Who should carry weight on the page, the individual doctors who claim miracles, or major agencies? Why should those individual doctors be portrayed as equivalent to the many critical researchers (and actual researchers, who are employed at universities doing research rather than simply working in a private clinic) and national and international bodies comprised of thousands of researchers? WLU (t) (c) Wikipedia's rules:simple/complex 20:00, 15 December 2009 (UTC)
Look at A4M - this version [[12]] which is after Tim did a massive revision on it, for reasons I will not speculate about here. I am sure that Tim was striving for due weight, and this is a topic with even less credibility than BHRT. He does make it a point to explain the beliefs, activities, and publications of the organization. There is far more actual information about their organization in that article than there is about BHRT in this article. If you are talking about an outsider with a view on BHRT I can see not giving weight to their arguments - for example, if the founders of A4M had strong views about BHRT, who cares? - but what I am trying to write about here are the actual creators of BHRT, much as Tim quotes the founders of A4M, and their goals and beliefs, without which there would be no article at all.
To me, the best argument can be made against something only if all of its strengths and weaknesses are laid out and acknowledged. If you don't make as strong a case as you can for the opposition, no one will believe in the strength of your argument against them. Riverpa (talk) 04:33, 16 December 2009 (UTC)

I have done extensive pruning of sources and text. This was cited to commercial supplement sites and even an off-shore pharmacy annd other terrible sources! That is some of the worst citing that I have seen on wikipedia. I hope that no one here was adding citations to off-shore pharmacies, that can be considered spamming. I also removed qualifications and titles from infront of their names. Let me know if there are any remaining problems in the history section, if not then lets move on to the next section.--Literaturegeek | T@1k? 13:10, 16 December 2009 (UTC)

Regarding credentials, and titles, I refer you to WP:MEDMOS which says "Do not hype a study by listing the names, credentials, institutions, or other "qualifications" of their authors. The text of the article should not needlessly duplicate the names, dates, titles, and other information about the source that you list in the citation. Always omit professional titles and academic degrees. It is necessary to specifically include such information only when a specific individual is being cited as an example of a person holding a minority view: You might write, "The AIDS Denialist Society says that HIV is entirely harmless", but just use a plain statement for the widely accepted fact, "HIV causes Acquired Immune Deficiency Syndrome." The individuals cited are certainly in the minority view, and as such should have their credentials restored to the article, as I already settled with WLU. Riverpa (talk) 18:29, 21 December 2009 (UTC)

Is this what all this dispute at least in the history section has been about, text cited to off-shore pharmacies and commercial supplement sites? We do not reference non-peer reviewed commercial sites (including drug companies) due to unreliability, COI; third party sources are needed preferably secondary sources.--Literaturegeek | T@1k? 13:13, 16 December 2009 (UTC)

@Riverpa - that article gives due weight to the mainstream opinion that the claims made by the AAAAM are bogus. That's good, and the AAAAM article spends a lot of time on this. But BHRT is not a specific "thing", it's a disparate collection of unsupported beliefs and theories. Our best sources therefore are the mainstream medical journals that discuss and refute these. BHRT is an idea (or set thereof), and one that has clearly found wanting. Would you prefer to put in place a series of quotations from these authors demonstrating that BHRT is thought to be a series of baseless assumptions and bad science? There are a lot of articles that state this, and a lot of statements from various agencies and representative bodies that back this up. The claims for BHRT can be summarized relatively easily, and also easy is demonstrating that most researchers and authoritative organizations don't think there is merit to them.
Laying out "strengths and weaknesses" only works when there is a serious debate within a scholarly community that there are two positions. That doesn't seem to be the case here - BHRT is seen by the scholarly community as unfounded, unsupported, unresearched and lacking the proof necessary to make positive claims. It's like arguing evolution should "teach the controversy" over creationism, or AIDS denialism should "talk about the flaws in the research on HIV" (not that extreme though, perhaps it is closer to the MMR vaccine and autism). There are flaws, there is controversy in HRT, but it's not about BHRT, it's about what the best science has to say. By putting the claims made for BHRT on the same plane as people who say it has no evidence base, the article gives the impression that they are on the same evidence base. They are not, CHRT has risks and benefits that are continually being studied, discovered and reported. BHRT has a bunch of claims made by a bunch of popular authors and practitioners who are not seen as leaders or experts in the field who do not do actual research on these claims but make them anyway. Where is the parity there, and where should it be?
@Literaturegeek - I would say that it's a good-faith effort to improve the page, but agree that the sources are not sufficient for any strong claims and would be much better supported if solid sources could be found. I would say that the sources are part of (and indicative of) the issues with that paragraph, but also included is basic issues of summary style and due weight. I don't object to the skeleton of the information, I object to the level of detail about tangential issues (like exactly who Lee and Wright are) and the specifics of their claims (i.e. you left in Lee's birth/death dates, and what he thought estrogen dominance did - I would remove both of those, and move the final two sentences about what and why BHRT practitioners recommend to a different section. Probably uses or administration). For me, it's a matter of experience with sourcing, style and a wide variety of pages leading to very different expectations from at least myself and Riverpa/Hillinpa. WLU (t) (c) Wikipedia's rules:simple/complex 13:23, 16 December 2009 (UTC)
The article first and foremost explains what A4M is, believes, promotes, and what its history is, directly quoting the founders when necessary, even though there is no evidence to support their claims. Again, I ask, how do you write an article about something without explaining what it is? Of course, the claims are then refuted, but first it states what they are. Kind of hard to write a respectable article without explaining the subject of the article. Please explain to me how A4M is different in its "thingness" to BHRT, and why A4M deserves a description of its unsupported beliefs while BHRT does not? And why, if the term BHRT is so disreputable, the IMS is defining it in its postgraduate monograph as "BHT is principally a construct within conventional HT than can usually be fulfilled by the use of existing commercial products that are familiar to all practitioners."? Riverpa (talk) —Preceding undated comment added 19:07, 21 December 2009 (UTC).
Ok, it was good faith, we all make mistakes I suppose. I hope we all agree that those refs, supplement and off-shore pharmaceutical site can't be used as sources. I have done another couple of edits which you may want to check out. I don't mind one way or the other leaving in the specific claims as long as they are put into their historical context. See my edit to see what I mean. Feel free to tweak or reword. :) If anyone has further comments feel free to make them or else if everyone is happy then we can move on to the next section. I don't think that anyone is going to be completely happy with the end result, so we should all be open to consensus and middle ground for difficult issues.--Literaturegeek | T@1k? 13:55, 16 December 2009 (UTC)
Interestingly, the article by Vance appears to be in a non-pubmed indexed journal; I don't see it as problematic right now, but it would restrict its use in other areas.
Estrogen dominance is currently not linked, but it has an article (and is a non-mainstream concept) - I'm OK with linking to it provided it has a caveat (provided by Fugh-Berman 2007) but I'd still like to remove the specific health claims that it contributes to breast cancer, etc. attributed to Wright. Wright is also mentioned in Cirigliano, and that particular article points to problems with his formulations and research, mentioning Tri-Est in particular. And apparently Tri-Est's basic science is both not peer-reviewed, and disagrees with other studies on the topic (and no follow-up was performed). WLU (t) (c) Wikipedia's rules:simple/complex 15:33, 16 December 2009 (UTC)
Ok, I have wiki linked estrogen dominance and agree that it is not an accepted belief by mainstream medicine. I don't mind removing the specific health claims but the other two editors oppose this happening from what I gather and it is cited to a reliable source, so I don't want to be the one that forces consensus or goes against it in such a situation. Feel free to expand the history section with the sources, Fugh-Berman 2007 and Cirigliano.--Literaturegeek | T@1k? 10:34, 17 December 2009 (UTC)
WLU in the diatribe above repeats his claim that "BHRT is seen by the scholarly community as unfounded, unsupported, unresearched and lacking the proof necessary to make positive claims." What does WLU mean by "BHRT"? Whatever WLU wants to mean apparently. He's certainly not referring to BHRT as the use of bioidentical molecules, because the International Menopause Society says that progesterone may be safer than progestins and that transdermal estrogens are safe than oral estrogens. This statement by a major organization have been repeatedly removed from this article by WLU. WHY? The statements are based on evidence. A review by top experts in Europe that concludes that progesterone does not have the breast-cancer promoting effect of many of the progestins.[13] The IMS opinion on transdermal estrogen is based upon several review articles that conclude that transdermal estradiol does not increase blood clotting like oral equine estrogens or ethinyl estradiol[14]. Scientific articles support the idea that much of the increase in DVT's,[15] strokes, and heart attacks[16] seen with conventional oral HRT can be avoided by using estradiol via the transdermal route, which is just what most BHRT practitioners prescribe. So there is a great deal of evidence, there are review articles, and there are statements from a major organizations supporting the idea that bioidentical HRT is safer than PremPro--the primary CHRT medication. So WLU is simply lying when he persistently claims that there is no evidence supporting greater safety for BHRT. WLU has been repeatedly confronted with this evidence, and offers a dizzying array of rationalizations to evade the facts--too tedious to repeat here. The fact remains that if BHRT means using the bioidentical molecules, as this article defines it at the start, then WLU is working hard to misrepresent the state of the evidence and assure that this article does not acquaint the reader with the truth about bioidentical hormone replacement. Is there a Wiki policy against lying? What do we do with such an editor? WLU's lying and evasion have meant that thousands of words have been written in this discussion to no avail whatsoever. If there is no way to remove such a biased, dishonest editor, can we replace the POV tag with a skull and crossbones so readers know that it's a toxic info dump?Hillinpa (talk) 13:08, 17 December 2009 (UTC)
Again, those sources do not refer to those molecules as bioidentical and would require us to ignore the specific statements about BHRT in favour of articles that don't use the word at all. They also are speaking about individual compounds, not about the hormones as a class and specific administration routes. This would require us to decide what an "appropriate" definition is and redirecting the page to talk about what we think bioidentical molecules are and what they mean. This requires considerable original research, undue focus on the minority opinion and results in the promotion of bioidentical molecules rather than a representative discussion of how they are viewed by the scientific community. Even articles that are specific about BHRT referring to compounded bioidentical molecules do not say that noncompounded molecules are superior, and those that address specific claims about specific molecules (i.e. Cirigliano and Boothby) point to the evidence being less clear-cut than could be portrayed.
Specific references about specific molecules should go into specific wikipedia articles and should not be synthesized to come to a new conclusion. And we certainly shouldn't be playing 'dueling sources' to determine on our own basis whether all (or even some) bioidentical molecules are good, or all (or some) bioidentical molecules are bad by choosing which sources are "good" and which are "bad". WLU (t) (c) Wikipedia's rules:simple/complex 13:45, 17 December 2009 (UTC)
Ugh, this is a tough dispute to resolve. :) Hill how are you determining that progesterone is bioidentical? Hillinpa, for the method of administration, i.e. transdermal being a safer method, would this not be more relevant to hormone replacement therapy article? A question, are there no FDA approved versions of HRT that are transdermally administered? Is this unique to bioidenticals? WLU, if you read the benzodiazepine article which is GA status, it does discuss different benzodiazepines, eg lorazepam, diazepam, chlordiazepoxide and so forth. It does so because these are benzodiazepines. Are you saying that progesterone is not bioidentical or not universally accepted as bioidentical? How does this article and review papers and the likes of the FDA determine what is bioidentical?--Literaturegeek | T@1k? 18:57, 19 December 2009 (UTC)
Check the Cirigliano article to validate bioidentical progesterone - there is a table in it that lists all the bioidentical hormones. Check Fugh-Berman for definitions of progestins, progestogens, and progesterone. Transdermal use is characteristic of bioidentical compounding, it was promoted first by Lee, I think. Creams are not regulated by the FDA, they are considered cosmetic use - Gee wouldn't it be great if all this info was in the article? Riverpa (talk) 18:46, 21 December 2009 (UTC)
Notice the WLU simply skirted the issue again--the issue being that one cannot say "there is no evidence" that BHs are superior to non-BHs when such evidence exists--no matter where one needs to look to find that evidence. IF it exists, and we know it does, then saying it does not exist makes one a liar. It's that simple. WLU's arguments about articles containing the word "bioidentical" is a ruse. It's complete nonsense at all levels. He even has Boothby quoting studies on estradiol and progesterone that never mention the word "bioidentical". The "scientific community" includes the International Menopause Society and those specialists who have published papers on the greater safety of progesterone c/w progestins and transdermal estradiol c/w oral estrogens, does it not? Doesn't the minority view deserve a hearing in this article too? Apparently not according to WLU. Go Figure.
Progesterone is bioidentical--no matter what product it is in. If you don't know that then I guess we must say that WLU has done his work well. Transdermal is definitely the safer method for estradiol, and BHRT docs generally, and any smart docs, will favor transdermal estradiol. So not all HRT is alike--but WLU doesn't want anyone to learn that from this page. Yes there are FDA-approved transdermal estradiol products (patches and gels) and any intelligent BHRT doctor is happy to use them if they are affordable for, and work well for the patient (see the book "Natural Hormone Balance" by Dr. Uzzi Reiss for an intelligent discussion of all issues by an experienced BHRT practitioner). Many medications are better delivered transdermally as whatever is swallowed is subjected to stomach acid and the first-pass effect--where the liver receives all the blood flow from the intestines and may metabolize the hormone or drug in an unwanted way. Swallowed estrogens cause all kinds of problem due to their strong effect on the liver.
"Bioidentical" is just as defined in the first sentence of this article--as having the same molecular structure as the endogenous, natural human hormone. Estradiol and progesterone produced in chemical factories aren't just bioidentical, they ARE human hormones as there is no chemical difference between them and human hormones. They are the same and they work exactly the same as a woman's hormones once in the body. Again, WLU is the one trying to suppress the super-simple, perfectly clear scientific meaning of "bioidentical" and make everyone think instead that BHRT is a package deal of untested practices, and thus a load of crap [[17]]. The article should deal with both issues--the scientific evidence regarding the bioidentical hormones, estradiol and progesterone, in all forms, and the controversies surrounding some BHRT practitioners and the pharmacies that make compounded forms of estradiol and progesterone. The problem that this article has is simple: It it cursed with a biased editor who will edit out anything, and resort to any rationale or subterfuge to serve his purposes. For one year myself and other editors (QuizzicalBee, Riverpa)have argued with WLU to no avail. WLU will not listen to reason. Hillinpa (talk) 00:08, 21 December 2009 (UTC)
I am concerned about the substantial number of objections to BHRT as demonstrated by NAMS, ACOG, FDA, Harvard Medical Watch, the Mayo clinic and other governing bodies having their warnings ignored in favour of the citation of individual studies (particularly non-review articles) about individual hormones being massed together to push the conclusion that the FDA, ACOG, NAMS, etc. are wrong. And I have long said that there is no reason to treat bioidentical hormones as a universal class when doctors treat them as a series of different compounds that must be combined, dosed and administered according to the unique profiles rather than classed as a group. In other words, doctors don't seem to believe that bioidentical hormones are identical to those in the body, therefore they are harmless. Cherry picking studies and painting all endogenous hormones as harmless and beneficial when it is very obvious that this is not the mainstream opinion, is very much against WP:OR in my mind. My other concern is the use of these primary studies to promote the use of bioidentical hormones, again despite the significant number of critical statements by good, medically-reliable bodies. Progesterone is one of a multitude of hormones produced by the body, but it is used at a variety of doses, through a variety of administration routes - some of which modify hormones. So a statement about how progesterone is better than X nonbioidentical hormone is a very tricky proposition. Is it? Has it been directly compared? Is it better via all administration routes? Is it equally studied? Is it used alone, or in conjunction? Should we be qualifying discussions with "bioidentical progesterone must be used in conjunction with other (bioidentical?) hormones to avoid proliferation of the endometrial lining"? How far do we go with this before we become a bioidentical how-to manual? Whould we really be trying to demonstrate (i.e. "prove") that NAMS, ACOG, the FDA, the Mayo clinic, etc. are "wrong", or that they're only talking about compounding and therefore noncompounded bioidentical hormones are "right"? How do we go about doing this without breaking WP:OR, WP:NOT, WP:SYNTH, WP:COAT and WP:NPOV like twigs across our knees? And how much are we creating a controversy where really there isn't one? Are serious doctors and researchers really spending their time fighting over how good BHRT is? Or is it popular accusations of "conspiracy" and journals being nothing but drug company media mouthpieces that are creating the impression of controversy when in the actual research and medical communities, there is none? WLU (t) (c) Wikipedia's rules:simple/complex 16:07, 22 December 2009 (UTC)

undent You are concerned about all the objections to BHRT - but these institutions only object to the "package deal" BHRT, which is the only one you will acknowledge, and you cherry-pick their objections by your choice of articles and your citations within articles. No one is treating bioidentical hormones as a universal class, and I don't know where you got that impression so stop citing it until you can point to a reference. There is some evidence that shows bioidentical hormones as preferable to non-bioidenticals. Some is all it takes. Where has anyone in this discussion painted all bioidentical hormones as harmless? Where has anyone indicated that any hormones are harmless? Please indicate or stop throwing accusations around.

I am afraid that your "strong offense" is not providing a very good defense. As far as whether progesterone is better than x hormone - well, we just re-state what the source says. Not hard, no one speculates about doses and routes of administration. Please stop setting up roadblocks and allow other people to get on with creating an article that actually has some unbiased information in it. Your repetitive wiki-laywering is tiring. Open your mind to what the rest of the research says, not just your oft-cited Boothby. Open your mind to the idea that the meaning of the term "bioidentical" has shifted with popular use and now encompasses more than you want it to.See IMS, and what they have been teaching in their post-graduate course for over two years. Riverpa (talk) 18:42, 22 December 2009 (UTC)

Question - do those agencies say BHRT is fine if the compounding and saliva testing were removed? WLU (t) (c) Wikipedia's rules:simple/complex 19:20, 22 December 2009 (UTC)
Of course they all do---How can you have failed to have noticed that? It's right in the intro. to this article! The standard line from all the US organizations quoted is that FDA-approved bios are expected to have the same risks and benefits as FDA-approved non-bios. They hold--as good partners of the FDA must--that all FDA-approved HRT products are ALIKE. It is a blatant falsehood. See the IMS statements and review articles I've previously linked.Hillinpa (talk) 18:38, 24 December 2009 (UTC)

Regulatory status in the United States

Lets move on to another section. What is wrong with this section? Views please. :)--Literaturegeek | T@1k? 15:13, 16 December 2009 (UTC)

Ok so no problems or yes there are problems?--Literaturegeek | T@1k? 18:59, 19 December 2009 (UTC)

Some random points about this section, for possible honing:

  • Internet should be capitalized, should it not?
  • Should there be a comma after "...misleading by the agency"?
  • The FDA references change tense a few times; would suggest they should be past tense, as we are talking about a response that was published in Jan. 2008.
  • The FDA citation in 24 also refers to only 7 compounding pharmacies, and does not ever imply that it ruled in favor of Wyeth. For some further background, I looked around the FDA website and found this official response from the International Academy of Compounding Pharmacists: [18]. It is worth reading for a very different perspective on this controversy. Should it be included/mentioned?

(It is also interesting to note that FDA has found no problems with any BHRT drug since the two in 2001.)

  • It is important to note that with so many doctors and patients using BHRT, some kind of standards for nomenclature and procedures should be a top priority of everyone involved. This might be a case where the compounding pharmacists should be expected to self-regulate, in lieu of further attack. To investigate whether they had done that, I visited their website, and did find a section on self-regulation, but it did not mention BHRT specifically. Maybe since this is a speculative comment it's not appropriate for the article, though.
  • I know we all say "The FDA," but since they call themselves simply "FDA" shouldn't the article reflect this?

Leha Carpenter (talk) 17:59, 22 December 2009 (UTC)

This section contains nothing about the FDA-approved bioidentical products on the market. What it does cover is the controversy over compounded BHs' regulatory status in the US. Maybe that content should be relocated to "Controversies"? Each component of compounded BH is regulated somewhat differently, and this section also shows none of that. Testosterone is not approved for women, yet mainstream physicians are using it off-label for them. DHEA is OTC, as are some hormone creams, considered cosmetic by the FDA. No indication of that, either. Estriol is currently banned by the FDA, though this is very recent, and it has been used for decades with no problem.(another controversy). The compounded product of the pharmacies is nominally regulated by the FDA, that is how we got those sampling tests in 2001. The pharmacies themselves are regulated by individual states.
So, there's lots of info to be put here, and none of it is in the article, not for lack of trying by some of us.
I think "the FDA" is fine, we talk about "the Fed" "the Whitehouse", "the OMB", etc. Can't account for their idiosyncracies, next thing they'll refuse to use the term bioidentical or something.  :-)
There may be little news about the compounding pharmacists vs the FDA because, last I heard, it might be headed for the Supreme Court. States are concerned that the FDA is trying to encroach upon their authority over pharmacies within their states, which the states regulate. Also, there seems little justification for the FDA withdrawing estriol from the market. No other USP preparation has received this treatment without having been shown to be dangerous in the marketplace. All controversial, so what goes in Regulation, and what goes in Controversies? Riverpa (talk) 19:22, 22 December 2009 (UTC)
I have no problem mentioning products approved by the FDA that have bioidentical components - this is done in an above section but it would be worth repeating (particularly if it comes from the FDA itself). I've added, sourced to Harvard but there are more detailed tables and break-downs available.
The section reads OK to me, everything is sourced to the FDA or a journal article. Some of Riverpa's concerns (existing, approved products; estriol; state regulation) are covered either in the section or elsewhere in the article. I would suggest keeping information about estriol's safety in another section, as this section is specifically about the US and in the US it is banned (not because it is not safe, but because safety has not been adequately demonstrated - there's a difference, in order for the FDA to approve medication it must be proven to have a good risk/benefit ratio). Irrespective of whether the FDA was justified in removing estriol, the fact is it did remove it, and we have the reasons why in the article - it's considered untested. I haven't added much on testosterone or DHEA because most of the sources don't really single them out, though there is some bits and bobs. Again, part of the problem is that BHRT is often considered synonymous with compounding, when if the definition is strictly applied, it almost doesn't exist as there are bioidentical products already available as part of CHRT. In that case, BHRT becomes solely about compounding and the rest of the claims belong in the specific articles. WLU (t) (c) Wikipedia's rules:simple/complex 17:03, 23 December 2009 (UTC)
Your knowledge of FDA practice is way off - as many have noted, if aspirin was to come to market under today's rules, it would not be an OTC drug. Estriol was grandfathered in along with many other products when current rules were enacted, and it did not have to prove its safety, and the FDA never had to approve it. Please stop making stuff up.
If you want to make this BHRT article solely about the compounding, do it, and I will not object. Then we will remove it from Medicine, and we will not have all the restraints about medical sourcing, etc. So please, either stop trying to push this definition on everyone else, or accept the alternative. Just stop the constant insistence about this point unless you are prepared to make the change, otherwise, stop repeating it over and over . Riverpa (talk) 05:49, 25 December 2009 (UTC)