I've requested the following from TimVickers. I've struck through the ones I got, and am trying to find the rest.
Burrell, BA "The replacement of the replacement in menopause: hormone therapy, controversies, truth and risk." Nurs Inq. 2009 Sep;16(3):212-22. PMID19689648
Mahmud K. "Natural hormone therapy for menopause. Gynecol Endocrinol. 2009 Dec 8. PMID19995152 This is a single practitioner's non-randomized, non-controlled, non-blinded, non-placebo mass case study. It is inappropriate for use as a primary source in addition to being a terrible, terrible "experiment".
Douma SL, Husband C, O'Donnell ME, Barwin BN, Woodend AK. "Estrogen-related mood disorders: reproductive life cycle factors." ANS Adv Nurs Sci. 2005 Oct-Dec;28(4):364-75. PMID16292022 Got it
Francisco L. "Is bio-identical hormone therapy fact or fairy tale?" Nurse Pract. 2003 Jul;28(7 Pt 1):39-44 PMID12861094 Got it
Watt PJ, Hughes RB, Rettew LB, Adams R. "A holistic programmatic approach to natural hormone replacement." Fam Community Health. 2003 Jan-Mar;26(1):53-63. PMID12802128 Got it
Curcio JJ, Wollner DA, Schmidt JW, Kim LS. "Is Bio-Identical Hormone Replacement Therapy Safer than Traditional Hormone Replacement Therapy?: A Critical Appraisal of Cardiovascular Risks in Menopausal Women." Treat Endocrinol. 2006;5(6):367-374. PMID17107222[20]
Wright JV. "Bio-identical steroid hormone replacement: selected observations from 23 years of clinical and laboratory practice." Ann NY Acad Sci. 2005 Dec;1057:506-24. PMID16399916 Got it
Adams C, Cannell S. "Women's beliefs about "natural" hormones and natural hormone replacement therapy." Menopause. 2001 Nov-Dec;8(6):433-40. PMID11723417 Got it
Cicinelli E "Bioidentical estradiol gel for hormone therapy in menopause." Expert Review of Obstretrics and Gynecology, Volume 2, Number 4, July 2007 , pp. 423-430(8) [21], not pubmed indexed?
Sites, Cynthia "Bioidentical hormones for menopausal therapy" Women's Health, Volume 4, Number 2, March 2008 , pp. 163-171(9)
M Lam Po, GWY Cheung, DT Shek, DTS Lee "Bioidentical hormone therapy: a review" Menopause, 2004 (need more details)
Taylor M "“Bioidentical” estrogens: Hope or hype?" Sexuality, Reproduction and Menopause vol 3, issue 2, 2005, p. 68-71 doi:10.1016/j.sram.2005.09.003
By using the search term "bio-identical", more sources came up including several new review articles. I will pass them along to anyone who is interested. WLU(t)(c) Wikipedia's rules:simple/complex13:48, 15 December 2009 (UTC)
Estradiol, CE, and ethinyl estradiol (EE) (bioidentical, natural, and synthetic, respectively), all appear to offer similar benefits and harms, with none faring better or worse than the others.34 The one caveat is that head-to-head comparisons of different estrogens are lacking because most studies involved comparisons with different coadministered progestogens. This recognized need should serve as impetus for further clinical trials. Nevertheless, there appears to be little sound scientific rationale or support for the most common mixture of ratios of estrogens in biest and triest or for any other customized ratios based on sera levels, as there are no sensible means of monitoring or ensuring that they are maintained (from hour to hour and day to day), and, most importantly, there is no proven physiological benefit in doing so. Although estrogen levels decrease during menopause due to loss of ovarian function, estrogen clearance rates are not significantly changed.128 The simple use of either estradiol or estrone will cause elevated levels of estriol.124 The addition of further estrogen metabolites (estrone and estriol) in an ad hoc compounded mixture containing estradiol, based on saliva or sera estrogen levels, in an effort to provide a theoretical ideal ratio seems futile because the exogenous estradiol and estrone fractions are subject to metabolism at different rates.32,129 It would make more sense to provide sufficient amounts of estradiol alone and then allow the woman’s own metabolism to provide for the
other estrogens. Therefore, the claim that no pharmaceutically manufactured product mimics the body’s production of estrogens other than such compounded products as triest and biest74 not only is unproven but also is highly unlikely to be the case. (Cirigliano)
Hi: I can see you are all working hard to make this a better article, and I commend your efforts. However, when you've finished with the major battles, it seems like it could really use a "cohesiveness" edit, to correct faulty sentence and paragraph structure, centralize the logic for the topic of each paragraph/section, and so forth. I would be happy to jump in there and try to do some of the basic structural stuff, but would not feel comfortable messing with the logic, since I can see most of it has been extremely contentious. (In other words, I'm not here to just criticize all the work you all are doing and not offer help, but I'm no "expert" (-: on the subject matter, and don't want to step on toes.)
Also, in the interest of really understanding the topic, wouldn't it make sense to reduce the number of citations from the one source (Boothby) to balance more with other sources? (Or at least supplement those refs with others?) I'm not sure why the article leans so heavily on one paper, and especially one that is, by the author's own admission, a position of belief (unless there is just no other article out there qualified to speak on any of the many sub-topics). It kind of makes me question the unbiased stance of the whole Wikipedia article...
Finally, I think a lot of the contention around what is or is not a qualified topic in the article could be easily eliminated by simply using "see" references to direct readers to related subjects that are regarded as tangential. Would that help?
I'm very much looking forward to being able to read and learn about this subject eventually, here on Wikipedia, and confident that, as with other Wikipedia articles, a rounded and readable overview of the subject will eventually emerge from your joint efforts. Please let me know if I can help more than hinder.
Welcome Leha. Your help will be much appreciated. The article is way too full of Boothby, but she is the most biased, least informed author WLU could find, and therefore suits his purpose just fine. The entire Boothby "chart" should be removed as should many other statements that present her opinions as facts. The article needs a lot of work, not only for coherence, organization, and flow, but more so for objectivity.Hillinpa (talk) 00:13, 21 December 2009 (UTC)
Thanks for stopping by and making the offer. I certainly don't have any objections, but I don't know how far you will get - I have tried editing for style according to guidelines, eliminating redundancies, fixing grammar, but it is all usually wiped out within a few days. I agree that the coherence of the article as a whole is also an issue, but I think that is a result of not having a firm direction and balance in the article. Maybe we can resolve something soon. Riverpa (talk) 19:59, 21 December 2009 (UTC)
Thank you both for the welcome. Because of the surrounding controversy and the length of time this has been contentious, I'm still reluctant to jump in a make changes--even little ones. I would like to go through the section-by-section you have all already got going here in Talk, and add my inputs there, but just to give everyone an idea of what I mean when I ask for more logical cohesiveness, I will add a brief summary in this section of those issues. (This is the part I will have to rely on you all, and maybe others, for, as I don't have the answers to all of my questions.) Leha Carpenter 03:32, 22 December 2009 (UTC) —Preceding unsigned comment added by Lehacarpenter (talk • contribs)
Overall Coverage Issues:
I would think the introductory section should answer the most basic questions about BHRT:
How is it defined (by most medical practitioners--see note below), and distinguished from CHRT, and does a controversy exist around either or both of these practices, or their definitions (too soon to get into what that controversy is all about)?
What are the goals of BHRT for the patient?
What hormones are used, and what are they made of? (And does BHRT ever employ non-hormones as a part of its regimen?)
What are the delivery methods, and (briefly) why are there more than one?
How do compounding and symptom relief differ as practices, and what are the basic merits and pitfalls of each (as methodologies)?
How are compounded formulas arrived at (who does the testing and prescribing, and basically, how are the tests performed)?
That's probably all you can fit in an introductory section.
I think there should be a section, outside of the Criticism section, that defines the methodology and rationale behind the currently used testing methods for BHRT, in more detail than in the introduction.
NOTE: While the definition of BHRT might be muddied according to various sources, the fact remains that regular medical doctors, in possibly extremely large numbers, are prescribing BHRT for their patients. This means that a definition of what is currently being prescribed should be included here, upfront and ahead of all controversy.
Well, that's a start. I will look for responses, and follow up soon with comments on individual Talk section-by-sections. If everyone, including the article's main author, is okay with me making minor edits for typos, sentence structure, and/or clarity, I can also do that. Thanks all! Leha Carpenter 03:47, 22 December 2009 (UTC) —Preceding unsigned comment added by Lehacarpenter (talk • contribs)
Okay, one more little note: my last two bullet points are to be taken within the context of BHRT, as I know there is a larger definition and use of both compounding and symptom relief. Leha Carpenter 03:51, 22 December 2009 (UTC) —Preceding unsigned comment added by Lehacarpenter (talk • contribs)
I agree with your ideas for the intro. I have made such edits in the past, only to have WLU revert them. He is opposed to any text that might make BHRT sound like an intelligent practice. I have just read the Boothby paper he quotes so much. It is an anti-bioidentical hit piece of very low quality. I see now that WLU is trying to make this article nearly identical to the Bootby paper. Please do jump in and edit the article as you see fit. I'll be happy to help with information and sources. As you see, myself and Riverpa are fed up with the WLU problem are seeking some kind of resolution before we waste our time editing this article again.Hillinpa (talk) 12:19, 22 December 2009 (UTC)
This is a lot if info for an introduction section. The lede section should contain a summary of info, so I think a separate intro section might duplicate the lede. Much of it is already covered in the article - see Components and Compounding for info on what hormones are used, for example. As far as goals, that varies greatly, while some BHRT pushers are touting anti-aging, mainstream is only pushing menopause relief symptoms. Regarding the compounding process, the lack of testing is the major issue, especially with the FDA.
Here is a something that I have been working on for a bit, maybe if we can get some agreement as to basic statements of fact we can move from there:
BHRT is a term that can be either:
a treatment mode that includes compounding, bioidentical hormones, saliva testing, treatment to attain test results, and marketing for some questionable purposes
or:
a mainstream medical option that includes FDA-approved bioidentical hormones, possibly compounding when needed as indicated by a prescribing physician, and treatment to relieve menopausal symptoms.
There is no bright line to separate these two concepts. They exist on a spectrum, where (from less accepted to more accepted):
1) Compounding pharmacies advertise their products on the internet, referring patients to physicians who will prescribe for them
2) Some treatments are designed to attain a specific saliva or blood level of hormones
3) Saliva testing is not regarded as useful for much of anything
4) Hormones are not useful for general preventive treatments (excepting limited bone retention use) or for anti-aging
5) Estriol has shown mixed results in the little research done on it, is used commonly outside of the US, and the FDA is trying to ban it.
6) Transdermal progesterone use has shown mixed results in research, with dosage issues paramount
7) The WHI has proven that CEE's have higher risks than previously thought. Mainstream medicine generalizes these results to include bioidentical products.
8) Compounding transcends its inherent risks only when necessary for a purpose validated by mainstream medicine.
9) Some evidence has shown that there are fewer side-effects when using bioidentical estrogens compared to CEE
10) Some evidence shows that oral bioidentical progesterone is preferable to progestins
I don't think that this is a complete list, I am sure that it can be improved. I am not saying that these statements need to go in the article, I am just putting them forward as an indication of the spectrum of beliefs regarding this issue, and the number of shades of gray that we have to deal with.
Also, as per WP:Style, the Criticisms section has to go. Criticism has to be integrated into the whole of the article, it should not be in a separate section. And there needs to be a Controversy section, especially for the Wyeth/FDA compounding legal wrangling that is going on right now, as well as the popular promotion, and the internet pharmacy advertising.
Part of the reason Boothby seems to be used so much is because of the table in this section where Boothby is used as a reference for each box (as well as once before the table). I consider this excessive, and only the citation just before the table is necessary. That would reduce the citations from 32 to 12. Boothby is also a peer-reviewed article that directly and squarely addresses specific claims about BHRT, citing both the claim and the evidence base to support it, while most others discuss BHRT more generically without addressing specifics. It's also useful for things like background and context. There are several citations in the lead, which is slightly redundant since the lead summarizes the body and citations there are optional. It's also used as a reliable source to the claims made by proponents, and a reliable source is preferred to say, citing webpages or sales sites. Many other uses are alongside other sources, essentially demonstrating that there are many sources that agree about those points. I have found that it is usually not very fruitful to say "x source is used too many times" as you can't exactly remove a source from the page at random in order to "balance" things. It's better to address whether specific uses are appropriate or not. WLU(t)(c) Wikipedia's rules:simple/complex17:13, 22 December 2009 (UTC)
WLU continues to repeat his claim that any presentation secondary or primary sources that deal with the actual science of estradiol and progesterone and not just with "BHRT" is original research. But let us see what WP:NOR actually says:
"To demonstrate that you are not presenting original research, you must cite reliable sources that are directly related to the topic of the article, and that directly support the information as it is presented. Material for which no reliable source can be found is considered original research...By reinforcing the importance of including verifiable research produced by others, this policy promotes the inclusion of multiple points of view. Consequently, this policy reinforces our neutrality policy. In many cases, there are multiple established views of any given topic. In such cases, no single position, no matter how well researched, is authoritative."
Notice that there is nothing here that sounds remotely like WLU's argument. There is also nothing in the entire statement of the policy that would make one think that one must avoid all sources that don't mention the word "bioidentical". Indeed, as bioidentical is defined as hormones that are molecularly-identical to the endogenous sex hormones, it is obvious that any secondary or primary sources that have to do with the safety and efficacy of replacing estradiol and progesterone, the bioidentical hormones, are relevant to this article. Everyone apparently grasps this except WLU. The statements of the organizations, and the reviewers that WLU includes and quotes do themselves quote primary and secondary sources on estradiol and progesterone that do not include the word "bioidentical". Research done on estradiol and progesterone is directly related to the topic of the article. The minority opinions of high-quality sources on the safety and efficacy of estradiol and progesterone belong in this article as they are the bioidentical hormones of interest.Hillinpa (talk) 00:39, 21 December 2009 (UTC)
The relevant section that I cite is "Do not combine material from multiple sources to reach or imply a conclusion not explicitly stated by any of the sources. Editors should not make the mistake of thinking that if A is published by a reliable source, and B is published by a reliable source, then A and B can be joined together in an article to reach conclusion C." I don't see how we can use articles about specific hormones to make claims about "bioidentical hormones" without resulting in an enormous piece of original research that essentially constitutes an essay. WLU(t)(c) Wikipedia's rules:simple/complex19:36, 22 December 2009 (UTC)
Your answer is non-responsive. You cannot de-couple "bioidentical" from estradiol and progesterone. Every organization and author you quote in this paper uses studies and reviews involving estradiol or progesterone--just look at their references! Bioidentical advocates also base their claim of greater safety on the wealth of studies using progesterone and transdermal estradiol. Secondary sources that are relevant to the safety of transdermal estradiol and progesterone c/w non-bioidenticals or integral to this article and NOT original research. Your tactic here is irrational and obviously intended to suppress relevant information on this subject.Hillinpa (talk) 11:37, 23 December 2009 (UTC)
WLU is in gross violation WP:NPOV in the general tone of the article and in many points. Let us remind ourselves of what the WP:NPOV actually requires:
"all Wikipedia articles and other encyclopedic content must be written from a neutral point of view, representing fairly, and as far as possible without bias, all significant views that have been published by reliable sources. An article should clearly describe, represent, and characterize all the disputes within a topic, but should not endorse any particular point of view. It should explain who believes what, and why, and which points of view are most common. It may contain critical evaluations of particular viewpoints based on reliable sources, but even text explaining sourced criticisms of a particular view must avoid taking sides. An article should clearly describe, represent, and characterize all the disputes within a topic, but should not endorse any particular point of view. It should explain who believes what, and why, and which points of view are most common. It may contain critical evaluations of particular viewpoints based on reliable sources, but even text explaining sourced criticisms of a particular view must avoid taking sides. When discussing the facts on which a point of view is based, it is important to also include the facts on which competing opinions are based since this helps a reader evaluate the credibility of the competing viewpoints. This should be done without implying that any one of the opinions is correct. It is also important to make it clear who holds these opinions. It is often best to cite a prominent representative of the view. Assert facts, including facts about opinions—but do not assert the opinions themselves."
WLU has done nothing but suppress any view of this topic other than his own, he's even edited out the view of the International Menopause Society because they were pro-progesterone! Yet this is the primary reason that BHRT exists and women are interested in it--they want to know what the science says about the safety of the bioidentical hormones vs. conventional HRT--and that information belongs right here. Rather than deal with this issue objectively, WLU has sought to endorse a specific anti-BHRT viewpoint, and has suppressed opposing views, sources, and evidence. WLU repeats anti-bioidentical statements throughout the article as if they were undisputed, when there is a minority opinion that is well-supported by sources. An objective article should just clearly state who says what, and not endorse any one point of view. This should be easy to do, yet WLU seems bound and determined that his favorite anti-bioidentical sources and bias should not be contradicted. For this reason the NPOV tag should remain until/unless this article does fairly represent the science and both the conventional "all hormones alike" opinion and the pro-transdermal estradiol and pro-progesterone opinions and evidence from significant sources.Hillinpa (talk) 01:05, 21 December 2009 (UTC)
What do most medical sources think about bioidentical hormones in the absence of compounding and saliva testing? What blanket statements can be found about "bioidentical hormones" when compounding, saliva testing, marketing and celebrity testimonials are removed from the equation? There's not much. It's my opinion that most sources say nothing and it's inappropriate to take the few COI sources that do (Schwartz, Moskowitz and Holtorf) and proclaim them as representing the majority. And further, it is inappropriate for us to write an article about transdermal estriol and progeseterone without becoming either a coatrack or original research essay that promotes them. WLU(t)(c) Wikipedia's rules:simple/complex19:34, 22 December 2009 (UTC)
Your opinion is not the arbiter of the content of this article. The sources are. Are you now saying that NAMS is COI? I again refer you to NAMS/IMS here [33] and suggest that you start reading rather than writing so much and you will see that they clearly treat BHRT as an entity sans saliva testing, compounding., et al. Riverpa (talk) 04:37, 23 December 2009 (UTC)
WLU fails again to respond in any rational way to criticism, and appears no to understand his own sources. The medical sources he relies upon (NAMS, Endocrine Society) make a point of saying that there's no difference in safety between non-bios and the bioidenticals estradiol and progesterone in FDA-approved forms--not including the compounding question which they address separately. They specifically link "bioidenticals" with research using estradiol and progesterone. They reference research using estradiol and progesterone. Notice that I make the point, fully supported by Wiki policy, that the minority opinion must be included and the article must be neutral in tone, and WLU claims that I'm trying to make the minority opinion into the majority opinion! We have the International Menopause Society's statement, we have major review articles on transdermal estradiol and progesterone, these are valid sources for this article--yet WLU deletes them whenever added. WLU claims that there is only one definition of BHRT (the package deal), and tries to suppress theprimary definition as the use of the bioidentical hormones estradiol and progesterone--a definition that is acknowledged in all sources, directly or indirectly. WLU is not neutral and is editing in an extremely biased manner, WLU is resorting to any ruse, or irrationaly counterattack that suits his purpose. I ask the other editors: What do we do about this?Hillinpa (talk) 11:46, 23 December 2009 (UTC)
Are you saying we should say that bioidentical hormones are expected to have the same risks and benefits of conventional hormones? I would agree with that. Also, are they saying there is no expected difference, or there is no difference? I would be surprised to see the latter, as an ongoing issue raised is the lack of research.
Incidentally, I would argue that your "primary definition" doesn't exist - per Schwartz, there is a lot of confusion regarding what "bioidentical" and "BHRT" mean. Is it just endogenous molecules? Is it the whole package? We are not permitted to choose a definition we like and go with it.
I reiterate my question - what do most sources say about BHRT when the compounding and saliva testing are removed? I would venture they are mostly silent. WLU(t)(c) Wikipedia's rules:simple/complex18:31, 23 December 2009 (UTC)
Well, when the sources one is referring to are written specifically to criticize compounded bioidentical hormones, as most of the sources you refer to are, then one might think that. When one looks to more balanced sources, one finds something different. Riverpa (talk) 05:53, 25 December 2009 (UTC)
The 2008 Boothby paper quotes, as its only evidence that BHRT has documented risks, a report of three cases of endometrial cancer occurring in women on compounded BHRT. This is anecdotal evidence--evidence of the lowest quality. WLU included that source in this article. Both Riverpa and myself have pointed this problem out to WLU and I tried to remove the source from this article. I further pointed out that endometrial cancer occurs in many women on conventional HRT also--no HRT regimen prevents endometrial cancer, at best it can lower its risk. WLU, who loves to throw Wiki policy acronyms at other editors, is here clearly violating the policy WP:MEDASSES which states, "Case reports, whether in the popular press or a peer-reviewed medical journal, are a form of anecdote and generally fall below the minimum requirements of reliable medical sources." I have therefore edited out this anecdotal report and the three other references to it in the article. Let us see if it stays out this time.Hillinpa (talk) 12:29, 22 December 2009 (UTC)
The point of the Boothby article is that a) it is a secondary source assessing claims about BHRT and b) proponents of BHRT have claimed that there are no risks to its use. In fact, there appear to be risks. You shouldn't be removing an entire secondary source (Boothby) on the basis of a single complaint. In addition, the Eden study was cited elsewhere in the article for other opinions of the author. Notably, this article was used once to reference the three individual incidents as a case study but was also used to discuss the goals of CHRT (symptom relief), the evidence basis for CHRT compared to BHRT (where you also removed a reference from FDA) and the lack of research for compounding and saliva testing. It's also useful for contextualizing why those three cases are worrisome, and again to illustrate that in fact, BHRT is not a risk-free panacea. It also states why BHRT presents an unusual risk of adverse outcomes - because it has not been studied. WLU(t)(c) Wikipedia's rules:simple/complex15:57, 22 December 2009 (UTC)
Please specify which source you are talking about, Boothby or Eden. No one has removed Boothby, just suggested that sourcing should be spread around to other reliable sources - as you say, there are plenty of them, so why not use more of them? The Eden piece is primary and anecdotal and has no place being cited, especially so many times, in this article, according to your own standards. Don't impose a rule on other people when you are not adhering to it. You make it quite clear that there are plenty of other sources that will support the points you are trying to support, so stop trying to force a sub-standard (by your own definition and WP's) reference on us and use them.
Which BHRT are you referring to now?: As you have previously written: "The whole package of bioidentical hormone replacement therapy includes salivary testing, compounding and wild claims. [34], or your more recent assessment where you negate the "package deal": "But BHRT is not a specific "thing", it's a disparate collection of unsupported beliefs and theories." But in this paragraph you are apparently still referring to the BHRT "package". When will you acknowledge that there is something beside your "package deal"?
Pick one. Stop switching your argument according to the way the wind is blowing. Acknowledge that there is another meaning, or many meanings, since it has now been shown that mainstream medical sources indicate that BHRT is used to refer to FDA-approved hormone therapies, sans saliva testing and compounding. Riverpa (talk) 17:10, 22 December 2009 (UTC)
Hillinpa removed the Boothby-sourced table wholesale here. Hillinpa removes the Eden article throughout here. As I discuss here, you can't blankly say "X source is used too many times" and further, Boothby's "overuse" is in large part an artifact. Eden's use is appropriate in many situations and the inclusion of the 3 case studies is, in my mind, also appropriate. The latter is of course an opinion, but the fact that Boothby cites Eden is a point in its favour in my mind.
Sources themselves are frustratingly unclear on the compounding-versus-bioidentical issue. I'm uncomfortable saying either way that "BHRT = compounding+saliva testing" versus "BHRT = just bioidentical molecules and compounding+saliva testing is an aberration." Certainly BHRT has been substantially associated with compounding+saliva testing, to the point that they were treated as synonymous for years and discussions are only now beginning to look at just bioidentical molecules in the absence of compounding and testing. The article does not benefit from the issue being papered over by claiming the critical sources are all wrong since specific hormones are just fine. WLU(t)(c) Wikipedia's rules:simple/complex19:30, 22 December 2009 (UTC)
If I thought that the Boothby table was so detrimental to the content of this article, I would probably remove it, too, but it is so poorly written and structured that it is barely comprehensible, and as such it is ineffective for just about anything.
I refer you to this edit [35] which shows how clearly the sources differentiate between compounded and non-compounded bioidentical hormones, and if you did not cherry-pick your sources so thoroughly you would see that. The only one papering over anything here is you. If you feel that the sources are unclear about this topic and are uncomfortable with the topic, please stand aside and let those of us who have no trouble finding clarity within the scientifically accepted sources to edit the article. Riverpa (talk) 20:11, 22 December 2009 (UTC)
Figuring out how to navigate the meanings is difficult, as is figuring out how to do so while adhering to OR, SYNTH, NPOV and UNDUE. I still see minimal (really, no) evidence that most mainstream doctors believe individual hormones are superior. For instance, the WHI found that CEE was more dangerous than previously thought, but didn't look at bioidentical equivalents at all. The solution is not to start citing primary sources in an unabashedly positive way (particularly when systematic reviews for individual hormones are themselves equivocal - [36], [37], "Estriol has some unique physiological effects, which differentiate it from estradiol, estrone, and CEE. Estriol would be expected to carry less risk for breast cancer, although no randomized controlled trials have been documented" from Holtorf). I don't want to have to read dozens of systematic reviews about what I see as tangential issues in order to come to a consensus on what the literature says about individual hormones that happen to be bioidentical. Particularly when there is no clearly positive reviews about hormones-that-are-bioidentical versus hormones-that-are-not and there are many, many sources stating "we expect these hormones to carry the same risks and benefits of the regular, already-studied hormones and there is no clear evidence to support assertions that they are safer."
It's not like the NAMS, ACOG, JAMA and FDA start their summaries with "though estriol, progesterone and other hormones are better than CEE and progestogens, compounding ruins this". WLU(t)(c) Wikipedia's rules:simple/complex20:45, 22 December 2009 (UTC)
You seem to be having some trouble finding references that regard BHRT as part of conventionally accepted medical practice, so I will provide this link to IMS here again. Of course, it doesn't use the word "individual", but no one but you seems to be using that word in this discussion. [38]. Before you respond again, you might try looking at this reference and informing the rest of us why you do not consider this an acceptable mainstream medical reference, other than the fact that it does not reflect your POV. Riverpa (talk) 04:31, 23 December 2009 (UTC)
undent Unbelievable. We point out that WLU is clearly violating Wiki policy, and WLU says he thinks it's OK to do so and reinserts the offending source. Boothby's claim (she is a pharmacist) that compounding carries additional risks rests solely on the anecdotal report, about a disorder that also occurs in women on no HRT and on conventional HRT, which no ethical scientist would ever include in a review. Boothby actually spends much of the article citing the dangers of conventional HRT, and trying to imply that bioidenticals are dangerous because CHT is dangerous! SO, what do we do about an editor that will violate any policy to keep an article biased? We obviously cannot work with this editor. He is unresponsive to any arguments or evidence.Hillinpa (talk) 11:59, 23 December 2009 (UTC)
If it's part of CHRT, then isn't it just CHRT? Did you want to split the page so it ignores any hormones part of FDA-approved trials, and just focus on the comprehensive definitions of BHRT - compounding, saliva testing, "natural" and unsubstantiated claims, and leave the hormones-that-happen-to-be-bioidentical for those articles? The IMS paper is first of all several years old, and second of all not a peer-reviewed article; it's somewhere between a conference proceding and a set of non-academic teaching notes. That would be why I don't believe the entire article should be re-written to reflect it and in fact I would hesitate to use it period as I don't see it as a strong MEDRS - it's not a consensus statement, it's a compilation of talks.
Hillinpa, you are correct. Bioidenticals are expected to be dangerous because CHRT is dangerous. There's no reason to expect these hormones to carry no risks when other hormones carry recognized, well-researched risks and many, many sources say exactly this. Bioidentical hormones are still hormones and hormones are drugs and medicines - they carry risks and benefits. Explicit, clear, and well-substantiated that one of the most significant concerns about BHRT is that it has not been studied extensively, yet it is still promoted as if it were, and further as if research had shown nigh-magical benefits and a complete absence of risks.
Your arguments are getting desperate. See WP:MEDRS for this quote
"Medical textbooks published by academic publishers are often excellent secondary sources. If a book has as its declared target audience students, it may not be as complete as a monograph or chapter in a book intended for professionals or postgraduates." The IMS piece is a monograph directed to postgraduates, which according to MEDRS, makes it an excellent reference.
And if you really feel that it is too old because it was published in 2007, what would your cut-off date be? I mean, a whole two years old in medical research, that's an eternity! Oh that might mean we can only use Boothby!!
If it's "just" CHRT, why do many of the sources treat FDA-approved bioidenticals separate from CEE's and synthetics when writing about them? The FDA is the only major source that consistently does not, and they have a regulatory interest in treating them so. Even the FDA is careful to reference "compounded bioidenticals" when it uses the term, rather than just saying BHRT or bioidenticals, as you want to do.
If it's a part of CHRT, it's a subset of CHRT. That doesn't mean they are equivalent. If we say CEE does that mean we aren't talking about CHRT?
No one is saying that bioidenticals carry no risk, except some compounding pharmacies and Suzanne Sommers. You are the one who keeps blaming people for that when no one has done that. You keep on repeating the statement like it will stick. I ask again, show me where or stop saying it. Riverpa (talk) 17:46, 23 December 2009 (UTC)
That's not a book, and it's not an academic publisher. I'm not saying it can't be used, just that we should use it with caution. Anything published more recently and in a respected peer-reviewed source would be better.
I would appreciate it if my reasoning was not described as "desperate", particularly as I haven't objected to that source outright, nor have I given a specific opinion on it. It, like all sources, has to be appreciated and used with respect to the entire debate. I objected to rewriting the whole page based on it, not on its use at all.
BHRT is a complicated issue plagued by multiple competing definitions and a whole lot of unexamined issues. BHRT doesn't have an absolute definition, and for that matter, neither does CHRT. It's akin to "complimentary and alternative medicine" - if something is proven, it's medicine. CAM doesn't really exist, it's essentially a series of unproven hypotheses that have some support but no demonstrated benefits. It doesn't mean that it doesn't work, only that there is no evidence it does. Once specific molecules are demonstrated to have a better risk/benefit profile, I'm sure they'll be adopted and become "conventional" and this whole page will be a moot, histiorical point. But we're not there yet, there is still considerable controversy. WLU(t)(c) Wikipedia's rules:simple/complex18:25, 23 December 2009 (UTC)
Now you admit it's complicated. Shouldn't the article reflect this? I'm afraid that your posts show that you really do not understand the nuances of all the issues surrounding HRT and BHRT. Only bioidentical hormones are actually hormones, non-bioidenticals are molecules that never existed on this Earth until invented by some scientist. Surely the former is more "natural" than the latter. The term "bioidentical" had to be invented because non-bios are called "hormones" too. Using bioidentical molecules is intelligent medicine--medicine has always favored correct molecules--consider levothyroxine, insulin, growth hormone, testosterone, cortisol (hydrocortisone)--all these commonly prescribed hormones are bioidentical and are preferred for this reason. Using the right molecules is just good medicine. BHRT is not alternative medicine--it is medicine, it is just done better or worse according to the knowledge and skills of the physician.
Regarding the current state of the evidence: The bottom line is that it is the non-bioidenticals that have been proven to be dangerous. The evidence indicates that bioidentical estradiol replacement can be dangerous in certain situations. Unopposed estradiol, even transdermally delivered, will increase the risk of breast cancer (Million Women Study). But transdermal estradiol given with natural progesterone has not been shown to increase the risk of breast cancer. In E3N/EPIC there was a direct comparison of transdermal estradiol with progesterone or various progestins. The progestins were found to increase the risk of breast cancer substantially, whereas progesterone did not increase the risk above baseline. Here's the study, which is mentioned in bibliographies of both the IMS and NAMS statements.[39] This study and many others dealing with breast cancer, progesterone, and progestins are discussed a major review article. [40] This is a secondary source of high quality that deserves to be included in this article. The authors conclude "We therefore suggest that when HRT is indicated, preparations containing progesterone and not a synthetic progestin should be used.."
Now after breast cancer, the second most-feared danger of HRT is blood clotting, here we find an overwhelming amount of evidence and reviews supporting the view that transdermal estradiol does not increase blood clotting AT ALL, and has not been associated with increased heart attacks and strokes.[41][42][43] Given the above evidence, you can see, finally I hope, that it is false to say that "all FDA-approved hormone products are alike". The International Menopause Society recognized both the advantages of transdermal estrogens and progesterone in its statement.[44]. I have pointed all of the above out to you many times, yet you continue to argue as if you've never been acquainted with this information. You are editing a paper about an issue of primary concern to the health of all women. Not only their quality of life, but their life itself depends upon getting accurate information about hormones. You need to acquaint yourself with the science.Hillinpa (talk) 19:45, 24 December 2009 (UTC)
CEE existed in the urine of horses, that's where it came from. And if a non-bioidentical hormone exerts an influence on a hormone receptor, it's pretty close to a hormone in my mind. The "natural" canard is dealt with repeatedly in sources - "natural" is meaningless and is used as a way of attaching fuzzy feelings to a relatively meaningless concept - multiple sources converge on this. Certain pig and bovine insulin molecules are used by diabetics because it gives a much more nuanced control over blood sugar - modulation rather than on/off switching. It's not up to us to decide what is "good medicine" - we cite the sources. Wikipedia is about verifiability, not truth.
Regarding the state of the evidence - again, many sources state that bioidentical hormones are expected to have the same risks and benefits as CHRT and it is premature to claim that BHRT has all the benefits and none of the risks. Campagnoli is from 2005 and appears to be contradicted by a Cochrane Review that states that it's not clear what sort of progestogen (including synthetic progesterone derivatives) has the best risk to benefit ratio [45]. Regards Løkkegaard, how do they define HT? And they specifically state "We were not able to test the effect of conjugated estrogens vs. 17 β-estradiol, as conjugated estrogens are infrequently used in Denmark" so I don't see how we can use it here. I just don't seem to see clear evidence from the medical community that bioidentical compounds are clearly seen as better, but I can see many statements suggesting they are expected to carry the same risks. Even the IMS statement that you have referred to repeatedly states that progesterone may or could justify their use beyond preventing endometrial hyperplasia, not "certainly does". It also says things like "There are insufficient data to evaluate the possible differences in the incidence of breast cancer using different types and routes of estrogen, natural progesterone and progestogens, and androgen administration." Hardly indicating that all decisions are settled and "natural" hormones are clearly superior. WLU(t)(c) Wikipedia's rules:simple/complex05:56, 28 December 2009 (UTC)
Neither I nor the authors cited are claiming that BHRT has all the benefits and no risks. This is yet another exaggeration on your part. I have shown you good secondary sources that state that some forms of BRHT have LESS risks than CHRT. Those sources may be considered in the minority, but they are relevant to this article and must be included as per WP:NPOV. The Cochrane review is limited to randomized, placebo controlled studies, primarily WHI and HERS, and the authors treated all estrogens and progestins as classes, they did not attempt to differentiate between types and routes. The authors did state "There is controversy over the degree to which the findings of WHI 1998 apply to any type of HT other than continuous combined oral CEE 0.625 mg with or without MPA 2.5 mg." That is the controversy that should be reflected in this article. The primary claim by BHRT practitioners is that the findings of WHI and HERS do not apply as shown by reviews in which transdermal estradiol is found to safer than oral estrogens with regard to thrombotic risk, and progesterone is safe to be safe than many progestins in regard to thrombotic and breast cancer risk. The Lokkegard study found transdermal estogen to be more safe in regard to cardiovascular risk. The Canonico study is a more rigorous review of studies that came to the same conclusion. Both authors spoke of "transdermal estrogen" instead of "transdermal estradiol", but you need only read the studies involved, and know the commercial market, to realize that the only transdermal estrogen products are those containing estradiol. ERGO, all "hormone" therapy is NOT alike. So in compliance with WP:NPOV are you going to stop deleting all sources that support that view that transdermal estradiol and progesterone may be safer than CHRT?Hillinpa (talk) 12:05, 28 December 2009 (UTC)
Anyone making claims for estriol should really read Cirigliano 2007, it has a pretty extensive coverage of it. Points out that it has been used in Europe and Japan, but that the evidence base for it is pretty suspect. WLU(t)(c) Wikipedia's rules:simple/complex17:35, 23 December 2009 (UTC)
Response to AMA question
It's late, so I will respond to the AMA questions only - again, please keep discussion here and not on my Talk page.
The citation that you link to is a three year old editorial, not the actual AMA policy. The only statement that can be interpreted as reflecting the AMA policy in the editorial is this:
"The Association adopted policy asking the Food and Drug Administration to conduct surveys of compounded bioidenticals for purity and accuracy. It also calls for mandatory adverse event reporting by the hormones' makers, including pharmacies, and a registry of these occurrences."
That does not say anything about benefits and risks, regulation, study, and the risks of compounding, which it what it is purported to support in the article. So if you can find their actual policy statement and it says what you think it says, great. Otherwise, this is not a suitable citation for the purpose you want. I looked for the policy and was unable to find it on their website.
As for as your addition of the Moskowitz COI, you are opening the door to adding COI to every other cited source in the article. Do you really want to do that? Riverpa (talk) 04:31, 28 December 2009 (UTC)
I would certainly be intrigued to know what other COIs exist for other study authors. Most of the peer-reviewed literature authors have academic positions in various universities. Moskowitz does not appear to.
The press release would appear to be adequate to represent the opinion of AMA even if it's not solely about the policy. I suppose if we're being pedantic the entire policy would be [46]:
“
D-120.969 FDA Oversight of Bioidentical Hormone (BH) Preparations
Our AMA will: (1) urge the Food and Drug Administration (FDA) to conduct surveys for purity and dosage accuracy of all compounded "bioidentical hormone" formulations; (2) urge the FDA to require mandatory reporting by drug manufacturers, including compounding pharmacies, of adverse events related to the use of "bioidentical hormones"; (3) urge the FDA to create a registry of adverse events related to the use of compounded "bioidentical hormone" preparations; (4) request that the FDA require the inclusion of uniform patient information, such as warnings and precautions, in packaging of compounded "bioidentical hormone" products; and (5) urge the FDA to prohibit the use of the term "bioidentical hormones" unless the preparation has been approved by the FDA. (Res. 706, I-06)
”
Even if the rest of the editorial is not the policy, it still represents the opinion of the AMA - it's on the AMA website, it's labelled an editorial, it doesn't appear to have been replaced, repealed or updated. It contains statements like:\
"...the medical profession has concerns with the safety and efficacy of these products when created through pharmaceutical compounding."
"Bioidentical hormones have the same chemical and molecular structure as hormones produced in the human body. Traditional hormone therapy relies on estrogen or estrogen-progestin products made by pharmaceutical companies and approved by the FDA. Compounded bioidenticals are typically derived from plants and formulated by a pharmacy to meet individual patient needs. They are not FDA regulated"
"Given that the compounded products have the same chemical composition as traditional therapy, the risks for heart disease, stroke and breast cancer must be considered the same until it is proven otherwise."
This just shows what ignorance the AMA can display. Compounded products using estradiol and progesterone do NOT have the same chemical composition as traditional therapy which contains equine estrogens and medroxyprogesterone. One has to know the facts in order to interpret such statements.Hillinpa (talk) 12:08, 28 December 2009 (UTC)
I tried, I really tried to make AMA opinion reflect the statement. It doesn't.
It's not a statement or a press release, it is an opinion piece in their in-house publication.
It's not on the AMA website, when you do a search you have to specifically search their publication (Not JAMA) to find it.
It doesn't talk about dangers of compounding.
It's not the opinion of the AMA, it's the opinion of the editor, who does not represent it as an official opinion of the AMA, and even he is pretty much just citing other sources.
You have some valid cites for those statements (I have not checked them all, but I will eventually) so why are you wasting time on arguing this point when, even as an editorial, it does not reflect what is in the article? It is after the words "have released statements" and it is not a released statement. Riverpa (talk) 13:00, 28 December 2009 (UTC)
As far as the monograph, it clearly indicates the acceptance of the BHRT terminology and concept as used in clinical practice, from a reputable mainstream medical organization. If you read my earlier extract of WP:MEDASSESS carefully, you will see that a postgraduate monograph is considered a more reliable source than a textbook, as it addresses a more advanced audience, and concentrates on one specific topic, allowing a more in-depth approach. So that is what we have here, a very focused discussion that is endorsed by a national arm of an international organization that is mainstream, and is dedicated to this topic. It is also presented from the clinician's view and so reflects the recommended current state of the art in this field, and is currently being taught that way.
You have argued many times that the mainstream medical sources do not acknowledge the existence of BHRT sans saliva testing and compounding: I expect that this reference will put that argument to rest. Riverpa (talk) 16:10, 28 December 2009 (UTC)
If you have any of those new sources, especially Douma and Sites, I would appreciate a copy. I would also love to see the Wright piece, and anything else would be great. Thanks Riverpa (talk) 18:11, 28 December 2009 (UTC)
What a mess this page is!
This is one of the worst Wikipedia entries I've ever seen. The vast majority of content should be removed, it's not necessary to detail every single controversy.
I propose the following structure:
Definition - BHRT is hormone replacement therapy using bioidentical (edogenous human) hormones. Don't forget that BHRT isn't just for post-menopausal women, it's for pre- and peri-menopausal women and for men too.
Components - BHRT is typically some combination of estradiol, progesterone, estriol, and testosterone. Describe without comparison the various delivery methods (oral, sublingual, transdermal, dermal) with minimal info about which forms are better for each of the hormones. Describe that BHRT patients can use already-made products purchased at a regular pharmacy or products from compounding pharmacies. Don't describe any controversy of compounding, it's not necessary here.
Typical goals of treatment - 1) in females, pre-, peri-, and/or post-menopause symptom relief or improvement of libido (all non-controversial), 2) in men, improvement of libido (non-controversial), 3) general health maintenance (controversial)
Controversy - This page need only mention that the only controversy is whether or not BHRT preserves health and/or prolongs life better than non-BHRT or no HRT at all, and that the reason the controversy exists is because there has yet been NO published study involving BHRT. It should be mentioned that humans have had BH's in their bodies their entire lives so it's ridiculous to claim that BH's are inherently "risky" or "dangerous", and that in women the risks of breast cancer, coronary heart disease, osteoporosis, and other serious diseases/conditions increase significantly at peri-menopause and increase again menopause, which could reasonably lead one to conclude that the loss of hormones is the cause of the increased risks. There could be mention of the timing of onset of BHRT, that delaying onset might actually increase risk.
I think it would be best to omit mention of the individuals who are most vocal on each side. I happen to agree with the pro-BHRT crowd and think that Suzanne Somers has made a great contribution, and I am using BHRT myself, but for this Wikipedia page I think mention of individuals on either side is superfluous. Think about the audience, many people coming to this page don't know much or anything about BHRT and they are looking for basic info. Other wikipedia pages are great at providing exactly that, but this one is a nightmare to read even for someone like me with rather extensive knowledge and personal experience. There are so many other web sites about BHRT and comparisons of BHRT with non-BHRT, it's not necessary to include it all here!
Also, let's get rid of the mention of saliva testing. Many women who use BHRT do not do saliva tests. I have blood tests done. Is there a page for saliva testing? If not, then add it, don't include the info here.
I'm about ready to completely overhaul this mess of a page because it irritates the heck out of me. Obviously someone can restore the original page, but really, people, we need to trim this thing down!
I think that we should be cautious in switching the page from one WP:POV to another. It would be great if everyone here could work out some sort of a compromise.--Literaturegeek | T@1k?19:09, 13 January 2010 (UTC)
I am not really happy with the article either, but it is a vast improvement over what it was back in October. I think it is repetitive, redundant, incoherent in places, and written poorly. Sources often do not reflect what they are supposed to be referencing. The major roadblock is editing to align with one editor's restrictive view of what BHRT supposedly is, and a lack of inclusion of any other viewpoints. That said, I think it is evolving for the better. We have found more references within the mainstream medical community that are allowing a more balanced viewpoint to emerge. Riverpa (talk) 21:33, 13 January 2010 (UTC)
I agree with both the perspective that there needs to be consensus among people who are working on the article (as opposed to a sudden overhaul by one person), and also that it's come a long way from where it was. I was re-reading this morning and actually felt that the article was beginning to paint a picture of accuracy. That said, I do agree with the notion that it's too long, and there are too many efforts at citing things from the point of view of controversy. I honestly think part of the problem is that this is a topic that is evolving in the world view very rapidly, but is just not in the mainstream yet. As such, it's valid to say that the article should hold back and present the medical mainstream view until that changes, but it's also valid to say that the medical mainstream view is changing. What I would really like to see this page do is to give readers a choice to look at "just the facts" of BHRT (the short version, without all the controversy), and/or learn about the changing perspectives, history, and some of the arguments, as well. Couldn't the controversy be contained within the History and Controversy sections, and then the other sections be about the actual practices and terminology of BHRT, without controversy?
I know I haven't really contributed much--I basically have just tried to work on the writing, and not the content--but would I would love to see this article come together. I think new people landing here do have that perspective that it's a mess, but I can see a lot of positive change emerging from the chaos, and I think just a good re-org of the content would make it extremely clear where excesses could be trimmed away. Leha Carpenter (talk) —Preceding undated comment added 18:12, 14 January 2010 (UTC).
You can't separate BHRT from compounding, "naturalness" saliva testing and controversy. Without these things, given the availability of these hormones as conventional FDA approved (bar estriol), it is simply hormone replacement therapy. Discussion of specific hormones that are bioidentical should occur in those pages, and great care should be taken in not promoting these hormones beyond the sources or specifically that they are better than equine estrogens or other hormones. There are only a limited number of authors who have published unmitigated, positive claims about molecularly identical hormones, while there are a vast number of sources that state they are expected have the same risks and benefits. We should be representing the significant controversy, not attempting to portray it as unreasonable. We don't go for "accuracy" or truth, we represent what is verifiable in reliable sources as is proportionate to the opinions found there (per our policy on undue weight). If the use of bioidentical hormones (minus compounding, etc.) is actually mainstream, that should be easy to demonstrate - I see an overwhelming, near-unanimous consensus that there is no reason to expect them to have fewer side effects as there isn't enough research yet to support this point. Certainly, criticisms should remain and should be substantial. WLU(t)(c) Wikipedia's rules:simple/complex23:54, 14 January 2010 (UTC)
This is not true. You can not or will not separate BHRT from the restrictive definition that you have assumed for it. The rest of us seem to be able to make that differentiation, as do most of the references, since they specifically refer over and over again to "Compounded BHRT' instead of just BHRT. Not all BHRT is compounded, not all BHRT practitioners use saliva testing, not all compounded BHRT is controversial, since apparently some people are allergic to the oil that Prometrium is mixed with, and must have progesterone compounded in a new vehicle. If you wish to only address the Wiley protocol compounded BHRT in an article, go edit that article. If you want an article on all compounded BHRT, I agree with your suggestion for a new article or renaming this one to BHRT (compounded), though I don't believe that it is in line with Wiki policy on content splits, and you may find that there are still many gradations of compounded BHRT to contend with. You seem intent on proving that BHRT is more dangerous and less effective than conjugated estrogens, by treating it all as the "package deal" of high doses of compounded hormones, saliva testing, and unfounded claims, though there is no foundation for that belief.Riverpa (talk) 17:57, 15 January 2010 (UTC)
From what I can tell, BHRT is for the most part synonymous with compounding; at best the views represented by Moskowitz, Schwartz and Holtorf deserve a single line stating that some proponents claim bioidentical molecules are superior, but again juxtaposed with the statement that these molecules are expected to carry the same risks and benefits - most articles state this, and add that compounding brings with it additional concerns over purity, potency and price. There isn't enough evidence or articles no have a page on noncompounded BHRT though, since the existence of FDA-approved compounds means this is simply conventional hormone replacement therapy. Wikipedia is about verifiability, not truth. Our policy on Wikipedia:Verifiability a core content policy, meaning it is the least negotiable of all the rules that are established. It's verifiable that there are serious concerns about BHRT, which is highly conflated with compounding, with minimal evidence from highly COI sources that noncompounded HRT with bioidentical molecules are safer.
The conventional use of compounding to avoid allergens or simply repackage is recognized by sources, but that's not why BHRT uses compounding - it appears to be a way of avoiding FDA regulations, particularly over the use of the unproven hormone estriol.
I am also well-aware that the Wiley protocol uses dangerously high, almost teenage levels of hormones, a feature not shared by other protocols. There's a separate page for the Wiley Protocol, it's dealt with only cursorily here.
I have asked before but I shall try again. What do you people think about this suggestion by WLU of discussing potential benefits of individual compounds on their respective pages? Perhaps the tone in some areas WLU can be improved as a compromise of sorts? I have not read the article recently though but can see quite a bit of editing has gone on in the past few weeks.--Literaturegeek | T@1k?00:01, 15 January 2010 (UTC)
This isn't just my suggestion, at least TimVickers has also suggested this and I believe others as well. I could try digging in the archives if anyone is really interested. In addition, there are at least a couple sources that state these hormones have not been compared head to head with CEE or other nonbioidentical hormones. I would also be cautious about using such broad-strokes articles rather than using review articles specific to each hormone. But that's a question for the other pages.
It may also be worth discussing splitting the page to just discuss "pure" BHRT - compounded, saliva tested, "natural" BHRT, and leave the claims for noncompounded hormones for other pages. Since there are already FDA-approved preparations containing all bioidentical compounds but estriol, the only thing that differs "BHRT" and "CHRT" is compounding, saliva testing and absurd claims.
I would also like to point out that I added a large number of potential references above, and this is in addition to the ones I already have on-hand that haven't been properly integrated. If we are to consider the preponderance of and total evidence found in peer-reviewed discussion, I think it becomes quite clear that the consensus is firmly against BHRT and there are only a small number of reliable sources that advocate for their use without further clinical trials. WLU(t)(c) Wikipedia's rules:simple/complex02:04, 15 January 2010 (UTC)
I have no problem with addressing the individual hormones on their respective pages, but you have to have some content on this page in order for the general discussion to make sense. I don't believe that I have been overly expansive in my explanation of the various hormones, but there should be some justification here for why BHRT practitioners consider the bioidenticals to be better than the non-B. TimVickers set the limitation that only research articles that used the term bioidentical should be used in this article, which is quite a restrictive limitation already; WLU would like to eliminate even that. Riverpa (talk) 17:57, 15 January 2010 (UTC)
TimVickers expressed the same sentiments I did (and now LiteratureGeek as well, for the discussion of individual hormones though not other ideas), suggesting it's a relatively innocuous one for wikipedia. At best, the specific hormones should be named, but their relative effectiveness and safety certainly shouldn't be explored or compared to other molecules. The justification of BHRT practitioners has been explored in several articles and found wanting in each case except Schwartz, Holtorf and Moskowitz. WLU(t)(c) Wikipedia's rules:simple/complex14:31, 18 January 2010 (UTC)
Statement in lead is inappropriate
The statement "BHRT is also used to describe the use of FDA-approved, commercially available manufactured bioidentical products, with the option of using individually compounded products if the situation warrants." gives the misleading impression that most people refer to FDA-approved drugs bought off the shelf as BHRT and this is very much not the case. If you asked a practitioner, a patient or a doctor what BHRT was, I don't think you would get this as an answer. Putting it in the lead, especially with many sources contradicting it (most sources would say that commercially-manufactured alternatives exist, not that they are what BHRT is made of) is inappropriate undue weight on a minority opinion that mis-characterizes what pretty much all groups would say about BHRT. WLU(t)(c) Wikipedia's rules:simple/complex15:37, 18 January 2010 (UTC)
This article is not about Compounded Bioidentical Hormone Therapy. If you want that article, please create it. We are not asking practitioners, patients, or doctors their opinions, we are going by the written references, which almost without exception, treat compounded bioidentical hormones separately from FDA-approved bioidentical hormones.
This article is about bioidentical hormone replacement therapy. If most sources say bioidentical hormone replacement therapy is about compounding, or even strongly associated with it, that's how it should be portrayed here. Most sources make the distinction in the form of "bioidentical hormonet therapy involves bioidentical hormones and usually compounding". They also make the point that most practitioners don't acknowledge that bioidentical hormones come as FDA-approved preparations and therefore don't need compounding. Most sources also say that the claims made for bioidenticals are unsupported and they should carry the same risks and benefits as nonbioidentical hormones. As much as you might want it ignored and portrayed as the flaw in bioidentical prescribing, compounding is integral to the approach of using solely bioidenticals, and in any case bioidenticals are still risk-bearing drugs. A point acknowledged by most sources. WLU(t)(c) Wikipedia's rules:simple/complex18:32, 18 January 2010 (UTC)
I think what WLU is saying is right, if sources and doctors and lay people view and define bioidenticals as compounded bioidenticals then this article should reflect this. I still don't understand but will repeat, if individual compounds which are technically bioidentical have certain benefits then why not dicuss this on the main hormone replacement therapy article and the respective individual hormone/drug articles? Can someone explain why this is not happening?--Literaturegeek | T@1k?01:10, 19 January 2010 (UTC)
As far as criticisms go it also doesn't really matter about the definitions - if a source defines BHRT as "compounded hormones identical to endogenous ones titrated through saliva testing" then goes on to criticize it for compounding, saliva testing, unuspported claims and risk/benefits that are expected to mimic researched drugs, we should report that. If they define it as "hormones identical to endogenous ones that are sometimes compounded and titration through saliva testing" and goes on to criticize BHRT for being unfounded, presenting the same risks and benefits as tested hormones, as well as presenting extra risks due to compounding, saliva testing being worthless and there being inadequate evidence, we report that. For the ones that state that there exists commercial preparations using these exact same hormones-that-are-bioidentical, those commercial preparations have known risks and benefits and without compounding, saliva testing and unsubstantiated claims, this is just FDA-approved HRT - which again isn't magic, isn't a panacea and isn't any less risky than other types of HRT. So again, what we have is a widely advertised approach to HRT which essentially isn't really any different than conventional HRT except for compounding, saliva testing, exagerrated and unsubstantiated claims, and perhaps estriol. The whole issue is a general mish-mash that conflates a bunch of issues, but the articles speak with a clear voice - there's no reason to believe that BHRT, compounded or otherwise, offer anything beyond the same risks and benefits of regular hormone replacement therapy - in fact, without compounding, saliva testing and estriol, BHRT is just risky, FDA-approved HRT. It's also extremely verifiable that lots of claims about safety and extra benefits are made, and are unsupported. WLU(t)(c) Wikipedia's rules:simple/complex13:38, 19 January 2010 (UTC)
Undent I re-print this Oct 29. exchange between you and I here because I cannot get links to the diffs since they has been archived. The same concepts holds: you are misrepresenting the sources as indicating that they only refer to compounded BHRT when in fact they make it a point to differentiate between compounded and FDA-approved BHRT. The responses that you offered do not address the point made, that most sources explicitly differentiate between the two.
quote begins ***
References used in the article and statements on their use of the term Bioidentical - compounded or no - italics added
Cirigliano - "This review of the literature related to compounded BHT and the practices of its advocates is to determine if sufficient scientific evidence supports claims of greater efficacy and safety and any additional risks and uncertainties not generally associated with CHTs."
From the abstract: "It is generally accepted that estrogen-based hormone therapies share similar efficacies as well as risks. Many FDA-approved and regulated pharmaceutically manufactured and branded conventional hormone therapies (CHTs) employ BHs." WLU
Adriane Fugh-Berman, MD and Jenna Bythrow, MS candidate "This article will focus on compounded bioidentical hormone preparations aimed at menopausal and perimenopausal women"
From the first lines of the first two paragraphs: "Bioidentical or natural hormones are being promoted to consumers as benign health tonics. The term bioidentical is a pseudoscientific neologism...Many bioidentical hormone products that require a prescription are prepared by compounding pharmacies" WLU
Lisa A. Boothby and Paul L. Doering "It is the purpose of this review to systematically examine the scientific rigor of the arguments posed by the proponents of bioidentical hormone therapy, and to differentiate the practice of bioidentical hormone therapy from the legitimate practice of pharmacy compounding."
From the abstract: "Bioidentical or natural hormones are expected to have similar efficacy and safety profiles as the commercially available hormonal therapies that have been studied in clinical trials, regardless of whether the active principle hormones are compounded by individual pharmacies or manufactured by large companies" WLU
Holtorf - "Bioidentical hormones are not a marketing term. The term has been used for more than a decade in the inserts to all FDA-approved commercial hormone preparations that contain hormones molecularly identical to human hormones. In a recent review of bioidentical hormones in menopause, Boothby and colleagues reviewed only the compounded formulations of bioidentical. The investigators made no mention of the commercially available bioidentical hormones. This omission inadvertently perpetuated the confusion, credibility, and even existence of bioidentical hormones in FDA-approved commercially available preparations."
Holtof and Erika Schwartz are the sole voices to claim anything special for bioidenticals. Schwartz sells bioidenticals and books singing their praises, and as the many other sources point out, there is no reason to expect their safety and efficacy profiles to be any different from any other forms of HRT. WLU (t) (c) Wikipedia's rules:simple/complex
NAMS - "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 17A-estradiol or progesterone."
Adding the follow-up sentence: "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." WLU
Kalvaitis "The controversy centers around the idea that compounded hormone therapies have not been tested and are, therefore, questionable for use."
Adding first sentence in article - "As a growing population of women reaches menopause, physicians may be fielding more questions about compounded hormone therapies — or, more commonly, “bioidentical hormones.”" WLU
Harvard Women's Health Watch - "Much of the confusion about bioidentical hormones comes from the mistaken notion that they must be custom-mixed at a compounding pharmacy....Unless your clinician has considerable experience with bioidentical hormones and a particular compounding pharmacy, you’re better off with a prescription for commercially available hormones, many of which are bioidentical."
And, the only citation that I found that uses the term Bioidentical to always refer to the compounded product and associated treatments:
Mayo - "Bioidentical hormones are custom-mixed formulas containing various hormones that are chemically identical to those naturally made by your body."
As you can see, Cirigliano makes it clear that his paper is about compounded BHRT, therefore he doesn't unnecessarily differentiate between compounded and non-compounded throughout the paper. He distinguishes between the two when he needs to differentiate between the use of conventional FDA-approved BHRT products, and BHRT the controversial treatment modality.
quote ends ***
"Most often", or "frequently" indicates that there is more than one valid definition for a term. You cannot ignore the significant minority opinion that is supported by published, peer-reviewed papers, as supported by WP policy, even though you keep trying to eliminate the minority view from this article because you don't like it. When an article specifically states that it is written about compounded BHRT, you cannot expect it to then address non-compounded BHRT other than in passing. You interpret this as indicating that non-compounded BHRT doesn't exist; I interpret it to mean that I should be looking for articles that specifically address non-compounded BHRT, which I have supplied to you, and which you choose to ignore. Riverpa (talk) 14:31, 21 January 2010 (UTC)
There's lots of references that cite Somers and her book as a huge driving force behind the BHRT "movement" or interest at least. The greater problem for me is the lack of expansion in the body - I fully believe this statement to be sourceable, but I'll try to dig up more substantiation and guts before reintroducing it to the lead. Until I can assemble better sources and support, I don't have an issue with removing it. WLU(t)(c) Wikipedia's rules:simple/complex13:19, 19 January 2010 (UTC)
I believe that I asked before but I forget the reasoning. Why is there no adverse effects, contraindications, interactions section etc? I understand that the article says the "same risks and benefits" as HRT, which is fine but the lay reader still is left wondering what the side effects are and of course are just going to ask the person supplying the BHRT who may very well be a charlitan. Surely there is a reliable source for this information? Are there groups of people for which this therapy is harmful and specifically should not be used in, i.e. contraindicated/special caution? The article is not following WP:MEDMOS as well as it could.--Literaturegeek | T@1k?23:51, 20 January 2010 (UTC)
If people are taking this compounded stuff which has potent pharmacological properties on the body and brain, lets say they get a simple and fairly common but unpleasant side effect such as anxiety, their regular doctor won't even know they are on BHRT and will just simply diagnose "anxiety" and refer to a psychiatrist etc. This is another downside of self-medicating outside of conventional medicine. Any sources for this aspect?--Literaturegeek | T@1k?23:57, 20 January 2010 (UTC)
The article is redundant is some areas, repeats what has already been said, I may try and fix this without losing content or sources in the next day or 2 if I get a spare half hour.--Literaturegeek | T@1k?00:02, 21 January 2010 (UTC)
I would say there are no adverse effects/contraindications for a few reasons - BHRT practitioners have not done any studies; conventional doctors see them as nothing more than regular hormones with unnecessary marketing nonsense attached; and since bioidentical hormones are treated as a "class" by practitioners, how can you have adverse effects for "all bioidentical hormones". We could put in the adverse effects for individual compounds, but that runs into the criticisms I've made before about putting in the benefits of or comparing different types of HRT - it's original research and hard to justify since BHRT for the most part is simply conventional HRT with some expensive bells and whistles.
I wonder if the article could follow MEDMOS since it's not about a single drug, but more of an approach which most doctors and researchers don't think of as medical or justified. It's possible that some of the review articles could be mined for this information (Fugh-Berman, Cirigliano and the Boothby articles spring to mind as promising for this) but it will also add free-floating criticisms to sections - in Estriol, it'll say "oh, and it promotes breast cancer". In Estradiol it'll say "oh, and it promotes endometrial hyperplasia if not appropriately matched with a progestin". And so forth. Simply put, there are no benefits that are known beyond simple HRT, and it's got the same risks as HRT. But if you're looking for sources, the review articles are good places to start.
Regards your self-medication aspect, I've seen no discussion of that angle. Rosenthal's article is a very interesting examination of BHRT as CAM, and Burrell, 2009 also touches on this quite interestingly - how BHRT tries to capitalize on the claim of being "advanced science" while still clinging ot being "natural", ignoring the research indicating HRT may be unnecessary in general and that "natural" means declining hormone levels post-menopause. WLU(t)(c) Wikipedia's rules:simple/complex13:46, 21 January 2010 (UTC)
As far as side effects specific to compounded BHRT, I could probably come up with something when I get the time, relevant to the compounding. I don't know if women could self-medicate with anything recognizable as compounded BHRT, most components are prescription only. Most regular doctors are very aware of the popularity of OTC supplements and would ask people if they are self-medicating with them - there are many which have bad effects, not just hormones. Riverpa (talk) 14:42, 21 January 2010 (UTC)
Thanks for the reply WLU and riverPA, I am sort of understanding a bit better but I am still a little confused. Let me give you an hypothetical example. Lets say someone is on propranolol for example, they find the standard tablet strength too strong but the next down tablet strength too low, they are elderly with arthritis and can't break the tablet. The pharmacist wanting to be helpful and also perhaps make a few bucks offers in agreement with the elderly person's doctor agrees to compound the propranolol to a customised dose. Ok so the drug is the same, the same contraindications, interactions and side effects would apply, the package insert if given would remain the same. Why is this not the case with bioidenticals? Is there not a package insert that comes with it or at least before they are compounded? Are these bioidenticals sold without any package insert or acknowledged adverse effects profile? Are you basically saying that these hormones are sold to customers with zero official information on adverse effects, contraindications etc? Excuse my ignorance. :) They are pharmacologically active so they must have side effects which would mirror those of conventional HRT or non-compounded versions of the hormone. I am not necessarily talking about increase breast cancer but sure that could be included but things like constipation, anxiety, insomnia, drowsyness, then rare side effects perhaps on liver or whatever, just like any other drug or drug class has its list of adverse effects. Any rebound or withdrawal side effects upon discontinuation? Etc.
Another example would be say injectable medicines, the route may cause an increase in incidence of side effects but the side effect and contraindication profile is basically the same. Or recreational drug, someone smokes cannabis or eats it the potential side effects are the same.--Literaturegeek | T@1k?23:17, 21 January 2010 (UTC)
I am not too interested in side effects specific to the compouding proceedure although if they can be cited sure but I am more interested in side effects which can occur as a result of intake of the compound(s).--Literaturegeek | T@1k?23:17, 21 January 2010 (UTC)
I have found no documented additional side effects for bioidenticals, besides the ones reported for CEE, which the FDA et al say should be extended to bioidenticals. Since there are no head-to-head studies between the two, or randomized controlled studies of bioidenticals, there is nothing that rises to the level of proving that the side effects of CEE do not apply to most bioidenticals, and that's the FDA's story and they're sticking to it. That does not include Progesterone, which has some basis to be considered safer, though mostly primary research at this point. The side effects that may apply to compounded products would relate to quality control, and possible use of undefined vehicles.
The more significant part of your questions relate to the issue of warnings, the compounding pharmacy is not currently required to supply any warnings to the end user of the compounded product. Those are controlled and regulated by the FDA and apply to specific FDA approved products, which these are not. This is another controversy, or maybe another safety issue, and should be addressed in the article more coherently than it currently is. Several of the medical organization statements are essentially calls for the FDA to require compounding pharmacies to provide that type of warning. But that may require a whole new regulatory requirement, each element of a compound might require a separate statement, and then how do you account for effects from different combinations? Manufactured products are defined and static, compounded products are variable. I would not envy the folks at the FDA who would have to figure that out.
What I would like to see, is that under Criticisms, Compounding and Saliva Testing should be split into two separate sections and addressed separately, as they are not necessarily linked. Or just eliminate the heading Criticisms altogether and have paragraphs on Saliva testing and Compounding. Compounding may be used without saliva testing, so they should be treated separately. That would allow a more logical and coherent explanation of the issues specific to compounding. To include only criticisms of compounding is unfair, since it has a valid place in the medical establishment. That would allow all content about Compounding to be gathered into one section rather than scattered about as it is.Riverpa (talk) 05:04, 22 January 2010 (UTC)
If we wanted side effects, we could go to the specific side effects of the individual hormones because they are drugs that already have a research base with side effects - we could even go straight to the black box warning for say, oral estrace, vaginal estrace cream, estrogel, estring, prometrium, prochieve 4%, but we'd have to dig probably in Europe for estriol. I consider this approach problematic. The only extra side effects the page would really require would be those of the compounding process itself - impurities, dosing too high or too low, and probably etc. I agree with Riverpa that the side effects of BHRT are expected to be the same as non-BHRT, and compounding presents more. WLU(t)(c) Wikipedia's rules:simple/complex19:13, 22 January 2010 (UTC)
Ok, I have made a start on the side effects section. Thank you for providing those links, very helpful. I am just realising that the side effect list is quite long! If we are going to do side effects for each individual compound we will end up with a rather long list. I am beginning to wonder now if we should briefly summarise the side effects perhaps according to body system effected, eg cardiovascular, cns effects etc rather than listing the individual side effects for each drug. and then have a "see also" wiki link to the side effects section of the individual compounds? The article isn't super bloated yet with side effects but it will be when we get through each hormone. So is the brief summary and a see also link a better idea? Let me know. :)--Literaturegeek | T@1k?08:57, 27 January 2010 (UTC)
Undent. That's more like a finish than a start... There's already sections that mention specific compounds, perhaps they could be rolled into them? I don't see the page as strongly bound to MEDMOS because it's not about a single drug - it's more about an approach. I do agree that a shortened version would be better, perhaps a more simple set of statements saying "have adverse effects on the X, Y and Z system". I'd have to check MEDMOS, is it standard to report on all side effects irrespective of frequency? Perhaps it would be better to restrict it to the most common ones? I'm not sure. WLU(t)(c) Wikipedia's rules:simple/complex13:42, 27 January 2010 (UTC)
Another option could be removing the table that currently shows the FDA-approved bioidenticals and instead expanding the sections on types of hormones. Instead of a section called 'estrogens', we list specific estrogens (estradiol, estriol, estrone), FDA-approved sources and side effects. WLU(t)(c) Wikipedia's rules:simple/complex13:52, 27 January 2010 (UTC)
Sorry for the delay in responding. I was trying to work the midazolam article up to good article status. It may look like a finish but I have not got to the contraindications and interactions and then the same with the other hormones. I don't think that the article needs to be strongly bound to MEDMOS but just thought that the adverse effects and contraindications etc needed more of a mention that just "similar risks and benefits". Restricting it to the most common ones is a possibility but serious ones need mentioning as well unless they are like very rare. For now I have just added a shortened version summarising the systems effected. When I have done all of the hormones we can always reassess and change how we present the information. These are my thoughts anyway. From memory of MEDMOS it is not necessary to report all of the side effects. You are welcome to rearrange my edits as you see fit but I am wondering if it is better if you wait until I have added all of the bioidenticals. I should have more time this week now that I have finished developing the midazolam article.--Literaturegeek | T@1k?08:26, 2 February 2010 (UTC)
One of the first proponents of the use of bioidentical hormone therapy was John R. Lee[3] whose claims fostered the unfounded belief in progesterone was a panacea for many health conditions.[4] Another proponent of bioidentical hormone therapy, Jonathan V. Wright, was in 1982 one of the developers of the BHRT compound Tri-Est, comprised of 80% estriol, 10% estradiol, and 10% estrone.[3] Wright's popular books on the topic have had a strong influence on BHRT advocates.[5]
Version 2
One of the first proponents of the use of bioidentical hormone therapy was John R. Lee.[3] He believed that "estrogen dominance" contributed to a variety of health problems and promoted the use of bioidentical progesterone to combat these effects.[6]
His claims fostered the belief in progesterone as a panacea, though there was no scientific proof to support them.[4] Another proponent of bioidentical hormone therapy, Jonathan V. Wright[7] has written a number of books on the topic and, in 1982, was one of the developers of the BHRT compound Tri-Est, comprised of 80% estriol, 10% estradiol, and 10% estrone.[3] BHRT practitioners recommend the use of Tri-Est, or Bi-Est, a similar compounded product, because they are purported to more closely mimic the ratio of circulating hormones in a woman's body than do commercially manufactured products.[8] Wright's popular books on the topic have had a strong influence on BHRT advocates.[5]
I believe version 1 is the better one. Version 1 excludes the theory of "estrogen dominance" which is not supported by research and from what I know is primarily a CAM and BHRT statement with no recognition by nonpractitioners. It is also redundant as the "health problems" and "panacea" statements are essentially the same thing. In addition, the link used to support it doesn't seem to justify this specific statement as the only mention of Lee in the article is this: "Over the past three decades the use of bioidentical progesterone cream has been a popular health option to help women overcome issues of estrogen dominance as well as symptoms of menopause, an approach made popular by John Lee, M.D." Ergo it is essentially unsourced but linked to a popular article that promotes the totally unjustified idea of estrogen dominance in contravention of WP:MEDRS and WP:FRINGE.
Regarding the second paragraph of version 2, there is no reason to link to Wright's resume when Rosenthal, 2008 is a more reliable source, a secondary source, and actually analyzes Wright's contribution. The sources also appear to be wrong as Boothby 2008 doesn't seem to discuss Biest or Triest at all, let alone why BHRT practitioners think they should be used. Boothby 2004 does, but does so critically, pointing out that it leads to a dose of hormones that is beyond what is necessary to maintain osteoporosis.
With this in mind, I'm going to adjust the history section again to reflect this, and the best sources we have available. There is no need to use a random website when we have peer-reviewed sources that will do. Particularly when the website strongly promotes bioidentical hormones without refering to the weaknesses identified in Rosenthal, Cirigliano, Fugh-Berman and both Boothby articles. I've put up an in use tag and will mine the five reliable sources for information so we can avoid the use of popular and biased websites. WLU(t)(c) Wikipedia's rules:simple/complex14:06, 22 January 2010 (UTC)
Have a good time with that. I don't believe much of what you say, since, for one, I used Cirigliano as the original reference about Wright, not Boothby until you changed it, and Cirigliano says "In another review by Wepfer,97 Jonathan V. Wright, M.D. is accredited with the move from estradiol as the sole estrogen used in BHRT to a triple-estrogen formula. Wepfer claims that the formula was based on individual estrogen levels determined from blood sera taken from Ia group of premenopausal, non-pregnant women.97" If you stopped altering the references you wouldn't have anything to complain about, but you are happier changing things to make them untrue. Doc James seemed to think it was OK since he didn't alter it. Your reading comprehension and research skills can't seem to find info that doesn't align with your views, and you deliberately change things that don't agree with your views. I am sure that the rest of your research mentioned above will be of the same quality as that gem. I do not concur with your changes since they are omitting information that should be in the article, as I also disagree with your deletion of the Controversies section, which will be restored soon. If you think it is redundant, you should fix it, not delete, as you have said to me before. Riverpa (talk) 16:59, 22 January 2010 (UTC)
Every piece of information on Lee and Wright I checked today and edited the page while the PDF for the relevant article was included. I don't believe I've made any mistakes, but feel free to check.
What information is now missing from the History section? The estrogen dominance continues to be an unnecessary addition that puts too much weight on a subject that isn't considered real by actual doctors and scholars and isn't actually used by anyone but proponents. I'm of the opinion that this section presents too much claim-counterclaim; since their actual opinions appear to be worthless as far as a research base goes, I'd rather simply remove them.
Controversies was removed because there was no real controversies - and a duplicate section on regulatory status in the US. The Wiley Protocol isn't really a "controversy", it's a controversial type of BHRT. For me this means a separate section in which the topic is summarized and the controversy alluded to - ideally a brief summary should be there, this one is inadequate, but I've got enough other stuff to do that I don't feel like taking the time to flesh it out. I believe I did fix it, but integrating it with another appropriate section - no information was lost and two sections with identical titles were merged into a single, comprehensive one. There's simply no need for a "controversies" section when we've got a title about the specific controversy - it's regulatory status. WLU(t)(c) Wikipedia's rules:simple/complex18:53, 22 January 2010 (UTC)
AnomieBot
I just trimmed the lead down a bit and removed the unnecessary, ugly references. This unfortunately left a large number of "Reference name X can't be found" tags in the Reflist section, but I'm hoping User:AnomieBOT will be along presently to correct things. WLU(t)(c) Wikipedia's rules:simple/complex13:45, 15 March 2010 (UTC)
NPOV
This article has evident bias--as seen in its misuse of definitions, its unjustified generalizations, and its exclusion of evidence and other points of view. Like other editors who argued extensively and in great detail against WLU in the past, I gave up in frustration. Neither I nor Riverinpa nor other persons had or have unlimited time to devote to fighting with such a determined propagandist over a Wiki page. WLU repeatedly, and without rational justification, removed every evidence, argument, or point of view that disagreed with his anti-bioidentical position. (Does it even make sense to be against human hormones?) I see now that WLU has gotten what he wanted--the page is fully owned by him and no one even bothers trying to change it anymore.
There is no point is rehashing any arguments with WLU. All his violations of Wiki policies, all his pseudo-arguments against including evidence and points of view have been exposed in the talk pages. The reader can begin with Archive_5 and work backwards. Fortunately, WLU is a lousy writer, so the intelligent reader can see quite quickly that this is a hatchet job. BHRT is a dead page and will remain so as long as WLU owns it.Hillinpa (talk) 14:51, 17 April 2010 (UTC)
Hillinpa, after coming to the article ignorant of the subject matter and familarising myself with the subject matter has made me think that the bias, dangerous bias is coming from the bioidentical HRT commercial promotors. How can distributing chemical compounds, with no package insert, which have side effects including increased risk of several cancers, psychiatric adverse effects, increased risk of heart attacks and a wide range of other serious adverse effects be considered anything other than dangerous? This could be argued to be the real propaganda. The article is quite tame in my view actually considering the fact that many women are almost certainly being killed due promotion of these drugs as a panacea, many women taking these drugs don't need them I am sure. I know this is a bit harsh but it is not me being harsh but rather the facts being harsh. Why are you not outraged at the fact that women are getting harmed and even killed unnecessarily by being sold bioidenticals without package inserts or oversite by a doctor? I believe WLU is a she.--Literaturegeek | T@1k?15:16, 17 April 2010 (UTC)
"Even killed unnecessarily?" Wow, I think you need to tone down your rhetoric! That's really inflammatory. It's also worth noting that ALL hormones have potentially serious effects, whether bioidentical or not. Bioident. advocates like to take all the potential negatives and ascribe them to the "unnatural" qualities of hormones. Allopathic supporters like to, in contrast, emphasize the dangers of non-medically supervised hormones, as if the one is safe and the other not. The reality is far more complex. And what we do know is that all of the potentially negative side effects of bioidents are the same potentially negative side effects of the kinds available at your local pharmacy. Sadly, oversight by a doctor does not necessarily guarantee freedom from worry. And while some women might be better off without hormones at all, it's also worth mentioning that for some women, like those under 40 who do not ovulate for whatever reason, they are at FAR more risk if they don't take hormones than if they do (according to the Harvard Nurse's Study, women who stopped ovulating, either due to surgery or premature menopause, before age 40, lived an average of 8 years less than otherwise similar women). Part of the reason why these issues are so hotly debated is that taking hormones has some pretty strong positives in terms of quality of life for some women (and length of life for a particular subset of women), while a very small percentage of women will experience serious side effects like cancers. Do you accept the positives you will definitely get while accepting certain small risks too? Or do you reject the positives and suffer in order to avoid increasing your risks of something that you may never have gotten anyway? Shouldn't women be allowed to decide for themselves? Shouldn't both doctors and bioident advocates lay out all the risks and benefits? Wouldn't it be nice if Wikipedia could have a decent entry about it, too?QuizzicalBee (talk) 21:07, 17 April 2010 (UTC)
Yes, I agree Quizzical, that some women need HRT and the benefits outweigh the risks. I do still maintain that bioidentical products sold without any warnings, package inserts are leading to unnecessary deaths. I also understand that oversite by a doctor does not guarantee freedom from risks. I believe that you have misinterpreted my post, I not talking about conventional HRT but the unregulated bioidentical market. I am not sure why you see that as rhetoric? I interpreted the post from Hillpa as hostile so I felt it necessary to talk about the facts that these drugs have life threatening effects and the way they are sold and promoted outside of conventional medicine is dangerous. I believe the entry now summarises the benefits and risks quite well now.--Literaturegeek | T@1k?22:14, 17 April 2010 (UTC)
Human hormones are not drugs. "Bioidentical" is simply the adjective that specifies that the molecule is a human hormone and not an altered molecule produced in order to gain a patent and monopoly profits. What you should be angry about is the fact that because of the gross misinformation circulating about the bioidentical human hormones--estradiol and progesterone--women are being denied the treatment of their severe estradiol deficiency--which is well-known to hasten their deterioration and death by heart disease, osteoporosis and dementia, not to mention causing depression, poor memory, hot flashes, vaginal atrophy, etc. etc. Replacing the hormones lost at menopause ameliorates the health problems caused by their absence--this is simple common sense. The question is how to best replace the hormones to confer all the benefits without causing harm. WLU has spent many hours on this article to suppress the fact that the correct human hormones delivered in the correct way--trandsdermal estradiol and progesterone--have not been show to have the dangers found with Prempro or birth control pills. WLU has suppressed scientific evidence of the safety and efficacy of real hormone replacement (not hormone substitution with patented drugs). It is only the non-bioidenticals that have been proven to be dangerous. It is true that unopposed estradiol, even transdermally delivered, will increase the risk of breast cancer (Million Women Study). But transdermal estradiol given with natural progesterone has not been shown to increase the risk of breast cancer. In E3N/EPIC there was a direct comparison of transdermal estradiol given alone, and given with progesterone or various progestins. The progestins were found to increase the risk of breast cancer substantially, whereas progesterone did not increase the risk above baseline. Here's the study, which is mentioned in the bibliographies of both the IMS and NAMS statements.[47] This study and many others dealing with breast cancer, progesterone, and progestins are discussed in a major review article. [48] This is a secondary source of high quality that deserves to be included in this Wiki article. The authors conclude "We therefore suggest that when HRT is indicated, preparations containing progesterone and not a synthetic progestin should be used.." After breast cancer, the second most-feared danger of HRT is blood clotting, here we find an overwhelming amount of evidence and reviews supporting the view that transdermal estradiol does not increase blood clotting AT ALL, and has not been associated with increased heart attacks and strokes.[49][50][51] Given the above evidence, you can see, that it is false to say that "all FDA-approved hormone products are alike". The International Menopause Society recognized both the advantages of transdermal estrogens and progesterone in its statement.[52]. Given this article's exclusion of scientific opinion and evidence regarding the requirement for estradiol and progesterone for female health, and the safety of restoring these two hormones as opposed to the dangers of oral estrogens and progestins, it is currently in violation of WP:NPOV which states that "all Wikipedia articles and other encyclopedic content must be written from a neutral point of view, representing fairly, and as far as possible without bias, all significant views that have been published by reliable sources. An article should clearly describe, represent, and characterize all the disputes within a topic, but should not endorse any particular point of view. It should explain who believes what, and why, and which points of view are most common." Hillinpa (talk) 08:10, 18 April 2010 (UTC)
I'm a he. QuizzicalBee, "even killed unnecessarily" is a concern - the hormones are handed out without packaging inserts, and promoted by BHRT proponents as being virtually risk-free, with no safety concerns whatsoever. LiteratureGeek has added references to these exact hormones using actual packaging inserts (many from Europe), which indicate that far from being risk-free the bioidentical hormones have the same risks as other types of hormones. Having not done the research to compare them head-to-head, advocates are unjustified in claiming they are better than their better-studied counterparts. Overall I think the page does a good job of indicating that BHRT is expected to be about the same as conventional HRT in terms of risks and benefits - but what do you think is incorrect, misrepresented or otherwise problematic about the page?
Hillinpa, hormones are drugs when introduced from an external source (since the definition of "drug" is a very loose thing). They alter the functioning of the body in wide-ranging ways. Bioidentical hormones may be less risky than conventional hormones, but until the research has been done, comparing them head-to-head, we can't know that. But look at the adverse effects section (which I did not write). They are sourced to packaging inserts for bioidentical hormones. These hormones have risks (and further, drug companies are already making a profit off of them, just like proponents are - to claim that only drug companies are motivated by profit ignores just how much of a markup can be made from selling compounded bioidenticals).
Also to Hillinpa - I have spent many hours reading and justifying my edits using reliable, peer-reviewed sources, which converge on a single message - bioidentical hormones are expected to be just as dangerous as conventional hormones. I have consistently pointed out that we should be using articles that are explicitly about bioidentical hormones, not using other sources to synthesize a new conclusion that "properly delivered" bioidentical hormones are safer and better than nonbioidentical hormones. By citing sources that do not use the term "bioidentical" (and none of those studies do) you are engaging in original research which is prohibited here. Further, in one case you are attempting to use the same source to say two different things - holding up the IMS statement as promoting bioidentical hormones, when it has a section on its third page ("Alternative Treatments") which actively criticizes and argues against their use. You can't use this source to say good things about bioidentical hormones without blatantly misrepresenting it by emphasizing the conclusion you like at the expense of the much more explicit conclusion you do not like.
The page is in keeping with NPOV, and this is demonstrated by the multitude of sources which converge on a single opinion - bioidentical hormones are not worth the hype, and in many cases are essentially identical to conventional hormone replacement therapy with all of its attendant risks. You wish to write an article which adheres to your definition and research - this is inappropriate. The page gives minor weight to the few, low-notability authors publishing in low-impact journals (who derive much of their income stream from bioidentical hormones) who think BHRT is better than regular HRT. This is appropriate and very much in keeping with our policy on a neutral point of view. WLU(t)(c) Wikipedia's rules:simple/complex11:31, 19 April 2010 (UTC)
You are still playing the game of defining the subject to suit your purposes. Either "bioidentical" means "identical to endogenous hormones", i.e. that the molecule is a human hormone as the title of the article says, or it means something else that you have in mind and are keeping quite secret. It cannot be both. It would be nice if you would dispel the confusion and begin the article with your definition. Then the reader would at least know what they are reading about. As long as "bioidentical" means "identical to the human hormone" then all evidence, reviews and statements regarding molecules "identical to the human hormone" are appropriate to this article and are not WP:SYNTH nor WP:OR. For goodness sake, you list the FDA-approved bios right in the page--and you quote some studies regarding the bios (in which they are not referred to as "bios"). It is evident that you are manipulating what is "acceptable" in order to support your bias.
You are specifically suppressing the sources like those I have mentioned. To exclude them for what you believe to be the consensus is inappropriate and a sign of bias. Read the NPOV again, and again. You have no right to exclude evidence, reviews, and position statements that differ from your POV just because the American FDA and several other drug-company funded organizations, and all the doctors who believe in the sanctity of these organizations support your POV. A significant dissenting view--and the evidence supporting it--must be included. Don't you think that women have a right to know that a safer alternative "may" exist? What right do you have to deny them that knowledge?
As an exercise in the science of the issue, just try this: Find any evidence that transdermal estradiol increases blood clots, strokes or heart attacks. Find any evidence that any estrogen (bio or non-bio) accompanied by progesterone has been found to increase breast cancer. In fact, I have shown you that the evidence says otherwise. For you to say that the risks are the same is a lie--plain and simple--no matter how many organizations or doctors are repeating it. Repeating lies is not good research or encyclopedic writing--ever.
Only persons unfamiliar with the workings of the FDA, drug companies, and the content of package inserts would believe that because a warning appears in the prescribing information it means that that risk has been found with that particular product. The FDA often applies warnings found for the class of drugs to any new drug in that class--just to be "safe". When it comes to female hormone replacement specifically, the results of the PremPro debacle are generalized and applied to all hormone products. This is done for legal and administrative reasons. Same with any glucocorticoid product--all list the same adverse effects even if not every adverse effect has been documented with every product. To determine the actual risks one has to look at the evidence regarding that molecule, delivered into the body in that way.
The NPOV tag stays until you agree to abide by the definition given at the beginning of the article for "bioidentical hormone replacement therapy", and you agree to abide by the Wiki policy on NPOV. It wouldn't seem to be too much to ask, but experience has taught me differently.Hillinpa (talk) 23:13, 19 April 2010 (UTC)
Transdermal alters the pharmacokinetics of the hormone, so that it is absorbed more slowly and dare I say "naturally", it avoids the sudden surge followed by decline, followed by a sudden surge in blood levels etc which occurs with oral preparations. If transdermally administered hormones show a reduced incidence or even avoidance of certain side effects, then all that can be said is that transdermally administration may have advantages over oral preparations. The reduction in side effects if confirmed is not to do with the drug being "bioidentical" but rather its method of administration. This is neither strange nor startling, it is widely known that intravenous administration (very rapid [and unnatural] surge in blood levels) greatly increases the risk of side effects of lots if not all drugs from antibiotics, to CNS drugs; oral administration is probably a happy medium between IV and transdermal. Hopefully this makes sense. My point is it seems that you are trying to apply findings of a different mode of administration to the structure of a compound which seems to me to be incorrect. Correct me if you feel I am wrong or misinterpreting.--Literaturegeek | T@1k?23:23, 19 April 2010 (UTC)
Your argument that one doesn't understand the workings of the drug companies and regulatory bodies is a logical fallacy because the bioidentical commercial industry have the exact same conflicts of interest that would apply to drug companies. Infact the likelyhood of corruption of process is higher for bioidenticals due to a lack of regulatory oversite, so your argument boils down to my "bioidentical drug company/industry" is better than your drug company/industry (without any references to back up allegations and seems belief only based).--Literaturegeek | T@1k?23:34, 19 April 2010 (UTC)
Ironically Hill, you are using the same techniques of argument as drug companies when you say "To determine the actual risks one has to look at the evidence regarding that molecule", this is exactly the same as the arguments made by the drug companies over benzodiazepines and drug scheduling when flunitrazepam and temazepam were moved from schedule IV to III that the risk/benefit ratio must be proven for each individual drug to reclassify etc to stop other benzos being reclassified. You are talking like a drug company person now hehe. ;-)--Literaturegeek | T@1k?23:45, 19 April 2010 (UTC)
Although there is some truth in the statement that individual drugs within a class can have a worse or better adverse effect profile; was just having a little fun with your posting when I saw you talking like a drug company person. :)--Literaturegeek | T@1k?23:50, 19 April 2010 (UTC)
First of all, the reason I objected to "even killed unnecessarily" is because the word "kill", in its primary definition, means put to death due to some intention to do so (just google the definition). So, yes, to accuse advocates and sellers of knowingly and with forethought killing people out of deliberate intention to do so is over-the-top rhetoric. Had you said "died unnecessarily", that would be a different matter. Personally, I have no doubt that women have, or will, die as a result of taking BHRT—just as many have died as a result of taking regular ol' Premarin or Prempro prescribed by their doctor and with the package inserts, and many have died due to lack of access to, or being told not to take, hormones that could have prolonged their life. I do not ascribe malice and deliberate intent to inflict harm in these cases, though certainly there are a lot of lawyers right now who are trying to prove just that in the class-action Prempro lawsuits. Basically, the villification of BHRT advocates implicit in what you said is frankly uncalled for—and unsubstantiated—and a violation of Wikipedia rules about keeping conversations civil. That was my objection. And personally, I find it misleading and object to people empasizing deaths perhaps due to one category of hormone, while not mentioning the possibilities of the same consequences of the other. It just sounds biased. You're right about the logical fallacy, Literaturegeek, which is why I try to avoid tarring one side when the other side could be equally at blame or in ignorance. But this is all a side issue and I've spent too long talking about it. The real issue is the wikipedia article. I've edited it a little bit where I feel that there is inadequte evidence to support some points—like saying that BHRT advocates (esp. Dr. Lee) think progesterone is a panacea. (I completely agree with you that this is true, but the reference you used doesn't support that. Evidence in its support will come from Lee's books and also some of the pro-progesterone websites. I think it would be useful to provide a list of things progesterone is supposed to cure/treat, because the list in and of itself acts to discredit Lee's assertions since the list is so all-encompassing). Other changes I made include some cleanup of sentences, or clarifications. QuizzicalBee (talk) 02:38, 20 April 2010 (UTC)
A few questions: In this sentence: "BHRT is used to reduce the symptoms of menopause. It is also promoted by some practitioners for anti-aging purposes, and as providing benefits beyond menopausal symptom relief" I think naming the benefits beyond menopausal symptom relief that are claimed, with sources would be good.
This sentence: "In the US, the practice of pharmacy compounding is governed at the state level, while the FDA has regulatory authority over the compounded product." Is this correct? From the context, I thought it would say "while the FDA has regulatory authority over the commercial product." Or something to that effect.
Also: I greatly changed the second paragraph under "Criticisms" as I felt it did not accurately reflect what BHRT advocates say, nor was there a complete symmetry between what they claimed and what was said not to be true.
I think this should be deleted: "The "Harvard Women's Health Watch", published by Harvard Medical School, puts forth the proposition that the emphasis on the word "natural" in the the marketing of BHRT may be a euphemism for "unregulated" rather than "safe". They point out that semantically, "natural" can be used to indicate any product with an animal, plant, or mineral source, and as such it also applies to hormones that are not bioidentical, including Premarin, as well as to the molecules extracted from soybean and yam." It's a semantic argument and doesn't address the validity or lack thereof of any claims.
I think this should also be deleted: "Compounded BHRT is more expensive than conventional, FDA-approved HRT and is often not covered by health insurance plans." this is not the fault of or a criticism of BHRT. Rather, it's a criticism of health insurance plans. After all, some health insurance plans won't cover birth control pills. But that does not address the legitimacy or efficacy of birth control pills.QuizzicalBee (talk) 04:34, 20 April 2010 (UTC)
Have either of you any response to my remarks concerning the WLUs exclusion of studies, review papers, and even the IMS's own statement regarding the safety of transdermal estradiol and progesterone over other forms of HRT? What do you say about an article that defines bioidentical HRT as using hormones identical to the human hormones, but then excludes all evidence regarding the safety of the bioidentical hormones? The makers of Prometrium--bioidentical progesterone--the one used in the studies WLU wants to exclude, proudly state that it is bioidentical on their homepage! WLU's game is over, the cat's out of the bag. OB/GYN's are being forced by their patients to prescribe bioidentical hormones--the FDA-approved ones.
Literature Geek, the reason that transdermal estradiol is more safe is that it avoids first-pass effect in the liver. Whatever one swallows enters the liver directly from the intestines in a very high concentration. The liver gets a massive overdose. In the case of oral estrogens--even oral bioidentical estradiol--this causes an increased production of clotting factors, increased C-reactive protein, and decreased IGF-1--none of which are good. Transexual male-to-females given oral estrogens had 40x the normal male incidence of blood clots, but when changed to transdermal estradiol has 0 increase in risk. Ethinyl estradiol is thousands of times more potent per mg than estradiol and it increases clotting even when take transdermally--witness the disaster with transdermal birth control patches (OrthoEvra). Regarding the FDA warning, nothing you said changes the fact that transdermal estradiol products all carry the same warning about blood clots as do oral estrogen products in spite of the preponderance of evidence showing that they do not increase blood clotting. For example, for Estrogel you'll read "Estrogens, with or without progestins, have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (such as in the lungs or legs), cancer of the uterus, and breast cancer in some women." Notice that this is a generic warning about estrogens based on the WHI and does not deal with the evidence regarding transdermal vs. oral estrogens. Likewise, Prometrium carries warnings due to the problems found with progestins, in spite of the evidence indicating the bioidentical progesterone does not cause those problems.
Quizzical Bee, the article as it stands is full of falsehoods. One of them is that compounded preps are more expensive. Divigel, Estrogel, and Evamist are pharmaceutical transdermal estradiol products. They cost around $80 to 200/mo. depending on the dose. At the local compounding pharmacy near me, the very same USP-certified estradiol in a cream that delivers the same amounts systemically costs $15-$20. Of course there may be some that charge a lot more, but I've seen the same low pricing at large mail-order compounding pharmacies too. What would a smart woman choose? What could possibly make the same estradiol in a compounding pharmacy's gel or cream a more dangerous creature than it is in a pharmaceutical company's gel or spray?Hillinpa (talk) 11:39, 20 April 2010 (UTC)
QB, the chart in lack of evidence is sourced solely to Boothby & Doering, since they are the only article directly comparing specific claims versus evidence. I can e-mail you the articles if you would like - today I spent some time correcting a variety of statements to the appropriate sources. In some cases your edits were improvements but in others they attributed text to articles that did not verify them. I've also added references to the "panacea" statements (though not in the lead per WP:LEADCITE - past versions end up being cited to a hideous degree, see for instance this version). I tried to indicate in my edit summaries where this is the case.
Also, "killed" doesn't always imply intent (murdered would) but women have been killed by their HRT. I read it as a term without intent, though I see how it could be read otherwise. The page itself does not use kill, murder, death or dead. I believe LiteratureGeek's statement was more about compounding pharmacies handing out bioidentical preparations (which are hormones, and therefore potentially dangerous - even when not exogenous as tamoxifen can attest to). LG is making a statement I myself have alluded to in the past - evil intent and greed is attributed solely to one side of the disagreement, the drug companies. Meanwhile, doctors and pharmacies who sell bioidentical preparations do so with less oversight, less regulation, less safety information, lower quality control standards and less accountability than pharmaceutical firms who, for all of their faults, still manage to produce compounds where you can trust that what it says on the package is within a reasonable degree, what you will be getting.
Regards the criticisms paragraph, I must comment on that specifically. I stuck as closely to Cirigliano as I could. Estradiol and estrone are both available in commercial and generic versions. Estriol is not, but this is noted as a separate issue due to FDA approval. Cirigliano is also explicit about testing not being meaningful. Again, I can provide the reference if you would like.
Hillinpa - Bioidentical in the dictionary definition of the term is meaningless (there is no universally-accepted definition, it is a neologism). However, it is commonly used to refer to the package of endogenous molecules with custom compounding and saliva testing (which are only bioidentical in the packaging, as there is modification once they enter the body - and some become bioidentical once they enter the body). That bioidentical hormones are available as FDA-approved compounds is part of the meaninglessness of the whole field - there is no "bioidentical hormone therapy", there is only approved drugs, nonapproved drugs, compounded and noncompounded. Advocates muddy the waters by attempting to separate good (compounded bioidentical) and evil (from the drug companies, who apparently want only to kill them). These charicatures do not help and are part of the difficulties in the page, the topic is complex and fraught with conflict. We represent the field, not reality - in other words, we report verifiability, not truth, as found in medically reliable sources, in a way which gives due weight to the mainstream medical opinion. The mainstream opinion is clear, there nine large, mainstream agencies or bodies that state HRT is expected to present the same risk, irrespsective the type. I have never seen any indication from you that you acknowledge the significant degree of skepticism about bioidentical hormones presented by these agencies, beyond the occassional ad hominem about everyone being in cahoots with the drug companies. You appear to believe you have The Truth and think wikipedia is the place to promote that truth. This is inappropriate. Until the mainstream medical opinion is that bioidentical molecules are better than non, this is the stance we take. Doctors are not "being forced to provide bioidentical hormones". The hormones prescribed are FDA-approved molecules with risk and benefit profiles that are known through research. There is no conspiracy, as many sources have stated there is a dearth of studies that directly compare different molecules and administration routes - you are seeing conspiracy where I see a simple lack of research.
And for the love of monkey Jesus, I'm not "suppressing" information and I've replied to these exact complaints about your use of primary studies repeatedly. The page is stuffed with sources, yours just require original research to shoehorn them in. We're supposed to be reporting the mainstream, not trying to define it. I'm not going to bother searching for terms when "bioidentical" works just fine and gets me exactly the sources I need. The NPOV tag stays until your concerns have been addressed, or found without merit. It is not a badge of shame, and it is not a way of showing you do not approve of it. Consistently, you have failed to provide adequate sources or policies to support your point, and ignored the sources and policies I have referred to. This is very aggravating.
As a final comment - what would a smart woman choose? Hopefully something based on science, recommended by their doctor. We are not a how to manual and we do not give medical advice. If you want to write either, you should choose a different online venue. The principles are, as always, WP:OR, WP:NPOV, WP:MEDRS, WP:UNDUE and WP:NOT. These are, and ever have been, the reason I object to your edits and suggestions. WLU(t)(c) Wikipedia's rules:simple/complex18:35, 20 April 2010 (UTC)
WLU: let me address what you have said here. First of all, I have read Cirigliano, and your claim of sticking closely to him is not the point here. I know you have read him. The point is that what you have done is to, at times, cherry-pick parts of him in misleading ways, strengthening your biases rather than conveying a NPV. For example, the “Criticisms” paragraph said, before my edit: “Advocates for BHRT have claimed that commonly compounded BHRT preparations are not commercially available, which is not true.” In reality, as you know, parts of it are true, and parts of it are not true, since 1) some BHRT preparations are commercially available, while others are not. By simply saying “not true,” you have obscured that fact, and left the reader with the impression that none of it was true. And 2) while some of the particular hormones like estradiol are available commercially, the combinations of hormones (triest, biest, etc.) are not available commercially. For that matter, testosterone in female-appropriate dosages is not commercially available, nor is it available alone, a fact Cirigliano mentions too. That is highly relevant. The next sentence that was there was: “Customized compounding does not actually provide customized results since it is aimed at producing a single hormone profile, which has not been demonstrated to be better than CHRT and does not consider the rate at which individuals will differ in the activity, metabolism and excretion of the hormones.” Again this is misleading, with it's universal "it is aimed". I assume you or whoever wrote the WP sentence are using the following sentence of Cirigliano as proof: “Customized compounded preparations, as advocated by some, are in reality a one-size-fits-all approach, as a single unproven profile is the gold standard of determining doses. The optimal ratios of estrogens that are sought in all postmenopausal women as advocated by some compounded BHT proponents...” Cirigliano says twice that only some advocate this. But the WP article does not qualify the assertion by saying that only “some” feel this way, implying that all believe in this one assertion that has just been discredited. That is why I rewrote the rest of the paragraph and a few other things—to clarify these points.QuizzicalBee (talk) 07:23, 21 April 2010 (UTC)
The definition of bioidentical is crystal clear and scientifically valid. The term is properly defined at the beginning of the article. Only those engaging in information warfare try to confuse its meaning. The word game you are trying to play here is hilarious. They are "bios", then they are not". FDA "bios" are not "bios", etc. Estradiol and progesterone are the bioidentical hormones in question--whether they can be given in ways that are more safe than other FDA-approved hormone products. I have not referred only to studies, but also to important review articles such as Campagnoli's comparison of progesterone and progestins, and Canonico's recent review of oral vs. transdermal estrogen. I have also referred to the Int. Menopause Society's statement about the potential greater safety of transdermal estradiol and progesterone vs. alternatives. The significant dissenting opinion and evidence must be included. It is clear--as QB points out above, that you are overstating your case. The fact remains: You have no right to create a straw man--your own silly version of BHRT--nor to suppress important information from various sources regarding the greater safety of the bioidentical hormones. Hillinpa (talk) 11:04, 21 April 2010 (UTC)
QB - sticking close to the sources is what we are supposed to do, per WP:V, WP:OR and WP:NPOV. As far as representing him fairly, regards the "Criticisms" paragraph, what do you think of my summary here? From what I can tell all hormones are available in commercial versions except estriol, which is banned by the FDA (and I noted this relation to triest and biest here). You did not adjust that section again, and I did my best to incorporate your points - is the current version acceptable to you? Is it a matter of bias, or detail? I think the current note of estriol's lack of availablility is adequate.
What do you think of the changes I made here regarding testosterone? It notes that it has limited availability.
Regarding your final point, I added "some" here. Is that acceptable?
Regarding your edits yesterday, my primary concern is with this edit. The packaging insert does not, from what I can tell, quantify the risks making it a misrepresentation of the source. Can you point me to the section of the packaging insert that verifies this statement?
Hillinpa - see the archived section on definitions. The way the articles use the terms incorporates much more than being molecularly identical, and "bioidentical" is really only used by advocates, or by articles criticizing the advocates' claims. My overall point is that the majority opinion is that bioidentical hormones are hormones, with all the attendant risks. Can you please tell me how we can, in keeping with wikipedia's policies and guidelines (particularly WP:UNDUE) substantially change the page when there are so many critical statements by so many agencies and bodies, all converging on the idea that there is no reason to expect them to be substantially less risky or more beneficial than conventional hormones? As far as method of dosing goes, Cirigliano contains a table spanning six pages which discusses a multitude of hormones and combinations - and most bioidentical administration routes are available in commercially-prepared versions. So what is your objection? You have referred to the IMS's statement, but you have not addressed how to deal with the statement "There are no medical or scientific reasons to recommend unregistered ‘bioidentical hormones’." I find your comment confusing since it about a route of administration, which is totally independent of whether or not a hormone is bioidentical. Why do you keep bringing up the route of administration when this page is about bioidentical hormones? I’m not arguing that different routes of administration are expected to pose different risks. No-one is, it’s a point we all agree on. I just don’t see the relevance for this page, which is about bioidentical hormones.
What are the sources for your dissenting opinions? What is my straw man? What evidence is there that the safest possible combination in all cases is bioidentical progesterone and estradiol administered transdermally?
Actually looking at the sources, Canonico 2008 states "One study suggested that type of oestrogen might be an important determinant of the risk of venous thromboembolism. In this study conjugated equine oestrogen was associated with increased risk whereas esterified oestrogen was not...recent data from one case-control study showed that norpregnane derivatives might increase the risk of venous thromboembolism whereas there was no association between venous thromboembolism and micronised progesterone and pregnane derivatives" and wraps up with the conclusion "More data are required to investigate differences in risk across the wide variety of hormone regimens, especially the different types of progestogens". Canonico is about route of administration, with only tangential mention of the type of estrogen.
Løkkegaard 2008 states "No associations were found with progestagen type or oestrogen dose" and again is about route of administration. "Norethisterone acetate was the only progestagen administered with the continuous combined regimen. Consequently, NETA-containing regimens were subdivided as to whether they were administered in a continuous or cyclic combined regimen. For cyclic combined regimens, no indication of a differential effect with various progestagen types was detected...We were not able to test the effect of conjugated estrogens vs. 17 β-estradiol, as conjugated estrogens are infrequently used in Denmark...Our study found risk estimates of MI comparable with estimates in randomized clinical studies. Our data suggest a lower risk with cyclic combined than with continuous combined therapy, and low risk with dermal or vaginal application of oestrogen." Again, this is about route of administration, with little emphasis on type of estrogen, particularly bioidentical versus not. They explicitly state they couldn’t compare CEE versus non. So what does that add to this page?
Fournier 2008 "We found that the risk of invasive breast cancer was significantly lower with estrogen–progestagen HRTs containing progesterone or dydrogesterone than with HRTs containing other progestagens." Progesterone is bioidentical. Dydrogesterone is not. Further, "E3N is the first epidemiological study that we know of to be providing results indicating that estrogen–progesterone and estrogen–dydrogesterone combinations may be the least harmful estrogen–progestagen HRTs regarding breast cancer risk. However, more evidence is required before these results can be translated into firm clinical recommendations for the management of menopausal symptoms."
Campagnoli 2005 does explicitly support avoiding synthetic progestins, but as a suggestion – "The greater BC risk persistently related to the use of HRT preparations containing estrogen and synthetic progestins seems in all likelihood due to the regimen and/or to the kind of progestin used.We therefore suggest that when HRT is indicated, preparations containing progesterone and not a synthetic progestin should be used". It’s a suggestion, but not based on a meta-analysis and not sufficient to throw out all the criticisms made of claims for progesterone, let alone bioidentical hormones.
Scarabin 2003 is 7 years old, and further is about route of administration. Not bioidentical versus synthetic.
So, even when I actually review the sources, which would require ignoring the rules against syntheses and original research, I don’t find them sufficiently convincing to substantially adjust the page, or to ignore all the statements made by so many bodies criticizing bioidentical hormones. I don’t understand why you conflate route of administration with molecular structure, and I am still far more convinced by the many critical sources than I am your bare assertions.
I am still irritated at the accusations that I'm "supressing information" or applying my own idiosyncratic rules, interpretations and definitions, when I have made every effort to justify my edits extensively with sources and policies. Please cease attacking me and justify your suggested revisions with reference to the sources that are explicitly about bioidentical hormones, in a way that gives due weight to the majority opinion. WLU(t)(c) Wikipedia's rules:simple/complex14:30, 21 April 2010 (UTC)
WLU, it is clear from the current article and from watching your behavior over several months, that you are determined to produce a uniformly anti-BHRT article. You happily include any anecdote, opinion, study, anecdote, review, or organizational statement that is anti-"BHRT", no matter the quality, and practically exclude any opinion, reference, statement, or opinion that is in any way pro-BHRT. You defend your bias by saying that you find this same bias in so many sources, therefore the article should be anti-BHRT. This is not appropriate for a Wiki article and violates WP:NPOV and WP:MEDASSESS as I've shown [53]. An objective and fair article about BHRT, on the other hand, would give a full and fair airing of the case against and the case for using bioidentical hormones, and against and for using compounded bioidentical hormones--including not only the scientific evidence of the greater safety of transdermal estradiol and progesterone in studies, but also statements from BHRT practitioners and compounding pharmacies--defending their practice and products. Uzzi Reiss is a senior OB/GYN who has written several books on hormone replacement for women--favoring using on the bioidentical hormones whether FDA-approved or compounded. [54]. This article would attempt a complete, objective airing of the cases from both sides. Maybe in some twisted way you believe that your are protecting women with this rant. You are not. You are preventing them from obtaining information of the utmost importance to their health and quality of life. Give them both sides and let them decide. To do otherwise is patriarchal and condescending.
You ask, "Can you please tell me how we can, in keeping with wikipedia's policies and guidelines (particularly WP:UNDUE) substantially change the page when there are so many critical statements by so many agencies and bodies, all converging on the idea that there is no reason to expect them to be substantially less risky or more beneficial than conventional hormones?" In a similar vein you state "So, even when I actually review the sources, which would require ignoring the rules against syntheses and original research, I don’t find them sufficiently convincing to substantially adjust the page.." The answer is simple--because objectivity, fairness, and scientific ethics all require presenting the case for BHRT in an article about BHRT. It's that simple. Answer me this: What makes the IMS position and the major review articles in major journals inadmissable as SYNTH and OR? Why does presenting the other side of the debate constitute SYNTH and OR? Your position, as best I can understand it, seems to be that because 9 out of 10 drug-company funded organizations ignore the evidence and review opinions that demonstrate that transdermal estradiol is safer than oral estrogens and that progesterone is safer than progestins, you are entitled to skew the article to only repeat "THE OFFICIAL TRUTH" and you can accuse any dissenter of OR and SYN. No it doesn't work that way. Including the dissenting position, the dissenting reviews and studies, and quoting writings of BHRT advocates in defense of their practice is not SYNTH or OR, its just good encyclopedia writing in an article that purports to be about BHRT.
You ask--"What are the sources for your dissenting opinions? What is my straw man? What evidence is there that the safest possible combination in all cases is bioidentical progesterone and estradiol administered transdermally?" I have presented review articles published in major journals regarding the greater safety of transdermal estradiol over oral estrogens (Regarding Løkkegaard, Canonico and Scarabin, I've pointed out to your before that the only "estrogen" given transdermally for HRT is 17-beta estradiol, the bioidentical estrogen, so that is what all these studies and reveiews refer to, this is easily discovered if you read the article.) Dydrogesterone has less breast cancer risk than other progestins because it is closest in structure to progesterone. Unfortunately is it not available in the US. The Campagnoli review quotes other evidence of the greater safety of progesterone regarding breast cancer. The EPIC-E3N is included in that review--an observational study including 10s of thousands of women and still in progress. It is the best head-to-head comparison of progesterone with progestins. It also shows that transdermal estradiol alone increases breast cancer risk, but not when combined with transdermal progesterone. So obviously, the safest combination is transdermal estradiol with progesterone. Maybe a picture is necessary. File:EPICE3N.jpgComparison of breast cancer risk for progesterone vs. progestins when combined with transdermal estradiol.
CHRT and BHRT differ regarding route of administration. The position of the organizations that you hold to be uncompromised authorities is that all hormone products are alike and have the same risk. So they deny that transdermal estradiol has less thrombotic risk than transdermal estradiol. Physicians who do BHRT generally prefer to use estradiol transdermally (See Uzzi Reiss's works, Holtorp, Schwartz, and others). I can easily provide many references. Compounding pharmacies are often also generally pro-transdermal vs. oral estradiol.
I do not fail to notice that you have not responded to my request to show me any evidence that transdermal estradiol increases DVT's, heart attacks or strokes as oral Premarin does, nor any evidence that progesterone increases the risk of breast cancer as Provera and other progestins do.
I see that you've now resorted in a few places to quoting package inserts for Prometium and Estrace and others to "prove" that they have the same risks as non-bios. That is not acceptable evidence in a medical article. As I've said, those are class warnings. Every problem ever found with Provera or any progestin is listed in that insert for progesterone. For you to include such inserts as evidence that progesterone has those risks is simply manipulative. All such references should be removed immediately.
I see you've listed Estratest as a testosterone-containing FDA approved product. Estratest contains methyltestosterone, a patented drug, not a human hormone. It is metabolized into a superpotent estrogen, and has been found to increase the risk of breast cancer, a problem never found with bioidentical testosterone replacement.
The statement "There are no medical or scientific reasons to recommend unregistered ‘bioidentical hormones’." is an opinion on pharmacy-compounded hormones, not on BHRT.
I will not bother repeating what I've said about your failure to honor the definition of bioidentical hormones and your bait-and-switch game of changing the meaning of "BHRT" to mean unstudied compounded products and associated practices. Indeed, all the anti-compounding hype in your article is misleading and dishonest. Every doctor who has ever prescribed a compounded form of a medication knows he is giving the same drug, just in a different vehicle. He/she expects it to have the same effect, only differing in relative absorption. Why haven't you allowed this article to contain any pro-compounding statements? To not do so is a sign of bias.
I ask, what do you call a physician who states that he/she provides BHRT, yet uses only FDA-approved BHRT products? Is he/she a BHRT practitioner or not by your definition? The makers of Prometrium call their product "Bioidentical" on the homepage. Do you believe that they are incorrect?
You state "My overall point is that the majority opinion is that bioidentical hormones are hormones, with all the attendant risks." This shows your lack of understanding of the issues. Bioidentical hormones are indeed human hormones. The converse is that the non-bioidenticals are not human hormones. It is the non-bios that have been proven to be dangerous in their usual oral formulations. Bioidenticals should NOT be considered to have the same risks as alien molecules until proven otherwise. The human hormones are natural to the body, exist in higher levels in younger healthier people, and their loss with aging has severe and well-documented deleterious effects. Anyone with some knowledge of molecular biology would find as ridiculous the drug-company funded organizations' claim that all 10 or 20 commerically sold progestins have exactly the same biochemical effects in the body as progesterone. In fact the evidence clearly indicates otherwise, and there is a lot more of it as there are many studies that compared Provera to progesterone, and progesterone usually was found to have more benefits and less or none of Provera's negative effects.
Another evidence of bias: Whenever you do quote a pro-bioidentical article--way, way, way down in your long unreadable rant--you feel compelled to mention that the author is biased because they make some money from BHRT, yet you do not mention that all of the organizations and most of the physicians (perhaps all) that rave againt bioidentical and compounded hormones are recipients of drug company money, therefore have a clear conflict of interest. Drug companies profit much more from non-bios, and they are trying to keep oral estrogens and progestins on the market in spite of all the evidence of their dangers--plus they are defending these dangerous products in thousands of lawsuits. If you impugn the motives of one side of a dispute, it is only fair to impugn the motives of the other also, don't you think?
Do not try to dismiss my arguments by believing I am stupidly in favor of all practices of all BHRT doctors and compounding pharmacies. I am not. Many do not know what they are doing--but this also goes for many conventional physician's ideas about hormone replacement. Saliva tests are not very helpful for pre-treatment testing, and they are worthless when transdermal hormones are being given as they grossly over-react--showing very high saliva levels that are not reflected in serum tests or actual symptoms. What I am arguing for is objectivity and fairness. Hillinpa (talk) 18:14, 22 April 2010 (UTC)
(undent) This is not a debate between pro and anti POVs it is about evidence. The evidence does not support the claimed special properties of bioidentical hormones. Doc James (talk · contribs · email) 18:18, 22 April 2010 (UTC)
Hillinpa, my "bias" comes from the sources. I did not come to this page with a bias, upon my reading of the sources I determined that the majority opinion is that BHRT is not worth the hype commonly associated with it. Wikipedia does not give a "fair and full airing" of the case for and against BHRT since that would be original research in search of the truth. Wikipedia is not a crystal ball and should not advocate for a single perspective. It should document the opinions of reliable sources and until the vast majority of sources claim that bioidentical molecules are better than synthetic or nonbioidentical molecules, that's what we should show. The citation of case studies is in my mind relevant because it indicates bioidentical molecules are associated with risks, as would be expected. The one case study article I recalled adding, Eden, is not currently cited as a source on the page. Reiss' books are not peer reviewed literature and therefore not medically reliable sources, and his bio page doesn't list other publications in peer reviewed literature.
Please do not refer to my careful analysis of your sources and arguments as a rant. Again, it is uncivil and projects a bias onto my edits I do not believe is warranted.
Claiming "patriarchy" is bizarre since this is about evidence. There is a lack of evidence sufficiently convincing that the wholesale embrace of bioidentical over nonbioidentical molecules is warranted, as evidenced by the many statements from authoritative bodies about BHRT.
It's not the IMS' statement that is so important and convincing. It is the IMS, ACOG, SOGC, the Endocrine Society, NAMS, FDA, AACE, AMA, ACS and Mayo Clinic, rather than the opinions of a small number of practitioners, that I find important and convincing of the idea that BHRT is not widely accepted or expected to be a risk-free panacea. We shouldn't be "presenting a case" for BHRT because that is not neutral, soapboxing, original research, and giving instructions. It is up to wikipedia to catch up to the mainstream opinions, not to make the mainstream opinion. And it is very much the mainstream opinion that we are expected to represent, not the cutting edge. Your position that we should ignore organizations because they are drug company funded is both ad hominenpharmanoia and totally unsourced - is there any reliable source you can provide that states that bioidentical hormones are suppressed because of pharmaceutical firms? Your approach would also not require "including the dissenting position, the dissenting reviews and studies" (they are already on the page), your approach would require proving that the mainstream caution about BHRT is unwarranted through a citation of original studies - which is original research and advocacy.
I get that your articles are about transdermal bioidentical hormones. My issue is that they compare primarily transdermal versus nontransdermal, not bioidentical versus nonbioidentical. It's quite possible that a comparison of transdermal nonbioidentical hormones with transdermal bioidentical hormones would demonstrate their safety profiles are identical, but we do not know yet because those studies have not been done. In fact, most of the articles you cited are explicit on this point. The conclusion you reach as "obvious" is not shared yet by the appropriate North American bodies, and their position is that until compared, all estrogens are expected to have the same risks. The bodies do not say do have, they say expected because the work has not been done. In other words, in the absence of conclusive evidence, they are being cautious.
I'm not bothering to provide evidence that one estrogen has less risk than another because I'm not making the claim, and because I have plenty of sources that make the better point that we simply do not know.
Progesterone is a bioidentical hormone. It has adverse effects. I didn't insert the claims, but I certainly think they should be present and that is one area where I think IAR should apply.
I wouldn't make a claim about an individual practitioner on the main page, because that's not the point. I will point out what reliable sources say about BHRT.
Pig insulin is not human insulin, but it is still used to great therapeutic effect in humans. Hormones are hormones, and carry risks. Bioidentical hormones carry risks. Tamoxifen is used to block human hormones to treat breast cancer - because endogenous estrogens can increase the growth or appearance of breast cancer.
I quote pro-BHRT articles in context of their authors' affiliations because I can source it. Can you source reliable sources stating the bias of all the non-proponents is due to bribery from pharmaceutical firms? Provide these sources for review, and we can discuss including them.
I don't think you are stupid, you show every evidence of familiarity with sources. I do think you are unable to adequately justify your edits through citation of the appropriate wikipedia policies and guidelines, or sources that are sufficiently reliable. That is, and has always been my issue. I have never dismissed your comments out of hand, I have always gone to great length to justify why I do, or do not, believe your points have merit. Sources, policies and guidelines have always been my stumbling blocks for supporting your points through edits to the main page. My previous post spent thousands of characters stating why I didn't think your five sources were adequate to adjust the main page. I take it seriously, even when I find the ongoing repetition and dismissal of my own reasoning aggravating.
Sorry, WLU, your argument does not fly. Let me remind you of Wiki's policy on NPOV:
Quote: Neutral point of view (NPOV) is a fundamental Wikimedia principle and a cornerstone of Wikipedia. All Wikipedia articles must be written from a neutral point of view, representing fairly, proportionately, and as far as possible without bias, all significant views that have been published by reliable sources. This is non-negotiable and expected of all articles and all editors.
"Neutral point of view" is one of Wikipedia's three core content policies, along with "Verifiability" and "No original research." Jointly, these policies determine the type and quality of material that is acceptable in Wikipedia articles. They should not be interpreted in isolation from one another, and editors should therefore familiarize themselves with all three. The principles upon which these policies are based cannot be superseded by other policies or guidelines, or by editors' consensus.
The neutral point of view is a means of dealing with conflicting perspectives on a topic as evidenced by reliable sources. It requires that all majority- and significant-minority views be presented fairly, in a disinterested tone, and in rough proportion to their prevalence within the source material. Therefore, material should not be removedsolely on the grounds that it is "POV", although it may be shortened, moved to a new article, or even removed entirely on the grounds that it gives undue weight to a minor point of view, as explained below."
Unquote
Your article fails to meet these criteria. Holtorp, Swartz, Moskowitz, and the IMS statement are all from reliable published sources, so are the Campagnoli and Canonico and other reviews and studies. You have removed or minimized them at every turn. You have instead cobbled together every anti-BHRT opinion you could find and thrown it into the article. You are applying a double standard as to what is admissible anti-BHRT and what is admissible pro-BHRT, and the same for anti-compounding vs. pro-compounding. For the anti-BHRT point, everything goes. For pro-BHRT, nothing is allowed. I can list all the low-quality and inappropriate citations, but it's clear I would be wasting my time at this point--and I want this article to remain as horrible as possible if it is not going to be rehabilitated. I cannot believe you are still trying to defend your comments attributing the problems of progestins to progesterone based on a class-specific FDA-required inserts. A package insert is a legal and regulatory document, it is not medical evidence and doesn't purport to be such. I don't need to, but I could show you that the evidence does NOT show that Prometrium causes all the problems that Provera causes.
Holtrof, Schwartz and Moskowitz are the minority. The IMS statement is critical of BHRT. Canonico is extremely equivocal and about route of administration, not bioidentical versus synthetic. Campagnoli is a suggestion that doesn't blanket recommend bioidentical hormones, is 5 years old, and apparently was unsufficiently convincing in that the recommendations haven't changed. I chose explicit sources that discuss BHRT specifically, it's not cobbled together. Also, the sources converge on a critical opinion, which is where I get the NPOV majority opinion from. It's not like I'm grasping at a small number of sources, critical sources far outnumber supportive.
You have presented only one view, that of North American organizations that are funded by one side of the dispute. This funding is public knowledge--it's on most of their websites if you search their for funding, contributors, "partners", etc. You can even read about how, if you give them enough money, you get to sit in on all policy meetings. Why do you think drug companies fund the medical organizations that define standards of practice? Altruism? If you don't understand basic conflict of interest principles do some research into it. NOTE: I am not and have never been the person saying that motivations should be discussed in this article--you are, but only for one side. I am trying to educate YOU. One doesn't need to have a mental disorder to grasp a conflict of interest, does one?
BHRT is primarily a North American phenomenon, are there European sources that are explicitly pro that I'm missing? Your comments about funding is again original research, there are no sources that I have seen. And since bioidentical hormones are so big in Europe, shouldn't we question all the European-funded bodies that explicitly support BHRT as superior, since I'm sure if I checked their webpages would also find corporate sponsorship. Your attempt to "educate me" looks very much like an attempt to discredit a large number of sources you disagree with and the "education" is irrelevant since it is based solely on your word and opinion, not on any reliable secondary sources. Without proof, "it's a conspiracy" is neither an argument nor a justification, it's an attempt to discredit one side of the argument a priori - and carries no weight. In fact, claims of a conspiracy raise WP:REDFLAG. Quoting the relevant section, "Certain red flags should prompt editors to examine the sources for a given claim...claims that are contradicted by the prevailing view within the relevant community, or that would significantly alter mainstream assumptions, especially in science, medicine, history, politics, and biographies of living persons. This is especially true when proponents consider that there is a conspiracy to silence them. Please drop any accusations of conspiracies that do not have sources to substantiate them. I base my edits on sources, not on my own opinion. WLU(t)(c) Wikipedia's rules:simple/complex23:25, 22 April 2010 (UTC)
In order to avoid bias the entire article needs to be re-edited. It is seething with anti-BHRT comments and innuendo. You may think you are being objective, but you are not. I do understand how a medically-naive person could get wound up by drug company propaganda against the idea of treating female hormone deficiencies with the proper hormones, delivered in the best way, but I must blame you for not correcting the induced bias once you were exposed to the evidence.
It is primarily critical because the sources are primarily critical. Calling peer reviewed literature and position statements "drug company propaganda" is ad hominem and not a reason to discard the source. Menopause is not a "hormone deficiency", it is a natural state for aging females. HRT's primary population is postmenopausal women, treating their symptoms with hormones is unnatural and carries risks. WLU(t)(c) Wikipedia's rules:simple/complex23:25, 22 April 2010 (UTC)
In order to meet Wiki standards, the article must not only mention the articles by Holtorp and Schwartz and others, but give them and their arguments a sufficient airing to raise doubts in the readers' mind about the "all hormones the same" doctrine. YOU don't need to present their case, you need to allow them to present their case and that requires more than just saying that they contend this or that. They don't need to take up the majority of the article, but just enough to make their points. Furthermore, the objective, balanced approach must begin in the lead. The article must also include important reviews of progesterone and transdermal estradiol like those of Campangoli and Canonico, including the graphic above from the Campognoli review--E3N-EPIC is the highest quality comparison study of progesterone vs. progestins in breast cancer risk that exists--yes it is evidence that not all progestins are alike. Those reviews are, by the way, referenced not only by Holtorp and Schwartz but also by NAMS, IMS, and others. They are therefore relevant to the topic, to published opinions and positions statements, and including them is it NOT SYNTH or OR.
If the page is missing "pro" BHRT sources, please locate them and present them for integration. Please ensure that they are explicitly about bioidenticals and do not require our policies to be ignored to be integrated (i.e. use the word "bioidentical"). If you have sources about estradiol, estrone, estriol, progesterone, etc. then feel free to integrate them with those pages, as has been said to you before. Wikipedia uses a neutral point of view, not "balanced treatment". The press tends towards "balanced treatment" (telling each side of the story as if each had equal merit, irrespective of how they are actually perceived by expert communities) as a way of commenting on topics they often lack the knowledge or awareness to comment on with any expertise (i.e. creationism and evolution, homeopathy, the moon landing hoax, etc.). Wikipedia gives a neutral point of view by presenting the topic as perceived by the relevant experts as demonstrated through citations of the literature, statements by governing bodies and other MEDRS, not the false approach of "balanced treatment". Note the part of the policy that states "The neutral point of view is a means of dealing with conflicting perspectives on a topic as evidenced by reliable sources. It requires that all majority- and significant-minority views be presented fairly, in a disinterested tone, and in rough proportion to their prevalence within the source material." The key is prevalence - most sources and bodies are critical. A small number are not. Many say the appropriate comparisons have not been done. When both views are roughly equal, then the page should reflect this. Such is not the case at present - skepticism is the norm.
Also note that for the most part the sources you have provided, and the sources already in the page, are explicit about not comparing different types of hormones head-to-head, so it is impossible to say "X hormone is better than Y", and particularly impossible to say X category of hormone is categorically better than Y. WLU(t)(c) Wikipedia's rules:simple/complex23:25, 22 April 2010 (UTC)
I appreciate that you spent a lot of time reviewing the studies--but you simply refuse to learn from them. You dismiss Campagnoli's review. I ask you, is there any other review of the evidence regarding progesterone, progestins and breast cancer that comes up with YOUR preferred answer? You say it's not a meta-analysis--so now YOU decide what is and what isn't an admissible study? Do you know of any meta-analysis on this subject, if not, don't we need to go with a review by a team of experts? Canonico's 2008 paper is a meta-analysis, yet you invent another justification for excluding that--that it is about method of delivery. Yet Holtorp states that "Transdermal estradiol, when given with or without oral progesterone, has no detrimental effects on coagulation and no observed increased risk for venous thromboembolism(VTE)" So there is this quote and many more from BHRT advocates showing that they do prefer transdermal estradiol delivery. So the method of delivery is central to this debate and should be included. NOTE: any evidence that any estrogen is safer given transdermally contradicts the mantra "all FDA-approved hormone products are alike". Yes, this evidence happens to involved bioidentical estradiol. Ethinyl estradiol was placed in patches once for birth control (OrthoEvra). It caused a significant increase VTE and was withdrawn.
From Canonico - "More data are required to investigate differences in risk across the wide variety of hormone regimens, especially the different types of progestogens". It did not examine hormone regimen, it examined route of administration. Does Holtorf state that transdermal estradiol is superior to trandermal non-bioidentical estrogen? Preferring transdermal, a route of administration, does not mean the type is superior. Compounding allows preparations to be prepared for virtually any route of administration, meaning that for BHRT, the route is irrelevant and not what the debate is about. Again, this page is about bioidentical hormone replacement therapy, not routes of administration for hormones in general. WLU(t)(c) Wikipedia's rules:simple/complex23:25, 22 April 2010 (UTC)
I don't know Doc James but he is apparently another person who is not acquainted with the evidence. I repeat, it is not ethically or intellectually responsible to state that there is no evidence that the correct human hormones delivered in the best way are more safe than any FDA-approved hormone products, when in fact such evidence exists and the International Menopause Society admits that it exists. Maybe some people just can't believe that American "authorities" are corruptible or would lie to them--and this post-Iraq! i don't think that naiveté is a Wiki principle, is it? Hillinpa (talk) 22:59, 22 April 2010 (UTC)
Okay so can you please provide this evidence below. The best 2 or 3 studies / reviews that say the bio identical is better than others. BTW not all of us are American and we have our own medication approval boards.Doc James (talk · contribs · email) 23:53, 22 April 2010 (UTC)
Note that per Cirigliano, BHRT is something almost solely found in the US. Europe does tend to use hormones-that-are-bioidentical. Campagliano would be the most explicit I've seen, being a secondary review article recommending with reservations that a nonsynthetic progestin be used (but progestins are only one aspect of HRT and themselves carry risks). Several sources have been explicit about there being no direct head-to-head comparisons across multiple types of hormones, and the other sources cited are about a variety of outcomes - breast cancer and heart disease for instance, and in all cases care must be taken to navigate the multiple critical sources. It is difficult to tease out absolutes, which is why in my opinion, the organizations are so explicit about all hormones being expected to carry the same risks, a recommendation which seems deliberately aimed at the extreme and unfounded claims for safety and effectiveness made by BHRT pharmacies and other advocates. "Panacea" is used several times and with good reason, as it is treated as a cure-all by the more extreme advocates. WLU(t)(c) Wikipedia's rules:simple/complex01:08, 23 April 2010 (UTC)
(Undent) Doc James, I have mentioned several studies above. The Holtorp and Campagnoli reviews contain many tens of studies comparing progesterone to Provera and progestins, the general gist of which is that progesterone does not have the deleterious effects of progestins, and is much better tolerated by women. I refer you to those studies for positive evidence that progesterone is better. But I ask you: On what scientific basis are the deleterious effects of Premarin and Provera--equine and invented molecules delivered by the oral route--generalized to transdermal estradiol and progesterone? They are not the same molecules. Estradiol and progesterone belong in the human body and no altered molecules will work exactly the same way. Oral and transdermal delivery are very different in their effects. Different molecules and different delivery methods cannot be considered to have the same benefits or risks until proven otherwise. That is the proper scientific perspective. I repeat--oral estrogens have been shown to increase blood clotting, DVT's and stroke, transdermal estradiol has not. Progestins have been shown to increase the risk of breast cancer and vascular events, progesterone has not. How one turns that evidence into an anti-BHRT case--I do not understand. The burden of proof is on the BHRT critic to present evidence that transdermal estradiol and progesterone combined have the same risks as oral estrogens plus progestins (e.g. PremPro). The burden of proof is upon the critic of compounded BHRT products to demonstrate that they are somehow less safe or effective than similar FDA-approved products.
WLU has made the philosophical point that replacing female hormones is unnatural. Indeed it is. Aging is perfectly natural, and the loss of hormones with aging is perfectly natural, but aging is also clearly deleterious. Therefore the loss of hormones with aging must also be considered deleterious until proven otherwise. Molecular biology is very clear on this point--we are programmed to deteriorate and die. We are not born to be immortal. We are born, we grow, we procreate, we live long enough to assure the survival of our children, and then we die to make room for the next generation and assure that evolution can act upon our species. How does Nature kill us? There are several mechanisms. One of them is that most of our major hormones decline with age beginning around age 25 to age 30. Given this reality, replacing hormones and other vital molecules that have declined with aging should be considered beneficial until proven otherwise. Indeed, there is no shortage of literature, accumulated over the last 70 years, on the deleterious effects of the low hormone levels, and the benefits of restoring estradiol, testosterone, insulin, growth hormone and other hormones to more youthful levels. Probably the best known advocate of this position is a Belgian physician, Thierry Hertoghe.
This is supposed to be an encyclopedia article on BHRT--the restoration of estradiol and progesterone lost due to the failure of women's ovaries with age. It should look and read like an encyclopedia article. BHRT is not only a matter of peer-reviewed replacement studies, or of positions taken by detractors. It is a sub-discipline of Anti-aging medicine (age management medicine). It is a growing social phenomenon. More doctors are doing it and more women seeking it with every passing day. Many books have been written about it by advocates and practitioners. The article should include information from all these sources. As with any encyclopedic treatment, the article must allow the advocates to present their arguments for their practice--arguments such as those I've just made above.
I have exposed the bias of the current article. I will not dissect its other weaknesses nor attempt to edit the article until we have an agreed-upon plan. I will not waste my time, nor yours. Here are my requirements for participating in this article and removing the NPOV tag:
1. "BHRT" is exactly as defined by the current first sentence of the lead. Whenever it is being used in a different sense, it must be so specified (e.g. "compounded BHRT")
2. All scientific evidence regarding the biological functions of estradiol and progesterone, and the safety and efficacy of their replacement by various methods must be admitted as relevant to BHRT as defined.
3. The lead of the article must reflect the controversy--including pro-BHRT positions in addition to anti-BHRT positions.
4. The article must allow BHRT practitioners to make their case for their practice--i.e. present their rationale for what they do and how they do it--mostly this will come from books or articles they have published.
5. The article should be neutral in tone--allowing each side to present their case and not resorting to exagerations and caricatures (i.e. "panacea", "no evidence", etc.)
6. All criticisms of BHRT must be met with the responses of BHRT advocates to those criticisms. Let the reader decide who has the better argument.
7. The same standards of scientific evidence should be applied to the anti- and pro-BHRT cases.
8. Either motives of both sides will be impugned, or neither side. If motives are discussed it should be in a separate paragraph rather than brought up at every opportunity.
9. If any editor claims that a statement is false or misleading as written, it should be amended or a rebuttal included in the text so that it is suitable to all parties.
10. No material will be removed arbitrarily unless it can be shown to be false or irrelevant. Hillinpa (talk) 13:28, 24 April 2010 (UTC)
As this topic is controversial for the section regarding scientific outcomes it should only contain references to peer reviewed published journal articles that review the topic at hand. Each so called side does not get equal voice. The best research and published statements get included all the rest does not except possibly under a section regarding society and culture were discussion of the controversy as a social / economic issue can use more lenient requirements for the refs.Doc James (talk · contribs · email) 16:38, 24 April 2010 (UTC)
Of course, the sections of the article dealing with outcomes should contain peer-reviewed literature only, and there is plenty of this to support the view that bioidenticals, properly delivered, do not have the risks of many FDA approved non-bioidentical products. Science has two major components: The observational/experimental facts, and the interpretation of those facts. The controversy here lies in the interpretation. The pharmaceutically-funded and oriented organizations and physicians argue that all PremPro's negative health effects are applicable to bioidenticals--from any source, delivered in any way. The pro-BHRT camp states that they are not--and presents peer-reviewed reviews and studies to support their view. The article should present the pro- and anti-BHRT arguments, don't you think? Do you agree with the 10 points I have made? If not, with which do you disagree and how would you alter them.Hillinpa (talk) 15:17, 25 April 2010 (UTC)
Progesterone is only one of many bioidentical hormones and any generalizations made about it can not be extended to all bioidentical hormones. The point made multiple times by multiple sources is that until direct comparisons have been made, they are assumed to have the same risks - it's a matter of risk-aversiveness because in the absence of evidence, the worst is assumed. That may be incorrect, but the only way to know is to do the studies. Drug regulations work by assuming no benefits until proven and high risks; the risk:benefit ratio must be demonstrated before it can be assumed the molecules are both safe and effective. We can not make those comparisons 'to help our readers know what's really going on' - that's original research and promotion of an idea well before there is adequate evidence. You can't simply assume all bioidentical, or synthetic estrogens taken orally do, or do not, have the same risk profile as bioidentical transdermal estradiol - research must, and until that is done, it is unlikely any substantial and responsible groups will endorse bioidentical hormones. And that's not even dealing with the fact that you're mixing administration routes, which has a huge impact on their effectiveness, safety profile, etc. Comparing oral estrogens to transdermal estradiol is not apples to oranges, it's grapefruit to motor oil.
Hillinpa, you state "How one turns that evidence into an anti-BHRT case--I do not understand." I'm not trying to do that. What I'm trying to explain is that you can't take one, or even two drugs, tested across a single administration modality, and extend from there a conclusion about all bioidentical hormones. I'm not trying to compare oral and transdermal anything, since this page is about molecular structure, not route of administration. And you have reversed the burden of proof - the burden of proof is to demonstrate that any hormone is less dangerous - this is the approach taken by the many agencies cited in the lead.
Evolution doesn't kill us to make room for our children, the gene pool just doesn't select for longevity. And again, you can't simply assume adding more hormones to any system is beneficial - even in situations of marked lack of endogenous hormones like hypothyroidism or diabetes, the hormones are prescription, carefully controlled and monitored. Hormones are not magic and all have risks. The anti-ageing medicine position is also seen as a form of unsupported extreme advocacy not taken seriously by most scientists.
This page is supposed to represent the BHRT position as it is seen in the majority press, per WP:NPOV. That's it. It should not look like an advocacy piece and should not represent idiosyncratic definitions or ideas. The books you cite are not WP:MEDRS. Popularity does not equal scientific merit. Advocates should not be editing this page, neutral parties citing reliable sources, should be.
As for your points, you do not determine the contents of the article. If those are your requirements, will you cease editing the page and talk page if we don't agree? I object to your points on the following policy and guideline grounds.
1 - OR, MEDRS & NPOV
2 - OR
3 - already addressed
4 - MEDRS (books not subject to peer review have not engaged with or been reviewed by the actual scientific community)
5 - RS source these very words, and it is neutral per the majority view (NPOV)
6, 7 & 8- UNDUE and MEDRS - not all opinions are equally valid
9 - RS are the basis of the article, not editor opinion
The E3N-EPIC study is only the most powerful comparison of progesterone vs. progestins. There are many others. The comparisons exist. To say they do not is incorrect. The "mainstream" position that the problems caused by alien molecules should be assumed to apply to the endogenous molecules is an interpretation. It is an highly improbable interpretation, and is the interpretation one would expect from persons funded by the makers of the proven-dangerous non-bioidentical products. The pro-BHRT interpretation--that those problems to not apply to BHRT until proven otherwise--should be presented, correct? In and article about BHRT? Holtorp and others can be and should be quoted on this point. The relevant studies do support the pro-BHRT position that Prempro's negative effects do not occur with transdermal estradiol and progesterone. That evidence should be presented.
It seems that your sole argument is this: because most "mainstream" organizations have a certain interpretation of the evidence (which could be called a bias), this is the ONLY interpretation that should be presented in this article, and that another interpretation MUST NOT be presented. This is incorrect. An article on BHRT is not encyclopedic unless it includes the pro-BHRT arguments and evidence. Neither I nor anyone else will prevent you from stating the facts: That "the majority of organizations state that xxxxx". You are free to describe the situtation as it exists. You are not free to suppress the minority, pro-BHRT case as presented in peer-reviewed papers and in books.
Method of delivery is relevant to this article since the mainstream sources deny that method of delivery makes any difference (in contradiction to the studies), while pro-BHRT physicians assert that method of delivery makes a difference. This is a difference between CHRT adn BHRT and must be included, and pro-BHRT papers referenced. I notice again that you alter the definition of BHRT ad libito to suit your argument of the moment. It's "molecules" only, then it's "practices", then it's "crap".
BHRT is no different than any other form of hormone replacement. It is prescribed by doctors. It is dispensed by pharmacists. The smart BHRT doctors do monitor replacement levels--in contrast to the "mainstream" opinion that no testing is necessary and symptoms alone can be used as a guide. No one has yet produced any serious evidence or arguments against replacing hormones that have declined from youthful levels due to age or disease. So if the "mainstream" is opposed to this practice, that too is just a matter of opinion, and it is an unsupported opinion at that.
No, neither this article, nor any article about a controversial issue should present only the "mainstream" position and prevent the opposition from presenting its case. Where did you get the this idea? It is certainly not consistent with WP:NPOV. There is a minority opinion, it is supported by commonsense reasoning and scientific studies, it is high popular among women, it is rapidly gaining more adherents. In fact, the "mainstream" is being dragged by both the patients and the evidence towards supplying BHRT and not alien molecules. The pro-BHRT viewpoint is a significant, defensible minority viewpoint that should be appropriately represented.
I have previously pointed out your violations of NPOV and MEDASSESS and your misuse of SYNTH and OR. I have noticed that you have presented some partial arguments against some of the requirements I listed above, and then just posted a list of Wiki policies that you think are applicable. Given my responses to the arguments you did make, I would like you to now show how any of those Wiki policies, or the principles of encyclopedic journalism, entitle you to dismiss any one of the requirements for a fair, objective article as I have enumerated them.
As an example of an article involving a similar, though less well-supported, controversy in the field of medicine, see Wikipedias's page on Orthomolecular Medicine. [55]. It adheres rather closely to the principles I enumerated. Notice that the pro-OM position and arguments are stated in the lead, and OM advocates are allowed to respond to all fundamental criticisms. The "mainstream" case is still strongly presented. The links section includes pro- and anti-OM links, as it should. What's wrong with making the BHRT article at least as fair and encyclopedic as that article? Hillinpa (talk) 15:17, 25 April 2010 (UTC)
As always, I'll rely on the sources that state there are no direct comparisons of synthetic versus bioidenticals, until explicit sources become available. I certainly won't rely on interpretation and I'll continue to cite sources that state until proved otherwise BHRT should be assumed to carry the same risks and recommend minimal doses for the shortest period of time. The pro-BHRT position is presented, it's just that there are numerous reliable sources pointing out that those positions are incorrect - the molecules do carry risks; the scientific majority has done a very thorough job of analyzing the appeals and statements about BHRT and taking them apart. Much of the page is actually aimed at popular ideas about bioidenticals by the way - that they are risk free and offer significant benefits in addition to simple vasomotor relief. Again, majority position gets majority text. What you call "bias" I call a well-sourced, neutral article giving due weight to the majority who are waiting for evidence. That the mainstream sources deny method of delivery is irrelevant is incorrect. I have never read a source that says method of delivery is irrelevant, I have read many that discuss how transdermal appears to offer superior benefits to oral therapy. Sources criticize the claims made about molecules, not delivery methods, and this page is not a discussion of delivery methods.
The "mainstream" position--if you will reread the statements of NAMS, ACOG, ES, etc.--is that all FDA-approved hormones are alike in their risks. Only in the IMS statement is a differentiation made between the safety of oral vs. transdermal estrogens. This differentiation is made prominently by BHRT advocates--therefore it is a difference between BHRT and CHRT (all hormones alike). You will have to figure out yourself by these organizations failed to mention results of various studies and reviews of transdermal estradiol vs. oral estrogens.Hillinpa (talk) 23:09, 26 April 2010 (UTC)
Again, "common sense reasoning" is original research; whether an idea has popular appeal is irrelevant since wikipedia is based on reliable sources, not popular appeal. As the sources develop and ideas about bioidentical molecules change, so can the page. I'm also sick of retyping my objections to your points. You've pointed to "disputes found in the archives". Well, my responses to your 10 points are found in the archives as well.
Note that you have been spelling Holtorf's name wrong for a very long time now. It's an "F" not a "P".
Orthomolecular medicine is a pseudoscientific approach that attempts to use vitamins as medicine, and assumes that if correcting a deficiency is good, then dosing well beyond (nearly overdose levels) must be better. Like BHRT, it relies on unwarranted assumptions that supraphysiologic have no ill effects. Like BHRT, it relies on direct appeals to the public and case studies rather than well-controlled clinical trials and science. That comparison does not help the BHRT cause. I'll just stick to finding and summarizing sources. WLU(t)(c) Wikipedia's rules:simple/complex12:22, 26 April 2010 (UTC)
Thanks for the correction on Holtorp. No thanks for utterly missing my point about the article on orthomolecular medicine.Hillinpa (talk) 23:09, 26 April 2010 (UTC)
(outdent) Quoted from Doc James
The best research and published statements get included all the rest does not except possibly under a section regarding society and culture were discussion of the controversy as a social / economic issue can use more lenient requirements for the refs.
WLU has tried to exclude all scientific evidence regarding estradiol and progesterone, the two bioidentical hormones in question, if the study did not use the word "bioidentical". Furthermore he relies on a sliding definition of BHRT--altering it from what is stated in the lead and using it elsewhere in the article to mean something else--like "using only compounded hormone products and following certain other practices... So the first two points I proposed above for producing some agreement on the content of this article were:
1. "BHRT" is exactly as defined by the current first sentence of the lead--HRT using molecules identical to the human hormones. Whenever it is being used in a different sense, it must be so specified (e.g. "compounded BHRT")
2. All scientific evidence regarding the biological functions of estradiol and progesterone, and the safety and efficacy of their replacement by various methods must be admitted as relevant to BHRT as defined.
These are the starting point for any agreement on the basic question of what this article is about. I would like to know whether all editors agree with these points, and if not, why not.Hillinpa (talk) 23:09, 26 April 2010 (UTC)
Please address the comments of other editors on the page.
There are many sources that state that what BHRT means varies depending on the source and speaker. Since this page is not about estradiol and progesterone, we should not be discussing their biological functions - that is for estradiol and progesterone. Those are only starting points for agreement for your version of the page. Consensus overrules individual editors.
I think the definition should be used according to the source, with acknowledgement that BHRT can represent many things, including compounding, exaggerated claims, and saliva testing, each of which is dealt with separately. I don't think we should be doing any comparisons between hormones unless specifically laid out in reliable sources as applying to BHRT. WLU(t)(c) Wikipedia's rules:simple/complex23:17, 26 April 2010 (UTC)
Section break 2
I take it then that you agree that "BHRT" is defined as mentioned in the lead and that when certain practices are discussed and criticized, the editors should be careful not to generalize such to all of BHRT.
Your response to the question of admissible scientific sources is ambiguous. The bioidentical hormones that advocates prescribe are estradiol and progesterone, and they do so because they believe that the facts of human physiology and the results of studies involving these molecules show that they are more efficacious and are more safe than non-bioidentical FDA-approved hormone products. One would expect any article on the subject to include the case for BHRT, as made by its advocates. So I ask for clarification: Do you and other editors agree that secondary sources like reviews of progesterone vs. progestins (Campagnoli, Holtorp, etc) and estradiol vs. non-bio estrogens--as mentioned by advocates in their papers and books--are appropriate to this paper? Or are you going to continue to maintain that the scientific evidence concerning estradiol and progesterone vs. non-bios be ignored if the word "bioidentical" does not appear in the review or study. Note that there are several problems with your position, one of which is that both the BHRT advocates and BHRT critics reference the reviews and studies that you would like to exclude. Both sides consider the information relevant to the controversy. Your attempt to exclude such source is thus artificial, at best.Hillinpa (talk) 11:06, 27 April 2010 (UTC)
I certainly believe in citing sources that state BHRT is ill-defined with no universally-agreed upon characteristics, but numerous characteristics that tend to cluster. The sole uniting theme is exogenous supplementation with endogenous molecules, heavily associated with compounding, exaggerated claims, unnecessary and unsupported testing, and targeted levels. That's how the sources treat it, that's how it is perceived in the lay populace, and it's not our job to proclaim some truth in order to right great wrongs of "misperception". That's how it's publicized, popularized and promoted by proponents, that's how criticisms engage, and that's therefore how we portray it until that portrayal, in reliable sources, changes.
Advocates prescribe many hormones, including the now illegal-in-the-US estriol. There is tentative evidence that progesterone may be better than medroxyprogesterone, but more clinical research is required to investigate and clarify this. My statements about sources, are as ever, the same - we should use MEDRS that specifically discuss BHRT and not use primary sources to synthesize a position that certain types of hormones are better than others. I would be willing to use secondary reliable sources, such as Holtorf, to state what proponents think, but unless it is university press, I am unwilling to accept popular books about BHRT. I will not comment on general topics, without a specific source. Campagnoli should not be used for the reasons I have enumerated above. If reliable secondary sources cite and review primary sources, I have no objection to those secondary sources being cited, just like I rely on reliable secondary sources to represent the majority opinion, per MEDRS and NPOV. I have no issue with Holtorf citing primary literature and I never have, I have issue with the idea that Holtrof can be used to overwhelm the massive amounts of critical sources.
If the agencies that currently criticize BHRT release position statements in the future saying certain (or even all) bioidentical molecules are superior to synthetics, the page can, and should be adjusted. That has not happened yet. That is, and has always been, my objection. WLU(t)(c) Wikipedia's rules:simple/complex13:56, 27 April 2010 (UTC)
The problem is, again, that you are selective in your sources, and insist on suppressing sources that in any way support using endogenous molecules. This is neither objective nor fair. It's a clear violation of WP:NPOV. MEDRS specifies a preference for secondary sources--fine. The BHRT case can be presented with secondary sources only. The IMS says progesterone may be safer than progesterone, that's a secondary source whose opinion you've misrepresented. Holtorp is a secondary source. Campognoli is a secondary source as are the reviews on transdermal estradiol. There are many more secondary sources that support the BHRT position. Quoting secondary sources that support BHRT is not a synthesis--right? You seem to be insisting that if one in any way contradicts the opinion of the pharmaceutically-funded organizations then one is guilty of synthesis, OR, or whatever acronym comes to your mind. Notice too that your article quotes secondary sources quoting primary sources--like the Boothby chart. So what is your argument against including secondary sources that support the BHRT position. On what basis do you want to exclude Campagnoli--the most comprehensive review of progesterone vs. progestins and risk of breast cancer?
Popular books are to be used as they would in any encyclopedic article--to inform the reader about what some BHRT practitioners do and say--not as medical evidence. Hillinpa (talk) 16:48, 28 April 2010 (UTC)
What sources am I suppressing, except by insisting on a standard of no original research, one of our core content policies? Particularly given so many sources are explicit that no direct comparison of molecule-to-molecule have been done? Even the sources you provided, as I've analyzed before, don't prove that bioidentical molecules are better than nonbioidentical, and many explicitly state that in the articles that the research they conducted was inadequate to answer this question. And as I've said before again, there are far more reliable, secondary sources that state that BHRT is considered unproven and dangerous, therefore WP:UNDUE states we should give that idea more weight. Quoting secondary sources that support BHRT is not a synthesis, and I have never said this. Quoting sources that explicitly support BHRT and basing much of the page on those sources is undue weight, a section of the neutral point of view policy. WP:SYNTH is part of WP:OR, a separate content policy. I'm not suppressing sources, I'm giving positive, pro sources less weight because there are less of them and there are so many health and medical bodies that are critical. Holtorf is present on the page, the IMS is as well with their statement about BHRT quoted in full (which illustrates by the way, the association of BHRT with compounding, saliva testing and purity concerns. You apparently have not understood my objections to why articles can and can not get included into the page - I have no objection to an article that is explicitly about BHRT being included in the page, if it is in keeping with WP:UNDUE. A reliable, secondary source that is explicitly about bioidenticals should be integrated into the page. The care is in how, and how much text they are given. A reliable, secondary source that is not explicitly about bioidenticals should not appear on the page. You are confusing my objections based on OR with those based on NPOV. I've already given my objection to Campagnoli, I believe it is a synthesis to include and newer sources that explicitly deal with the issue should be used instead. Also, it discusses estrogen + progesterone preparations, for breast cancer only. Actual BHRT and HRT in general is far more complicated and should be dealt with using explicit sources. Again, if bioidenticals are proven to work better than regular, across the board, as a category, and are adopted by most or all agencies as the best and most appropriate treatment (or even as a good option for some patients), the page should reflect this. But the sources must come first, not our own analysis.
Again with the pharmanoia. You think that Erika Schwartz or Kent Holtorf are motivated purely for the good of their clients, and not at all by the fact that they, as individuals, make a lot of money that goes directly into their bank accounts, off of their consultations and publications? Pharmaceutical firms can be criticized for polluting research and pushing their bottom lines, but the exact same thing can be said of alternative medicine people who don't research and publish in mainstream journals but instead complain about how their concerns aren't taken seriously. If they want to be taken seriously, they should submit their claims to empirical testing and public scrutiny and criticism like real scientists and researchers.
Popular books shouldn't be used when there are reliable, secondary sources that summarize the popular arguments (like Cirigliano and Boothby). Particularly since they summarize the arguments, then rebut them - even more invaluable. WLU(t)(c) Wikipedia's rules:simple/complex17:21, 28 April 2010 (UTC)
Campognoli is a secondary source of highest quality reviewing studies that compare progesterone and progestins. Since progesterone is one of the two bioidentical molecules in question, Campagnoli's review is relevant and should be summarized in this article. Again, your insistence that scientific research concerning the bioidentical hormones must use the word "bioidentical" is a cheap manipulation and an obvious information warfare technique. It is bias plain and simple and unacceptable for an editor of this page. No author of ANY secondary source, including all pharm-funded organizations, takes this silly position.
Regarding pharmanoia, I'm in very good company. JAMA published, in 2009, the recommendations of a blue ribbon panel on medical professional organizations and conflicts of interest. [56]. You can read more about it here [57]. Their recommendations included 1. Aim for zero-dollar support from industry over the long term; reduce industry funds to 25% or less of the operating budget as soon as possible. 2. Refuse any industry funding for guideline-writing activities and appoint to guideline committees doctors who have no financial conflicts. 3. Require physicians who will serve in leadership positions to end any industry relationships before taking office. NAMS, ACOG, and the Endocrine Society are heavily funded by pharmaceutical companies that make non-bioidentical hormones. Those companies' desire to equate risks of non-bios and bios is obvious--both to maintain non-bio sales and defend lawsuits against non-bios. It is a fact that this funding vitiates their opinion on this matter--not to mention the monies accepted by their individual members who create policy statements. These three organizations influence all other organizations and physicians--who view them as authoritative. Therefore, I now insist that the funding of these organizations be mentioned in this article, just as you have mentioned the ties of authors of pro-BHRT articles to the BHRT industry. This is only fair and it will give the reader the necessary background needed to interpret the statement from the organizations. Given that the organizations you rely upon are known to be compromised, you position that the article should reflect their view, almost exclusively, is exposed as uninformed and biased.Hillinpa (talk) 11:41, 29 April 2010 (UTC)
I know pharmaceutical companies present a mixed blessing - cheap, reliable manufacturing of necessary drugs, along with intense conflict of interest and dishonest promotion of drugs and conditions with their only concern being their bottom line. My first point is that without specific evidence of conflict of interest resulting in a flawed analysis, you can't simply discard and discount sources. My second point is that boosters of bioidentical hormones share these same issues of profit presenting a competing motive to intellectual honesty and scientific rigour. As a final point, those recommendations could apply equally well to any advice written by bioidentical promoters such as Erika Schwartz, Kent Holtorf, TS Wiley and any compounding pharmacist who sells unregulated bioidenticals. Your point about NAMS, ACOG and TES ignores the fact that the same drug companies make bioidentical hormones, and ignores the fact that the cautions agains bioidenticals don't just come from NAMS, ACOG, TES, but also from the AMA, the FDA, the Australian Menopause Society, SOGC, AACE, the ACS, Harvard Health Watch, the Mayo Clinic, M. Cirigliano, MS Rosenthal, A Fugh-Berman, J Bythrow, M Taylor, K Kalvaitis, SE McBane, LA Boothby, PL Doering, S Kipersztok, J Chervenak, N Panay, A Fenton, CK Sites, AH MacLennan, DW Sturdee, A Pines, DW Sturdee, MH Birkhäuser, HP Schneider and M Gambacciani. Without concrete evidence that the reason all these people are wary of bioidenticals because of teh evil drug companies!!!! rather than the specific molecules not being compared for safety and efficacy head-to-head, your pharmanoia point is not something helpful to be repeated. You've made your point here - drug companies have an effect on advertising, scientific research and claims about their products. Now accept mine - there has been no demonstration that all opposition to BHRT is due to drug companies, and there is no evidence that all these sources are "compromised". "My" position isn't "my" position, it is the position of the majority weight of scholarly sources, and there is no evidence that all of these sources take their positions because of money from drug companies. This is ad hominem, a logical fallacy that fails to deal with any of the points made in the sources themselves. WLU(t)(c) Wikipedia's rules:simple/complex12:29, 29 April 2010 (UTC)
My point is that the article must be objective and neutral. IF you are going to point to a conflict of interest for those publishing pro-BHRT articles, you must also mention the COI for those publishing anti-BHRT articles. COI is not an ad-hominem argument, it is an established legal concept--a person profiting from making a decision for one party cannot be considered capable of rendering an objective opinion. The final arbiter is the scientific evidence, not the opinions of compromised sources--so this article must rely more heavily on the actual scientific studies, and less on opinions. You evaded my point about the importance of NAMS, ACOG, and TES. They are considered authoritative in this field, and therefore are able to prejudice the entire medical establishment. The AMA and FDA are also strongly influenced by pharmaceutical money and interests. Pharm. corps now fund the much of the FDA's activities, and then there is the revolving door phenomenon among government regulatory agencies and the corporations that they regulate. As for all the authors you mention, do you really think that most physicians are going to contradict the FDA, NAMS, ACOG and TES? They know very well what they should do to maintain their income and reputation. Are you able to prove that none of those authors has accepted pharmaceutical corp money--and that none of them have any intention of ever accepting pharm. payments? You should be aware that any physician who is considered an authority in any field generally has multiple pharmaceutical corporation ties. Effective information control always works from the top down. Control the head, you control the body.
The article should reflect sources, indeed. However, because of the COIs, perhaps we can agree that the article should focus more on sources that actually deal with the bioidentical vs non-bioidentical scientific evidence, and less so on sources that express mere opinions regarding the evidence. You have indulged in an excessive repetition of anti-bioidentical opinions while under-representing the actual reliable sources of scientific information--the many secondary sources and primary sources that have actually compared bioidentical molecules with non-bios. Look at the article--if you can. The case against using the correct molecules is repeated ad-nauseum, while pro-bio arguments and evidence are weakly presented, couched in COI language, and found only near the bottom of a long rant--to which few readers will arrive. An objective article will instead allow pro-bio sources to make their arguments and present their evidence at ever step---starting in the lead. An objective article will use the same standards of evidence for the pro-bio as for the anti-bio positions. As it is you use any kind of source you want for the anti-bio position, including the terribly inadequate assertions of Boothby--selectively quoting primary studies in her chart, and you include package insert warnings that are not scientific sources at all. The article is over long, repetitive, and biased. When I have time I will see start to make some edits, and we will see just how tolerant you are of an article that is actually more objective and fair, allowing the pro-BHRT to present their case for using bios, and for using compounded bios. There are many good sources. Hillinpa (talk) 12:03, 30 April 2010 (UTC)
Undent. Neutrality is achieved through fair representation of the relevant expert soures - which the page does. For wikipedia, the final arbiter is verifiability, not truth, meaning we use sources to document the scientific opinion, not build a case we think is appropriate. COI isn't a reason to discount sources outright - it's a reason to be cautious in interpreting its contents. I'm not advocating for the removal of sources for COI reasons. I will also point out that Schwartz, Holtorf and Moskowitz are all directly involved in generating profits from the sale of bioidenticals. The organizations are not, though they do receive sponsorship from the companies. This continues to be a worthless discussion. We've both made our points, and I think the current page is adequate. I'm certainly not going to buy into a conspiracy theory as a justification for editing the page. As far as I'm concerned, the COI discussion is over. All the sources deal directly with bioidenticals, and we certainly shouldn't be citing primary sources to debunk secondary - so you have expressed an opinion that is essential the exact opposite of a long-standing guideline on how to deal with medical sources. My discussion of that is over as well. We express verifiability, not truth, we do not engage in original research, we give due weight to the scholarly majority, we rely on secondary sources, we do not adjust the page on the basis of conspiracy and speculation, and discussion is based on consensus. Our goal is not "objectivity", our goal is to proportionately represent the scientific consensus. The page does so. WLU(t)(c) Wikipedia's rules:simple/complex12:40, 30 April 2010 (UTC)
So far, all discussion with you has proven worthless--on that I agree. The page is not only inadequate but also highly biased and repeats falsehoods as if they are undisputed truth. An encyclopedist does not decide on truth, and so must allow the other party to rebut criticisms with their own arguments and sources, especially when criticisms are neither supported by evidence or known biological principles and come from sources with a clear COI ("e.g. all hormone products have the same risks"). Not only do you fail to include the minority arguments and evidence, you have a double-standard for anti-bio vs. pro-bio sources, as I have repeatedly shown. The tone of the article also is sufficient evidence enough of bias. Let us see what the moderator will have to say.Hillinpa (talk) 10:51, 3 May 2010 (UTC)
Once again - the critical sources do not say "all hormones have the same risk". They say "all hormones, in the absence of contrary evidence must be assumed to have the same risk." As in, despite all the bleating about how risk-free the hormones are, the proponents haven't done the actual work to substantiate their point. Which is part of the reason so many actual researchers are irritated by their relentless cheerleading. WLU(t)(c) Wikipedia's rules:simple/complex13:30, 3 May 2010 (UTC)
I have repeatedly demonstrated that the scientific evidence (studies and review articles plus the IMS statement) shows that transdermal estradiol does not have the clotting risks of oral estrogen products, and that progesterone does not have the breast cancer risk of most oral progestins, Provera most importantly. You have removed all such sources from the article in the past and will do so again. So for you and your drug-company funded sources to say that "there is no evidence...must be assumed to have the same risk" is a clear-cut case of lying. Lying about evidence is not a respectable scientific procedure. This page is not based upon evidence, it is a repetition of OPINIONS about the evidence from compromised sources. You have worked very hard to exclude any actual discussion of the evidence from good sources, and to include sources of the worst kind to support your opinion. This is so evident to anyone reading the page that I think it best to leave it as it is--a monument to the power of corporate propaganda. Smart women know they are being had. Only a skilled propaganda specialist can turn "bioidentical" in to a dirty word, and make using the correct hormones seem crazy, when the known facts of human physiology and the results of replacement studies using bioidenticals by the proper route and in proper balance support their greater safety.Hillinpa (talk) 10:58, 10 May 2010 (UTC)
"You have removed all such sources from the article in the past and will do so again" - yup, per WP:OR
"So for you and your drug-company funded sources" - please see WP:NPA, and all my previous comments on this issue. Note that I have never accused or dismissed your points as being in the pocket of "big bioidentical", despite your relentless advocacy for the molecules. I've always tried to justify my efforts through a combination of policies, guidelines and references.
"... is a clear-cut case of lying" - nope, this is the summary of multiple WP:MEDRS.
"Lying about evidence is not a respectable scientific procedure" - agreed, but we're an encyclopedia based on verifiability, not a peer-reviewed journal that publishes original research on a topic.
"This page is not based upon evidence..." - 60+ sources beg to differ.
"...it is a repetition of OPINIONS about the evidence from compromised sources." - you have not provided any sources to substantiate the "tainted sources" point, ever. And the compromise runs both ways since the advocates of BHRT tend to also be people who publish books on the topic (which I doubt they give away for free), and charge expensive consulting fees for essentially their opinion on what FDA-approved hormones to use.
"You have worked very hard to exclude any actual discussion of the evidence from good sources, and to include sources of the worst kind to support your opinion." - WP:MEDRS, WP:OR, and [58]. You may not like my sources or my discussion, certainly you've never shown evidence of conceding I may have a point, but they're all there.
"This is so evident to anyone reading the page that I think it best to leave it as it is..." - excellent, I have no issue with that. Will you please alert Atama that no mediation will be needed.
"...using bioidenticals by the proper route and in proper balance support their greater safety." - and when reliable sources become available indicating what the safest mixture of hormones, dosing regimen, delivery route and so forth are, for the appropriate genotypes, then the appropriate wikipedia pages can be adjusted to reflect this. It's just not there. We both agree - the safest regimen is the best one. We just disagree on the evidence base. Be comforted that if you're right, if transdermal bioidenticals are the best approach, then eventually the research will bear this out. WLU(t)(c) Wikipedia's rules:simple/complex16:50, 10 May 2010 (UTC)
Mediation Requested
When all attempts to get WLU to allow this article to conform to Wiki policies failed, I requested mediation. See [[59]] One editor recently did offer to mediate, I am trying to see if he/she is still willing.Hillinpa (talk) 08:26, 18 April 2010 (UTC)
Since the controversy around this article has flared up again (after being quiet for months), I think that mediation might be merited here. If the parties involved are interested, I could reopen the original mediation request and we can start a discussion. I'll watch this page to see what others think. -- Atama頭20:36, 20 April 2010 (UTC)
Since at least the two of you are willing, give me a little time to review the original mediation request, recent activity, discussion on this page, and then I'll create some structure for the discussion. -- Atama頭22:35, 20 April 2010 (UTC)
Sorry that it has taken so long but there is a lot to wade through here. I try to be very thorough and prepared before I start a discussion. -- Atama頭23:29, 26 April 2010 (UTC)
^Somers, Suzanne (2004). The sexy years: discover the hormone connection: the secret to fabulous sex, great health, and vitality for women and men. New York: Crown Publishers. ISBN0-609-60721-9.
