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The half-life seems completely bogus. E.g. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=2943134&dopt=Abstract mentions 40-60 hours. —Preceding unsigned comment added by 82.130.46.87 ( talk • contribs) 15:45, June 2, 2007
Evidence shows that Wyeth knew the dangers of Medroxyprogesterone Acetate (the "Pro" in Prempro) but marketed it in reckless disregard for the risks to the women who received it.
Another Loss for Pfizer in Drug Suits
http://www.nytimes.com/2009/11/24/business/24wyeth.html?fta=y
By DUFF WILSON
Published: November 23, 2009
Bioidentical progesterone shown to be more efficacious than synthetic MPA medroxy progesterone in peer reviewed clinical study in mainstream literature.
"The effect of progesterone compared with MPA included a 30% reduction in sleep problems, a 50% reduction in anxiety, a 60% reduction in depression, a 30% reduction in somatic symptoms, a 25% reduction in menstrual bleeding, a 40% reduction in cognitive difficulties, and a 30% improvement in sexual function. Overall, 65% of women felt that HRT combined with progesterone was better than the HRT combined with MPA." Quoted from Holtorf
Reference: Fitzpatrick LA, Pace C, Witta B. Comparison of regimens containing oral micronized progesterone of medroxyprogesterone acetate on quality of life in postmenopausal women: a cross-sectional survey. J Womens Health Gend Based Med. 2000;9(4):381–387. UGAcodon ( talk) 23:58, 1 July 2010 (UTC)
This is what the edit will look like:
Bioidentical progesterone shown to be more efficacious than synthetic MPA medroxy progesterone. (Holtorf Reference Here)
"more efficacious" doesn't say much in itself: I'd suspect that a higher dose of MPA would be more effective than a lower dose, so the real question is the comparison of therapeutic widths. Holtorf seems to support that progesterone is better in that respect than MPA, but unfortunately I can't access the complete article. However, the phrasing "has been shown to be..." is a bit too matter-of-fact for my taste given that HRT is a rather controversial topic and Holtorf might not be completely NPOV as far as I can tell. Given the WHI results, I think that phrasing should be done with great caution – this shouldn't look like "bioidentical = effective and harmless". -- ἀνυπόδητος ( talk) 09:23, 3 July 2010 (UTC)
Regarding the statement that Holtorf has been accepted on Bioidentical hormone replacement therapy: A quick glance at the page suggests that this is as part of the discussion on the controversy surrounding bioidentical hormones. Quote: "Bioidentical hormone proponents Erika Schwartz and Kent Holtorf criticized a 2008 review of literature on bioidentical hormones..." and that's how it should be: Explain that there are proponents and opponents. If a source is from people who have certain stance, say so, and preferably mention alternative views as well. See WP:WEIGHT. -- ἀνυπόδητος ( talk) 09:40, 3 July 2010 (UTC)
The difference between MP and MPA is apparently equivocal. See here. Someone mentioned merging the two, I'm not sure yet, but if not then clarifying the difference would be helpful. WLU (t) (c) Wikipedia's rules: simple/ complex 13:47, 3 July 2010 (UTC)
The section Clinical profile is getting a bit off-topic, I'm afraid. This article is about MPA, not progesterone. Any ideas? Is this necessary at all at this place? -- ἀνυπόδητος ( talk) 07:18, 5 July 2010 (UTC)
—Preceding unsigned comment added by UGAcodon ( talk • contribs) 10:48, 5 July 2010 (UTC)
Here are the links: MICHAEL CIRIGLIANO http://www.solaltech.com/doctors/3/Bioidentical%20Hormone%20Therapy--%20Cirigliano.pdf
FDA Guidance http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM135336.pdf
"Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman."
The FDA guidance is referring to comparing the MPA used in the WHI to other combinations of progestins. Progesterone, which is not a progestin, is not mentioned anywhere in the guidance. The phrase, " assumed to be similar" is not refernced properly by the FDA guidance. UGAcodon ( talk) 14:12, 5 July 2010 (UTC)
2) Why is FDA concerned about compounded “BHRT” drugs?
FDA is aware that a growing number of pharmacies compound hormone drugs for treatment of the symptoms of menopause. These pharmacies often promote their compounded drugs as “bio-identical” to the hormones produced by a woman’s body, and the phrase “bio-identical hormone replacement therapy” has been used to describe these drugs.
Some pharmacy compounders claim that their compounded “BHRT” drugs are a “natural” alternative to FDA-approved drugs, because the compounded hormones are purportedly identical to the hormones produced in the body. These pharmacies may also claim that their “natural” compounded drugs are safer and more effective than FDA-approved menopausal hormone therapy drugs. FDA is not aware of any credible scientific evidence supporting these claims. Nor is FDA aware of sound evidence showing that the side effects and risks of compounded "BHRT" drugs that use estrogen and progesterone as active ingredients are different than those of similarly formulated FDA-approved menopausal hormone therapy drugs. Because many claims regarding the safety, efficacy, and superiority of compounded “BHRT” drugs have not been proven, FDA is concerned that these claims mislead patients and practitioners. Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.
This section (which isn't about "clinical profile" since all it talks about is how it compares with progesterone) is already quite lengthy considering the length of the article, and shouldn't get any longer. This is particularly relevant considering just how damning the general consensus is of BHRT. I've tried to contextualize as much as I could, particularly with Panay & Fenton's editorial (available by e-mail) but I really don't want a lengthy set of primary sources detailing how much greater progesterone is than MPA (Holtorf's research, from what I can tell of a quick review, is still fairly biased and oversells a couple papers). The expansion of the page should come from the other sections which are sorely missing. WLU (t) (c) Wikipedia's rules: simple/ complex 16:58, 5 July 2010 (UTC)
Cirigliano The Cirigliano article can hardly be considered neutral or non-biased, since it was ghostwritten by PharmaWrite, as acknowledged by Cirigliano at the end of the article under editorial assistance. Pharmawrite was paid by Wyeth to write pro-Prempro articles in the medical literature and "recruit" doctors to be the authors. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aHBqo8_f_lLA
Cirigliano is an internist at U Penn in active clinical practice. Medline lists 8 articles to his name, with only one dealing with women's hormone therapy.
The Cirigliano article was published in Journal of Women's health, whose editor has disclosed numerous financial ties to the synthetic hormone industry, and runs Wyeth funded ghost-written pro-synthetic hormone industry articles. see: http://www.nytimes.com/2008/12/12/business/13wyeth.html?scp=2&sq=wyeth&st=cse
Panay and Fenton see: http://www.imsociety.org/editorial_board.php Financial Disclosure for Climacteric Editors-in-Chief Anna Fenton (New Zealand) Nick Panay (UK). Dr Anna Fenton, (New Zealand)Endocrinologist Dr Fenton has disclosed that she is or has been a recipient of research/grant funding from, a consultant/advisor to, and a member of the speakers’ bureaux for: Pfizer/Wyeth, Merck Sharpe and Dohme, Bayer Schering, Eli-Lilly, GlaxoSmithKline, Sanofi-Aventis and Novartis.
Mr Nick Panay Queen Charlotte’s & Chelsea Hospital, London, UK Mr Panay has disclosed that he has acted in an advisory capacity, performed research and/or lectured on behalf of the following companies: Baxter, Bayer Schering, Eli Lilly, Galen, Janssen Cilag, Merck, Novo Nordisk, Novogen, Organon, Orion, Procter & Gamble, Se-cure, Servier, Shire, Solvay, Storz, and Wyeth.
With these financial disclosures, these are clearly Non-Neutral POV secondary sources. I would be interested to see any other Non-Biased, Non-Ghostwritten secondary sources that actually review the medical studies comparing clinical profile of medroxyprogesterone to other progestins, and progesterone. This would be quite helpful here.
By the way, do you have a pdf of the Panay Fenton article? UGAcodon ( talk) 12:04, 6 July 2010 (UTC)
I am requesting mediation and dispute resolution on Medroxyprogesterone regarding WLU placing statements without a valid reference. See the changes regarding section Comparison with progesterone. UGAcodon ( talk) 01:23, 6 July 2010 (UTC)
Two secondary reviews state, " When combined estrogen/progestin therapy is used, the risk of breast cancer is consistently higher than that of estrogen alone use." see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1974841/ Review - Progestins and progesterone in hormone replacement therapy and the risk of breast cancer by Carlo Campagnolia
Also see second review: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670363/ Expert Opin Pharmacother. 2006 December; 7(18): 2455–2463. Current breast cancer risks of hormone replacement therapy in postmenopausal women by Nirav R Shah
These two reviews indicate the weight of the medical evidence supports the claim that progestins added to HRT increase breast cancer risk in women. This increased breast cancer risk was also demonstrated in the women's health initiative study which used medroxyprogesterone added to premarin. The study was halted early due to increased breast cancer in the drug group compared to placebo. see http://jama.ama-assn.org/cgi/content/full/288/3/321 UGAcodon ( talk) 11:27, 12 July 2010 (UTC)
Per
Talk:Medroxyprogesterone 17-acetate#Difference between Medroxyprogesterone acetate and Medroxyprogesterone, the compounds appear to be discussed substantially as if they were identical. Are there sufficiently few differences between the two that unique aspects of MPA can't be dealt with in the body text of medroxyprogesterone acetate?
WLU
(t)
(c) Wikipedia's rules:
simple/
complex 16:40, 12 July 2010 (UTC)
This is the
talk page for discussing improvements to the
Medroxyprogesterone article. This is not a forum for general discussion of the article's subject. |
Article policies
|
Find sources: Google ( books · news · scholar · free images · WP refs) · FENS · JSTOR · TWL |
![]() | Ideal sources for Wikipedia's health content are defined in the guideline
Wikipedia:Identifying reliable sources (medicine) and are typically
review articles. Here are links to possibly useful sources of information about Medroxyprogesterone.
|
![]() | This article is rated Start-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | ||||||||||||||||||||||||||||||
|
The half-life seems completely bogus. E.g. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=2943134&dopt=Abstract mentions 40-60 hours. —Preceding unsigned comment added by 82.130.46.87 ( talk • contribs) 15:45, June 2, 2007
Evidence shows that Wyeth knew the dangers of Medroxyprogesterone Acetate (the "Pro" in Prempro) but marketed it in reckless disregard for the risks to the women who received it.
Another Loss for Pfizer in Drug Suits
http://www.nytimes.com/2009/11/24/business/24wyeth.html?fta=y
By DUFF WILSON
Published: November 23, 2009
Bioidentical progesterone shown to be more efficacious than synthetic MPA medroxy progesterone in peer reviewed clinical study in mainstream literature.
"The effect of progesterone compared with MPA included a 30% reduction in sleep problems, a 50% reduction in anxiety, a 60% reduction in depression, a 30% reduction in somatic symptoms, a 25% reduction in menstrual bleeding, a 40% reduction in cognitive difficulties, and a 30% improvement in sexual function. Overall, 65% of women felt that HRT combined with progesterone was better than the HRT combined with MPA." Quoted from Holtorf
Reference: Fitzpatrick LA, Pace C, Witta B. Comparison of regimens containing oral micronized progesterone of medroxyprogesterone acetate on quality of life in postmenopausal women: a cross-sectional survey. J Womens Health Gend Based Med. 2000;9(4):381–387. UGAcodon ( talk) 23:58, 1 July 2010 (UTC)
This is what the edit will look like:
Bioidentical progesterone shown to be more efficacious than synthetic MPA medroxy progesterone. (Holtorf Reference Here)
"more efficacious" doesn't say much in itself: I'd suspect that a higher dose of MPA would be more effective than a lower dose, so the real question is the comparison of therapeutic widths. Holtorf seems to support that progesterone is better in that respect than MPA, but unfortunately I can't access the complete article. However, the phrasing "has been shown to be..." is a bit too matter-of-fact for my taste given that HRT is a rather controversial topic and Holtorf might not be completely NPOV as far as I can tell. Given the WHI results, I think that phrasing should be done with great caution – this shouldn't look like "bioidentical = effective and harmless". -- ἀνυπόδητος ( talk) 09:23, 3 July 2010 (UTC)
Regarding the statement that Holtorf has been accepted on Bioidentical hormone replacement therapy: A quick glance at the page suggests that this is as part of the discussion on the controversy surrounding bioidentical hormones. Quote: "Bioidentical hormone proponents Erika Schwartz and Kent Holtorf criticized a 2008 review of literature on bioidentical hormones..." and that's how it should be: Explain that there are proponents and opponents. If a source is from people who have certain stance, say so, and preferably mention alternative views as well. See WP:WEIGHT. -- ἀνυπόδητος ( talk) 09:40, 3 July 2010 (UTC)
The difference between MP and MPA is apparently equivocal. See here. Someone mentioned merging the two, I'm not sure yet, but if not then clarifying the difference would be helpful. WLU (t) (c) Wikipedia's rules: simple/ complex 13:47, 3 July 2010 (UTC)
The section Clinical profile is getting a bit off-topic, I'm afraid. This article is about MPA, not progesterone. Any ideas? Is this necessary at all at this place? -- ἀνυπόδητος ( talk) 07:18, 5 July 2010 (UTC)
—Preceding unsigned comment added by UGAcodon ( talk • contribs) 10:48, 5 July 2010 (UTC)
Here are the links: MICHAEL CIRIGLIANO http://www.solaltech.com/doctors/3/Bioidentical%20Hormone%20Therapy--%20Cirigliano.pdf
FDA Guidance http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM135336.pdf
"Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman."
The FDA guidance is referring to comparing the MPA used in the WHI to other combinations of progestins. Progesterone, which is not a progestin, is not mentioned anywhere in the guidance. The phrase, " assumed to be similar" is not refernced properly by the FDA guidance. UGAcodon ( talk) 14:12, 5 July 2010 (UTC)
2) Why is FDA concerned about compounded “BHRT” drugs?
FDA is aware that a growing number of pharmacies compound hormone drugs for treatment of the symptoms of menopause. These pharmacies often promote their compounded drugs as “bio-identical” to the hormones produced by a woman’s body, and the phrase “bio-identical hormone replacement therapy” has been used to describe these drugs.
Some pharmacy compounders claim that their compounded “BHRT” drugs are a “natural” alternative to FDA-approved drugs, because the compounded hormones are purportedly identical to the hormones produced in the body. These pharmacies may also claim that their “natural” compounded drugs are safer and more effective than FDA-approved menopausal hormone therapy drugs. FDA is not aware of any credible scientific evidence supporting these claims. Nor is FDA aware of sound evidence showing that the side effects and risks of compounded "BHRT" drugs that use estrogen and progesterone as active ingredients are different than those of similarly formulated FDA-approved menopausal hormone therapy drugs. Because many claims regarding the safety, efficacy, and superiority of compounded “BHRT” drugs have not been proven, FDA is concerned that these claims mislead patients and practitioners. Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.
This section (which isn't about "clinical profile" since all it talks about is how it compares with progesterone) is already quite lengthy considering the length of the article, and shouldn't get any longer. This is particularly relevant considering just how damning the general consensus is of BHRT. I've tried to contextualize as much as I could, particularly with Panay & Fenton's editorial (available by e-mail) but I really don't want a lengthy set of primary sources detailing how much greater progesterone is than MPA (Holtorf's research, from what I can tell of a quick review, is still fairly biased and oversells a couple papers). The expansion of the page should come from the other sections which are sorely missing. WLU (t) (c) Wikipedia's rules: simple/ complex 16:58, 5 July 2010 (UTC)
Cirigliano The Cirigliano article can hardly be considered neutral or non-biased, since it was ghostwritten by PharmaWrite, as acknowledged by Cirigliano at the end of the article under editorial assistance. Pharmawrite was paid by Wyeth to write pro-Prempro articles in the medical literature and "recruit" doctors to be the authors. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aHBqo8_f_lLA
Cirigliano is an internist at U Penn in active clinical practice. Medline lists 8 articles to his name, with only one dealing with women's hormone therapy.
The Cirigliano article was published in Journal of Women's health, whose editor has disclosed numerous financial ties to the synthetic hormone industry, and runs Wyeth funded ghost-written pro-synthetic hormone industry articles. see: http://www.nytimes.com/2008/12/12/business/13wyeth.html?scp=2&sq=wyeth&st=cse
Panay and Fenton see: http://www.imsociety.org/editorial_board.php Financial Disclosure for Climacteric Editors-in-Chief Anna Fenton (New Zealand) Nick Panay (UK). Dr Anna Fenton, (New Zealand)Endocrinologist Dr Fenton has disclosed that she is or has been a recipient of research/grant funding from, a consultant/advisor to, and a member of the speakers’ bureaux for: Pfizer/Wyeth, Merck Sharpe and Dohme, Bayer Schering, Eli-Lilly, GlaxoSmithKline, Sanofi-Aventis and Novartis.
Mr Nick Panay Queen Charlotte’s & Chelsea Hospital, London, UK Mr Panay has disclosed that he has acted in an advisory capacity, performed research and/or lectured on behalf of the following companies: Baxter, Bayer Schering, Eli Lilly, Galen, Janssen Cilag, Merck, Novo Nordisk, Novogen, Organon, Orion, Procter & Gamble, Se-cure, Servier, Shire, Solvay, Storz, and Wyeth.
With these financial disclosures, these are clearly Non-Neutral POV secondary sources. I would be interested to see any other Non-Biased, Non-Ghostwritten secondary sources that actually review the medical studies comparing clinical profile of medroxyprogesterone to other progestins, and progesterone. This would be quite helpful here.
By the way, do you have a pdf of the Panay Fenton article? UGAcodon ( talk) 12:04, 6 July 2010 (UTC)
I am requesting mediation and dispute resolution on Medroxyprogesterone regarding WLU placing statements without a valid reference. See the changes regarding section Comparison with progesterone. UGAcodon ( talk) 01:23, 6 July 2010 (UTC)
Two secondary reviews state, " When combined estrogen/progestin therapy is used, the risk of breast cancer is consistently higher than that of estrogen alone use." see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1974841/ Review - Progestins and progesterone in hormone replacement therapy and the risk of breast cancer by Carlo Campagnolia
Also see second review: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670363/ Expert Opin Pharmacother. 2006 December; 7(18): 2455–2463. Current breast cancer risks of hormone replacement therapy in postmenopausal women by Nirav R Shah
These two reviews indicate the weight of the medical evidence supports the claim that progestins added to HRT increase breast cancer risk in women. This increased breast cancer risk was also demonstrated in the women's health initiative study which used medroxyprogesterone added to premarin. The study was halted early due to increased breast cancer in the drug group compared to placebo. see http://jama.ama-assn.org/cgi/content/full/288/3/321 UGAcodon ( talk) 11:27, 12 July 2010 (UTC)
Per
Talk:Medroxyprogesterone 17-acetate#Difference between Medroxyprogesterone acetate and Medroxyprogesterone, the compounds appear to be discussed substantially as if they were identical. Are there sufficiently few differences between the two that unique aspects of MPA can't be dealt with in the body text of medroxyprogesterone acetate?
WLU
(t)
(c) Wikipedia's rules:
simple/
complex 16:40, 12 July 2010 (UTC)