In chapter 1 we examined the importance of the blood measurement of HRT – hormone replacement.
This chapter 2 reviews the evidence for the importance of the source, the origin of HRT.
The textbook WOMENS’ BODIES, WOMENS’ WISDOM by ObGyn Prof Christiane Northrup (2nd Ed Piatkus UK 1998) is the only book found which details “the source of all marketed sex hormones”: which at that time, was –
i) EQUINE : MARES’ URINE for Wyeth-Ayerst’s Premarin estrogens;
But “all other prescribed sex hormones are derived from
ii) PLANTS -yams and soya:
the Estrogens – estradiol, estrone, estriol, mestrone, diestranol;
the Progestins – progesterone; norethisterone & dydrogestone;
Testosterone – implants, Sustanon and all the TT esters; and
Tibolone – a weak synthetic estrogen-progestin-androgen:”
(to which RSA has added the African potato/yam for: Moducare); except
iii) SYNTHETICS: the (progestins) levonorgestrol & medroxyprogesterone were
the exceptions, listed as being ‘synthetic’ ie presumably laboratory synthetised.
In April 2008 Northrup reasserts the primacy of for-survival mother Nature’s optimally evolved bioidentical hormones over the 50 year old xenohormones including synthetics – of for-profit Father pharmaceuticsl like Wyeth. see link http://www.drnorthrup.com/news/bioidentical_hormones.php
But (other than E2, TT, DHEA & progesterone) we cannot ROUTINELY measure the dozens of SH which HT (ie other than human estradiol, testosterone, progesterone, DHEA) eg premarin, progestins produce in the blood – estrone, estriol; ethinylestradiol; equilins; progestins; or anabolic steroids; – whether these derive from mares’ urine, soya, yam, African potato, black cohosh or laboratory synthetics.
Thus it is not THE ORIGIN of SHR WHICH MATTERS, BUT WHETHER it (HRT) gives PRIME hormones ( DHEA, TT, E2, progesterone), MEASURABLE IN THE PATIENTS’ BLOOD.
As Dr Lee Vliet points out in SCREAMING TO BE HEARD (Evans, New York, 2001), “Conjugated estrogens eg Premarin is only 0.5% measurable E2 estradiol; the other 99.5% we cannot routinely measure: 50% is estrone, the rest is scores of other horse estrogens not found in humans”, ie not routinely measurable.
So women are urged by Wyeth, and allowed by the FDA, to take a potent pregnant-mare based compound which ensures some measurable estradiol level, but also ensures potent estrogens at more than hundredfold the bloodlevel of the optimal physiological estradiol level. No wonder oral premarin promotes major complications early in most women, and lifethreatening if continued for more than a dozen years. Why do Regulators (eg the FDA) allow this, except for massive profits for the Regulator, the fiscus, and Industry- Wyeth which creates many jobs, and the Disease Industry that has to take care of the increasing complications of the premarins?
As Vliet’s graphs show, “systemically administered E2 is the ONLY estrogen which raises predominantly the plasma E2 level – the prime youthful estrogen; as opposed to all other (and inferior ) estrogens, which compete with E2 for the estrogen receptor ERs. Premarin especially binds tightly to the ERs”, suppressing and blocking what little E2 older women get or make.
Arising from eg Vliet, there are some six emotive issues to be distinguished in all HRT:
(i) While humans are omnivorous, few usually drink even their own urine, let alone milk, meat or urine from pregnant mares; drinking urine as medicine is condemned by allopathic medicine.
(ii) Thousands of mares across North America are kept pregnant, permanently catheterized,
sedated, tethered to collect their gallons of urine which only Wyeth may (presumably by patent) use (@>$17/liter) to extract Premarin;
(iii) Because of the risk of allergy and eg prion (BSE) infection transmission let alone HIV and newer infections, animals are no longer used as SOURCE of ANY HRT except Premarin; (salmon calcitonin may still be a rare exception). Medicinal products derived even from man (from blood or organs) regularly cause immune or infection disaster..
(iv) Premarin is the only HRT in common use which reportedly has still not been fully characterised – hence Wyeth, via the FDA, has for 50 years deviously prevented any other manufacturer from registering a generic! It is said that at least 40 different steroids have been detected in Premarin; since these are the breakdown products of horse pregnancy, it is not surprising that (while it reduces symptoms and slows osteoporosis), complex Premarin is badly tolerated and rejected by the majority of women (who do not want to feel pregnant).
(v) Recent major RCTs have failed to show benefit from Premarin in older women with vascular or dementing diseases; and
(vi) Up to 80% of women started on oral HRT –( which in the USA is mostly conjugated Estrogens) – abandon it within 3 years…
Routine animal milk, eggs, meat, and food plant ingestion may all produce allergy and infection when eaten by humans; but provided the hormones synthesized from ANY chemicals are molecularly identical to human hormones, they are human hormones and, if injected without contamination into humans – whether they be insulin, adrenaline, E2, TT, erythropoeitin, granulocyte-stimulating factor, parathormone, growth hormone, chorionic gonadotropic hormone, cortisone or progesterone – cannot cause allergy (unlike eg the synthetic hormone derivative prednisone),..
But Premarin is the sterilized extract of ALL steroid waste products from pregnant mares’ urine, and only about 50% of it’s hormones (E1 and a trace of E2) are identical to human steroids. Other mammals’ meat can produce allergy in humans even when cooked. Hormones surely cannot be cooked or they decompose. Many people are allergic to dairy products; yet women are universally prescribed to drink the product of mares’ urine – and most women abandon it within a few years – wisely so, since the incidence of breast cancer rises steadily with total estrogen dose [Henderson BE , Paganini-Hill A, et al, UCLA: JAMA: 1980;243:1635-9: Menopause, ERT and BRCA 1971-’77:) in 138 BRCA cases, most of risk increase was on Premarin in those with ovaries – which make women intolerant of more than low dose ERT.. RR for BRCA for a ERT cumulative dose >1,500 mg(ie 7yrs) was estimated to be 2.5 in women with ovaries vs 0,7 sans ovaries].
To date the FDA – the US Government- sticks piously to it’s defence to the death of Wyeth’s unique right to produce generic premarin since no-one is yet certain of the precise steroid composition of premarin- which the FDA allows to be marketed only by Wyeth although it is long out of patent, and it’s composition (as a biological urine extract) reputedly varies from batch to batch. http://www.fda.gov/CDER/news/cebackground.htm.
It should be noted that the FDA approved Cenestin soy-based “conjugated estrogens CE ” in 1999, now apparently replaced by Barr Pharmaceuticals with Enjuvia, also a plant-derived formulation of 10 synthetic conjugated estrogens http://www.enjuvia.com/patients/about_enjuvia/Default.aspx.
Does it surprise that there are precisely two randomised controlled trials, for 3 -4 months, in 121 women, done in France & USA, published on the clinical benefit of these two (Barr’s) plant-based conjugated estrogens? http://jcp.sagepub.com/cgi/content/abstract/42/3/290.; http://linkinghub.elsevier.com/retrieve/pii/S0378512203002408. American women beware.
But Barrs must be rubbing their hands in glee at the vindication of CE for appropriate use in lower than conventional dose for up to 9 years in the young women in the USA Womens’ Health Initiative (Rossouw ea 2004) RCT.
chapter 3 will examine THE IMPORTANCE OF ROUTE OF HRT?