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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 199 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?

ndb

and 7 years since they postulated that statin benefit might be negated long-term by adverse  non- CVD mortality at CVD risk below 1.3%pa.

It is almost 40 years since as a junior medical registrar I was first advised to take lipid-lowering drugs (clofibrate- just a few years before the cancer link came out),

and  have since then been advised  to take statins .

I have never done so  (for my familial mild-moderate type 2b  lipidemia),  because the evidence has never justified such experimental and long-term unproven synthetics (as with modern antidiabetic and anti-osteoporotic wannabe money spinners) in search of $billions for the western Drug Corporations and their investors and lobbyists.  

   Lately,  despite the massive statin trials, the last  statin  metanalysis (2003 from University Slovenia) again failed to show any reduction in non-CVD cardiovascular  disease mortality;

and since CVD is the major cause of death and disability  ONLY in those who already have such disease, statins remain indicated only in secondary prevention -as was shown in the last two major trials published, in 2002 ( ALLHAT-LLT  and WESCOPS), now confirmed in the Japanese MEGA study  (2006) of low dose statin, which (in primary prevention in a slim population)  showed similar barely significant 1/3 CVD mortality benefit- significant reduction only in myocardial infarction -  but no significant other  cardiovascular or non-vascular benefit even after a mean of 5.3years, 41 000 patient-years.   

 Last month  Theo Jacobson from Emory University in Atlanta GA  commented that myalgia is the leading reason why patients abandon statins. 

 In 2000 he already questioned the marketing hype for statins  that “the lower the cholesterol level is driven, the better” . 

The growing scandal is the increasing marketing  pressure  by Big Pharma lobbyists (including  some Regulator  staff) to promote prescription and even over-the-counter use of statins to achieve ever-lower low-density lipoprotein levels even in the absence of any vascular disease or CVD risks- including the farcical inclusion of statin in a PolyPill (led by Ward and Law and the BMJ in  UK). .

 Last year Kilmer McCully himself  (the father of the homocysteine hypothesis in CVD 1969) points out that the dramatic fall in CVD mortality  since  it’s USA peak in 1955 correlates well with voluntary and mandatory fortification with B6, B9 and B12 (let alone niacin) .

We may also note that  falling  premature CVD mortality coincides with

• the increasing use of metformin the past decades  (which lowers all-cause morbidity and mortality, and new diabetes, by 1/3,  and overweight by about 8%); for both treatment and prevention of type 2 diabetes, overweight, lipidemia and polycystic ovary syndrome.;
• and with increasing use of appropriate sex hormone replacement for aging men and women (which lowers all-cause morbidity and mortality by 1/3); .
•  and with targeting of lower blood pressure levels even in the elderly hypertensives since the SHEP trial (1985).   
•  and with growing intake of supplementary fish oil ((which lowers all-cause morbidity and mortality by  almost 1/2);  
•   and  of other insulin sensitizer- Nitrric oxide - antioxidant -metabolic promoters  (like vitamins A,  B1, B3,B7, C, D, E, K, calmag, zinc, chromium and other trace elements), and the dozens of our other  crucial  biologicals that decline with aging and illness, (like coQ10, n-acetyl cysteine, arginine, carnitine, carnosine, ribose, chondroglucosamine, lipoic acid, taurine, bioflavinoid, thyroid, melatonin  etc).

And while statins have legion adverse effect from insidious fatigue to myositis and hepatorenal impairment; dermatitis, depression; reducing steroid levels and virility; and lately  producing even lung damage, (unlike the natural supplements listed  that are the best drugs),  they have never been shown to have the slightest benefit on non-CVD pathology, from overweight and insulin resistance - diabetes  to arthritis. Manufacturers and lobbyists have studiously avoided head-on trial comparison with  the natural CVD preventatives  listed above which simutaneously address both the underlying metabolic cause of hypercholesterolemia (insulin resistance and atheroma) and all the other major common degenerative diseases of aging. So the direct highpressure marketing od statins to the public  - without prescription - for other than severe resistant hypercholesterolemia is thus dangerous massive corporate fraud.

So there is every reason why statin use should be severely limited to only  high-risk CVD cases i.e. those with  dangerous homozygous familial hypercholesterolemia resistant to all other  interventions.

see for references:

(more…)

DOES THE SOURCE,  MEASUREMENT, DOSE, BALANCE, and  ROUTE OF ADMINISTRATION OF SEX HORMONE THERAPY HRT MATTER?

Chapter 

1.      THE IMPORTANCE OF THE MEASUREMENT OF BLOOD LEVELS OF SEX HORMONES

          While urologists,  andrologists and internists  demand blood hormone  levels to diagnose male hypogonadism ,  adrenal, thyroid  or other endocrine dysfunction ,  many gynecologists still apparently  give postmenopausal HRT without ever measuring levels.

           Do baseline and achieved sex hormone levels matter ?

           Older authorities(mostly male or trained by men) did not believe so; hence we still see women presenting  on  eg implants or Premarin up to 2,5mg/day for years, with Estrogen  levels of well above 3nmol/L ->10 times what is necessary and safe),  or SHBG levels well over 200nmol/L; some of them grossly bloated and dysfunctional if not with mushrooming breast cancers or  the obesity metabolic syndrome.

      The textbook HORMONE REPLACEMENT THERAPY HRT (A Wayne  Meikle ed: Humana Press, USA  1999: p266) says  in Men’s Sex Hormone Replacement SHR: “the  general principle of SHR  is to normalize the (TT) level”.  “The safe course is to duplicate normal physiology as much as possible:  HRT  should allow self-administration, be convenient, affordable, minimal discomfort, with predictable responses. TT-cypionate  or TT-enanthate  100mg/week maintains physiological levels between 16-32 ie mean 24nmol/L.   Mixtures of short-and-long-acting TT  (eg Sustanon) are  thus  not recommended”.

At p412 Davis & Burger, for TT Replacement  in women, say:  “replace TT levels to at least the UPPER level of  normal physiological range for young ovulating women”.

     Meikle’s  authoritative  Textbook thus stresses the importance of  duplicating  normal human  physiology .  This  requires  using human systemic (ie not oral) hormones which can  and  must  be measured before and periodically on SHR -

 ie  using only systemic TT in men, systemic TT + E2 + Progesterone in women.

The 2000 Management of the Menopause Millenium Review (Studd JW ea, London) strongly promotes measuring hormone levels and balance in both sexes: ”calcium loss decreases with serum E2> 72pmol/L; vasomotor symptoms at >126-252pmol/L; and lipids changes at  250pmol/L- whereas breast cancer BRCA cells responds  to  E2>36pmol/L”  but does not say how these interact with TT levels;  so it is  important to monitor the serum E2, to keep it in the therapeutic window above about 100 but below 250pmol/L ie mean about 200pmol/l;  many women do not feel better on solo ERT – so few persist  on it; Studd ea  thus recommend “E2 patch rather than orally, for less hypertension, gallstones, DVT & hepatic protein formation.”      “it  is mandatory to measure BMI and % body fat;   the single best screen for Insulin resistance is a  fasting glucose/insulin(G:I) ratio below 4,5.

       “Depression is the commonest functional disorder of aging men, in whom aging sexhormone changes - PEDAM(Partial Endocrine  Deficiency of Aging  Men)-  include falling androgens, rise in SHBG, arteriosclerosis  & CVD,  and decrease in brain hormones & wellbeing – with especially decrease in melotonin & sleep, muscle strength, RBC, cognition, bone,  immunocompetence,  &  erection.”

       The Johannesburg gynecologist editor of Wyeth’s Menopause Update August 2001 certainly advocates frequent E2 measurements to titrate the frequency and dose of E2 implants, “aiming for a blood level of 0.35-0.45nmol/L: side effects occur when the dose exceeds the patient’s needs”.  Kopenhager in the same issue promotes “lowdose ERT – 1mg/day oral E2 causing less side-effects like headache, swelling or mastalgia, without increase in body mass”; but he overlooks the fact that 0.05ug of E2/day systemically will often suffice, that body weight says nothing about the steady gain in fatmass and loss in muscle  mass with aging and unopposed estrogen.   Prof  Frank Guidozzi from Johannesburg in the same issue makes the  point about TT replacement even for men – 250mg ester/ fortnight intramuscularly ie  a mean 12mg TT/day, or 5mg/day by patch, or 120mg undecanoate/day orally..

          As Fritz Schumaker said, there is a need for the right amount of  all things, from water to air.  A bit too little or a bit too much food, insulin or cortisone will be seen and felt fairly soon; whereas with thyroid, vitamin D and the sex steroids it may take months to years before it becomes apparent – when it may be too late, with broken marriage, spirits, heart or bones, or cancer.  Optimal doses, blood levels and balance  are apparent throughout nature and  for all hormones – with balance between the hormones – between the strengthening androgens and the fattening estrogenics – being the most important to balance the bloodpressure and lipids, thrombosis and bruising, fat-mass and lean-mass,  concrete and intuitive skills,  hypo-and hyper-immunity,  apathy and drive.  

            Well-published clinical studies for 80 years since hormone measurements began (McLeod  & Banting; Albright; Dubois, Masters, Bulbring, Hayward, Stoll, Mackay,  Wang, Henderson, Greenblatt, Speroff, Vermeulen, Roitt & Delves, Nieschlag & Behre, Motohashi,  Studd, Whitehead, Maartens et al)  have  shown the importance of  titrating doses and measuring  bloodlevels of the superhormone family - estrogens and androgens, cortisone, insulin and thyroid -  in men and women,  on every system, the mind and body.

OPTIMAL SEXHORMONE LEVELS

Sue Davis et al from Monash University  have been eloquent advocates of normalizing female TT levels above the 1.5nmol/L level;  this has been done by eg  Schleyer-Saunders in London, Gelfand and Gambrell in Augusta,  Morrie Gelfand et al at McGill Quebec, and Davey’s group  in Cape Town for over 30 years. There seems to be wide consensus that E2 level should be between 0.1-0.25nmol/L – but bearing in mind that breast cancer increases in proportion to the estrogen dose, and that plasma E2 reflects the (free)  plasma estrogens and androgens only in the presence of normal SHBG and in the absence  of any other estrogenics.

The Healthy TT level in Young Men

      Most seem to take it for granted that, at any adult age, a plasma TT anywhere above the bottom of the population range (eg 10nmol/L) is normal and adequate. Pfizer claims  in it’s Viagra trials that only impotent men with TT below about 8nmol/L were excluded,  since  those with TT level less  than about 2sd or 20% below the lower range of “normal” were not classified as hypogonadal.

Yet this level is 1/4 of the vigorous youthful 35-40nmol/L which we sometimes find in dynamic men even  in their mid-fifties.  Aversa A ea in  Italy (in Clin Endoc 2000:53:517-22) show how Androgens and Erection correlate, that  older  impotent men have  TT  around 13-19, mean 16nmol/L  ie half the level of young men;  those with vascular impotence having 25% higher E2 & SHBG, and  40% lower free TT (only about 45pmol/L,  versus 75pmol/L) than in  the psychogenic group; thus fTT correlates with penile elasticity;  (cf  male TT “normal range” at all age  9-35 ie mean 22nmol/L- whereas eg Greek  recruits at  army intake: mean TT level about 32nmol/L-Mantzoros et al).

        Salmimies’ paper  (1982) already 20 years ago illustrated that there is no sharp cutoff point for impotence, for response to TT:  “15 diverse hypogonadic men received im TTEnanthate (25 to 250 mg TT) or placebo injections 2 weekly, each dose for 4 weeks. All patients with pre treatment plasma TT values below 2 ng/ml(ie <7nmol/L) reported impaired sexual function. In four patients with TT between 2 and 4.5 ng/ml who reported impairment, TTE 50 to 250mg successfully improved rated sexual behaviour. Four matched men with TT level in the same 2 - 4.5ng/ml range reported high erectile function that did not change with TT E inj. These data indicate that male sexual behaviour is impaired at an individual plasma TT below between 2.0 and 4.5 ng/ml “       ie : the range of erectile loss or response is at least between 7 and 16nmol/L on their assay.

But did they, does anyone,  give enough TT, achieve adequate blood levels for long enough in non-responders?

     Andy  Guay’s 2001 abstract  illustrates the same point, there is a (?semilog) linear response ; (as  is  seen eg in Gilbert Forbes’  1980’s elegant demonstration of the semilog linear response between total TT dose and lean body mass over years). In Guay’s 44 patients (apparently 50-70yrs old) studied in detail, altho 14.9pg/ml is in the lowest quintile of the “normal” fTT range, there was 100% response to Viagra. Drop the fTT 30% and the response fell 25%; drop the fTT 45% from 14.9 to 8.1 and the response drops 84%; drop the fTT 50% to 7.4 and the response drops by 91%.

      This predictable dose response curve correlates with the finding in wasting AIDS, (Rabkins’ and Wagner’s,  Bhasin’s, and Grinspoon’s groups), that some sick men with AIDS wasting do not become anabolic at 100mg TTenanthate/ week but, improve only when the dose is increased to 150 or even 200mg/week imi- ie to a mean TT level of 30 - 40nmol/L. Bhasin’s group in LA was the first to report, in 1995, that in HEALTHY men, modestly superphysiological doses of TT cypionate or enanthate  (eg 200mg/week) (which no more than double normal  TT blood levels to around 60nmol/L,  still below the danger level of 80nmol)  improve muscle mass and strength by 10-20%; and correspondingly in frail elderly – without adverse effect.

      Thus it is  obvious that there is no arbitrary TT bloodlevel cutoff point above which Viagra is justified de novo before trial of TT replacement. Since there are no absolute contraindications to physiological systemic human TT replacement [except untreated (prostate or breast) cancer]; and since there are no risks of such measured replacement except with untreated frank heart-failure, jaundice or untreated cancer, the phosphodiesterase inhibitors  PDI (with risk of sudden death) are never justified (at a local cost of about >US$130/month) until weekly subcutaneous gluteal selfinjection of depot TT has been tried for a few months at a cost of about US$3 to $5/month.

Our own search  a few years ago (Burman, Bornman ea)  traced over 73  published reports of studies which give TT levels in groups of  “normal” men  the past 40 years; of which about 64 reports measured TT levels in men below 39 years of age. Four  were longitudinal studies in such young men, amongst about 38 longitudinal and cross-sectional studies.  Bearing in mind Klee and Vermeulen’s recent conclusions (2000-2001) that laboratory method (RIA) has changed little the past 40 years and that all reliable measures (TT, fTT, bioavailable TT etc) correlate fairly well,  our plots confirm that  mean male TT level falls about 0.7% per year (range 0.2% to 2%pa) between youth and old age ie about 40% over 50years;  but that in healthy lean  young men under 39years, the mean TT level has remained about 24nmol/L(+-16%) for 40 years; in the 22 studies between 1958 & 1985, the range was 16-35nmol/L-mean 25; in the 42 studies since 1987, the range was 14-40nmol/L-mean 27nm; – Bornman’s Pretoria series(in young men admitted for voluntary sterilization) understandably  yielding the lowest testosterone means…

          But these figures belie that  while TT falls modestly, the TT/(E2XSHBG) product  falls drastically since both E2 and SHBG rise with aging, especially with disease: eg values may change  from  youthful (TT) 25X(SHBG norm) 20/(E2: 0.1X measured SHBG:20) = 250;  to  an aging man’s     15X20/(0.15X30)   = 66; ie the TT/E2 product has fallen by 75%.

Chapter 2 follows soon.

Neuropathy is depressingly common- whether autonomic, motor and/or sensory nerve dysfunction , -positive (eg pain) or negative (loss eg numbness or weakness). “According to the most widely accepted definition, neuropathic pain is initiated or caused by a primary lesion or dysfunction in the nervous system. As much as 3% of the population is affected. Neuropathic pain may result from disorders of the peripheral nervous system or the central nervous system (brain and spinal cord). The definition now includes fibromyalgia.” en.wikipedia.org/wiki/Neuropathy. But as diabetes, malnutrition and alcoholism increase, so will neuropathy.

In 2007 O’Connor ea. University Rochester NY compared treatment with different first-line postherpetic neuralgia (PHN) medications; finding that an antidepressant (desipramine) was more effective and less expensive than an anticonvulsant (gabapentin)- which was more effective than the newer wannabe substitute pregabalin. www.medscape.com/viewarticle/561745

The Mayo Clinic simply lists the many designer (ie prescription) treatments tried, from topical therapies to systemic- pain relievers, antidepressants and anti-seizure medications. www.mayoclinic.com/health/peripheral-neuropathy/DS00131

Wikipedia lists dozens of relatively common causes; but, curiously, the only specific treatment it lists (apart from “symptomatic therapies” ) is the new drug pregabalin. en.wikipedia.org/wiki/Peripheral_neuropathy

Whereas in 2006 Head from Dover, ID USA www.ncbi.nlm.nih.gov/pubmed/17176168 noted that “peripheral neuropathy (PN) associated with diabetes, neurotoxic chemotherapy, human immunodeficiency virus (HIV)/antiretroviral drugs, alcoholism, nutrient deficiencies, heavy metal toxicity, and other etiologies, results in significant morbidity. Conventional pain medications primarily mask symptoms and have significant side effects and addiction profiles. However, widening research indicates alternative ie natural medicine may offer significant benefit to this patient population. Alpha-lipoic acid ALA , acetyl-L-carnitine, benfotiamine, methylcobalamin, and topical capsaicin are among the most well-researched alternative options for the treatment of PN. Other potential nutrient therapies include vitamins (pyridoxine B6, biotin B7, folate B9, E), myo-inositol, omega-3 and -6 fatty acids, glutathione, L-arginine, L-glutamine, taurine, N-acetylcysteine, zinc, magnesium, chromium, and St. John’s wort. In the realm of physical medicine, acupuncture, magnetic therapy, and yoga have been found to provide benefit”.

Also in 2006, Peters ea at Kings College London showed significant improvement relative to placebo with vitamin BCo (B1 250mg, B2 10mg, vitamin B6 250mg and B12 0.02mg with or without B9; p<0.001) in alcoholic neuropathy. alcalc.oxfordjournals.org/cgi/content/full/41/6/636

Alpha lipoic (thioctic) acid ALA (Gunsalus 194 is first listed on Medline as major benefit for hepatitis in 1958 and for diabetic neuropathy in 1961. It is an important human biological anti-oxidant, insulin-sensitizing enzyme cofactor in aerobic metabolism, and a heavy metal chelator. www.en.wikipedia.org/wiki/Lipoic_acid

Now Ruessmann ea in Germany (Diabetes Complications. 2008 Apr show that after 5years treatment with ALA 600mg /day for diabetic neuropathy, “when ALA was stopped, neuropathy relapsed within 2 weeks in 73%; but in those swopped from ALA to gabapentin 1200mg/d, only 42% responded - the other 55% did not respond to gabapentin up to 3600mg/day; on which 45% developed intolerable symptoms.. They found that ALA not only relieves neuropathic symptoms but also neuropathic deficits eg impaired sensory function; with trivial side-effects compared to symptomatic therapies.” www.ncbi.nlm.nih.gov/pubmed/18403218.

Hence there are plenty of natural micronutrient supplements - the chief of which is ALA, in a powder combination (with vitamins A, B, C, D, E, myo-inositol, glutathione, L-arginine, L-glutamine, taurine, N-acetylcysteine, GABA, 5HTP, zinc, magnesium, chromium, and herbs eg galega, gymnema and St. John’s wort), and fish oil- that will reverse/ lessen both the neuropathy and the underlying causes(s) including type 2 diabetes.

BBC NEWS again reports that “osteoporosis drug risks heart”, because some recent studies -in NEJM and the Annals of Int Medicine - found up to doubling in the incidence of atrial fibrillation.

But the only people who need Fosamax and other bisphosphanates used for osteoporosis are those with vested interests in this lucrative designer industry, since most people will develop osteoporosis unless it is prevented.

Why use these potentially lethal drugs for osteoporosis when they are not clinically necessary? and when they do not reduce non-osteoporosis mortality, contribute nothing to prevention of all the other inevitable diseases of premature aging? (see the Bisphosphonate Deception below - 6 April , 19 March, 5 March - eg they may cause jaw necrosis, longbone fractures, toxoderma, oesophageal obstruction, diffuse pain.. ).

Osteoporosis is easily preventable and reversible - and all risks (fracture, vascular, cancer, infective, arthritic, depressive, dementing) minimized - by sensible lifestyle plus the simple early and permanent safe lowcost combination of natural proven appropriate preventatives - the vitamins B,C,D and K; and minerals calcium, magnesium, boron and zinc (as eg a powder For-BoneSpan Blend), and appropriate physiological millennia-old HRT (for men, testosterone ; for women- testosterone plus estradiol -whether as daily cream / patch, or fortnightly tiny subcutaneous self-injection, or 3-6 monthly subcutaneous implant ).

Most doctors fail (or choose) to understand that appropriate hormone replacement is a hundred-year old internal medicine - endocrine - speciality to protect all the body systems from lethal deficiencies, not a surgical decision “just” about gynaecological or sexual protection. They choose to ignore that while endocrine diseases are increasingly common - all needing appropriate hormone therapy eg diabetes types 1 (insulin), and 2 (metfomin), hypothyroidism (thyroid) , Addisons disease (cortisone) etc - the commonest endocrine deficiency is aging-related hypogonadism, which affects 100% of women and at least half of men if they live well past middle age.

Yet many people - and doctors- fall for the nonsensical marketing hype of the gigantic designer drug industry, that appropriate hormone replacement is dangerous and unnecessary, and that the commonest hormone deficiency of aging - hypogonadism- does not need permanent and natural hormone replacement, can be treated instead with xenotherapy - non-human - designer drugs like the statins, antidepressants, bisphosphonates, nonsteroidal anti-inflammatories, progestins, SERMS, phytohormones.

They gloss over that these substitutes each have serious risks, and none of the global multisystem benefits of physiological balanced human sexhormones - eg prevention of hypertension, diabetes, atheroma, infection, depression, sarcopenia, premature death - that have been refined by a million years of evolution.

It is convenient for them to ignore that all other endocrine replacement is with physiological measurable human hormones- including testosterone for men- but for profit reasons for the past 50 years, half of aging humans - with the commonest endocrine deficiency, gonadopausal women - are fobbed off with inappropriate oral xenotherapy. Increasing numbers of women and and doctors are understandably rebelling against this fraudulent nonsense. But with clever journalists and researchers paid millions to churn out disinformation about old and proven therapy - including lobbyists in universities and professional bodies- in favour of patent drugs, it may be difficult to find healthcare providers willing to go against the Disease-Industry controlled mainstream, the obvious economic imperative that Prevention Does Not Pay, Only Disease Pays..

It’s tragicomedy that the BBC – the quintessential British spokespersona – laments NHS woes: * UK c.diff deaths ‘rising sharply’ * “The equivalent of one person an hour dies in hospital from clostridium difficile, figures suggest.”

And yet Authorities there and mostwhere are still in denial about enforcing simple safe low-cost multi-system prevention – in this instance to keep people out of bed and hospital, off antibiotics.
Authorities- regulators, politicians, the Tax Man – benefit as hugely from disease as do their fairy godmother the Disease Industry- the Drug conglomerates and their researchers and lobbyists, private hospitals, medical schemes - that pay them handsomely and creates myriad factories and jobs.

So because it is not profitable, Prevention Does Not Pay, no matter that it adds decades to health:

*There is no move to ban smoking, to make it (and sale, and allowance thereof) a criminal offence.

*No move to immediately jail drunken drivers for a long time, and on second offence permanently confiscate their driving licence and ban them permanently from current and future public office and public vehicle driving, be they judges or janitors, cabinet ministers or cabbies.

*The banning of deadly polluting coal-and oil-powered vehicles and major electricity sources has been blocked for decades by the endlessly greedy and ruthless oil-based industry magnates, despite the fact that these finite energy sources are desperately needed for other purposes. Now the world faces immediate famine because the oil-based transport-and energy behemoths (who have blocked investment in natural – solar - energy for decades) are paying bigger dollars for crop and marine resources as energy supplies than most consumers can afford to pay for these finite resources as food.

*No official move to acknowledge that the best drugs for both prevention and chronic treatment are the long-proven natural low-cost vigorous safe daily doses of a few score appropriate micronutrient supplements - vitamins (~15), minerals(~10) and biologicals (human and other species’) that are increasingly inadequate in the food chain in longer-lived increasingly overweight stressed humans facing worsening man-made epidemics and environmental disaster.

*No serious move yet by the US FDA- the chief protector of the new drugs industry of the west -English- Europe- Japan – (against the interests of consumers) to enforce integrity, insist that no chronic designer drugs for the chronic major common degenerative diseases be released for general use until they have been proven both at least as safe and effective as those already existing and effective, in major randomised controlled trials of a mean of at least 8years, head to head against both older designer drugs, and long-proven natural drugs, for similar purpose, in those diseases.

*The past decade alone has seen condemnation of myriad unproven unnecessary and risky released drugs –
on Wikipedia alone at least a dozen - eg Propulsid; cerivastatin; Vioxx; pemoline; benzbromarone; torcetrapib; and the discrediting of the non-steroidal anti-inflammatory drugs as no better - and potentially more hazardous than- appropriate cortisone and micronutrient use, and
newer designer antidepressants and anticlotting agents as less safe and effective than appropriately used older ones;

*the unnecessary anti-osteoporosis bisphosphonates that are increasingly associated with the very long-bone fractures they are supposed to prevent;

*and most especially the wannabe oral anti-diabetic anti-atheroma and anti-obesity drugs – statins, rimonabant, glitazones, meglitanides and sulphonylureas - as inferior to and less safe than metformin, the 85year old plant extract which is the only designer drug ever proven as invaluable panacea in a 20year RCT, tested against sulphonylureas, but not against all other modern designer drugs which (as in more recent studies) have never been shown to meaningfully reduce all-cause morbidity and mortality as does metformin.

The until-recent FDA haste to licence new drugs after scanty trials was reminiscent of the criminal conspiracy between the FDA and industry that licenced the already contested diethylstilbestrol Chicago trial of 1950- and kept that drug on the market another 25years after it was discredited. And it was in stark contrast to the FDA (to protect USA drug companies) blocking drugs already in highly effective use elsewhere for decades, like lithium carbonate, metformin and betablockers.

Since no drug corporations promote the out-of-patent old and proven agents, authorities cannot afford to promote truth - that the only remedies for chronic prevention that lower all-cause disease and mortality by between a third and a half - overweight, obesity, diabetes, cancer, hypertension, arthritis, osteoporosis fractures, vascular disease, acute infections, depression, dementia - are:

-fish oil a few grams a day- which also drastically lowers behavioural and learning disorders;
-a lowcost simple blend of a few score other proven natural micronutrients - the fifteen vitamins, ten minerals and the human / other species’ biologicals including herbs;
-metformin titrated to tolerance about 2.5gms a day, for both prevention and treatment of overweight, diabetes type 2 and most major chronic degenerative diseases; &
-appropriate conservative balanced sex hormone replacement in most older men and women, as proven in the landmark Womens’ Health Initiative and Finnish Oulu randomised controlled trials, and numerous other studies in major centres in North America, UK, Europe, Australia and South Africa, since 1953.

It is a tenet of endocrinology for the past 60 years that all major hormone deficiencies should be replaced permanently and physiologically with the same human hormones, yet there are still those, even medical specialists, who would deny this to those most in need – from middle age onwards, especially women. At least some of these specialists have the honesty to disclose that they are well paid by drug compnies to be advocates and trialists for the wannabe designer drugs to supplant the old.

Recognition of appropriate measured low cost HRT and the other proven listed supplements for all aging people would of course rob the drug industry of perhaps 90% of it’s market for it’s wannabe designer substitutes that the FDA allows to be marketed prematurely until enough people die of their complications or shortcomings.

In fact, while no study shows that any modern drug for common chronic degenerative disease prevention does any overall - mutidisease- good, reduces all-cause mortality, those who promote and practice such published truth – that the old is better - are threatened with prosecution.

A new Dutch paper at a current Breast cancer BRCA congress in Berlin is reported by the BBC as showing that by 2006, “deaths fell by 30% in those women who had screening mammography in their late seventies” ; http://news.bbc.co.uk/go/em/-/1/hi/health/7352483.stm And From New York, “Screening mammography in elderly patients beneficial” - but no actual benefits to the patients are disclosed, unless one considers surgery without symptoms or disease beneficial to the patient rather than the service provider. http://www.eurekalert.org/pub_releases/2008-04/arrs-smi041108.php.

Mammography is by definition diagnostic not screening if there is already a clinical reason for mammography ie a palpable lump worrying the patient or doctor. Screening, like surgery, is surely by definition justified only if it offers some material benefit to the patient?

But do these (reports published without results to see, in studies, not randomised controlled trials) justify doing screening mammography SMG on all postmenopausal women not at known risk ie who do not have/ have never had any risk factors including on regular manual palpation and family history?
What difference does it make if one simply waits till the elderly woman has a palpable ie still relatively small lump picked up (if ever) at (her) routine (monthly) (self)exam, and a simple non-disfiguring excision done?

It is common cause that all common cancer is less aggressive in the elderly and is rarely the cause of death or disability. http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Breast_Cancer_Less_Aggressive_in_Elderly_Women.asp ; http://www.accessibility.com.au/news/noncancer-deaths-more-common-among-breast-cancer-survivors

All Health Authorities advocate regular (~annual) SMG at least on women 50- 69years , with the upper limit being extended to 75years in some countries. Authorities & governments would – such screening means huge sales, jobs , taxes, profits, kudos.

Since BRCA is the commonest cancer in non-smoking better-off women,the pros and cons of presymptomatic diagnosis is an enormously emotive topic - quite apart from the toasted breast sandwich involved.

But the perennial question remains. Is fear, and the widespread availability of expensive high-tech screening, being used to promote the giant profitable screening industry - does high-tech detection of silent asymptomatic breast, colon or pelvic cancer actual give long-term benefit to patients ? when many such silent cancers are present at death without every having caused symptoms, impairment or disease.

The USA Government health authorities in 2007 show that despite policy promoting SMG, the rates of SMG have fallen in 2000 - 2005. Is this negligence, or common sense?http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5603a1.htm

THOSE IN FAVOUR SAY AYE!
Automated high-tech screening mammography is passionately advocated by service providers, who favour all types of high-tech universal screening:

in the Swedish Two-County Trial of SMG, in “ 77 080 women randomised to an invitation to SMG and 55 985 to no invitation, . there was a significant 31% reduction in breast cancer mortality in the invited group . There was 12% non significant increase in deaths from other causes among breast cancer cases in the invited group (95% CI 0.96-1.31; p=0.14). A conservative estimation gave a significant 13% reduction (RR 0.87, 95% CI 0.78-0.97; p=0.01) reduction in deaths from all causes.
<a href=”http://”>

In the 14 year follow-up from the Edinburgh randomised trial of breast-cancer screening in 54600 women, unadjusted results showed a difference of just 13% in breast-cancer mortality rates between the intervention and control groups (156 deaths [5.18 per 10,000] vs 167 [6.04 per 10,000]; rate ratio 0.87 [95% CI 0.70-1.06]).. http://www.ncbi.nlm.nih.gov/pubmed/10371567

The 16-year mortality from breast cancer in the UK non-randomised study of Early Detection of Breast Cancer set up in 1979 in England and Scotland recruited women aged 45-64 years. Breast-cancer mortality was 27% lower in the two screening centres combined than in the comparison centres. No reduction in mortality in the two breast self-examination centres combined was seen The results support those from randomised trials in Edinburgh and elsewhere, and show that a reduction in breast-cancer mortality resulting from screening can be achieved in the UK. There was no evidence of less benefit in women aged 45-46 years at the start of screening; the effect of screening in this age-group begins to emerge after 3-4 years. . <a href=”http://”>http://www.ncbi.nlm.nih.gov/pubmed/10371568

THOSE AGAINST generally stay mum- it’s dangerous to go against populist opinion that is driven by major financial interests..
But in 2006, Gøtzsche PC and Nielsen at the Nordic Centre analysed all randomised controlled trials, and controversially questioned “whether mammography screening does more good than harm. The two trials (Canadian) with adequate randomisation did not find an effect of screening (RR risk ratio 1.1) on cancer mortality, including breast cancer after 10 years, or on all-cause mortality, after 13 years. Breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. Numbers were significantly 30% larger in the screened groups. CONCLUSIONS: Screening likely reduces breast cancer mortality. But based on the risk level of women in these trials, the absolute risk reduction was 0.05%. Screening also leads to over-diagnosis and over-treatment, with an estimated 30% increase in eg lumpectomies, mastectomies and radiotherapy, or an absolute risk increase of 0.5%. This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged but 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm. Women invited to screening should be fully informed of both benefits and harms.” http://www.cochrane.org/reviews/en/ab001877.html

THE CANADIAN TRIALS:
Comparing screening mammography alone versus manual examination (usual care) alone from 1980-85,
Tony Miller et al in the Canadian National Breast Screening Study of women followed through for 13 years showed similar breast cancer death rates and similar survival rates whether by manual breast exam or SMG:
In two groups each of 19700 aged 50-59years at outset, http://jnci.oxfordjournals.org/cgi/content/short/92/18/1490 . The average lead time for the mammography plus physical examination group has been estimated to be 3.6 years (95% CI = 2.7–5.5) and that for the physical examination-only group was 1.5 years (95% CI = 1.0–3.3 years); therefore, the lead time gained by mammography was, on average, 2.1 years. All-cause Mortality was similar at 0.35%pa and breast cancer mortality 1/7th of that at 0.05%pa
(c/f .01% in Finland , with no benefit from SMG – Antilla ea 2008 http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18226204), while invasive BRCA incidence was 0.23%pa ie the BRCA mortality rate from invasive breast cancer irelative to those who got invasive BRCA was about 22%pa. .
In the two cohorts each of 25215 age 40-49yrs at outset, - http://www.annals.org/cgi/content/full/137/5_Part_1/305 ,
all-cause mortality was 0.1%pa and breast cancer mortality 1/3rd of that at 0.034%pa were almost identical comparing the two group while invasive BRCA incidence was 0.19%pa; ie the BRCA mortality rate from invasive breast cancer relative to those who got invasive BRCA was about 22%pa.
In this study, only slightly more BRCA were detected by mammography alone or by manual exam alone than by usual care; but twice as many BRCA ie 0.04% pa- were detected by combination of SMG plus physical exam -. Thus screening mammography offers only marginally more detection than manual exam, and no better survival..”

Analysis of studies of results of high-tech ie technology-based screening for lung; prostate, colon, uterine and ovarian cancers, cholesterol- lipidemia or cardiovascular disease similarly gives no strong evidence favouring widespread screening in asymptomatic people without relevant symptoms or risk factors. It is common cause that, in those without strong family history of common major degenerative disease, of premature deaths and disabling diseases, preventable smoking, obesity- diabetes, vascular disease, dementia and fractures affect probably tenfold more people than preventable cancers.

From the published data, there is just not enough evidence to justify that either the state, or medical schemes, should pay for routine high-tech screening for any disease in those who do not have risk factors or symptoms.

Instead, all patients and doctors should be compelled by Regulators, employers and medical schemes to regularly monitor blood-pressure, dental and eye health, BMI and waist girth, since early simple management of any abnormalities have proven major longterm benefits and cost-savings, without any of the costly risks of eg false-positive high-tech screening, or of waiting for disease – obesity, vascular accident, blindness etc - to present. Changing peoples’
lifestyle, exercise patterns is not easy, but huge benefits accrue therefrom.

So perhaps the compromise, to meet the concern of the hawks, is that since (unlike prostates), removal of small suspicious colon polyps and breast lumps is easy, all at low risk should be accepted for breast/ colon imaging once in midlife; and if this screening be negative, left in peace unless something develops or eg the woman or man starts on HRT.

By contrasr: Only Disease Pays the Disease Industry; so is it ethical to allow people to wilfully continue destroying their health with alcohol, smoking, overweight, neglect of hypertension, then allow them to rely on their health scheme/ insurer (which may be the State) to repair them at enormous cost, support them if disabled, when major disease breaks out?

And is it ethical for low-risk asymptomatic patients who can afford it to be encouraged to have futile repeated high-tech screening? http://news.sky.com/skynews/article/0,,91168-1269537,00.html
http://www.webmd.com/breast-cancer/news/20080304/new-feedback-on-high-tech-cancer-screen</a>
When the only interventions from young age that have been proven to reduce by about 50% all-cause mortality from the common major chronic degenerative diseases of aging are:
Regular exercise; no smoking; avoiding overweight, maintaining normal bloodpressure;
Fish oil a few grams a day;
And other essential multisupplements in balance that deplete in the food chain and with aging and pollution
ie all vitamins , minerals and biologicals- (human, other species’ and plant, and appropriate HRT (thyroid, sex hormone, cortisol replacement).

next time you are at a Mall bookshop, browse through if not buy Joseph Stiglitz & Linda Blimes’ new book The Three Trillion Dollar War.
see The Times Online article review.

It details why greedy leaders ancient and modern go to war - for the massive profit, at the expense of others.

The three trillion dollar cost so far of Bush’s War on Terrorism (the cost calculated by leading economists) is just the cost to Americans,
excluding many times that cost for the rest of the world affected by the permanent state of war and resultant rampant inflation, further global warming and burn-up of commodities.

Never mind the hundreds of thousands killed or maimed in the conflict, and incalculable damage to health in the region, the ripples hugely aggravate poverty, mental ill-health and starvation in the rest of the world, as aggression and counter-aggression racks up the stakes between all hawkish leaders like Bush, Blair, Putin, Mugabe, Zuma at al. .

As Stiglitz & co say, one can speculate how such untold war costs could have been spent on peaceful developments everywhere, no matter that USA families - who earn an average of $70 000 a year - can afford it, while the majority of earthlings- as in South Africa - survive or die on less than a dollar a day, often below $1000 per family per year.

But who cares about lives and health lost, the doubling in basic food costs when war is untold billion-dollar contracts to presidents and their business cronies including medical suppliers, as even South Africa experiences.. We wish we could forsee imminent closure better than Margaret Attwood’s Oryx and Craik…

BBC Friday, 11 April 2008 00:08 UK

“Stem cell hope for osteoarthritis“

but who except the investors need stem cells, when oral glucosamine- chondroitin usually restore the joint cartilage and function effortlessly and naturally over months?