SPECIALIST NATURAL MEDICINE CLINIC 2015

SPECIALIST NON-XRAY PAIN, BONE, BREAST, BRAIN,  HEART, CHEST, GENITOURINARY, HORMONE RISK SCREENING  @ NATURAL MEDICINE CLINIC

for appointments for consultations,   or non-xray procedures by registered practitioners :  Sure Touch breast prescreening on  Saturday mornings next on  7 February 2015  by Sister Zeneath Ismail – cash R650 (then R450 if followup scan desired within 3 months);   -QUS  ultrasound quantitative bone density  cash R450 -tariff item 3612-  anytime;  Unlike radiologists’  and thermography reports (which describe only  the imaging finding), the rates quoted include relevant breast or bone consultation and management planning  by specialist nurse & physician.

IF BOOKED TOGETHER, (not necessarily the same morning) then combined breast and bone screening is R1000.

OTHER SERIOUS health problems ARE DEALT WITH BY CONSULTATION DURING THE WEEK (OR ON A DIFFERENT SATURDAY MORN) : heart- ECG,  fatigue, HRT, sexual health, hypertension, depression, memory/dementia, lung & lungfunction, anaemia-haematology; kidney/bladder/pelvic, hormone-endocrine, depression, osteoporosis, sleep, diabetes, thyroid, adrenal; cramp; skin,  infection including STDs & HIV/AIDs, stroke, epilepsy-neurology, dizziness, heartburn/digestive/liver,  neuropathy,  sexual health, menopause, HRT, genitourinary; immune problems, or arthritis relief;

Thermography no-touch infrared screening  for suspicious  cancer /inflammatory  changes:  by Radiographer Melinda-next 23 March 2015.   R900 breasts; R1100  head and  upper;  or lower body & pelvis;  R1300 whole body.

Bookings/queries contact Evelyn/ Reyhana / Val at  the Natural Medicine Clinic, 1st Floor no 15, Grove Medical Bldg, opp ABSA (parking ABSA Parkade )  near Warwick/Cavendish  Square Claremont Cape Town RSA, ph +27216831465 or a/h +2783 4385248 or reyhanadaya@yahoo.com  .

For the disabled – by arrangement  drive  up the ramp  to the Clinic door on the Grove Bldg 1st floor  parking deck.

Under CMS Council for Med Schemes Reg 10(6), open Medical schemes eg hospital plans  have to pay from their own funds (not members’ savings) for appropriate outpatient consultation (tariff item 0191) for  PMBs ie major conditions eg  cancer,   depression, neck/spinal problems, serious heart, lung, other disease., etc. Breast and osteoporosis concerns are generally part of menopause consultations N95.9   (if not already eg breast cancer code C50) and thus are often billable  med scheme benefits. The menopause billable item only applies if you are 45yrs upwards, unless you have had total hysterectomy.

On patients’ requests, appropriate invoice can be prepared and submitted to your scheme for refund of your due benefits. Some schemes eg hospital plans  falsely deny due benefits until reported to their regulator  CMS. For medical plans where the billable tariff benefit rate is higher than the breast screening fee paid, the med plan rate 0191  will be charged eg R790 by the contracted  specialist,  and refundable by Discovery to the member. some basic schemes eg Keycare, Bonitas require preauthorization, or referral by their contracted GP  .

UPDATE FEB 2012: WANNABE ALTERNATIVE HRT eg TIBOLONE LIVIFEM IS INFERIOR TO APPROPRIATE HORMONE REPLACEMENT.

neil.burman@gmail.com

24 Feb 2012  Sharifah Zainab asks about safety of tibolone after more than 10 years on it; and whether and how to wean off it.

 

No new singnificant studies change the hard evidence that tibolone may

do more harm (than good) eg may increase stroke, breast cancer, fatness and vaginal bleeding. The comprehensive Cochrane review of last week affirms this:          Cochrane Database Syst Rev. 2012 Feb 15;2:CD008536.Short and long term effects of tibolone in postmenopausal women. Formoso G ea WHO Collaborating Centre ,  Modena, Italy.  “Tibolone is an option available for the treatment of menopausal symptoms, based on short-term data on its efficacy. However, there is a need to consider the balance between the benefits and risks of tibolone as there are concerns about breast and endometrial cancer as well as stroke.   MAIN RESULTS: When compared to placebo, tibolone was more effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 847; OR 0.42), although only the 2.5 mg/day dose of tibolone was significantly better than placebo; but with increased vaginal bleeding (seven RCTs, n = 7462; OR 2.75). When compared to equipotent doses of combined HT, tibolone reduced vaginal bleeding (15 RCTs, n = 6342; OR 0.32) but was less effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 545; OR 4.16).As for long term safety, two major RCTs of tibolone versus placebo provided the most relevant data. An RCT of 3098 women with breast cancer and menopausal symptoms was halted after 3.1 years because of increased tumour recurrence (OR 1.50). However, in another RCT that selected osteoporotic women with negative mammograms (n = 4506) tibolone was associated with a reduction in breast cancer compared to placebo after 2.8 years (OR 0.32) although the trial was not specifically designed to assess that outcome and the number of overall events was low. In the same RCT, an excess risk of stroke was observed (OR 2.18). There was no clear evidence of a tibolone effect on endometrial cancer compared with placebo given the low number of events (seven RCTs, n = 8152; OR 1.98).There was no evidence of a difference in long term safety between tibolone and combined HT. AUTHORS’ CONCLUSIONS: Tibolone, used at the daily dose of 2.5 mg, may be less effective than combined HT in alleviating menopausal symptoms although it reduced the incidence of vaginal bleeding. There was evidence that treatment with combined HT was more effective in managing menopausal symptoms than was tibolone. Available data on the long term safety of tibolone is concerning given the increase in the risk of breast cancer in women who had already suffered from breast cancer in the past and in a separate trial the increase in the risk of stroke in women whose mean age was over 60 years. Similar concerns may exist for estroprogestins but their overall benefit-risk profile is better known and is more directly related to women with menopausal symptoms.”

Why use a risky synthetic  drug designed for profit when as this column repeatedly stresses, there are so many safe natural supplements that reduce all risks?

update : Jan 2010:  WEIGHT GAIN ON TIBOLONE:

Hester asks about a better option HRT since she has gained 5kg in a few months on Livifem tibolone.

One cannot treat an unseen patient by email based on a one-line history.

all one can advise is,  read about the serious risks and deficiencies of quick-fix heavily marketed snakepills compared to finely tuned natural products eg human hormones and other natural supplements evolved/designed over millennia rather than recently in for-profit laboratories.

There are  two  new  illuminating papers on tibolone since the November review:

Dr Peter Kenemans writes from the Netherlands Vrije Universiteit:  Tibolone revisited: ‘still a good treatment option for healthy, early postmenopausal women‘.

Drs de Melo and Pompei from Sao Paolo UniversityTibolone reduces osteoporotic fracture risk and breast cancer risk, but increases the risk of stroke.

The Ziaei paper detailed below  addressed only weight issues, and describes average results.

In the  Royal Free Hospital  study in London in 1995, they found that  in their 300-patient experience over 8 years ie medium term –  an impressive 2400 patient years- that  “The major side effect was weight gain and/or a tendency to bloating and oedema which occurred in 11.28% of our women”.

This doesnt mean that tibolone increases fatness- most women inexorably get fatter and frailer once past menopause. Certainly they dont do this if they maintain good balance of human hormones- testosterone, estradiol, progesterone, thyroid and insulin-  with a sensible blend of  all the other other scores of useful  supplements, and  diet and exercise.

By contrast, shortterm controlled trials – 6 months from Turkey (2006, and 2009) and  Ziaei’s 9month trial- show that in the short term, tibolone reduced body fat and waist.

BEAR IN MIND THAT MANY STUDIES SHOW THAT EVEN JUST 10 YEARS OF APPROPRIATE SEXHORMONE THERAPY FROM EARLY IN MENOPAUSE HAS MAJOR LONGTERM BENEFITS ON REDUCING ALL RISKS eg FRACTURE, CARDIOVASCULAR AND DEMENTIA RISKS IN LATER LIFE – without any significant adverse effects. . There do not appear to be published any studies of tibolone or any other wannabe substitute  over  a mean of more than 5 years. But women now often survive more than one-third of  their lifespan post menopause- that is another 35+ years. No modern designer chronic drug  has been used and observed reasonably continuously to be safe for much more than 10years .  The only designer drugs which have been used continuously for much longer are perhaps the old diuretics and some  antihypertensives.

Tibolone is yet another designer progestin- and the Women’s Health Initiative showed that, even when started appropriately soon after menopause,  progestin (medroxyprogesterone MPA)  reversed the myriad benefits of  premarin alone  in respect of worsening fracture, breast and cardiovascular risks.

This contrasts with natural supplements like eg minerals and vitamins, the plant extracts reserpine and the  prohormone metformin,  and all the human hormones- thyroid, insulin, cortisone, testosterone, estradiol- which many patients have used continuously for over 40 years with nothing but benefits in appropriate doses.

So as always its up to  you the patient to decide whose advice, what to try. All any doctor can do is (in a brief consultation) offer advice from his experience and ongoing update studies – which may not be up to the minute. You have to decide about shortterm benefits versus long-term possible risks. In the few months on tibolone, are you just swollen-eg  needing to reduce salt?- or fatter  waist with higher bodyfat,  bloodpressure, insulin resistance etc?

Nov 18, 2009

a new study last month bears out the futility of spin,  focussing only on benefits in abstracts. The small short (9month) trial by Ziaei ea in Tehran Iran  on Comparative effects of continuous combined hormone therapy and tibolone on body composition in postmenopausal women concludes  that The effect of tibolone on body composition is favorable and therefore tibolone may be regarded as an alternative to continuous combined postmenopausal hormone therapy MHT .  Tibolone significantly increased weight, BMI and FFM and decreased WHR after the treatment in comparison with baseline (p < 0.05). However, only weight and BMI increased significantly in the CEE/MPA group after the treatment (p < 0.05). There were significant increases in weight, BMI and fat mass in the control group after 9 months..  So they confirmed what has been obvious all along: that postmenopausal women gain weight and fat post menopause, and on xenohormones (premarin+provera) gain even more fat at the expense of losing lean mass. A synthetic xenohormone progestin like tibolone increases weight, BMI,  and FFM (it’s androgenic property) –   but they ignored the multiple deficiencies of tibolone (unlike appropriate HRT), that it increases breast cancer,    stroke, vaginal bleeding and endometrial cancer and perhaps CVD, and fails to reduce either all-cause or breast cancer mortality, or depression or  dementia. .

SUMMARY: No published trials have yet shown any alternatives as good as appropriate HRT (ie estrogen -progesterone- testosterone) for overall long term benefits post menopause.

eg  with  the synthetic progestin tibolone – the 3 year LIFT trial had to be stopped early due to strokes, and in  the 3year LIBERATE trial breast cancer recurrence increased 44%. As the International Menopause Society IMS keeps stressing, all synthetic sex hormones are inferior to appropriate balanced sex hormone replacement for eg menopause symptom relief, and against osteoporosis fractures. Many different modalities relieve the short-term menopause symptoms, but these matter far less than the long term preventable degenerative effects of hormone deficiency- which are the primary concern of patients, carers, internists and geriatricians. The average gynecologist (surgeon) deals only with  menopause symptoms, which mostly subside well within 10 years ie by age 60years – but that’s when all aging medical not gynecological problems start,   increasing  incapacity problems – vascular, cancer, fracturing, mental, mood, fattening, frailty, sex, incontinence and thus loss of decades of quality life.

Analysis To August 18, 2008 ·

The LIFT trial report by Steve Cummings et al (NEJM   August 14, 2008  The Effects of Tibolone in over 4000 Older Postmenopausal Women -mean 68years)  is another nail in the coffin of tibolone.

The LIFT trial was stopped after a median of just 34 months because Tibolone doubled strokes – up from 0.34% to 0.66% per year. .

Tibolone,  unlike appropriate HRT, has no significant reported benefit on all-cause mortality, on cardiovascular disease (which increased by 37% – p0.28), on memory/ dementia and on depression , although  it almost halved fractures –  but  it doubled the risk of stroke, trebled rate of breast discomfort and vaginal bleeding- which  rose from 2.9% to 9.5%; even the incidence of cervical dysplasia rose from 3.2% to 7.6%. And it increased weight in this already overweight cohort by an excess of 0.6kg in 3years..

Breast and colon cancer rates were too low to draw conclusions about benefit. “The tibolonegroup also had a decreased risk of invasive breast cancer (relativehazard, 0.32; 95% CI, 0.13 to 0.80; P=0.02) and colon cancer(relative hazard, 0.31; 95% CI, 0.10 to 0.96; P=0.04)” – but the incidence of these and coronary artery disease were each only 2 – 3% pa on placebo..

So it finally  confirms tibolone as just another synthetic progestin looking for a disease to treat, much inferior to real supplements including  appropriate HRT (vitamin D and   lowdose parenteral human estradiol-testosterone-progesterone) for reduction of all the major diseases of aging. There are no contraindications to, only benefits from  such long term appropriate  steroid hormone replacement.

Update November 2009:

In a further LIFT trial report (Ettinger & Cummings Sept 2008), Tibolone treatment for 3 years minimally increased endometrial thickness, hyperplastic polyps, and endometrial carcinoma.

In a Danish trial , tibolone had no benefit on cartilage degeneration. whereas appropriate HRT has benefit (Forsblad Scandanavia 2004).

In the massive 31-country 2002-4 LIBERATE trial (Feb 2009 Kenemans ea ) in over 3000 women after breast cancer, recurrent breast cancer increased 44% with tibolone over a mean of 3.1yrs. Tibolone was not different from placebo with regard to other safety outcomes, such as mortality (respectively 72  vs 63 patients), cardiovascular events (14 vs 10), or gynaecological cancers (10 vs 10).

A report in September 2009 from Health and Human Services’ Agency for Healthcare Research and Quality suggests that tamoxifen, raloxifene, and tibolone used to treat breast cancer significantly reduce invasive breast cancer in midlife and older women, but also increase the risk of adverse side effects.

Regretfully, tibolone has not fulfilled early  hope that it might be the first designer drug since metformin to be another panacea, reduce all-cause morbidity and mortality even in postmenopausal  women.

It appears that despite 40years  use elsewhere, tibolone (not invented and marketed by a US corporate)  has still not been  and is unlikely to be licensed for use in USA – like SERMS (tamoxifen, raloxifene) its benefits are so limited that they are not  enough to balance it’s risks. .. doubling the risk of stroke and increasing the already high  general risk of breast cancer by 44% in only 3 years. Whereas  all (ie multisystem) risks and frailty are reversed by the safe threescore mix of natural supplements plus appropriate balanced physiological human hormone replacement as regularly set out in this column. .

ABANDONED DOCTRINE OF TRUTH IN MEDICINE: POSTMENOPAUSAL HRT:USE HUMAN TRANSDERMALS. WHY RISK TABLETS? BIG PHARMA WINNING THE DISINFORMATION WAR.

 5 June 2010. neil.burman@gmail.com 

Part 1: Transdermal better than oral estrogen for replacement: the importance of appropriate HRT.

part 2: Information warfare, Big Pharma, Appropriate HRT and the Doctrine of Deception.

PART 1: TRANSDERMAL BETTER THAN ORAL ESTROGEN: THE IMPORTANCE OF APPROPRIATE HUMAN HRT OVER PATENTED MEDICINES :

The  health bite today from the BBC  correctly highlights one of the many critical reasons why appropriate routine Hormone Replacement HRT should be taken permanently  by any route  – but preferably transdermally, not as tablets.  In the appropriate low human dose HRT reduces the natural risk of stroke- and of the far more common chronic major diseases that cripple and kill – ie heart disease, cancer, fractures, dementia..

  But the Menopause Societies (South African, British  and  International) ie BMS , SAMS ,   IMS , and  the BMJ must promptly issue strong statements to the media condemning the BBC again for its typical misleading  elementary misreporting- in this instance  as regards progestins..  

 Transdermal and oral hormone replacement therapy and the risk of stroke: The source report –  this week’s BMJ –   describes HRT use in UK over about 6.7years among postmenopausal stroke victims mean age 70years (50 to 79) compared to matched controls without strokes. But the inexcusable error in the BBC report is that it twice mentions progesterone as being quoted in the BMJ study- which is nonsense.  The  BMJ report never mentions progesterone,  it repeatedly says progestogen -ie synthetics progestins since these were and are deliberately and wrongly routinely prescribed (instead of progesterone) for HRT due to manufacturer-led market disinformation.

  Progesterone is the original natural progestogen- but no major drug company promotes it, so it has been rarely used except by thinking women who prefer to use prime ie human – bioequivalent- hormones!  

In the adjusted risk statistics, lowdose transdermal estradiol TD replacement  0.025 to 0.05mg a day lowered stroke risk by 19%; whereas the average gynecologist’s  arbitrary  patent pharmacological oral  dose (20 to 40fold higher than the TD dose)  of  about 0.625 conjugated estrogens CE equivalent to 1 to 2 mg estradiol OET ) a day increased stroke risk by 35% . Thus, in contrast to lowdose estradiol  TD which reduced the natural stroke rate, OET  and highdose  estrogen TD  increased the stroke rate by 50% – 90%.  

COMPARISON WITH USA WOMENS’ HEALTH INITIATIVE WHI:  the WHI  showed that on premarin 0.625mg/d the absolute  risk of stroke in USA women age 50 to 79years was about 0.3% ie 3 cases per 1000 women per year -but about 45% higher in depressed women on antidepressants. And  depression is even  more common after midlife, especially without HRT. This cohort from the volunteer WHI trial  was a mean of 63years at enrolment ie 7years younger than the British real-life cohort; and since the risk of stroke approximately doubles with every 10 years of aging, the basic risk in the British study women may have been about 5 cases per 1000 per year or 33 per 1000patients over the duration of the British stroke and HRT study. ie annually 4 cases per 1000 on lowdose estrogen TD versus 6 cases per 1000 on OET 

Despite vast evidence  that physiological replacement doses of the human hormone progesterone (the original progestogen in humans) has endless benefits for older adults, doctors, government clinics and committees overwhelminglly still are lead by the marketing hype of drug companies (and the regulators  lobbyists and governments they fund) to use  drugs designed for profit  eg xenohormone progestens that they wish  were and falsely claim are as good as the original one that our bodies produce.

Truthful information  on HRT for women is widely and easily available from even Wiki    and the real authorities like the British and International Menopause Societies, and any university department of gynecology. .   Thus today’s BBC report reflects the BBC’s willful  neglect  of the most basic check of its facts before publishing health bites. In this case, it misleads women that  conventional combined oral HRT (in fact containing the synthetic progestin that most drug companies and doctors encourage women to take) is beneficial in somewhat lowering the risk of stroke  (never mind womb cancer) – whereas such synthetic progestins. progestogens   especially in oral HRT have numerous sinister other adverse effects  eg breast cancer and heart disease,  compared to the numerous proven benefits of  lowdose human progesterone. .

KEEPS: THE DEFINITIVE HEAD-TO-HEAD TRIAL OF APPROPRIATE HRT: ORAL vs NON-ORAL ERT WITH OR WITHOUT PROGESTERONE.: The small but definitive 5year KEEPS double blind randomized controlled trial RCT is now more than half way through and due to report in 2012, comparing the alternative regimes in women in the early menopause (10years younger and less overweight than in WHI) . “ KEEPS is a multicenter trial that will evaluate the effectiveness of 0.45mg of conjugated equine estrogens CEE Wyeth Premarin, a weekly estradiol TD Climara patch delivering 0.05mg estradiol a day -( both in combination with cyclic oral, micronized progesterone (Prometrium Solvay) 200mg for 12 days each month), and placebo”.

Recent information from KEEPS is that it is proceeding smoothly, with no significant differences so far between the three arms- no increase in serious adverse events has yet been seen by the Independent Monitoring Committee in the still unblinded results.  

 Wyeth (now Pfizer since 2009) is not crossfunding KEEPS, although they may be hoping that  their premarin in lower dose will prove to be as safe as or better than estrogen TD in the medium term.. But given the ~70year experience with oral HT mainly premarin 0.625mg/d promoting breast cancer increase (although not mortality) after >12-15years of use , it is remotely unlikely that even ¼ of the long-standard premarin oral dose will prove anywhere as safe and effective as parenteral balanced human hormones for permanent protection in aging women.  One hopes it is, to vindicate the insistence of so many doctors on still prescribing OHT for  even just the first 10 years of menopause,  despite so much damning evidence to the contrary (see this entire website of reviews).

SO WHY PRESCRIBE, RECOMMEND HRT PILLS FOR POSTMENOPAUSAL WOMEN? when hard evidence is that non-oral  balanced human HRT (appropriate estrogen, progesterone and testosterone) is far superior in both benefits and zero risks for women? Whereas it is common cause that conventional oral HT ie about 0.625mg CE or equivalent started at menopause increases the  early risk of dangerous deep vein thrombosis DVT; and  begins to increase the risk of breast cancer to above that of untreated women after a cumulative dose of about 2 – 3 gms oral estrogen – after 10 – 15years ie by prime post retirement midlife in the midsixties. It is only some compensation that other cancers, fractures, ischaemic heart disease, dementia and (breast cancer- and all-cause) mortality, are reduced by appropriate m0dest doses of such OET combined with appropriate progestin; but such regime increases the risk of DVT, gallstones and fatness frailty- increasing body fat with increasing muscle wasting due to collagen loss which also promotes increase in the natural tendency to fractures and urinary incontinence by the midsixties.

Promoters of oral estrogen, bisphosphonates, SERMS,  and strontium cleverly ignore the hard fact that by far the greater risk for aging fractures is not bone density but muskuloskeletal ie failing bone and muscle strength and global co-ordination – which bisphosphonates do nothing to promote, while estrogen and strontium nad SERMS  may promote bone strength but not crucial muscle strength, and SERMS double the laready very high rate of stress urunary incontinence. .

  American major authorities do anything to promote their own commercial interests.  so they have long given their drug regulator the FDA – which is unashamedly paid for by big pharma- unbridled licence to make nonsensical claims and draconian laws. And because drug companies fund the FDA and the lobbyists and legislators in USA to promote their  products, (in a $trillion disease industry – some 8% of American GDP) they have the vast profits to in turn influence medicines regulators and legislators throughout the world to follow their profitable lead.

So  only the FDA and regulators  decide what foods are good for people, what supplements (of microfood stuffs) people may take, and licence designer synthetics for human prescription after trials of only a few months in a few hundred subjects – but insist  that old proven nutritional remedies may not even be claimed to have any health, preventative and therapeutic benefits unless they have undergone massively costly controlled trials that Big Pharma will never fund.

 Their hypocritical deadly nonsense is then to use draconian measures to stop suppliers from making any health claims for even supplements that are well known to be gold standards for prevention and treatment eg fish oil and the scores of other highly effective and safe biologicals- minerals, vitamins, human (eg glucosamine, chondroitin, n-acetylcysteine, coQ10, arginine, carnitine, carnosine), and plant products- that are (co)-hormones, antioxidants, true anabolics, nitric oxide promotors, anti-inflammatories, antidepressants, memory and vision promotors, neurotropics, insulin sensitizers, antiatheroma, hypolipidemic , antimicrobial etc. .  

In fact they now proclaim that citizens may not even buy supplements, foodstuffs  or even legally prescribed compounded hormone creams made from legal components (as are all other prescriptions made by manufacturing pharmacists practicing alone or in Big Pharma), unless the FDA has proclaimed them safe, because “they have not been proven safe”.

 This despite the facts that most  enduringly successful prescription drugs  (eg reserpine, metformin, digoxin, the synthetic progestins) are derived from/ based on successful evolution of and human experience  with the parent supplement eg vitamin, mineral and other biologicals  (eg non-oral progesterone, estradiol, testosterone)  over thousands of years,   and millions of patient years experience  in the past >100years of scientific discovery. 

The Disease Industry- FDA-Big Pharma – organized medicine international network- proclaims that no claims may be made for the benefits of supplements (the vehicles, parents  of most prescription drugs in use) unless they have been tested in rigorous trials to the same standards as designer drugs are recently tested.  

Yet the FDA and regulators allow the marketing of generics- chemical identicals but often far from identical pharmacology and therapeutic action- without clinical trials. Where is the logic for the vendetta against supplement creams  like individually compounded bioidentical hormones that produce measurable physiological levels and appropriate relief?

 This despite the fact that millions of patients have been and continue to be  damaged (iatrogenesis that results in vast numbers of hospital admissions and deaths annually) the past 50 years by drugs promoted by the FDA at the pushing of Big Pharma, based on far too short poor and often fraudulent reports which the drug industry ruthlessly manipulates.

  This led to the disasterous use of stilbestrol in pregnancy from the 1940s to the 1970s;         to the disasterous registration and extensive liberal prescription – in many cases even promotion over-the-counter- of practolol, thalidomide,  chloromycetin and other antibiotics;     potentially fatal unnecessary patent anti-inflammatories  up to the Cox2   inhibitors (eg Vioxx, celebrex) as painkillers;  barbiturates benzos and antidepressants;   lately sulphonylureas and glitazones as firstline drugs for type 2 diabetes instead of the gold standard metformin; new antihypertensive drugs as firstline therapy instead of the goldstandard lowdose amiloretic plus reserpine; appetite-weight suppressants instead of metformin;  bisphosphonates for osteoporosis instead of the goldstandard combined dozen vigorous vitamins minerals and sex hormones that halve all major diseases; and statins for uncomplicated mild to moderate cholesterolemia  instead of goldstandard combined minerals vitamins  metformin and HRT.

  And the simple fact that drug companies  will no longer risk funding head to head trial of one of their profitable drugs against gold standard old drugs or supplements of proven great all-disease medicinal value; since prevention does not pay- only disease pays.

The cost of protectionism for the lucrative Big Pharma industry – for the sake of trade and taxes – is vast  as witnessed by governments sponsoring eg statin , H1N1 flu vaccines , modern antidepressants, bisphosphonates and nonsteroidal anti-inflammatories, and when each of these products of unproven benefit in mass use nets the manufacturers  obscene multibillion dollar profits- in the case of vaccines, with 100%  indemnity guaranteed them at taxpayers’ ie the consumers’  expense!

The lesson from the new UK  study of oral versus estrogen TD is that appropriate ie balanced physiological-dose  human sex hormones are the logical 1st-choice prevention and treatment for postmenopausal women (and their peer mates) – not the multirisk wannabe synthetic substitutes that  Big Pharma keep hammering on the public- new psychotropes, NSAIDs, Cox2 antagonists, statins, bisphosphonates which lack the multisystem benefits of physiological balance of evolution-evolved natural micronutrients ie nutriceuticals.

Part : 2. DOCTRINE OF CENSORSHIP and DECEIPT;   vs DOCTRINE OF TRUTH/… see next review above this.

MELATONIN, LIGHT, SLEEP, SEX, DECAY; AND THE GRAVE RISKS OF DESIGNER WANNABE SUBSTITUTION.

neil.burman@gmail.com

THE ANTIOXIDANT ANTIAGING CHIEF HUMAN HORMONE MELATONIN DELAYS / LESSENS MENOPAUSE, PARKINSONS, GALLSTONES,  HYPERTENSION, HEADACHE, SEASONAL AFFECTIVE DISORDER, AGING,  ALZHEIMERS, CANCER, INSOMNIA,, OSTEOPOROSIS & GASTRO-OESOPHAGEAL REFLUX;  ONLY EXCESS LOWERS MOOD AND LIBIDO. .

Since melatonin improves sleep & serotonin level,  it not surprisingly lowers LH  luteotropic hormone and thus libido in the pharmacological doses marketed (3mg) .

Surprisingly,  there are only 8 papers on  melatonin and aging  human sexual activity  on Pubmed search..But is it a surprise that there are 186 melatonin AND sexual activity  papers on Pubmed since 1992?  including  many on  a designer melatonin agonist agomelatine– of which one of the latest  – in Prescrire a month ago- concludes: “agomelaline new drug. Adverse effects and no proven efficacy;.. Very high doses of agomelatine are oncogenic in animals. The risk in humans is not known. Dizziness, gastrointestinal and cutaneous disorders have been observed. Agomelatine is probably hepatotoxic“.

PHYSIOLOGICAL HORMONE BALANCE VERSUS SYNTHETIC DESIGNER SUBSTITUTES:
But there are lots of self-reports on Google confirming  what physiology tells us, that hormone balance is what matters.

Doctors (and hence patients) choose at their peril –  at the behest of Big Pharma, heavy marketing-  to ignore physiology – what nature teaches us about optimal function . Big pharma made a killing before WW2 with  the isolation,  patenting and mass sales of natural supplements eg hormones starting with thyroid and insulin. But these soon ran out of patent, so Big Pharma has zealously employed massive armies of researchers  and lobbyists to develop and promote synthetics cribbed from natural products ie synthetic designer drugs. The high number of $billion-a-year raincheck drugs is a tribute to their clever marketing and sleight-of-hand concealement of adverse reports – but not for the many  thousands of patients who have suffered or died as a result of eg fenfluramine, Vioxx,  Prepulsid and lately sibutramine, rimonabant, glitazone, and vaccines….

But Industry has not yet succeeded in generating a synthetic designer ie patentable form of thyroid hormone to exploit the millions with thyroid deficiency, nor a substitute for the human heart-made  hormone  digoxin, which – like the uniquely lifesaving  plant extract metformin- defy the inventiveness of Big Pharma’s  ruthless quest for  megabuck profits.

Big Pharma wants us to forget that all modern drugs for chronic use were and are  based on ancient endogenous and mineral/plant based drugs .

The chief brain antidepressant HORMONES serotonin ie its precursors (5H)tryptophan and other natural  antidepressant like St John’s wort and marine omega3;  and the chief brain anxiolytics GABA and progesterone, and harmless plant anxiolytics like valerian,  were soon supplanted by synthetic antidepressants, barbiturate-benzodiazepine and progestin designer drugs. Industry has exploited the growing dialysis market by promoting grossly costly  designer synthetic- not human- erythropoeitin analogues.

These designer drugs have been so cleverly marketed by Big Pharma – and thus politicians, governments which  Big Pharma massively funds  directly and via taxes and job promises – that for chronic use let alone acute illness they have almost wiped out the use of highly effective remedies used for millennia.  eg Lithium and metformin were ignored by the FDA for 25 years despite being the gold standard elsewhere for bipolar and type 2 diabetes respectively.  For common hypertension, rauwolfia-reserpine is  still the goldstandard bedrock treatment in a dose of  0.1mg/day or  less , combined with the also-suppressed perfect synthetic (potassium-magnesium- calcium conserving saluretic) vasodilator amiloretic amilozide in low dose. But the antihypertensive drug industry has bought so many in the antihypertensive trials and regulatory hierarchy that Europe and Britain have abandoned reserpine; and in South Africa these “experts” beholden to Big Pharma have removed these gold standard drugs from firstline therapy recommendations and even from the formulary of state clinics because they were too cheap at below a US$ a month. .

And melatonin output (average only 55mcg a day) is inverse to bloodpressure ,  it reduces both hypertension, and the anemia of renal failure, and nicotine-related vascullopathy.

The Chinese already 2500 years ago were using gender-specific sex human hormones derived from the ‘sublimation’ of youthful human urine to treat gender-specific diseases and deficiencies. But since the extraction of  sex hormones from the urine of humans in this age of viral and prion plagues (let alone the aesthetic and logistic problem of buying billions of gallons of human urine each year)  is not on, Wyeth – with the increasing monopolistic complicity of the FDA-USA government- simply substituted human hormones by xenohormones- horse estrogens (from the mass farming of tethered catheterized mares) and synthetic progestins- for both contraception,  and HRT for women. Hence the problems  for older women of the Womens’ Health Initiative which used exclusively Wyeth’s PremPro.

And industry attempts to keep a stranglehold on the  vast diabetes market by continually synthetising new depot forms of human insulin; and  synthetic alternatives to the gold standard and  only plant-derived antidiabetic prohormone (metformin, in use for well over 50 years, the only drug ever that has been tested in a 20year randomized controlled trial, and proven to be the only prescription drug that reduces all major diseases and thus deaths by almost 50% -) by continually bombarding the market with largely unnecessary synthetic designer drugs to discourage use of metformin, diet and lifestyle change. These include  new sulphonylureas, acarbose, glitazones and now gliptins, none of which have undergone longterm trials, and which uniformly prove (unlike established old drugs) to have major adverse effects even at registered doses.

Like amphetamines, orlistat  and rimonabant have had to be progressively restricted- sibutramine is the latest to be cancelled last week in Europe. due to adverse effects that the suppliers finally failed to prevent becoming common knowledge. Is it surprising that the USA FDA – which runs  on the massive funding of and input from Big Pharma-  has still not suspended sibutramine use there?

And surprise surprise- Wikipedia dismisses metformin for weight loss with one reference, although there are scores of trials including major 3-5year  prevention trials on three continents that show that metformin use in the overweight  (even BEFORE diabetes occurs) produces both significant fat loss and approximate halving (30 to 80% reduction) in new diabetes and new cancer.

And  wiki  confirms that while the human hormones leptin,  amylin and gliptins-incretins- work in synergy with all other hormones, micronutients to potently regulate optimal sugar and fat and energy metabolism, none of them have been marketed as the natural forms- that is the last thing that Big Pharma – the FDA- Uncle Sam wants when with some effort they can already market designer adaptations to produce more golden  $billion raincheques.

This despite the fact that Turek’s 2010 USA transcontinental trial showed recently in rodents that   combination injection of the natural hormones amylin and leptin “decreased food intake (by 26%) and reduced body weight (by 15%) and epididymal fat (by 78%)”. 15% of 100kg body mass is 15kg weight loss“.  A year before, Ravussin ea published the 6 month trial in obese humans of the designer derivatives of leptin and amylin  confirming that the patented combination  indeed lowered body weight by 12.7%.But the common adverse effect of the injection was nausea.

This farcical commercial merry-go-round – which puts patients at grave risk- is  despite the fact that there are dozens of safe proven natural ie unpatentable antidiabetic insulin sensitizers/ obesity-reversing supplements freely available, from garlic and fenugreek to galega officinalis, gymnema, coleus, calcium, chromium, zinc and vitamin D3.

MELATONIN DOSE:
Hypnotics  including melatonin promote sleep, not sex. Hence sex works best after sleep  rest ie well after midnight,  early morning. But unlike melatonin, designer synthetic hypnotics have dangerous side-effects and addiction problems, without any longterm benefits.

Clearly for anyone not in an institution or at risk of cancer,  melatonin dose should be kept as low as is prudent to optimize sleep – not sedate.

This dose may be as low as 0.05mg/night- hence dose should be titrated upwards from a pinch to the average optimal of 0.25mg/night, but as high as is well tolerated without hangover/daytime drowsiness.

So for the hyperanxious-anxiety-panic disorders, melatonin may well best be taken  in the morning at low dose, and early evening to unwind.
That low dose reverses impotence in rats is not surprising- 10 to 100mcg/kg as used in rodents equates to between 1-10mcg/kg in humans ie  0.05 to 1mg in adults.

Studies show that the right dose for sleep in humans is about 0.1 to 0.3mg – not the 3mg caps/pills that are unthinkingly marketed, prescribed and swallowed by unwise patients.

Melatonin in excess can worsen depression and cognition; and even be arousing.
but since it generally improves sleep and growth and reproduction and energy balance  and immunity and bloodpressure and cancer control and anorexia – fragility reversal,
it should equally clearly be supplemented at night in physiological dose ie 0.05 – 1mg- combined with especially vitamin D3, and during the day or for an hour before sleep with bright (sunshine or artificial light) exposure, which dramatically improves Parkinsons disease..

LEVELS OF MELATONIN AND LIGHT:
The recent Bronowski Institute study shows how bright fluorescent light (does a TV or computer screen count? – surely?)  should be encouraged for an hour before bedtime since it markedly reduces Parkinsons; but in older people should then be followed by a melatonin supplement  dose  for all the antiaging reasons. As Rabbi Michoel Gourarie writes in Personal Growth, turning on a light in the dark- even the one small candle of ancient times- can do as much to cheer up one or a host of people.

So especially in institutions sleep should be preceded by bright light for an hour before lights out.
The most most important  aspect for us all is sequential light (both via stimulation and via vitamin D – soltriol -from sunlight) ; and  then darkness for sleep’s melatonin  value in insomnia & fatigue and especially against autism, ADHD, cancer, hypertension, diabetes (insulin sensitizer ), & especially for retarding menopause ie infertility.

The recent trials data increases greatly the potential of melatonin against premature aging ie against cancer as well as against gonadopause  that was already widely promoted 15 yrs ago by Regelson, Colman  and Pierpaoli – In 1995 Pierpaoli in The Melatonin Miracle summed up how melatonin given to aging mice maintained youthful size gonads, significantly higher sex hormones, and extended their healthspan and lifespan by 30% ie to a century in human terms.

The first 7.5year case followup  of melatonin benefits in delaying menopause came from Poland 2 years ago; but already in 2005 an Italian team  Bellipanni ea showed in a 6month study that melatonin 3mg/day “abrogates hormonal, menopause-related neurovegetative disturbances and restores menstrual cyclicity and fertility in perimenopausal or menopausal women. At present we assert that the six-month treatment with MEL produced a remarkable and highly significant improvement of thyroid function, positive changes of gonadotropins towards more juvenile levels, and abrogation of menopause-related depression.”

Previously  in 1992, Sandyk ea in New York proposed that “There is evidence that pineal melatonin is an anti-aging hormone and that the menopause is associated with a substantial decline in melatonin secretion and an increased rate of pineal calcification.” .  And in 1984 Aleem ea had shown “Suppression of basal luteinizing hormone concentrations by melatonin in postmenopausal women.” ie that supplemental melatonin can suppress rising LH – although the primary cause of menopause is gonadal aging-  exhaustion,- which in  both men and women leads to the compensatory rise in LH if the pineal and pituitary glands are themselves still capable of responding to feedback. The primary cause of  hot flashes is due largely  to falling estrogen level, with  all other menopause symptoms being caused by gonadal hormone exhaustion.  But Bellipanni’s 2005 study showed that melatonin supplement  could produce better gonadal and thyroid hormone output.

So all  aging folk should  take the combined hormones vitamin D3 about 5000iu/day,  and  melatonin,  building slowly to perhaps   1 –  3mg  at night, from age 30yrs if not earlier;  but with cancer, under medical supervision, building to vit D3 10 00 to 50 000iu/day ( monitoring the serum calcium) and melatonin  to perhaps  40mg/d – plus a titrated dose of the anticancer prohormone metfornin. .

ARE SYNTHETIC HORMONES THAT WERE DESIGNED FOR CONTRACEPTION IN HEALTHY YOUNG WOMEN SUITABLE FOR POSTMENOPAUSAL PREVENTION?

It is at least 70years  since modern science suggested hormone contraception with prolactin or progesterone or estrogen; and since estrogen therapy of menopause was first described (by Prof Joe Meigs himself) on Pubmed – with presentation of endometrial cancer after 8 years on estrogenics .

In general, after 50 years of hormone contraception since we were students, with more than a hundred million women now on low-dose hormone contraception, such synthetics – a progestin with or without ethinylestradiol EE2 – are considered pretty safe in current low dose compared to unplanned pregnancy or physical contraceptive methods, provided contra-indications are respected; with almost 50% reduction in future endometrial and ovarian cancer; and no change in mortality from breast cancer.

But in A Short History of Oral Contraception (2006), Prof Wolfgang Oelkers notes that Ethinylestradiol EE2 was only discovered in 1938 and the first highly active progestin in 1954, leading to the registration of the first oral contraceptive OC pill in USA in 1961-  and within 10years the occurrence of malignant hypertension on such OC pill, with acute and often irreversible renal failure due to the EE2 activating both the renin-angiotensin syndrome and thrombosis. (I had the misfortune to have to put on chronic dialysis a beautiful young university student who presented on such OC pill in 1974 with thrombotic thrombocytopenic purpura with irreversible renal failure, while I was working at the Leeds General Infirmary under the dialysis pioneer Dr Frank M Parsons).

Oelkers notes that even ultralow dose combinations of EE2 and 3rd-generation progestins can still cause thrombosis; and “The thromboembolic risk associated with the recently introduced transdermal combined  contraceptive Evra®does not seem to be any better than modern oral contraceptives, since it also uses EE. This, unlike natural oestradiol, seems to affect hepatic protein synthesis  independent of its route of application.    In postmenopausal hormone replacement therapy, the transdermal route of oestradiol application seems to be devoid of a prothrombotic risk.  Development of a transdermal combined hormonal contraceptive with oestradiol instead of EE would provide a great next  chapter in this endocrine story.

Wiki reports that The Ortho Evra contraceptive patch and the Evra contraceptive patch are both intended to gradually release into the systemic circulation approximately 20 µg/day of ethinyl estradiol and 150 µg/day of norelgestromin. Since such hormones bypass hepatic metabolism, no wonder the doses delivered still have thrombotic risks. 

Does that make such massively profitable contraceptive hormones that were designed in fierce competition for fertility (and ovarian) suppression in healthy young women both safe and effective for the ageing no-longer-healthy fattening (post)menopausal women? Parenteral physiological balanced HRT does not cause the fattening and muscle loss that OHT does.

Now young Janey asks an important question: “I am 56 yrs old and very happy with Yaz (ethinyl estradiol EE2 plus drospirenone). I do menstruate while on the placebo. I would like to find a doctor who will let me stay on Yaz, which I like a lot, or if absolutely necessary try the Testosterone, Bi-estrogen, Progesterone combo. I worry about weight gain that occurs in almost all cases of oral HRT. I need the bone protection and hair, skin and vagina health benefits that have been wonderful on Yaz. “

CANCER RISK OF ORAL XENOHORMONE THERAPY:

In July this column last visited ovarian cancer as a relatively rare disease but with high (70%) mortality due to its late presentation, hence feared more  than other womens’ cancers eg breast, endometrial or cervix.

So it is worth revisiting the major Danish observational study spanning 10 years published last July ; which documented almost a million women for   8 years. The crude primary ovarian cancer OvCa incidence rate in never-users (5 million women-years) was only 0.04%, vs 0.052% in current  HT users (1.4million women-years) ie overall, hormone therapy HT increased the risk by 1.3, or 30%. That study concluded: “Combined therapy with norethisterone was associated with an increased risk of epithelial ovarian cancer (RR, 1.55; 95% CI, 1.36-1.76), which was not significantly different from the RRs associated with medroxyprogesterone, levo- norgestrel, or cyproterone acetate CPA”.

The only regime in that series which was not statistically significantly associated with increase in OvCa was in the 23 women who developed OvCa on solo transdermal E2TD ie hormone replacement HRT (out of a total of 64000 women-years on E2TD), where OvCa relative risk increased by 13% but the 95% confidence interval spanned unity (0.74 – 1.71) ie not significant . By contrast, oral estrogen HT for some 287 000women years increased OvCa risk significantly by 34%; and any progestin added to estrogen ie in some 847 000 women years increased OvCa risk above no HT by 47% to 68%.

This neutral effect on OvCa only of unopposed E2TD is most reassuring for women. All the synthetic progestins they compared – including the antiandrogen CPA- were associated with significantly more OvCa (let alone BRCA).

The nub of the matter is that gynecological cancers generally do not apparently proliferate without the influence of female cyclical hormone levels- FSH, LH, estrogen – and especially oral estrogens and progestins. In the main study of cancer with Turner syndrome, in 3425 women in UK followed for some 17years ie 58000 patient-years, breast cancer was 70% less common than average women, while the only gynecolological cancers that appeared to increase were endometrial cancer 8fold at age 15-44years, and gonadoblastoma of the ovary by 8% by age 25years- and gonadoblastoma is over 90% associated with the ‘male’ chromosome Y . These statistics are reassuring considering that most such women were treated with oral estrogen therapy, and that uterine cancer is avoidable if estrogen therapy is appropriately opposed with some progestin, with periodic withdrawal bleeding allowed.

Unbalanced anabolics eg vitamins or sex hormones merely promote dormant malignant cells already present, they do not cause cancer de novo; and adult cancers take an average of 20 years to present clinically.

There is no report on Pubmed of testicular cancer developing on testosterone TT replacement let alone abuse; nor of increased ovarian or breast or uterine or colonic cancer in long term female testosterone users – if anything long term testosterone replacement in women appears to diminish breast proliferation in rodents, monkeys and humans, as this column has regularly reviewed..

It is common cause from clinical menopause practice and trials that pharmacological ie unphysiological oral estrogen – progestin therapy – while improving bone density- increases body fat and if anything decreases lean ie muscle mass and collagen -hence the increasing postmenopausal fatness frailty and urinary incontinence of elderly women on oral HT.

DROSPIRENONE

The new combinations with  drospirenone for contraception ( Yaz/Yasmin- drospirenone DSP -ethinylestradiol EE2 in fertile women), and post menopause (Angeliq – DSP -estradiol E2) certainly seems to reduce fluid retention and thus weight and hypertension problems, and to have anti-androgenic benefits when required. There is apparently no published longterm data on DSP to judge it’s influence on cancer and mortality.

This column has regularly detailed reasons for postmenopausal women PMW to avoid oral transhepatic sexhormone therapy with the high doses of oral estrogen needed to control menopause symptoms, and the multiple adverse effects of transhepatic xenohormones like EE2, premarin and progestins. But 50 years of experience including the under 60’s cohort of the WHI, and the Oulu trial (Heikkinen ea ) certainly showed overwhelming benefit of oral estradiol/conjugated estrogen-progestin combination when started appropriately in well young PMW for up to 10 years. It has been well known for three decades that continuing such OHT well beyond 10 years gradually increases the incidence of BRCA above non-users.

However, as we have repeatedly discussed, why should Kitty subject herself to the longterm risks of eg breast cancer from such oral use of any designer hormones like orohepatic estrogens and progestins? when evidence is that physiological human HRT with non-oral, or oral micronized (see Dr Lee Vliet’s books) sexhormones, has no risks, only benefits – especially when human E2+- estriol E3 are balanced by progesterone P4 and testosterone TT as by creams, or implants, or tiny subcutaneous self-injection, all easily available by prescription in US.

And when oral EE2 ethinylestradiol for contraception is associated with low but real thrombosis and biliary risks; and when it is enormously potent compared to human estradiol; and when it’s successor competitor diethylstilbestrol DES is still causing horrendous problems in women and their children and grandchildren after it was recklessly prescribed from the 1940s to the 1970 without there ever being evidence of benefit let alone safety.

Lowdose EE2 has certainly proved it’s relative safety when used as birth control in young healthy non-overweight women. But just as oral prempro has proved that it causes problems and little benefit when started after the age of 60years in overweight women ie those already with atheromatous disease, why take potent synthetic oral EE2 post menopause? Using a potent synthetic is neither prudent, physiological nor replacement.

Recently a Brazilian trial confirms equal benefit of “nonoral HRT (nasal spray- estradiol -micronized vaginal progesterone) ; or oral HT (low-dose estradiol-drospirenone ) for 2 years on metabolic, vascular and body fat risks in early postmenopause;” but once again that “Triglycerides and von Willebrand factor levels decreased significantly only with nonoral treatment”– ie the nonoral- parenteral- route is better protection against atheroma and thrombogenesis.

DSP combined with oral E2 is certainly theoretically advantageous HT for those PMW with hypertension and fluid retention. But since no longterm trials or studies of DSP use are available yet, it is too early to judge if DSP+E2 is as safe as physiological HRT with appropriate combination of E2/ estriol E3/ P4/ TT.

But as we have repeatedly pointed out, the evidence from both evolution, and 60 years of experience, and trials, is that physiological parenteral human hormones ie not by the orohepatic route have distinct safety and physiological benefits, as comprehensively detailed by l’Hermite, Genazzani ea on behalf of the International Menopause Society recently , as well as all the data this column has previously reviewed on the importance of balance non-oral testosterone as part of the HRT regime.

So the answer for Janey is: be a volunteer guinea-pig if you like, but dont use Yaz (ie EE2)  but rather use  the natural  E2 -containing Angeliq – in low dose. Since all other synthetic progestins increase ovarian cancer in women, rather use natural progesterone parenterally until Schering publishes a controlled trial showing that drospirenone does not increase ovarian cancer when fed to reproductive age female rodents (let alone women) for the human equivalent of a decade or more. There are no human studies reporting drospirenone use for a decade or more.

But  preferably enroll yourself in a longterm randomized comparative trial of the new (eg Angeliq)  versus the old. – balanced appropriate estradiol-estriol-progesterone-testosterone, whether as a cream or depot injection-  titrated to what suits you.  Why risk the new but long-term unproven when the evidence for the old (as long as human evolution with balanced non-oral human estrogen +P4+TT) is so strong.

And while you may find out the best for you  by your trial and error without longterm adverse effect, none of us may  learn better by your self-experimentation?

IS THERE A VITAMIN (D3) CONSPIRACY OF SUPPRESSION?

neil.burman@gmail.com Cape Town.

This column regularly  reviews and refers  to  the contentious issue of Regulators and Big Pharma suppression and disparagement of natural micronutrient supplements – The Vitamin Wars in which Jack Drummond and Linus Pauling were so embroiled by persecution and assassination-  so as to promote sales of designer drugs and focus on treatment not primary prevention, on the obviously sound shortterm  economic principle that prevention does not pay, Only Disease Pays.

Recent key papers perhaps expose the falseness of the vitamin  conspiracy, the condemnation if not regulatory suppression of free choice  supplements in favour of risky designer drugs like antimicrobials on the FDA’s  (ie the New Drug Industry’s)  efforts to protect the Disease Industry with the self-serving but poor argument  that experience and observational and evolutionary evidence are not good enough, only randomized controlled trial evidence will do.

This despite the major studies that vitamin D in optimal  dose, like vitamin C, in  fact in optimal multinutrient combination, offers better protection – prevention and treatment- than any designer drugs against all diseases, from acute and chronic infections eg  flu, HIV and other  STDs,   and tuberculosis and other bacterial (and parasitemia) infections, to autoimmune, lipid- hypertensive-vascular disease, depression and cancer, prevention of frailty and fractures, even sexual-reproductive health, dementia and multiple sclerosis – as Dr John Cannell of the Vitamin D Council repeatedly details.

Earlier this year a  research centre in San Francisco estimates benefit of increased vitamin D status in reducing the economic burden of disease in western Europe. The reduction in direct plus indirect economic burden of disease was based on increasing the mean serum 25(OH)D level to 100nmol/L, which could be achieved by a daily intake of 2000-3000 IU of vitamin D.  For 2007, the reduction is estimated at euro187,000 million/year. The estimated cost of 2000-3000 IU of vitamin D3/day along with ancillary costs such as education and testing might be about euro10,000 million/year. Sources of vitamin D could include a combination of food fortification, supplements, and natural and artificial UVB irradiation, if properly acquired. Steps to increase serum 25(OH)D levels can be implemented now based on what is already known.

A University Toronto study last month on    How to optimize vitamin D supplementation to prevent cancer, based on cellular adaptation and hydroxylase enzymology by Prof Robert Vieth Univ Toronto, Canada  analyzes the question of “what makes an ‘optimal’ vitamin D intake” ie  ‘what serum 25-hydroxyvitamin D [25(OH)D] do we need to stay above to minimize risk of disease?’. This simplistic question ignores the evidence that fluctuating concentrations of 25(OH)D may in themselves be a problem, even if concentrations do exceed a minimum desirable level. It explains why higher 25(OH)D concentrations are not good if they fluctuate, and that desirable 25(OH)D concentrations are ones that are both high and stable.”

A new study last week from Finland probes the benefits of vitamin D in institutionalized adults with intellectual disability ID, who may eat poorly and seldom get any sunshine. . Those given 800iu vitamin D daily for 6 months did better than those given simply 150 000iu imi at the start, when all had a mean vit D bloodlevel of 40nmol/L, the oral dose group having a final level of 82 compared to 62 nmol/L in the other group. PTH fell in both groups, but target D3 level of 80 was attained in 42 % orally vs 12%  imi.

and now this week Pietras ea from Boston  detail how Vitamin D₂ Treatment  50 000iu fortnightly for up to 6 years for Vitamin D Deficiency and Insufficiency in Boston increased vitamin D levels from 67  to 117 nmol/L, without change in blood calcium, and no kidney stones- but with persistent vitamin D deficiency in perhaps 10%, for a variety of possible reasons. They agree that oral vitamin D3 is the best preparation. This is retailed in South Africa for as little as  R6 (($0.80)  per 50 000iu. In fact, unless the patient has shortterm absolute contraindication to oral-enteral  supplement, there is no better (ie parenteral)  route  for vitamin D3 if not all supplements than via the stomach.

The short answer is that, from local and international experience with such doses, there is indeed no evidence of harm, only benefit- ie nothing to lose. Prudence dictates query about history of hypercalcemia/ kidney stone problems, and baseline and followup check of at least serum calcium phosphate and creatinine if not also vitamin D  levels, to judge whether dose of 2000iu or 10 000iu/day (or 50 000iu every week or month)  is both enough to produce stable blood level in the range of 125 to 150nmol/L, and safe for the individual.

RESTRAINING UNNECESSARY RISING COSTS OF COMMON DRUG THERAPY AND CONFLICTS OF INTEREST:

The review published yesterday by Discovery Health  “Medicine expenditure up by 26% in private healthcare industry” based on the Mediscor Medicines Review resonates with this week’s editorial from JAMA on Resolving Unreported Conflicts of Interest. Apart from anticancer therapy (which affects relatively few patients but is very costly), by far the two top drug costs to the private  health system in RSA  are antihypertensive and hypolipidemic drugs.

But why are these two groups of drugs 1/6th of  local private medicines expenditure?

The reason is quite plainly vested interests- between prescribers, drug developers and retailers, for  well-known reasons:
1.  Modern western medicine  rarely attempts to address the pathogenesis  of disease – it takes too much effort by prescribers and patients to try to change diet and  lifestyle. And  the only “modern” drug that addresses the main causes of the common degenerative diseases – overweight, (pre) diabetes type 2, lipidemia, atheroma, thrombosis,  hypertension, cancer, arthritis, dementia – is the antioxidant, insulin-sensitising, energising,  nitric-oxide-promoter, antilipidemic, antithrombogenic, antihypertensive, anti-infertility, anti-PCOS,  appetite-and-weight-suppressive,  anticancer, and diabetes-preventing   plant-derived metformin. This is the only prescription drug  ever – with zero serious persisting adverse effects in appropriate dose –    that has been  shown (including in the only 20year randomized controlled trial ever) to actually reduce all  major morbidity and all-cause mortality by over one-third.

2. Only new ie under-patent drugs are $billion dollar –a-year rainchecks in a $trillion dollar industry where only disease pays (not prevention- which keeps patients out of hospitals & specialist centres  and off new drug) .

So the Disease Industry has correctly pinpointed overweight and hypertension as the two leading risk factors to bombard consumers with new drugs;

but  has created the  gigantic marketing ploy  that these common lifestyle-diet problems  need designer drugs: that
average mild to moderate hypertension must be treated by combinations of angiotensin-and adrenergic, and calcium-blockers – which  do not reduce all-cause morbidity and mortality.;
and  even average lipid levels  by statins and now even the futile  ezetimibe –which do not reduce all-cause morbidity and mortality;
and overweight-obesity  by patented drugs like Orlistat and Rimonabant –which do not reduce all-cause morbidity and mortality  ,
and type 2 diabetes by new sulphonylureas, glitazones and even more toxic and expensive injectables  like gliptins- –which do not reduce all-cause morbidity and mortality .

But  simple analysis of the hundreds of better-quality  published studies and trials (not those ghost-written in glossy journals  for drug companies to promote their products) shows that:

For average mild-to-moderate hypertension, no modern drugs (with many serious  adverse effects)   surpass for benefit  the triple and zero-side-effect  combination of lowdose reserpine plus lowdose coamiloretic- in RSA costing retail about R45 per 4 months ie about $2/month;

For average-risk overweight adults with or without lipidemia and diabetes, nothing surpasses the global benefits- major reduction in all-cause mortality and mortality- of  metformin started in low dose eg 250mg/day and increased  slowly to tolerance.
Obviously primary prevention  for everyone includes a few grams a day of the essentials that  deplete at all ages with longevity, the degrading food chain,  pollution and stress – the natural ~50  replacement supplements of  vitamins and minerals and the human biologicals EPA+DHA, CoQ10, arginince, carnitine, n-acetyl cysteine, alphalipoic acid, taurine, carnosine, MSM, chondroglucosamine, lutein, bioflavinoid,  choline, inositol, 5HTP, GABA, melatonin, plus key plant supplements eg ginkgo, milk thistle, galega, gymnema, coleus etc;

all of which can be simply taken as a powder blend in water twice a day with a teasp of cod liver oil or a fish oil capsule;
at a global retail cost of as little as R100/$12 a month ( plus  in older people, appropriate physiological  human sex hormones).

So while there is some- but relatively little-  competition between generics, the major saving in both cost, risks and prevention is between therapeutic equivalents eg lowdose coamilozide+reserpine, metformin, and other safe effective  supplements – which are all that are needed for prevention and most treatment of all the major degenerative diseases of aging including osteoporosis  (which agents  Industry and their funded lobbyists- researchers, academics, regulators  try persistently to denigrate if not actively suppress)-  vs other newer- and heavily marketed  classes of antihypertensives, appetite ,  lipidemia and osteoarthritis-osteoporosis  suppressants.

This issue of promoting evidence-based best  therapeutic equivalents is indeed blowing against the wind, the tsunami of $billion dollar adspend by Big Business to promote their designer labels. But all countries- while  run by ruthless politician big business looking after their own interests – do pay some lip service to restraining the normative  monopolistic and price-fixing racketeering that screws the man in the street- both in gross overpricing, and in massive tax evasion by big business, and in rigging of elections and tenders .

Our own Medical Schemes Council is in the process of open consultations about the revised necessary and approved drug lists for all diseases in the medical schemes industry. Hence urgent vigorous debate is urgently required – in all countries- before vested interests further strangle citizens’ choice of and access to both cheap old drugs to eg reverse the dropping of reserpine by bureaucrats in UK, Europe and state clinics here, and reverse the rising tide of suppression of the best prevention and treatment there is- the base of all modern medicines – minerals, vitamins and the numerous proven safe human and plant biologicals.

The trend by the FDA and EU and Big Business in RSA must be reversed, before they (in the interests of their own pockets filled with paybacks by Big Pharma) put all supplements totally on prescription by health professionals- the very people whose livelihood (including their shares in Big Pharma, med schemes and hospitals) depends on new quick-fix designer drugs which cure and prevent no chronic degenerative disease ie on avoiding effective doses and combinations of proven supplements.

As it is, the medical schemes in RSA are now compelled to pay for the services of witchdoctors (who admittedly probably kill far fewer people than do modern prescriptions and surgery for non-urgent conditions) yet these schemes- while insuring for profit people who persist in suicidal and homicidal smoking and alcohol and sexual behaviour-  flatly refuse to pay for the best prevention  there is – the supplements mentioned- because  they are neither promoted by Big Pharma nor on prescription.

Numerous references are available under many keywords on this website below.

ndb

WIKIPEDIA IS INVALUABLE, BUT BEWARE IMPORTANT BIAS IN IT’S CHRONIC DISEASE ARTICLES PART 1:

Wikipedia is now the top and invaluable reference source for the public.

Wikipedia entries are commendably frequently updated; but this does not mean that the entries are both up to date, objective and unbiased, since they are constantly being altered by conflicting outside editors.

We suggest amendments in  Wiki  health entries where appropriate as follows.

It will obviously have most effect if the recommendations to Wiki are based on consensus by the relevant international leaders- eg the International Society for Aging Males ISSAM, the International Menopause Society IMS, the International Pediatric Association, and so on; NOT by drug companies and their product promoters including individual disease associations (which by definition do not take a holistic multisystemic  view) or private and academic national groups whom/which drug companies sponsor/influence- including the problem of ghost writing! Many entries on Wiki appear to suffer from this problem of vested interests.

INTRODUCTION: EBM:

The Wiki article on EBM  Evidence-based_management ie  Evidence-Based Medicine hits the nail on the head. Medical diagnosis and treatment need to be evidence- based- but as the heretical pioneers Shaughnessy and Slawson stress, this must be POEM- patient-orientated evidence that matters. However, for the Drug Industry and their state arm  the USA FDA, the chronic major degenerative diseases are the biggest money-spinners since they arguably need lifelong drugs. Hence the Disease Industry  has invented epidemics of chronic diseases that were regarded as inevitable or self-induced until drug companies came up with designer drugs for each new  disease to medicalize – eg  epidemics of erectile dysfunction, mild to moderate hyperlipidemia, anxiety, mild-to-moderate depression, mild PMS and menopause syndromes, smoking, alcoholism,  and so on. Then  they and the FDA  generated trials and procedures  testing these patients with new “diseases”, and convinced the public that despite clinically insignificant benefits in trials often lasting well under a year, tested against only placebo,  the drugs could be registered  for chronic use even though there were long- proven natural remedies that did as well or better. They (their well-paid researchers, statisticians and often professional spin writers) then produce and pay for publication of  drug  trial reports claimed to be favourable, even though the evidence is weak or in fact adverse. . And the FDA is at least consistent- it still allows American chronic drugs to be thus launched with  only short trials, without head-to-head comparison against proven remedies – but blocks dubious foreign drugs like rimonabant..

Hence in our lifetime we have seen the rise and spectacular  fall – fatal for many patients- of many trumpeted medicines – of  stilbestrol, anabolic steroids, practolol, thalidomide, ticrynafen, barbiturates, antidepressants, fenformin, Vioxx, benzbromarone, troglitazone, cerivastatin, antiarrhythmics, phenfen, and antiplatelet drugs. And the Bush Administration recently forced through legislation immunizing the drug industry against claims for  damages from failed drugs! Mostly me-too drugs whose sole need and purpose was to create profit for industry for a few years before complications force their disappearance. This indeed is the FDA – Drug Industry’s  60  year commercial War Against Humanity (Elaine Feuer)  and compassion, Al Gore’s The Assault on Reason, Naomi Klein’s Disaster Capitalism, Ivan Illich’s Medical Nemesis.

The FDA-Disease Industry (and medical schemes)  then calls this sham  process  EBM, and denies the same recognition to long proven  optimal remedies  eg parenteral human HRT because there is no need, and no sponsor, to do long-term trials on natural remedies long-proven in clinical practice studies. The only “designer” drug – metformin- which is in fact a simple tagged plant extract-  that has ever been subjected to a 20 year trial  was effectively kept  off the USA market until the  trial was nearing completion in the mid-1990s – ie metformin in the UKPDS, which proved to be the only designer drug ever that almost  halves both all mortality and all chronic major degenerative diseases including type 2 diabetes. And still the FDA demanded a 10-000 patient one-year trial  – COSMIC- to prove the safety of metformin- after all, it was a Scottish invention and long-proven European drug, thus not to be trusted because it was not invented in USA. As if the Americans were not of recent European origin.

Similarly, the FDA (and the British)  embargoed/derided  lithium- the gold standard drug against bipolar disease- until 1970, forcing Mogens Schou to do an unethical double-blind withdrawal trial on stabilized patients to prove it’s efficacy – 100% of whom relapsed within 6 months on placebo, and restabilized back on Lithium. .

Hence all drug study and trial reports, especially for  registered drugs – however prestigious the journal and origin- have to be examined carefully to see if they were done without bias/spin to paint the new drug in a rosy light. The Womens’ Health Initiative most certainly was not unbiased despite the close to $1billion cost – it scandalously failed to test Wyeth’s two xenohormones against the gold standard, human estradiol and progesterone. Similarly, the statins for mild-to-moderate hypercholesterolemia  have never been tested head to head against the only drugs that reduce all-cause morbidity and mortality by 1/3 to 1/2- metformin, fish oil, appropriate balanced human hormone replacement, and a blend of effective safe doses of all the beneficial minerals, vitamins and biologicals including some herbs.

Similarly, the Viagra trials were fraudulent- they excluded men with frank hypogonadism (since Viagra will not work without testosterone priming). But Pfizer  and the FDA also colluded to refuse to disclose, publish the testosterone levels of men enrolled in the Viagra trials- when it has been known since the early 1980s that there is a dose-response correlation between erectile function up to a plateau above a serum testosterone of about 4.5ng/ml 16nmol/L -.1982 Salmimies ea. It turns out from other Viagra trials that the serum testosterone of trialists was around 13.5nmol/L.. So most of the men using Viagra/Cialis  did not/do not  need 2 Viagra tabs a week costing hundreds of dollars a month (as the NHS was conned into providing), but a conservative shot of depot testosterone perhaps 160mg every fortnight at a cost of below $5/month- with far more multisystem benefit, and none of the deadly risks (sudden death or stroke or blindness) of Viagra.

The Wiki article on erectile dysfunction dismisses testosterone deficiency as being a rarer cause of erectile dysfunction, but fails to mention the obvious, that partial androgen deficiency ie a serum testosterone below the mid-range -ie average- often responds to adequate depot injection trial of testosterone to elevate the blood level into the mid range of healthy young men (not just the range of elderly men, as is so often done).

Such is the power of fraudulent drug company deceit in collaboration with Regulators.

It is hollow hypocrisy that the UK has now introduced a regulator of alternative practitioners- but neither the USA, UK nor  other governments  have ordered their Medicines Regulators  to drastically restrict many of the scheduled drugs discussed below (and a few risky complementaries like black cohosh and kava) when there are far safer proven  alternatives. Manufacturers and Regulators themselves are certainly not going to do this- not when their  raison d’etre is well-paid screening and registering as many new drugs as possible, not policing old drugs.

PART 1: THERAPY OF COMMON MULTISYSTEMIC DEGENERATIVE DISEASES OF AGING:

1.1 Hypercholesterolemia and statins

1.2 Osteoporosis and Bisphosphonates

1.3 Hypertension and antihypertensives

1.4 Diabetes type 2, Obesity, metformin and other weight-reducing drugs.

1.5 Pain, arthritis and NSAIDs.

1.6 Fish Oil

1.7 MULTIPLE DESIGNER DRUG INTERACTIONS

PART 2: SEX HORMONES see next publication.

1.1 Under hypercholesterolemia wiki says “statins are the most commonly used and effective forms of medication for the treatment of high cholesterol”. But the wiki entries on statins, cardiovascular disease and hypercholesterolemia, and Pubmed, give no evidence to justify statins’ heavily marketed primary use in mild-to-moderate hypercholesterolemia and diabetes, no reference that shows they are as good and safe as the old proven combination of natural evidence-based remedies – vitamins, minerals and biologicals (including appropriate eg non-prescription fish oil, carnitine, CoQ10, arginine, ribose, carnosine,  galega officinalis- metformin, and appropriate sex hormone replacement).

It is metformin and appropriate HRT, not statins, that reduces both cardiovascular and all-cause deaths by at least a third, and meformin that halves the incidence of new diabetes when used preventatively in the adipose with insulin resistance etc. It is metformin, not statins, that merit marketing over the counter:  in sensible use imetformin is totally safe, unlike unregulated poisons like cigarettes, alcohol and  sugar.

None of the vast statin trials show that statins do any good other than lowering CVD risk by a third. So it is a blatant dangerous lie to state as Wiki does that “statins are the most effective medication for treatment of high cholesterol”- this claim certainly does not apply to the universal common mild to moderate hypercholesterolemia MMHC. Familial or secondary severe hypercholesterolemia justifying statins is generally rare; and  the indolent overweight/ diabetics with MMHC have enough problems with diabetic cardiovascular disease, neuromyopathy,  and osteoporosis without the added risk (fatigue; myalgia; hepatorenal; depressive; sexual; skin; respiratory impairment; and cancer associated with severe hypolipidemia) of statins, when metformin and the other antioxidant insulin-sensitizing supplements like appropriate HRT are safe and far more effective across the board – and do not deplete and antagonize  crucial and very expensive CoQ10 as statins do..

1.2 Under bisphosphonates, wiki says “In osteoporosis, alendronate and risedronate are the most popular first-line drugs. If these are ineffective or the patient develops digestive tract problems, intravenous pamidronate may be used. Alternatively, strontium ranelate or teriparatide are used for refractory disease, and the SERM raloxifene is occasionally administered in postmenopausal women instead of bisphosphonates”.

But popular does not mean most effective or safe. Wiki quotes no sources to prove that bisphosphonates- now with a notoriously long list of complications – or the designer drugs mentioned are anywhere near as good and safe for osteoporosis and all diseases of aging as the baker’s dozen of appropriate human HRT, vitamins and minerals. The popularity of bisphosphonates, premarin, statins and SERMs is obviously based simply on heavy marketing.

1.3 ANTIHYPERTENSIVES: the Wiki entries for hypertension, antihypertensives and reserpine are in total conflict – for the obvious main reason that the main entries are written by those sponsored by new-drug companies. On the other hand, Wiki says correctly under Reserpine: “it is one of the few antihypertensive medications that have been shown in randomized controlled trials to reduce mortality… In some countries reserpine is still available as part of combination drugs for the treatment of hypertension, in most cases they contain also a diuretic.”  see Pubmed  for at least a dozen such landmark studies.  It was confirmed as recently as the SHEP(1995) and ALLHAT (2007) trials that combinations containing reserpine are the best for resistant hypertension. And numerous trials up to the 1990s showed that lowdose reserpine plus a lowdose diuretic is as good as any more modern drug for mild-to-moderate hypertension. And trials show that lowdose thiazide diuretic plus a potassium-sparing diuretic eg amiloretic is better than a thiazide alone, and such combination was the only drug regime  associated with halving of dementia in the Cache County study.

It has been established for decades, and we see in hypertension practice every day, that the best results, with zero adverse effects, are with low dose of reserpine eg starting with ½ a reserpine tablet (ie 0.125mg/day) and half an amiloretic tablet (ie 27.5mg/day); usually reducing to ¼ of each tablet daily after a week. In many cases the dose can be reduced to 3 times a week because amiloretic has a gentle action over 24hours, but reserpine over weeks- so (unlike with modern drugs) forgetting the occasional dose does not matter. It’s cardioprotective, bone-protective and antianxiety benefits persist, with neutral effect or benefit on the metabolic and allergic and oedema  problems that abound with modern regimes.

But under Antihypertensives and Hypertension, this optimal regime is barely mentioned to be condemned – because it is old-fashioned, and the most effective therapy for mild to moderate hypertension. But it costs as little as $0.50 a month in eg South Africa, 1/300th of the price of an inferior designer combination like Prexum Plus. So it was removed from state codes in eg UK, Europe and South Africa precisely because it is too cheap and too good, it drastically reduces revenues from modern drugs. This despite the fact that this optimal combination has not been tested as first-line therapy against any modern drug- trials up to the 1990s showed that it was too good, so no drug company dare allow head-to-head trials again. And Regulators and involved politicians simply ignore these hard facts since their massive incomes depend on promoting modern, not old, drugs.

1.4 Antidiabetic and anti-obesity drugs: Wiki correctly says “Metformin is usually the first-line medication used for treatment of type-2 diabetes.” In practice, it is always the first line drug in a new type 2 diabetic since such patients invariably have excessive visceral girth and body fat if not rising BMI (above about 23kg/sqm except in a gymnast/athlete). But Wiki then perpetuates a disinformation myth: “Initial metformin dosing is 500 mg twice daily but can be increased up to 1000 mg twice daily”. This is nonsense, the reason why so many patients drop out of metformin trials and treatment, since perhaps half of us ( especially smaller people) are genetically slow metabolizers of metformin. . Metformin must simply be started at very low dose eg ¼ tablet (125mg/day), and adjusted upwards every day or two to tolerance- avoiding more than reduction in appetite and loosening of stools… with this simple approach, whether for diabetes control or, far more important, for obesity-diabetes and polycystic ovary syndrome prevention , the average tolerated dose is about 2.5 to 3gm a day in split dose (except with the new sustained release tablet). .

Wiki then says “metformin is also available in combination with other oral diabetic medications.”- but this is also dangerous marketing hype, such fixed combinations are to be avoided at all costs  since combination of metformin with any other antidiabetic drug both brings the disastrous risk of hypoglycemia, and neutralizes some of the benefits of  optimal dose metformin combined with optimised diet and lifestyle.  This is the heart of the reason not to delay metformin till diabetes- neurovascular- pancreatic disease is established, by when sometimes irreparable damage – glycation – is common, with irreversible eg kidney, nerve, eye or heart damage.

Wiki correctly states that the French drug  rimonabant was soon abandoned, and never released in the USA. And under Obesity Wiki indicates the adverse effects and lack of longterm safety-efficacy data that confirm why orlistat and sibutramine have no place in overweight-obesity-diabetes prevention and treatment when metformin is by far the best proven. .

1.5 NSAIDS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS: The Wiki entry is pretty good except that it ignores the obvious – not only are these drugs poor analgesics, little better than the old paracetamol Tylenol, but they also have major risks- not just gastrointestinal bleeding but also heart and kidney failure, dermatoses and sudden death. Wiki discreetly omits to mention that there are many cheap proven old supplement NSAIDs  that in combination do better without risk (eg MSM methylsulphonomethane; vitamins (B3, B5, C, D); curcumin; cat’s claw, boswelia, bromelain, arnica, fish oil) than the problems of aspirin and the other myriad patent NSAIDS; and that, trauma aside, NSAIDS do nothing for the cause ie the underlying disease.

And there is no evidence whatsoever to support the for-profit rationale for promoting use of the NSAIDS- that they (even ibuprofen) are any better or safer short-term or long-term than judicious appropriate use of paracetamol+-codeine, or natural supplements eg judicious appropriate steroids- whether corticosteroid, secosteroid (vitamin D3) or sex steroid SHRT eg estrogen and testosterone. Detailed referenced reviews the past year on each of these topics are published below.

1.6 FISH OIL: Coyly, the only NSAID that Wiki lists under “other” is omega 3 – which actually reduces all major degenerative diseases and mortality by 20 to 50%…

But Wiki certainly gives full credit to the myriad health  benefits- and lack of adverse effects- of fish oil -EPA+DHA – in appropriate dose.

1.7 MULTIPLE DESIGNER DRUG INTERACTIONS: The older we are, the more likely we are to suffer from multiple chronic diseases, the more likely we are to be recommended different drugs for each disease- especially if we shop around consulting a doctor per disease. In particular, the use of multiple designer and synthetic drugs that interfere with normal metabolism is high risk- and becomes higher in older people who are prone to combined degenerative diseases like osteoporosis, muscle frailty, vascular disease, diabetes, anxiety, depression, arthritis and infections.

Eg there are on Pubmed since 1992 at least 6 reports on serious bisphosphonate – induced dermatoses, and 9 on statin dermatoses. . Statins are notorious for causing insidious myositis- especially with antibiotics; and there are reports of myositis-arthitis with bisphosphonates.   Statins can cause interstitial pneumonitis, fatigue and  weakness; bisphosphonates can contribute to lung problems via reflux, antihypertensive drugs via bronchial irritation. NSAIDs cause gastritis, oedema, hypertension, heart failure. the modern antidiabetics and antihypertensives  can aggravate heart failure. Yet doctors who advise against any HRT and other medicinal supplements frequently prescribe statin, bisphosphonate, NSAIDs, modern antidiabetics, antihypertensives  and periodic antibiotics together. This is criminal, since these drugs are mostly  unnecessary in either mild-to-moderate lipidemia, or osteoporosis, or arthritis, or hypertension, or  type 2 diabetes.

In conclusion, especially as specialists  (except for the old-fashioned increasingly rare general practitioner and the specialist in general internal medicine) tend to be increasingly specialized in one niche organ system or area of medicine ( but not in comprehensive and preventative care) , it is obvious that for serious illness, the patient is advised to study personally the latest illness advances  remedies and problems. But for researching health matters, the public is advised to use the websites of international multidisciplinary expert associations eg ISSAM- the International Society for Aging Males; IMS- the International Menopause Society; and  Medline- Pubmed;

rather than those which are prone to commercial or academic  bias (by local vested/ financial  eg drug/ equipment company/institutional interests) like Wikipedi,   universities, patient support associations,  the FDA/NIH, other National Health Services,  private practice  and craft groups,  or patient’s or lay associations’ reports and advice; especially the mass media which are especially open to marketing hype and sensationalism, and which with publication deadlines and bias to sensationalism, bad or lurid  news,  seldom succeed in tracking down objective unbiased expert opinions.Like Only Disease Pays, Only Bad News Pays.

And once disinformation is published, the media  (unlike Wikipedia) rarely bother to give equal time to  or opportunity for correction of misinformation- eg withdrawing bad information from websites. Which is not to say that old ideas should be deleted from the internet- they should just give the date of last update, and indicate if they are outdated.
Wikipedia health articles should be depended on only if they are certified by international multidisciplinary consensus bodies (of specialists and family practitioners)  like ISSAM and IMS.; or if material facts are referenced to a verifiable expert source. For the reasons stated, neither trials, reviews, metanalyses or “expert opinions” – even on Pubmed- are necessarily reliable evidence.

Detailed reviews of all these topics have been published the past year below on this column.

HealthSpan Life! Update: TEN NEW STUDIES CONFIRM THE OBLIGATION TO START METFORMIN EARLY:

It is obvious everywhere that, however one may arbitrarily and numerically define them, overweight let alone prediabetes  and obesity impairs health and function.  

 

 The Importance of Treating Overweight and Prediabetes has been repeatedly stressed in this column.  

More than ten new studies published the past month or so  are further mandate  for early and permanent  metformin  use to tolerance for major reduction of both infertility and pregnancy loss, overweight and new prediabetes/ metabolic syndrome, early hypertension,  lipidemia, and  thus cardiovascular disease,  cancer, arthritis, depression, sexual dysfunction, hirsutism and cancer;  as well as managing established diabetes of either type.

Metformin in sensible use never causes more than nuisance symptoms easily prevented by gradual upwards (and if necessary downwards) dose titration; and perhaps reduces   risk of death even if (like any other drug)  it is foolishly continued without reduction and consultation in the face of worsening illness.

Thus like often lethal aspirin, it should simply be available at health counters and pharmacies, in contrast to statins or black cohosh which can insidiously cripple; and alcohol and tobacco smoking which are the most lethal chronic d yet unscheduled recreational addictive  drugs which actively and passively kill thousands every day.

And (never mind cigarettes) unlike the invaluable metformin, there is no indication for manufacture and marketing of paracetamol acetaminaphen with which  the slightest overdose- 6 tablets at once- can kill, when there are many perfectly safe natural mild analgesic-anti-inflammatory substitutes for it. 

IN RETROSPECTIVE STUDIES 

Tian ea Beijing 2008 found that “metformin use for a mean of 6.6years is safe even in elderly diabetics”.

 

Monami ea Florence Italy 2008  found that “metformin  use for more than 3 years for diabetes associates with 72% reduction in cancer”..

 

Fronstin ea  USA  2008: “analysis of 63,000 patients in a  USA 2007 Health  Survey showed major impact  on quality of life –  loss of work productivity of  5.6 weeks per year for prediabetic patients compared to their healthy counterparts. Less than 40% of all prediabetic patients are even aware of their condition and therefore can’t take the steps necessary to prevent it from progressing to a full diabetes diagnosis.” This stigmatizes the overweight as patients, but the stark loss of productivity (in all spheres of life disussed below) requires this to bring home the obligation on health carers, families, parents  and employers  let alone the public to take early and sustained action.

 

IN  TRIALS:

In mice,

 Gundewar ea 2008  New York & Harvard  show that “lowdose metformin given from the time of myocardial ischemia halves mortality from heart failure”.. as was shown in Canadian diabetics on metformin, whose mortality was halved;

 

Wang ea  Shanghai China 2008  show that  ”Metformin significantly inhibits cell proliferation and apoptosis in all  human pancreatic cell lines”;

 

in humans

CARMOS (Greece  2008) was not a double-blind but an open randomised RCT “in 366 overweight / obese middle-aged subjects around 53yrs, BMI 32kg/sqm, bloodpressure around 140/89 but without cardiovascular disease CVD. Metformin just 850mg/day  compared to standard management for 1 year lowered the incidence of new diabetes from 8.1% to 1.1% ie by 86%; lowered the incidence of new prediabetics from 18.5% to zero; and the incidence of metabolic syndrome from 15.5% to 2.6% ie by 83%; and significantly lowered LDL cholesterol.  There was no significant fall in body mass index BMI compared to the controls.” The average tolerated Western dose of metformin in diabetics is 2.55gm/d, which in the obese produces a sustainable loss of about 6kg – up to 20kg; but in perhaps more out-door living Greeks on the legendary Mediterranean diet, even that moderate dose of metformin did wonders, so presumably their previous experience with it must have justified that dose. And of course, without some measurement of relative fat/lean mass,or of  subcutaneous fat and waist girth, one cannot say if they showed meaningful fat loss with gain of lean mass. .

 

By contrast, in a Dumlupinar University trial 2008 in Turkey   “324 mostly overweight patients [with white coat hypertension WCH, mean 47yrs (15 to 70yrs) , 42% overweight and 44% obese] self-selected themselves for a 6month open trial of standard care with or without metformin  metformin  up to 2.55gm a day. Compared to controls, those on metformin lost 6.6kg weight vs 2.1kg(C);  WCH resolved in 69% (M)vs 26%(C); lipidemia in about 50% (M)vs 17%(C); normalization of fasting bld glucose  occurred in 44%(M) vs 9%(C); and improvement from obesity to overweight or overweight to normal weight in about 20%(M) vs 4.5%(C).” Thus metformin at standard dose was 3 to 5  times as effective as standard therapy alone in reducing  obesity, WCH and lipidemia. 

 

Toronto University   gave metformin 1500mg/day to 32 nondiabetic women with raised insulin and breast cancer for 6 months, showing that it significantly lowered  risk factors for both CVD and cancer  – insulin resistance, lipidemia and obesity.

 

A Johns Hopkins review  (Nicholson 2009) confirms that, while metformin greatly improves fertility and pregnancy outcome, in gestational diabetes metformin gives far lower rates of neonatal hypoglycemia than insulin .

 

Resvanian ea Isfahan Iran 2008 show that metformin 1500mgday greatly enhances Intense-Pulsed-Light-Assisted Hair Removal in Patients with Polycystic Ovary Syndrome.

 

Ratner ea in the USA DPP 2008  show that after pregnancy diabetes, metformin halves the occurrence of later diabetes.

 

 

These studies thus add weight to the previous gold standard evidence making obligatory the  early and permanent use of metformin to tolerance  at any age in all  who cannot keep their weight and waist girth within normal limits:  ie estimated body fat  (by bioimpedance analysis BIA scale, by Harpenden calipers or by calculation from BMI) below about 15kg (Knapik 1983), or waist girth below about 80cm in men, 75cm in women. Absolute body fat is more realistic than relative ie percentage fat since those who exercise regularly may have far higher lean mass %. Obviously 15kg of fat will be less obvious on a 2m tall 90kg person (ie 16.67% fat) than one of 1.5m (ie 30% fat).

 

     While the average “first-world” middle-aged woman today measures a hefty ~33% body fat, and while no more than about 5kg of body fat seems essential for health (except in freezing climates), the exception (apart from a to-some desireable feminine full figure) is  women trying to fall pregnant, in whom body fat of about 12-15kg ie 20-22% seems optimal for fertility (Rose Frisch’s hypothesis; debated by van der Spuy  ea). At much above or much below this fat level, hypothalamic-pituitary- adrenal– gonadal regulation understandably  skews away from fertility.   There is obviously heavy controversy over whether mankind  acquired it’s capacity for limitless adipocyte growth (and thus suicidal obesity) due to evolution via aquatic apes, as opposed to extended survival in ice ages- which except for eg the Esquimeaux, polar bears and walrusses, ended some 20 000 years ago – and the ice caps (and their obese denizens) are fast disappearing with global warming. 

 

 

But the plant extract metformin  is the only drug proven by centuries of use and 80 years of research that with sensible use to tolerance (like all other foodstuffs) if started early and permanently,  reduces all common major chronic degenerative diseases by about half – and new diabetes by up to 90% – as reviewed repeatedly in this column, – other  new studies  from St Petersburg Russia (Anisimov ea), 80), Tennissee  (Gosmanova ) , and UK –  Bodmer,  Holman  UKPDS and Bailey  about Metformin: A multitasking medication.

 

The 1-year CARMOS trial joins the three ±3year  landmark  (China – Wenying: Chin J Endoc Metab, 2001,17,131-6;  USA  2002; & Indian 2006) Diabetes Pevention  Program DPP trials showing  what we see in Africa, that in very different races and regions (ie on all continents),  metformin reduces the incidence of new diabetes (depending on baseline body build,  energy intake /expenditure, and  startup and final metformin dose) compared to placebo – by 27% in India (metformin 0.5gm/day) to  31% USA  (1.7gm/d) to 60% China (0.75gm/d) to 83% Greece (0.85g/d). Thus in full tolerated dose (mean 2.55gm/d in the UKPDS) which none of these trials claim to use), metformin  must add decades to health.

 

Both evidence and common sense show  that:

i. there is much genetic variation in human metformin metabolism, and

ii. there is some metformin dose:body mass proportionality; and

iii. metformin complements, but does not replace the need for sensible diet and exercise, and

iv. metformin does not do away with the need for minimization  of any drugs which reduce insulin sensitivity eg salt, cooked fat, alcohol, oral estrogen especially with progestin, sugars,  betablockers, cortisones, psychotropes, diuretics, antidiabetics, and smoking/snuff (and arguably even aspartame- the infamous Canderal). Like tobacco use, refined sugar and cooked fats are anything but necessary and healthy foodstuffs – with alcohol overuse, they are the prime causes of the saccharine diseases -especially if combined with each more than about 10gms a day.. .

 

 So to avoid early drop-out (25% in the USA DPP),  metformin  HCl – easily  buffered by eg calcium carbonate- must always be started low eg at  125mg (1/4 tablet)  twice a day, and built up to comfortable tolerance (by perhaps  25% increase in dose each day) over a few weeks;   with  in case of new symptoms,  the dose temporarily stopped for a few doses till symptoms subside, and then resumed with slower upwards dose adjustment;

 

It is common cause that sexual and erectile function never mind reproduction are progressively impaired by increasing obesity and thus insulin- glucose intolerance,  and glycation.

Thus it is obvious that the earlier metformin is added  to tolerance to prevent increasing overweight, the better both sex and reproduction  and erectile function will work.

 

And even in diabetics let alone prediabetes, metformin with sensible use has zero adverse effects that are not easily avoided/ reversed by dose reduction- as shown in both giant metformin trials in type 2 diabetics that were completed  a decade ago:  the almost 20 year long UKPDS (Holman ea)  – about 12000 patient years; and the year -long landmark American COSMIC trial (Cryer ea at Bristol-Myers-Squibb BMS 2005 )  some 9000 patient years- mean age 58yrs.

When we asked, BMS refused to explain why the results of the  COSMIC trial – done on USA volunteers-  were scandalously not published for some 7years. While the numbers were too small to reach statistical significance, the table of adverse events in their trial showed that especially in the 2/3  over 65yrs, gastrointestinal, infection, neoplastic and vascular adverse effects were 25% to 66% more common in the control group than on metformin. The only paper apparently ever published on the COSMIC trial did not mention the changes in blood sugar / other markers achieved; but did show the remarkable superiority of metformin: “By study end, 90% of the metformin group and 77% of the usual care group were still receiving their initial study treatment, while 5.4 and 19%, respectively, had switched to the alternative treatment arm. Apart from adverse events, the most common reason for switching from initial treatment (<1% of patients) was lack of efficacy (1.5 % vs 4% respectively in the metformin and usual care groups).

       

In fact, when we asked for the paper, BMS and their parent metformin patent-holder Merck actually denied knowledge of this biggest-ever planned metformin  ab initio trial in diabetics (mandated by the FDA and started in 1996 as a condition of registration in USA)  even in 2005 after the results had first been presented at a diabetic congress.

 

This inexusable delay in publication may or may not be due to the fact than these metformin-partner companies first wanted to see the successful launch of their new patent combination Glucovance  (metformin plus a sulphonylurea- either glyburide or glibenclamide), on which the first human RCTs were published only in 2002 -and which have been increasingly  discredited except as last-ditch therapy due to the serious risks of sulphonylureas. “One already-marketed combination diabetes pill, Glucovance, a combination of metformin and glyburide, generated sales of $330 million in 2001″. “Glucophage (metformin), which had more than $1.3 billion in sales in 1999 (presumably in USA), loses patent protection in September (presumably in USA, in 2000). The economics of antidiabetic drugs are staggering:  ”Diaßeta glyburide in the U.S. and Canada; glibenclamide in most of the rest ….. World-wide sales of oral diabetes medications reached $7.8 billion in 2003″.

 

So antidiabetic drugs alone generate sales of around $10billion a year?

 The $multibillion smoking-alcohol  industry aside, overweight is the main natural gateway to diabetes, hypertension, lipidemia, ischemic and hypertensive heart –brain- kidney and peripheral vascular disease, dementia, arthritis, cancer and thus decades- premature disablity and death. So the global market for high technology created by the epidemic of overweight plus smoking (including cosmetic and cardiovascular procedures) must already have passed $trillions a year.

             

And a cheap safe plant derivative like metformin or galega, combined with other panaceas like vitamins, minerals and plant and animal biologicals can reduce this epidemic by up to 90%.

 

No wonder Merck, BMS, Pfizer, Bayer  and their fellow Big Pharma  and research and political connections including Regulators and Governments do everything in their power to cover up, suppress, regulate  non-patentable supplements (including galega) that can eliminate the profitability (and most jobs)  of the disease industry, and largely do away with research for new remedies for the chronic major degenerative diseases.

 

A Medscape review    now reminds us in  ”Diabetes and Cardiovascular Disease Among Older Adults: An Update on the Evidence” that “Treatment should be individualized with consideration given to patient preference and quality of life.”   But this is not licence for regulators, doctors  and medical schemes to disparage and delay preventative metformin use, or people to continue reckless obesogenic diet and lifestyle, which takes decades off  life and, worse, off healthspan; and the sooner makes them (or their dependents) unnecessarily needing the support of others.

Metformin is the only chronic preventative drug that in tolerated (and low cost) dose – alone but especially combined with appropriate other supplements (vitamins, minerals  and biologicals including fish oil and   hormone replacement-   reduces ALL risks of the major chronic degenerative diseases from conception to death. Contrary to the vested interests that promote disease and newer synthetic drugs, there is never an absolute contraindication to metformin – merely appropriate dose adjustment.

Thus metformin is the necessary obligatory first drug to prescribe permanently for all with overweight/ excess body fat; let alone those  with tobacco/alcohol use, suspected polycystic ovary syndrome; (pre)hypertension; lipidemia; vascular disease;  and prediabetes/ diabetes.

Until metformin is made available without prescription, it is  freely available as the parent herb galega officinalis – even if retailers have to be forced to order the standardized herb extract to US/UK/Japanese pharmacopoea standard on request. Like metfomin and antihypertensive and most other drugs, the dose of galega is simply cautiously built up to tolerance and effectiveness – in this case appetite reduction and gradual weight loss.

 

CONSERVING ESSENTIAL FAT -SOLUBLE SUPPLEMENTS, SEX and ALL-DISEASE PREVENTION

CONTENTS:

ABOUT FATS & CHOLESTEROL

1. FISH OIL

2 VITAMINS A; D; E; K.

3.HORMONES: THYROID; HEART; ADRENAL; GONADAL.

FAT-SOLUBLE POISONS STORED IN BODY FAT ;

NON-ESSENTIAL “ESSENTIAL” OILS.

ABOUT FATS & CHOLESTEROL: Most nutrients – sugars, proteins and micronutrients-  are water-soluble:
Water abounds -we are ~30% to 75% water depending on how fat we are;
and water-soluble vitamins, minerals,  sugars, proteins and other nutrients abound  in our food chain.
It is common cause that the water-soluble vitamins – (the nine  vitamins B plus vitamin  C)- give enormous  extra multisystem protection in safe megadose supplement. These are ubiquitous if often inadequate for modern pollution, stress and epidemics  in the average  urban (or rural poor) raw and even in the lightly cooked produce/  food-chain we eat.

FATs include both the solid and the liquid form; but “fat”  – ie (semi)solid at body  temperature- is ubiquitous in human diet; once cooked, animal or vegetable or dairy , its all the same saturated sludge. Except in milk, fat is solid in animals and produce, as anyone who has had a deep cut knows- it doesn’t run out!

Expressed uncooked plant oils ie liquid at room temperature, or as the natural vegetables,  are much better  for health than cooked or animal fats,    But  they are largely omega 6 / 9 (like the omega 6 arachidonic acid in meat); and if indeed plant oils provide  omega 3, it is    ALA- alpha-linolenic acid  , not the crucial essential marine omega 3  eicosapentanoic EPA/ docahexanoic acid DHA – to which ALA is poorly converted by humans..
As opposed to oil,  FATS in humans appear to serve only a few purposes: energy storage for times of starvation; insulation against cold and falls; and synthesis of eg estrone and leptin. But the higher the fat stores, the greater the risk – eg vascular sludging (ie grime), cancer, inflammation, and trauma to weightbearing joints eg the spine, hips, knees etc.
In temperate climates, human adults carry  ideally at most 13 – 15% fat (except for women wanting to fall pregnant, when about 20-25% fat is optimal – Beth Frisch’s  hypothesis).
OIL on the other hand  is essential for lubrication in both engines and animals- and with the oil-soluble micronutrients  especially the EPA-DHA and the sex hormones – for  supple skin, mucosa (eyes, mouth, vagina), joints muscles ligaments and tendons, brain and heart . But many choose to ignore this crucial deficiency  in aging people, and instead prescribe toxic designer  “anti-inflammatory” drugs, or omega 6.
List of essential nutrients :- Wikipedia gives a useful list of the traditional dozens of essential nutrients : but this list includes many which are adequate in a prudent diet.
But the growing “news”  is on the rediscovery of the crucial protective role of appropriate  fat-soluble supplements for prevalent diseases – stress, pollution and aging eg the marine omega3 EPA and DHA;  fish oil; coQ10,  vitamin K,  and the steroids vitamin D, testosterone, progesterone and estrogens;    as opposed to the water-soluble crucial micronutrients eg arginine, carnitine, coQ10, ribose, N acetyl cysteine; glucosamine-chondroitin; lutein-zeaxanthine, essential minerals etc.
FAT SOLUBLE MICRONUTRIENTS however, are far fewer than water-soluble micronutrients, and thus have even more important diversity and potential deficiencies since our primary physical anatomy is the fatty cell membranes, and our fatty mammalian nervous systems (about 8% fat, 80% water, 10% protein):
CHOLESTEROL is obviously the crucial basic building block for cell membranes, and steroids – which we lower too far (with eg starvation or  statins) at our grave peril.  Cholesterol–  the principal sterol synthesized by animals-  is an essential component of mammalian cell membranes to establish proper membrane permeability and fluidity.  Minimum levels of cholesterol are essential for life.  Cholesterol may act as an antioxidant, in the manufacture of bile and helps digest fat, important for the metabolism of the fat soluble vitamins A, D, E and K., and is the major precursor of the various steroid hormones (which include cortisol and aldosterone, and the sex hormones progesterone,  estrogens, testosterone). It also covers nerves in the form of myelin, to conduct nerve impulses.    Recently, cholesterol has also been implicated in cell signaling processes. But since the liver makes about 1gm cholesterol a day, it is not essential in the diet.

1. FISH OIL– perhaps the most important supplement there is-  as the till-now unique and only source of the essential fatty acids EPA and DHA, is discussed at length.
Along with nuclear fallout), we  WW2 & baby boomer generations got plenty of fish oil as kids  – in breast milk; as cod liver oil in malt; or  provided fish was lightly cooked, or raw- sushi or eg pickled (not cooked) herring (not fried). And of course there were plenty of oily fish around- sardines, anchovies, pilchards, mackerel, tuna, salmon, cod. But these are now increasingly scarce, or polluted whether wild or farmed. We now rarely find even canned pilchards or salmon with the fish oil left in the cans- it is usually run off and replaced by harmful saline or plant oil. And northern hemisphere fish is increasingly contaminated by heavy metals let alone synthetic xenoestrogenics  like dioxin, PCBs, insecticides etc which are rapidly sterilizing the planet (look at the 90% fall in the bee population in N America- no bees, no cross-pollination, no flowers, no plant produce). .
So we now all need to take fish oil to get our essential minimum 800mg EPA+DHA a day.
A popular myth is heavy metal contamination of fish oil. But  toxic heavy metals are water-soluble and bind heavily to proteins, so there are none in clean commercial fish oils. see 1, 2 – which are indeed  rigorously controlled for deadly industrial  solutes like PCBs, DDT, dioxin.

In Alzheimer’s disease, the latest research affirms the likely protective role  especially for  the elderly of early and permanent fish oil supplement ie DHA; and the harm of supplementing plant oil ie excessive arachidonic acid.

2. VITAMINS

2.1 VITAMINS A- CAROTENOIDS– the provitamin A beta-carotene β,β-carotene  – is crucial in supporting skin, vision,  memory, and immunity against infections eg viral. Patients with acne have been shown to have low blood levels of vtamin E and especially vitamin A. Beta-carotene is composed of two retinyl groups, and is broken down in the mucosa of the small intestine  to retinal, a form of vitamin A.. so supplementing b-carotene provides us with vitamin A as we require it.
There is apparently no toxic dose of bcarotene C40H56, but prudence- if only to avoid yellow skin- is not to much exceed 15000iu/day;   whereas excessive vitamin A –retinol  C20H30O-  dose increases incidence of some cancers eg in smokers.
No trial has been published comparing head-on the patented (vitamin A- modified)  oral designer drug isotretinoin Roaccutane C20H28O2  with combination of the skin nutrients: beta carotene C40H56  plus vitamins B C D E plus fish oil and zinc. Since most of the latter have proven major anticancer, antiviral, cardiovascular and antidiabetic as well as (like betacarotene) antiinfective, skin and memory benefits, there is no comparative evidence to justify except as last resort  the use of toxic isotretinoin for cystic acne, especially not in children.

The careteinoids C₄₀H₅₆O₂ lutein and it’s isomer  zeaxanthine are crucial in protection against visual loss- macular degeneration- and Alzheimer’s disease.

2.2 VITAMIN D There is a flood of new research  papers recently  on the importance of vigorous (not traditional 400iu/d) vitamin D supplement   against  all major acute and chronic diseases including infections.
It becomes clear that we optimally need vit D  bloodlevels of ~80-120nmol/L, ie  5000iu to 10 000 iu/d rather than 400-800 iu/d,  just as men and women  need testosterone .
There are now well over fifty conditions associated with suboptimal vitamin D levels. (adapted from Dr Joe Mercola) :

aging	dermatoses: eczema; acne,  Psoriasis ,lupus.	Multiple Sclerosis
Alzheimer’s disease	Diabetes 1 and 2	Muscle pain IgA nephritis
Asthma	Hearing loss	Obesity
athleticism impaired	Heart disease	osteoporosis
Autism	Hypertension	Parkinson’s
cancer*	hyperactivty learning disorder, ADHD	Periodontal disease, cavities
chronic fatigue	infertility  miscarriage prematurity pre-eclampsia	prostatism, BOO
infections; Septicemia	Insomnia	Rheumatoid- & osteo-arthritis,SLE
Crohn’s disease	learning disorder	schizophrenia
Cystic fibrosis; COPD	Macular degeneration; myopia	seizures
Depression	Migraines	thrombosis

*cancers of  breast, colon ovary kidney and endometrium occur much less in sunny places in the world.

One cannot  find a major acute, or  chronic, youthful  or degenerative  aging, disease not on this list;     and only fish oil may have wider benefits.   Even age-related lung function decline has strong inverse relationship with baseline vitamin D level; which is not surprising considering how osteoporotic shortening and bowing restricts the lungs, and lack of vtamin D weakens muscles.
So perhaps only  regular outdoor workers – hikers/bikers/swimmers –  with strong muscles and bones need not worry about their vitamin D level.

But the cost of a vitamin D3 measurement is awesome  in RSA (R660) or about US$66. Ultrasound BMD sceening is a  more affordable indirect screen, with checking of calcium bloodlevel occasionally so as not to overdose vitamin D.

Vit D production  from sunshine apparently self-limits vitamin D production for safety to about 400 to 2000iu internal synthesis/day. Vit D in cod liver oil is regulated by treaty to  about 100iu/gm oil.
The manufacturing industry has reportedly, without announcing it, redefined and sells “pure” vitamin D powder as 100iu/mg instead of the scientific standard  40 000iu/mg; thus what they sell  as pure  “vitamin D3” is actually 0.25% . So we have to pay freight for 99.75% inert filler to be shipped around the world. This too is the standard commercial fraud.

So for  the benefits of safe vigorous vitamin D 6000iu/day or 50 000iu /week, we need a vit D supplement.

2.3 VITAMIN E the mixed tocopherols are most important fat-soluble antioxidant   vasodilators; but dose should not exceed about 1600mg 800iu/day since, like betacarotene, this vitamin in excess is  associated with increased lung cancer when combined with the 4000 carcinogens that smokers choose to ingest . Supplement of vitamin E may benefit circulation, Parkinsons, Alzheimer’s or visual loss.

2.4 VITAMIN K supplement has recently  appeared to  be almost as important as vitamins  D and C supplements in preventing not just warfarin dose instability,  but also osteoporosis fractures, cancer and cardio/ vascular disease. The only major difference is that vitamin K supplements do not appear to reduce infection- but vit K supplement may be safe & worthwhile during/ after antibiotics to avoid vitamin-K deficiency (and thus bleeding and increased vascular, bone and cancer risk ). In the recent ECKO trial from Univ Toronto (Cheung 2008) , vit K just 1mg/d halved fractures in postmenopausal women over 2 -4yrs despite no clear increase in bone density.

3.  HORMONES:

3.1 THYROXINE T4 AND TERTROXIN T3 are  the  crucial fat-soluble thyroid hormones (combined in Diotroxin) which especially after mid life often require replacement for either poor thyroid production or for resistance due to antibodies.

3.2 STEROIDS:

3.2.1 CARDIAC GLYCOSIDES eg digoxin are hydrophilic ie fat-soluble natural steroids from plants and animals (apparently from our adrenals and brain)  that strengthen heart contraction and slow the heart in preventing/ treating rapid atrial fibrillation. Obviously we have evolved them too over a million years, and plant glycocides have been used medicinally for centuries if not millenia.

3.2.2 ADRENAL: CORTISONE (and ALDOSTERONE)  are also  crucial fat-soluble adrenal  steroid  hormones which may with aging or stress burnout (type C personality) justify  replacement orally for relative if not absolute cortisol deficiency.

3.2.3 SEX HORMONES: the  all-systems ie anti-aging benefits of lifelong parenteral primary  human sex hormones  testosterone, estrogens, progesterone  (from the gonads and adrenals)  have  been documented for millennia, and confirmed for sixty years with their appropriate supplementation- reducing all-cause mortality and morbidity by at least 1/3- especially testosterone and it’s daughter estrogens for men and women; and increasingly in new studies that parenteral estrogen halves the risk of heart attack post menopause.    eg .https://healthspanlife.wordpress.com/2008/11/05/proof-again-parenteral-estrogen-halves-the-risk-of-heart-attack-post-menopause/.

The American National Osteoporosis NOF website for patients  has legion bewildered queries from  patients being told dogmatically by their  doctors that they must take new  (risky and long-term unproven) designer patent  single-target  ie fraudulent drugs eg bisphosphonates, strontium ranelate  for osteoporosis – not the old and proven  safe dozen appropriate  natural multisystem supplements that combat all chronic major degenerative diseases as well as optimizing childhood development, learning-memory, and defence against  infections –  ie the freely available  vits B 6,9,12, C, K, calmag, zinc, boron, manganese, proline, fish oil, and for sexhormone imbalance/ inadequate levels, appropriate testosterone for both sexes plus appropriate parenteral estrogen for women (or occasionally DHEA where appropriate). .

4. CoQ10 ubiquinols :    these vital antioxidant insulin sensitizers appear beneficial in doses of up to 300mg/d against heart failure ; cancer; migraine; Parkinson’s; oral-gingival disease; Alzheimer’s; hypertension; COPD; and cardiac arrest.
Compared to niacin, fish oil, CoQ10 and other insulin sensitizers, there is no justification for the use of statins for mild-to-moderate  lipidemia, when these synthetic designer drugs are a cause of coQ10 depletion (reported repeatedly since 1990)    and  do nothing for non-cardiovascular disease and mortality including insulin resistance;
and when (because drug companies will not risk head-to-head trials of statins against alternatives)  there is no evidence  that statins are as good  (against mild-moderate  hypercholesterolemia-associated CVD) as eg niacin and other vitamins-minerals, fish oil, metformin, coQ10, arginine, carnitine, ribose,  and other insulin-sensitizing antioxidants;
and when supplementing CoQ10 also does nothing for the myopathy let alone impotence caused by statins.

FAT-SOLUBLE POISONS STORED IN BODY FAT such as DDT or PCBs, are also stored in the fatty tissues, but the body has no use for these substances and they are NEVER withdrawn from these fatty tissues for any valid use within the body.
These harmful chemicals (DDT, PCBs) do leak out of fatty tissues (during times of sweating, for instance), but when that happens there is no beneficial use for them in the body — and they cause far more harm  than good after they have leaked out.
Worse, these poison are stored in the body fat of all flesh we eat (just as heavy metals are stored in protein ie muscle); hence vegetarians run lower risk.
Worse, aluminium (which is not usually water-soluble) accumulates in  the brain (let alone bone), and is one of the few minerals that has no known biological benefit, but contributes greatly to dementia and fractures.
Worse, there has been massive pollution of reserves by recycled water effluent from sewage works and industry, leading to global fauna sterilization /destruction by the masses of contraceptive and anabolic steroid hormones prescribed for humans and  animals (Deborah Cadbury: The Feminization of Nature 1997 )  that threatens to sterilize and thus wipe out most of humankind this century.
And worst of all, deliberate adulteration of commercially grown meat/fish for accelerated growth by anabolics – especially the high-risk synthetics like ethinylestradiol and progestins- is especially poorly regulated since the industrialized countries  notoriously dump these (as well as stocks of eg dangerous insecticides, and genetically modified seeds)  via ruthless politicians/middlemen on poor countries like South Africa  where there is minimal monitoring of transgressions.

NON-ESSENTIAL “ESSENTIAL” (PLANT) OILS eg from cloves, tea tree, garlic,  mrenthol, eucalyptus, citrus, rose, may indeed have medicinal benefits used topically/ in aromatherapy; but are outside the scope of this review since they are not human biologicals like the vitamins, steroids and essential fatty acids..
IN CONCLUSION: whether by design or random evolution, we developed dependent on if not from  sea life, and especially marine oil, fat-soluble micronutrients; but with longevity, and as we become eaters of largely cooked flesh and produce, with depleting marine fish reserves, we need marine oil and fat-soluble micronutrients ever more- not processed plant oils and cornstarch.
It’s like all other natural supplements and valued old products:
Nothing has yet contradicted  that metfomin (a plant extract) is the last “synthetic” ie drug industry  designer preventative  for chronic prescription use that actually reduces all-cause mortality and morbidity ie is the panacea; without enough insulin sensitizers, excess calorie are simply diverted to more cholesterol and body fat;

while  the natural supplements: FAT-SOLUBLE  fish oil; vit D3; and testosterone, +-  extra estrogen  for women  – look like they may prove equal  to if not better than metformin solo as panaceas.

You can’t beat nature/creation  for providing healthy options;                                                                      nor  endless human greed in trying to do better for profit by promoting designer substitutes?

If we continue to destroy species -especially marine life- at the rate mankind is doing, there will soon be no marine life- EPA/DHA – left- and  the science industry  (unlike nature) has yet to work out how to make them.