Tag Archives: sex

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.

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 EuropeThe 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