Tag Archives: Fosamax

UPDATE: SUPPLEMENT CALCIUM PHOSPHATE & VIT D3- NOT BISPHOSPHONATES – FOR OSTEOPOROSIS. BISPHOSPHONATES ARE LONG-PROVEN CRIMINAL FRAUD.

neil.burman@gmail.com  

The calcium phosphate  imbalance – hyperphosphatemia and hypocalcemia and  acidosis – of chronic renal failure causes havoc on bones and circulation, and can be considerably mitigated by supplements with dolomite (CalMag)  – (NOT aluminium)- and vigorous vitamin D3,  and timely dialysis and transplantation. .

But apart from rickets and renal failure, IATROGENIC PHOSPHATE DEPLETION by antacids is a perhaps-forgotten hazard of chronic antacid ingestion : dozens of papers on Pubmed since the early 1970s to the 1990s attest to the common problem even in adults outside hospital.  The authoritative University of Oregon website  sums up the need: the recommended daily  phosphate allowance RDA for adults is about 700mg (up to 1200mg in pregnancy) – but the safe upper limit is at least  3000mg/day.

The common causes of adult chronic phosphate deficiency include (apart from food- soil phosphate depletion that blights crops; anorexia nervosa; diuretics[ thiazide, Diamox);  in perhaps descending order of prevalence: fructose (now used as profuse sugar substitute in the cooldrink and fast food industry);  vitamin D3 deficiency; poorly controlled diabetes and insulin excess; alcoholism;  starvation and diarrhoea- malabsorption:- but especially chronic ingestion of phosphate-free antacids of sodium, calcium, magnesium and  especially  aluminium. Given the  accumulating toxicity of aluminium in bone and dementing diseases, there is no longer place for aluminium antacids, which should be banned.

A recent review of Medication-induced Hypophosphatemia from Greece stresses that diuretic and bisphosphonates (eg Elisaf ea 1998) are the chief causes. A 40year old article in the BMJ lists thiazides as a cause, although  Massry ea showed a decade later that thiazides blunt the hypercalciuria of phosphate depletion..
And this week a 3year study from Germany of 4000 women on oral bisphosphonate shows a median oral bisphosphonate treatment duration of 145.5 days. Persistence rates after 1 and 2 years were 27.9% and 12.9%, respectively. These abysmally poor medium-term compliance figures tell us how badly patients tolerate and view bisphosphonates.

Hence, dont use bisphosphonates for osteoporosis. There is no need for them  with their  major risks. Use appropriate harmless calcium-magnesium phosphate and vitamin D. There has never been convincing evidence to justify prescription of biSphosphonate for osteoporosis.

It is symptomatic of the pernicious influence of Big Pharma that the Wiki section on osteoporosis devotes dozens of lines to designer commercial drugs heavily promoted and prescribed by the Disease Industry, that have never been proven to be necessary let alone safe;  but only a few lines to the score of natural essentials that reverse both osteoporosis and all other common degenerative diseases of aging.     It doesnt even mention phosphate supplementation, though it mentions phosphate depletion as one of the many causative factors in osteoporosis- ignoring the fact that bisphosphonates actuallly worsen phosphate depletion in some studies. .

February 10, 2011    In today’s NEJM N Engl J Med  Bisphosphonates for Osteoporosis, Vis Dijkman and Lems at the hallowed VU Amsterdam bewail that a 67year old woman with osteoporosis was not treated with a bisphosphonate..

This is precisely the reflex response that marketeers of such synthetic drugs spend millions to obtain by doctored trials, massive advertising, ghosted papers in leading journals that crave such marketing adspend, and employment of spin doctors and lobbyists… to promote $billion sales.. . .

Although bisphosphonates and other modern designer drugs like strontium halve fracture rates, they cost a fortune, and have deadly albeit arguably rare risks; and have negligible need or indication except profiteering.

It is indeed medical malpractice when such patients are not placed on the economic safe multisystem protective supplements freely available in any democracy .

So where is the indication for such heavily advertized contentious patented designer drugs when they do nothing for multisystem health -especially frailty and falls, the chief risk factor for fractures – and all-cause morbidity and mortality?

When osteoporosis and all the other associated chronic major degenerative diseases of aging are at least halved, adding health to years, by the sensible combination of at least 20 micronutrients- fish oil, appropriate balanced human hormone replacement and a sensible powder blend of the vitamins, minerals and biologicals-that have each been shown to strengthen all-system health at little cost and no significant risk?

 update 29 Jan 2011 Prof Heaney’s team showed in a 12 month trial published last year  that while  women on  a potent anabolic agent with phosphate intake less than 1000mg/day,    phosphate and carbonate salts of calcium  appear to be approximately equally effective in supporting  vigorous bone building in osteoporosis ;   but  phosphate salt may be preferable in patients with restricted phosphorus intakes”.  Combined Vitamin D and balanced sex hormones , the other minerals  and vitamins, are potent anabolic agents.

Hence it becomes clearer  from Heaney’s and White’s respective recent trials that since so many older women have relative calcium and phosphate deficiency- without obsessively checking  the plasma  calcium-phosphate product too regularly-  modest  supplementary tricalcium phosphate eg eg 1 gram a day can be given with eg modest calcium carbonate a gram a day to provide  about 700mg calcium and 200mg phosphate a day, safely  combined with the score of other natural bone-and muscle-anabolic supplements mentioned below and in previous reviews on this website. If the plasma  calcium and phosphate levels and product do not rise to the mid-upper range of healthy people despite all the other supplemments, if desireable  the dose of calcium phosphate can be titrated upwards and the calcium carb dose downwards .

It is intriguing that,  predictable hypocalcemic hyperphosphatemia from  chronic renal  failure  and hypoparathyroidism aside, on Pubmed and Google, phosphate overdose has  rarely been reported in adults , and then in bizarre circumstances.with gross overdose of eg sodium phosphate for purgation. Search for “calcium phosphate overdose” on Pubmed and Google reveals no case reports. Such is evidence-based medicine-  there is no report and thus no evidence of  serious  risk from appropriate use of oral calcium phosphate supplements.

By contrast, already by 1976 Heaney and Saville   showed that bisphosphonate elevated blood phosphate and calcium, but reduced both bone resorption and mineralization by about 50%.

Hence there is no place for bisphosphonates in the treatment of osteoporosis, when it is calcium-magnesium phosphate that is needed.

23 January 2011      Regulators, Administrators, medical schemes, Academics, specialists and family practitioners must produce evidence for patients to support why they (the Healthcare Industry)  promote patent synthetics like Fosamax – bisphosphonates BPN-  and  Pro(el)os  – strontium ranelate-  ahead of solidly evidence-based century-recognized and  balanced physiological safe low-cost natural multisupplements like vitamins, minerals and the past century,  appropriate human steroids. 

The accumulating evidence against synthetic designer drugs which target solely bone, and for well-proven combined safe approriate natural supplements  that benefit all bodily systems –has been updated regularly for bisphosphonates eg alendronate- the Fosamaxes – and strontium ranelate– Prot(e)os.  .  

In PHOSPHATE NUTRITION AND TREATMENT OF  OSTEOPOROSIS     Professor Robert Heaney in 2004   anaylses the crucial role of adequate phosphate in the elderly.     As we had hardwired into our brains in organic chemistry at med school 50 years ago, the main cation mineral elements in bone are calcium and phosphorus in the ratio of 2:1 in the matrix hydroxyapatite- [Ca3(PO4)2]3 Ca(OH)2; whereas potassium and magnesium are the main and thus most vital cellular ie intramuscular cations; and sodium (chloride) extracellularly. Thus while overall cationic mineral balance  including sodium is crucial,  calcium, magnesium, phosphorus and potassium are the main locomotion- strength –  cations. .   Heaney and Chris Nordin have for almost 50 years urged  dietary balance of calcium and phosphorus to optimize bone – why do doctors and Regulators continue to ignore this basic truth?

The association of calcium and phosphorus balance in senile osteoporosis goes back on Pubmed to at least 1953  if not to the 1930s.

But Pubmed and Wiki are  only  small windows on history.   It is salutory that on Pubmed  osteoporosis was already reported by Wherry  in a fulltext report dated 1894 ! It was already a scourge in Egyptian women 4000 years ago.    My thick  Lancet volume for 1839-40 does not list osteoporosis, nor does my  bulky 2 volume 1959 Oxford Universal Dictionary.

 Nor does my facimile  Sir William Osler’s Principles and Practice of Medicine 1892- but under rickets, for the frail child  it warmly recommends  milk as the chief food; phosphorus dissolved in olive oil; cod liver oil; and iron iodide given with the oil. And on the next page under scurvy, Osler discussed Dr James Lind’s  as yet unidentified antiscorbutic factor  which some felt might be due to the alkaline salts in fruit; with in children  fracturing scurvy very much like rickets  The Google layout of the 1901 edition  is of course longer, but the section on rickets treatment was identical.

 By WW2 Fuller Albright recognized one extra  major osteoporosis  link- menopause-  and began treating such women  successfully with estrogen replacement HRT.

So by WW2, decades before bisphosphonates for profit were thought of, mainstream medicine already knew about the chief nutrrients for healing bone-  cow’s milk for its calcium, potassium, protein and vitamin D; cod liver oil for its abundant vitamin D3;  iron, iodine, phosphates,  lemon juice for its vitamin C, and estrogen.

 Thus it is unsurprising that, apart from the major food components-  protein (nitrogen) and energy (starch and fats) ,   strength and upright posture and locomotion depends on maintenance of optimal micronutrients-  calcium magnesium potassium  phosphate, vitamins especially C and D,  and acid-base  balance  in the blood,  ie in the diet. 

It is common knowledge that as kidney function fails, with  unrestricted diet, acid and phosphate accumulate and calcium falls with calcification of vessels and tissues and weakening of  muscles and bones.       

But in average aging women (who mostly undergo loss of crucial anabolic steroid hormones in early  midlife,  decades younger than men), as Heaney says,  dietary phosphate deficiency becomes another major risk factor for osteoporosis- which is aggravated by  increasingly earlier menopause, vegetarianism, regression to tea and sandwiches diet, and increasing intolerance for dairy products and darker climate,  let alone  in devout muslim women applying cultural  avoidance of all sun exposure; and        

  •  the idiotic marketing and preaching of  pills like B-D-cal- which provide harmful unopposed daily 1500mg calcium as citrate or carbonate  with a trivial vitamin D3 dose of perhaps 400iu a day
  • aggravating the increasing calciferol deficiency from decreasing dairy intake; urban work indoors and no-longer compulsory sport at schools; and the idiotic omission of meaningful supplements of all the other essentials that become deficient with diet and aging- bone-and-muscle trophic minerals and vitamins especially magnesium, boron, selenium, manganese, zinc, iodine, even  strontium, fluoride;  and vitamins B, C, K;
  • and the modern irrational and adverse denial of appropriate  balanced physiological gonadal hormone replacement after age 60yrs.
  •   This is in turn worsened by the liberal use of purgatives;  calcium-magnesium-wasting furosemide,  SSRI antidepressants, corticosteroids and ethanol; and  aluminium and synthetic  antacids and deodorants rather than calcium magnesium salt.  

And as Heaney says, confusing  the phosphate retention of kidney failure with people with normal kidney function- who in fact have phosphorus depletion worsened by high calcium intake.    

       As he says,  supplement with  Calc (tri)phosphate works best, to provide  a positive phosphate balance of perhaps 90mg/day to maintain serum phosphate well within the healthy range of 1.5 to 2mmol/L. Calcium triphosphate provides some 400mg calcium and 200mg phosphorus per gram, thus 400mg a day of this salt will provide only 160mg calcium but perhaps adequate 80 mg phosphorus a day – dose to be adjusted simply on the blood calcium and phosphate levels if not just on progress in bone density restoration. The remaining adequate supplement of calcium- ~500mg/d –  is provided by eg calcium carbonate   1500mg a day, and of magnesium eg 300mg/day as mag -ox 500mg/day.     There is no reason why females should be far more vulnerable to fractures because of targeting merely the mediocre peak bone density of average women at 30yrs instead of that of young men.

 If everyone were encouraged to take safe vigorous combined appropriate supplements, premature aging diseases would fall greatly, cutting need for hospitalization, prescription modern drugs and acute-care specialists by far more than half ie putting thousand of health workers out of work other than to care for the increasing numbers of old survivors- pensioners. .

  So  it is now clear that Bisphosphonates and ranelate- Proteos/Protos- are unnecessary for osteoporosis when the latter is so easily healed and prevented by all the natural supplements discussed above, and when these patented synthetics designed solely for Big Pharma profit have rare but deadly adverse effects eg lethal DRESS syndrome, oesopageal ulceration-stenosis and cancer, and devastating teeth and jaw loss let alone collapse of the femur.

 NEW TRIAL SHOWS NATURAL PHOSPHATE IS BETTER THAN BISPHOSPHONATE :   Now a new paper from Liverpool University UK  by White ea confirms that natural phoshate supplement does better than bisphosphonate- alendronate, BNP- in restoring bone density  in patients..

This expose of the redundancy of potentially crippling BNPs comes just 10 years after Rogers et al in Scotland noted that ” After more than 30 years of clinical use, bisphosphonates’ molecular mechanisms of action are only just becoming clear”- they reduce bone resorption necessary for bone remodelling. .

But the BNP deception goes back a lot longer. Already in 1990 Prof  Reid ea in New Zealand showed that BNP produces a gradual rise in serum phosphate- BUT   ” an acute and sustained inhibition of bone resorption followed by a more gradual reduction in bone formation… over the 12 month period. “.  This explains clearly why BNPsreduce fracture rate in the shortterm, but can produce disasterous osteonecrosis and long bone fractures.

COMBINATION SUPPLEMENTS: In 1999 Reginster ea reported ia randomized controlled trial showing that lowdose monofluorophosphate MPF  (20mg fluoride) in osteoporotic women for 4 years decreased fracture rate as much as calcium supplement alone.   In 2009 Castel-Branco ea showed in a metaanalysis that hyroxyapatite was significanlty more protective than calcium alone.  

By 1999 the world’s   leading  osteoporosis research team – Christiansen and Riis, still active after 26 years together – showed  in a similar 2year trial that the  same dose MPF  plus 50ug estradiol and NETA produced an exciting 11.8% increase in spinal bonemass density compared to 4% on the HRT alone, and only 2.4% on the MPF alone. The same team in 1996 showed that in 15year followup, postmenopausal women fall into two groups: as opposed to the 70% majority slow bone losers, the 49 fast losers    “had at all sites significantly less bone mass than the normal bone losers (p < 0.001). 23 women had experienced a peripheral (Colles’) fracture and 25 a spinal fracture. The fracture groups had generally significantly (p < 0.05) less bone mass than the group without fracture, both in the forearm, spine, and hip and they also had the highest rate of bone loss after menopause (p < 0.05). Baseline bone mass and rate of loss predisposed to the same extent to fractures with ODD’s ratios of about 2. If both low bone mass and rate of loss were present, the ODD’s ratio increased to about 3.”    For three decades they have promoted appropriate estradiol and modern progestin replacement, withdrawal of which leads again to steady bone loss.

   So why are BNPs-  and increasingly strontium ranelate – – trumpeted as the most-prescribed drugs for osteoporosis? Quite simply- because health workers do what academics and professional bodies, Regulators and osteoporosis associations, politicians and Magnagement dictate- and thus what Big Pharma dictates since Big Pharma with its $multibillion  a year raincheck synthetic (but long term never  tested ) drugs pays such lobbyists well to research and register and promote their ever-new modern drugs before they go out of patent or are cancelled due to major adverse effects- or proof that they are actually useless. .

No matter how superior and safe combined supplements have been abundantly proven to be against fractures and all other common degenerative diseases of aging, no Big Pharma company is going to massmarket any supplements or combination of these when they are not patentable. So the  AntiOsteoporosis Big Pharma lobbyists- the FDA and academic researchers, are well rewarded to denigrate effective natural supplement combinations since these are not patentable. It  is obvious  that no  western ie allopathic Medical School  can resist ie function without the massive research funding from Big Pharma.

Balanced natural supplements (which we evolved on and from in available diet over aeons – which protect all systems in the body- reduce all diseases and mortality drastically. Their free availability as foodstuffs (and human HRT as prescription supplements)  is thus increasingly suppressed by eg the FDA, NHS , European Medicines Authority and medical schemes at the behest of their paymaster Big Pharma, for whom Only Disease Pays.

 Hence BNP  promotion and prescription for common osteoporosis is longstanding criminal fraud when simple supplements including phosphate heal bone without any of the horrendous   risks of BNPs. We dont need reminding that BNP  were developed to treat cancer bone pain ie terminal disease.  Their use for common osteoporosis has never been remotely justified.

One may thus well ask again- since natural phosphate and the other essential supplement micronutrients are abundant, low cost, and so safe (like everything else in life- in appropriate balanced dose)- and so well known to become deficient with ageing and restricted diet- why did and do Authorities and Regulators allow heavily marketed synthetics phosphate salts- BNPs – and synthetic strontium salt- to be launched and continued to saturate the market before there was good proof of both need for them and evidence of long term safety, lack of major adverse effects?

It is trite to repeat that Regulators are there to protect the public- in this case consumers, patients- not promote reckless profiteering by ruthless corporates.

The essential role of abundant phosphate in diet was already exquisitely described by Harmon ea from Illinois in 1974 in pigs, (whose physiology so closely resembles humans)  where paralysis and bone loss were prevented simply by adequate phosphate diet supplement to improve the calcium:phosphate balance in diet from about 2:1 to 1.4:1. The paper details references going back decades- so the benefits of adequate phosphates were already long and well known to science.

 In the face of such simple nutritional benefit of natural microsupplements, why else except for commercial gain would research on BNPs already be reported since 1958?  and their use against osteoporosis since 1971?   Guanabens already reported BNP -associated long bone fracture in 1994 ; and he reviews the problem of vitamin D and phosphate deficiency related osteomalacia in a study a few months ago. 

It is painfully obvious that synthetic drugs like BNPs  that produce low bone turnover will cause brittle bones- osteomalacia, as Whyte reviewed in 2009.  So why use such drugs, when all that patients need – if they cant take abundant sunshine and milk- is some balanced lowcost multisupplements.   So it becomes increasingly negligent to promote, prescribe the synthetic drugs BNPs and SrRanelate, and high calcium-low vitamin D pills; and withhold balanced proven multisupplements.

Why do Regulators and so-called Expert Committees allow BNPs, SrRan  and high calcium-low vitamin D pills (followed by expensive patents like synthetic designer  HRT – xenohormones, and calcitonin and terapeptide ), to be the “most popular prescriptions” for osteoporosis (dictated largely by Big Pharma, and surgeons- gynecologists and orthopaedists – not metabolic nutrition-physiology-based endocrinologists and dieticians) – unless such authorities are in commercial cartel collusion with Big Pharma and the  fracture industries against patients’ interests? Why are payors and the most vulnerable older women- patients and others- allowed to be fleeced, preyed on  like this for profiteering by poor health?

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Update on institutionalized modern medicines fraud: REBUTTAL & COUNTERREBUTTAL: IMPACT OF ADVERSE NEWS MEDIA ON PRESCRIPTIONS FOR OSTEOPOROSIS: EFFECT ON FRACTURES AND MORTALITY

neil.burman@gmail.com  

REBUTTAL OF: IMPACT OF ADVERSE NEWS MEDIA ON PRESCRIPTIONS FOR OSTEOPOROSIS: EFFECT ON FRACTURES AND MORTALITY

18 months ago a warning was published about   the risk of Negligence  Damages for  Prescribing Bisphosphonates- Fosomaxes- for common osteoporosis. 

 A year later an updated review of the evidence rebutted    the attempt by an Australian group (Phillip Sambrook  MD, BS, LLB, FRACP  ea )  to promote routine use of bisphosphonates, blame the news media for wrongly sensationalizing these largely unnecessary drugs’ rare but lethal  adverse effects. 

 Now three other eminent Australian professors, of   Oral and Maxillofacial Surgery and  Endocrinology  (Paul Sambrook, Chris Nordin and Alastair Goss) publish a further rebuttal  of Phillip Sambrook ea for serious errors in underestimating by at least twentyfold both the incidence and the seriousness of bisphosphonate risks.

 In  a USA case for damages against Merck,  for irreversible  osteonecrosis- resulting in jaw amputation-  following Fosamax, a patient was last year awarded $1.5million . This American class action is about over 1500 Fosamax cases against Merck.  So far two related case against Merck  have been  dismissed. But all such cases are on appeal. The robust American tort system may yet hammer Merck. .

 As recently as october 2010 Merck staunchly defends Fosamax’s safety for osteoporosis.

The FDA has recently added a warning about Fosamax-related thigh fractures.

But no evidence has ever been published that the catastrophic risk of bisphosphonates- however rare-  is justified for routine osteoporosis when

1.In common osteoporosis, Bisphosphonates have no multisystemic benefits  except for halving fracture risk, and

2.Appropriate combination of natural supplements- as this column has repeatedly revewed -approximately halve all risks ie of both osteoporosis fractures and all other common major diseases of aging, and thus chronic disability and deaths, without any significant risks.

Curent Authority statements eg from the Mayo Clinic simply fail to say this- why risk bisphosphonates?  New reports  in November-December of dozens of osteonecrosis cases on bisphosphonates  have just appeared on Pubmed  from Italy, Germany, Romania and Spain.

In fact a major international study has just beeen published showing the obvious, that survival in the elderly is strongly linked to gait speed and mobility. It is common cause that such integrated function is dependent on optimal joint, neuromuscular and cardiovascular integration- to which (- unlike the score of natural human micronutrient supplements that deplete with age-) bisphosphonates and strontium contribute nothing except bone density.

Fosamax lobbyists studiously avoid the plain  truth that it is not osteoporosis; but frailty – falls –  that is the chief cause of major elderly fractures- and that bisphosphonates and strontium may make bones appear denser.

Its too early to judge strontium ranelate (which also has rare but catastrophic risk- the DRESS syndrome); but fosamaxes in some cases  make bones more brittle; without in the slightest combating senescence frailty ie muscle, mobility, vascular, cancerous, arthritic, immune, mood, cognitive and neurological deterioration (unlike the multinutrient microsupplements – vitamins, minerals and biologicals like fish oil, chondroglucosamine, sex hormones which together halve all chronic major degenerative diseases and premature mortality) ..

August 15, 2010 Regulators like the FDA  and WHO the world health organization and  their worldwide equivalents are notorious for bowing to their chief funders- Big Pharma- in registering new designer drugs on the flimsiest evidence, often despite vociferous objection from some honest assessor at the Regulator; then waiting till there is an uproar of complaints over the drug before they belatedly demand more evidence of cost-benefit from the manufacturer, and admit that key adverse data were  suppressed from the outset- as happenened and is still happening most notoriously  in the case of aspartamate Canderal.

And what was obvious from the word go,   that  in the case of last year’s swine flu vaccines and the spurious pandemic declaration, the Regulators/WHO expert committees were  heavily loaded with biased specialists paid by  vaccine  manufacturers.

But why are the fosamaxes and other  bisphosphonates  still allowed to be prescribed  for osteoporosis? When the first report of long bone fracture associated with them first appeared on Pubmed 16 years ago (Guanabens 1994) and they are unnecessary -indeed contra-indicated – for osteoporosis.   Not for nothing does a  recent ABC Good Morning America broadcast   ask: “Fosamax: Is Long Term Use of Bone Strengthening Drug Linked to Fractures”?  

This review is in fact an update on The Fraud of Modern Medicines.

 A recent review from Oxford    lists the myriad adverse effects of bisphosphonates. They say “All four  currently approved nitrogen-containing bisphosphonates have a favorable tolerability and safety profile.” But why don’t they discuss the reality which is that although all these adverse effects  may be infrequent, why risk such serious  complications  such as 30% incidence of oesophagogastric symptoms?; oesophageal stenosis and cancer?, toxiderma, atrial fibrillation, eye, muscle bone joint pain?; or incapacity from jaw and teeth loss or  longbone fracture related to bisphosphonates for osteopororis?,  when bisphosphonates  are clinically unnecessary and unjustified for osteoporosis.

 Why dont they state the truth, that there are no head to head trials against the basket of proven natural supplements, comparing fracture and global benefits versus risks of bisphosphonates ? Most reviews eg Wikipedia say bisphosphonates are “ the leading prescription for osteoporosis”; but this is simply for the same reasons that statins are for lipidemia, angiotensin blockers for hypertension and sulphonylureas/ glitazones are for type 2 diabetes, and aspartame is for artificial sweetening- because drug companies market such hoped-for $billion rainchecks overwhelmingly, and fund no comparative trials against the gold standard old supplement basket that makes most hazardous modern drugs like statins, glitazones and bisphosphonates mostly redundant.

Filleul ea from Univ Mona, Belgium have just reviewed the world literature from 2003-2009, finding 2400 cases of BIOJ bisphosphonate induced osteonecrosis of the jaw. of these about 215 were not cancer cases. Such cases very rarely occur without cancer. So why risk them?

 So why does an Australian team bewail decreased use of the fosamaxes? Impact of adverse news media on prescriptions for osteoporosis:effect on fractures and mortality. Their statistical modelling is perhaps no more than promotion of bisphosphonates since it ignores the high number of adverse effects that bisphosphonates cause long term; and the major reduction in allcause disability and premature mortality that balanced appropriate supplements ( instead of bisphosphonates ) produce. Why would the lead author of so many papers- Professor Phillip Sambrook – promote bisphosphonate as the prime pharmacological prevention, and only calcium and vitamin D as the supplementary prevention of osteoporosis fractures?  when the evidence so strongly favours safe multisupplements including appropriate lowdose hormone balance as preventative against all major chronic diseases? Can a new-drug proponent who sits on the medical advisory boards of and has received speaker fees from Amgen, Merck Sharp & Dohme, Novartis, Sanofi-Aventis and Servier. be considered objective ? Their critique of the media for publicizing the potential disaster from bisphosphonates is hollow when they fail to mention the numerous potential risks, and the numerous benefits instead from supplements.

Geusens, Sambrook ea in 2008 published  a major review on Drug Insight: choosing a drug treatment strategy for women with osteoporosis-an evidence–based clinical perspective.. ‘The most important clinical determinant in the clinical choice of drug therapy for fracture prevention is a woman’s fracture risk; second is the evidence for fracture prevention in terms of spectrum, size and speed of effect. Other determinants include the potential extraskeletal benefits and safety concerns of the drugs.” But they again studiously avoid considering supplements (vitamins plus minerals plus appropriate hormone combination) as one of the drug regimes, especially as osteoporosis is simply one of the co-morbidities of aging, and far less of a risk for premature death and disability than stroke, cardiovascular, cancer, diabetes, frailty, dementia, arthritic disease and premature death – all of which can along with fractures be avoided and mitigated by the basket of supplements. So their review is surely biased in excluding all but new designer patent drugs while excluding the best and safe anabolics. .

 It is well proven from observational studies that longterm use of appropriate natural supplements reduce all-cause mortality by at least a third:              In the Womens’ Health Initiative WHI, appropriate hormone replacement HRT reduced all-cause mortality i.e. deaths from vascular disease, cancer and  fractures by 1/3 as well.    In the UKPDS the plant extract metformin reduced all-cause mortality also by 1/3. Understandably, metformin halves the incidence of new diabetes by reducing insulin resistance,  hence it also reduces fracture risk let alone cancer and vascular disease risk .   

 Incontestable data shows that epidemic deficiency  of vitamin D ,  vitamin C, magnesium, vitamin B especially B6,   vitamin K,    fish oil,    and prime hormone dysregulation  (thyroid, insulin,  cortisol vs androgens and estrogens)   in first-world aging populations are associated with increased mortality from all degenerative diseases especially fracturing, cardiovascular and cancer. It also showed that  vigorous supplements of balanced vitamins,  minerals (especially B,C,D,K, and Ca, Mg, Zn, Bo, Mn, Se, Cr), fish oil,  and human sex (co)hormones (testosterone, progesterone, estradiol, metformin) drastically reduce all morbidity and especially fractures  even  (perhaps especially )  in the well-off over nourished..  

  In contrast to bisphosphonates- which are aimed solely at reducing fracture in the at-risk elderly and thus reduce all-cause mortality by perhaps 10%-  these supplements in appropriate doses and balanced combination  reduce all-cause aging disease and preventable premature mortality by at least 50%, without any adverse risks. .  

Neville-Webbe ea (2010)  note that bisphosphonates have anti-cancer potential. So use it for terminal cancer fracture pain. Why use it for anticancer potential in those with just osteoporosis when the basket of supplements (including approriate HRT, vigorous dose vitamin D and if approriate metformin) gives safe  global protection against all the major aging diseases?

 Just the reduction in excess diet omega6 oils will mean that only 10% of the current necessary omega3 daily allowance (3.5gm) will be essential.  

 In 2007 a leading team from the International menopause Society  Genazzani ea  warned that “Recent controversies with hormone replacement therapy (HRT) have caused much concern in women and their health-care providers. As a result, the number of HRT users in USA has fallen dramatically. Consequently, the potential HRT-induced reduction in fracture risk is lost so that, in the next few years, we can expect an excess of 43,008 fractures per year in women aged 65 – 69 years. In addition, the recent evidence on the merits of early initiation of HRT on cardiovascular disease risk and neurocognitive function and the effect of type and combination of hormones on breast cancer risk now require an urgent review by the regulatory authorities of their recommendations about HRT.”

 Now – 8 years after the  debacle the WHI caused – the Endocrine Society has at last come out with a Position Statement admitting the grave consequences from the hysterical misinterpretation of the early release of the Womens Health initiative results in 2002-2004, especially in rising fracture and colon cancer rates from avoidance of appropriate HRT in menopausal women across midlife. . Let alone, as Genazzani ea said above and we discussed at international, UK and European menopause meetings in 2003-2006, the potential loss of benefit against breast cancer, heart, stroke, depressive, diabetic and neurocognitive problems.

 In conclusion: A major intervention is required from governments, world authorities  to reduce all-cause morbidity and mortality : by drastically curtailing the marketing and prescription of rarely essential prescription designer drugs like bisphosphonates, and strontium ranelate for osteoporosis;  by insisting on increasing universal intake of proven natural multisupplements that are increasingly deficient in the food chain for the poor,  for infants, youngsters and the multiplying  aging- in the latter, including appropiate HRT;  and by forcing the processed food industry to stop stuffing foods and drinks with not just salt  and aspartame but also fructose, sucrose, various growh hormones, and omega6 oils.

But neither Big Pharma manufacturers, governments, so-called independent regulators, nor university and private practice leaders or retail pharmacists will do so, promote evidence-based supplements over risky new drugs- there is too much money at stake from lost taxes. research funding, lower under-patent snake-oil sales and far less major disease and hospital admissions.

So it is up to patients and honest healthcare providers to insist that evidence-based supplements – not trading practice based on huge marketting and snakeoil preaching for profiteering – be prescribed for prevention/ managing the major diseases of aging including osteoporosis.

SIMPLE SAFE LOWCOST RISK MEASUREMENT AND CORRECTION: THE SOCIOECONOMIC IMPACT OF OSTEOPOROSIS

  neil.burman@gmail.com

Already just since April 2010, Pubmed (the on-line catalogue of peer-reviewed medical journal papers)  reveals four reviews – from USA, Mexico, Ireland and Cambridge UK-  on the huge socioeconomic impact of neglect  of long-available safe cheap measurement  and prevention of osteoporosis in aging populations. Especially that osteoporosis is underdiagnosed, and hence the need for improved use of diagnosis screening and preventatives.

And another study  from France reviews the deadly potential cutaneous (let alone gastrointestinal and other) risks of bisphosphonate and strontium drugs  prescribed for osteoporosis . Their  risk of serious adverse effects  may be <1:10 000 – but no study has ever been done comparing such $billion raincheck designer drugs with simple balanced lowcost safe combination of the score of natural supplements (some 7 vitamins, about 8 minerals and 5 human biologicals- costing as little as about US$10 a month) that are proven to prevent and heal osteoporosis let alone have major benefit on most major chronic diseases. .

The analogy is so simple- one does not treat :

anything but major pain with opioids or risky non-steroidal drugs  (or a sore throat with antibiotics) when simple safe modest-dose non-addictive analgesics and local therapy suffice; or

overweight,  or type 2 diabetes , or common mild to moderate hypercholesterolemia with any designer drug but metformin until control (with diet, lifestyle, supplements including metformin and appropriate other hormone adjustments)  is no longer good enough; or

 mild to moderate  hypertension requiring drug therapy with anything but perfectly safe lowdose reserpine plus lowdose amilozide – which suffice in almost 90% of mild to moderate cases- when more modern designer drugs (eg betablockers, angiotensin-converting – enzyme inhibitors and even the older methyldopa and calcium channel blockers) and newer drugs  both have infrequent but serious adverse effects, and are   less effective (they do not have the long duration and safety record of reserpine plus amilozide that makes it so effective even with erratic use) .

The socioeconomic model that measures the impact of a therapy only on one disease eg osteoporosis obviously also by intent supports the global profiteering and job-creation interests of Big Pharma and their well-rewarded allies – Government, Regulators, Universities, Research, Corporations and private practice. For these big-money industries, the use of a safe shotgun of unpatented and nonprescription supplements that more than halves the incidence, premature disability and mortality of both fractures AND all the common major aging degenerative diseases is anathema, since it reduces the Aging Diseases Industry from a $trillion goldmine in the aging who still vote, travel and earn, to a $billion expense when it matters far less- in the very old.

Hence Big Pharma is fighting a global war to abolish free choice of foodstuffs and supplements, conspire with governments to dictate what sources of foodstuffs must be eaten, and put all micronutrient supplement under doctors’ prescription! and above all else, suppress comparisons of designer prescription drugs with the gold standard old drugs and highly effective safe combinations of supplements.

This column has regularly published the growing irrefutable proof that high technology appliances and drugs are simply not needed to measure, prevent and treat common fragility fracture risk or any of the associated linked common chronic degenerative aging diseases.

And Guglielmi ea from Italian and Singapore Universities recently published another landmark review  confirming the voluminous evidence,  recent reviews from UK, that quantitative ultrasound QUS scan has replaced Dual Xray DXA bone mass density BMD  scan as the goldstandard fracture risk measurement test in common practice . Portable lowcost and therefore far more widely available QUS avoids the irradiation risk of costly centralized DXA, and the increasing overreading of bone density and hence risk score with aging due to accumulating calcification over the lower spine and hips.

It is of course intuitively and logically obvious that QUS devices that fix the target bone at a standardized site between the QUS heads as with eg the heelbone in eg the Norland CUBA footbox will eliminate most performer technique variation with a manually moved contact as in eg the Sunlight Beammed system.

Southampton University UK has also just published a study showing good correlation between peripheral QUS measurement and direct bone density measurement of excised fractured femoral heads from elderly hip replacement patients. .  .

And a Madrid team has just published a survey showing good correlation in children between 5 and 12 years between QUS measurements  and calcium-vitamin D intake.

CONCLUSION:  Safe and lowcost QUS can and thus should be used for bone risk measurement at all ages and locations – including schools and even the bedside;  in contrast to DXA which must not be used in those who are pregnant or not  at least post reproductive if not post-middle-aged.

Even in    the chronically frail or mentally dependent, periodic QUS screening is as crucial as eg bloodpressure screening since eg hypertensive , elderly, dementing or stroke patients share so many risk factors, and are thus are even more prone to osteoporosis- and incidental osteoporotic fracture easily converts the walking wounded  from needing supervised care to being totally wheelchair- or- bed- dependent.

UPDATE: THE FRAUD OF BIG PHARMA MODERN CHRONIC DRUGS

neil.burman@gmail.comUPDATE: see 14 June 2010. The Statin Scam Unravels. 

 

Update: 6 May  2010: this week’s recall of Johnson and Johnson’s Tylenol, Motrin, Zyrtec, and Benadryl due to negligent contamination , in particular of Tylenol for children, leapfrogs America’s household favourite Johnson and Johnson J&J to 2nd place (with at least 6 bad drugs) in the fraudsters mafia roll of dishonour behind the unreachable leaders Pfizer with about a dozen notorious fraud drugs. What is another $81million fine to J&J  that had sales of >$63billion in each of the last two years with profit of above 20%, and that despite the recall still maintained this turnover in quarterly sales for the 1st quarted this year? 

The major thing is that despite J & J’s gross negligence endangering the lives of children, the FDA has taken no other action against them. They terrorize  with armed marshalls  for trivia and shut down small firms making safe health supplements and physicians using them, but the Big Pharma mafia are the darlings of the FDA and Government since they pay such vast amounts in fees and taxes to Govt and lobbyists- politicians and academicians- trialists – that they are untouchable in every country.. 

14 April 2010: So we  can throw away the fraudulent  Pfizer’s fraudulent Neurontin gabapentin  we have been taking? when there never was  evidence that it is as good and safe as it’s parent (our chief brain neurotransmitter aminoacid )  GABA; while it’s younger twin sister  Lyrica – pregabalin– designed  for extension of patent benefits –  is worse  … just like we can throw away the chronic nonsteroidal anti-inflammatories eg Voltaren diclofenac , Vioxx and Celebrex  that are  such heart risks, poor painkillers,   and do  nothing for the underlying destructive chronic disease process. Drugs for massive profit for the beloved Big Pharma Industry that  politicians go to endless lengths to protect.- even Obama and George Brown as witnessed by the multibillion dollar swine flu scam, even now  in 2010 with Obama’s Pharmacare bill. 

 And now Harvard  University shows that even Neurontin and lamotrigine  increase the risk of suicide by42% and 81% respectively. So the long list of fraudulently overmarketed  or hazardous -improperly registered  or prescribed drugs  without adequate trials or obligatory definite  indications-  grows. 

And then there is the Disease Industry hypermarketing technique of Diseasemongering-  promoting previously ignored or unrecognized variable human traits like anxiety, insomnia, lowgrade depression, mild  hypercholesterolemia, female low sexual desire, erectile dysfunction, postural or stress backache- to diseases requiring permanent designer drug therapy eg benzos, viagras, prozacs, statins, NSAIDS nonsteroidal anti0inflammatories;  or “corrective surgery” for all. 

Pfizer,  Bayer, GSK  and  Roche  with the 100% support of their respective government regulators and politicians   continue to vie for top place as the biggest fraudsters of all time – competing with  the food, tobacco, booze, media, vehicle, financial, lawyer, minerals, fuel  and politics  industries..   

Why is this? Because the public – taxpayers and the poorer consumers- are at their most vulnerable, pawns if not cannonfodder and guineapigs  when it comes to trust in government regulators and the giant consumer product  industries – manufacturers and big distributors-  that Govts  regulate – especially the disease and drug industries.  

  And government regulators are controlled by elected politicians   who ( apart from a few altruistic successful honest folk who stand out and are nominated for  or called to office -but not Ralph Nader) –  as  mostly  lawyers or failed businessmen/ workers or carreer trade unionists,   rarely seek higher office  except to further their own financial interests and power lust.   

Winston Churchill and Frank Rooseveldt vie with Margaret Sanger, Mahatma Ghandi  and Nelson Mandela  for honour as the leading persistent (western)  fighter for justice, human rights of the 20th century if not all time, since they were skillful – brave  but above all tough enough (unlike many heroic martyrs) to survive to see it through. 

Hence there is enormous incentive for collusion between politician/ government officials who control the taxes and spending thereof,  and the big businesses that control the big money that escapes the tax officials – including Big Pharma. In South Africa there is no incentive whatsoever for the MCC Medicines Control Council Regulator to work efficiently as all income it generates is absorbed by the Fiscus/Dept Health, which blatantly refuse to produces annual financials for the MCC – effectively a parastatal supposedly under an independent CEO and Board. 

 Below is a list of costly modern disaster or dubious largely chronic drugs and their manufacturers that earn  the profound distrust of consumers: (where there are a proliferation of me-too analogues in a group eg benzos, statins, NSAIDS, bisphosphonates, only the original one or two are listed since they led/lead the pack): 

PFIZER -Wyeth -Searle – Upjohn:  Neurontin; Geodon,  Bextra,  Zyvox,  Lyrica; Lipitor;  Celebrex; PremPro; aspartame; Rezulin;  Viagra; and Ativan=lorazepam/ Xanor=alprazolam – two  of the most addictive   chronic  “anxiolytic” benzos – again, in Wiki and MIMS their  indications are far fewer than the pages of problems they  cause us since the 1970s , papering over and masking symptoms by numbing the mind (as with alcohol and smoking) instead of patients addressing the underlying cause of their anxieties with psychotherapy including learning self-hypnosis control.   

Collectively, Pfizer (the conglomerate of rash clones it has swallowed) has as many modern disaster/fraud  drugs as the next two combined of its  major league fraud competitors: 

Johnson & Johnson – Risperdal  ;   prepulsid;  Tylenol, Motrin, Zyrtec, and Benadryl 

Bayer – Trasyol; Yaz/min Baycol, Paxil, Flonase, Cipro; 

Astra-Zenca – I.C.I. – Seroquel, Nexium ; Crestor,Tenormin, Losec; and thalidomide.. 

Roche  – Xenical, Roaccutane, Tamiflu; Valium. . 

Glaxo-Smith-Kline  GSK -swineflu vaccine; Avandia, Paroxetine. 

Sanofi-Aventis (Hoechst-Rhone-Poulenc)  – Actonel  ; benzbromarone;  swine flu vaccine; Cosaldon -Trental [Cosaldon R was an excellent peripheral vasodilator oxypentifylline plus vitamin E; then Hoechst subtly started downplaying Cosaldon R as it’s patent expired, and introduced the slightly phonetically changed  and far more costly ‘new’   drug Trental pentoxyfylline.. Hoechst would naturally not explain (except obviously on grounds of profiteering from the new patent substitute)  why they substituted an inferior “new”  drug for the better  older version which included the safe dose of vitamin E.] 

 Merck – Vioxx; Zocor,   Fosamax; gardasil. 

Eli  Lilly – Prozac, Zyprexa; memantine ; and DES-diethylstilbestrol, perhaps the most infamous of all commercialized drugs in causing problems even in grandchildren of those so recklessly exposed to it without evidence of benefit. (Eli Lilly was the last company to stop manufacturing it – in 1997! despite evidence of it’s disasterous effects published in 1953, and of cancer from 1971 . ) 

Novartis -Ciba Geigy- Voltaren, swineflu vaccine. 

Abbott labsMeridia=Reductil   

Biogenesis labs – Acomplia; rimonabant  

Bristol-Myers Squibb -Pravastatin;   Plavix, warfarin; And the sustained  cover-up of the COSMIC  metformin  obligatory postmarketing trial  done at the insistence of the FDA on a huge 9000 subjects for 1 year in about 1996/7.   This trial was eventually submitted for publication only in 2004 and thus published in 2005- but for the previous year  BMS and their licensor  the original patent-holder  Merck  denied any knowledge of such a trial although the summary was presented and published a year earlier at a US diabetes congress by the authors, and we supplied the COSMIC abstract- written by BMS researchers who did the COSMIC trial- to BMS and Merck… .        why would BMS and Merck  delay publication of this trial  for so many years, and blatantly deny knowledge of it after the first report of the trial result at a USA diabetes congress ? 

The answer can only be the predicted- because it confirmed in the biggest metformn trial cohort ever- 8000 patient-years- that metformin in diabetics gave zero significant adverse drug effects, with the all-cause deathrate in fact 9% lower than in those on other conventional antidiabetic therapies; and  four major diabetes prevention  trials of metformin in four continents confirmed that it at least halves the incidence of new diabetes- with zero significant adverse effects; and in the intervening years between this trial and it’s result publication, both BMS and Merck developed and launched their respective combinations of metformin and a sulphonylurea (M + SU) . This despite the fact that it was clear since at least the 1970s that the addition of sulphonylurea to  metformin is a desperate last resort since it is fraught with risk of hypoglycemia and reversal of the reduction in fatness produced  by metformin alone.           

A new  retrospective study just published from the UK patient database confirms the  folly known all along  of combination of SU with metformin in that  that over a mean of 4 years on therapy, the metformin+SU therapy reduced all-cause mortality by 23% compared to SU alone; while metformin alone compared to SU alone reduced mortality 1/3 more ie  by 30% – with trivial risk of hypoglycemia. This was similar to the outcome in the 20year UKPDS RCT, where metformin reduced all-cause mortality by 36% over a mean of 13 years, making it the safest and most effective  drug ever patented for  chronic degenerative  disease. . 

And note the cynical folly of the many manufacturers of the grossly overpromoted and overprescribed  bisphosphonates and statins  – which  have numerous serious adverse effects and  should be last-ditch therapy in metastatic bone cancer and in rare  serious hyperlipidemia, not for osteoporosis, not for mild to moderate lipidemia and certainly not over-the-counter as profiteers crave. 

ENDURINGLY BENEFICIAL MODERN CHRONIC DRUGS: 

The above drugs contrast with vey  few modern chronic designer drugs that are still the leaders in their fields, whether as original or generic – although none of them has been shown to address all-cause mortality and pathogenesis. 

Pfizer’s Norvasc=amlodipine  is a rare modern designer exception – dating from the late 1980s,  it’s patent has only just run out-  proving it’s enduring worth for longterm hypertension therapy as the premier 4th-line drug to add when reserpine 0.125mg plus amiloretic 1/2 (ie HCT 25mg + amiloride 2.5mg)  daily are inadequate for optimal control; with very low risk of serious adverse effects. 

BMS’  Captopril & Merck‘s  Renitec – angiotensin converting enzyme inhibitors ACEI –  date from the mid-late ’70s, and while they were and are the first of the invaluable ACEI inhibitors, 5th line antihypertensive drugs for common use, they have formidable potential for lifethreatening adverse effects- but they are on essential drug lists. In the past dozen years big pharma has attempted to substitute angiotensin 11 receptor blockers ARBs, for the aging ACEI,   but a recent metanalysis shows that neither group of drugs significantly lowers fatal or nonfatal cardiovascular events- and they all (unlike reserpine + coamiloretic + amlodipine) have risk of life-threatening  adverse effects. 

DRUGS FROM THE GOLDEN AGE: 

Virtually all other current  designer drugs of enduring and safe worth for chronic longterm use originated from the golden era of innovative and enduring designer drugs mostly around WW2 up to the 1960s: 

The modern  birth control OC pill taken chronically  by millions of women for up to decades for either contraception or symptom control, certainly dates enduringly and endearingly  from the post war Golden Era  as     Estinyl (Schering 1930s)  , with  or alternatively just a  progestin. Modern preparations are relatively so safe that they are the preferred contaceptives for millions of young women.  But we have just seen two young women unwisely started on Bayer-Schering’s Yaz/Yasmin develop in one case hypertension and major weight gain, the other hives- so such innovations are not necessarily better than established brands of OC . 

MSD’s 40year old Sinemet still the firstline gold standard for Parkinsons; Moduretic- amiloretic/ amilozide- still the first drug and permanent baseline  (in low dose eg half tab3 x a week or 1/4 – 1/2 a day) for hypertension; Epilim valproic acid for epilepsy; Tryptanol; 

Sanofi-Aventis Hoecht’s Lasix furosemide still the leading diuretic for  chronic severe heart failure, cirrhosis, nephrosis. 

Merck’s 80yr old metformin- the only laboratory – originated drug (a teak of the galega plant’s biguanide) that reduces all-cause mortality – by no less than 36%, without a single serious adverse effect or mortality if sensibly used; 

Bayer’s Adalat; Aspirin (1899) ; prednisone; 

Novartis-Ciba-GeigyImipramine-Tofranil the first successful commercialise and still enduring major antidepressant. 

Roche’s                            Rivotril; 

Abbott-Knoll                Isoptin; 

GSK’s  Zyloprim;   Imuran;  Panado- still the lead patent mild-moderate painkiller, safe at prescribed dose. 

Pfizer -GDSearle’s  Aldactone; Sulfasalazine; and the 100year old phenytoin -Dilantin, still a longterm lifesaving antiepileptic despite occasional major adverse effects. 

Boot’s  Brufen-  the NSAID nonsteroidal anti-inflammatory drug on Essential Drug Lists,  altho there is no evidence that this group of drugs is essenntial since they do not alter the course of the underlying chronic inflammatory disease or reduce longterm mortality and morbidity, are little if at all better than Panado+- codeine as painkillers, and have formidable risks. http://en.wikipedia.org/wiki/Ibuprofen#History  

Astra-Zenca-ICIs   Inderal was the first of the major new cardiovascular protectant beta-blockers which  are essential drugs., altho all have formidable potential adversity ; as with ACEI, no special optimal favourite has yet emerged;  they have some special chronic indicatiions, including heart conditions and special cases of hypertension. . 

THE BIG PHARMA RAINCHECK  MONEYSPINNERS: 

The US drug industry is reputedly worth >$100billion a year and the biggest industry to >$200billion; and globally some $643 billion, of which the United States produces almost half.  The gross industrial output in USA was apparently about $26 thousand billion in 2008 ie the drug inductry alone approaches 8% of total gross manufacturing output there.   

 It is surely no co-incidence that virtually all  the above  common fraud-drug  pharmacy companies are among the dozen top money-spinners listed on 2009 financials.. But perhaps the biggest racketeering of modern times has yet to be quantified, perhaps  $100 billion  of wasted money on last year’s swine flu  “pandemic” that never happened, in futile mass screening lab tests and vaccines and Tamiflu – giving massive profits  (some companies claimed >$6billion) with total indemnity against litigation to Roche, GSK, Novartis,  Baxter,  Sanofi et al.. The USA-dominated WHO hastily changed the core definition of pandemic early in the North American outbreak so it could declare the nonsensical pandemic to suit the pockets of the profiteering American-European conglomerate and the political lobbyists they employ in Government and beaurocracy… 

 So do we wonder why we can’t trust Big Pharma prescription drugs and doctors’ judgment? Read the stats of a 5years study of the relevant risks,  of  deaths from prescription drugs in USA ( versus natural supplements)  exceeding  over 106 000 to 1.   Thats why Big Pharma and it’s “regulators” like the US Govt FDA, the UK MCC, European medicines Authority EMA, and organized doctors, are so desperate to stop the public buying the supplements people choose- when early and permanent use of balanced natural supplements at least halve serious disease and thus medical consultations, prescription drug use and hospitalization. For profit, only disease (not prevention) pays. 

Of the  103  drugs that achieved  $billion sales  in 2006,: considering the chronic  disease drugs, only valproate and J & J’s contraceptive dates back to the 1980s; Wyeth’s Premarin-Prempro dates back to 1995; and  (omiting duplicate entries) only 33 were oral drugs for chronic major common degenerative (as opposed to infective or malignant or autoimmune )  diseases.  And of the ~33 , only  10 (in descending order of sales value on that list)  even vaguesly justified their  ranking and sales- amlodipine, venlafaxine, bupropion, metoprolol, Viagra ,carvedilol, valproate, ramipril, paroxitine and premarin- 

Reuter’s forecast of the 10  >$5billion raincheques for 2010  include in descending rank for common chronic diseases only the tablets Lipitor, Plavix, Diovan and Crestor- none of which are  proven essential drugs for common average disease use. They are there solely because of heavy marketing by Big Pharma, despite their mediocre results and major potential risks, with far better results given by long-proven natural supplements or by lowdose reserpine-amiloretic combination, then amlodipine . 

Finally, landmark  drugs that were not invented by, or were laregly ignored by,  suppressed by drug companies as medicinals: 

EDTA ethilenediaminetetraacetate was invented 80 years ago but never patented by Big Pharma as a medicine. Yet as an oral nutritional supplement in modest dose it is perfectly safe, and removes toxic lead, mercury, iron and many other heavy metals  (now routinely polluting the environment -food and water- chain)  from the body,  as well as uric acid– being effective preventative against gout, and an antiatheroma agent. It is apparently not a scheduled medicine in either USA, UK or South Africa, being a routine ie harmless – beneficial- food  additive preservative. 

Yet despite the vast evidence favouring fish oil, metformin and EDTA as perfectly safe and effective chronic  anticoagulation, the Disease Industry persists in promoting rat poison- warfarin, dicoumarol– as the common chronic anticoagulant, despite its’ proven risks of promoting hemorrhage, fractures – already known since at least 1998vascular calcinosis already known since 1998 and most recently published last month; and even cancer .   

Metformin is unique, the widest multidisease panacea ever extracted (from a traditional antidiabetic plant)  and patented. Like EDTA it was eventually identified in 1922 by university researchers Werner and Bell in Ireland – but only patented  and produced for routine diabetic use since the 1950s- and deliberately obstructed for use in the USA for another 40 years by the FDA and Big Pharma, which were busy as bees designing and mass marketing far less safe and effective USA sulphonylureas although these were already discredited by the  UGDP  almost 50 years ago, when metformin was ‘rediscovered’ and came into its own. 

Reserpine  also a plant (rauwolfia) extract  remains (with coamiloretic, amilozide)  both in low dose the first-line drug treatment of all classes of hypertension– which since the prevalence of this disease now approachines 50 % in aging adults, makes these drugs amongst the most prevalent essential drugs needed. As even wiki says,  from many major studies over decades, “Reserpine is one of the few antihypertensive medications that have been shown in randomized controlled trials to reduce mortality” – in at least a score conclusive trials of the individual components reserpine, thiazide and amiloride, the triple combination is by far the best firstline therapy, at a cost in South africa of about  $US1 a month.. . But Big Pharma and its profiteer lobbyists continue to suppress the combination fraudulently based on decades-old overdosage data. 

By contrast well over 100 natural micronutrient substances – cinnamon, garlic, ginger, codeine, reserpine, digoxin, huperzine A, galega-metformin and many other plant extracts; vitamins especially B,C,D  in higher dose; , minerals especially calmag,  zinc, chromium, boron, iodine, iron  and even lithium; and human biologicals that deplete with aging like glucochondroitin, CoQ10, acetylcysteine, arginine, cartnitine , GABA, 5HTP  and almost 20  other hormones  replaced chronically – provide almost every chronic major degenerative  disease with the best prevention and treatment, without the almost invariable  risks of  the modern designer chronic drugs discussed above. 

 Since alcohol and tobacco, salt and sugar are still freely sold over the counter OTC  without any restrictions except some  to children , the commonest causes of chronic degenerative disease in more than slightest daily usage, it is obviously lowdose vitamin K,  vitamin C and D, lithium, magnesium, reserpine, metformin- galega  and EDTA that should be mandatorily supplemented in the food chain for the fattening aging 1st-world populations, and allowed OTC purchase;  while indications are severely limited  for prescription of sulphonylureas, statins, bisphosphonates and the dozens of other disaster or dubious  designer drugs listed above.

DEBUNKING THE MYTH OF BISPHOSPHONATES: time for class action:

Again we must ask: why are patients with cancer, let alone those with  “simply” osteoporosis,  given bisphosphonates?

Body’s review from Belgium in 2006 sums  up the belief system created by the Disease industry: – cancer patients are given it for osteoporosis, or for metastatic bone disease with high blood calcium.

Yet a new paper from Gutenberg University Germany (Al-Nawas ea)  shows that 1 in 20 ie 5% of 75 women with breast cancer  given bisphosphonate between 2000 and 2006 developed osteonecrosis of the jaw. That’s just the severe cases identified.

The far bigger study from St Louis & Arkansas Universities  last year (Wang-Gillam ea)  surely gives the  answer for most cases: why give toxic bisphosphonates which do not address the underlying pathogenesis- when this is always multifactorial.  They showed that, as in osteoporosis without cancer, most such patients have simple easily correctable deficiency of vitamin D let alone many other universally deficient supplements. They found that “of 321 women with breast cancer given bisphosphonate,   267 were taking the drug for osteoporosis and 54 were taking the drug for metastatic bone disease. Of the 209 who had had a vitamin D level checked, only 3.8% received more than 600iu vitamin D a day. Only 38.8% patients had a 25-OHD level >30 ng/ml; Serum PTH levels rose as serum 25-OHD concentrations declined to <30 ng/ml. Even in the group of patients with a serum 25-OHD level >30 ng/ml, four of 74 (5.4%) had secondary hyperparathyroidism.”

“This study revealed that vitamin D insufficiency has a high prevalence among breast cancer patients being treated with a bisphosphonate for osteoporosis or metastatic bone disease and that supplementation of calcium and vitamin D is underused in the care of these patients. This finding suggests that it is probably more appropriate to set the level for vitamin D adequacy to a screening 25-OHD level of >30 ng/ml ie >105nmol/L. we advocate routine screening of the 25-OHD concentration for vitamin D deficiency in general.”

Now Cohen ea from Columbia University New York question  the use of bisphosphonate in younger women with osteoporosis, when easily correctable deficiencies are so often the cause.

And a new  Kaiser Permanente community Effectiveness study  by Feinstein ea in fact shows that in 10 years to 2006, on bisphosphonates some 1830 elderly women at high risk of osteoporosis fracture had no significant reduction in major fractures.

We know that bisphosphonates require adequate vitamin D levels to work. The bizarre joke is that Big Pharma is even marketing bisphosphonate paired with lowdose vitamin D. Why on earth poison harmless effective vitamin D with a toxin that can cause bone collapse, gullet ulceration and obstruction, toxoderma, muscle damage and arrhythmia?

We know that even oral HT with CEE and progestin reduces hip fractures by up to 40%; but we also see regularly that combined HRT including parenteral testosterone and all the other proven supplements  steadily increases bone density into the normal range in the severest  osteoporotic, AND reduces  especially falls and fractures by reversing frailty.

As Brown   says in a comprehensive 2008 review, restoring vitamin D deficiency with 800 instead of 400iu daily already doubles the reduction in fractures, and greatly reduces falls in the elderly. Hence we must agree with her, and Geller and Adams from UCLA 2008, that vitamin D in effective dose – reportedly to a safe  meaningful blood level of >35ng/ml ie 100-130nmol/L, in company with appropriate parenteral combined HRT and  the other dozen balanced vitamins and minerals,  can more than halve  both fractures and all other common degenerative disease risks. We have discussed repeatedly in this column that appropriate  testosterone- estradiol replacement greatly reduces all-cause morbidity and mortality even in men or women after cancer.

So the question remains: why (except for marketeering, profit motivations) are patients with osteoporosis or cancer metastases being given notoriously toxic bisphosphonates- which have never been shown to be safe let alone beneficial long term – when it has been known for decades that adequate replacement with natural appropriate supplements- including balanced calcium, magnesium, zinc, boron, manganese; vitamins B,C,D & K, and appropriate physiological testosterone and estradiol to restore the healthy balance of  healthy youth- and especially vigorous vitamin D3 supplement. 1, 2 – rebuilds and maintains musculoskeletal health..

Osteoporosis is like diabetes, hypertension, obesity, cancer, cardio/neurovascullar, arthritic, mood and dementing diseases, a multi- $billion-dollar a year  target for the designer drug industry -let alone the diagnostics and invasive medical  industries. For these industries, lucrative drugs, tests and surgery far outweigh the boring counseling about lifestyle and lowcost micronutrient preventatives- which would make designer drugs, costly tests and surgeries – hospitalization-  virtually obsolete for medical conditions except for those who live to be the oldest of the old.

The NIH years ago introduced incentives in far higher consultation fees  for cardiologists and cardiac surgeons to spend time counseling patients about better diet, lifestyle and medicine use instead of invasive procedures and surgery- which do not address the underlying pathogenesis eg overweight, stress-cortisol, insulin resistance. Such an approach resulted  in eg cardiologists Drs Siinatra and Roberts virtually abandoning invasive cardiology since virtually every patient with ischemic heart disease could and can  be cured with intensive consulting room management including optimization of designer drugs and curative supplements.

It is apparent that no mainstream physicians bother to publicize this approach to the equally common but far more disabling problem of osteoporotic fractures- which kills or leaves impaired far more patients than vascular disease. eg the  the latest reviews of treatments for postmenopausal osteoporosis  available as abstract or fulltext on Pubmed- a  Canadian consensus 2003 , Hauselmann & Rizzoli 2003 and Cosman 2005 failed to even mention true preventatives beyond futile lone calcium and lowdose vitamin D – despite there  being study evidence to support vitamins B6-9-12, C,  K,  magnesium, zinc, boron, manganese,  (fluoride if low in local water), and physiological replacement of deficient testosterone/ DHEA -estradiol.

No-one is going to support trials of  combined natural supplements to prevent and treat osteoporosis when the disease industry, as well as the osteoporosis associations which they invariably fund and feed with drug information, all have vested interests in avoiding simple universal combination prevention.

The study from Wang-Gillam et al opens the way for wider class actions 3, 4 by Regulators and  patients against the promoters,  marketeers and prescribers of all bisphosphonates, since it has always been clear that  adequate replacement of natural supplements would have done  and do far better.  But Regulators are in fact co-conspirators since they allow modern drugs to be widely used without evidence that they are as good as long-used safe and cheap  old supplements.

Despite the high cost (in money and suffering) of bisphosphonates and other designer drugs eg Forteo against osteoporosis, no trials have shown that they reduce all-cause mortality – ie unlike natural supplements (which address all common diseases – improving defenses against fractures, depression, infection, cancers, vascular disease, dementia etc, and thus halve premature morbidity and mortality),  bisphosphonates’  only action is to -disastrously  –  stop necessary bone remodeling. It is common cause that  the chief causes of osteoporosis- muscle and general frailty, aging’s catabolic dominance- are not aided by designer drugs like bisphosphonates and Forteo; only anabolic agents like parenteral testosterone replacement, vigorous vitamin D and the combination of other micronutrients listed above do so.

Avoidance of this central issue – failure to address underlying pathogenesis and numerous simply correctable micronutritional deficiencies  –  is the major fraud of teaching, marketing and promoting predominantly designer drugs and technology – in which fraud Regulators, politicians and often academics cravenly conspire, Elaine Feuer’s The FDA  War against Humanity.  Not for nothing did one of the greatest social philosophers of the 20th century  Ivan Illich call organized medicine- the capitalist  Disease Industry –  Medical Nemesis.

Is it an overstatement to say that bisphosphonates are clearly even worse chronic disaster than statins – where the damage is usually insidious but reversible- or NSAID class drugs- which can simply kill by thrombosis or bleeding; or SSRIs-  which can trigger suicide? The other modern drugs (after thalidomide)  do not, like bisphosphonates, disfigure and maim.

SENSIBLE OSTEOPOROSIS PREVENTION DOES NOT RISK HEALTH, ONLY DESIGNER DRUGS DO SO.

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

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

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

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

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

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

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

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