Tag Archives: bisphosphonate

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.

update: BISPHOSPHONATES AND MALIGNANT BONE PAIN: REBUTTAL AND COUNTER-REBUTTAL

 neil.burman@gmail.com

update 2 Oct 2010: a practitioner asks what to do for a  white female 58years:
1998 ductal cell. lumpectomy, radiation, 15 nodes removed.  Tamoxifen  5 yrs.
2009  lobular cell. double mastectomy, nodes removed.  Aromasin  for next 5 yrs.
Osteopenia -2.3  found inside  1 yr .    on
Boniva ibandronate  4 yrs, stopped recently. 
 Doesn’t want to take IV drug for osteoporosis. 24 hr urine calcium  normal.  High vitamin d levels.
takes a lot of calcium,  vit d, vit c, vit b complex sups. Takes Prilosec omeprazole for reflux and hiatal hernia. chronic insomnia.
The questioner does not reveal her bodymass index or resting morning cortisol level or insulin resistance- all of which may well be raised; nor give her crucial vitamin D and C  intake or vitamin D  blood level. It is a question of evidence, not opinion – dogma- or laboratory average population ranges , as to what are optimal intakes and blood levels.

This column  has regularly reviewed the conflicting views and evidence  on osteoporosis;  BNP and breast cancer; and the safe multisystemic efficacy of using the score of natural supplements- including appropriate combined hormone replacement therapy – that safely oppose both osteoporosis – bone and muscle frailty-  and the associated chronic major involutionary diseases of aging especially vascular disease, dementia  and cancer. .

 The antireflux proton pump inhibitors PPI drugs notoriously aggravate osteoporosis; and for average reflux are not necessary with use of slippery elm, apple cider vinegar, simple calmag  and sensible diet and lifestyle.  It has been known for years that PPIs  more than double risk of osteoporosis, so why take them?. 

On the other hand, the pluripotential hormones of darkness and light –  vitamin D3 and  Melatonin – combined with the other mulibeneficial natural supplements that synergistically relieve/ reduce insomnia,  reflux pain,  cancer, depression, memory loss  and all other significant major chronic degenerative diseases of aging.

As this column regularly updates, Metformin too is a natural supplement (plant) co-hormone- a veritable panacea-  that reduces all major chronic disease and mortality by about a third- including cancer; and  dementia perhaps via reducing serum amyloid levels.let alone tissue oxidation, glycation, vasculopathy. BPN has none of these extraosseous benefits, only deadly risks.  

 Similarly, appropriate transdermal human estrogen but not oral xenoestrogen- CEE-  reduces serum amyloid in postmenopausal women,  while low testosterone raises serum amyloid in men.

So middleaged patients are at terrible risk of anxiety depression hypercortisolemia, frailty fractures, vascular disease , cancer and dementia after cancer, especially with sex hormone suppression or blockade. They do not need the myriad risky designer drugs touted for prevention of more cancer etc, all they need urgently and permanently is the scores of appropriate natural balanced supplements as this column regularly reviews- most of which supplements can simply be mixed in a tub of customized powder blend to be drunk twice daily. .

:Feb 13, 2009    In response to  Death-knell-for-bisphosphonates-for-osteoporosis-breast-cancer-time-for-class-action-against-bisphosphonate-damage last week,  a world-renown emeritus professor of radio-oncology comments:

“the action of the bisphosponates BPN is to inhibit osteoclastic action and thus reduces bone resorption; the patients tell the story- they get immediate and sustained relief from bone pain; if they  are on opiates the need is much reduced. Of course palliative RT is valuable, but often if pain recurs after RT the BPN give welcome relief, at least in my experience.

The  IV BPNs are also very useful in the oft-times encountered hypercalcemia often threatening myeloma- and other cancer patients. I am not however, too conversant with D3 in this setting!” But the first reference links are the latest in the clinical field of BPN and cancer.

Other than  in terminal cancer cases- when it doesn’t matter what convenient pain relief is used-  the problem with bone pain in cancer always is, what is the cause? either bone resorption from the catabolic effect of cancer (via eg high parathyroid hormone PTH);  OR cancer eating away at bone itself, OR something else common OP  unrelated to the cancer.?

But FOR CANCER-RELATED bone pain lesions – whether directly from cancer there, or from remote metabolic effect –  where are the trials comparing BPN with other antiresorptive antineoplastic ANTIINFLAMMATORY ANALGESIC ANABOLICS ie testosterone (or occasionally estrogen/ other antiandrogen)  and vitamin D3?

Obviously bone metastases are attacked with appropriate chemo-/ xray XRT, cortisone, testosterone AND if deficient, vitamin D3.

To put it the other way round: where is the evidence that BPN – at cumulative cost and risk-  adds benefit to the multiple attack? where the evidence that- unlike testosterone and vitamin D3- BPN has any benefit except on bone pain? Hypotheses based on in vitro and animal and human cell culture studies have  not translated into even good observational comparative evidence favouring BPN as good benefit:cost ratio for osteoporosis or cancer.

The oncologist answers in the traditional mode, by experience that BPN works. But evidence-based medicine EBM asks where is the comparative evidence for BPN to challenge the evidence that we have better multi-attack without BPN – when these supplements are not equally commercially promoted and tested in controlled trials for the usual commercial  reason ?

The dream of drug manufacturers is eternal, that their raincheque designer drug- statin or BPN or antihypertensive- will prove to be a safe multisystem panacea as is metformin and many  other supplements like vitamin D3 or testosterone. But after more than 30 years of BPN and statins, no trial in humans has yet shown this for BPN or  statin or any other original designer drug.

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.

SCREENING TO MANAGE/ DELAY THE DISEASES OF AGING – especially OSTEOPOROSIS FRACTURE RISK MEASUREMENT:

neil.burman@gmail.com, Cape Town, South Africa.

UPDATE 15 October  2010

Patients with relevant symptoms,  or  those with serious familial risk factors,  must be relevantly investigated.

Those who claim to be and appear well need only a few proven regular simple and relatively low-tech noninvasive screening steps – which unless applied  opportunistically should be scheduled periodically:

1. Systematic history-taking questionnaire and relevant interrogation & physical exam (including periodic whole body skin examination for melanoma);.

2. Electronic bloodpressure on arm (and  ankle if it is significantly raised on the arm) –  standardized certified (by eg world or national authorities)  electronic upper arm machines eliminate the major risks of mecury contamination and observer error and digital preference;

3. Body fat and lean mass measurement. Height change. Fitness measurement.

 4. Pap smear for the younger who have been sexually active.

5.  Relevant for-age hormone imbalance appraisal.

6. Mobile five minute Ultrasound Fracture Risk Measurement;

7.   Eye pressure and retinoscopy by a trained optometrist; and 

8   dental evaluation.

It is never too early and never too late to start prevention including appropriate screening, diet, exercise -lifestyle; and permanent appropriate supplements – vitamins, minerals, herbs and human biologicals; and occasionally lowdose proven old prescription medication  eg appropriate HRT or antihypertensive medication.

SERVICE TO THE COMMUNITY: MEASURING FRACTURE RISK BY ULTRASOUND : KEEPING THE YOUNG GROWING, THE AGING MOVING, AND ALL LEARNING!!

A new study from Perth University Australia promotes BMD screening for osteoporosis.  They conclude: “A major key to improving osteoporosis management is to actively identify all patients at risk and proactively engage and encourage them to seek assessment and management.” Precisely as with neglect of risk of glaucoma and hypertension, the University Pittsburgh similarly notes “Older adults demonstrate several beliefs that may be barriers to osteoporosis screening, including low belief in susceptibility to osteoporosis. These beliefs should be targeted with patient education to improve screening rates.”

Note the latest running update from UK universities below  (Aberdeen 2006 and Cambridge 2009) on the growing validation of regular ultrasound bone density measurement at 10year interval at all ages from toddlers upwards .

Major frailty fractures (hip/spine) are a major cause of disability and death amongst the aging – only 4 out of 5 survive at least a year after such injuries, and only 1 in 5 recovers completely from them. Prevention and better recovery requires effective and safe treatment of the underlying osteoporosis and the fractures. Screening and simple necessary supplements apply to children, women at all ages, and many men at risk- whether from frailty, alcohol, cortisone, cancer, malnutrition, chronic illness , unintended weight loss, laziness or longevity.

Thus screening applies to all. Marked height loss with a wedging spine – the ‘dowager’s hump’- indicates progressive fractures of the spine (ie of vertebrae, discs)., an indictment of negligent ignorance or neglect of simple preventative measures by the patient, relatives and carers. And medical schemes have to pay for fractures as Prescribed Medical Benefits.

The myth is that osteoporosis is a disease of bone. It is rarely a primary disease of bone (eg degenerative, metabolic, cancer) but like rickets mostly of the neglect of mineral and other deficiencies – neglect of exercise, sunlight, healthy alkaline (high-produce-low meat) diet, vitamins, minerals, protein, fish oil, and appropriate human hormones. Genetics plays a part, but only a small one.

Sunlight alone is not an adequate source of the crucial vitamin D except in those spending hours working outdoors in light clothing- and few people now drink therecommended four glasses of fresh milk a day, let alone (in this age of television, PCs, and abolition of compulsory school sport and phys-ed) exercise and sleep,  that used to build strong kids.

 Osteoporosis, hypertension and the other major aging diseases share so many common risk factors that neglect of easy permanent prevention is a tragedy. Early signs of  adiposity,  hypertension  and musculoskeletal frailty by simple regular tests are safe economic markers of the preventable diseases of premature aging: frailty, obesity, diabetes, heart-attack , heart/ kidney failure, stroke, memory loss/dementia, arthritis, fractures, cancer,blindness, disability and early death.

Obviously growth ie increasing height does not confirm strong bones but sometimes the opposite. The biggest risk marker for aging fractures (apart from obvious factors like physical laziness, immobility, early castration, thyroid, liver/kidney impairment, rheumatoid arthritis, type 1 diabetes, and excessive use of drugs (alcohol, furosemide, aluminium, betablockers, antireflux agents and anti-inflammatories  not least cortisone steroids),  is not osteoporosis but frailty and falls- which modern synthetic anti-osteoporosis drugs – the Fosamaxes, Proteos, Forteo, Livifem) do nothing to reverse. Naturally their heavy marketing fails to say this. Whereas, within reason at least, the higher the weight the stronger the muscles and bones get to carry the load – Wolff’s law (1892) . Hence by common sense, musculoskeletal strength is proportionate to BMI bodymass intake rather than to height.

The simple and safe economic multi-supplement that prevents and reverses osteoporosis also – with addition of a few other supplements – largely delays or prevents the other common diseases of aging – and can improve thin bones, poor circulation and much arthritis. Popular synthetic designer drugs like cholesterol-busters and warfarin may actually worsen frailty, fractures, cancer and vascular disease.

And while anti-osteoporosis drugs do make bones harder, they may increase vascular and cancer risks, cause terrible allergy and digestive problems, and worsen risk of fractures, jaw disintegration and teeth loss. Pictures on Google show this horror complication,  from a drug group which has no compelling indication since natural supplements ALWAYS prevent and reverse the osteoporosis. 

These designer drugs (despite earning $ billions) do nothing to prevent the other associated diseases of premature aging. In fact new research published this July suggests that drugs which slow down healthy bone turnover eg bisphosphonate may actually worsen the risk of diabetes .

The Wikipedia BMD description is balanced, and mostly about DXA.  “ DEXA is currently the most widely used, but ultrasound has been described as a more cost-effective approach to measure bone density” – usage depends on marketing rather than efficacy or necessity! “The USA National Osteoporosis Foundation recommends BMD testing for the following individuals:

All women aged 65 and older regardless;

 Younger postmenopausal women with one or more risk factors.

Postmenopausal women who present with fractures (to confirm the diagnosis and determine disease severity). Estrogen deficient women at clinical risk for osteoporosis. with vertebral abnormalities. Or history of eating disorders ;

 receiving, or planning to receive, long-term cortisone therapy.

 with primary hyperparathyroidism.

being monitored to assess response or efficacy of osteoporosis therapy.

 They omit chronic wasting illness like alcohol intake, cancer, HIV, bowel or kidney or heart or lung disease etc..

Of the Four Limitations of BMD the Wiki article discusses, two don’t apply to QUS in average women:  

 1. the size of the patient & overlying tissue dont apply to QUS at the heel (except when BMD is almost irrelevant- the grossly obese, or those with elephantiasis- massively swollen feet.)  

 4 DXA is a major error problem in elderly women- like the spry  82yr old I screened recently who has severe arthritic spine  and aortic  atheromatosis – ie   the overlying calcification in bone- and bloodvessels- give serious falsely high DXA readings that we have to ignore. The same applies at the hip.    It is especially in older patients- and in kids in whom one at all costs wants to avoid irradiation- that QUS is the only good method.

Their Limitation 2- “in some circumstances bone density is a poorer indicator of bone strength” is the major reason why bisphosphonates are so risky- they improve BMD ‘hardness’, but sometimes make bones more brittle. – hence osteonecrosis.

And of course a further advantage of the standardized modern fixed-double-head heel scanner is that it does not involve the performer- sonographer-  variability and repetitive-strain injury risk  – of the older hand-operated scanner probe.

Remember that it is not low bone density  that is the greatest risk factor for fracture, but frailty, falls, poor muscle strength and co-ordination. – which Fosamaxes, Proteos, Livifems and PTH injections certainly dont benefit. Giving just calcium with lowdose vitamin D does very little to reduce fractures but in fact worsens vascular calcification ie disease.

ULTRASOUND vs DUAL XRAY DEXA BONE RISK MEASUREMENT:

 Recent major reviews by Cambridge UK (Moayyeri A Khaw KT ea 2009)  and Aberdeen UK (Stewart, Kumar & Read 2006) Universities confirm (over 53 000 patient years) that the gold standard for monitoring fracture risk over 10 years is the portable quantitative ultrasound bone density machine QUS which measures fracture risk without xray, by ulstrasound scanning at the heelbone..

The just-published Screening for Osteoporosis: Update for the U.S. Preventive Services Task Force (Nelson ea 2010)  and trials from Taiwan (Lee 2010) and University Pittsburgh (Cauley 2010) and now from Southampton UK (Cook ea) come to the same conclusion – that QUS measurement is as effective for screening as DEXA for determining hip and spine fracture risk  in both men and women and children . As with height, weight, waist girth and bloodpressure, the younger (from childhood) these measurements – including heel bone density – are started, the earlier the risk of stroke, heart disease and fractures can be determined and simple steps taken to promote future health.

Cincinnati Childrens’ Hosptal   already in 2007 published reference curves for BMD in children, so we have standards for all ages. But it is increase in childrens’ Z scores with time that matters..   Conversely, waiting until diabetes, cancer or fracture occurs, or till the heart, brain, joints, vision or kidneys are severely damaged, is the height of folly, since supplements, modern drugs and surgery can then do precious little to restore and preserve health. Even in those suffering dementia, and the stroke-impaired, it is worth monitoring and managing bloodpressure and osteoporosis, since recurrence of strokes, avoidable fractures and bed-bound immobility bedsores create far higher cost and burden to manage.

McCue C.U.B.A. Clinical™ Contact Ultrasound Bone Analyzer says: “ Never before has assessing a patient’s risk of fracture been easier or more cost-effective than with the C.U.B.A. A dry ultrasound sonometer, the C.U.B.A. Clinical™ is designed to perform a heel measurement in less than a minute. The world’s first dry ultrasound system (no water bath). Patented internal electronic phantom for simple calibration. Lightweight (22 lbs.) and easy-to-operate. Does not produce ionizing radiation. Cost-effective assessment of risk of fracture.       Recent studies suggest that the VOS mode is better for crosscomparison with DXA XRAY screening; while the BUA mode may be better for serial comparison ie trend of change.

FRACTURE RISK MEASUREMENT IN SOUTH AFRICA:

Our experience in Cape Town the past two years is that the CUBA machine regularly recalibrated (like the DXA machines) with a standardized phantom is consistent and reliable with the limitations discussed in this review. . Normally only the left foot is done (the machine does an average of 3 to 4 readings in 2 minutes to get a satisfactory average), but we may do both feet IF there is any doubt that the feet may be different- obviously the ‘healthy” foot will be the better one for reflecting whole body bone density (as we calculate by averaging the hips and spine). The CUBA system can for practical purposes always be used as long as the patient can sit with one foot in the QUS footbox- ie a bedbound patient must be able to sit up (ideally in a chair rather than at the bedside) for 5 minutes – and sit fairly still for about 3 minute. This is far less demanding than lying on a trunk scanner. .

The law in South Africa is that  although medical schemes deny it daily to patients, all open medical (including ‘hospital’)  plans are compelled to pay the member’s benefits themselves (not from patients’ savings) for outpatient diagnosis and management of most major chronic diseases including menopause and fractures, ie under the Prescribed Minimum Benefit PMB regulations – provided the healthcare provider is registered eg doctor with the medical council HPCSA..

Osteoporosis itself is not one of the core 27 PMBs; it is however one of the 270 conditions covered as Diagnostic Treatment Pairs; but fracture is a prescribed medical benefit, and fracture risk measurement must therefore be payable as a necessary diagnostuic test. .

The State eg Groote Schuur Hospital GSH  provides free regular screening breast mammography for the ‘well’ – although this screening procedure in women without risk factors has been increasingly discredited for years as possibly increasing unnecessary biopsies, breast cancer, anxiety, and death risks for women; but GSH does not   provide DEXA bone density screening for referred patients on outside referral via  outpatient  referral. However,  Groote Schuur Hospital last year published a major local population study validating such ultrasound heel scanning against DEXA.

 Some schemes themselves pay for bone density screening; and osteoporosis, while others don’t yet acknowledge the importance of fracture risk measurement, and so reject claims. The medical aid tariff rate for ultrasound bone density (item 3612) is about one fifth of that of the xray DEXA scan. Obviously this tariff – like that for eg a mammogram- is for the procedure, and does not include the usual fee for a medical consultation. The scan report simply says whether it is normal or not, any change relative to previously; and thus when it next warrants repeat, and perhaps consultation with a doctor.

Affordable QUS osteoporosis  fracture risk measurement (CUBA system)  is available at the Peninsula Osteoporosis Screening and Natural Management Centre at Grove Building Medical Centre near Cavendish in Claremont.   (phone or fax 021 6717415)  for appointment (or phone 0836299160 for further information); the service is also available in Gauteng.      

    Members of indigent families are screened within reason, at nominal cost.

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.

UPDATE: WHY TAKE BISPHOSPHONATES OR ANY SYNTHETICS FOR OSTEOPOROSIS?

 as this column has previously discussed,  osteoporosis fracture prevention requires nothing but a sensible lifestyle plus sensible  lowcost  permanent cocktail of natural supplements that reverse all chronic degenerative diseases- eg calmag, boron, zinc, manganese; vits B C D & K,  proline, and lowdose appropriate  HRT. Better late than never, but the earlier started the better.

 

The  heavily marketed commercial moneyspinners-  bisphosphonates BNPs; strontium ranelate; calcitonin, parathormone, SERMs eg raloxifene; tibolone; and statins – each have significant risks and costs, and none give  the multisystem protection of the scores of  evidence-based natural supplements.

 

          The reviews and trials  of bisphosphonates the last year  are especially alarming for zoledronic acid (ZA Reclast / Zometa)   

Today’s FDA  (Grewal) last month reports that ZA and Aredia give an osteonecrosis (O.N) risk of about 1:10 000 patients; alendronate a risk of 0.7/ 100 000 patient years.

this year Italy  (Ibrahim) reports an incidence of 1.5% ONJ in 500 cancer patients over 4yrs- and all those patients were treated with ZA.

Harvard Dental School  (Wessel) this year reports 30 cases of  O.N of the jaw ONJ over 4 years – all on ZA.

But Univ Arizona  (Hess) this year reports  99 cases of ONJ after bisphos in patients without cancer- 85 for OP, 10 for Pagets. 87% were women and 83%  had  oral not  iv BNP.

 

The international HORIZON Z.A.osteoporosis  trials last year reported 1 case of O.N   in each  2500  arm of trialists  on ZA or placebo (mean 74yrs (65-85yrs)  treated with annual  ZA versus placebo injection; there was  35% reduction in fracture rate at  mean followup 1.9years  in those  enrolled after hip fracture ie tertiary prevention ;

  and 70%  fewer fractures at 3yrs in women enrolled with osteoporosis.- secondary prevention  (ZA 1.1%pa, placebo 3.6%pa).

      There was  however no significant difference in major adverse events or non-fracture deaths (the causes of death of  the majority. were not reported).  However, serious atrial fibrillation was 3 times more common in the month after ZA than after placebo.  By  1.9yrs after the hip fracture and starting ZA  there were fewer deaths on ZA 4.5%pa than placebo 6.7%;  but in the slightly younger and fitter majority ie  those without  prior hip fracture, by  3 yrs, there were 16% more deaths on ZA (1.13%pa%) than placebo(0.97%pa%).

    These 2007 Horizon trials  thus highlight that delaying prevention  till the hip collapses more than trebles the deathrate .

     What they  mysteriously neglect to  report is the quality of life, mobility after major osteoporotic fracture- when it is common cause that waiting for major disease before starting prevention is disastrous- sudden death, stroke, dementia; or that at best 20% of patients  recover full health and mobility after hip fracture.

 

          However, (as usual with commercially sponsored trials to promote a new drug – ie seeding trials) baseline conventionally proven natural therapies were severely limited, probably to falsely exaggerate the benefit of the trial drug:  so  (while almost half were apparently on raloxifene), all  including the placebo arm were given a baseline  regime only of vitamin D and modest dose calcium.

          The Sponsors  thus chose to ignore the longstanding evidence from major studies and trials –  that no designer drugs are needed to reduce both osteoporotic fractures and most all-cause aging diseases: – merely appropriate supplement/ replacement with, calcium, magnesium, zinc, boron, manganese, all 13 vitamins and the biologicals ( proline,  lowdose appropriate sexhormones, fish oil  – and  for other multisystem protection,  eg arginine, carnitine, CoQ10,  glucosamine, chondroitin, MSM etc.).

 

    While it is common cause that quality of life QOL  is greatly improved by appropriate HRT in the menopause transition- the midlife decade of menopause symptoms ,

      longterm QOL outcome is  conveniently not mentioned in any bisphosphonate papers that span the progressively more risky  decades after the midsixties –  although this QOL attribute for ZA is a main goal that  Novartis mentions in it’s registration motivation   ” The unique  once-yearly dosing of this medicine has the potential for significant compliance benefits and improved quality of life for women with osteoporosis.”  

 

        Despite the fact that trials of bisphosphonates for osteoporosis started over 20 years ago, no such claim of improved mobility and QOL long term  is made, so there cannot have been any significant improvement shown.  There are exactly two  small trials, from Italy and Turkey,  that lasted one year looking at QOL, that showed improvement in QOL on (alendronate or   nerindronate or calcitonin)  plus calcium/vit D versus calcium/vit D alone. Short term study- one year – says nothing about the average 35yrs of life expectancy after the perimenopausal midlife decade. .

 

 The bisphosphonate trials also blithely omit  that the top risk factor for osteoporotic fractures is not bone density but overall  physical – frailty, falls; and while  major fractures are common in the old, they dont happen,if the patient dies early,  or they  matter little if the patient is first disabled (before fracturing) by far more common cardiovascular-stroke problems or dementia.

     Nobody can claim, show  that bisphosphonates, SERMS, tibolone, calcitonin, strontium have any significant long term benefit on overall premature major diseases of aging and mortality.  Unlike appropriate HRT, or fish oil, or metformin, or vigorous other combination of natural supplements (vitamins, minerals and  biologicals including herbs) , no modern chronic designer patent drug  for chronic prevention has been shown to  significantly reduce all-cause morbidity and mortality – especially diabetes, CVD-stroke, osteoarthritis, fractures, major depression and dementia. .

 

    So there is no justification or need  to take bisphosphonates or any other newer patent drugs for osteoporosis – and why take the risk of bisphosphonate arrhythmia, toxicoderma  or osteonecrosis?