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.