This column commented on New Year’s day on the latest adverse reports on bisphosphonate – early silent histological bone changes, and oesophageal cancer.
And a new review has just appeared from the American Dental Association showing that osteonecrosis of the jaw occurs in 4% of alendronate Fosamax users even with shortterm use.
Medscape reports this week that two papers on bisphosphonate adverse reports from 2008 are among the 10 most read news items by general internists the past year. That’s good news, because at least Internists (by one of whom this column is largely written) are taking note.
We hope that patients, family practitioners, dentists, gynecologists, lawyers, regulators, medical schemes and orthopaedic surgeons also read these reports.
2008 has become the death knell year for bisphosphonates for osteoporosis:
search of Pubmed under “bisphosphonate adverse effects case reports” lists dozens of reports –
*osteonecrosis of both the jaw and long bones leading to bone collapse;
*malignancy with high mortality;
* lethal oesophageal inflammatory lesions (even with intravenous bisphosphonate) ,
*severe musculoskeletal pain including synovitis (eg carpal tunnel syndrome), arthritis;
*cutaneous vasculitis, toxiderma;
*many eye pathologies eg nodular scleritis, uveitis.
This column has repeatedly pointed out that
# there is never compelling indication in osteoporosis for a bisphosphonate since
# excellent improvement in bone density with abolition of osteoporosis fracture risk is always provided by the ±baker’s dozen of long-proven natural supplements;
# this safe economic combination provides significant all-system protection permanently, whereas bisphosphonates were designed to and do target only osteoporosis, and
# bisphosphonates have had to be progressively limited in duration of use – now down to 2 years.
So it’s like oral sex hormone therapy OHT:
# Why use oral HT (for “convenience”) , when avoiding the oro-hepatic route reduces the needed dose for clinical effect by 90 to 95%, and thus avoids both shortterm risks of OHT- thromboses, gallstones, unmasking of undetectible cancers-
and longterm gradual increase in breast cancer with accumulating dose much beyond 10 years;
# why use bisphosphonate at all?
when there are more effective- natural – supplements that also give multisystem protection lifelong.
So, while waiting for ponderous Regulators (despite the screams of bisphosphonate manufacturers) to ban bisphosphonate for osteoporosis,
It has become clearly negligent for anyone to promote, approve, prescribe or supply bisphosphonate for osteoporosis.
The evidence set out in this column till today is now so incontrovertible that
# it becomes necessary to advise patients already on bisphosphonates for osteoporosis that bisphosphonate is far from the best prevention/ treatment, and they should change over to the ~baker’s dozen of proven natural supplements.
# no judge can uphold the defenses of those who are sued when patients present with one of the numerous complications of bisphosphonates;
# those registered “authorities” (medical practitioners, pharmacists, medical schemes and other providers/ gatekeepers) who continue to prescribe/ dispense/ advocate/ pay for / allow bisphosphonate for osteoporosis should be reported to their respective Regulator be prosecuted, and convicted of scandalous negligence for ignoring the tidal wave of reports of complications, the past 5 years.
Ignorance of recent problems, failure to check Pubmed for warnings is no excuse when we are all bound to operate according to the best evidence – not regulatory / academia /concensus decisions which are often based on opinion and group interests rather than the evidence – and when it takes 2 minutes to do an update Pubmed search on the risk-benefit of any drug.
Nobody can longer be tolerated to prescribe, advise, dispence or gate-keep/ regulate medicines who does not have constant access to and use Pubmed.
It is criminal to argue as defence that these complications were “negligible, not seen in double blind randomized controlled trials” – which never last long term ie well beyond 10 years –
and that the nutritional supplements – all of which are part of human biology- have to be proven in trials to be better than eg the bisphosphonates-
and that authorities had decided that eg the bisphosphonates were safe enough. .
To vindicate the bisphosphonates for primary use in osteoporosis is and always has been simple. It was and is up to the drug industry to produce the trial results of head-to-head comparison against the basket of proven supplements for long enough- 5 to 10 years- as was done for metformin in the hallmark 20year UKPDS (1998), when the supplements together, but not bisphosphonates, have been shown to reduce all-cause chronic degenerative disease and mortality by about half. .Manufacturers ducked that obligatory necessity, as the Regulators (ie Governments) constantly allow them to do with new drugs for chronic disease..
But it would now be unethical to enroll patients in such a tria – of bisphosphonates for osteoporosis- without first showing them and independent assessors the safety and risk data on the respective arms of such a trial- and thus unethical to do such a trial since nobody would give informed consent on the evidence already available.
The analogy is, ironically, mercury amalgams- falsely disguised under the term “silver” fillings since they are up to 75% mercury, (not silver) -which are at last, after decades of heeldragging, being banned (as they were banned in Scandanavia last year) because of the indisputable decades-known systemic toxicity of mercury, which the FDA finally had to concede in a USA recent court prosecution of the FDA. If that applies for ” pregnant women, unborn babies and children”, then surely read all humans.
Imagine having to take a government to court to force it to follow long-available strong scientific evidence- but thats what also happened in South Africa recently over mandatory treatment for AIDS – and the “responsible” ministers -a medical doctor, and the president (a British MA in Economics) no less- repeatedly ignored court orders, until they were belatedly removed.
Now we must if necessary go the same legal route over bisphosphonates for osteoporosis if regulators will not take swift heed and stop their use as primary therapy for osteoporosis. Human rights demand no less.