J Oral Maxillofac Surg. 2005 Nov;63(11):1567-75.
THE CASE
I view the sudden publicity in Australia of biphosphonate associated jaw osteonecrosis with some suspicion.
There are three main uses for this group of drugs, for the prevention of osteoporosis, to treat Paget's disease, and as part of the treatment of metastatic diseases. This necrosis has been mainly noted in the latter group of patients, furthermore these patients usually receive the drug, either zoledronate or pamidronate, intravenously.
The Adverse Drug Reactions Advisory Committee (ADRAC) reported in 2005 that it had received 13 reported incidents of jaw osteonecrosis associated with biphosphonates. Only one of the 13 cases was associated with an oral biphosphonate, alendronate. This corresponds quite closely with studies going back to 2003 in the US, which also found that the incidence with the oral forms of the biphosphonates was quite low (see graph above).
One study concluded:
"Oral bisphosphonate-induced osteonecrosis is a rare but real entity that is less frequent, less severe, more predictable, and more responsive to treatment than intravenous bisphosphonate-induced osteonecrosis."All this is really a preface to the point of this article.
This side effect has been known for four or five years, there are probably hundreds of journal articles on this and related topics. There are even law firms in the US specialising in biphosphonate tort. The real questions are:
Why has this suddenly become an issue? After several decades of watching the machinations in the drug industry, I know that things like this don't suddenly just happen. Someone somewhere has an agenda. Is there a new drug about to be released that does not have this side effect?
Why has the Pharmaceutical Benefits Advisory Committee (PBAC) given preference to expensive biphosphonate treatment ($40 to $50 a month), but no longer subsidises quite cheap calcium supplements ($13 a month), which are just as effective for some, but not all, patients? Calcium supplements do not have this horrible side-effect.
Why, when one arm of the healthcare system (ADRAC) was able to report these side effects in 2005, was another arm, the Therapeutic Goods Administration (TGA), only able to publish an alert on 11/12/2007 after the problem was publicised by the ABC? The sudden rise of this issue could also be part of a power play within the TGA, now there is a new Minister for Health.
Unfortunately this adverse publicity will scare the crap out of patients who really need treatments for osteoporosis or Paget's disease. If you are taking one of the oral biphosphonates such as alendronate or risedronate, the risk is low. Don't worry unless you have symptoms but go and see your doctor anyway and ask if you can take calcium instead. Also go and visit your dentist and explain that you have been taking a biphosphonate.
Australian brand names of biphosphonates
alendronate...............Alendro and Fosamax (oral)
clodronate.................Bonefos (oral)
etidronate.................Didronel and Didrocal (oral)
pamidronate.............Aredia and Pamisol (injection)
risedronate...............Actonel (oral)
tiludronate................Skelid (oral)
zoledronate...............Zometa (injection)
MY VERDICT
All this is another sad legacy of the Howard years, when the boards of supposedly independent bodies were filled with people likely to be sympathetic to the social engineering aims of that Government. The best people were not appointed, and many good people left under the strain of trying to do their jobs with intellectual honesty. Our Health Minister, Nicola Roxon, has a big job on her hands just unravelling this.
Unfortunately this will not be the only nasty issue to come out of the TGA, there are other instances of inefficiency and political interference waiting for their 15 minutes of fame.
HISTORICAL NOTE
This condition is reminiscent of, and seems to be related to, the disfiguring disease prevalent in workers exposed to white phosphorus in match factories in the 19th century. It was usually called "phossy jaw".
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