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Concern over osteoporosis drug -

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ALI MOORE: In these days of hi-tech medicine it might seem there's a pill to cure every ill.

But some of those pills can also have serious side effects.

Right now across Australia thousands of people suffering osteoporosis or cancer are being
prescribed medications that contain a class of drugs called bisphosphonates.

These drugs are intended to maintain bone density.

But there's emerging evidence these same drugs can, in certain situations, cause your jaw bone to
dissolve.

This debilitating and disfiguring side effect is called osteonecrosis of the jaw, which means jaw
death.

While medical experts are urging people using the medication not to panic, they are also concerned
drug companies and doctors are not warning people of the dangers associated with this drug and they
suggest there are alternative treatments.

Nick Grimm reports.

DR JOHN HENNESSY, ORAL AND MAXILLOFACIAL SURGEON: Are you tender at all?

BRUCE EDWARDS: Not particularly.

NICK GRIMM: Bruce Edwards is suffering a ghastly side-effect caused by one of the drugs he hoped
would help him beat his bone cancer.

JOHN HENNESSY: And your jaw movement is not restricted today?

BRUCE EDWARDS: Not at all.

JOHN HENNESSY: OK.

NICK GRIMM: It is literally rotting away his jaw causing shards of bone to piece his gums.

JOHN HENNESSY: Let's just have a little look Bruce.

BRUCE EDWARDS: When it gets sharp, I've just got to ring John and come and see him and get him to
break a bit more off it. Break the sharp

pieces away.

NICK GRIMM: So the bone is actually protruding into your mouth?

BRUCE EDWARDS: I put it to the same thing as when you've had a tooth out and sometimes when it has
broken off, a bit of the old tooth

sort of works its way through the gum. That is what this is sort of like only it is harsher and
sharp and it really cuts into the side of the

tongue.

NICK GRIMM: Bruce Edwards is one of an estimated 500 Australian who in just four short years have
developed osteonecrosis of the jaw or

ONJ. It is often dubbed "dead jaw" for very good reasons.

JOHN HENNESSY: (to Bruce Edwards) Still the same problems or anything new?

It is not fully understood why but what occurs is widespread death of what was previously healthy
bone. The condition is progressive. The

condition is incurable.

NICK GRIMM: If the cause of "dead jaw" is not yet fully understood, there is consensus that the
culprits are these drugs known as bisphosphonates. They include brands like Fosamax, Actonel and
Zometa along with their generic versions.

It is now clear these drugs commonly used for strengthening bones can have the opposite effect on
the jaw bone - preventing it from healing when damaged. It is the mouth where such bone injuries
occur. Typically when teeth are removed. Infection can then enter the exposed wound killing the
bone and causing it to start rotting away.

Slowly the decay spreads. In the worst cases dissolving the jaw bone until it breaks.

BRUCE EDWARDS: I thought it was doing me good. I had no side effects that I knew of at the time
while I was being administered the drug.

NICK GRIMM: And what was your reaction?

BRUCE EDWARDS: Fear. Fear of the unknown more than anything else.

NICK GRIMM: The question is, how many other people using these drugs could also be in danger.

PROFESSOR PHILIP SAMBROOK, UNIVERSITY OF SYDNEY: Some patients just look at the scary headline if
you like, and may not sort of balance the benefit they are getting versus a very low risk.

JOHN HENNESSY: Nobody knows yet. The odds probably range from one in some thousands potentially in
the worst case scenario down to one in ten.

NICK GRIMM: And that might still understate the risk. An international medical task force recently
warned ONJ is rapidly evolving and the true incidents may be higher.

Yet the growing concerns didn't stop the Howard government actively encouraging of the most popular
bisphosphonate, Fosamax.

JOHN HOWARD: Which is a wonderful drug for treating osteoporosis.

NICK GRIMM: In December last year, John Howard and his Health Minister, Tony Abbott announced that
they had put the drugs on the Pharmaceutical Benefits Scheme.

TONY ABBOTT, HEALTH MINISTER: So a great day for older people and I think, if I may say so, more
good news from the Howard government.

NICK GRIMM: It is hard to imagine Valerie Engel would agree. She didn't learn about the risks
associated with the drugs until it was far too late.

VALERIE ENGEL: So I have got destruction of the nerve area around the bottom lip and it is very
uncomfortable. I just hope that something can be done about it so I can chew again.

NICK GRIMM: Valerie Engel was prescribed the bisphosphonate Fosamax after being diagnosed with
borderline osteoporosis four years ago.

She has since lost two dental implants and has difficulty eating. It has also impaired her ability
to battle her other medical problems including recently diagnosed cancer.

VALERIE ENGEL: I don't think I'm that unintelligent but it really didn't occur to me that the drugs
would have any real side-effects.

NICK GRIMM: Bisphosphonates are a booming business for drug companies. 300,000 Australians are
currently prescribed the drugs for osteoporosis and doctors claim there is ten times that number
still undiagnosed.

For drug companies that it a potential market of up to three million people.

(excerpt from US TV advertisement)

NICK GRIMM: But the 7.30 Report has discovered that patients haven't been told all they need to
know about the risks - or the true benefits.

RAY MOYNIHAN, AUTHOR, 'SELLING SICKNESS': Drug companies generally tend to play down the
side-effects of their products and exaggerate the benefits of their products.

(excerpt from US TV advertisement)

NICK GRIMM: In the United States, law firms are urging ONJ sufferers to join a class action against
pharmaceutical giant Merck which

produces the Fosamax brand.

US ADVERTISEMENT: There is no evidence out there at all that it prevents osteoporosis.

NICK GRIMM: Significantly the US litigants have looked to Australia for their evidence citing
research by Alister Goss a Professor in the specialised field of oral and maxillofacial surgery. He
argues that the of ONJ is the result of twin health epidemics, osteoporosis and dental disease.

PROFESSOR ALISTAIR GOSS, ROYAL ADELAIDE HOSPITAL: Every year about 10 per cent of all Australians
end up needing a tooth extraction so you've got two very common conditions which collide.

NICK GRIMM: In fact, according to Australia's health regulator the Therapeutic Goods
Administration, the most effective way to prevent ONJ is to avoid losing any teeth.

TGA DIRECTIVE: 'Prevention is of the utmost importance. Dental assessment and treatment should be
completed before commencing bisphosphonate treatment'

NICK GRIMM: The TGA issued that directive well over a year ago but the 7:30 Report has discovered
drug manufacturers haven't told their customers. Their consumer information contains only vague
hints, for example, patients are told to see their doctor if they experience "jaw problems
associated with delayed healing and infection".

As Australia's drug watchdog the TGA is supposed to keep the public informed about possible
side-effects of prescription medicines. Yet it was only when the 7:30 Report asked in writing if it
was satisfied with the information being provided by drug companies that the TGA shouldered its
responsibility and announced that it will order the drug companies to publish the full facts.

TGA DIRECTIVE: "Warnings on the risk of ONJ in the form of precautionary statements should be
included, to ensure there is clearer and more consistent information for patients."

NICK GRIMM: No one from the TGA was available to be interviewed for this story. Similar requests of
the drug company's concerned were also unsuccessful, however they did tell us that they're now
working on improving their product warnings.

PHILIP SAMBROOK: The companies don't want people to have side effect, they want to know what the
truth is.

NICK GRIMM: Professor Philip Sambrook is one of Australia's leading osteoporosis experts and one of
the chief advocates of the use of bisphosphonates to treat the condition.

Is there any danger at all that bisphosphonates are being over prescribed?

PHILIP SAMBROOK: We estimate that there are about over just over 2 million people, 2.2 million
people in Australia with osteoporosis. The

figures suggest that we're treating somewhere between 250,000 and 300,000 so we're only treating
about 10 per cent of the patients in Australia with osteoporosis. So our society, and Osteoporosis
Australia would argue we're under treating.

NICK GRIMM: However Philip Sambrook admits half the people currently prescribed bisphosphonates
could instead be using simple alternatives like calcium.

So would it be reasonable to say that 50 per cent of people, it could be advisable for them to use
an alternative form of treatment for their osteoporosis?

PHILIP SAMBROOK: It could be advisable for them if they have risk factors especially.

NICK GRIMM: For seriously ill patients like Bruce Edwards, bisphosphonates will undoubtedly remain
an important weapon for fighting diseases like cancer and severe osteoporosis.

But the questions hundreds of thousands of other Australians must now ask themselves is whether in
their own cases the benefits of these drugs are really worth the risk.

BRUCE EDWARDS: I don't look at it as a death sentence but I look at it as another hurdle we've got
to jump over and we hope that this is the final end of it.

NICK GRIMM: But you obviously wouldn't recommend it to anybody?

BRUCE EDWARDS: Heavens no. No, I would not. No, I wouldn't recommend it to anybody at all.

ALI MOORE: Nick Grimm with that report.