MARK COLVIN: A drug that's been widely used to give pain relief may pose a long term health danger and could even be responsible for an unknown number of deaths.
DI-GESIC is now banned across Europe and America.
The Australian Medical Association, a number of eminent pharmacologists and the regulator, the Therapeutic Goods Administration, agree. And yet DI-GESIC is still available in Australia.
Peter Lloyd reports.
PETER LLOYD: DI-GESIC has been around for decades. Not a lot of people use it these days because there are alternative pain killing drugs. But that's not a choice for a small number of people like Suzie Masters, who has endured a life time of surgeries for a birth defect of the heart.
She says DI-GESIC is the only painkiller that allows her to lead anything approaching a normal life.
SUZIE MASTERS: I had three major surgeries, one under the left arm when I was 11 months old, one from the shoulder blade to under the armpit on the right side when I was five years old. And then the repair job when they actually took my heart out of my body when I was 12 years old, of which I've got chicken wire in my sternum to keep it all together. And eventually, I was put on DI-GESIC which helped the pain amazingly.
PETER LLOYD: But what works well for people like Suzie Masters may also present a serious risk of sudden death in patients with kidney conditions, and those taking other prescriptions.
It's for that reason DI-GESIC was banned around the world. Last year the Australian regulator, the Therapeutic Goods Administration, de-listed it too.
But the manufacturer, Aspen Pharmacare, took the TGA to court. And it won.
The Court of Appeal was the Administrative Appeals Tribunal. It concluded that the benefits of DI-GESIC outweighed the risks.
And some in the medical community are in uproar.
They see the case as a worrying demonstration that the TGA cannot protect the public.
Andrew Somogyi is a professor of clinical and experimental pharmacology at Adelaide University.
ANDREW SOMOGYI: Well when drugs go onto the market and remain on the market, we look at two things. One is, is the drug still effective, and b) is it not harmful.
And the problem with this drug, we now recognise that in high-ish dose, and in the elderly in particular, that its breakdown product accumulates in the bloodstream and is toxic to the heart and can cause sudden death.
PETER LLOYD: In future, patients will be asked to sign a form to acknowledge they understand the risk.
Professor Somogyi wants Aspen Pharmacare to accept the worldwide trend about its product and withdraw it from market rather than fight to maintain a medicine that may do harm.
ANDREW SOMOGYI: Well because it is unsafe and it is not as effective as other medicines that we have for acute pain in Australia.
PETER LLOYD: Have you had a response from the company about that proposal?
ANDREW SOMOGYI: I haven't and nobody that I know of has.
PETER LLOYD: And neither has PM.
Today the company declined to talk about DI-GESIC. A spokesman said the company is awaiting final instructions about labels and the wording of the form that patients will be required to sign.
The AMA (Australian Medical Association), though, is fighting back with some medical guerrilla tactics. It's telling doctors to stop filling prescriptions for DI-GESIC to try and kill off the market in the drug.
Its president is Dr Steve Hambleton.
STEVE HAMBLETON: The black box recommendation for DI-GESIC in this country is do not initiate the use of Dextropropoxyphene containing products for any new patients, whether for the treatment of acute or chronic pain.
PETER LLOYD: Now why is it that a body like the Administrative Appeals Tribunal gets the right of veto over a decision made in the public good context by the TGA?
STEVE HAMBLETON: Well that's a good question. You know the TGA we rely on as medical practitioners to give us some very good advice about medical products. We select carefully experts to review the information about the products that are proposed to be available in Australia, and indeed products for which there is some concern.
PETER LLOYD: You're building a case here for why the TGA does a good job. Why didn't the AAT see it your way?
STEVE HAMBLETON: I'm not sure. I'm not sure of the reason that the appeal was put through.
PETER LLOYD: So why then, the audience must be asking the same question themselves, why then can a big pharmaceutical company win against those odds?
STEVE HAMBLETON: That's a very good question, particularly when we have hand-chosen experts, if you like, that are trying to advise us. And we have a, well I guess a relatively middle of the road position saying that if you're on it and you're safely on it you can stay on it for the time being subject to those rules about prescribing. But we certainly wouldn't want to see it being prescribed for anyone new.
MARK COLVIN: The AMA's president Steve Hambleton ending Peter Lloyd's report.
PM also approached the TGA for its side of the story on why it lost the fight to de-list DI-GESIC. It hasn't responded.