GLASSON: Good afternoon, ladies and gentlemen.   I just want to make an announcement.  As you know, yesterday the US Food and Drug Administration put out a warning in relation to a number of drugs, but particularly a drug called Ibuprofen, which, in broad terms, is a non-steroidal anti-inflammatory that's prescribed for patients with pain, basically.  Chronic pain, chronic inflammation.

             As you may know, over the last - or since 1^st January, this drug which was available only at pharmacies now is available across the counter in supermarkets.

             We know that Ibuprofen has significant side effects, particularly if taken in a chronic capacity, and those side effects particularly relate to gastrointestinal bleeding - that's bleeding from the stomach - and also can have adverse effects in relation to blood pressure control and kidney function.

             So I suppose our concern has been that, first of all, this drug has been listed such that it can be [indistinct] the pharmacies, that the labelling is not adequate to inform patients as to the possible adverse effects of this drug, particularly in relation to the older patients that may be on drugs to thin their blood, and on other more complex medications that Ibuprofen can interact with.

             So I suppose we want to make it very clear to the average Australian out there, don't panic.  If you are on this drug please go and see your doctor, please talk to your pharmacist about it and decide whether the dose you are on is appropriate, and also to make sure that it's not adversely affecting other drugs that you're taking.

QUESTION: [inaudible]

 GLASSON: Yeah, when we look at the process by which this drug was listed, we've known of the side effects of this drug for a long time.  It's a very good drug and very effective, don't get us wrong.  But I suppose we want to make sure that the public out there are aware of those side effects, and also look at why did we list it, in the sense of making it available in pharmacies?  Was that in the interests of the patient, was that making sure that the patient had, you know, better access, they've got better healthcare?  Or was it for some other reason?

             I'd like to think the drug was listed to ensure that the average Australian had a better outcome and a better healthcare, not end up with a higher side effect profile.

             And so I think that we've got to understand that this drug does have adverse effects.  As effective as it is - and it is a very good drug - but it should be done in consultation with your pharmacist and with your general practitioner.

QUESTION: Is this representative of [inaudible] the way [inaudible] scheduling these drugs?

 GLASSON: Yeah, I mean, we're specifically requested to look at the makeup of that committee that actually schedules these drugs, and make sure that obviously nothing - in an open way, in other words we're not blaming them or suggesting anything wrong - but just look at the process by which we actually look at the scheduling process. 

             Make sure there's sufficient consultation with the pharmacy industry and with the medical profession, to ensure that the - those drugs that are listed for sale across the supermarkets are done for the right reason.  And as we said, that's for the better access to patients, hopefully better price but not put patients in a situation where it might impinge upon their health in the long term.

QUESTION: Do you think the consumers [inaudible] being put at risk [inaudible] sales, for and against drugs on the shelves?

 GLASSON: The cynical ones amongst us would say that's happening.  I mean, at the end of the day the drug companies are very, very powerful, they have tremendous political influence and I think that, when it comes to that, there's a certain amount of pressure to get these drugs out on the open market.

             Obviously, once they're on the open market, you've got advertising.  And we'd like to think that if that advertising does occur it really reflects the truth about that drug, and really sends a clear message that if you have chronic pain please go and see your doctor and discuss the issue. 

             There's no point in treating the symptom when you don't know what the underlying cause is.  But these patients may in fact have some severe organic disease, such as a cancer for which you're taking these pain tablets for, and so we really need to find out why they're getting the pain and if the doctor then decides, with the pharmacist, that the Ibuprofen is the appropriate drug, so be it.  And making sure that that does not interact with other drugs the patients are on.

QUESTION: Has Australia been caught napping on this issue?  Have health authorities been caught napping?  Are we reacting to the Americans?

 GLASSON: Look, we brought this issue up last year, obviously, because we were concerned about this drug being listed in the first place.  And we did send a letter to the Minister, Mr Abbott, in October, indicating our concern about it.  So I think the Americans - the Food and Drug Administration - have responded appropriately, and I would expect Australia to do the same thing. 

             In other words to send out sufficient warnings, not to panic people but to make people understand that anything you take, particularly on a long-term capacity, may have adverse effects.  And particularly taking other drugs - and that includes complementary drugs - at the same time.

QUESTION: So there was an opportunity to act earlier than today?

 GLASSON: Well, there was.  Obviously we were waiting for a response back from the Minister about this issue, just to see what the makeup of the National Poisons and Drug Committee is, and I suppose to see what guidelines they use when they decide about listing drugs for supermarket sale.  And to make sure, as I say, it keeps the interests of the patient and the health and the overall benefit of the patient at the forefront.

Ends