Discussion on Arthrits Drug, Vioxx

BILL GLASSON: A very good morning to you.

CLOSE: How long was Vioxx on the market?

GLASSON: Well, it was on for many years and it was a very, very effective drug - as was that class of drugs. And I think the important point for people to understand is this was very much a dose-related effect. In other words, people who were on high doses of Vioxx for long periods of time were probably more at risk, but the vast majority of patients listening who were on Vioxx were on a lower dose and really at minimal risk.

And I think that's - the company was very responsible in withdrawing the drug. But having said that, there were many patients actually getting significant benefit from that drug and obviously have now been moved on to other groups of drugs or other drugs within that same class.

CLOSE: Yes, when you talk about this class of drug it's these COX2 inhibitors and there are quite a few question marks around these I understand?

GLASSON: Well, look, there are and, as you said, the whole class of drugs has come under question at the moment. But, as I said, that the vast majority of patients are on lower doses of those class of drugs and have very little in the way of side effects. And I think it's a matter of balancing what are the benefits to the patients and what are the side effects? Nothing's ever completely safe. I think it's very important to understand that.

And when you balance the risks of those people that have got very severe arthritis and try to determine what quality of life they've got with or without the drug, then I think it's really a matter of each patient weighing up the risk benefit ratio and saying, "Well, listen, there are risks but at this dose they are quite low, but it's giving you this, you know, this improvement in quality of life." So it's a matter of sort of balancing, I suppose, the whole issue.

CLOSE: I understand that, but this particular drug, Vioxx, was fast-tracked through clinical approvals, was it not?

GLASSON: Well, I can't, look, I can't comment on that. I know that in general drugs that come on to the market these days go through very rigorous testing over a number of years and essentially don't get to the market unless they sort of, you know, reach certain sort of levels of efficacy.

So I can't comment specifically on Vioxx per se, but I can say across the board that the Therapeutic Drugs Administration Australia who approve drugs that do go on the market look specifically at what research has been done, you know, what are the side effects of the drug and what are the benefits.

CLOSE: Well, while many people may have benefited, it's been implicated in over a thousand events of which around about 30% resulted in deaths. That's pretty shocking figures though, isn't it?

GLASSON: Well, they are but just make sure that is a cause and effect - in other words, often in this situation you're dealing with an older patient with multi‑system failure, lots of other diseases going at the one time. And so I think we specifically have to look at those patients and say, "Did this drug cause their death?" - because a lot of people die for other reasons, and then assume that it might have been due to the fact they're on Vioxx. So I think we've got to get a lot more data here, get the facts before we sort of I suppose draw too many long‑term conclusions.

CLOSE: Yes, I should mention that around about 300,000 people in Australia were on Vioxx prior to it being withdrawn from pharmacies.

GLASSON: I think that's - it is true that, and I think that people - I don't want people to panic because the vast majority of people are on lower doses, moderate doses and really have had - would have little effect, side effects from that drug. So for those people on high doses for other reasons they are probably more at risk.

But for those that have come off it, please understand that we'll try and get the facts and figures for you to make sure that that risk is not ongoing if there is a risk.

ROSS SOLLY: Dr Glasson, I know you said that the checks and balances are in place, but is there any reason at all why this - I mean, if this was fast-tracked, that maybe short cuts might have been taken or that something might have slipped through, some sort of sign there that maybe there was a side effect for people who took it?

GLASSON: Yes, I mean, there really is, you know, this whole class of drugs it implicates, not only Vioxx but there's a whole - Celebrex, the whole class implicated. I don't believe that all those companies fast‑tracked the drug. I think that there's been - if you look at what research goes into actually bringing these drugs on to the market, it is very significant.

And the regulating bodies stipulate that they must have, you know, five years of testing or whatever is required. And so I think people should feel confident that new drugs that do come on the market are tested properly. But having said that, no drug is without side effects, nothing that you take is without a side effect. And you've got to balance that side effect with the benefits that that drug gives you.

And so I think that, you know, if there's a simpler way of treating something without taking a pill, do it. But at the end of the day if you can't live a quality of life without having that pill, then essentially, you know, you've got to make the final decision.

But as I said, it's a good class of drugs. It has a much lower rate of gastrointestinal and people actually live a much better quality of life on that class of drugs. But we have to make sure that we get the evidence, make sure that evidence is properly sought out and that we can give recommendations back to patients for the long term.

SOLLY: Dr Bill Glasson, before we let you go this morning, there are reports in one paper in particular that the Health Minister Tony Abbott is under pressure to wind back the Medicare safety net, which was a key plank of the Federal election campaign. Apparently the pressure's coming from the money Ministers, Mr Costello and Senator Nick Minchin. What do you think about the possibility of that being wound back now after it was such a key element of the election campaign?

GLASSON: Well, look, I've just been on a pollie-pedal with Tony Abbott last week and I brought the issue up with him because we'd heard on the grapevine that the money men are trying to put pressure back on the safety net. Listen, this Government was elected on a number of platforms. One of the major platforms was the health platform and the aspect of the health platform that people voted for was that safety net.

I think that the voters out there would become very cynical if they see a major clawback from that safety net. It is an important plank in the future of Medicare, I suppose, remodelling, and I congratulate the Government for bringing it in. But if they're now going to destroy the integrity of the safety net, then I can tell you that the profession, but more importantly, the patients, particularly out in the nappy‑bank land where they're paying huge costs of mortgages and the costs of bringing up families. When suddenly they lose that security and affordability of the safety net, they will be very unimpressed, so I'd suggest‑ ‑

SOLLY: But what sort of effect do you think it will have, Dr Glasson? Do you think people will jump out of private health insurance or‑ ‑

GLASSON: Well, I think it may have that impact but I think more importantly is that this is a very important plank to the current Medicare system, and that it really delivers security and affordability to patients. And I say to the Government for the amount of money that you're putting into the safety net, compared to what you're putting in the overall health system, it is quite insignificant.

And so please let this run for another year or so. Then we're happy to look at the threshold and look at where they need to be adjusted. But don't do a knee‑jerk reaction now because what the safety net has done is picked up on the $2 billion worth of out‑of-pocket expenses that you and I have been paying for the last 10 years.

This is not new money that's in the system. This is money that you and I have been paying that suddenly the safety net's picking up. It delivers tremendously from the point of view of those people with chronic disease and those people with young families. And so I'd like to think that the integrity be preserved and I ask the Prime Minister to step in here to try and prevent any major I suppose reshuffling, a rejigging of the system at this stage.

CLOSE: Well, we know you have your scrubs on, you're ready to go into theatre. Dr Bill Glasson, thank you very much for your time today.