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Discussion on arthritis drug, Vioxx.



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Media Transcript

Date released:

11 April 2005

Discussion on Arthrits Drug, Vioxx

ANDREA CLOSE: If you watch Four Corners on

ABC Television tonight you will hear the story of as many as 300

Australians who may have died from the side effects of the

arthritis drug, Vioxx, before it was withdrawn from pharmacies

last October. This is according to medical estimates. And to tell

us more about this is Dr Bill Glasson, the President of the AMA.

Good morning to you, Dr Glasson.

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.

Date released: 11/04/2005

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