Dec 21, 2016

Bizarre nanny state codeine policy an excruciating headache for taxpayers

The decision to ban consumers from managing pain with codeine will cost taxpayers, and is based on some bizarre assumptions.

Bernard Keane — Politics editor

Bernard Keane

Politics editor

The public health bureaucracy planning to put regular over-the-counter pain relief out of reach for millions of Australians admits its intervention will cost taxpayers hundreds of millions of dollars. In a pre-Christmas sneak release reminiscent of the Australian Bureau of Statistics' controversial 2015 census announcement, yesterday the Therapeutic Goods Administration announced it would ignore public opinion and cut access to all pain relief products containing codeine except via prescription. A public outcry forced the health bureaucrats to pause a planned ban in 2015. But from 2018, Australians wanting access to codeine, which is a more effective form of pain relief than supermarket-sold paracetamol products, will have to go to a GP to obtain a script. The public health lobbyist body the Advisory Committee on Medicines Scheduling, run by government-appointed health bureaucrats and academics, made the decision based on a report commissioned by the TGA by consultants KPMG. The male-dominated committee decision has already been criticised for ignoring the needs of women with endometriosis. Given the TGA originally proposed the ban, it remains the case that no independently commissioned study has been done of the proposal. [The unaccountable pencil-pushers who want you to suffer more pain] Doctors' groups were originally highly supportive of the ban, which would mean Australians would be forced to visit GPs more in order to access any pain relief products beyond the low-impact headache tablets available from supermarkets. However, that necessarily means a big additional call on taxpayers via the Medical Benefits Scheme, as well as some additional Pharmaceutical Benefits Scheme costs. A report commissioned by the Pharmacy Guild -- which opposed the change -- claimed that, after removing the variety of circumstances in which no additional GP visit would be necessary for someone who had previously purchased codeine over the counter from pharmacists, the proposal would require 8.7 million additional GP visits per year at an annual cost of $316 million, or more than $4 billion over a decade, adjusted for inflation. While this industry costing is clearly self-interested and probably overstated, the KPMG offers a figure every bit as problematic: it claims the number of additional GP visits would be less than 10% of the number proposed by the Pharmacy Guild report -- just 540,000 a year -- and the whole cost would substantially fall after the first year because (for reasons not explained) costs "would taper off over time". KPMG's cost of the impact of the ban on the MBS and PBS is just $268 million over a decade. But some of the assumptions underpinning the report appear, to the layperson, at least eccentric. Most bizarrely, the report assumes that non-codeine pain relief -- for example, paracetamol from the local shops -- can be readily swapped with codeine without any diminution of benefit for users: "for most of these consumers, as the evidence indicates, there is no incremental health effect of the use of low dose codeine combination products compared to using these analgesics without codeine". Those who rely on codeine to manage intermittent but serious pain might take a different view from the consultants employed by the public health lobbyists. [Sorry, nanny statists, alcohol is good for you] The report arbitrarily assumes that five deaths will be prevented each year by the ban, and also assumes that most consumers will have ready to hand a valid repeat script for codeine-based pain relief from their GP when needed, rather than needing to undertake an additional visit to a GP to obtain a new script. The report also assumes that the government will fund an education campaign relating to the ban and ways for consumers to access pain relief. However, "the question of how an education campaign for consumers would be funded, and what form it might take is still to be determined and is dependent on the regulatory process changes, if any. The cost of this campaign was not included in these costings." Remarkably, the modelling and regulatory impact statement for the decision include no assessment of the tighter restrictions on availability introduced after the TGA's first, abortive effort to ban access to codeine in 2015. The Pharmacy Guild rolled out MedsASSIST nationally after a New South Wales and Queensland trial in April this year, to track people's purchase of codeine products -- the reason why you're now asked to produce a driver's licence or other ID when you purchase Panadeine Extra at the chemist. Indeed, KPMG explicitly rejected using data from MedsASSIST in its work. The TGA has decided to ignore MedsASSIST entirely in its decision. Averaging the cost estimates of the PGA and KPMG reports suggests that the total cost to taxpayers of the ban via higher MBS and PBS costs would be over $2 billion over the coming decade. But assuming the PGA report significantly overstates those costs would still mean a substantial impact on taxpayers in a health system where funding is already under serious pressure and the government is looking to curtail, not increase, cost pressures within the MBS and PBS budgets. And that's separate from the core problem of the TGA's ban: that its committee of public health lobbyists knows better than individual Australians how to sensibly manage their pain without calling on governments to regulate and fund them.

Free Trial

You've hit members-only content.

Sign up for a FREE 21-day trial to keep reading and get the best of Crikey straight to your inbox

By starting a free trial, you agree to accept Crikey’s terms and conditions


Leave a comment

25 thoughts on “Bizarre nanny state codeine policy an excruciating headache for taxpayers

  1. Philip Darbyshire

    Thanks Bernard. A painfully lousy decision. How many of us who use Panadeine etc occasionally and yes, ‘for pain’ will start stockpiling soon? More work for already harassed GPs and more expense for patients.

  2. paddy

    This decision is such a stinker, I suspect (and hope) it will end up being quietly dropped before it’s actually imposed on the poor suffering masses.
    There’s still a whole year of outrage to go.

  3. Jackson Harding

    Bernard, in health care we use this thing called evidence. E-V-I-D-E-N-C-E. Same creature you’ve been calling for in other areas of public policy.
    The evidence for codeine is not pretty. In double blind trials (the gold standard) codeine/paracetamol combinations are no more effective than paracetamol alone. Similalry in double blind trials codeine/ibuprofen combinations are no more effective than ibuprofen alone. In addition codeine is actually an inactive compound. It relies on conversion in the body to morphine to work. Except anywhere between 10 and 20 % of the population don’t actually have this enzyme, so for them codeine does precisely nothing. Zip. Zilch. Nada. Not a thing. No effect at all. Not even a smidgen of effect. A smaller subset of the population are rapid or hyper metabolisers. They get pronounced nausea, chest pains, and stomach cramps when they take codeine. Any other drug that was inneffective or not tolerated by 25% of the population wouldn’t be available at all, not even on prescription, and you’d probably be one of the first in the commentariat to be saying so.
    Then we have the problems with addiction and overdose. So the evidence for codeine is pretty bleak.
    This is actually what you so often bewail as missing in our public life – good public policy.

    1. Lee Tinson

      And yet it works great for me and my osteoarthritis. Apart from that, I saw precious little real evidence used in the KPMG report. KPMG should work exclusively for either Donald Trump or Peter Dutton, both well known for not requiring facts to help them to a conclusion.

      For those for whom it doesn’t work, they can be trusted not to use it (I know this because I know such people).

      For those whom it makes sick, well I suspect they can also be trusted not to use it. I also know people who have been prescribed oxycodone etc who don’t fill their prescriptions because it make them sick.

      The problems with addiction and overdose have been far from adequately documented. For instance, how bad can the addiction problem be if such large proportions of the population get either nothing or sick from using it? The problem with overdose (and here I’m probably using at least as many facts as you have) is more likely to be from liver failure from overuse of paracetamol or ibuprofen (you know … say 8 tablets per day over a shortish period will achieve that). With the current tablets, barring a really stupid attempt to commit suicide, you won’t overdose on codeine.

      So, Jackson, your comment, just like the self-serving pronouncements I’ve been hearing on TV, simply don’t add up. It isn’t even close to good public policy. It’s a stitch-up to benefit someone financially, I suspect, at a huge cost to the community. They’ve been trying for a couple of years now, whoever they are, and now they’ve finally found a bureaucracy and a government stupid enough to fall for it.

      1. Jackson Harding

        It’s still a poor drug. The dose in the over the counter form is homeopathic. Those who say they get benefit from it (such as yourself) show the same increased efficacy as those given a placebo. Perception bias is at play here.

        In larger doses (paracetamol 500 mg/ codeine 30mg) it does have extra benefit. That’s known as panadeine forte and has always required a prescription. This decision doesn’t change the availability of that combination, it’s still prescription only. It’s also where most of the addiction and overdose issues arise.

        And oxycodone causes side effects because it is an effective opioid. The side effects and the pain relief go hand in hand.

        This decision was killed off last time by big pharma and the retail pharmacy mafia. When those two say they want to keep something then that’s when it’s time to get suspicious.

        1. old greybearded one

          And you may say what you like. Many studies have shown that different people respond in different ways. Aspirin and ibuprofen type drugs worked well for me, but I cannot take them as I have to take warfarin. Paracetamol unaided is a bloody waste of time, as a good many studies have also shown where joint pain is involved. If it is pain enough to bother me panadol is useless. Panadeine works. My mother was the same. I do not live where there is a doctor on tap at a moment’s notice and I probably use panadeine a few days a month. I already had to show my photo ID at my pharmacist so the whole thing is bullshit.

    2. Oliver Frank

      Well said. This is the important evidence that codeine is not a very good medicine. Since codeine exerts any effect at all only by being metabolised to morphine, but only some people, some experts in pain management want to see codeine taken off the market altogether and replaced by appropriate (usually low) doses of morphine if and when any opiod is needed.

  4. Dred Layfet

    A black market in scripts and codeine is coming.

    1. Oliver Frank

      We already have that, my friend.

  5. Lingo

    Plainly silly, and like many others, I – having regular severe toothache spreading through the jaw – will suffer if it goes through. Just a niggle about the term ‘nanny state’ though. The nanny state, to me, is one which intervenes to foster the safety and wellbeing of all its charges – just like old fashioned nannies used to. This, seatbelt legislation, anti smoking/assistance for quitting smoking campaigns, import controls on flammable nightwear and so on. There’s barely one of those that I don’t accept and heartily endorse. The sort of ‘policy’ sneaking through now is that of a bullying state. The overall safety and wellbeing of the mass of Australians is clearly not its driver.

  6. Mayan

    The black market will provide, and provide more problems than the TGA can possibly imagine.

    As for paracetamol, given its low effectiveness and severity of side effects from overuse, it probably wouldn’t be approved were it a new drug.

    JH: while codeine might be of much use to some, it benefits many. Your views are sadly typical of the condescension of the medical profession and the nobility in suffering BS of the god botherers.

    1. Jackson Harding

      No, my views are based on 25 years practice dealing with acute pain as an anaesthetist and from reading the scientific literature. Low dose codeine in addition to paracetamol or ibuprofen has been shown, repeatedly, to be of no additional benefit. Plain, undisputed, scientific fact. I am well aware many people will insist otherwise, but the evidence does not support this, it is in fact what is known as perception bias.

      The other people who will say other wise are the retail pharmacists who make a motza selling it, and big pharma from producing it.

      1. Lee Tinson

        And yet, as I said before, it works for me just fine. Has anyone thought of ditching either the paracetamol and the ibuprofen and just going with codeine? I bet you didn’t.

        You clearly have had no experience with codeine in those 25 years, not working in an area where codeine is even used at all, and reading literature doesn’t qualify you to make the sort of off-hand and yes, condescending, claims you are making here today.

        1. Jackson Harding

          I use opioids all day every day. I have a detailed, in depth, comprehensive knowledge of all opioids (and a host of other analagesic drugs). That’s my job. Dealing with pain is what I do for a lving.

      2. Mayan

        Wow, Jack, what an interesting wad of contorted reasoning.

        You claim to be concerned about deaths and hospitalisations, yet you (and your ilk) forget the hundreds of deaths due to paracetamol each year, never mind the stomach problems due to aspirin, nor the deaths and anorexia facilitated by laxatives, all of which are available in practically unlimited quantities. So, you obviously do not care about death and injury due to codeine.

        Let’s also take a moment to emphasise that the TGA guesses this clamp down will save five lives each year which, let’s be honest, is rounding error.

        You would have those who suffer sciatica, dental pain, flare-ups of carpal tunnel, endometriosis etc. go to the GP. Those things aren’t necessarily chronic conditions, which means you wait up to two weeks to get an appointment with your regular GP. Or you could see another, who might conclude erroneously that you are doctor shopping and lecture you – at a time of great pain – in a condescending tone. Nothing like a little sadism, huh?

        You mention that it doesn’t work for all people. Really? Should we make things that don’t work for all people prescription only? How about prescription only cold packs. Yeah – they don’t always relieve pain, so let’s restrict them. So, clearly that isn’t your motivation.

        You mention that a small number of people might experience harm from them, especially in high doses, so they should be prescription only. See above for other things that can cause harm. Come to think of it, some foods can cause harm, especially in high quantities, so best not eat anything without medical advice. Obviously, that’s ridiculous, as is your concern trolling.

        We might be getting close to something there, and maybe that is behind the push for prescription only: some people just plain like the codeine, and that brings us to issues of ‘abuse’. Let’s face it, there is also a neo-prohibitionist movement in Australia that hates alcohol, so why not anything else with a potential psychoactive effect?

        However, that argument has issues. Not only does it channel puritanical notions of disapproval toward pleasure, and also religious notions of virtue in suffering (Who doesn’t enjoy waiting a couple days to get a root canal without medication?), but it also touches on your (you and your ilk’s) sadism mentioned above. During prohibition, the US government put poison in moonshine as a deterrent, while we now tsk tsk as a handful of people chasing a high OD on paracetamol with which the codeine is mixed. A sort of “It’s bad for you to get high and we’ll hurt you to prove it is bad for you to get high” sort of thing. Normal people call it sadism, or even psychopathy.

        So, to recap: many people find it beneficial; some people abuse it and suffer because of its admix; and some people get no benefit; all while other harmful substances are ignored.

        Finally, the medical profession sells more than its share of bogus, even harmful treatments, ranging from profitable knee surgery that offers no improvement upon a placebo through to the mutilation of intersex infants, which at least a half find harmful and even ruinous. So, please save the sanctimony and condescension for a time and place when you come back with logic and clean hands.

        1. Jackson Harding

          Actually you got one thing totally wrong. I don’t want them going to the GP for a script for a piddling dose of codeine. I want them to go to Aldi to by a generic brand of plain old paracetamol, which will probably be cheaper than the combo they are buying from the pharmacist right now.

  7. Altakoi

    The report doesn’t assume that codeine containing pain relief can be swapped with no-codeine containing pain relief, the clinical trials clearly demonstrate that. This is not an absolute finding – its just that the amount of codeine in the products being considered is near homeopathic. Thats largely why that are S3 and not prescription to begin with, there is so little effect that there is very little risk of side effects when taken as advised. The risk balance the committee has been asked to make is to trade off the interests of a large number of responsible people who derive no additional benefit from low dose codeine, against the interests of a small number of people who take these products excessively and suffer harms from the paracetamol or NSAID component. Higher dose codeine products remain available and have always been prescription, the effective component of the existing products – paracetamol and NSAIDS – remain available from pharmacists. Thats pretty much a no-brainer on risk – benefit, eg it retains all the benefits and eliminates the risks. For what its worth, on the male dominated committee 5 of 9 nominated members or women and they are not ‘bureaucrats’ but qualified pharmacists with a fair amount of direct knowledge of consumer behaviour between them.

    1. Lee Tinson

      The report does exactly that. And as you say, it isn’t true.

      Near homeopathic? Really?

      “That’s largely why they are S3 and not …” so why the fuss?

      Your claim of the large number of people who use it responsibly and get no benefit is so nebulous as to be laughable. You couldn’t design a double-blind experiment which would ethically get you reliable results.

      As for the small number of people who abuse the product, the case you’re making here would be for the banning of paracetamol. Good luck with that!

      1. Altakoi

        1. Homeopathic. Yes, really. As in the gold standard of ineffective things sold largely for marketing purposes.
        2. The fuss is because a fairly significant number of people do not take the product as advised.
        3. Its a pretty easy clinical trial to design. Its been done, its in the regulatory dossiers for the products involved as well as the published literature.
        4. This is a significant point of misunderstanding. People with opiate addiction take these products in excess in an attempt to get an effective dose of codeine. That leads to paracetamol or ibuprofen toxicity. Its not a case for banning either, its a clear case for separating the two products.

  8. Barnino

    Bernard, you are often right, but this time you are wrong.
    As others have indicated: the amount of codeine in OTC combinations with paracetamol or NSAID’s is ineffectual (shown repeatedly in scientific blinded trials), unless you take enough to risk killing yourself with liver toxicity (from the accompanying paracetamol) or kidney toxicity (from the accompanying NSAID). Australians are suffering death and serious injury from these effects. So it is just stupid to sell these medications.
    Doctors (I am one) are sometimes avaricious, but on this occasion, they are not acting to try to get more patients; they are working to improve public health.
    Codeine in higher dose is effective for moderately severe pain in roughly 2/3 of people. But as stated already, it is totally ineffective in about 10% of people; is dangerously over-effective in 1% of people; and has intolerable side-effects in perhaps a third of people.
    A pretty crappy drug, with better alternatives available.

    1. Lee Tinson

      There are a lot of people out there using panadeine and the like to cope with arthritis, and it works very well for a lot of people. I am one such person. For the roughly 44% of people for whom this drug is unsuitable, they won’t use it. For the 2/3 who would benefit from higher-dose, I suspect they also get some benefit from the lower dose as well.

      “A pretty crappy drug …..” well, maybe. The better alternatives you allude to are almost certainly only available with a prescription. For a large number of people it is cheap, effective (despite all the unsubstantiated claims by professionals who ought to know better than to say such things) and convenient way to safely manage a situation by themsleves.

      You and your colleagues are making an unnecessary problem for a whole lot of people who are happy with the way things are. Why don’t you just butt out already?

  9. old greybearded one

    An absolute bloody pest. Meanwhile the addicts break into the old people’s houses and steal their opioids and we can’t even get a 24 hour cop shop. That will be four out of four members of my immediate family who cannot buy a useful pain killer without a script.

  10. Itsarort

    I’m no accountant but even a 10% increase in ‘visits’ to the local Medical Centre would be significant dollars for the business – if nothing else, it’s just money to be had.

Share this article with a friend

Just fill out the fields below and we'll send your friend a link to this article along with a message from you.

Your details

Your friend's details