Friday 30 November 2018

In pain, on patch

Pain is a peculiar thing. It is perceived by the mind as the brain gets signals from the periphery about damage. It is one of the symptoms of inflammation, for example, and I've argued that is adaptive / useful because experiencing pain or tenderness will persuade you to protect that part of the body from further damage. Then again, some people start to experience pain, terrible immobilising pain, when there is no apparent damage. It must be especially frustrating to experience this pain in a phantom limb which obviously you cannot scratch or rub.

That's pain. As a relevant aside let me report that Pat the Salt m' aged father-in-law developed a weeping sore on the pinna of his ear: probably a Staphylococcus infection; and probably the consequence of his immune system being less feisty than it was when he was 16. It wasn't clearing up so the GP prescribed a course of oral antibiotics. Within a few days, the ear looked a lot better, so that was good. But his intestinal flora had been decimated in the process and that was probably not-so-good. Of course I wondered if his ear would have gotten better in time without the intervention. I also wondered if there wasn't an effective anti-bacterial cream that could be applied to the site of infection and leave his GI tract to fight the good fight on his behalf.

It turns out that sort of solution is available for pain management. It is called Versatis, is manufactured by Pfizer and its licensees, and is an adhesive patch loaded with a 5% solution of lidocaine. Lidocaine is cheap as chips, but Versatis is expensive and the government picks up the Versatis tab each year to the tune of about €30 million. Or rather did pick up the tab but now no longer does so.

Joe Duffy, the self-important opinionated RTE talk-show host was having a rant about the decision by the HSE, on the advice of the HPRA, to cease supporting this therapeutic regime. Obviously, if €30 million has been saved and each prescription costs North of €1,000 a year, there are a lot - about 25,000 - of people out there who will be feeling a sense of deprivation, not to mention feeling aggrieved, not to mention re-suffering pain. Several of these called in to tell their anecdote. "It's purely down to money" claimed Kilmuckridge GP Dr Val Lawlor, as if saving tax-payers' money was obviously a bad thing. There are other pain-killers which are still supported by the HSE, most notably oral pregabalin aka Lyrica about which I waxed lyrical two years ago.  If it was me, and I wasn't paying the bill, I'd prefer something applied locally, topically, rather than have an oral medication coursing through my liver and lights perhaps causing a variety of side effects.

And contra Dr Lawlor and Joe "soundbyte simple" Duffy, the HSE is not directly trying to save money, it is trying to get value for it. To this end, there is another office filled with feeders at the public trough: The HPRA, Health Products Regulatory Agency, An tUdarás Rialála Táirgí Sláinte [prev]. They are scientists, quants and statisticians all charged with assessing the evidence for medical benefit and setting that against the cost. Actually, the quants are in another body: National Centre for Pharmacoeconomics NCPE. They apply a standard formula, probably based on QALYs - quality adjusted life-years - [multiprev] to establish each cost:benefit ratio. If the benefits outweigh the costs by a given threshold then HPRA gives their appro and that cohort of sufferers get relief. Of course, if there is political capital in subverting this ostensibly fair system, then the Minister of Health will bend the rules for the few, and pretend this has no impact on the many.

Here's the [20 page!!] summary of the evidence for the HSE's decision to stop paying for Versatis earlier this year. It reads like the only scientific study for the efficacy of Versatis patches was one investigating "treatment of neuropathic pain associated with post-herpetic neuralgia (PHN)". That study found significant benefit over placebo for that condition, so that's the only condition for which HSE will pay. Because nobody has sponsored a case-control study for the relief of whip-lash pain, or rheumatoid arthritis pain, then the HSE cannot, or will not, countenance paying Versatis prices for those can't-get-out-of-bed sufferers.

Because he is simple, Mr Duffy chose to make a head-to-head comparison between those who had been deprived of Versatis patches and the current hoo-har about 'high fat diet cures cancer' claims in a book called The Ketogenic Kitchen. That is like saying that the cops shouldn't catch me speeding - they should devote their energies to apprehending murderers; they can do both, of course. The MS Society has a more adult response. The HSE effectively has two standards of care:
  • Treatments where the benefits are so fuzzy that they are unwilling to venture tax-dollars on their support. Here, if you have sufficient funds, you can choose to pay the price demanded by big pharma. 
    • The corollary of this is that people in the care of the HSE [everyone in the Republic] can only buy such meds from a reputable source. The Internet, even a huge company like CVS in USA, is not an HSE-approved source. So you can't order 4% Lidocaine patches from them at $1 a go. Irish Customs and Excise will indeed seize such shipments on arrival and destroy them if you cannot show that they are legal according to our health watchdog.
  • Therapies / regimes which are demonstrably wrong-headed or for which there is no good evidence for efficacy. Here, the HSE will not allow sale to anybody. They realise that sick, pain-hobbled people, are not in the best position to be rational and few are qualified to interpret an adverse report from a reputable body like The Cochrane Index.
It seems unlikely that post-herpetic neuralgia is the only painful condition that will respond to Lidocaine patches. I would therefore expect that there are people a) with other sources of agony b) which were relieved by Versatis up until the ban and c) cannot reasonably afford €1,000 /year. But I don't think it is scientific or fair to bend the evidence-based rules for sensibly spending on health just because a talk-show gives voice to a succession of articulate people who stand to benefit. €30,000,000 a year would pay for a lot of nurses, trolleys, speech-therapists, STI-avoidance leaflets . . . or whatever your favourite gripe is about the deficiencies of the health service in Ireland.

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