The Dark Ages of pain management : Australia, 2012

The Question

I asked a well-regarded pain management specialist recently a simple (if loaded) question. I asked : Do you agree that Australian pain management is a decade behind the US and other first-order countries? His answer shocked me to my core.

The Answer

He said “No.”.

Now this is where I must beg to differ from a conservative medical opinion. There’s a huge difference between considering yourself to be on the cutting edge of medical science, and actually being there. Unfortunately, for most (if not all) medical practitioners in general, and pain management specialists in particular, this is poorly understood. Let me explain.

Mmm, shellfish…

In 1998, an omega conotoxin (part of a shellfish’s poison defense) was synthesised in the US, and was almost immediately approved for use in patients via intrathecal delivery. This marvellous stuff is known as Ziconotide. While it has a number of significant and deleterious side-effects in some patients, it offers an enormous improvement in pain management, from both an efficacy and from a tolerance perspective. It’s much more powerful than morphine, and unlike morphine, it has NO (that’s zero!) measured tolerance increase. That means you need to use less of the stuff to mask pain, and you generally don’t have to increase the dose as your body becomes accustomed to the stuff. How cool is that?, I ask chronic pain sufferers.

The bits that show I’m fully qualified to discuss pain.

So, being the well-read and stupidly naïve patient that I am, I asked my pain specialist about Ziconotide as an alternative to my own constantly failing pain management regime. His initial response was, “It’s not approved for use in your intrathecal pump.”. This was surprising, since the documentation from 1999 and 2001 stated quite clearly that Ziconotide was approved, specifically and singularly, for the exact pump model I have implanted (a Medtronic Synchromed II-40 – Model 8637). To his credit, he did contact the Australian Medtronic people, and after a couple of weeks I was able to extract a “confirmation” through him, that it was, according to them, not approved for use in any Medtronic pumps, period.

WTF?

I was starting to get cognitive dissonance headaches, and I guess this is where most patients would give up : after all, who wants to argue with one of Australia’s leading pain specialists AND the company who made the equipment? Me, that’s who.

So I sent my specialist a copy of all the Ziconotide documentation, including the specific FDA approval document details, the followup documentation from other US medical specialists detailing the issues with management of the stuff, and so on, and requested that he forward the written information to Medtronic, and get back to me with an answer.

After another few weeks of the usual thing (you know, 24/7 pain, getting all the side-effects and none of the benefits of what was in the pump, apart from massive increase in tolerance and pain), and hearing nothing, I asked during my next appointment-slash-pump dose increase if there had been any news from Medtronic Australia. Oh yes, he said, there was.

Oh yeah…No.

Medtronic Australia’s stated position was that since Ziconotide was not approved by Australia’s regulatory authority (the Therapeutic Goods Administration) for use in patients, the approval of the FDA for the use of Ziconotide in Medtronic equipment was a moot point. When I pushed a bit harder, I found that no-one in Australia’s medical echelons is even considering Ziconotide (or any of the related conotoxins) for use in treatment of patients with chronic pain – despite the fact that the drug has been used for more than 12 years in the US, and is still classed as a first-tier analgaesic in that country!

I was really starting to see double standards everywhere I looked. So I asked what it would take to get the damn drug into a trial in Australia. I was informed that if I wanted to set up a trial of Ziconotide, I would have to front up a minimum of AUD$400,000 before anyone would show any interest in looking at its use in patients with chronic pain in Australia. No-one in the pain managment specialties were interested at this time in trialling Ziconotide, or any other conotoxin, for use as a chronic pain management option for Australian patients. (Aside : I would love to be proven wrong about this, so please feel free to comment if you are aware of any program evaluating Ziconotide or any other similar conotoxin for use in chronic pain management!)

[Additional Info]

My previous pain management specialist (perhaps one of THE most highly regarded pain specialists in Australia) talked quite a bit about conotoxins, but wasn’t prepared to discuss or explain much beyond the risks, and nothing about the benefits. Of course, this was the medical individual who harangued and insulted my wife and I in a special consultation, because I refused to allow his mentor, a real butcher of a medico, to continue treating me after failing to perform basic medical precautions during the last pump implant – a situation that I now have to have further surgery to correct.

So I’m not entirely satisfied with the willingness or compassion of the pain management people here in Australia, which is actually what prompted me to write this article in the first place. I had to redact so much it almost wasn’t worth including, but I’m feeling a bit saner now.

[End of Additional Info]

I should state here, for the record, that I would probably disqualify myself from any possible study using Ziconotide. I have too many mental health issues with depression and mild bipolar disorder for Ziconotide to be an appropriate treatment option, even given that I’m unlikely to be one of the 10% who do suffer from those particular side-effects. So it’s not really helping me, not in the long run, but I can’t imagine why so many people who should know better won’t put their money where their bank accounts are and get with the rest of the world (or at least, with the rest of the world as it was thirteen years ago).

The Bottom Line

So where does this leave us? Well, it leaves me frustrated as hell, and it leaves Australians with chronic pain problems fairly and squarely out in the cold. Unless we can get a petition or some other means of attracting attention to this dereliction of compassionate duty, we’re stuck with the same old same old – pethidine, bupivicaine, morphine, hydromorphone, fentanyl, or if you’re really lucky (like me) maybe sufentanil or remifentanil. But don’t hold your breath for anything modern, that costs money and we’re apparently not worth it.

I’d be interested to hear if anyone would consider joining me in setting up an online donation site to help fund, if nothing else, then at least Ziconotide testing here in Australia. The way I figure it, is if we have the money, we then have some control over getting a trial started, and managed properly, perhaps an ongoing cause to bring Australian medicine out of the dark ages.

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