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April 26, 2015 / molehunter

new anti melanoma drugs-hype to substance ratio and affordability

http://www.onclive.com/web-exclusives/Hodi-Speaks-to-Significance-of-Phase-II-Data-on-Ipilimumab-Plus-Nivolumab-in-Melanoma

The world of new chemical agents to treat stage 4 (i.e. widespread) malignant melanoma has been buzzing since the discovery and widespread use of Imilimumab (Yervoy, Bristol Myers Squibb). This drug is a monoclonal antibody produced, as far as I can tell, from genetically modified mice, which works on the immune system. It has quite a few significant side effects, gives stage 4 melanoma sufferers on average an extra 13 weeks of life, and costs £80,000 for a course of treatment. That’s more than the combined price I paid for the family homes I bought in 1981 and 1985.

Now Ipi (as its called for short) is being used in combination with other agents. The trial linked to at the top of this post is of Ipi plus Nivolumab. The results are somewhat better and are being hailed as pointing to ‘a penicillin moment’ i.e. the realisation of the long awaited ‘magic bullet’ which will kill all the cancer cells and make someone completely free. Alas, its not that good. Side effects are magnified and Nivolumab is even more expensive than Ipilimumab.

Yes, the drugs offer some hope. They appear to work better than anything else so far in this deadly stage 4 melanoma situation, but they are not a cure. The study above talked about 24% complete response rates. That’s not cure, that’s response. We don’t yet know how many of these patients will still be alive in 5 years, or even 2 years.

I heard an American specialist talking about the new chemotherapy regimes being trialed in stage 4 melanoma when I attended the Melanoma Focus meeting in London last autumn. He said that treatment regimes based on combinations of the newer agents (immune modulators like Ipi, Nivolumab and Pembrolizumab) plus the BRAF inhibitors like Vemurafenib and the emerging MEK inhibitors could cost anything from $150,000 to a million dollars per patient. And this isn’t even for a one-off course of chemo that will cure, the people are still going to be fairly sick, some will die from the toxicity of the drugs.

Folks, and I include with every sympathy melanoma patients and relatives who may come here, we can’t afford this. We just can’t. I don’t want to offend anyone, but a million dollars or pounds to give people a few extra months of life simply is not affordable when you consider the thousands of people every year diagnosed with melanoma. Seriously, if we put every patient with stage 4 melanoma on Ipi plus Nivolumab, that would cost about £150,000 x 3,000 patients =£450,000,000. A year. That’s before we add in BRAF and MEK inhibitors, which would at least doble the costs t around a £ billion, about 1% of the total NHS budget. There are thousands of other priorities and NOBODY wants to pay an extra penny in tax, although plenty of people want someone else to pay more in tax. Can’t be done folks, sorry, its the arithmetic.

Its no good saying the drug companies should just sell the drugs cheaper. It costs about a £billion to bring a new drug to market, and like I said-Ipi is (as far as I know) a monoclonal antibody made from genetically modified mouse blood. Just think what it costs to harvest, isolate and purify a single antibody from mouse blood. Incidentally, although I am OK with medical research involving animal experimentation and genetic engineering (subject to checks and balances) many people have strong feelings about both subjects, but seem to go quiet when its cancer treatments we are talking about. Just saying.

Yes, I am biased since I teach early diagnosis of skin cancer for reward (although I could earn more money easier doing cosmetic dermatology or in other ways if money was what drove me) but at least I am open and honest about my bias. We are all biased one way or another. We have to think these things through rationally rather than be led by an emotive ‘what if it was your mother or daughter!’ shroud-waving agenda. We know for sure that we can save a lot more lives, easier and far cheaper by better public education about how to pick up a dangerous mole and better access to well trained doctors and nurses who know how to use a dermoscope. This was one of the lessons put across at the World Dermoscopy Congress which I just attended.

It is easier to get headlines about raising public or private money for a ‘life saving’ treatment for a named individual, especially when its a mother. I sympathise. But even if what I posted above offends some people, please at least do the math. Prevention is better than cure, what’s more it could be better achieved and very cheaply by training one GP in every group practice in dermoscopy skills. Our dermoscopy course this year will train around 100 doctors and nurses for a total cost in the region of  £14,000. For the cost of  50 course of combined melanoma chemotherapy, and allowing for greater use of on-line learning, we (and a few others like us) could train half the GPs and practice nurses in the whole UK in earlier detection of melanomas.

The main focus of this blog will continue to be posting actual cases for education, but this issue is getting bigger very fast, and key opinion leaders are so nervous of talking about it for fear of offending victims and their families, that i felt I had to say something. You may not agree. Comments are welcome.

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One Comment

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  1. aswillman / Apr 26 2015 12:11 pm

    Totally agree with your sentiments. Since doing your course, I’ve been using a dermatoscope and whilst inexperienced, am getting better. I’m just about to get the attachment to allow me to take photos so I can hopefully get some peer review. I am now the focal point in the practice so the more I see, the better I get. As you say, a trained GP in every practice & we can hopefully prevent some of this horrible disease.

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