ClinicSpeak: some reflections on my first visit to India

Why is India such an inspiring place? #MSBlog #MSResearch #ClinicSpeak

"As I reflect on my return flight from my lecture tour in India I am beginning to realise that one of the largest unmet needs in MS, globally, is access to disease-modifying therapies (DMTs). Although MS is relatively uncommon in India, the sheer size of the population means that there probably as many MSers living in India as there are in the UK, i.e. greater than 100,000. There is no NHS in India to pick-up the tab for high-cost DMTs; as a result of this less than 5% of MSers living in India are on a DMT. The only criterion for accessing DMTs in India is wealth. One neurologist told me that several of his patients are forced to buy their interferon-beta injections on a weekly basis; they simply don’t have enough money to pay for a month’s supply. His patients often miss injections as they simply unable to raise enough money to pay for the next week’s supply. Please note, these are not poor MSers, but the relatively well off. In comparison, the poor are left to face the consequences of untreated MS; the shredder is left to shred. This is why my ‘essential list of off-label DMTs’ is so important.

After speaking to many neurologists in Delhi, Bangalore and Hyderabad it became apparent that, apart from steroids, they simply don’t use off-label DMTs. For example, none I spoke to use azathioprine. This is in contrast to South Africa, where neurologists do use off-label medications in the state system. In India the MSologists practice evidence-based neurology and are of the opinion that if a drug is not licensed it should not be prescribed. I tried to explain to them that because a particular drug is not licensed for treating MS it does not mean that it is ineffective. The factors that dictate whether a drug gets licensed, or not, is largely determined by how much a drug is going to generate for the Pharma company who developed it. Drugs that are off-patent, or have a short patent life, are not going to get licensed. An executive from a large Pharma company recently told me that their break even number is $450 million per year in global sales; if a drug is projected to have sales of less than this they will disinvest and either sell it, or license it, to a smaller company to develop or they will mothball the programme. He told me that the regulatory requirements to maintain a licensed drug in Europe alone are close to €500,000 per annum. What chances have we as academics got of licensing, and maintain a license, for any of the drugs on the essential MS off-label DMT list?

The licensed DMTs have had, and have, large and sustained marketing campaigns promoting their use, which is why neurologists perceive them as being the only options for treating MS. Interestingly, with biological therapies such as the interferons and glatiramer acetate, the prevailing wisdom in India is that the biosimilars will never be as good as the innovator products. My wife who works in advertising and branding will say that is because of the power of the brand. India like any other developing country has aspirations; being able to prescribe state-of-the art licensed medication is very important to them and the patients they treat. I don’t have a problem with this practice, and actively support it; it is the majority of MSers who can’t afford the medications that I am concerned about.

Getting neurologists in resource-poor settings to adopt off-label prescribing is going to be very hard; simply blogging about it is not going to make it happen. I am going to need a much wider and smarter campaign and help from the wider MS community. Any ideas and/or help is welcome. Another option is to lobby Pharma to adopt the same strategy as they did with HIV; i.e. to have two pricing structures one for rich countries and another for developing ones. The chances of this happening, however, are low; MS is simply not politicised enough and does not have the same level of activism as the HIV community. MS is not considered a global health problem; it simply doesn’t get onto the healthcare radar in developing countries. Unfortunately, this does little to help the individual with MS. Each person with MS needs help; why should we forget about them because they live in resource poor countries and can’t afford licensed DMTs?

On a positive note I feel more energised about clinical neurology than I have been for some time. I am now almost 3 months into my sabbatical and for the first time I beginning to see a different vison of what I need to do before April 2015 when I start clinical work again. I need to get MSologists in resource poor settings to consider adopting treating-2-target of NEDA using off-label drugs. I am convinced my proposed list of drugs, if used actively as part of a strategy to treat-2-target, can make a real difference to the lives of the MSers they look after. To simply leave them to be ravaged by their disease is not an option. It was also reassuring to note that access to MRI in India is widespread and relatively cheap; much cheaper than the UK. There seemed to be a consensus that MRI monitoring of disease activity was needed, and in fact is practiced, by all the neurologists I spoke to.

The service that neurologists in India provide is truly remarkable under very challenging circumstances. On my visit to NIMHANS, a large and truly world-class neuroscience centre in Bangalore, I couldn’t quite comprehend the scale of India’s medical need. NIMHANS treats over 450,000 patients per year; they see approximately 600 new patients per day. There is no booking system; very ill patients are triaged and seen in the A&E, the others queue and are seen on a first-come first-seen basis in outpatients. Patients start queuing the night before and many wait 12-14 hours to see a neurologist. In one consulting room I met a man who left Kolkata (Calcutta) on the 5th December to travel by train and bus, to Bangalore to be seen by a neurologist on the 15th December at 11am in the morning; he had started queuing the night before. He wasn’t complaining, on the contrary, he was clearly very grateful to be seeing a neurologist. Please note this is a trip of ~1600km one-way; by the time gets home it will have taken him at least 2 weeks. This puts into perspective the waiting times of MSers at the Royal London Hospital; I get anxious when my patients have to wait longer than 30 minutes to see me.

Please note my trip to India coincided with the Indian launch of dimethyl fumarate (DMF) and was sponsored by Biogen-Idec. I spoke on NEDA, treating-2-target, end-organ damage, DMF and how I saw DMF fitting into the treatment algorithm. I suspect that only 5% or less of the MSers in India will be able to afford DMF; it is the ones who can’t afford DMF that concern me most. I would like to thank my hosts for making my trip such a remarkable one. India is an enchanting country, diverse and rich in culture; its peoples are happy and have a spiritual dimension to their lives that we in the West seem to have lost. Time takes on a different dimension in India; there is no rat race or an urgency to complete a list of tasks. I feel more relaxed and content than I have in a long, long time; I intend to make it last. I can’t wait to return to India with my family to discover more of its hidden wonders and to stay connected to its way of life and the philosophy of its peoples."

CoI: multiple; please see slide 2 of presentation for specific disclosures.

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