Time is Brain, even in MS! How quickly should we treat MS? DrK makes the case for treating everyone as quickly as possible. Do you agree? Can you help us convince Biogen about the case for a Brain Attack Trial?
When we were at the ECF meeting in Baveno DrK came up with a very important trial design to maximise the protection of the brain in MS. We all know that 'Time is Brain' and most MSologists will have patients who have had catastrophic relapses whilst waiting for a diagnostic workup and/or DMTs. We also know that MS activity tends to be clustered, i.e. one of the best predictors of a relapse is a recent relapse. Instead of putting patients with possible early symptomatic MS at risk from having to wait why don't we to treat them all with natalizumab to protect their brains and spinal cords? This is analogous to treating stroke. Why natalizumab? It is one of our most effective DMTs, it works very quickly, it is given as an IV infusion, hence there is no problem with adherence and is very safe for up to 12 months. It is also relatively safe in pregnancy. During this 12 month period, the neurologist and the patient can then decide what strategy they want to pursue in the long-term. This could be to continue natalizumab long-term or to switch to another DMT, or in the case of an alternative diagnosis the drug can be stopped. To make the Brain Attack Trial a reality we would have to get Biogen to ask the EMA to license natalizumab as a 1st-line treatment. This may require data. Hence we are proposing that Biogen sponsor a 'Brain Attack Trial'. This would become even more important if you can derisk the PML problem associated with natalizumab. Imagine if we can reduce the risk of PML to zero? Who wouldn't want to start on natalizumab as a first-line therapy? Natalizumab will become the one and only platform therapy. The problem with this is that Biogen has other DMTs in the MS space and the Brain Attack Trial will potentially result in natalizumab cannibalizing their other DMT market. How bold is Biogen?
I can't resist a business anecdote. Sony invented the Walkman, which transformed the way we listen to music. Sony then developed a digital version of the Walkman, i.e. their version of iPod. This was done a decade before Apple launched the iPod. However, Sony blinked and you should never blink in business. The issue was that Sony also produced content via Sony Music and other record labels (e.g. Columbia Records) and as a result of this Sony Executives decided it was too risky to launch the digital Walkman and decided to keep it under wraps and mothball it. Sony was worried that a digital Walkman would fuel digital piracy and cannibalize the music industry. Fast-forward a decade an Apple launches the iPod, which transforms the music industry, kills the Sony Walkman, revitalises Apple and the rest is history. Sony was the one company, outside of Apple, Steve Jobs admired and feared most. Have you compared the recent fortunes of Apple and Sony? Joseph Schumpeter, the famous economist, calls this creative destruction.
The moral of this story is that if Biogen doesn't do this study another company will and Biogen will run the risk of becoming the Sony of the MS world; first admired, then envied and finally irrelevant.