Multiple sclerosis (MS) is a demyelinating disease of the central nervous system with an unknown aetiology. MS has a geographic pattern of prevalence with high prevalence rates between 45 degrees and 65 degrees north. In much of the northern hemisphere, there exists a prevalence gradient, with increasing prevalence from south to north. While genetics may partially explain the latitudinal gradient, it is not strong enough to exclude exogenous variables. Kurtzke initially came up with a three-zone scale for low, medium, and high prevalence zones. He defined high as 30 or more per 100,000, medium as 5-29 per 100,000, and low as less than 5 per 100,000. In this study, 131 geographic datasets (geocases) were spatially analyzed to determine whether the existing global prevalence scale needed to be updated. The mean prevalence rate was 67.83/100,000 with rates ranging from 350/100,000 to 0/100,000. The results of this study suggest that the commonly referenced scale for global MS prevalence needs to be updated with added zones to reflect significantly higher prevalence rates in some areas of the world. We suggest a five-zone scale: very high (170-350), high (70-170), medium (38-70), low (13-38), and very low (0-13).
Scotland is MS central and whilst one can have high medium and low and this report suggests or very high very low etc. but at the end of the day it is horses for courses as it makes no difference to treatment options.
We asked should Primary Progresssive MS be an Orphan Disease, as it may make it an easier route towards new treatment. Maybe I should have asked what needs to be done.
Part of that is that we need to talk to the regulators, such as the FDA and the EDA.
However to talk to the European Medicine Agency costs £30,000 for a few hours and here lies a problem.
No Academic has the spare £30K lying around to blow on some Brussels Bureaucrats.
This means two things that that an academic is unlikely to: (a) Change the definition of progressive MS as an orphan disease without support and (b) will not get a (repurposed) drug licensed without a change in the process or without pharma backing. Academics and Neuros just don't have the resource.
Am I wrong?
Why so much, well you have to get a panel from across Europe to agree on such issues. Flights and trains and hotels cost money. Pharma has to pay this to speak and get answers from the regulators. So to get MS designated as an Orphan disease, we need deep pockets.
Maybe pharma have tried already....and failed
Maybe the MS Societies could do this, maybe with pharma backing if they all chipped in a few quid to fund.
Maybe a public lobby to get change.
Maybe I am talking nonsense
But without action nothing will change.
Labels: Big Pharma, MS