Marlo: Can you explain what off-label drugs are?
David Baker, Professor of Neuroimmunology: Okay, so off-label drugs are drugs that are available for something else. So you could have like a cancer drug or a drug for epilepsy, for example, and you think it might have some use for multiple sclerosis, so although it’s not licensed for multiple sclerosis it’s already been licensed for another indication which allows a doctor to prescribe it, kind of. So that’s what it is. So it’s a drug that’s available but it’s not licensed for multiple sclerosis, used in a different way from what it was originally intended. But there could be quite a few of those being developed and particularly for progressive MS there’s a number of drugs that are being trialled and if they’re shown to be useful, then they could be used off-label.
Marlo: Is it easier to get something licensed for multiple sclerosis if it is already available for something else?
David Baker: No, it’s very, very difficult. In fact it probably will never happen, and that’s because of the way that the system’s geared. So to get a licence the pharmaceutical industry have to pay millions and millions of pounds to develop that and they’re kind of not really interested in developing old drugs, they want to develop new drugs. So they do two things. They reinvent an old drug to make it a new drug. An example of that was Cladribine which was kind of made as a pro drug, which means it becomes active when you eat it, or Teriflunomide was the metabolite of another drug that was used in arthritis, or tested in arthritis. So they’re very shrewd in how they do it, but it’s really about doctors taking a chance of doing good by trying things new. But it’s unlikely that they’ll ever be licensed just because of the cost of actually licensing the drugs. I mean I don’t know how much it is, but it’s millions to do that and so no academic’s got enough money or kind of the knowledge to how to do it. So it requires a whole team, so pharmaceutical companies pay companies an awful lot of money to do all the regulation. So the document for the licensing may be 100, 200,000 pages long, you know, and somebody has to write all that in a way that the regulators want and we just don’t have the knowledge how to do that.
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