This is not the right way to get a drug licensed

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The Independent Online

A licensed drug tested specifically for the licensed indications is safer for patients than an unlicensed one. The efforts by Genzyme, the Sanofi subsidiary, to obtain a licence for alemtuzumab in multiple sclerosis should therefore be welcomed.

Patients would then have confidence that the drug is suitable for their condition and would not have to rely on the opinion – and necessarily limited experience – of their personal consultant.

However, Genzyme has gone about it in a way which, while potentially benefiting patients in the future, is disadvantaging them now. That is what has upset the three leading neurologists who have protested to Jeremy Hunt.

The company has not encouraged off-label use of the drug for MS, but it has tolerated it for many years. Now, abruptly, it has cut off the supply. Existing patients may find themselves unable to complete their treatment and new patients may miss it altogether.

The demands of bureaucracy have trumped the needs of patients. If, when alemtuzumab is licensed, the price rises sharply, as predicted, that will compound the pain.

Small wonder the drug industry is unloved.