FDA's rejection of alemtuzumab divides neurologists

Has the US Food and Drug Administration asked for an impossible trial, or protected patients with multiple sclerosis from a drug with unknown benefits and clear risks? If 6% of the interferon-treated control patients over-reported their symptoms (inadvertently, or because they had previously failed...

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Bibliographic Details
Published in:	The Lancet (British edition) 2014-03, Vol.383 (9920), p.859-859
Main Author:	Mullard, Asher
Format:	Article
Language:	eng
Subjects:	Alemtuzumab Antibodies, Monoclonal, Humanized - adverse effects Attitude of Health Personnel Drug Approval - legislation & jurisprudence Drug dosages Drug therapy Humans Internal Medicine Multiple sclerosis Multiple Sclerosis - drug therapy Neurology United States United States Food and Drug Administration
Online Access:	Get full text
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Summary:	Has the US Food and Drug Administration asked for an impossible trial, or protected patients with multiple sclerosis from a drug with unknown benefits and clear risks? If 6% of the interferon-treated control patients over-reported their symptoms (inadvertently, or because they had previously failed on interferon and wanted to be switched to a new drug) and 10% of alemtuzumab-treated patients under-reported their symptoms (perhaps because they had high hopes for alemtuzumab and didn't want to be taken off the drug), the treatment-experienced pivotal trial can be written off as a false-positive result, showed one FDA analysis.
ISSN:	0140-6736 1474-547X