A senior doctor has by the means of BMJ raised a serious concern over licensing of new drugs for commercialization purposes.
This has come after natalizumab, a new drug for multiple sclerosis, was approved and thereafter recalled after three months. This was done after three trial patients developed a life threatening condition while being treated.
AdvertisementThe drug was licensed by the US Food and Drug Administration in 2004 on the basis of short term results from two unpublished trials. The result was that when tested it was on 28 February 2005, recalled after three trial patients developed progressive multifocal leucoencephalopathy (PML). The result was that in between two of the patients died.
The approval of natalizumab and its recall after three months raises questions about the fast tracking of new drugs by the FDA for commercial licensing. This was brought to the fore by consultant neurologist Abhijit Chaudhuri.
The warning signal is here and it must be paid heed to so that in the future such mistakes are not repeated.