The charges presented in the Food and Drug Administration's warning letter to James Wilson, head of the University's Institute for Human Gene Therapy, if true, paint a bleak picture of the Institute's operations.
These new charges come close on the heels of the University's decision to strip the IHGT of the ability to carry out human trials, following the reports of an independent committee and a previous FDA report on IHGT clinical research issued after the death of a patient enrolled in one of the Institute's trials.
The University has maintained that the violations cited in previous reports have been largely peripheral to the fundamental research being conducted by the IGHT.
The FDA's new charges call that assertion into question. The FDA letter alleges numerous offenses in the basic practices of the Institute's animal research lab. The charges include lapses in research protocol being reported as amendments without noting their effect on the outcome of the studies, a lack of quality-assurance monitoring that allowed animals to be used that may have been unfit for the study, inconsistencies n recording the status of test animals, data being stored improperly, a lack of certain formal guidelines for evaluating data, and dozens of other lapses in the conduct of basic research that have the potential to invalidate the lab's work .
The charges, if true, seem to belie the University's argument that the violations committee by the IHGT were mainly administrative issues, which did not effect the validity of the group's work.
The FDA challenges the accuracy of the basic conclusions of the laboratory's work and raise the possibility that poorly conducted animal research paved the way for problems in human trials.
We also have to wonder why the University seems surprised with each set of increasingly serious charges, despite having formed two committees specifically to investigate the IHGT"s practices.
The University's previous responses are no longer sufficient to defend the Institute's work in the face of the FDA's latest allegations.
We eagerly await the University's response to these new charges.Comments powered by Disqus
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