The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA warning letter late last year for a number of serious problems with his stem cell trial including failure to promptly report patient deaths to the FDA.
Another issue noted by the FDA was lack of proper oversight of other participating investigators in the trial at locations around the globe. The list goes on and on of big problems detailed in this long letter. Notably the issues in this mid-November 2016 warning letter were reportedly “addressed” according to a follow up letter from the FDA (see close out letter link at bottom of the warning letter webpage) so hopefully that means at least some improvement.
However, this warning letter raises many longer term concerns. For instance, if Dr. Burt’s team did not report patient deaths properly to the FDA, did they also not tell future prospective trial participants about how often deaths occurred? As such, were trial participants properly consented in terms of being informed about potential risks to them?
The wording of the letter signals the seriousness of this situation and the FDA says at the start:
“We have determined that you violated regulations governing the proper conduct of clinical studies involving investigational new drugs, as published in Title 21, Code of Federal Regulations (CFR) Part 312…”
Has this big, complicated trial gone a bit out of control?
In addition and more broadly, other aspects of Dr. Burt’s stem cell clinical trial work have potentially problematic issues that still may not be resolved and that raise difficult bioethical questions. These other concerns will be the subject of a follow up post.