FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials

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.

Richard Burt Warning Letter

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.

30 thoughts on “FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials


    • @Therese,
      It’s more a question of how the risk of death is portrayed to patients during the consent process and if a patient asks the NW team, “How many people have died?” whether they get an accurate, up-to-date answer? Apparently the FDA itself was not told of some patient deaths within the 72 hrs required, but rather something like a year after the fact.
      Paul


    • And further yo How Many, what’s the secret information you have regarding deaths and how the information was presented. “You understand you can die” is pretty straight forward IMO.


      • “You understand you can die” is not the same as “Based on deaths that have occurred so far, you have a 1%, 10%, 25%, or 50% chance of dying”. The numbers matter.


        • No they don’t when you are going to live a life of total pain and misery and a slow painful death from your terminal illness. I wonder if you’ve ever had a chronic illness been so sick you could cut your own food or told to go home and die by your GP?


          • Yes they do matter. It’s one thing to tell a desperate patient that there is a risk of death when that risk is theoretical, meaning no one has yet dies but it cannot be ruled out (i.e. Covering one’s ass). It’s quite another to say 12 patients out of 50 who have undergone this treatment have died. I’m all for people having access to Burt’s treatment no matter what the risk might be – as long as they are properly informed of the risks and choose to to take them.


  1. Dr Burt saved my life he is amazing and his team wonderful. I believe in everything he does and his professionalism.


  2. It is a serious procedure and MS IS a serious condition…I’m sure 99.9% of MS candidates are aware of the dangers and possible rewards of HSCT. Nothing new but the FDA possibly getting pressure from Big Pharma to slow the procedure from going mainstream.


    • I don’t think 100% of MS candidates even realize it’s not a terminal illness.

      Nor a condemnation to a lifetime of severe pain and limitations.

      I was diagnosed 10 years ago; lesions in my brain and spine. Still completed my PhD, still working full time at a job I love, still walking, and if you asked me if I’d risk a 10% chance of dying to “cure” the condition, I’d stared at you strangely and then see if you had the time to sit down and talk about the sort of catastrophic language people use around chronic illness to make it sound like our lives are going to be not worth living and are therefor basically disposable.


  3. BIG PHARMA will do EVERYTHING IT CAN to KEEP THIS LIFE SAVING TREATMENT FROM BEING AVAILABLE IN THE US. They are spending a LOT of lobbyist (aka bribe) money to stop HSCT in the US because they will lose BILLIONS on their crappy meds that DO NOT WORK. HSCT has been being successfully done in other Countries for OVER A DECADE to put MS in remission. The GREED of Big Pharma here in the US will forever be trying to stall it here. Don’t let the FDA and Big Pharma ruin your chance at getting better. Go out of Country.


          • I apologize for butting in here. But, I’m neither a doctor nor a scientist so I suppose I don’t require rigorous studies or proof the way the biomedical research community does. For my purposes as a layman, having some knowledge into Supreme Court decisions that have allowed for the giving of money in exchange for political favors to count as “free speech” and for corporations (like big pharma) to count as “persons” is enough. That the corporate sector operates in ways which undermine democratic and even patient values is not a surprise to me or something that I personally need proof of. If you want specific numbers, studies, evidence, proof or data reminiscent of clinical trials that reflect this then you might have some research to do. Perhaps you are a scientist or health care professional. So work of this sort could very well be right down your alley.


            • Do large companies lobby in Washington? Of course they do. But if someone levels a specific claim like “Big Pharma is spending a lot of money to stop HSCT in the US”, then yes, some kind of evidence of this should be cited or else it’s just baseless BS.


              • I’m not sure what counts as proof or evidence in this instance. Maybe Baseless BS is in the eye of the beholder. But, there is a Sage Encyclopedia of Stem Cell Research. Page 589 makes some interesting points about how ISSCR (International Society for Stem Cell Research) could allegedly be the creation of big medicine “devoted to blocking any stem cell treatment that might threaten the drug industries bottom line.” Yes. Just an allegation. But, I don’t like to give the powerful the benefit of the doubt they do not need from a little guy like me. The powerful garner enough money and purchase plenty of influence from the big players to do that all by themselves.


    • SCT saved my life and that’s a FACT the only Fact people should be listening too.
      Dr Burt is a pioneer and a geneius that’s a FACT. Until you walk in my pain, fear , disease I think people shouldn’t comment.


      • The only FACT is that you THINK he saved your life. This is not however a clinical fact, as no statistically significant clinical evidence resulting from a controlled clinical trial has been presented.

        FACTS need EVIDENCE.


        • I wrote a response that included the actual letter and the fact that this issue was solved in December of 2016. It was deleted. The fact that this was written without accurate detail is very irresponsible. Also, as I said in my previous post (that was deleted) people do not THINK he saved their lives, they KNOW he did…before judging someone on their opinion, do more homework.


          • Hi, I had Stiff person syndrome and developed encephalitis of the cerebellum. I’m the first person to have the hsct procedure outside of Canada and USA. I had my transplant in September 2016 at the Royal Hallamshire hospital in Sheffield England using Dr Burt protocol. I had the more aggressive varient of SPS and was months from certain death. Professors warned me of risk of death and were reluctant to proceed because of the uncertain outcome however, I managed to convince the Professors that this was the only option left to me.
            Dr Burt saved my life and although recovery is slow it is also sure..before the procedure there was no hope of a future and now there’s a future of life.


  4. I think the FDA is trying to stir up some stuff because Dr. Burt has been doing this study for many years and is possibly reaching the end. It’s a shame that NOW they are looking at this. Why not over the years? Are they doing this with any other stem cell transplant studies? This trial has been going on for so many years that it would be surprising that there were no incidents. As far as THINKING he saved lives, that is the opinion of the person whose life has been saved. I think he saved me from a a much worse future…and, yes, I am EVIDENCE of that FACT.

    Here is the actual document:
    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm548176.htm

    And, Dr. Burt responded which resulted in the following letter:
    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm548813.htm


  5. One patient died of pneumonia (not related to the treatment), one patient died of kidney stones (not related to the treatment) However, because they are in the study they must be reported within 72 hours. Apparently that was not done.
    It also appears that all the other issues are related to the training and documentation of expansion sites in other parts of the world.

    That’s my read on the FDA warning letter.

    I think the FDA got a bug in their butt after the stem cell THERAPY (not transplant) in FL that blinded a number of patients. This is unrelated to the work by Dr Burt but probably shook up the FDA. (Just my opinion)

    I’m also surprised that the FDA has jurisdiction of activity all over the world. That seems like overreach to me. (Again, only my opinion.)

Leave a Reply