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.
I am forever grateful to Dr Burt, Carol Burns, Amy and his wonderful team! 2023 I will be 10 years post Systemic Scleroderma and my doctor here said it wouldn’t work! HE IS THE VERY BEST AND MY CHILDREN WILL BE FOREVER GRATEFUL TOO xx
Dr. Richard K. Burt saved my life. I had Progressive Systemic Scleroderma, Stem Cell Transplant was 2/22/2011. It stopped the progression of the disease. It has been 11 years now since the Transplant. I am still alive because of Dr. R. K. Burt and his Staff at Northwestern at Chicago, IL Until you have been in our shoes, please don’t question Dr. Burt’s Clinical trials, they do work. We ask for his help and he delivered.
I was treated by Dr. Burt in 2005 along with Dr Pierce, and Dr.Douglas Losordo. Had it not been for this group of clinicians , I was destined to have bilateral above the knee amputations. Seventeen years later I am cured of the peripheral vascular disease that almost took my legs. I owe my life to Dr. Burt and his team.
Richard – are you now in remission for CIDP? The Mexico places are known to not do follow ups or keep accurate data on patient progress. I’ve yet to find one person with CIDP who had good results from their Mexico based treatments. I’d be happy to hear it helped you?
Over 14 years ago my then 16 year old daughter had stem cell transplant at North Western with Dr Burt as our lead doctor. We were told upfront about the chances for death and all the other risks. I think what people and the FDA are failing to realize is that patients such as my daughter are already on at deaths door trying desperately trying to survive. Since my daughters transplant I have spoken with other families in search of a miracle….. that is what stem cell is. One last chance to live. Today I have a healthy daughter and 3 beautiful grandchildren. We are forever in debt to Dr Burt and the staff at North Western.
So now they want to fight against something that’s proven worldwide & already a first line choice in some countries. I did this on Mexico in 2016. My last Tysabri infusion was on 2/2/2016. My Tysabri was $19,606 every 28 days, 13 times a year. That’s 30 infusions I did not have to do. That’s over $600,000. Biogen better find another disease to profit from. Oh and by the way, the procedure cost $54,500. The FDA & the pharmaceutical companies are crooks that work hand in hand! Keep them sick enough to need your meds. MSers are repeat customers to them & the pharmaceutical companies.
My friend had SCT by Dr. Burt in January 2017. She is out of horrible pain, able to walk without fear of falling, had no new lesions at her followup visit , and is enjoying her life free from MS
That is awesome! We need to March to the White House and throw the canes, walkers and wheelchairs along with the toxic meds we don’t have to take anymore in the front yard to make a point that this needs to be a treatment option at diagnosis of m.s. and other autoimmune diseases. I was pissed before my HSCT and I feel the same now. Ahrg!
There is no comparison reading about SPS and witnessing someone living with this disease. It is simply heartbreaking watching my 41-y-old patient experiencing extreme pain 2/2 violent involuntary jerking movements, and a mile long list of additional physical manifestations, and psychosocial distress she has to endure on a daily basis. In additional, the lack of information and understanding on those surrounding a person affected with this disease causing great frustration and even harm to the affected person. She expressed if she would have an once of a chance to live a somewhat normal life she would be willing to try any clinical trials knowing risks and potential benefits.
HSCT is the only treatment that works. Google HSCT blogs to see mpre people who have had this life changing treatment a hematopoietic stem cell transplant using patients own stem cells. It was a no brainer, I had an EDSS of 6 and have one that is a 2 now. No more spasticity, peeing my pants and no more toxic disease modifying drugs.
http://www.chasingstemcells.wordpress.com
There is many incorrect items in your part 3 graph. This should not be on here unless you have applied for treatment. They don’t seek desperate people, the FDA study (not trial, that is why it is not free) is very set on their criteria, I was not accepted. Dr. Burt and Northwestern are in my insurance network and would have paid if I was accepted, I let them know they were in network). Many insurance companies have paid. The Off-Study patients were ones that did not fit aspects of the criteria, but Dr. Burt believed they would see benefits. Google HSCT blogs and you will see.
We have very lucrative autoimmune diseases. People should take some science and biology classes please.
It is very uncommon to find a neurologist that supports HSCT as a treatment for autoimmune neurological disorders (such as MS and CIDP, etc.). Neurologists know a whole lot about nerves but usually know quite little about the actual underlying pathogenesis of autoimmune diseases which reside in the immune system. Because neurologists are typically not educated, not trained and not experienced in HSCT and why it is the most effective medical intervention so far discovered for hematologically-rooted autoimmune disorders, it is human nature that someone ignorant on the subject will not support something they don’t understand. I like to use the analogy that you wouldn’t choose a house painter to fix your car engine because it is a complete mismatch of skills, so why would you choose a neurologist to consult about your immune system? (A hematologist is the right specialty.) For treatment of these disease types, seems like the only skill most neurologists have is to prescribe a lifetime of drugs that have no hope of halting the underlying autoimmune disease the way HSCT can.
https://www.youtube.com/watch?v=G7P4iFg048k
http://www.chasingstemcells.wordpress.com
Amen!
I need help please. My sister is suffering from relapsing polychondritis. Its a horrible, extremely rare auto immune disease. She has contacted Dr. Burts office twice to discuss therapy, but no reply. Has anyone on this blog been treated for polychondritis and been cured? Can anyone offer suggestions on how to get into see him? thank you
That is terrible, I had my HSCT in Puebla, Mexico. Best thing I ever did, they provide a 2bd 2ba apartment and a driver. I hope you find some help.
This is Leslie’s info. email Danielle she is busy so give her maybe 2 weeks?
http://www.myfighttokeepsmyelin.com/p/clinica-ruiz-hsct.html
and this info should help to see what they can do if they can?
http://www.medicinenet.com/relapsing_polychondritis/article.htm
Suzanne Starley, Try reaching out to one of his nurses named Rachel Schmitt at (312) 695-6186 or via email rachel.schmitt1@northwestern.edu
Good luck!
I too am a benefactor of HSCT by Dr. Burt five years ago.
Isabel
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.)
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
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.
Can you cite any proof of this?
Proof of which fact? “Bill Jones”.
“BIG PHARMA is spending a LOT of lobbyist (aka bribe) money to stop HSCT in the US”
Proof that BIG PHARMA is “spending a LOT of lobby (aka bribe) money to stop HSCT in the US…”
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.
Archie is so full of himself that he knows your disease better than you do, holy shit this is a new level of arrogance.
Interesting that the FDA went after Dr. Burt but haven’t lifted a finger regarding Cell Surgical Network…
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.
EXACTLY.
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.
So very glad to hear you are managing your disease so well. However, not everyone who has MS has the same experience you have. My sister died at 56 of complications of MS. It was a horrible death. She was a paraplegic at the end of her life, could not sit, could not speak, could not dial a phone. I don’t know if she would have chosen stem cell replacement but it might have made a huge difference in her life–like seeing her son get married. Everyone’s life is worth living. No ones life is disposable. But not every person’s disease or treatment is the same.
Wow! – things going wrong with stem cell trials that are not at “unregulated clinics”?
Dr Burt saved my life he is amazing and his team wonderful. I believe in everything he does and his professionalism.
Dr. Burt saved my life too. I was diagnosed with Progressive Systemic Scleroderma around 2008-2009. I had a Stem Cell Transplant Feb. 22, 2011. The Transplant stopped the progression of the Systemic Scleroderma . Feb.22, 2019 will be eight yrs. for me. I was sixty-two yrs. young when I had theTransplant. I get out and maintain my own yard, mowing, trimming weeds, working in my flower beds, etc. I do get fatigued easily but I have learned how much I can do and when to quit. Dr. Burt is my Hero; I would not be here if it wasn’t for Dr. Burt.
Dr. Burt and his Staff told me what to expect before, during and after Transplant. It was scary but I survived. I signed many papers, I knew what I was getting into.
Dr. Burt saved my husbands life and thanks to him and his staff he has his life back !
So how many have died? I only saw a few reported on FDA site from treatment for SPS.
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.
“died” not “dies”
All patients are warned of the risk of death. Spreading information otherwise is irresponsible of you.
@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
I asked and I got a reply. There were very few deaths — 1 or 2 at the time– and none for treatment of CIDP. I went ahead with the trial 7 years ago. I am still in remission.
Congratulations!!!!! I had it done in Mexico when Dr. Burts office said I wasn’t sick enough.
Thanks for pointing these issues out. Do you think these types of occurrences are isolated instances?