Stem Cell Program That Treated Selma Blair Closes Its Doors

Stem Cell Program That Treated Selma Blair Closes Its Doors

Richard Burt, MD, the chief of Northwestern Medicine’s immunotherapy for autoimmune diseases division, is taking a sabbatical, and the stem cell program he has headed for many years, which treated a number of people with MS, is shutting down.

Burt headed a Phase 3 clinical trial testing hematopoietic stem cell transplantation (HSCT) with a group of 110 MS patients from Sept. 20, 2005 to July 7, 2016. Follow-ups ended in January 2018, and encouraging results for the trial were published a year later. But about six weeks ago, on a patient-run Facebook group that focuses on Burt’s study, the closing of the HSCT clinic was abruptly reported:

After 30 years developing HSCT for autoimmune diseases from animal models to phase I, II, and III studies, and 15 years of working 24/7/365 to be available to care for both inpatients and outpatients, Dr. Burt will wind down transplant over this year and afterwards is taking an academic research sabbatical to focus on publishing articles, publish a requested medical textbook on this field, educational talks to help other centers through America develop this therapy, and work on another scientific stem cell discovery that Dr Burt wants to bring to clinical trials to help patients. Dr Burt and his entire team are extremely grateful for the support and gratitude of all his patients. We are so proud and honored to have traveled this path with you. Thank you from all of us.

Since that was posted on Facebook, a spokesperson for Northwestern Memorial HealthCare has confirmed the closing for a number of media sites, including The Scientist magazine.

What do you think of this news? Join the discussion in our MS forums.

Concerns about Dr. Burt’s HSCT clinical trial

The story in The Scientist includes a number of concerns about the Burt clinical trial. One scientist quoted in the article who is apprehensive about the study is stem cell biologist and blogger Paul Knoepfler. He raises the point that the Burt program charged $100,000 or more to participate in the trial.

Also, in late 2016, the U.S. Food and Drug Administration sent a warning letter to Burt, alleging that the trial “violated regulations governing the proper conduct of clinical studies involving investigational new drugs … .”

The Scientist goes into details of the FDA warning and quotes Burt as saying the letter had nothing to do with his sudden sabbatical: “Burt stresses that the closure of his clinic is not linked to issues cited in the FDA letter. ‘In December 2016, the FDA sent a follow up letter saying our response was satisfactory and that there were no further actions or questions. The FDA found no treatment-related deaths in any of the studies,’ he writes to The Scientist in an email.”

Selma Blair casts a spotlight on the Burt clinic

The clinical trial Burt conducted became more widely known a few months ago, when actress Selma Blair told her Instagram followers that she was among those who received HSCT at his Northwestern clinic. Though the formal MS clinical trial ended in July 2016, Blair was treated this summer, possibly under the FDA’s expanded access process. It allows patients with a life-threatening or serious illness to receive a non-FDA-approved treatment, outside of a clinical trial, under certain conditions. On Instagram, Blair writes, “I am improving due to #hsct #drburt. … I can walk much better.”

Was the HSCT clinic closure routine or pressured?

Burt’s Phase 3 clinic trial ended in 2016. It finished its follow-up work in early 2018 and published its findings at the beginning of 2019. So, was there a reason to keep the doors of the Northwestern stem cell clinic open any longer?

The Scientist reports that during his sabbatical, Burt plans to work with U.S. universities and clinics to make his HSCT protocol more available, saying, “This is in my assessment … the best way to help the world, and humanity, and help patients to move this forward, to get the treatment more widely around the world.” All currently enrolled patients will continue their treatment at the center, Northwestern Memorial HealthCare’s media relations director has told The Scientist. No new patients will be seen.

Was the closing of the clinic a routine evolution of Burt’s HSCT work or did it come under pressure? Somehow, I don’t think we’ve heard the end to this story.

You’re invited to visit my personal blog at www.themswire.com.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.
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Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

26 comments

  1. Jeanine Shahin says:

    Dr Burt and his team are excellent. I wish there more like him. I don’t know of a more compassionate and caring doctor. After all who would call back at 2 am on a Sunday morning.

  2. Wayne Wenzel says:

    What Burt’s critics conveniently fail to account for is that research studies of MS drugs are paid for by profit-oriented drug companies. But HSCT is not a drug, it is a procedure that eliminates the need for a patient to use an MS drug. A typical MS drug provides the patent-holding pharma company with $60,000 to $100,000 of continuous yearly revenue per patient. Moreover, none of these drugs are as effective against MS as HSCT.

  3. HUD says:

    Leave it to the damn FDA to pressure a successful treatment regimen to shut down. Sure, it does not work for everyone and to varying degrees on different types of ms. The point is that there are so many successful cases that have been treated in Dr. Burt’s program. It has literally given many patients stability,recovery or moderate improvement. What a shame! I sure hope he is able to seed the knowledge to the birth of many more treatment centers.

  4. Anonymous says:

    Fred Hutchinson sent me info in their program with an attached document that pointed out the cost may be 350-550K that insurance won’t cover.

  5. Chris Masters says:

    Dear Sir,
    This is very personal for those of us who have had HSCT. Mostly because it saved us from a long, drawn out death. You must have an autoimmune disease and go through this treatment to understand. Autoimmune diseases are devastating and highly debilitating, some more so than others. The disease ravages your life, and slowly takes away your independence. I was 42 and unable to dress, bath or toilet myself independently.
    What Dr Burt has accomplished should be shared with the world in a positive and beautiful light. He devoted 24/7/365 to the thousands of patients he has helped. $100,000 for the ground-breaking treatment that has forever changed my life, being hospitalized for 2-3 weeks, is less than my insurance paid for 6 days when I was originally diagnosed with CIDP. Furthermore, those of us who were able to get HSCT at Northwestern have a bond with each other and Dr Burt & staff, which is worth no amount of money. Helping someone at their most venerable time… having the passion and drive to be available to your patients 24 hours a day (3am fever and Dr Burt called me)…
    Bottom line, thank you for your article. Please recognize you are writing about and around all of our lives that have been involved. I truly pray that Dr Burt is able to spread his knowledge throughout the US and world to make this the standard of care for autoimmune diseases and MS.

    • Ed Tobias says:

      Hi Chris,

      Thanks for your comments.

      Having lived with MS for 39 years I think I understand, pretty well, how personal the HSCT issue is. Currently, I’m being treated with Lemtrada which, I think, is about as close as you can get to HSCT without going through that treatment.

      I believe that HSCT should be available in the US and that it shouldn’t cost $100,000 out-of-pocket to be treated with it. I appreciate Dr. Burt’s efforts to bring HSCT treatments to people in the US. And you’re right, having any doctor available 24/7 in a world where many won’t even give you fifteen minutes for an exam is a blessing.

      The final sentence in Dr. Burt’s January, 2019 JAMA article, reporting on his findings, says “Further research is needed to replicate these findings and to assess long-term outcomes and safety.” So, my question is why shut the clinic rather than continuing HSCT trials in Chicago? I must be missing something. Since you were one of his patients, do you have a feeling for why Dr. Burt has shut the doors? Could the clinic have continued the research without Dr. Burt’s presence?

      I wish you continued success with your treatments.

      Best regards,

      Ed

  6. Dole McDougall says:

    Ed’s opinions serve as bookends around quotes from an article that has now been recycled 3 TIMES. That is more akin to gossip than Journalism. The number of things that the other writes assumed and that Ed has wrong are countless.
    Reprinting other sources and simply putting your own spin on it is just plain lazy.
    And would all of you stop quoting Paul and referring to him as a stem cell biologist if you aren’t going to ask him any SCIENTIFIC questions?

    • Ed Tobias says:

      Hello Dole,

      Thanks for taking the time to comment.

      When I write something for MS News Today my purpose is to share, and sometimes comment on, something that I’ve read or done that I think others interested in MS would find interesting. I don’t claim to be doing original reporting, unless I’m writing about my own experiences.

      I’m concerned that you feel that I’ve written something that’s wrong. I’d appreciate it if you would tell me, specifically, what I’ve written that’s inaccurate so that I can correct it.

      Thanks,

      Ed

    • Lynn says:

      I just think it’s interesting how a this clinic closed down in 2016 to the public but a celebrity over a “regular” person had access to this treatment. Makes me feel like money talks and the average person would not have this readily available to them. It is very disappointing in my opinion as so many people have suffered much longer with this disease than a celebrity that has recently brought awareness to an ongoing disease.

      • Shannon says:

        Hi gang, some misunderstanding and partial information here. My college-age son was treated by Dr. Burt so I’m familiar with all of this. Dr. Burt was able to legally treat patients on-trial and off-trial, as noted in the article. Either way it costed the same, but individual insurance plans’ coverage varied. Some people paid entirely out of pocket, others had basically everything covered. Selma Blair seems to have been treated as Dr. Burt’s most recent trial finished the treatment phase. She could have been part of the trial or not. Burt has treated many, many patients off-trial.
        He’s an amazing man, brilliant, kind, devoted. The pace he worked for so long must have had tremendous personal costs.
        And yes, my son remains in drug-free remission and has seen remarkable improvements.
        Be well, everyone.

        • Ed Tobias says:

          Hi Shannon,

          Thanks for taking the time to comment. It’s great to have info from people who’ve been there done that.

          Let me please ask where the misunderstanding is in what I wrote. If the trial ended at the end of the summer of 2016 and Ms. Blair was treated in 2018 I have to assume that she was treated off-trial. Did you see a mistake elsewhere? I want to make sure that what I wrote is accurate.

          Most importantly, however, I hope your son continues to do well.

          Regards,

          Ed

  7. Colleen says:

    If Lemtrada works for you, that’s fantastic. It doesn’t work for others, so don’t take a possible solution for others away. Lemtrada is nothing like HSCT, so that’s false. I know MANY in Lemtrada who are doing horribly, so it doesn’t work for all.

    Why attack a dedicated doctor? Why do you care? Why not learn from those he treated first? Are you getting money from Lemtrada or something?

    Dr. Burt is the most amazing, dedicated doctor I’ve ever had. I had HSCT in March 2018.

    No doubt, it saved me. I’ve had MS for 10 years and it just got so aggressive and stopped responding to medications. I was told by other doctors to just keep trying meds that kept putting me in the hospital. Hospital stay after hospital stay. Dude effect after dude effect. Then, they lost hope and told me to just go on disability- which I refused. My life was not over. At one point, I was one 17 medications at 1 time, working full time, a mom and just trying to hold it together. My body and brain were betraying me. My right side was losing control. Not only was I spiraling physically, but mentally and emotionally as well. I’ve actually thought about taking my own life because I just couldn’t handle it anymore and thought maybe it would just be easier to be gone.

    HSCT saved me in so many ways. Dr. Burt may not know this because I didn’t have many complications and I was a rather quiet and easy patient…always smiling because I was so used to wearing a mask to hide the hurt. I didn’t realize just how bad I was until I started feeling better after HSCT. My body and brain are no longer attacking me. MRIs are showing no new activity.

    Dr. Burt was the only doctor who listened and got me answers. He came by every day. EVERY DAY. I owe him my life. My physical health and my emotional health.

    If any of you journalists want to actually sit down and talk about my experience, I’d be happy to. You can also meet my children who almost lost their mother if it wasn’t for Dr. Burt.

    • Ed Tobias says:

      Hi Colleen,

      Thanks for taking the time to comment and I’m sorry for my delayed response.

      I’ve very glad that HSCT and Dr. Burt helped you so much. I wish that HSCT was available to more people, at an affordable cost, right now.

      Just to be clear, however, I never attacked Dr. Burt. I only reported on what appeared to be a sudden, unexpected closing of his clinic and gave what I believe was an accurate report of the results of his study and some problems that the study encountered. I still believe, as I said in my column, that there is more to Dr. Burt’s sabbatical than has been reported so far.

      Ed

  8. Geoff Flynn says:

    It’s amazing the amount of effort that goes into controlling a patients options. If you’ve looked into a treatment and there’s scientific research to back it up you should be able to pursue it.

  9. Greg Bond says:

    I underwent HSCT at Northwestern under Dr. Burt in 2004. I agree with the others in that he is not only a great Dr., but also very personable with awesome bedside manner, as is his staff. At that time, it only cost me $50,000 or so out of pocket, the hospital paid the bill for the private room I was in for 18 days, and also assisted in housing in Chicago for the 3 weeks of testing and conditioning regimen prior to the 5 days of chemo that wiped out my immune system.

    The treatment lasted about 5 years, then I had a relapse and have been on DMTs ever since, the latest being Lemtrada which I just finished round 2 about a month ago). I have been able to stay employed and my physical impairments are minimal (can still ride a bicycle 20-30 miles and walk 4 miles in about an hour) and am 58 years old. I have no doubt HSCT, while not a cure, did minimize the disease.

  10. Jon says:

    I’m so furious! Reading about people who had HSCT in 2004! Nobody, no neurologist, no doctor ever talked about it with me until my Neurophysio mentioned it as an aside only a month ago. I’ve now been diagnosed for 30 years. If I had HSCT 15 years ago I might now not be 7.5 EDSS!

  11. J. Sherst says:

    I could never afford the cost it was to go to Northwestern for HSCT.
    Instead I went to Pirogov Hospital in Moscow, for HSCT for my MS.
    I had MS for about 14 years prior and it was affecting my mobility and I was plainly getting alarmed with the losses I was living with.
    It is 2 years later and my MS is still in remission.
    HSCT should be available for all people with autoimmune diseases that can benefit by it.
    It has been available for decades for types of blood cancers and for small cell vasculitis – it should be a human right that we can get this treatment. I only wish I went sooner. It is very sad and very wrong that this treatment is not available to all.

  12. Patricia Dehart says:

    I wish HSCT was available for me, I had to medically retire in November 2017 and I’m in so much pain I go to physical therapy twice a week. It would be great to have some relief, some normalcy back, if it was available for someone like me. . Low income.

  13. Michael Drohan says:

    Head to Clinica Ruiz in Puebla, Mexico, like i did. $55,000.
    https://www.hsctmexico.com/

    To be honest though, I’m not seeing life-changing results from it. I went there 16 months ago, and left with 1000 mg of rituxan, too. So with all of that, I will say I haven’t had any new disease activity. However, I’ve also had no lasting improvement to my symptoms. I had a spinal tap at 12 months and my doctor at the NIH recommended I return to medication, so started ocrevus in june.

    However, I don’t feel like I fell for a scam or it wasn’t worth my time. HSCT is still new for MS, including the proper protocol (type and amount of chemo, etc), so perhaps the fact I had MS for 14 years contributed to that, even though I’m young at 32. Many have had great results.

    Do your research and this is not the end of HSCT for MS! It’s out there, and hopefully Dr. Burt will start consulting with hospitals interested in setting it up.

    • Ed Tobias says:

      Hi Michael,

      Thanks for taking the time to comment. It’s important to hear from people who’ve actually “been there, done that.”

      I wish you well. And Dr. Burt, too.

      Ed

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