Welcome! This blog contains research & information on lifestyle, nutrition and health for those with MS, as well as continuing information on the understanding of CCSVI and cerebral hypoperfusion. This blog is informative only--all medical decisions should be discussed with your own physicians.

The posts are searchable---simply type in your topic of interest in the search box at the top left.

Almost all of MS research is initiated and funded by pharmaceutical companies. This maintains the EAE mouse model and the immune paradigm of MS, and continues the 20 billion dollar a year MS treatment industry. But as we learn more about slowed blood flow, gray matter atrophy, and environmental links to MS progression and disability--all things the current drugs do not address--we're discovering more about how to help those with MS.

To learn how this journey began, read my first post from August, 2009. Be well! Joan

Wednesday, March 15, 2017

Tony Traboulsee and the Lemtrada story

It is now quite obvious that Anthony Traboulsee meant what he said back in 2010. He does not believe the venous system has anything to do with Multiple Sclerosis, and that people with MS should not worry about their vascular health.  They simply need to take their drugs.

This is in sharp contrast to peer-reviewed research conducted in labs around the globe; redefining the connection of the brain to the vasculature.  link

Commenting on the failure of the UBC trial to prove any benefit in (under) treating stenotic veins, he gave patients the bright side.
“Fortunately, there are a range of drug treatments for MS that have been proven, through rigorous studies, to be safe and effective at slowing the disease progression.”  

Macleans Magazine journalist Anne Kingston questions why the UBC CCSVI trial released results before the study was actually completed.  Read her well-researched article here:  link

I think it's important to understand exactly why Tony needed to stop further exploration of the vascular connection to MS and state that the UBC study was the final word which debunked CCSVI research--- even though his study was not complete, and there are other placebo control CCSVI studies currently in Australia and Italy.  He wants this research over.  Tony's whole life, lab and career hinge on the maintenance of the EAE autoimmune model of MS, and the success of drugs.  Especially one monoclonal antibody which targets the protein CD52 found on t and be cells, called Lemtrada.

Tony has been working hard for the Sanofi Genzyme Company for several years, as a saleman for Lemtrada.  He is a paid researcher and spokeperson for Lemtrada.  He has been touting this wonder drug around the world.  Don't believe me?   Behold, the google results of Traboulsee + Lemtrada.
link

Genzyme Corp. paid out over 5 million dollars to US doctors from 2013-15 for promoting Lemtrada.  This information is not available for Canada--but I believe we can assume that payments were equally high.   link

Lemtrada is Dr. Traboulsee's "Top Pick" for his MS patients.  Here's a blogger sharing this news.
Today is my 3rd MRI. I have a new neurologist.....Dr. Traboulsee also gave me some new options to check out, including his top pick called Lemtrada.  Lemtrada sounds like an interesting choice, as it is administered one or twice a year.   link
Tony believes that Lemtrada is the future of MS treatment.    
But this isn't actually true.  Lemtrada can't the future, because it's the past.  It has a very well-documented research history since the mid 1900s, and has been used as an MS treatment since 1991, when it was called Campath.

Campath (alemtuzumab) was developed to treat B cell leukemia, but there were problems with that, so it was tried for immune suppression for organ transplants, and had a few too many side effects there, so it was tried in autoimmune diseases.   It never became the big money maker drug companies had hoped for.  It was first used as an off-label drug for multiple sclerosis in the UK.

The problem with using Lemtrada/Campath as an MS treatment was that it did not help people who were already progressive.  In fact, as researchers were dismayed to find out, people with progressive MS disease worsened on the drug.

“We realised that, although we had stopped disease activity in terms of new inflammatory brain lesions and had reduced the number of attacks that people were having, most of our patients were continuing to deteriorate.” The problems that the patients had when they started Campath-1H treatment were slowly progressing. This observation puzzled the researchers. If MS is an inflammatory autoimmune disease, why was Alemtuzumab treatment failing to help people in the progressive phase of the disease even though the treatment seemed to turn off inflammation?
link

Unfortunately, this did not lead to a clinical improvement in the disability in these patients. In fact, their disability worsened with time at a rate of 0.02 EDSS points for each patient each year. Evidence for continued neurodegeneration in these patients was shown by progressive cerebral atrophy on follow-up MRI scanning. This particular group of patients who showed continuing disease progression had the highest inflammatory load prior to commencing alemtuzumab therapy. This group of patients were followed up with MRI scanning many years later (14 years post treatment) and did not demonstrate any increase in lesion load but did demonstrate further cerebral atrophy [Coles et al. 2006]. This was reflected in their EDSS score, the median being 7.5 (range 4.5–9) at latest follow up [Hill-Cawthorne et al. 2012].
link

Campath 1H treatment was associated with a sustained and marked reduction in the volume of Gd enhancement, indicating suppression of active inflammation. Nevertheless, many patients developed increasing brain and spinal cord atrophy, T1 hypointensity, and disability. 
link


Disability in all but one of the 37 patients continued to worsen progressively despite alemtuzumab treatment, as previously reported.8 9 At the last recorded follow-up, a median of 14 years post-treatment, the median disability estimated in 35/37 patients was EDSS 7.5 (range 4.5e9). Relapses were uncommon but were not systematically captured.  link

So, as you can see from these studies, to claim that Lemtrada slows progression or reverses MS is simply (excuse me) bullshit.  What has changed?  Campath has been renamed and rebranded.  It's being given to a very specific population of people with MS.  Lemtrada is helpful for people with highly inflammatory, brand new MS, because it wipes out the immune system and halts inflammation.  As I've referred to this kind of immune ablation before--it's like "using a sledgehammer to swat a fly."   This early intervention is being touted as a "window of opportunity."

Treatment response to alemtuzumab is strongest as long as active inflammation is the predominant pathophysiological feature, and it is becoming less efficacious in neurodegeneration-dominated later stages of the disease. Thus, the optimal placement of alemtuzumab within treatment algorithms of MS is crucial. The impressive efficacy of alemtuzumab is counteracted by a less favorable safety profile. link

Tony knew how to get around that problem of MS progression.  He only enrolled young people and people with early RRMS in his Lemtrada trial.  And voila!  Success!  It's amazing what drugs can do when you get rid of those pesky older and progressive patients.  He saved them for the CCSVI trial, where the median age was 50, and most were progressive.

Now that he’s managed a trial of 80 patients on Lemtrada (alemtuzumab), Traboulsee believes the future of MS is very treatable. Traboulsee believes he’s part of a movement that’s 10 years ahead of the curve and thinks this treatment might be resetting the immune system in patients who receive it. -link

What a trend setter Tony is with his deadly drug from the 1900s!  It is because of Tony's work that Lemtrada became available in Canada in 2013.  Tony's trials at UBC paved the way.  Yet even with all of this hoopla in Canada, the FDA panel in the US was concerned about adverse effects and lack of evidence and decided not to approve Lemtrada.

They then voted almost unanimously that the sponsor had not provided sufficient evidence of a reduction in disability with alemtuzumab, but then subsequently decided that, assuming the efficacy results were as they appeared, safety results would not preclude approval. The panel also voted unanimously (with 2 abstentions) that if the drug were approved, it should not be indicated as a first-line agent in MS.
link

The FDA panel mentioned the fact that Lemtrada had only been tested in young patients, those with a new MS diagnosis, and that the adverse effects of this drug were too risky.  Like me, they read the prior research on Campath.  They did not think it was an appropriate first line treatment for those newly diagnosed.  And then, after pressure was put on the FDA by the National MS Society with some help from Genzyme,  in a surprise turn-around ruling, Lemtrada was accepted by the FDA with black box warnings.  Sadly, since 2013,  we have a better understanding of the long-lasting side effects of Lemtrada.

Like a severe B-cell mediated disease of enhancing demyelination, which was caused by Lemtrada, and is even worse than just MS. link

or death from cancer, ITP and thyroid disease and a slew of other problems that come from destroying immune cells....
Patients did have serious, even fatal, side effects while using Lemtrada, including viral infections and infusion reactions, and the drug may cause malignancies such as thyroid cancer, melanoma, and lymphoproliferative disorders. As a result, it is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy), to ensure that patients prescribed Lemtrada are enrolled in the program and undergo periodic monitoring to detect potential health risks. 

Which makes sense, when you consider the Kipnis Lab's recent discovery of a new lymphocyte which protects the gut and the brain.  These type 2 lymphocytes are called "powerful defenders" and may be essential for the brain to heal after injury or an MS relapse.  We have no idea on how destroying them with Lemtrada may affect long term health.
link

Don't believe me?  Let's hear from some of Tony's patients--- from public reviews.

I've had R-R MS for 18 years. I've been symptom free for 5 years. My previous MS Specialist, Dr.Hoogie retired and the doctor he referred me to was on mat leave when it was time for my annual check-up so I went to see him. He's well reputed as a researcher and is head of the MS Clinic at UBC, so I thought I was in good hands. I found out he is not what I want in a Doctor. He pushed his drug study on me really hard. I went home and researched the drug he's studying and it has caused death due to massive organ failure in one patient the UK. I don't have severe enough MS to want to try that kind of drug. When I asked him questions, he didn't really answer them clearly. I went back to my GP and asked for another referral to another MS Specialist. I strongly believe he should not be a practicing Doctor - he does it to pressure and try to recruit more patients for his studies and because he has to. I'm sure he's a good clinician and researcher. If you have a severe case and want to try to get access to what will be expensive, and hard core drugs that are not yet available to the public, go see him. But I don't want to be a lab rat.
                                                      +++++++++++
To begin, I was diagnosed with MS just over 18 years ago, a mere six months after graduating high school. Following a couple of weeks in the hospital, I was referred to the UBC MS Clinic and assigned to Traboulsee. He lied to me from the start, insisting there were no treatment options for the neuropathic pain and muscle spasms I suffered. Instead he claimed that there were only clinical trial studies and that he could do nothing more than sign me up to become a lab rat. Out of desperation, I enrolled on one clinical trial which saw me bed ridden from the side effects of that drig that was later proven to be useless for MS. When telling Traboulsee this during the trial, he ignored my severe reactions to the trial study drug and tried to convince me that I was actually doing better because of the experimental drug, though he should have been able to know that since the study was double-blinded. At one point I was able to procure a copy of my records from the clinic, only to find that Traboulsee had falsified many portions of my records, including one that indicated he had recommended various medications to me which I had refused. In reality, I had requested one type of medication for my MS symptoms which Traboulsee had refused me on the basis that he didn't like my attitude in not wanting to take part in further trial studies. Traboulsee should also set he watch as he is always an hour late for every appointment. He never answers any questions, is always reading the patient file, and ignore basic human rights.
                                                         ++++++++++++
I believe that the behaviour of this Doctor is unacceptable, he was rude, condescending and at times devoid of any compassion or empathy. Moreover, he has extremely poor communication skills. I believe he is quite brilliant in his research, however, he should not be dealing with patients on a one on one basis. The sad part is he truly sees nothing wrong with his behaviour and can be vindictive and arrogant if you question what he has said. By not listening to his patients and showing them compassion he is doing a disservice to those looking to him for help.
                                                         ++++++++++++
This doctor is horrible and a complete jerk. If you care about your health of that of a loved one you will seek medical expertise elsewhere. Nightmare treatment and responsible for the loss of my loved one. Only cares about research and treating patients as guinea pigs. Arrogant, condescending and doesn't care about human life or treatment - he only cares about MRIs and research not the person. Unsympathetic and a complete jackass of a person.
                                                        +++++++++++++++
Horrible. Saw him in summer, I have been so upset about his lack of care his and condescending tone that I am only now able to write this. Cares about money not about treating patients. Avoid this "doctor". He has to look things up on Google. Smug, wants you to join a clinical trial, otherwise dismisses you.
You can read more here:
link

So, where does this leave us?  
I have no idea where it leaves you, but I hate having to write about this man.  I hate his arrogance, his lack of compassion, his lack of morals, ethics, and his tunnel vision.   This is why I said I was walking away earlier this year...because I abhor these people and what they do to others, and it's upsetting. 

But I keep writing and staying involved, because I love other people more.  I was recently told by a commentor on this blog that I have no right to say anything about MS, because I do not have it.  She said that I do not understand how it feels to have an incurable disease.  And I agree with her.  I have no idea.  But I don't think that means I can't discuss new research, or walk alongside people with MS and encourage them.   Nor do I think I need to say that there is no vascular connection to the MS disease process, when more and more peer-reviewed science continues to show this reality.

I've been going thru test results with a girlfriend this week.  Her husband was just diagnosed with MS.  She's asking for more blood panels, allergy tests, consulting with a vascular doctor and neurologist, and working with her GP.  I'm going through all the various diet and lifestyle programs with her as her family comes to grips with this diagnosis.  This week I also had a delicious seafood dinner overlooking the Pacific with another girlfriend who has MS, and she is thriving and healthy and amazing. I answer e-mails and phone calls, and try to encourage others.  Because I live with proof of the importance of dealing with vascular health.  I tell everyone, I AM NOT A DOCTOR.  But I can read, and I can write.  And I can encourage.

Jeff reminds me every single day that people with MS have more control than the Traboulsees of the world tell them.  That the vascular connection is real.  It may not be the complete picture, but it is part of the answer.

I hope there is an investigation into conflicts of interest with Dr. Traboulsee and the UBC Clinic.
If you have MS, and you love Lemtrada, and it's changed your life, no need to flame me.  If you love Dr. Traboulsee. good for you!   I'm happy for you!  Honest!  Be well, and continue in good health.   My concern is that the UBC clinic is not looking at the big picture in MS treatments and manipulating research.  And we all want the complete picture, right?

Just doing some "debunking" of my own.

Joan




14 comments:

  1. Thank you, Joan, for keeping us updated and getting the truth out there. It gives those of us with MS hope for the future!
    Gayle Caswell

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    1. You're welcome, Gayle. I hope there will be an investigation into scientific misconduct and conflict of interest in this case.

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  2. Thank YOU Joan. You have provided so much valuable and real information for us to assimilate. You have provided so much encouragement. I shudder to think where I would be ... if not for you! October 2009 I was looking at a one way ticket to Switzerland. I was declining rapidly. Then everything changed for the better November 21, 2009! You have been my driving force to live a better life and now I feel I have purpose. You have become one of my heroes! I love you and do not want to lose you. xoxo

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    1. I ain't going anywhere. xo Keep on keeping on, Shirley. You're MY HERO.

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  3. Joan, you have no idea the physiological changes my body just went through while reading your research. Powerful. It's truly remarkable how our gut feelings are profoundly accurate. Thank you. Thank you.👍 Thank you.💖. I am going to try to get Greg's UBC Neuro to read your post when we see her in June. I have HOPE.

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    1. I'm honored to be able to help, Bev. I believe Dr. Helen Tremlett has been very vocal and has published on problems with drug studies. Perhaps she might comment?

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  4. I too thank you for your continuing research on this subject! I deeply appreciate everything you do and support you wholeheartedly. Canadian MS folk are truly lucky to have you as our advocate.

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    1. you are more than welcome, Nadine! Stay well and enjoy your beautiful country. xo

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  5. Thank you always Joan . Keep speaking out always.

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    1. thanks so much for your support, Lynne. xo

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  6. Joan, I have said this before and I will keep saying it: Your words are powerful... and, I know it takes a toll on you because I feel it too. My nerves spike every time I see the shame and evil of UBC clinic. I lived through it all at that clinic, and have the relapses to show. I don't have to keep speaking and sharing, but I do it for the others, the ones who need to know, like I needed to know. So thank you, and know that every word you speak (and Anne Kingston, and Dr. Zamboni, and others) is so very very valuable, and so very appreciated. We will prevail. Love.

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    1. Thanks, Sheryl-- appreciate the affirmation. Yes, it's hard to continue to see this research, which has helped so many, be discounted without correct protocols or follow up. And it's painful to see liars win--believe me, it's tough in my country's politics, as well. Poor and sick people, our most vulnerable populations, are the ones who pay for greed. It's a psychopathy...and it's exhausting. But, we carry on. Thank you for not going away, and for being so open. It's appreciated. with love, J

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