Exciting New MS Treatment!

NEWS RELEASE

A new MS drug appears to alter fluid dynamics and repair the blood brain barrier!
In fact, 63% of the patients treated with Perfuza (toxicmuzab) had no new or enhancing MS lesions at 12 months! In light of recent discoveries of the brain's lymphatic vessels and the connection to venous flow, we are thrilled to be able to offer MS patients a drug treatment which may be addressing CNS fluid dynamics.

Here's more on the impressive results of Perfuza from a recent publication in JAMA---

We found a reduction in the mean number of new brain lesions (corresponding to more lesion- free patients) in the toxicumab group compared with the placebo group at 6 to 12 months. The delayed and positive effect on the magnetic resonance biomarker suggests that toxicumab could affect the dynamic of the blood-brain barrier.

Gadolinium enhancement is a marker of damage to the blood-brain barrier, whose time course depends on lymphatic drainage18 and hence on venous drainage from the skull.19 Previous studies have reported that venous pressure is lowered3 and cerebrospinal fluid dynamics is improved20 after taking toxicmuzab, thereby favoring the drainage of cerebro spinal fluid into the dural veins, which depends on a pressure gradient between the subarachnoid spaces and dural veins.21,22

Another study23 reported that white matter lesion load was inversely correlated with reduced cerebrospinal fluid dynamics, as measured by MRI. In addition, flow improvement through the internal jugular veins owing to toxicmuzab has been reported to improve brain perfusion in patients with RRMS.21 It has also been reported that the development of a new MS plaque was preceded by sustained MRI-detected hypoperfusion before the plaque was identified on MRI.24,25

link

Incredible, right???  Finally.  A drug which can potentially affect the blood brain barrier!
Perfuza (toxicmuzab) may be the greatest money-making MS drug in history.
Projections are now at 2-3 billion for 2018 alone.


Only kidding.

The paper I'm quoting from, verbatim, is the recent JAMA review of angioplasty for CCSVI from the Brave Dreams clinical trial. 

Just replace my made up block buster drug Perfuza (toxicmuzab) with angioplasty to restore venous flow.   And then, write a conclusion and snarky editorial that says that we should not pursue this treatment any further, and that CCSVI research is over.

Even though the conclusion of the paper says that over half of patients saw benefit in cerebral blood flow from CCSVI treatment.

The editorial which goes along with this publication is actually incorrect.  The author of the editorial, Dr. Ari Green***, claims that there was absolutely no benefit in those treated for CCSVI, that there was no reduction in new lesions.  Here, read the editorial for yourselves, and read the paper again, and tell me---isn't this incorrect?
https://jamanetwork.com/journals/jamaneurology/fullarticle/2664000

***Dr. Green has received personal compensation for activities with Inception Sciences, Mylan Pharma, Medimmune, and Bionure. Dr. Green has received personal compensation for serving on the board of Inception Sciences. Dr. Green holds stock and/or stock options in Inception Sciences. Dr. Green has received research support from Inception Sciences, Biogen, and Novartis.  link
Dr. Green's Inception Sciences Company owns the patent for an antihistamine-like molecule thought to remyelinate neurons. I wrote about the absurd hype regarding a 1.3% improvement in visual acuity here:  link

To recap---this published paper from the neurologists of the Brave Dreams trial just proved, conclusively-
1. CCSVI is a real condition in people with MS.
2. There are a variety of venous malformations.  There were patients with closed jugular valves, refluxing blood flow, and hypoperfusion.
3. Venoplasty was able to restore normal flow in 54% of the patients.  Not all malformations can be treated with PTA alone.
4.  63% of treated patients had no new MS lesions on MRI at 12 months.
Doesn't this count for something?  At least additional study?

What is real news? What is fake news?
Is this simply spin or is it something darker?

If a room full of neurologists look at the results from CCSVI venoplasty and conclude 
"The delayed effect of venous PTA 6 months after the procedure on the magnetic resonance biomarker suggests a possibility that PTA may produce benefit for a subgroup of patients with MS. This should be further analyzed and investigated." 

yet still write a conclusion and editorial suggesting CCSVI research be stopped--- what is reality?

Please, tell me.  Honestly, I'm flummoxed.

More ahead.
Joan

Dr. Michal Schwartz was right.

The last hundred years or so, all of neurological disease research has maintained that any immune cells which showed up in the brain were there for one of three reasons:  to protect the brain against infection, in an autoimmune reaction (as in MS) or during an inflammatory attack (as occurs after stroke or ischemia.)  But immune cells as part of a healthy, functioning brain?  Absolutely not!

MS researchers have continued this dogmatic narrative, based on the "successful" development of EAE and immune ablating and suppressing drugs.  They maintain that the brain is immune privileged, and the blood brain barrier is meant to keep immune cells out.  And they've been suppressing the heck out of MS patients' immune cells ever since.

Recent research from the University of Virginia and the Kipnis Lab has called all of this into question.  It now appears that a healthy immune system is connected to the brain,  Exactly as it is in all other organs, via lymphatic vessels which drain into veins.

But even before the U of V publication, there has been one researcher who has single-handedly challenged the dogma on the immune privileged brain.  She has asserted the need for immune cells in our central nervous system.   She has been ridiculed, mocked and ignored--because she has stated that immune cells are supposed to be in the brain to aid, repair and rebuild.  She has published on the premise that immune cells are neuroprotective.
link

Dr. Michal Schwartz of the Weizmann Institute of Science has questioned whether immune ablation and suppression  in multiple sclerosis drugs was the correct approach.  Her research showed that it was essential not to completely stop the immune cells entering the MS brain, but to retrain the cells:  immune modulation, rather than immune suppression.  She continued to publish that immune suppressing drugs had fallen short, that MS continued to progress.  She thought it was impossible that the brain would have given up its ability to be assisted by the immune system.  It simply did not make sense to her.  Why would our most important organ not need the immune cells?
link

Immune ablation and suppression never made sense to me.  Subsequently, I've been following her research ever since Jeff was diagnosed with MS in 2007.  And that's why Jeff has only ever been on Copaxone, which was developed at the Weizmann Institute.  Copaxone retrains the immune cells thought to be causing damage, and leaves the others intact.

Dr. Schwartz likes to quote Abraham Lincoln--
"If you are doing any revolution, do not try to convince your opponents,
if you are right, you don't need it.  If you are wrong, it will not help you."

Dr. Schwartz has been quietly conducting her revolution in Israel, publishing her research in medical journals, and speaking out on the absolute necessity of immune cells in the brain.  As she says, "A healthy mind depends on a healthy immune system."  These so-called lymphocyte "auto-immune cells", which MS drugs sought to inhibit, were the exact same ones her research showed were needed to repair the brain.  And she established her theory of "protective autoimmunity."  Her research continued to show that these cells were needed to create new stem cells.
link

Immune cell suppression and ablation will need to be reconsidered now.

She has been brave enough to keep on this trail.  And now, with the recent U of V research,  it appears she was right all along.
Here's Dr. Schwartz presenting her research in plain English.
Give her fifteen minutes of your time---listen to her revolution.
link


Be careful with serious immune ablating and suppressing drugs, especially while we're still learning about the function of immune cells in the CNS.  If this past week and the U of V research has taught us anything, it's that we simply don't know what we don't know...

be well, be hopeful,
be educated,

Joan