Dear Mark,
I was recently forwarded a copy of an email which you had sent to one of
your patients regarding the CCSVI issue. I was not surprised by your
unwavering belief that CCSVI is nonsense but was slightly taken aback by
your over-the-top view that all those who think that CCSVI treatment
may be of value are nothing more than frenzied, cult members. I was
also somewhat surprised that you mentioned me but was glad you asked an
important question ”who am I to question the word of the
many self-acclaimed experts who feed this frenzy like the rock doctor
Embry whose lifelong study of lifeless objects has given him the wisdom
to comment on such complex issues?”
You are correct that my primary scientific research activity for the past
42 years has revolved around inanimate rocks, mainly those in the
Canadian Arctic Archipelago. I’ll be glad to send you some of my
published geological papers if you have an interest in such things.
I must point out that it has not been my geological studies which have
“given me the wisdom” to comment on complex issues associated with
multiple sclerosis. My knowledge on MS comes from reading thousands of
scientific papers and countless abstracts on MS and related subjects
(e.g. nutrition, autoimmunity in general, and more recently vascular
issues). My pursuit of scientific knowledge in regards to MS has been
driven by a desire to ensure my son is doing everything he can to
prevent the progression of his MS.
I would emphasize that I try hard to make sure any written comments I make on MS,
especially recommendations on how to help control disease progression,
are backed by solid science, including both empirical data and critical,
rational reasoning. I suppose you could say that many years of
geological research have instilled this hard-core, scientific approach
so perhaps you are not entirely wrong with your statement that the
source of my MS “wisdom” is my geological research.
I thought it might be useful if I discussed how we sharply differ on three
important scientific issues which dominate decisions regarding the
treatment of MS. These issues are CCSVI, vitamin D and the CRAB drugs.
These differences show how we significantly vary when it comes to doing
science and to using science to guide actions. Following this, I will
wrap-up with a few possibilities on why such differences between us
exist, despite the fact we both would claim we are scientists wanting to
understand MS so as to allow us to make recommendations on how to treat
it.
CCSVI
The first topic is CCSVI which continues to divide the MS community. As a scientist, I
try to stay up to date on the literature but it wasn’t until July, 2009
that I came upon Dr Zamboni’s work, 4 months after he had published his
watershed paper on CCSVI. After reading that paper, I immediately read
all the available papers on CCSVI as well as major past references on
vascular issues in MS. Once I had completed my literature research,
which included carefully going through the Zamboni papers up to three
times each, it was apparent that either impaired venous drainage was
very likely an important factor in MS or that Dr Zamboni and his
associates were incompetent or frauds. There basically was no middle
ground given the apparent robustness of the Zamboni research.
A review of the extensive scientific contributions of Dr Zamboni and his
colleagues over the past 25 years removed any doubt as to their
impeccable scientific credentials and their solid competency when it
comes to vascular research. Thus, their impressive clinical and
theoretical studies on CCSVI, combined with past studies on vascular
issues associated with MS, and the fact that CCSVI nicely explained some
previously inexplicable features of MS (e.g. venocentricity of
lesions, associated iron deposits, continued disease progression despite
the complete destruction of the immune system), gave me no choice but
to accept the proposition that it was very likely that CCSVI was an
important factor in MS. This in turn led me to facilitate and encourage
the dissemination of CCSVI information and to call for extensive
research into CCSVI and MS in August 2009.
Since my initial immersion into the CCSVI literature, I have closely followed
CCSVI research and this has included visiting with some of the
researchers themselves. I have been most impressed with the CCSVI
research being done at the University of Buffalo and their work,
involving 500 subjects, has robustly confirmed the high association of
CCSVI with MS. Such a high association, the plausible biological
mechanisms which link CCSVI to the MS disease process, and the
established nature of the venous problems associated with CCSVI,
establish beyond a reasonable scientific doubt that CCSVI plays a role
in the MS disease process.
I have also kept a close watch on the results of worldwide CCSVI treatments because such results, due
to their high numbers, are important scientific data that cannot be
ignored. Currently, there are at least 75 centres worldwide doing CCSVI
treatment and between 100 and 200 procedures are now being done each
day. These treatments involve the use of venography which is the gold
standard for the identification of CCSVI and, of the 12,000+ patients
treated so far, over 90% have had undoubted CCSVI. Furthermore, there
have been thousands of well documented cases of substantial improvement
of a variety of MS symptoms following CCSVI treatment.
As a scientist, I cannot ignore the CCSVI treatment data and to do so would
be bordering on scientific incompetence/fraud. To sum up, the published
scientific data on CCSVI and the many thousands of clinical procedures
which have identified and treated CCSVI leave no reasonable doubt as to
the existence of CCSVI and that it plays a role in the MS disease
process.
I would contrast my objective, scientific appraisal of CCSVI with your emotional and non-scientific approach. I
assume the first time you were exposed to the science of CCSVI was
through the CTV documentary and that you had failed to read the papers
which had been published on this topic before that time. Your public
response to a group of MS patients that the Zamboni work was a hoax
before you had read his papers, reveals a complete lack of scientific
method and objectivity by you on this subject. Furthermore, your
insistence on ignoring the results of many thousands of CCSVI procedures
also underscores your inability to take an unbiased, scientific
approach when it comes to CCSVI. I will discuss possible reasons for
such a failure later.
The bottom line is that you have not spent time with the CCSVI researchers, you have not read most of the
200+ scientific papers which bear directly on the CCSVI question, and
you have not taken the time to evaluate the results of the huge number
of CCSVI procedures which have been done. Any claim that your comments
regarding CCSVI are science-based is not supportable. Thus, when it
comes to CCSVI my comments on the subject are given much more weight
than yours simply because I know far more about the subject than you do
and most importantly, I have taken an objective, scientific approach to
CCSVI and MS, not an emotional, highly prejudiced one like you have. I
can only encourage you to try to be more objective and scientific when
it comes to CCSVI.
Vitamin D
The next topic is the role of vitamin D in MS. When I began my studies of
the MS literature, my main goal was to identify environmental factors
involved in MS. It seemed this would be the best approach for devising
potential therapies for treating the disease. By 1999 there was enough
solid and diverse scientific data to indicate that vitamin D deficiency
was involved in MS. Given this, I advocated for the use of vitamin D
supplements both as a strategy to prevent MS in the first place and to
treat it. This was a classic case of a scientifically-backed therapy
which offered nothing to lose (vitamin D is extremely low cost and
completely safe) and all to gain in terms of prevention and treatment.
At this time I also published a short note in Annals of Neurology on
vitamin D and lesion formation (with a recommendation for a 4000 IU
supplement) and I made available on the internet a comprehensive
document on the science of vitamin D and MS.
Notably over the past 10 years there have been scores of studies on vitamin D and MS,
all of which have supported and confirmed what we knew back in 1999 –
there is a good chance adequate vitamin D will prevent MS in many cases
and that it will have therapeutic value for those with MS. I would say
that I have read at least 750 papers on vitamin D with at least 250 of
those directly related to vitamin D and MS. Given that my scientific
abilities and literature research allowed me to identify vitamin D as a
useful therapy for MS in 1999, the question becomes what did your
scientific approach achieve for you regarding vitamin D and MS.
You may recall in November,2006 we both attended an AAN MS Guideline
meeting in Boston. I gave a presentation on vitamin D and MS and the
potential value of developing a guideline on such a topic. Following my
talk, you made light of the concept of vitamin D for MS calling it
alternative medicine that had no place in the meeting. It was very
obvious you had not read any of the vitamin D literature or you would
not have made such an unsupportable and revealing statement.
I have also learned that you do not recommend adequate vitamin D (enough
to raise one’s 25D level to between 125-175 nmol/l) to your MS patients
and you do not let your patients know that there is a reasonable chance
that adequate vitamin D from birth onwards will prevent MS. It is clear
that you have not taken a scientific approach when it comes to vitamin D
and MS and your patient care has consequently suffered. Again, I can
only suggest you take some time to review all the vitamin D and MS
literature in an objective and comprehensive fashion.
CRAB drugs
The CRAB drugs (Copaxone, Rebif, Avonex, Betaseron) is one topic I am sure
you know lots about given your involvement in clinical trials and your
very strong and lucrative financial ties to the drug companies that
manufacture these drugs. I also have a great interest in these drugs
because they represent a potential therapy for my son.
When it comes to such drugs, the key question is whether or not they affect
the progression of the disease or not. If they do, then they would be a
reasonable therapeutic option despite their high cost and adverse side
effects. However, if they do not slow progression, then I would say they
are possibly worse than useless. So the obvious scientific question,
which we both are interested in, is whether or not any of the CRAB drugs
slow MS progression.
Given that you prescribe such drugs to your newly diagnosed patients and give talks (often for money)
advocating the use of such drugs, I can only presume that you firmly
believe that the drugs do slow disease progression. I am not sure what
you base such a belief on but I have to assume it is mainly based on the
clinical trials which tested the effect of the drugs using frequency of
MS relapse and number of new MS lesions as proxies for determining if a
given drug affected progression or not. You and I both know that there
have been no clinical trials which have lasted long enough to directly
determine if any of the CRAB drugs actually do slow MS progression or
not.
From a scientific perspective, it became essential to determine if frequency of MS relapse and new lesion formation
correlated to MS disease progression and were thus valid proxies in
clinical trials. I have read most studies connected with the MS drugs
and over the last few years have been impressed with the studies which
have shown that those two proxies do NOT correlate with disease
progression. In fact it was found those with fewer attacks progressed
faster and farther!
To emphasize this critical point I have to quote Dr George Ebers, one of the premier MS researchers in the
world on this. Dr Ebers states “Clinical trials of multiple sclerosis
have been uniform in utilising invalidated outcome measures. This has
occurred to a degree to which it is difficult to find parallels in
medicine in general. It is quite clear from natural history studies that
relapses have very little if anything to do with long term outcome. Similarly, MRI
measures have been thoroughly evaluated within large datasets and found
to be similarly non-predictive for meaningful outcomes.” These are conclusions from hard science and have to be respected and used when it comes to actions regarding the CRAB drugs.
I assume you have read the key papers which demonstrate that relapse rate
and MS lesion formation cannot be used to determine if a given drug is
of value for slowing MS. I trust you will agree that currently we have
no good scientific evidence that the CRAB drugs slow MS progression. In
fact, we now have a three long term studies which indicate that the drugs do not slow MS progression
by showing that those on the drugs reached the same EDSS end points in
the same time as those not on the drugs (Boggild et al, 2009; Veugelers
et al, 2009; Ebers et al, 2010).
Given the above scientific evidence and reasoning, I have advised my son not to use a
CRAB drug and I also advise others not to use a CRAB drug which provides
no benefit and which has adverse side effects such as flu-like symptoms
and painful injection site reactions. It is somewhat bothersome that you
claim to be a scientist and to follow the dictates of evidence-based
medicine but continue to prescribe drugs for which we have no reliable
scientific evidence that they do any good. In fact, the current data
indicate they do not work.
I have to again quote George Ebers on the problem of “widespread embracing of dubious and poorly validated outcomes by some MS
investigators, often in contexts where there are egregious conflicts of
interest, threaten academic credibility not to mention long term
professional autonomy.” There is no doubt that many
neurologists are prescribing the CRAB drugs, not because the science
says they work, but because it is financially advantageous to do so.
Given your “egregious conflicts of interest” when it
comes to the CRAB drugs and your disregard for the science concerning
these drug, I assume you can understand why you have no credibility on
this subject.
Summary
I have pointed out three main differences between us when it comes to various
factors and MS. I objectively follow the available science which tells
us that:
1) CCSVI is highly associated with MS and is very likely an important part of the disease process,
2) Vitamin D deficiency is an important factor in the onset and progression of MS.
3) The CRAB drugs do not have any effect on MS disease progression.
These science-based conclusions have led me to the following science-based recommendations that anyone with MS:
1) Be tested and, if need be, treated for CCSVI.
2) Take an adequate vitamin D supplement and ensure any first degree relative also takes such a supplement.
3) Do not use any of the CRAB drugs.
On the other hand you ignore much of the current science and, on the basis
of blind faith rather than scientific analysis, tell your patients
that:
1) CCSVI does not exist and persons with MS who see potential value in CCSVI treatment are frenzied cult members.
2) Vitamin D supplementation represents alternative medicine and has no place in MS treatment or prevention.
3) The CRAB drugs are of value and should be used by persons with RRMS.
Finally we are left with the question of why I have chosen an unbiased
scientific path whereas you have gone in the opposite direction. My only
hypothesis to explain this is that your financial ties to the drug
companies have prejudiced you against any non-drug therapy such as
adequate vitamin D and CCSVI treatment and made you blind to the robust
data which demonstrate the drugs do not slow MS progression. On the
other hand, with my son having MS, I have all to lose and nothing to
gain by not ensuring that I carefully examine all scientific hypotheses
for MS in a rigorous and unbiased manner. Perhaps also the fact I was
trained as a scientist (PhD) whereas you were trained as an MD (ie
engineer) might also come into play when it comes to the great
difference in our application of science for helping persons with MS.
I hope this answers your question of why persons with MS trust what I
have to say about various proposed therapies for MS far more than they
trust you. They can tell the difference between an objective,
science-based analysis and a self-serving, unscientific opinion every
time.
Ashton Embry