[ASC-list] Request for your thoughts on the following... [SEC=UNCLASSIFIED]

Justin Coleman colross at tpg.com.au
Wed Feb 27 09:54:03 UTC 2013


Hi Rob

 

Your initial instinct to be cautious was correct.

 

In summary, I think the response is 'dodgy as'. It uses the all-too-common
mix of exaggerated claims, explanations why only surrogate end points were
used, 'truth by anecdote' and reasons why the usual rules of scientific
evidence cannot be applied in this case. 

 

I had never heard of the product, and have not researched it independently,
but luckily your respondent has set forth the 'affirmative' case in all its
glory. There is nothing in his argument thus far to distinguish this from
the thousands of other products per year that fall by the wayside after an
initial sales campaign because they don't actually work. I'm open to decent
evidence to the contrary, but if it existed, I suspect it would already have
been cited below.

 

Cheers

Justin

 

Dr Justin Coleman

http://drjustincoleman.com/  

 

From: asc-list-bounces at lists.asc.asn.au
[mailto:asc-list-bounces at lists.asc.asn.au] On Behalf Of Angie Good
Sent: Wednesday, 27 February 2013 12:23 PM
To: asc-list at lists.asc.asn.au
Cc: 'Robert Fuller'
Subject: [ASC-list] Request for your thoughts on the following...
[SEC=UNCLASSIFIED]

 

Posted on behalf of Rob Fuller (robertbrucefuller at gmail.com)

 

 

Dear ASC,

 

Firstly I want to say I am not trying to defame anyone here but I would
personally love to get your thoughts on the following correspondence and
possibly a comment on the validity of the arguments used. 

 

Disclaimer:

This is a personal matter and I am not speaking as a representative of my
employer.

 

The context:

Recently I was asked by a friend to check out a product called Protandim, he
pointed me to a video online and asked what I thought. I did a quick search
on the product and concluded that the scientific evidence of the benefits of
its use is thin.

 

I was unaware that this personal conversation would be passed along to a
third party, I had hastily summarised my thoughts and sent the email from my
iPhone with spelling errors etc. You can understand I didn't realise that my
email was being forwarded to a representative of the company selling
Protandim. Imagine my surprise when I received the following email reply.

 

Hey Rob,

 

Thanks for the excellent comments.  I had to defer to my business sponsor
Dr. Ranga (Ph.D.) to answer those questions.  He is a former research
scientist and Ph.D. in Nutritional Medicine from the University of Wisconsin
and practises as a clinical nutritionist from his practice in Sydney where
he has been using Protandim as part of the treatment protocol for his
patients (many of whom have cancer). I am sure you understand the jargon he
uses - I certainly don't! LOL

 

---------

 

My email:

I watched the video and looked at the studies, I think in principal the idea
of reducing oxidative stress is good but they are drawing a long bow on some
of the claims. 

 

There is also the question of why the only human studies are so old and why
mice studies have been conducted extensively. It would be very easy to have
a randomized controlled study of users, and test oxidative stress levels
after 1,2,3,6,12,24 months. Then they could rightly claim the protandim does
reduce oxidative stress (with the marker or indicator they are choosing to
use) as for what a reduction in these markers means for health and disease
prevention or "anti-aging" is yet to be proven.

 

Also the claim that taking the pill with the ingredient together is more
effective than the ingredients on their own has not been shown, that is to
say you could find ways to have the protandem ingredients in your diet.

 

Lastly oxidation is a necessary part if body and cellular process, whilst
there is of course a role for anti-oxidants Anything that may be too an
antioxidant effective may  impinge on the functions of the cell by reducing
available oxygen?

 

That's how my science brain is seeing it, but I have said to people etc that
if you find something that makes you feel good (proven or placebo) then you
should go for it (within reason). What I don't condone is unsubstantiated
claims and people trusting that the benefits are proven and possibly being
taken advantage of.

 

-----

 

The Response:

What claims goes the ABC video state? 

Dr. McCord clearly states that he is making no claims and when necessary
studies are done claims could be made...

If any claims are made they are by consumers through testimonials. 

 

TGA approval certificate lists a long list of conditions that Protandim may
alleviate. This is after they have thoroughly investigated the studies,
patents, manufacturing processes, promises, QC etc. 

 

ABC video wasn't done by the company or request from the company. It was an
investigational report after the first small human clinical study results
were released. This study that lead to the ABC report is obviously a
preliminary study by LV to test the lipid peroxide levels came down using
Protandim. 

 

The company lost money in the initial period marketing Protandim via retail
and explains at lest to me why expensive double blind placebo controlled
trials were not initiated. Even if the company did find research like
Pharmaceutical companies do to get approval from FDA, anyone on can then say
the research was funded by LV so not impartial, biased, researcher could
have been paid etc etc...

Coming from working in research for many years in university and research
institutes focused on lab research, I understand the difficulties smaller
companies face in running proper research or clinical studies. 

Preliminary university studies always use mammalian animal models as it is
cheap and reproducible as well as results can be seen fast. 

The studies conducted by the universities LSU etc are still preliminary
studies to show rats or cell lines respond to Protandim. The next phase of
research usually occurs when other medical research groups when searching
for nrf-2 work to conduct their own research find these preliminary work and
investigate the use of a natural formula to study the nrf-2 activation
pathway and how this could help in disease. 

The first such study is the Netherlands research study on Protandim
comparing its nrf/2 activation to BG12, Fumarste, and Sulforaphan (brocolli
extract). They found Protandim to be superior and recommended its use in
treating MS as part of the treatment protocol. 

The synergistic effect was demonstrated in the studies submitted  for patent
application. Having a patent stating that CRP can reduced by Protandim and
get it approved I think is significant. 

There are many herbs with nrf/2 activity but the level of activation occurs
if a number of different membrane receptors are bound by the respective
ligands simultaneously thus higher activation of the kinase which
phosphorylation KEAP 1. 

Partly it's the due to number of receptors activated that the synergy  works
better. This is also the reason why ancient Chinese and Ayurvedic formulae
have several herbs. 

Unlike allopathic thinking of one drug one target, traditional medicine
looks at synergy. 

 

Most current medical research is focussing attention on studying the
Epigenetics of synergistic traditional formulae. 

We are fortunate that Protandim is the forerunner of such formulae and has
the initial level of validation. 

 

Other than that all I can say is my own clinic results of over 200 patients
having significant to almost miraculous effects and on some cases medically
"untreateble" genetic conditions. 

 

You can contact Dr Kama regarding her experience with a genetic blood defect
which predisposes to blood clotting problems leading to difficult conception
and miscarriage. After 1-2 months of Protandim not only dud she fall
pregnant but had great pregnancy and delivered the baby a few months ago.
These are real cases of people benefitting. There cases that you can contact
the patients and they are happy to tell their story. These people are not
distributors and only consumers of the product. 

 

Oxidation under necessary conditions such as in microbial infections are
important functions of leukocytes  and these reactions are generally using
super oxide free radical and hydrogen peroxide and some by products of HP
metabolism. 

However hydroxyl radicals and peroxy nitriles and other lipid oxidation by
products are highly toxic to cells. 

Our issue is as we get older we are more subject to DNA mutations due to
telomere issues as well as high environmental toxic loads. 

 

Since we are under these conditions 24/7 we need the extra support of
external antioxidants as well as internal antioxidant enzymes and peptides
like glutathione. Again the importance of a balanced toxicants free diet
cannot be over-emphasized as we need the amino acids, vitamins, minerals etc
to biosynthesize the enzymes. 

 

We can eat foods that are high in the ingredients found in Protandim such as
turmeric, green tea. But other inducers such a withania, bacopa, and millk
thistle are not palatable nor available freely as a fresh herb. Also even if
we take these herbs we have no guarantee that the active ingredients such as
withanilides, silybin etc are present in the herbs at the right
concentrations. 

Protandim herb batches have to go through nrf/2 activity tests which require
DNA microarray technology to assess. 

This type of QC testing is very expensive thus another reason why the
company may not have invested in big trials. 

My own training in food/medical microbiology techniques such as dark field
microscopy and its use in assessing blood has consistently provided me with
proof of lowered oxidative stress even after 15 days of Protandim. As you
may or may not know red cells are very sensitive to nutrient deficiency,
direct damage by heavy metals, and free radicals generated by toxic metals,
as well as leucocyte activity during infection and 

Inflammation processes, auto/immune as well as allergies. 

While research studies showed TBARS levels reduced by Protandim use, this
test is detecting only lipid peroxide (malondialdehyde). Where as my testing
of red cell sensitivity shows the protective effect of Protandim against
multiple oxidants as well as its other known benefits such as
anti-inflammatory, anti/fibrlytic etc. 

 

Just as a last comment, during an infection, the ARE gene segment and its
encoded gene products up regulated by Protandim will not occur in leucocyte
as the infection fighting takes higher priority. However in other cells the
up regulation can take place providing a protective effect on those cells. 

It is interesting to see blood of patients with Parasitic infections change
dramatically after Protandim while on anti-parasitic herbs and
immuno-stimulators herbs. The blood picture shows the high level of
neutrophil activity and the resulting cell debris due to the production of
free radicals in defense. However the red cells are not affected by this
activity due to Protandim effect within these cells. 

Anyway didn't meant to write this long and hope it helps to clarify some of
the very valid issues brought up by your friend.

 

It is always good to deeply investigate any formula before taking it myself
and recommending to patients. I can say confidently that after 2 years of
personal use and testing and trialling as described above, I will take the
formula as long as they make it. 

 

Ranga

 

 

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