Posted on behalf of Rob Fuller (robertbrucefuller@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

 

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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.

 

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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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