Monday, December 15, 2008

How to Determine Quality in Supplements, Part 3

Hopefully by this time I have already established in my first two posts on this subject that there are some serious problems in terms of quality in the supplement industry. To verify some of those assertions, consider the following list of just a few of the common problems that exist in dietary supplements:
  • Inaccurate label claims of herbal products. Monmaney T. Labels’ potency claims often inaccurate, analysis finds. Los Angeles Times, August 31, 1998.
  • Lactobacillus products mislabeled and contaminated. Hughes, et al. Microbiologic characteristics of Lactobacillus products used for colonization of the vagina. Obstet Gyneocol 1990;75:244.
  • Herbs seriously contaminated with heavy metals and pathogens. Bateman, J. Possible toxicity of herbal remedies. Scottish Med J 1998;4:7-15.
  • Nutrient interactions inhibit mineral absorption from multiple vitamin-mineral supplements. Shils, et al. Modern Nutrition in Health and Disease Vol 1.8th ed. Philadelphia: Lea & Febiger; 1997. pp. 216-217.
  • Calcium supplements contaminated with lead. Bourgoin B, et al. Lead Content in 70 Brands of Dietary Calcium Supplements. Amer J Pub.Hlth. August 1993, Vol. 83, No.8
  • Herbal weight loss products cause lethal side effects because of being tainted with dangerous drugs. August 2002, Media Inquiries: 301-827-6242
  • Herbs contaminated with mold. Halt M. Moulds and mycotoxins in herb tea and medicinal plants. Eur J Epidemiology 1998;14:269-74
  • Liver failure and serious liver injury occur with herbs contaminated with drugs. U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Nutritional Products, Labeling, and Dietary Supplements November 19, 2001

So how can you know if a supplement company is in the health science business rather than in the business of selling pills? Here are some things to look for:

1. GMP certification. Like I mentioned in my first post, this is the ONLY way to know if a company is just tooting their own horn or if the quality of the company has been analyzed by a reputable third-party placing their stamp of approval on their manufacturing systems.

2. Assays. An assay is an analysis of finished products and their individual ingredients. Most companies do not perform assays because they are not required by the FDA and they are expensive. But this is the only way to tell if a batch is contaminated with mold, fungus, heavy metals, pharmaceutical agents, or other foreign substances. Many companies that do perform assays do them randomly, perhaps one batch out of every 10 or 20. However, responsible quality control demands that assays be performed on every batch because purity is not guaranteed with every batch of new raw material.

3. Human evaluations for safety and efficacy. Unfortunately, this is a rarity in the supplement industry. Most companies base the safety and efficacy of their products upon third-party research done on various individual ingredients, but they do not test the actual products themselves in a clinical setting. It cannot be assumed that just because the third-party research on Echinacea, for example, showed a certain degree of safety and efficacy does not mean that once the Echinacea is manufactured into a product in a particular facility that it is then going to pass stringent QC/QA measures and that it will have that same effect in the clinical setting. This is especially true when the ingredient is combined with other agents. Most third-party research is done on individual ingredients, not on combinations. So most supplement manufacturers produce products simply assuming that if the research on Echinacea shows benefit in immunity, and the research on Goldenseal shows similar benefit, then why not combine them for an even better result? While that works out sometimes, at other times ingredients can actually compete with one another and cancel each other out. So it is important that there be a system in place that provides human safety and efficacy studies on the finished products to be able to provide a high level of predictability.

4. Extensive scientific Team. Most companies, if they have scientists on staff at all, have maybe 2 or 3 overseeing the entire operation. I find it difficult to believe that 2 or 3 scientists, or even a half dozen, could efficiently oversee the formulation, manufacture, and testing of thousands of bottles per month of product while also keeping abreast of the latest research. I didn’t say it couldn’t be done. I just said I find it difficult to believe that it could be done efficiently. I tend to trust a broader range of expertise which incorporates botanists, professional wild crafters of herbs, PhDs, MDs, chiropractors, clinical nutritionists, and naturopaths all working together to pioneer breakthroughs in the nutritional industry, to produce nutriceuticals that pass the scrutiny of all the various disciplines involved, to stay abreast of all the latest research, and to oversee the operations. If I needed a heart operation, I would want at least two qualified heart surgeons on hand, several nurses, an anesthesiologist, etc, rather than trusting my health to just a couple of guys with stethoscopes. Nutritional products are no different. We take them into our bodies. They affect our biochemistry, and I want mine to be produced by the most extensive scientific team with the most years of experience possible.

5. State of the Art Facilities. This goes back to GMP certification. A manufacturer can throw a few scientific-sounding terms your way to make their operations sound impressive, but you really have no idea what their operations involve without a third-party analysis of their facility and operational system. I had one doctor tell me that he toured the facility of a doctor’s line supplement company who I will leave nameless, and he said that it really wasn’t anything more than a big dank warehouse with a few machines. And yet somehow they were still proud enough of the place to give tours of it. That’s not what you want to see from a supplement company, especially one that is marketing their goods to doctors.

6. Product Innovation. One of the elements that a sophisticated product line should possess is unique product innovation and industry firsts. A true science-based company that is helping to blaze new trails in nutritional medicine will invest in the process of scientific discovery and well-designed research to bring previously undiscovered compounds and new applications for already-known compounds to the market. Honestly, most nutritional companies even in the professional market are what I call “me too” companies, meaning that they piggy-back off the research and product innovation that other companies have already pioneered and create their own spin-off products with slight variations and cheaper price tags. In a free market system that is certainly a legitimate way to forge a business. However, if enough practitioners patronize me-too companies based upon getting what they hope will be the same kinds of products for less money, eventually all the companies who actually invest in research will no longer be in business, or at least not be able to do the research any longer.

As you can see, there is a lot to producing supplements that are of true quality, more than most people could ever imagine. Just looking at the ingredients on a label and checking to see if “quality” is somewhere in the marketing is not a good way to determine the quality of your supplements, and neither is looking for less expensive products necessarily. True quality costs money, and a more sophisticated line will usually reflect that in their prices. That is true of organic food, it’s true in the extent of training that certain doctors receive and the services they offer, it’s true in the automobile industry, it’s true in the clothing industry, and every industry under the sun. And it’s certainly true in the supplement industry. You get what you pay for, and when patients understand that they are more inclined to comply with the practitioner’s recommendations instead of going down to the local franchise pharmacy to purchase their supplements.

In conclusion, practitioners should help their patients understand the difference between companies that are in the health business and those that are in the business of selling pills. Those that are in the health business will adhere to the standards discussed in this and the previous posts, because as as Dr. Jeffrey Bland likes to say, “The most expensive supplement is the one that doesn’t work.”

Tuesday, December 9, 2008

How To Determine Quality in Supplements, Part 2

A good share of doctors who are evaluating a supplement line and/or a specific product do it like this: They will look at the label and check for certain ingredients. All done. If they like what they see in terms of ingredients, that is all they think they need to know.

Allow me ask this question: If a healthcare consumer were looking through the yellow pages for a good holistic practitioner, would you say that they have investigated their choices thoroughly by simply looking at the educational degrees of the various practitioners and the services offered? I think you would agree that just because someone has certain letters behind their name and offers a particular service does mean that their level of expertise is what you are after. I heard a joke that illustrates this point. “Do you know what you call a medical student who graduates with a C average? Answer: Doctor.”

I have been adjusted by chiropractors who I will never let touch me again, but others seem to have a magic touch. I have met self-proclaimed nutritional gurus who are so “out there” in their philosophies that I wonder how they ever got be doctors, but I would trust my own family to others. If you are like me, you don’t want just anyone with his/her name on a shingle adjusting your spine or overseeing your medical care.

Shouldn’t we be just as scrutinizing with the supplements that we are taking on a daily basis, and shouldn’t doctors be even more scrutinizing when it comes to supplements with which they trust their livelihoods?

If you believe that a supplement line merely calling themselves “professional” and talks quality and markets themselves to doctors automatically makes them a company turning a quality product, then I have some beachfront property in Kansas I would like to sell you. :-)

Everyone Talks Quality
When was the last time you saw an advertising line like this: “Our quality control is above average.” Never, right? Nearly every supplement manufacturer will provide you with full-color advertising showing people in white lab coats looking at samples in a test tube or through a microscope. Everyone says that they are second to none in terms of quality, just like every restaurant says that they maintain a clean kitchen, just like every car manufacturer wants you to believe that their brand of car is the safest and most reliable on the road, etc. So how do you differentiate effective marketing from true quality?

Unfortunately, there IS a big problem with quality in dietary supplements. Bear in mind that the supplement industry is not regulated by the FDA, and that means that standards of quality are self-imposed. In other words, it is up to each individual company how much money they want to spend on quality measures. And that is perhaps why there are not more companies that are GMP certified (see my last post).

There is much more to determining the quality of a product or supplement line than just looking at the ingredients of a label, because there are some serious problems that exist in the supplement industry regarding quality that I’ll talk more about in the next post. For today’s post, however, I want to focus on the difference between what’s on a label and what is actually represented in a product.

Analyzing Raw Materials
Nearly all supplement companies get their raw materials from third-party suppliers. Remember, there are no FDA standards to guide supplement companies in how they select their raw materials, so most of the time companies make their decisions based upon price and based upon the claims of the raw material suppliers. If the companies selecting these raw materials don’t analyze what they are buying prior to the purchase, then they really have no idea what they are getting.

For example, the therapeutic parts of the herb, Echinacea, are in the flowering bud, not the stem or the roots. Yet a supplement company can buy a batch of Echinacea from a third-party supplier not knowing that most of the raw material is stems and roots and possessing almost no therapeutic benefits.

Even the true therapeutic parts of the plants can vary from batch to batch, and that’s why comprehensive lab analysis are important to verify the different constituents of the plant.

The herb, St. John’s Wort, for example, contains hyperforin and hypericins that give the herb the therapeutic benefits. In a recent analysis of four different suppliers of St. John’s Wort, all varying in price, the lab analysis showed the following:

The first three samples, ranging in price from $12.32/kg to $19.00/kg, all had incomplete assay information and/or had incorrect assay methods. There was no detectable hyperforin in any of them, and although there were adequate levels of hypericins, all three samples had suspect adulteration with synthetic hypericin. All three samples also had heavy metal contamination.

In contrast, the fourth sample of St. John’s Wort – by far the most expensive of the four at $36.00/kg – was identity confirmed with a complete and correct assay method, had therapeutic amounts of hyperforin at 3.0%, and therapeutic amounts of natural, unadulterated hypericins at 0.3%. Likewise, there was not any heavy metal contamination.

A scrutinizing supplement company would know what to look for in all four samples, so they would first of all have to know what a correct and complete assay method looks like to be able to determine if the information presented in the assay report actually means anything. It’s not enough to just have an assay. You have to know the correct assay methods. Secondly, the scrutinizing company would know what levels of the therapeutic agents to look for, as well as levels and types of possible adulteration. Thus, a company that is truly in the health business will choose, in this case, sample #4 even though it is three times more expensive than some of the other samples.

As a last point, what do you think the suppliers of samples 1, 2, and 3 do after a company with high standards rejects their raw materials? You guessed it. They just take their shoddy raw material and go sell it to another supplement company who either doesn’t do any raw material analysis at all, or one who doesn’t perform the proper methods of evaluation.

So price is definitely not the way a responsible consumer, whether it be a practitioner or a patient, should be choosing their supplements.

In my last and final post on this subject, I’ll address six other markers of true quality in supplements. Stay tuned.

Tuesday, December 2, 2008

How to Identify a Quality Supplement Line

The food supplement industry is one of the fastest growing industries in America and abroad. It is little wonder that new supplement lines are sprouting up all over the place.

For scrutinizing practitioners who want and need to provide the absolute best for their patients, how does one wade through the marketing to determine quality that is worthy of the clinical setting?

As I embark upon this subject, let me say up front that you should not take my word for any of what I’m about to tell you. I have worked in the supplement industry for 15 years now and have been privy to information to which most practitioners are not exposed. But in that I could rightfully be accused of having biases because of my associations, I encourage you to check out my claims for yourself.

Good Manufacturing Practices (GMP)
One of the most important markers of quality in supplement manufacturing that a scrutinizing practitioner needs to know about is Good Manufacturing Practices (GMP). There are three entities that offer GMP certifications. They are the Natural Products Association (NPA), the Therapeutic Goods Association (TGA), and the National Sanitation Foundation (NSF). These organizations are reliable third-party sources of gold standard analysis on the quality of supplement manufacturing. Their analysis involves random audits that scrutinize areas that most practitioners would not even know to ask about, such as determining if the kind of paint used on the walls is producing off-gassing, whether or not the water is ultra-purified, analyzing the joining of walls to the floor to make sure that there is a gradual and sloped transition so that no dust can gather in the corners, analyzing the machinery and the operating systems, and testing the knowledge of the people running machines to make sure that each person’s procedures matches GMP standards.

This is merely a partial list, as a GMP audit usually takes up to two weeks to complete, and companies seeking GMP certification do not know when the audit is going to take place. The auditors simply show up unannounced, so the company had better be operating according to those standards 24/7 to score a passing grade.

The primary goal of GMP is to ensure that the manufacturing processes operate in a state of control. This state of control acts as a filter to help eliminate product contamination, mix-ups, and errors. GMP certification offers health professionals and their patients a basis for trust that the supplements they are using are safe and match label claim.

GMP is Good Business
GMP certification is good business for both the company in question and the doctors and patients using their products because it reduces exposure to potential product liability issues. Remember, in today’s culture anyone can sue anyone for almost anything. If a patient ever sought legal actions against a doctor for his or her administration of a certain nutritional product, the backing of GMP certification that is consistent with how drug companies manufacture their products could help protect both the doctor and the supplement company.

Also, GMP certification reduces exposure to regulatory enforcement actions.

I have included the GMP framework at the end of this post for those interested in learning more.

Aren't All Supplement Lines Operating with High Standards?
It takes multiple millions of dollars to get a manufacturing system and facility up to the very stringent GMP standards, but the certification itself costs only $200. Many companies claim that they are “GMP compliant,” or “operate according to GMP standards,” but these claim beg an important question. If a company has already spent the millions of dollars it takes to get up to GMP standards, why would they not spend another $200 to validate their quality claims by getting certified? As it appears to me (for whatever my opinion is worth), the companies who are not certified remain that way because either they know up front that they cannot pass the audits, or because they have already attempted to get certified but failed the stringent auditing process.

As it currently stands, there are only two doctor’s lines that maintain GMP status, and there is still only one doctor’s line that is certified on all three levels.

Yeah, but…
One common argument against GMP certification used by non-GMP companies is that the GMP process doesn’t take into consideration ingredient selection. In other words, an aspirin or calcium carbonate product can be GMP certified. So ingredient selection and product design certainly play an important role.

I agree that GMP is not an all-encompassing standard of what differentiates a quality line from those that are not. However, GMP is like a doctor who has a certified degree offering treatment versus someone like myself who has some knowledge of healthcare but has no license. A scrutinizing patient would and should raise an eyebrow at a person who said, “Well, I have all the knowledge that any other practitioner has, I just never got my license. But you can trust me because I offer the same care that any licensed practitioner would.” In order to validate the knowledge, training, and skill of any person offering healthcare, a license or certification must be in hand.

Similarly, a scrutinizing practitioner should also raise an eyebrow at a company who claims to operate according to GMP standards but never bothered to get certified. A product line can be making great choices in terms of their ingredient selection but then fail in other vital quality procedures. What good is the best Ginko raw material, for example, if the manufacturing process fails in many important markers of quality determined by the GMP certification process? If a company will not invest the $200 it takes to get GMP certified, then it should not be assumed that that company is operating on that level of quality in spite of what they claim. Nor should it be assumed that that company is doing the due diligence in other areas of quality not analyzed by GMP.

Remember, every supplement company is in business to make money, and talk is cheap. A practitioner really has no idea what goes on behind closed doors unless the system in place is analyzed, scrutinized, and certified by a reliable and recognized third-party placing their stamp of approval on the operating system. And that’s why GMP is important.

In the next post, I’ll address a few other important determinants of quality.

________________________

The GMP framework involves:
Technical Controls
-Materials
-Buildings
-Equipments
Operational Controls
-Policies
-Procedures
-Records
Relational Controls
-People (Employees and Suppliers)

GMP controls include the use of procedures that control each step and records that confirm procedures were followed and provide traceability in the following areas:
· Receipt and storage of raw materials, in-process materials and finished product.
· Manufacturing process
· Testing (raw materials, in-process and finished product)
· Filling, labeling and packaging
· Finished product approval
· Document Review
· Release and distribution
· Change control

Monday, November 24, 2008

Why Food Matters

In the 15 years that I have supported doctors in their use of clinical nutrition, I have always tried to take a balanced perspective and emphasize the fact that even the most sophisticated supplements should not be expected to take the place of a healthy diet. Diet lays the foundation for health and vitality, and supplements are just that – they supplement the diet.

But therein lies a big problem.

Here in the Midwest the concept of what eating healthier looks like is almost amusing. A lot of people seem to think that as long as their Wendy’s hamburger has some iceberg lettuce and a slice of tomato they are eating healthy. But the problem doesn’t seem to be isolated to the Midwest. Current statistics from the NHANES study show that two thirds of the U.S. population are overweight, with a third of those classified as obese. Likewise, a Surgeon General report indicates that 7 out of 10 leading causes of death in the U.S. are preventable and diet-related.

In caring for the chronic health concerns of patients, it is imperative, of course, to coach them on their diet and why the diet is so important. One of the concepts to attempt to get across to patients is the fact that each bite of food carries a message to the cells of the body. What message is being communicated depends on what kind of food is being ingested.


Think of it this way: If your automobile requires diesel fuel, but you put in regular unleaded, it won’t take very long at all for the automobile to respond negatively. While our bodies are far more sophisticated and intricate than an automobile, the same concept still applies nevertheless. The human body was not designed to function on chemical concoctions like bologna and chips and Velveeta cheese and Lucky Charms and the endless assortment of man-made food stuffs. While the human body has the innate ability to make adjustments and function somewhat normally on junk food diets for long stretches of time in some cases, eventually system failures begin to occur.

When system failure does occur, instead of changing the fuel that caused the breakdown in the first place, what most Americans tend to do is put duct tape on the engine light, so to speak, by suppressing symptoms with one or more drugs.

We absolutely must begin to help people understand that heart disease, for example, is not a result of statin drug insufficiencies. Depression is not a Prozac deficiency. Arthritis is not due to not having enough COX-2 inhibiting drugs. These drugs have their place and benefit when used appropriately, but they do not lead to better health.

A Diagram of a Protein Kinase
Achieving better health is contingent upon changing the messages to the cells. Recall that our biochemistry is a complex system of signals involving kinases, hormones, and a delicate balance of other intracellular messengers. These signals can become altered due to the kind of messages being sent from the food we eat. Bad food equals bad messages resulting in poor function. Good food equals good messages resulting in improved and optimal function. It’s as simple as that. The human body in spite of its Divine design cannot function optimally for very long when the signals are destructive, and this is a concept most Americans have yet to understand and that most doctors have yet to communicate effectively to their patients.

In the Christian circles in which I grew up and am still a part it was and is popular to refer to the human body as a temple, a Biblical reference. The concept being communicated is that we need to respect our bodies and not abuse them with drugs and alcohol and cigarettes. I couldn’t agree more. However, it is not uncommon even in Christian circles in America to avoid these vices yet still over-indulge on a daily basis with every nutrient-deficient, chemical and sugar-laden junk food under the Milky Way. And somehow many people remain blind to this double-standard.

Since I’m picking on my church-going brethren a little, allow me to use an historical and Biblical reference to illustrate my point.

In the book of Proverbs, chapter 23, verses 1 through 3, it says:

“When you sit to dine with a ruler, note well what is set before you, and put a knife to your throat if you are given to gluttony. Do not crave his delicacies, for that food is deceptive.”

This passage was written approximately 4,000 years ago in the Middle East. In that time and place, it was only the rulers and dignitaries – the wealthy of the culture – that ate calorie-rich, nutrient deficient foods. Refined foods, animal fat, and copious amounts of alcohol were daily indulgences. However, the commoners subsisted on wild game and fresh fruits, vegetables, and grains that they farmed themselves. As a result, the “diseases of kings and queens,” as they became known, were common among the elite of the culture, but very uncommon among the working class. What were the diseases of kings and queens? Heart disease, obesity, arthritis, and other degenerative maladies were the afflictions of the rich of that time. And today America is an entire nation of people who know such endless abundance that the entire population is suffering from the diseases of kings and queens. That’s why the writer of Proverbs warns against excessive food indulgences and encourages self control.

By the way, I think the last phrase of Proverbs 23:3 is interesting. It says that that food can be deceptive. What is “deceptive” food? I believe the message is clear. It’s food that looks good and tastes good and thus promises pleasure, but in the end it robs one of life and vitality. It deceives those who excessively indulge in it.

Inspiring Behavior Modification in Patients
Inspiring behavior modification in patients remains problematic for many practitioners because of time constraints in the ability to offer patient education. There are some fantastic resources, however, to aid in this endeavor.

First, there is a new movie due out anytime called, Food Matters. Click here to view the trailer. This will be an eye-opening and educational movie that can inspire your patients toward change.
Likewise, the movie, Super-Size Me, a documentary about a man who ate nothing but fast food for 30 days and almost didn’t live to tell about it, sheds some sickening light upon the fast food industry and what kind of health consequences it is having on America.

Lastly, there is a certification course called, First Line Therapy, which is a three and a half day training on Therapeutic Lifestyle Changes (TLC) that can aid practitioners in helping patients to undergo the necessary changes to transform their health. The patient education tools and program guides that this program offers make it easy to inspire and guide patients in taking control of their own health.

Not to minimize the importance of supplements, it is true that supplements can often bring about dramatic improvement without lifestyle changes. But I believe the most profound health benefits will be realized when diet and physical activity form the foundation and supplements are used to support these efforts.

Tuesday, November 18, 2008

The Truth about Sucralose (Splenda)

Sucralose is the new rave in artificial sweeteners. Many believe it to be a healthy alternative to proven neurotoxic substances like aspartame. But not so fast. One cannot base one's opinion on the healthfulness of an artificial sweetener (or anything else, for that matter) based upon the marketing hype of the manufacturer.

I'm offering today's post with the help of my friend, Dr. Ed Zimmer, who wrote an excellent detailed article on this some time ago. What you see here are excerpts from Dr. Zimmer's article.


From the article:
I have read the FDA’s multi-page final ruling for the approval for Splenda® (sucralose) and am deeply disturbed. There is an old saying: “What you don’t know can’t hurt you.” Splenda® is a great example of how this statement could not be further from the truth. So, I am going to give you facts about Splenda® and the man-made chemical, sucralose, and allow you to come to your own conclusion as to whether you think it is a good idea to allow yourself, your children, or anyone you care about to be dosed with this chemical on a regular basis.

Understanding The Chemistry
The first thing that you need to know is that sucralose is not a natural molecule. All you need to do is to take a look at the chemical name for sucralose to understand that it is not natural (see diagram). It is a man-made chemical that falls into the class of chemicals known as chlorinated hydrocarbons. Other chemicals that fall into this same category include many dangerous pesticides like dioxin and DDT. The chlorinated monosaccharide, 6chloro-6-deoxy-D-glucose is a known neurotoxin. Thus, sucralose falls into a category of molecules that should immediately raise serious questions about potentially deadly health concerns.


To be fair, however, you need to know that not all chlorinated molecules are toxic to humans. We cannot, in good faith, immediately make the connection that sucralose is a toxin just because it is a chlorinated hydrocarbon.

Not So Splendid...
To be a little more specific about how sucralose is made, man has taken a natural sugar molecule and forced three chlorine groups to be unnaturally added. The addition of these three chlorine groups causes the body to not recognize the molecule as sugar any longer. The benefit of this for the marketplace is that it creates a molecule about 600 times sweeter than sugar that is not used by the body to make energy. Thus, it has no calories.

The logical question to ask next is how the addition of these three chlorine groups affects the natural sugar molecule. The only way to assess what this new, unnatural molecule will do to humans is to perform studies. This is where the scary part begins.

You would assume that in order to gain FDA approval there would have to be numerous independent studies done to prove the safety of this chemical. You would also assume that if the studies performed raised any questions about potential health concerns that the FDA would err on the side of safety and would not approve a questionable chemical as being safe for consumption.

You assume too much!

As you read about the following information, remember that McNeil is extremely proud of the studies they have done on sucralose.

The Testing of Splenda®
As is common with the FDA approval process, the only testing and studies supplied for consideration were done by the very same company that had financial interests in the product. The truth is that if their study results were negative in nature they would stand to lose billions of dollars. This is quite a motivation to design studies in a way that would decrease the chances of negative results. And, as you will soon see, any negative results were vigorously defended and explanations were quickly formulated.

The studies supplied to the FDA by McNeil (the maker of Splenda®) addressed a number of concerns including but not limited to:

• Fetal Toxicity • Reprodcutive Toxicity • Cancer Causing Potential • Immune System Toxicity • Brain Toxicity • Kidney Toxicity • Diabetic Effects • Environmental Effects
As I stated earlier, you would expect that the results from these studies would have shown no real concerns, as the FDA did approve sucralose for human consumption. This, unfortunately, was not the case and the FDA went out of its way to defend the negative study results instead of erring on the side of safety for consumers.


What The Studies Revealed...
All of the studies submitted to the FDA for approval were animal studies. So, we really do not know what sucralose does to humans from these studies. The studies submitted by McNeil revealed some very disturbing findings. I will use direct quotes from the FDA Final Report so that you can see exactly what the results were. The partial list of negative findings follows.


The testing for gene toxicity (cancer potential) revealed:


“...sucralose and its hydrolysis products showed weakly genotoxic responses in some of the genotoxicity tests.”

“Tests for clastogenic (capable of causing breaks in chromosomes) activity of sucralose in a mouse micronucleus test and a chromosomal abberration test in cultured human lymphocytes were inconclusive. Sucralose was weakly mutagenic in a mouse lymphoma mutation assay.”

“Results of three other genotoxic tests were inconclusive: The chromosomal abberration assay in cultured human lymphocytes, the sex-linked recessive lethal assay in Drosophila melangaster, and the covalent DNA binding potential study in rates. 1-6DCF (a by-product of sucralose) was weakly mutagenic in the Ames Test and the L5178Y TK+/- assay.”

So, sucralose and its by-products did show some toxicity to genes. This is not a good thing as it could potentially lead to the development of cancer. The FDA simply dismissed these finding stating that the 2 year cancer studies done in rats were negative and thus, the findings of gene toxicity were insignificant. This was quite a leap of faith taken by the FDA. In other words, The FDA suggested that since limited tests done in rats did not show any increased cancer rates, the actual finding of gene toxicity should be completely dismissed. And, they were.

I ask you to think about how cancer develops in people who are exposed to cancer-causing toxins. Take asbestos exposure for example. When did people exposed to this toxin develop cancer? Did it take months, a couple of years, or many years? The answer is many years. Most people did not develop cancer for over a decade.

So, how can the FDA simply dismiss findings of gene toxicity through a two-year rat study and conclude that sucralose will not cause cancer in the long-term?

The testing for immune toxicity revealed that sucralose caused damage to the immune system:
“...when rats were fed sucralose in a 4 to 8 week range finding study the following effects were noted: Decreased thymus and spleen weights (immune tissues) , lymphocytopenia (reduced white blood cells), and cortical hypoplacia of the spleen and thymus.”

In an effort to reduce the negative impact of these findings, McNeil then followed this up with a study that only lasted 28 days. This new study again showed disruptions in immune functions at higher dose sucralose fed rats, but not in lower dose groups. The FDA found this 28 day study to be sufficient in defining the safety of sucralose for dosing in humans to not cause immune function disruptions. The bottom line is that the studies conclusively showed that sucralose could have a negative effect on the immune system.

One of the more disturbing findings revealed through the FDA Final Report concerned the testing to determine the neurotoxicity (brain toxicity) of sucralose. Remember that sucralose is of the same family of chlorinated hydrocarbons as are many dangerous pesticides. The question of neurotoxicity is a big one.

McNeil conducted two neurotoxicity studies, one in mice and one in monkeys. The tests were performed for only 21 and 28 days, respectively. How in the world would a 28 day study give the FDA enough comfort to make their conclusion that sucralose is not neurotoxic for long-term use by humans?

Interestingly enough, a 2006 peer-reviewed study in the journal of Headache presented a case study where sucralose was a trigger for migraine headaches (Headache. 2006 Sep,46(8): 1303-4.)
But wait, the FDA stated that sucralose was not neurotoxic. Testing for brain toxicity was done in monkeys for only 28 days! Could they have been wrong?

Are you comfortable with the conclusion that sucralose has no neurotoxicity? Instead of rushing to approve this chemical, why didn’t the FDA call for longer term human trials? Again, is the FDA looking out for you, or for the company?

Because of space restraints, I will summarize the other negative findings from this FDA report. The FDA dismissed all of these findings as not having been substantive.

• Enlarged liver and kidneys • Reduced growth rates • Decreased red blood cell count • Extension of pregnancy periods • Decreased fetal body weights • Subcutaneous Fetal edema (swelling of the fetus) • Increase in HbA1C (Hemaglobin A1C a marker for bad sugar control)

The bottom line is that the limited amount of studies performed on sucralose have raised serious questions about this chemical’s negative effects on immune system function, brain function, fetal toxicity, and the increased risk for cancer. These are not conspiracy theories. These facts are found in the FDA’s own report. The FDA simply doesn’t think these facts are important.

McNeil, for obvious reasons, wants you to believe that their product is safe. I am frightened by what I have learned and am far from convinced.

As you sort through the data I have provided for you in this article I would like you to consider a number of important questions.

Is sucralose natural in any way? My answer: No, it is a man-made chemical in the same class as many pesticides.

Is Splenda® (sucralose) good for you in any way? My answer: No. Your body can’t even use it to make energy.

Have there been legitimate questions raised regarding the safety of Splenda® for human consumption? My answer: You bet there have!

When those questions are raised, do you feel that the FDA errs on the side of safety for consumers? My answer: Not by a long-shot! Why not call for additional INDEPENDENT long-term studies to completely answer the legitimate questions that have been raised?

Have there been any human studies completed with Splenda® to address these major concerns?
My answer: None after 8 years!

Knowing about the potential negative effects on the immune system and the nervous system would you give this chemical to your children or to the child growing in your womb? My answer: No way!

Final Thoughts
Most of us have an inherent trust that our health care system, as a whole, is looking out for our best interests. In general, I have to say that I do not necessarily disagree with this statement. However, you should not be blinded by the fact that many aspects of our health care delivery system regard profit over your well-being. In my opinion, the FDA too many times is one of those organizations.

I am dismayed by how many of my patients and my close friends dismiss any negative information about a product if it has been approved by the almighty FDA. I urge you as a consumer of health care to guard against falling into a false sense of security simply because something has FDA approval. There are hundreds of drugs that have been approved by the FDA only to have been removed from the market many years and many deaths later. (This concludes Dr. Zimmer's article.)

My Concluding Remarks

Some alternative natural sweeteners to consider are Stevia and Xylitol, fructose and honey. But steer clear of anything that was made in a laboratory and that is a chemical. I would encourage you to check the labels of your chewing gums, commercial teas and colas, and anything packaged, because nearly all commercial products that don't contain sugar contain at least one chemical sweetening agent.

Again, I would like to thank Dr. Zimmer for thoroughly researching this issue.

Dr. Zimmer received his undergraduate degree in Chemistry from DePauw University in Greencastle, Indiana. His Masters work in Nutrition was completed at Bridgeport University in Connecticut. He graduated Summa Cum Laude from the National College of Chiropractic and was voted outstanding graduate by the faculty. He and his wife, Sherri, have five children.

Tuesday, November 11, 2008

Natural Modulation of Detoxification Pathways

Recall from my last post that the liver has two major pathways – Phase 1 and Phase 2 -- that are involved in transforming toxins into water soluble substances for excretion. These pathways are dependant upon specific micronutrients for their function, and certain natural compounds can positively affect their efficiency.

Green tea catechins, for example, have been shown to stimulate the detoxification systems through selective induction of both Phase 1 and Phase 2 metabolic enzymes. Likewise, watercress, artichoke, milk thistle, and the ellagic acid found in pomegranate have all been shown to provide modulation of the Phase 1 pathways and support for Phase 2 conjugation activity.

Certain micronutrients, too, play a vital role. N-Acetylcysteine (NAC) promotes detoxification by acting directly on reactive oxygen radicals. NAC is currently the “gold standard” for management of acetaminophen poisoning.

The methyl donors, choline, methionine, and folate play an important role in balanced detoxification by providing cofactors for Phase 2 conjugation reactions.

These pathways are also dependant upon sufficient macronutrients for their function. Adequate protein, quality carbohydrates and fats, and fiber are important in supporting these pathways and maintaining healthy metabolism during a detoxification program.

To that end, the two formulas in particular that provide the foundation for nutrient-tailored detoxification are the liver supporting nutriceutical and the detoxification medical food.

The medical food provides a broad-spectrum blend of both micro and macro nutrients for support of the detoxification pathways. The first product of its kind, this formula is the only such nutritional product that meets the FDA’s criteria for “medical foods,” and enjoys more than 20 years of research. In study after study, the medical food shows dramatic improvement – more than 200% in most cases -- in Phase 1 enzyme activity, as well as the Phase 2 pathways glucaronidation, sulfation, and glycine conjugation. All these pathways are absolutely necessary in the liver’s ability to clear toxins. (see graphs below)

Phase 1 Caffeine Clearance
221% Improvement in Phase 2 Conjugation 200% Improvement in Glucaronidation
283% Improvement in Phase 2 Sulfation
In other clinical trials evaluating the medical food's effect on symptoms associated with Fibromyalgia, chronic fatigue, chemical sensitivities, allergies, and migraines, the use of the medical food along with a modified elimination diet brought dramatic relief within two weeks and almost complete eradication of symptoms after only six weeks.

As a complement to the medical food, the encapsulated formula provides several compounds listed above that could not be included in a medical food because of the taste factor. Ellagic acid, watercress, silymarin, and artichoke are compounds that provide powerful bifunctional modulation of the liver pathways.

Used together, these formulas provide complete therapeutic nutrition for the elimination of synthetic chemicals.

As a stand-alone regime, the medical food would need to be used at no less than 2 scoops 3 times per day along with the modified elimination diet provided in the accompanying detoxification patient guide. One could modify the dose by adding 4-6 capsules per day of of the encapsulated formula.

For even more complete and aggressive support, one could consider the use of the nutriceutical for the kidneys. Featuring even higher levels of NAC along with cordyceps and Chinese Salvia root, this formula supports kidney function, provides great antioxidant protection, and promotes the final stage of toxin elimination, which is through the kidneys.

This three-tiered program is what I used to treat my toxicity sickness that I talked about in my last post, with unforgettable results.

Tuesday, November 4, 2008

Nutrient-Tailored Detoxification: Battling the Toxins that Make us Sick

It was the first week of December and I was overdue in putting the finishing touches on the painting I had begun months before. In a swell of motivation, I decided to get all the work done in one weekend, taking down all the doors in the house and transporting them to my garage. Since it was December it was cold outside, and being the manly man that I am (smirk) I didn’t give any thought to the possible damage that breathing the noxious fumes of oil-based paint might cause. I feverishly painted and sanded and painted some more for two straight days, proud of all that I had accomplished when the doors were re-hung.

At first I felt fine, but in a few days I began having severe flu symptoms. Because of the delayed reaction, I did not attribute my sickness to the paint, but thought I had simply come down with a winter flu. I pounded my stash of immune-support herbs and vitamins that usually work so wonderfully, but this time nothing happened. A week went by and I was no better, and curiously there was no fever and no swollen glands. But I had the same aches, pains, and fatigue that are usually associated with influenza.

Six weeks went by and my symptoms persisted. I sought advice from several practitioners but nothing was helping until a doctor friend of mine examined me and suggested that I was toxic. I knew how I ate and took care of myself, so his suggested surprised me….until I remembered my weekend of painting with no ventilation. Dumb!

My friend suggested a four-product detoxification program for me that almost immediately began to affect my symptoms. The first day I was slightly better. By the fourth day I was feeling significantly better, and by the eighth day I was symptom free. While I didn’t enjoy my sickness, it was great to personally experience the power of the same nutrient-tailored detoxification regime that I had been detailing my clients on for so many years.


A Brief Biochemistry Lesson…Just to Refresh Your Memory
One of the body’s primary methods of getting rid of toxins is through a conversion process in the liver. This is how it works:

Upon exposure the Phase 1 liver pathway, known as the Cytochrome P-450, goes to work to convert the fat-soluble toxin into an intermediate metabolite. I’ll spare you the specific chemical reactions, but substances that are fat soluble cannot be eliminated in that form. The liver’s job is to convert them into molecules that can be excreted. After the first step is complete, the phase 2 enzyme pathways kick in to further convert the newly-created intermediate into a water soluble substance. This process is known as biotransformation.


Overload Leads to Imbalanced Pathway Activity
In order for biotransformation to work properly, the two pathways have to work in concert. The primary reason is that the intermediate metabolites created by the Cytochrome P-450 pathways are actually MORE toxic than the original substance. So the Phase 2 pathways must be able to keep up so that these noxious chemicals can be readily excreted.

Therein lies the rub.

Because of massive amounts of toxic insults that people living in industrialized nations absorb, the system of biotransformation cannot keep up. The Phase 1 pathways stay locked in overdrive transforming all the toxins into intermediates, but the Phase 2 pathways bog down attempting to make the necessary conversions for excretion. And because of the log jam of intermediate metabolites that ensues, a huge amount of oxidative stress sets in because of the toxic nature of these metabolites that are not getting excreted. The toxins, however, have to go somewhere, so the body tries to hide them away in the fat cells in an attempt to protect the vital tissues and organs. In doing so, the neurological system is often affected because of the large amount of fatty tissue in the brain and nerves.

It has been proven that there is often a link between toxic exposures and neurological impairments. Just as compelling, though, are the studies proving that if caught in time, neurological impairment is reversible with nutrient-tailored detoxification therapy.

In the next post I'll go into more detail about specific condition applications, protocols, etc. So stay tuned.

Tuesday, October 28, 2008

New Discoveries in Supporting Inner Cleansing


The Environmental Protection Agency (EPA) estimates that every year more than 6 billion pounds of foreign chemicals are released into the environment. Our planet has become so thoroughly polluted that environmental pollutants can even be detected at the north and south poles, carried there by wind and ocean currents.

Besides the environmental toxins we are exposed to, dietary toxins also flood our systems and contribute to the toxic cesspool within our bodies. And even our clothes and bedding are sources of toxicity, as many new clothes, mattresses, and bedding are treated with fire retardants!

All these exposures add up. It has been determined that there are at least 167 synthetic and carcinogenic chemicals lodged in the tissues of the average human. These chemicals have even been discovered in mothers’ placentas and breast milk.


How the Body Chelates Heavy Metals
The body has its own method of dealing with heavy metals and other toxins. The protein, metallothianene (MT), which is present in all body cells, has a two-fold purpose. In the absence of heavy metals it serves to transport zinc and copper. However, when there are toxic metals present, MT binds to the metals, carries them out of the cell through the membrane into circulation, making the metals available for conjugation in the liver. But because the toxic load is often overwhelming to the body and impossible to keep up with, conjugation bogs down, and there apparently isn’t enough MT to efficiently rid the body of the noxious chemicals. Thus, toxic metals remain lodged in cells throughout the body, leading to all manner of maladies ranging from the vague to the serious.


Health Consequences of Heavy Metal Burden
Following is a list of maladies common to toxicity:
· fatigue
· muscle weakness
· muscle and joint pain
· depression
· anxiety and mood swings
· concentration difficulties
· irritability
· headaches
· kidney stress
· elevated liver enzymes
· flu-like symptoms

Nature to the Rescue
The good news is that within the wonders of nature there are compounds that can help the body keep up with the toxic burden of our environment and lifestyles. While the importance of bifunctional modulation of the liver detoxification pathways through natural compounds like ellagic acid, N-Acytelcysteine, green tea catechins, silymarin, and others has gained wide acceptance in the field of natural medicine, there is now a way to even more efficiently mobilize toxic metals stuck in the cells.

By upregulating metallothianene, we can make the body more efficient in eliminating the heavy metals to which we are daily exposed.

Through the science of proteomics (evaluation of how certain proteins effect physiology and pathophysiology), scientists at the Functional Medicine Research Center (FMRC) are able to identify unique applications to various natural compounds. Earlier studies have confirmed that zinc supplementation improves MT levels, but through proteomics research, other natural compounds have been identified that upregulate MT much more efficiently than zinc alone.

The study at FMRC involved the supplemental use of a formula containing zinc, curcuminoids, andrographis, and a combination of extracts of hops for a period of 10 days. No dietary modifications were involved except the avoidance of alcohol. MT levels were evaluated at intervals throughout the study, and a urinary excretion of heavy metals was evaluated at the conclusion.

After only a few days, MT levels increased by 37-fold, and held fast at a 10-fold increase during the four-day washout period. Heavy metal excretion increased substantially with nearly every metal measured (see figure 1). (Note: Mercury excretion occurs primarily through the feces, so significant changes were not expected to be seen via urine. Even so, some of the patients evaluated experienced a 9-fold increase in mercury excretion through the urine, indicating a probable large excretion of mercury through the feces.)


The Newest Generation of Detoxification Nutriceuticals
Make no mistake. Supporting the liver detoxification pathways is still a vital part of any detox protocol, because that’s where the process reaches its conclusion. Toxins mobilized from the cells via upregulation of metallothianene still make their way to the liver for biotransformation. However, the possibility of upregulating this important cellular protein using novel nutritional approaches was not a possibility to any great degree until now. Through ongoing proteomics research, the leading thinkers in nutritional science are continuing to set the bar in the field of functional medicine. The latest metallothionene-upregulating product and its related research is testimony of the multi-faceted power of natural compounds.

This new formula was administered at 3 tablets twice daily in the study, and that same dose is recommended for at least a month for anyone with toxic exposures. Supporting the liver detoxification pathways with nutrient-dense nutriceuticals and medical foods would provide multi-dimensional nourishment for state-of-the-art support for the body’s cleansing processes.

Tuesday, October 21, 2008

Natural Immune Support, Part 2

Here’s something that not a lot of people know:

Between 60 and 70% of the body’s immune defenses are concentrated in an area of the gut known as the Gut Associated Lymphoid Tissue (GALT). (By the way, 70% of the body’s serotonin is made in the gut, too!).

It is imperative, therefore, that the gut flora – the good bacteria that colonizes the intestines – be intact. Good bacteria like lactobacillus acidophilus, B. Lactis, and others, are not only good for helping with digestion, but they are also important for the assimilation of nutrients from food, supporting hormone balance, neurostransmitter balance, and yes, even the immune system.

But maintaining the life of these healthful bacteria is more of a daunting task in today’s world than ever before. Dietary insults like the sugar, caffeine, alcohol, and highly processed foods can diminish these important organisms. Likewise, antibiotics in the pill form and from the ones hidden in commercial meats are a death blow to our bacteria friends. Antibiotics (meaning, “anti-life”), are designed to annihilate all forms of bacteria, good and bad. What is often left over after a round of antibiotics are the resistant bad guys who then gladly take up residency where the good guys once were. And that can eventually wreak havoc on the health of the GI, the immune system, hormone balance, and one's mood!

Thankfully, we can replace much of these friendly organisms with supplemental “probiotics” (meaning, “pro-life”).

While the list of probiotic organisms is a long one, there are a few that research has shown are the best choices in enhancing immunity.

Firstly, the probiotic strain Bifidobacterium lactis HN019 has shown remarkable immune-enhancing qualities.
In a 2001 study on the elderly reported in the American Journal of Clinical Nutrition, thirty healthy elderly volunteers (age range: 63–84 y; median: 69 y) participated in a 3-stage dietary supplementation trial lasting 9 wk. During stage 1 (run-in), subjects consumed low-fat milk (200 mL twice daily for 3 wk) as a base-diet control. During stage 2 (intervention), they consumed milk supplemented with B. lactis HN019 in a typical dose (5 [1] 1010 organisms/d) or a low dose (5 [1] 109 organisms/d) for 3 wk. During stage 3 (washout), they consumed low-fat milk for 3 wk. Changes in the relative proportions of leukocyte subsets and ex vivo leukocyte phagocytic and tumor-cell-killing activity were determined longitudinally by assaying peripheral blood samples.

Increases in the proportions of total, helper (CD4+), and activated (CD25+) T lymphocytes and natural killer cells were measured in the subjects’ blood after consumption of B. lactis HN019. The ex vivo phagocytic capacity of mononuclear and polymorphonuclear phagocytes and the tumoricidal activity of natural killer cells were also elevated after B. lactis HN019 consumption. The greatest changes in immunity were found in subjects who had poor pretreatment immune responses. In general, the 2 doses of B. lactis HN019 had similar effectiveness.
Am J Clin Nutr 2001;74:833–9

Likewise, the Lactobacillus Rhamnosis HN001 and the Saccharomyces Boulardii strains have shown similar immune-enhacing benefits. In fact, L. Rhamnosis HN001 was shown to lead to “an increased ability to fight infectious diseases” in subjects who were already healthy. J Am Coll Nutr. 2001 Apr;20(2 Suppl):149-56. In other words, the addition of L. Rhamnosis HN001 made a strong immune system even stronger.

A Cold and Flu Prevention Protocol
During this time of year, a basic foundational regime for prevention of colds and flu would be to take the vitamin C complex (see my last post), and include 1 capsule of the L. Rhamnosis/B. Lactis, S. Boulardii formula on an empty stomach. This formula is the newest probiotic designed specifically for immunity. It contains 5.5 billion live organisms of S. Boulardii, 3 billion B. Lactis HN0019, and 1 billion L. Rhamnosis HN001 per capsule. For acute infections, one could go up to 6 per day.

Not Limited to Colds and Flu Alone
This new probiotic formula is what saved me from a bout with “Montazuma’s Revenge” when I was in Mexico last year. Laying on my bed in the fetal position for about six hours, a friend came to the rescue with his last capsule. In a half hour I was up and around and feeling great again. GI infections are a great application of this powerful probiotic combination as well.

Monday, October 6, 2008

Natural Immune Support, Part 1: Super-Charged Vitamin C

Yeah, I know. Vitamin C is old news. Everyone wants to hear about something new and exotic, and nature’s pharmacopeia has no shortage of great immune support substances. Mushrooms, Echinacea, and vitamin D just begins to scratch the surface of all that nature has to offer in terms of immune support. But vitamin C, especially the admixture form which has unique leukocyte stimulating properties, remains one of the most powerful immune support agents on the planet.

The white blood cells are so dependent upon vitamin C for their function that they work to concentrate as much as 80 times more of it inside the cell than outside in the blood. The scientific breakthroughs in vitamin C research are attributed to Dr. Linus Pauling, who recommended daily doses above 10 grams, and 15 grams for times of immune challenges and stress.

A New Era of Vitamin C Research
Most of the original research on vitamin C was performed with straight ascorbic acid. While ascorbic acid by itself certainly does have benefit, as Dr. Pauling clearly showed, it must be understood that ascorbic acid is only one component of vitamin C-rich foods, and providing more of the substances found in those foods could provide more broad spectrum support.

In an attempt to support this assertion, Drew Medical college in 1994 performed a comparative analysis on ascorbic acid against an admixture of various vitamin C metabolites and precursors on leukocyte activity. What they discovered was completely unexpected, but unmistakable.

The study showed that ascorbic acid actually suppressed leukocyte activity by 30% for four hours before any immune stimulation occurred. After the four hours, there was indeed a significant spike in leukocyte activity, but the previous four hours of immune suppression was alarming.

In comparison, the admixture showed no initial suppression of leukocyte activity, and in fact showed a slight stimulation almost immediately, with the most significant gains after four hours (see figure 1).


Additionally, the comparison showed a 25% better uptake into the white blood cell with the admixture compared to the ascorbic acid alone, indicating a stronger effect on overall immune function (see figure 2).


After the results were published, a propriety blend of the exact admixture used in the Drew Medical College study was created and is available as a nutritional supplement.

How the Admixture Vitamin C is Ultra Different
Instead of using the straight ascorbic acid, the proprietary formula features a fat-soluble form of vitamin C called, ascorbyl palmitate, which represents a molecular bond between palmitic acid and ascorbic acid, resulting in better uptake into the white blood cell.

Additionally, this formula features various ascorbates, which make the formula a neutral pH, which is good news for those who would otherwise be sensitive to vitamin C because of the acidic nature which can cause stomach upset and a tendency toward loose stools in some people.

Lastly, the admixture vitamin C formula adds various vitamin C precursors and metabolites, such as hesperidin, which rounds out the antioxidant nature of the formula.

An Ultra Potent C for Everyone
This new way of delivering vitamin C is provided in a 250 mg chewable, 500 mg and 1000 mg tablets, and a powder that is 4.3 grams per teaspoon. A maintenance dose would start at 1-2 grams per day, and for immune challenges one could go up to 12-16 grams. Because of the neutral pH, even the higher doses should be well tolerated by most people.

My Personal Testimony
I got sick a lot growing up. Like clockwork it was almost guaranteed that I would have at least 2-3 colds per year, and one to two bouts with the flu or strep. That trend lasted into my twenties when I went to work for Metagenics. Immediately after starting work for Metagenics and beginning the use of some of the various products, the frequency and duration of my illnesses fell sharply. In fact, since beginning the practice of placing one teaspoon (4 grams) of the vitamin C admixture powder in juice mixed with my anti-inflammatory medical food every morning, I almost never get sick. On the occasions when I feel like I’m fighting off something, I will boost the intake of of the vitamin C powder up to 12 grams or more, or 3 to 4 servings of the powder in hot water or juice, and my symptoms usually dissipate within a few hours if I can catch it early enough. (By the way, there’s something about mixing it in hot water like a tea that seems to boost the body temperature, open up the sinuses, and jump start the immune system almost immediately, even though it doesn't taste very good.) Even on the occasions when I don't catch an infection early enough and it starts to take hold, the severity and duration is a fraction of what one would usually expect from a head cold or the flu when using the natural immune support.

Of course, there are many other substances in nature that one can use to boost immunity, but in my opinion, vitamin C is the starting place.

Monday, September 29, 2008

Re-Thinking the Flu Vaccine

Aah, Autumn! My favorite time of year. Mild temperatures, brilliant colors, football…..and flu shot campaigns!

Judging by the forcefulness of the advertising one would think that the flu shot is vital for the very survival of mankind. But is there more to the story? Yes!

According to the British Medical Journal (BMJ), the flu shot needs to be reconsidered.

Dr. Tom Jefferson, coordinator of the Cochrane Vaccines Field in Rome, Italy who was quoted in the BMJ article, said much of the data supporting yearly flu vaccinations was flawed and found that there was little merit in wintertime flu shots. BMJ editor Fiona Godlee agreed, stating that she was critical of the way the UK evaluated the merits and costs of annual flu shots, calling for change in British procedure.


In Britain, experts say the people most at risk -- such as the elderly -- should get the vaccine during the flu season. However, it is difficult for scientists to make the vaccine effective because the influenza viruses mutate, and the strains which are circulating change from year to year.

Dr. David Salisbury, director of immunization at the Department of Health, acknowledged that the vaccines were not perfect, but remained hopeful. "We are hopeful that new vaccines currently in development may overcome some of the concerns raised about efficacy."

But some disagree with the concept of yearly flu vaccinations entirely.
"The winter flu shot myth is based entirely on junk science designed to serve the interests of pharmaceutical companies who sell the vaccines," explained Mike Adams, consumer health advocate and author of the book, Conquering the Common Cold. “An honest look at the science reveals the unavoidable truth about flu shots-- they're virtually worthless at preventing the flu," Adams said. "People would be much better off to skip the shots and engage in healthier exercise and dietary habits."


The Centers for Disease Control and Prevention (CDC), perhaps the biggest advocate of flu shots, has admitted in a study published in Morbidity and Mortality Weekly Report that the 2007-08 flu vaccine was only 44 percent effective, making the flu season the worst since 2003-04.


Flu vaccines are formulated based on health officials' educated guesses about which strains of the virus are most likely to be circulating in a given year. Three of these strains are picked for inclusion in the vaccine. On the rare occasions when officials guess correctly, the vaccine is between 70 and 90 percent effective. When they don’t guess correctly, well, the results are not so good.


This past year most flu infections were caused by a Type A H2N2 Brisbane strain that was not included in the vaccine. Another common infectious agent was a Type B Florida strain. According to data collected by the Marshfield Clinic in central Wisconsin, the 2007-08 flu vaccine was only 58 percent effective against the Brisbane strain and totally ineffective against the Florida strain.


Researchers usually measure the severity of a flu season by comparing either adult or child mortality data. By both measures, the 2007-08 season was the worst in recent years. In the 2003-04 season, the flu vaccine also failed to function at peak effectiveness, due to the primary infectious agent for that year not being included.


It also appears that flu vaccines are largely ineffective in the populations for which they are most highly recommended, according to the British Medical Journal study. Dr. Tom Jefferson, quoted earlier, conducted an extensive review of previous studies on the effectiveness of inactivated [dead virus] flu vaccines on hospital admissions, death rates and time off work.

"We've got an exaggerated expectation of what vaccines can actually do," Jefferson said. "I'm hoping American and European taxpayers will be alerted and start asking questions."

Jefferson notes that recommendations for flu shots have significantly increased in recent years, a move he says may not be justified.

"I looked at the evidence described by systematic reviews and confronted it with policy and I found that there is a massive gap," he said. "Almost none of the benefits that these policy documents list are actually given by inactivated vaccines or, if they are, they are given in slighter measure."

Consumer health advocate Mike Adams called flu vaccine shots "one of the greatest medical cons perpetrated on the populations of the world," and questioned new U.S. policies pushing the vaccines on young children and expectant mothers.

"Flu shots only prevent colds in about 1 percent of people who get them, making them 99 percent useless," Adams said. "They also inject unhealthy substances such as mercury preservatives directly into tissues, poisoning the patient with a chemical burden that accumulates with each flu shot."

In contrast, there is a cornucopia of nature-derived substances that boost the immune system and strengthen the body against illness and infection – none of which present a toxic load to the body like flu shots. But more about that in the next post.

Monday, September 22, 2008

New Help for Connective Tissue Disorders

Did you know that there are 200 disorders tied into the umbrella of Connective Tissue Disorders? New advances in nutrition-specific proteomics and nutrigenomics now provides a new and incredibly effective protocol for care of many of these various disorders, which is a long list. Other than the primary genetic disorders such as the Ehlers-Danlos Hypermobility, Marfans, and Osteogenesis Imperfectus, the following disorders have been included also:


· Scoliosis
· Sunken chest (pectus excavatum)
· Barrel chest (pectus carinatum)
· Fibromyalgia
· Double jointedness (hypermobility)
· Migraines
· Mitral Valve Prolapse
· Back pain
· IBS
· Muscle twitches and ticks
· Vertigo
· Easy bruising
· Neck pain
· Kyphosis (rounded shoulders)
· Frozen shoulders
· Sciatica
· Itching/sensitive skin
· Muscle cramps, especially in the calves
· Obsessive compulsive disorder
· Tinnitus
· Scarring
· Cellulitis as a result of infection
· Plantar Fascitis
· Rheumatoid arthritis
· Systemic Lupus
· And lots of others…
(source:www.ctds.info)

Significant scientific breakthroughs in nutritional medicine provide hope for many of these disorders.

At the Functional Medicine Research Center, a study on patients who previously did not respond to multiple manual adjustments given a formula containing berberine, folic acid, tetra iso-alpha acids from hops, niacinamide, and selenium had 70% pain management within 24 hours and sustained at 47% pain management at 7 days (average)!

This formula works by down-regulating an enzyme pathway called, MMP, which is a collagen degradation mechanism. It would be especially appropriate for tendonopathy, repetitive injury, hypermobile joints, and soft tissue injuries. For chiropractic physicians and osteopaths who perform manual manipulations, it would be appropriate for all patients who do not hold their adjustments.

Mechanism of Action
Matrix Metalloproteinase (MMP) are collagen-digesting enzymes naturally produced by chondrocytes after injury. They serve, in part, to remodel new connective tissue just like osteoclasts remodel new bone tissue. However, poor diet, lifestyle, repetitive injuries can trigger cell signals which can lead to over-activated release of MMPs. Excessive release of MMPs can damage and degrade healthy tendons and cartilage tissue.

The new extra-cellular matrix-supporting product called has specific natural compounds shown in studies to regulate specific MMP enzymes. For example, tetra iso-alpha acids from hops modulate MMP-13. Selenium addresses MMP-1 and MMP-2. Folic acid impacts homocysteine to positively influence MMP-9, and niacinamide down-regulates the tissue-damaging PARS cycle. Berberine, known best for its anti-pathogen power, is also an effective ingredient which can prevent skin inflammation and the degredation of extracellular matrix proteins.

Results of Research
In a multi-site evaluation of 12 “difficult” patients where previous bodywork was only mildly helpful, the nutritional formula was given for 7 days. The patients’ average initial pain score on a 1-10 scale (10 being the worst) was 7, and the average initial flexibility score was 3 (1 being the worst in terms of stiffness). Pain scores over the course of seven days were “dramatically” decreased (range: 2-4) relative to the baseline median score of 7. Flexibility scores also improved.

A case study provided by Dr. John Hallawell, DC, showed that significant improvement in range of motion and trigger point sensitivity allowed the application of deeper manipulation compared to prior to the administration of the product.

A Testimonial
I prefer to stick to research rather than testimonials, but once in a while a testimony is helpful when combined with the research.

Mara from Michigan has the connective tissue disorder, Ehlers-Danlos, the hypermobility type. As she describes it, “the tendons and ligaments don’t form well and become like old rubber bands and do not have the elasticity that is the norm. So anything inflammatory will make it a lot worse and I start dislocating. However, thanks to lifestyle changes and Metagenics, I got out of most of the braces, gave up the inflammatory foods and comparatively speaking was doing lots better. But the connective tissue pain has still been hounding me and I have never been able to exercise since any repetitive motion would end up dislocating me. I received the [nutritional formula] on a Friday afternoon. I took two right then and two before bed, two the next morning. By noon on Saturday almost all the pain in my elbow was gone! Within 4 days it didn’t even hurt to the touch anymore and within three weeks, my chiro was able to adjust my back, my shoulders finally released, and I am pain free for the first time in a year! I can’t even tell you how wonderful that is! I did go off for a couple days and the pain started coming back. The great thing is now that I have a loading dose in me, it will work within half an hour now.”

This new formula is another in the growing family of unique Selective Kinase Response Modulators (SKRMs) created with the proteomic method. Proteomics is the science of how certain substances effect physiology and pathophysiology. This method allows researchers to remove the guesswork associated with much of the extrapolation of the research associated with nutritional compounds and allows them to evaluate exactly how certain combinations of nutrients are going to effect physiology and pathophysiology. Thus, a new era has emerged that may provide new hope for those suffering from chronic connective tissue disorders.

Monday, September 15, 2008

Making Sense of the Super Juice Craze

Paul Zane Pilzer, author of the monster-selling book, The Wellness Revolution, predicts that the next TRILLION dollar industry will be in the field of wellness.

Indeed, supplement sales alone enjoy double digit growth every year, and so it stands to reason that manufacturers of novel new products and services will begin popping up all over the place.

Enter then, the new craze of Super Juices.

I’ll leave the manufacturers nameless, but you know them. Sellers of acai berry juice and all manner of exotic fruit juices supposedly providing nutrient power unmatched by any substance in the Milky Way are now commonplace. But are these juices, or even the now mundane commercial orange and grape juices we have enjoyed for so many generations really all that good for you?

Consider this: By law all juice (and milk) manufacturers must pasteurize their products before being brought to market in order to kill any pathogens. Pasteurization involves boiling in temperatures up over 220 degrees for 20 minutes. By the time that boiling is complete, all of the potential pathogens are dead, but so are most of the nutrients. What’s left over is what little nutrients, if any, that survived, and a whole lot of fruit sugar. Might as well drink Hi-C.

This point was dramatically illustrated in a study entitled, Antioxidant activity of pasteurized and sterilized commercial red orange juices. Here’s the abstract:

Abstract
Blood orange juice is a typical Italian product whose red color is primarily associated with anthocyanin pigments. Two orange-based products are present on the market: pasteurized pure juice with 40 days of shelf life, and sterilized beverage containing minimum 12% of concentrated fruit juice. The aim of the present paper is to verify the relationships between the antioxidant properties and the anthocyanins content in a sampling of pasteurized and sterilized commercial red orange juices. The anthocyanins composition was determined by HPLC-MS/MS, while the antioxidant activity was evaluated by the Briggs-Rauscher reaction, selected in order to acquire information at acid pH values, by three radical scavenging assays (DMPD, 2-2-azinobis-(3-ethylenbenzothiazoline-6-sulfonic acid) diammonium salt (ABTS), DPPH), and by FRAP assay to monitor the ferric reducing power. Results showed that antioxidant activity, particularly when measured by ABTS method, is positively related to the content of anthocyanins and that the reduction of anthocyanins content, typical of commercial long-shelf life juices, leads to a remarkable loss of antioxidant power.1

In my opinion, juicing is great as long as you juice fresh foods yourself and drink them immediately after. If you do your own juicing but save your left-over juice for future consumption, oxidation by itself will kill off a good portion of the nutrients. So drinking your own juiced foods immediately after juicing can provide huge amounts of body-ready nutrients. But be careful. Do this only in moderation. When juice is liberated from the pulp and fiber of the food it came from, it no longer has the benefit of that fiber to slow the absorption of the sugar into the bloodstream. So drinking a lot of even the most nutrient-dense juices can spike blood sugar and contribute to metabolic syndrome.

I’m a juicer myself, but only occasionally. I don’t juice every day, and usually only when I feel like I’m coming down with something or when I’m fasting. For a daily supplement to my diet, I rely on therapeutic levels of micronutrient blends like Multigenics and Ceralin Forte, and powerful phytonutrient blends like the ones found in Celapro. These are ways to provide one’s self with huge levels of disease-fighting antioxidants without the sugar, and because they don’t have to be pasteurized, they maintain their therapeutic value and antioxidant strength throughout the manufacturing process as verified by third-party laboratory assays.

Juices, on the other hand, are typically not analyzed for their nutrient content after pasteurization and processing. The claims being made regarding the antioxidant value in the marketing are usually references to the berry or fruit itself, and the consumer is supposed to make the mental leap that if the fruit is good, the sterilized juice should be even better. Unfortunately, what looks good in full-color glossy ads do not always represent good science and are often just a shade off from the whole truth.
Conclusion? In my opinion, commercial juices, especially the grossly over-priced superfood juices, are gimmicks that cannot be validated with scientific scrutiny.
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Reference:
Alberto Fiore 1, Luca La Fauci 2, Rinaldo Cervellati 3, Maria Clelia Guerra 4, Ester Speroni 4, Stefano Costa 4, Giacomo Galvano 5, Antonino De Lorenzo 6, Vanessa Bacchelli 3, Vincenzo Fogliano 1, Fabio Galvano *
1Department of Food Science, University Federico II, Naples, Italy2Department of Agro-forestry and Environmental Science, Mediterranean University of Reggio Calabria, Gallina di Reggio Calabria, Italy. Fax: +39-95-3512013Department of Chemistry G. Ciamician, University of Bologna, Bologna, Italy4Department of Pharmacology, University of Bologna, Bologna, Italy5Department of Agronomical, Agrochemical and Animal Production Science, University of Catania, Catania, Italy6Department of Neurosciences, University of Tor Vergata, Rome, Italy

Monday, September 8, 2008

Wonder Nutrients for Cognition, Part 3

In the two previous posts I focused on specific natural compounds, Huperzine A and Ginko, that are effective in managing cognitive decline. In this post I’ll provide strategies for effective overall brain protection, focusing on a single product which has become one of my personal favorites because of its rich content of three nutrients primarily: Acetyl-L-Carnitine (ALC), N-Acetylcysteine (NAC), and Grape Seed Extract.

Acetyl-L-Carnitine (ALC)
ALC is a vitamin-like substance that is responsible for the transport of fatty acids into and out of the mitochondria, and is the form of carnitine found naturally in brain tissue and is thought to be substantially more active in the CNS. ALC increases cardiolipin, which is an important phospholipid that serves as a co-factor for a number of critical mitochondrial transport proteins. Supplementation with ALC may also improve energy production within brain cells.


An analysis of controlled studies reports that persons with subclinical or clinical dementia given 1.5 to 3 g ALC daily have shown improvement in numerous clinical measures of cognitive function. In two large multicenter, crossover trials, geriatric patients given 1500 mg of ALC daily for 90 days experienced improvements in clinical tests of cognition, memory, and depression over controls. In other double-blind, placebo controlled trials, ALC-treated subjects showed less mental deterioration as rated by cognitive and AD assessment test scores.


N-Acetylcysteine (NAC)
The protective effect of NAC is believed to be related to its restoration of brain glutathione (GSH) levels. GSH is central to antioxidant defenses in the brain and is an important component of detoxification of ROS. GSH, however, does not cross the Blood-Brain-Barrier, so oral supplementation with precursors such as NAC and alpha-lipoic acid are the best way to increase brain levels.


NAC has been shown to increase mitchondrial complex 1 activity and markedly improve mitochondrial electron transport chain activity. In animal models of traumatic brain injury, NAC significantly restored mitochondrial energy producing mechanisms (electron transfer, energy coupling capacity, calcium uptake activity.


Other Vital Nutrients for Brain Function included in Ceralin Forte:


  • Grape Seed Extract: Acts as a neurological antioxidant, provides protection for nerve cells, and supports circulatory function.

  • 5-Methyltetrahydrofolate (5-MTHF): Supports neuron life cycle, neurotransmitter metabolism, methylation, homocysteine metabolism, and nervous system function.

  • Vitamin B6: Involved in the conversion of glutamate into calming GABA,supports neuron life cycle and nervous system function, as well as methylation and homocysteine metabolism.

  • Vitamin B12: Supports neurotransmitter metabolism, neuron life cycle, methylation, homocysteine metabolism, and nervous system function.

  • Thiamin and Riboflavin: Involved in mitochondrial function.

  • Niacinamide: Provides neuron protection and nervous system function.

Putting Together a Brain Protection Protocol
Unfortunately some of the best formulas for neuron protection are also the most expensive. However, a good one-two combination that is cost effective is the Ginko and Rosemary formula along with EPA/DHA from fish oil. You’ll recall from previous posts that EPA and DHA from fish oil provide support for the brain and nervous system such that it has actually been shown to raise the IQ. For those over 40 who are not feeling quite as mentally sharp, I like the addition of the brain antioxidant formula featuring acetyl-L-carnitine, NAC, and grape seed extract at 1 capsule 2-3 times per day. This formula provides some great cross-over antioxidant support that is also important for detoxification and many other body functions. For those experiencing noticeable cognitive decline, the use of the Huperzine A formula is a must at atleast 2 per day.
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References:

  1. Carta A, Calvani M, Bravi D, et al. Acetyl-L-Carnitine and Alzheimer’s disease: pharmacological considerations beyond the cholinergic sphere.

  2. Ann NY Acad Sci 1993;695-26.

  3. Murray, MT. The many benefits of carnitine. Am J Nat Med 1996;3(2):6-14.

  4. Salvioli G, Neri M. L-acetylcarnitine treatment of mental decline in the elderly. Drugs Exp Clin Res 1994:20(4):169-76.

  5. Cipoli C, Chiari G. Effects of L-acetylcarnitine on mental deterioration in the aged: initial results. Clinical Ter 1990;132(6 suppl):479-510.

  6. Pettegrew JW, Klunk WE, Panchalingam K, et al. Clinical and neurochemical effects of acetyl-L-carnitine in Alzheimer’s disease. Neurobioll

  7. Aging 1995;16(1):1-4.

  8. Sano M, Bell K, Cote L, et al. Double blind parallel design pilot study of acetyl levocarnitine in patients with Alzheimer’s disease. Arch Neuroll

  9. 1992:49(11):1137-41.

  10. Xiong Y, Peterson PL, Lee CP. Effect of N-acetylcysteine on mitochondrial function following traumatic brain injury in rats. J Neurotrauma 1999:16(11):106 7-82.

  11. Dringen R. Metabolism and functions of glutathione in brain. Prog Neurobiol 2000:62:649-71.