Friday, February 27, 2009

Neurofeedback: A Powerful Tool for Cognitive and Developmental Testing and Rehabilitation

Once in a while I run across a device or therapy other than that of nutritional protocols that I feel is important to share. Neurofeedback is one such therapy that holds promise for those with cognitive issues and for parents with children who have developmental challenges.


Sometimes referred to as EEG (Electroencephalogram) or Neurotherapy, Neurofeedback is the process of training a brain to learn to modify or control the brainwave activity through auditory and visual feedback. Neurofeedback is a gentle method of creating a balance within the central nervous system. It is painless and non-invasive in its approach.


The training process is measured by use of pictures on a computer screen and sensors on the head. The approach can be compared to potty-training. An individual is taking an internal organ and training it to respond by feedback. If a patient is producing an amplitude (strength of a signal) in a specific frequency level that is within the parameters that the technician has set, then music will begin and the picture will move. If the individual is outside those parameters then the music and the movement stops.


The process starts with a compilation of the participants emotional, behavioral and cognitive abilities, concerns and personal goals. After a thorough meeting involving some standardized tests and reviewing their social history a profile is created. The profile is used to develop academic and cognitive strategies for school, home and work. This profile is a starting point for memory, problem solving, reasoning and speed processing enhancement.


Most individuals will be asked to come as often as possible in the beginning of their therapy. It is not uncommon to come 5 days a week in the beginning. The first twenty sessions are the most important. The central nervous system is learning a new neuronal pattern and just like exercising any muscle the more it is practiced the more habitual that movement becomes. The total number of sessions vary and are dependant on the individual, their progress and their personal goals. A common number of therapy sessions range from 25-40.


Computer games, board games and card games are many times used during the session as a method of teaching a new cognitive strategy. Relaxation techniques such as autogenics, visualization, Hemi-Sync music and diaphragmatic breathing are taught to the individual as well.

Many times "home work" is given to the family so they can continue to practice at home, school or at the workplace.


EEG neurofeedback helps many different disorders and conditions. It seems to be effective for several reasons: It helps to remind the body how to relax the muscles, which allow the nerves to "let-go" and not respond until needed. It also allows the blood to flow through the body at a normal rate and volume keeping blood pressure lower during daily activity. Most disorders or conditions are affected by stress. Therefore, as the body reacts to the stress in a different manner the characteristics of these diagnosis' will decrease.


Conditions that can be treated by neurofeedback are:

· Anxiety Attacks
· Apraxia
· Aphasia
· ADHD
· Autism
· Bi-polar Disorder
· Depression
· Dyslexia
· Hypertension
· Learning Disabilities (LD)
· Migraines
· Oppositional Defiance Disorder (ODD)
· Pain Management
· Stroke
· Tourette Syndrome (TS)
· Traumatic Brain Injury (TBI)


Benefits to Expect:


Improved Sleep:

· Falls asleep within 20 minutes
· Stays asleep
· Wakes Refreshed

Cognition:

· Improved memory skills
· Increased flexibility in thinking
· Heightened sense of documentation and focus
· Increase in the speed of processing information
· Better reasoning skills
· Able to think faster
· Better strategizing and deduction skill

Behavior:

· Better sense of self control
· Better social skills
· Less anxiety
· Less needless body movement
· Less impulse behavior
· Less obsessive/compulsive behavior
· Reduction of addictive behavior

Attitude:

· More involved with family events and discussions
· More willing to share ideas and thoughts
· Happier and more content
· More composed physically/mentally
· Better self confidence
· Reduction of stress related behaviors such as headaches, nail biting, twisting hair, hair pulling, motor or vocal tics


I was introduced to neurofeedback through my friend and client, Dr. Lise DeLong, PhD, who is the founder and director of Cognitive Connections on the southside of Indianapolis. Dr. DeLong also offers a variety of nutritional protocols related to cognitive function and stress, as well as hyperbaric oxygen therapy, which helps to oxygenate the brain and body and can be useful for a variety of conditions. Her website offers some compelling case studies on Neurofeedback. http://www.cognitive-connections.com/.

Thursday, February 19, 2009

Are Taking Supplements "Worthless?" An Analysis of the Women's Health Initiative Study (WHI)

The February 9, 2009 issue of Archives of Internal Medicine reported that multivitamin use did not protect the 161,808 postmenopausal women enrolled in the Women's Health Initiative Study (WHI) from common forms of cancer, heart attacks, or strokes. Thus, the pharmaceutical industry-funded media hype has been that taking multivitamins are “worthless.”

Contrary to the hype of the recent article, however, the WHI study did not have as a primary goal to study the effects of vitamins on women's health. Rather, the study focused on 4 primary areas:
  • The health effects of postmenopausal hormone replacement therapy.
  • The effects of a low fat diet on cancer risk.
  • The effects of calcium and vitamin D intake on postmenopausal fracture risk.
  • Watching for new risk factors for disease such as cancer, CVD, and fracture risk.

Although it was not the goal of the WHI to evaluate the importance of taking a multivitamin, somehow certain authors have misconstrued this study as a black mark against taking vitamins.
In the study, researchers simply asked the participating women a series of different questions, one of which was whether they took a multivitamin at least once a week or not. Once a week? There is not a single vitamin supplement on the planet that is going to provide much benefit taken only once a week, or even three times a week. To do any good, a multivitamin should be taken at least a couple of times a day. But the medical authors conveniently forgot to mention that little detail. No surprise there.
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Now, the absurdity of this article is perhaps best revealed by this point, since one would not expect any multivitamin to do much good taken only once or twice a week or so. However, for the sake of demonstrating just how shady this information is, let us consider the bigger picture.
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Misrepresenting the Facts
For those that were taking a multivitamin in the WHI study, no additional information was asked for, such as what type and brand of multivitamin, how much of certain nutrients the supplement provided and in what forms, why they were taking them, etc. It was suggested by the authors, however, that people take multivitamins specifically to reduce risk of cancer and cardiovascular disease, and it was assumed, of course, that all multivitamins are created equal and that everyone took adequate amounts with regularity. (Of course, anyone who is familiar with the science of supplements knows that there is a wide range of quality in supplement manufacturing, ranging from "pharmaceutical grade" to simply awful.)


There are some fundamental problems, of course, in these assumptions. So we must ask some clarifying questions:
  • Do people really take multivitamins specifically to ward off cancer and heart disease?
  • Is that the purpose of a multivitamin? Or is a multivitamin designed to prevent nutrient deficiency diseases?
  • Are cancer, cardiovascular disease, and postmenopausal fracture risks exclusively nutrient deficiency diseases, or are there other factors that play into these diseases such as stress, diet, exercise, toxin exposure, etc?
The author’s own conclusions were that other large-scale studies that monitored for a sufficient period of time (greater than 10 years) have shown reduced cancer and CVD risk. However, the WHI study lasted only 8 years. Perhaps longer duration is the key. In addition, these women were observing a higher quality diet than what is typical, so it is quite possible that they did not have the kind of disease risk factors as those who observe a typical American diet. The author seems to assume, however, that everyone gets adequate amounts of nutrients from the diet.

From the article:
"...No one denies that an adequate intake of vitamins is essential; however, vitamins can and should be obtained from eating enough healthy foods rather than from swallowing vitamin supplements..." http://health.yahoo.com/experts/healthnews/15053/are-you-wasting-money-on-multivitamins/


So then, should we assume that practitioners can just tell patients to “eat better” and they will? What does “eat better” mean in this day and age of nutrient-depleted, heavily processed and refined foods? What does “eat better” look like when even the “fresh” produce at your local grocery store is so nutrient-depleted from modern farming methods that there is scarcely any nutrient value left at all? Have you driven by McDonalds or a Steak-N-Shake lately? Perhaps “eat well” means putting an extra slice of iceberg lettuce on your Quarter-Pounder. I dunno.


The truth is, according to a Surgeon General report, 7 out of 10 leading causes of death in this country are diet-related, and the NHANES II study showed that most Americans are woefully uneducated about diet and nutrition, and most are deficient in several important nutrients than can be resolved with supplements. In fact, the problem of nutrient deficiencies is so bad that most Americans are not obtaining even the pitiful amounts recommended by RDA standards for intake of micronutrients. Indeed, the first NHANES study from 1994 stated that the disease, scurvy – a vitamin C deficiency disease, is still present in developed countries because of the prevalence of widespread nutrient deficiencies. J Gen Intern Med. 2008 Aug;23(8):1281-4. Velandia et al.


“Oops! I didn’t mean to contradict myself.”

What is not apparent to the casual observer of the misleading headlines in this article, and what is evidently not even apparent to the author himself is the fact that the article contradicts itself.

"...All this is not to say that specific vitamins supplements are never desirable. Vitamins can be valuable in certain situations. Folic acid supplements in women who are pregnant or plan to become pregnant can help to prevent serious neural-tube defects that affect the baby's brain and spine..."

Umm…didn’t you just say that supplements are worthless? So which is it?

Since the most important time for folic acid sufficiency is prior to conception, would it not be better to take a daily multivitamin that contains sufficient folate instead of finding out one is pregnant and then suggesting a prenatal?


"...Supplements of vitamins C and E, beta-carotene, zinc, and copper may slow the progression of vision loss in people with early macular degeneration..."

Sounds like a case for a multivitamin right there.


So here are three good examples of a need for a multivitamin other than suggesting it is being taken specifically to reduce cancer and heart disease risk.

Most Western Diets are Nutritionally-Flawed
It can no longer be assumed that people can get all the nutrients they need just by eating better. The toxic load on the human race due to chronic stress and environmental toxicity is higher than it has ever been in human history, and that places a demand for life-giving nutrients to circumvent these challenges.


Think of the human body as an automobile, and the nutrients we take in as the fuel. If a heavier demand in placed upon the automobile by placing a big load in it and driving it uphill against the wind for a long distance, what will happen? The engine works harder and requires much more fuel. Similarly, when heavy demands are placed upon the body by stress and toxicity, the body requires more fuel in the form of vitamins and minerals in order to function optimally. If it does not get those vitamins and minerals, eventually systems begin to break down.

This is not rocket science, folks. The prevalence of chronic disease such as cancer, heart disease, diabetes, osteoporosis, arthritis, etc. is ravaging the American landscape, and conventional medicine has done little to slow the progression of it. Surely these scourges can’t be nutritionally-related! Must be a drug deficiency of some sort, huh?

The fact is, there are more well-designed studies showing the benefits of taking multivitamins than I have room to list here, and in fact the Journal of the American Medical Association – perhaps the most prestigious of all the medical journals – suggested in 2002 that all Americans should consider taking a multivitamin.

The Business of Disease
Why then, is there so much resistance against taking vitamins in the medical community?
Let me ask you a series of questions to get at the heart of the matter:
  • Why do Democrats and Republicans accuse one another and resist each other on most issues?
  • Why does Chevrolet advertising take aim at Honda, and Nissan’s against Toyota?
  • Why does Burger King advertise that they have conducted international analysis of people’s hamburger preferences and a majority say that they like their burgers over McDonalds? Do you wonder if they really do those surveys, or at least do them in a fair and unbiased manner?
I could go on, but you get my point. “But surely this does not apply to American medicine. It’s not a business trying to make a profit. It’s medicine!”
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If that’s really what you think, I’ve got some beautiful beachfront property on the moon I would like to sell you.

Of course American medicine is a business. It’s big business! And like a lot of businesses these days they seek to sell their wares by casting a dim light on the competition, which in this case is alternative forms of medicine, which includes supplements. The American Medical Association (AMA), for example, has long worked to discredit alternative medicine and has even been found guilty by U.S. federal courts of engaging in a conspiracy to destroy chiropractic medicine. The AMA, which is largely considered a joke by anyone familiar with natural health, is hardly a credible source for publishing scientific findings on nutrition. To protect the multi-billion dollar drug industry, the AMA would say practically anything, I believe. But folks, it’s worse than that.

What the Unholy Trinity (the pharmaceutical industry, the FDA, and conventional medicine) is guilty of is inhumane. They purposefully misconstrue the facts and even design “studies” that produce the results that they want the public to hear, thus robbing countless Americans of life-saving information for the sake of fattening their already-overstuffed pockets. Only God knows how many people have died because of not having access to information that could have saved them, and instead having drugs pushed on them, exposing them to chemicals that are responsible for more than a 100,000 drug-related deaths per year in America alone (imagine the angry uproar if vitamins killed even a fraction of that amount). And these fat-cat executives use those excess dollars to pretty much fund the news networks, magazines, and newspapers with their monstrous advertising budget, and thus these media outlets publish anything they're told. God forbid that they should ever publish any of the thousands of studies showing the benefit of supplementing the diet. But when a piece of junk science gets published, that’s what you hear about.


Here’s what I mean by junk science.

How to Manipulate a Study

Here’s a great example of how the powers-that-be in modern medicine tell you what they want you to hear.

Last year the Cochrane Library, a widely-read source of information on conventional health matters, launched an attack on vitamins A, C, E, selenium and beta-carotene, claiming that these vital nutrients were linked with a higher risk of mortality (i.e."they'll kill you!"), and as a result scientists began telling consumers to stop taking vitamins altogether. But with all the benefits of antioxidants already well known to the well-informed, how did the Cochrane Library arrive at such a conclusion? Easy.

The researchers reviewed 452 studies on these vitamins, and they threw out the 405 studies where nobody died! That left just 47 studies where patients died from various causes. One study was conducted on terminal heart patients, for example. From this biased selection of studies, these researchers concluded that antioxidants increase mortality.

Just in case you do not yet recognize this as the scientific fraud that it is, let me rephrase what happened. These scientists claimed to be studying the effects of vitamins on mortality, right? They were conducting a meta-analysis based on reviewing established studies. But instead of conducting an honest and unbiased review of all the studies, they arbitrarily decided to eliminate all studies in which vitamins prevented death and kept people alive! They did this by "excluding all studies in which no participants died." What was left to review, then, was only the studies in which people died from various causes.

Brilliant! This sort of twisted “science” would earn any teenager an "F" in high school science class. But apparently it's good enough for the Cochrane Library and the Archives of Internal Medicine to name just two, not to mention all the mainstream press outlets that are now repeating these outrageous and fallacious conclusions as scientific fact.

Using this same cherry-picking method for reviewing previous studies, one could find evidence to support practically any conclusion under the Milky Way. Mike Adams of Natural News explained how this is done in his article, Vitamins A, C and E Increase Mortality! (and other nonsense from the realm of junk science). He writes,
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"Let's say that I took a look at 100 studies reviewing the effects of aspirin on erections. And let's suppose I arbitrarily decide to eliminate all the studies involving men, leaving only studies involving women. I could then announce -- with the evidence to back it up -- that "Aspirin Linked with Drop in Erections!" Why? Because nobody in the groups I look at had any erections at all. Sure, they're all women, but that's beside the point. By arbitrarily removing selected studies from my analysis, I can "prove" just about anything, even if it's utter nonsense. The antioxidant study did the exact same thing by eliminating all studies in which people were kept alive and healthy while taking antioxidant vitamins. Or, put another way, the lead researchers on this study purposely eliminated all the studies involving healthy people, leaving only the studies involving people who were about to die anyway. Never mind the fact that antioxidants might have actually extended the lives of some of these people by a few days or weeks -- the fact that they died while being treated with vitamins is enough, it seems, to point the finger at the vitamins themselves.
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If a suicidal stock broker leaps from a tall building, and you hand him a vitamin C tablet on the way down, then it's obviously the vitamin C that kills him, right? That's the conclusion of this [method of conducting studies]: Take a bunch of patients who are about to die, load 'em up with antioxidants, and tally the inevitable death toll. Then announce, with great fanfare, your findings that 'Antioxidant Vitamins Increase Mortality!' "

Much "scientific research” is Anything But

As you can see from these particular examples of junk science, the credibility of much of what happens under the guise of "science" is now so incomprehensively awful that it makes one wonder how many drugs the researchers are on. You would think that people literally have to be on drugs to come up with such poorly-designed studies and then to have the temerity to announce their results with a straight face. But money and power often are often just as distorting to people’s judgment as mind-altering drugs.

It turns out that the implications of drug-induced distortions of judgment are not far off the mark. A recent survey in Nature found that 20 percent of science academics use mind-altering drugs for non-medical reasons, supposedly to boost academic performance. That's one out of five researchers engaged in illegal drug use! This is a group that takes more mind-altering drugs than what is passed around at a Grateful Dead concert. And then they have the audacity to announce their "scientific" studies that lack such credibility you have to wonder if their drug abuse is used to dull their consciences.

So what we're seeing in this latest article attacking the efficacy of supplements is just another example of not merely bad science and bad reporting, but deceptive science and deceptive reporting.

And that's the world in which we live.
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Some of the information in this article was adapted from two Mike Adams articles from Natural News: Vitamins A,C, and E Increase Mortality, and, The big vitamin scare: American Medical Association claims vitamins may kill you.

Monday, January 19, 2009

Grape Seed Extract shown to Kill Leukemia Cells in Laboratory



A new study conducted at the University of Kentucky and published in the journal, Clinical Cancer Research, found that leukemia cancer cells exposed to grapeseed extract (GSE) were rapidly killed through a process of cell suicide known as "apoptosis."


In these laboratory studies, an incredible 76% of leukemia cells died within 24 hours thanks to the ability of GSE to activate a protein called JNK, which regulates apoptosis. In a healthy person, apoptosis is a normal part of cell biology. Every living system creates cancerous cells. There are hundreds or thousands of "microtumors" in every living human being, but cancerous cells in healthy people destroy themselves once they realize they are flawed. This cellular process, however, requires healthy cell communication, and that's dependent on adequate nutrients.


Grapeseed extract appears to accelerate this process in cancer, helping them more rapidly assess their own flawed state so they can engage in apoptosis (cell suicide), thus protecting the larger organism (the body).


It's important to note that this recent study was conducted in a lab, not in humans, so its conclusions cannot necessarily be translated into saying that "grapeseed extract cures cancer.” However, it does indicate quite convincingly that if the unique phytochemical molecules found in grapeseed extract can be delivered to leukemia cells with sufficient potency, they may play an important role in accelerated cancer cell apoptosis, thereby protecting the whole organism from unabated cancer. If the results demonstrated in the labs at the University of Kentucky can be replicated in humans, it could potentially position grapeseed extract as one of the most powerful natural chemotherapeutic agents yet discovered.


Grapeseed extract has been studied and demonstrated to be remarkably effective at killing cancer cells for many different types of cancer, by the way, including cancers of the breast, prostate, lung, skin bowel and stomach.


Eat more Grapes?
Eating more grapes is certainly a healthy and protective thing to do, in that they are a source of resveratrol and various protective phytonutrients. However, in order to get the protective effect of grape seeds, you would obviously have to eat grapes with seeds in them, chewing the seeds and all. Today it’s not even very easy to find grapes with the seeds still in them on the market because of the demand for seedless grapes. As an alternative or complement to eating grapes, grape seed extract is available in supplement form.


I recommend combining grape seed extract with other important chemoprotective nutrients for a well-rounded and powerful antioxidant complex. N-acetylcysteine and acetyl-L-carnitine are two of the most powerful antioxidant compounds on the planet that would provide a powerful synergistic combination with grape seed extract.


See my post on antioxidants for more on this subject.

Thursday, January 15, 2009

New Frontiers in Bone Health


Bone loss has been traditionally understood as being an issue of lack of calcium, vitamin D, and minerals. While these factors certainly play an important role in why people develop osteoporosis, it is not the only factor to consider. In fact, after age 50 it may be secondary to other more profound issues.


Consider that there is a distinct and important difference between bone density (mineralization) and bone matrix quality. The matrix of the bone is a mesh of collagen microfibers that can be compared to the iron rods that provide structure and support to the pavement in highways. Without the iron mesh, the pavement would deteriorate very quickly under all the wear and tear of the traffic. The mesh of collagen fibers is what provides bone their structural strength and is what minerals attach to.


A DEXA scan, therefore, may not be the most accurate way to assess bone health because a DEXA only looks at bone density, or the minerals that are attached to the matrix. A DEXA cannot provide any information on what is underneath the surface of the bones, thereby providing little or no information about the actual strength of the bones and the quality of the matrix.


In consideration of this fact, it becomes necessary to not only provide minerals and protein for support of bone density, but also provide nutritive substances that will address the quality and structure of the bones.


A New Approach to Bone Support
Before the age of 50, give or take, estrogen is adequate and thus the equilibrium between bone formation and bone resorption is intact. As estrogen declines, however, that equilibrium begins to uncouple, and bone resorption speeds up, thereby causing a faster rate of bone turnover that the formation process cannot keep up with. As a result, bone matrix begins to weaken first, and eventually bone density – that which is visible on a DEXA scan – begins to be effected as well as minerals no longer have an adequate structure to attach themselves. So by the time bone loss begins to appear on a DEXA scan, bone matrix has already been significantly compromised.


It becomes necessary then, to address the uncoupling of bone formation vs. bone resorption.


A 2008 randomized placebo-controlled study at the Functional Medicine Research Center on 76 menopausal women was performed to assess the effectiveness of a non-calcium containing nutritional formula on various markers of bone health, including bone breakdown, bone remodeling, and bone formation. The formula contained reduced iso-alpha acids from hops, berberine, vitamin D3, and vitamin K1. The berberine and hops extracts were used for their effects on modulating proinflammatory signals (NF-kB, RANK, RANKL-mediated TRAP activity) and modifying the expression of certain protein kinases (GSK-3). This strategy has a quieting effect on osteoclast activity,thus creating a better balance between bone formation and bone resorption. Vitamin K promotes metabolism of bone proteins crucial to bone quality and the support of axial and peripheral bone mass. Vitamin D promotes calcium absorption and the process of bone mineralization, as well as supports bone remodeling by modulating inflammatory signals.


In the 14-week trial using 2 per day of the nutritional formula, bone turnover as measured by osteocalcin significantly slowed in the treatment group trending toward youthful levels. Osteocalcin increased in the placebo group. Likewise, all other measurements of bone matrix quality, including IGF-1 and P1NP (bone formation), and NTx (bone resorption), all improved significantly with the treatment group, whereas the placebo group worsened.


This approach is most appropriate for women with low estrogen levels due to menopause, hysterectomy, or any other condition resulting in low estrogen. It is best combined with substances rich in collagen protein, calcium, bone growth factors, and other minerals such as microcrystalline hydroxyapatite concentrate (MCHC) so as to address both factors of bone health – bone density and bone matrix quality. Women who have adequate estrogen would probably be best suited to concentrate on the MCHC approach, and add the berberine and hops complex as they approach the menopausal years.


Happily, there is now an approach that shows promise in addressing a largely overlooked factor in bone health where there was none before.

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.

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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