(This post first appeared on FON Consulting in December 2014)
Written with Lise Alschuler, ND
What a firestorm! Ever since Dr. Paul Offit’s book, Do you Believe in Magic: The Sense and Nonsense of Alternative Medicine was released last summer, there’s been a burst of new negative dietary supplement study results and position papers. Editorials, featuring provocative headlines such as: Enough is Enough: Stop Wasting Money on Vitamin and Mineral Supplements and Don’t Take Your Vitamins, have been published in prominent medical journals and major media outlets, many authored or co-authored by the omnipresent Offit, himself.
In response to the loud and growing chorus of conventional and academic physicians opposing dietary supplementation, The Council for Responsible Nutrition, and Natural Products Association have released their own statements. This article attempts to break through the din and unremitting confusion sown by the media whir around dietary supplements, the industry that champions their use and public health in general.
First, a few disclosures: My company FON Consulting currently consults and collaborates with several nutraceutical companies. I also admit to personally ingesting a significant amount of supplements ever since working at a mom and pop health food store in 1980, and in even greater quantities when diagnosed with ‘incurable’ leukemia in 1991. Can I objectively write on this topic? You be the judge.
My success achieving complete remission of chronic lymphocytic leukemia without traditional intervention and using quality nutraceuticals as part of a comprehensive, personalized integrative cancer therapy regimen has been well-documented by my oncologist, Lee Nadler, MD, a Harvard Medical School dean and one of the world’s largest NIH funded investigators for cancer and HIV/AIDS.
Though relatively less impressive, the manner by which I reversed my osteoporosis (spine) and osteopenia (hip) diagnoses to normal range within in a three year period should be noted from an endocrine standpoint. While the supplement cocktail is simple: Vitamin D3, K2, calcium and magnesium, the overarching lifestyle component that includes this supplementation is more involved.
Well-placed nutraceuticals continue to play a key role in managing my degenerative disk disease. Fifteen years after undergoing a lower-lumbar laminectomy (disk surgery without fusion), I’ve discovered fish oil, curcumin and green tea extract combined with a low inflammatory diet and routine Pilates enables me to “prevent” painful flair-ups. I rarely find it necessary to resort to my well-stocked medicine cabinet filled with symptom-fixing standbys like oxycodone, diazepam, steroid dose packs and NSAID and Cox 2 anti-inflammatories in “reaction” to flair-ups. Do I use these drugs when absolutely necessary? You bet.
Regarding my personal use of dietary supplements and documented outcomes, I’m an anecdotal case. There is no one-size-fits-all formulaic approach for those with similar conditions. I am an n of 1.
A staunch proponent of well-placed high quality nutritional supplementation, I’m greatly disturbed by the irresponsible material sourcing, shoddy manufacturing standards and unethical marketing and sales tactics of fringe cavalier manufacturers, influencers, patients and, yes, even medical practitioners. It’s shameful how these bad actors are unnecessarily tarnishing the reputation of an incredibly important industry. From my vantage point, I offer the following facts and commentary:
Nutrients are Best Derived from Food
Pesticide and antibiotic-free organic whole foods are the best source of vitamins, minerals and most nutrients. For large parts of the population, however, finding these quality food sources remains difficult. Unfortunately, for most people, aggressively advertised high calorie, high glycemic, inflammation- and oxidative stress-causing unhealthy foodstuffs are cheap, plentiful and readily accessible (think government subsidized GMO corn and soy). Regrettably, this is what comprises our nation’s Standard American Diet (SAD)! You may do okay without supplementing … if you’re among the minority who’s sufficiently affluent and educated to identify, purchase and ingest copious amounts of the good stuff thus possibly getting enough quality nutrition to prevent or even reverse disease. But as we continue to engineer more and more nutrition out of our food, it becomes ever-more doubtful.
Studies Have Shown Dietary Supplements to be Effective, Ineffective, and Sometimes Harmful
Evolution biology proves that vitamins have been essential to life forms for billions of years; and early life forms including primitive humans could manufacture their own vitamins but, curiously, lost this ability over time. By the early 20th century scientists discovered that the human body requires minute amounts of 13 organic molecules to ward off certain maladies and diseases such as blindness (vitamin A), severe anemia (vitamin B12) and rickets (vitamin/hormone D) and scurvy (vitamin C).
There have been numerous studies, ever since, looking at the safety and effectiveness of dietary supplementation for disease prevention and treatment. While many have shown no positive effects, others have shown statistically relevant positive effects. Clearly, some studies have shown negative effects and contraindications when certain supplements are combined with specific drugs, or when they’re consumed by those with certain conditions or diseases.
The science continues to be all over the place. Hundreds of millions of dollars have been spent (I believe largely wasted) on large and small studies with thousands of subjects. In the U.S. (mostly through NIH, OCCAM and NCCAM) we tend to take synthetically-derived nutrients (think Centrum® Silver in lieu of quality, whole foods-based, highly bioavailable products), administered in low potencies (again, think Centrum® Silver or One-A-Day®) and test them in isolation—focusing on one outcome.
Originally designed for pharma research, this reductionist model has unfortunately been highly ineffective for dietary supplement research.
Typically these designs offer no controls for lifestyle and behavior and do not adequately assess baseline nutritional status or individual physiology. Furthermore, many of these studies use an inferior product and may not study a dose sufficient to change physiology.
Nutrition expert Dr. Alan Gaby did a good job here examining the designs for the recent studies published in the “Annals of Internal Medicine”. In a new meta-analysis in the Journal “Nutrients”, Balz Frei, professor and director of the Linus Pauling Institute at Oregon State University concludes that most clinical studies on vitamins are flawed by poor methodology. And, to top it off, despite all of these issues, there is actually a large—and growing body of evidence demonstrating the safe and effective use of supplemented nutrients. Regrettably, these studies just don’t seem to get their fair share of the media spotlight.
FDA Provides Poor Oversight of Dietary Supplements
Supplements fall under the jurisdiction of a severely budget-challenged and thus understaffed FDA that’s unable to audit but a fraction of nutritional supplement manufacturers. This is further complicated by the fact that, unlike pharmaceutical drugs, dietary supplements are not tested for safety and efficacy before they’re sold; essentially deemed innocent until proven guilty.
What’s more, the government strongly relies on manufacturers to self-comply with established CFR part lll supplement manufacturing regulations. Fortunately, most dietary supplement companies do comply and reliably produce quality products.
The list of dietary supplement manufacturers and product lines is vast and sales are growing exponentially, making oversight even more difficult for chronically overstretched FDA inspectors. None of this should reassure already confused consumers trying to confidently make intelligent purchasing decisions.
Fringe Hucksters and Quacks Abound
Though most dietary supplement companies do comply and reliably produce quality products, there are a handful of unscrupulous manufacturers who, sadly, will continue to skirt legal requirements and market inferior products as long as they’re able to avoid the scrutiny of the FDA.
We know that the FDA cannot possibly test every dietary supplement (literally tens of thousands) or audit every manufacturer, but, thankfully, scores of dodgy manufacturers have been reported to the agency since the Dietary Supplement Health and Education Act (DSHEA) went into effect in 1994.
These unprincipled manufacturers produce dubious products. They may bring items to market that contain botanicals, mostly coming from China and often comprising high levels of pesticides. Other supplements have been found to be contaminated with feces and urine due to poor quality manufacturing standards. Also, there have been instances of performance-enhancing powders and supplements testing positive for anabolic steroids and other pharmaceutical agents and even dozens of additional products shown not to include the ingredients or amount of ingredients claimed on the label. Finally, a decade ago researchers tested several Ayurvedic remedies in a health food store in Boston finding that 20 percent contained potentially dangerous levels of mercury, arsenic and lead.
Then there’s whole different body of concerns pertaining to the serious problem presented by some herb/drug combinations and contraindications caused by several natural agents. However, while there are plenty of reasons to be highly concerned about dietary supplements, it’s critically important to keep this all in context. While the fringe elements and bad players should not be tolerated, we should keep in mind that the volume of adverse effects reported for natural products is miniscule compared to pharmaceuticals, purported to take over 100,000 American lives each year.
Responsible and Quality-Directed Manufacturers
Clearly, the reputation of an entire industry has been tainted by some bad players manufacturing and marketing inferior and sometimes dangerous products. However, there are many companies selling carefully sourced products containing high-quality ingredients. These trustworthy companies meet sound manufacturing processes and include third party certificates of cGMP compliance on their labels.
Companies including Ayush Herbs, Bio-Tech, BioClinic Naturals, Carlson, Designs For Health, Gaia Herbs, Genestra, Heel, Innate Response, Jarrow, Douglas, Klarie Labs, Metagenics, Integrative Therapeutics, Life Extension, Nordic Naturals, Thorne Research, Perque, Protcol for Life, NOW, Pure Encapsulations, XYMOGEN, Vital Nutrients, Kirkman Labs, and New Chapter, are among a growing group of natural product enterprises that are manufacturing and marketing high-quality pharmaceutical grade food-based products meeting stringent content and purity verification processes.
Clinics, community and hospital-based systems (including academic medical centers) should be working with these manufacturers to create in-house natural product dispensaries to further strengthen and evolve their integrative medicine service lines. Several of these companies also manufacture private label products for select retailers and physician offices. These elite ‘quality-first’ nutraceutical companies have been in the business for decades, effectively and consistently supporting the health of millions of consumers around the world.
Chain and Big Box Retailers
Unfortunately, price trumps quality for most consumers when it comes to dietary supplements. Price-conscious buyers patronizing retailers or e-tailors such as GNC (General Nutrition Center), Vitamin Shoppe, Costco, Vitacost and CVS may be purchasing brands featuring low potencies and/or containing synthetic agents that happen to be well-sourced and considered safe but are not likely on par in terms of quality and bioavailability (potential level of nutrient absorption into the bloodstream) with some higher quality manufacturers.
The ‘Oz Effect’ Sows Consumer Confusion
I like Dr. Mehmet Oz. He’s a brilliant, well-intentioned man and a true friend of integrative health. Through his significant television and web media platforms, he’s educated millions of consumers on the profound power of lifestyle and behavioral change.
But I do find something very troubling with Oz and several other (i.e. Dr. Joseph Mercola) integrative-directed nutrition gurus with large followings: they seem to loudly recommend and tout the amazing healing effects of a new product or dietary supplement every single day. Consumers are constantly hearing “buy this”, “take that”!
According to retailer reports, the ‘Oz Effect’ is huge, almost Oprah-like, causing products to fly off shelves practically overnight. I believe this is a huge disservice to viewers of the Dr. Oz show. I’ll tell you why.
Drs. Oz and Mercola, and scores of dietary supplement manufacturers, physicians, media personalities and nutritionists, are creating an epidemic of expensive urine!
Celebrity physician media endorsements foment massive consumer confusion regarding dietary supplements. Again, people should get the bulk of their nutrition through food by eating a clean plant-strong diet featuring low glycemic intake, lean protein and plenty of hydration. By consuming a colorful rainbow of fruits and vegetables, one should get adequate amounts of disease fighting phytonutrients, vitamins and minerals. However, most of us, try as we may, are incapable of meeting our optimal nutritional needs through food alone, bringing us to the next fact.
The future of Personalized Nutrition is Well-Placed Quality Nutraceuticals Based on Actual Biological Need
Some people do have specific nutritional deficiencies. Others are simply unable to absorb essential nutrients. Many can benefit from high quality supplementation … IF they truly know what their bodies need!
Proper individual assessment is vital to maximizing the effectiveness of dietary supplementation. Simple blood tests can check vitamin and nutrient levels. Other nutritional lab work, often covered by insurance payers, can look at glycemic levels and myriad additional biomarkers such as inflammation and free radical (pro-oxidative stress) levels.
In the hands of a qualified healthcare provider, i.e. naturopathic doctor, integrative medicine physician or functional medicine physician, proper assessment of these biochemical markers can more accurately inform a range of dietary and supplement recommendations. All of this is tightly aimed at creating a biological milieu of properly balanced biomarkers and nutrient levels, thus genuinely making one less susceptible to a number of chronic diseases.
By repeating these labs at appropriate intervals and undergoing a thorough symptom assessment from a qualified provider, supplementation recommendations can be adjusted and dosing titrated based on actual data instead of guesswork.
This process forms the basis of naturopathic medicine and underpins functional medicine. Naturopathic, integrative and functional medicine focus on the causation of disease—the underlying deficits that cause so much chronic disease and the flurry of associated symptoms that typically drive patients to their doctors. Proper assessment removes the guesswork regarding dietary supplementation.
Natural Agents and Intellectual Property: The Reality.
The natural ingredients contained in dietary supplements cannot be protected as intellectual property. If a formulator or manufacturer has a unique delivery system or attaches a distinctive group of agents to an already protected product or agent, intellectual property protection can be sought through the process of submitting a provisional and, later, a utility patent application. A quality utility patent can run $25,000 or more in fees. Importantly, there is no guarantee preventing another entity from creating a similar but slightly different formulation and securing its own patent protection! As long as natural agents cannot be adequately protected as intellectual property—leaving little incentive for manufacturers to spend large sums of money on extensive quality research—most investigation of dietary supplements will continue to emanate from academic centers and the federal government.
• A balanced healthy diet should always provide the foundation of human nutrition.
• Dietary supplements can be helpful, harmful or just a plain waste of money, depending on product quality, usage and actual need.
• Before starting a dietary regimen that includes supplementation, consumers are best served by seeking guidance from a trained integrative, functional or naturopathic doctor and undergoing a proper assessment to determine actual nutritional need.
• Research designs originally created to test pharmaceutical agents in isolation are not always effective when studying the efficacy of dietary supplements.
• There are quality manufacturers doing terrific work, fringe companies selling inferior and/or tainted products and large retail chains selling synthetically derived nutritional products with limited bioavailability. Consumers need to be made aware of these differences and encouraged to take a closer look at options.