For those who have read what I have previously written about probiotics, you’ll know that I am cautiously optimistic about their potential usefulness as a medical therapy, despite the tendency towards overstating the results of the limited clinical trials so far done in veterinary species. The theoretical principle, that administering living organisms orally can have beneficial effects on the GI tract and, potentially, systemically, is certainly reasonable. And there is clinical evidence supporting benefit in humans for some causes of diarrhea and other GI tract disease. The literature concerning veterinary use is very limited and preliminary, with both possible risks and benefits reported but no clear, indisputable evidence for clinical benefit. Still, I certainly think additional research is warranted, and I do sometimes use some probiotic products in my own patients for antibiotic-associated diarrhea.
However, I have a number of concerns about probiotics. Little is known and less understood about the composition and function of the normal GI flora, and what role, if any, organisms not normally found in the gut can have when given therapeutically is unclear. Independent testing of many probiotic products has also identified serious quality control problems, so it is currently impossible to trust that what you think you are getting is really in many of the commercial probiotics. However, my biggest concern about probiotics is that their widespread acceptance and use goes well beyond what is justified by the available evidence, and this can easily lead to direct harm and even more easily to the kind of indirect harm that comes from substituting unproven remedies for well-demonstrated ones. Exaggerated claims and unscientific, deceptive marketing practices are common in the promotion of such products, and this raises the chances of their doing more harm than good. The assumption of safety and efficacy that is often made about CAM products has certainly proven, in the case of some such products, to be unfounded, with real harm resulting.
One of the most egregious examples of this is a product which I recently looked into after hearing a number of my clients talking about using it in their pets. Primal Defense is marketed by Garden of Life, and the marketing materials are a laundry list of exaggerated and unsupported claims. Some examples:
“Healthy people usually have a ratio of approximately 85% good to 15% potentially harmful organisms in the intestinal tract. In some cases, even those who appear to be well might have an unfavorable ratio as a result of daily exposure to environmental toxins and a modern lifestyle. “
Here we have the usual vague “toxin” gambit, suggesting that normal life is full of poisons that we need their product to protect us from.
” Large scale use of pesticides, herbicides and other chemicals has changed the bacterial balance of the soil. In order to obtain the benefits we historically acquired from consuming foods cultivated in healthy soil, Garden of Life developed a Homeostatic Soil Organism Probiotic Blend utilizing 12 species of beneficial microorganisms.”
The idea that modern agricultural practices can affect soil ecology is pretty obvious. The suggestion that this somehow creates deficiencies in nutrients or human/pet gut ecologies that we need this product to correct is totally manufactured and unsubstantiated in any way.
The very use of the term “Homeostatic” is a bit of pseudoscience marketing, since this term has no recognized meaning with regard to probiotics and was apparently made up just for the purpose of making this product sound “sciency.”
The story, however, gets a lot scarier. The marketing of this product involves a great deal of outright lying and deception. The founder of Garden of Life, Jordan Rubin, was fined by the Federal Trade Commission (FTC) for false advertising in connection with Primal Defense and other product in 2006. This including fabricating claims about clinical research studies to support his product claims. He was also ordered by the Food and Drug Administration (FDA) to desist from making false and unsubstantiated health claims in 2004. Mr. Rubin has also claimed to have several academic credentials, including a NMD (naturopathic medical doctor) and PhD. Both degrees, and other credentials he has claimed, come from unaccredited correspondence schools, one of which was actually ordered to close by the state of Hawaii in 2003 for fraudulent practices.
Marketers of Primal Defense frequently state that there is clinical evidence to support their claims for the product. However, no real clinical trials seem to have been published in any recognized scientific journals. For example, claims are made on a number of websites regarding a clinical trial of Primal Defense supposedly published in the journal Progress in Nutrition (Goldberg, P.A. “Primal Defense Homeostatic Soil Organisms As Applied To Medically Unresponsive Chronic Disease Conditions In Adults” Progress In Nutrition Supplement Volume 4 January 2002). The journal is not listed on PubMed, Science Citation Index Expanded, or any other resources listing legitimate scientific journals. The accusation has been made that it is a fake journal funded by Garden of Life, but I cannot confirm this. In any case, it is clearly not a legitimate peer-reviewed scientific publication, and the author is a chiropractor who seems to publish predominantly in chiropractic journals and newsletters, not real science journals.
A bit more investigation into Mr. Rubin explains pretty clearly his lack of respect for legitimate scientific research or academic credentials. He is the paragon of faith-based medicine whose books, including The Maker’s Diet and Patient Heal Thyself, detail his belief that his own GI disease was cured through a combination of prayer and changes in diet based on “biblical principles.” As he puts it:
“My father had just gotten through telling me he had spoken to an eccentric nutritionist on the phone. My father didn’t want me to get my hopes up so he had investigated the man’s program himself. The nutritionist told my father he believed I was ill because I was not eating the diet of my ancestors, based upon Biblical principles.
When my father told me about all of this, naturally, I was curious…It fit into my belief system. In an effort to start all over, I took myself off all nutritional products and read the Bible to see what people ate thousands of years ago. I also learned that the longest living cultures in the world had one thing in common: they consumed living foods that abounded with beneficial microorganisms.
A few weeks later, I got on a plane, still bound to my wheelchair, and headed for southern California to live closer to the man who would teach me how to eat from the Bible. After integrating into that particular nutritionist’s program some of my own findings about nutrition and health from the Bible I saw some improvement…During my forty days and nights of parking my motor home close to the beach, I prayed, listened to music and planned everything around buying, preparing and eating my food…The combination of the Biblical diet and the HSOs had restored my health.”
The use of science to try and justify Mr. Rubin’s unscientific nutritional theories are pure marketing, taking advantage of the respectability that real science has earned through the results it produces. His approach is ultimately based, as so much CAM is, on personal revelation, and supported primarily through anecdote and testimonial. His books, his Garden of Life company, his Biblical Health Institute, and all the other pieces to his lucrative nutrition business are paradigms of snake oil marketing.
Such a marketing approach can turn a potentially legitimate, if not yet ready for primetime, therapy like probiotics into pure quackery. If you can’t trust Mr. Rubin’s claims about his own credentials or the research evidence behind his products, why should you have any faith in his products themselves, even if they claim to be something potentially useful like probiotics? CAM marketers like to attack the honesty and ethics of mainstream medical product manufacturers, such as pharmaceutical companies and commercial pet food makers. And all too often, there are real reasons to be skeptical of these industries. But for all that, they have an established, public record of legitimate science behind many of their products, often thanks to vigorous government regulation requiring it. Companies like Garden of Life illustrate why the unregulated supplement industry (aka Big CAM) is not only not entitled to the assumption of better ethics that they often receive, but it quite likely gets away with even more ethically questionable practices than the mainstream medical and diet industries, which are at least better supervised and regulated. I do not often feel justified in prescribing probiotics, but when I do I certainly have no intention of using a product such as Primal Defense marketed by a man who not only bases clearly unscientific advice and products on personal divine revelation but who seems to have no discomfort promoting his ideas and products with obvious and egregious deceit.